L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

København den 06.03.2023

British American Tobacco Denmark A/S

Bernstorffsgade 50

1577 Copenhagen V

Denmark

Tel + 45 39 55 63 00

CVR 13801134

www.bat.com

British American Tobacco Denmark A/S takker for muligheden for at afgive høringssvar på høringen

vedrørende;

Udkast til forslag til lov om ændring af lov om tobaksvarer (Implementering af dele af

delegeret direktiv vedrørende opvarmede tobaksvarer m.m.)

Med venlig hilsen

Anders Preben Burlund

Government Affairs Manager

British American Tobacco Denmark A/S

British American Tobacco Denmark A/S (House of Prince)| Bernstorffsgade 50

–

1577 Copenhagen V

–

Denmark - CVR 13801134 | A member of the British American Tobacco Group

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

BRITISH AMERICAN TOBACCO DENMARK A/S & NICOVENTURES TRADING

LIMITEDS SVAR TIL SUNDHEDSMINISTERIET

KOMMENTARER ANG. NATIONAL IMPLEMENTERING AF DELEGERET DIREKTIV

OM OPVARMEDE TOBAKSVARER OG ANDEN REGULERING AF NIKOTIN- OG

RØGFRI TOBAKSVARER

LOVFORSLAGET OM ÆNDRING AF LOVEN OM TOBAKSVARER M.V., LOVEN

OM ELEKTRONISKE CIGARETTER M.V., LOVEN OM RØGFRI MILJØER OG

DIVERSE ANDRE LOVE.

6 MARTS 2023

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

INTRODUKTION

............................................................................................................ 3

SAMMENFATNING

........................................................................................................ 5

DET DELEGEREDE DIREKTIV OVERSKRIDER PÅ ULOVLIG VIS DE

DELEGEREDE BEFØJELSER

...................................................................................... 6

DEFINITION OG KLASSIFICERING AF THP

............................................................. 14

SUNDHEDSMÆSSIGE KONSEKVENSER VED IMPLEMENTERING AF

DET DELEGEREDE DIREKTIV

................................................................................... 17

ALDERSKONTROL VED KØB

.................................................................................... 18

KONKLUSION

.............................................................................................................. 18

1.1

INTRODUKTION

Dette anbringende fra British American Tobacco Denmark A/S (driver også virksomhed under

navnet House of Prince A/S) ("BAT

Denmark")

og Nicoventures Trading Limited

("Nicoventures") (dette "Svar") reagerer på en høring om udkastet til lovforslaget om

ændring af loven om tobaksvarer m.v., loven om elektroniske cigaretter m.v., loven om forbud

mod salg af tobak og alkohol til personer under 18 år og loven om røgfri miljøer (under ét,

"Lovforslag").

Dette dokument reagerer især på den foreslåede implementering af det delegerede direktiv

2022/2100/EU af 29. juni 2022 ("Delegeret

direktiv")

vedrørende opvarmede tobaksvarer

("THP'er") i dansk lovgivning samt visse forslag vedrørende alderskontrol for køb af

tobaksvarer og nikotinprodukter.

BAT Denmark og Nicoventures er medlemmer af koncernen British American Tobacco

("BAT"). Nicoventures er involveret i udviklingen og kommercialiseringen af BAT's udvalg af

alternative tobaksvarer og nikotinprodukter. BAT's hovedfokus var historisk set traditionelle

tobaksvarer, men koncernen fokuserer i stigende grad på udvikling og kommercialisering af

ikke-brændbare alternativer til konventionelle cigaretter til voksne rygere, der ellers ville

fortsætte med at ryge. Dette omfatter udvikling og salg af THP'er både globalt og inden for

EU, herunder i Danmark. BAT Denmark er ansvarlig for distribution af BAT's THP'er i

Danmark.

BAT Denmark og Nicoventures omtales samlet som "BAT" nedenfor.

Det delegerede direktiv

Det delegerede direktiv ændrer og supplerer direktiv 2014/40/EU af 3. april 2014

("Tobaksvaredirektivet" eller "TPD") og blev offentliggjort af Europa-Kommissionen

("Kommissionen") i EU-Tidende d. 3. november 2022. Det delegerede direktiv ændrer artikel

7, stk. 12 i tobaksvaredirektivet således:

"Andre tobaksvarer end cigaretter og rulletobak samt opvarmede tobaksvarer er undtaget fra

forbuddene i stk. 1 og 7. Europa-Kommissionen kan vedtage delegerede retsakter i

overensstemmelse med artikel 27 med formål at kunne trække denne undtagelse tilbage for

en bestemt produktkategori, hvis der sker en væsentlig ændring i forholdene som fastsat i en

rapport fra Kommissionen.

1.2

1.3

1.4

1.5

1.6

Europa-Parlamentets og Rådets direktiv (EU) af 29. juni 2022 om ændring af Europa-Parlamentets og

Rådets direktiv 2014/40/EU om ophævelse af visse undtagelser for opvarmede tobaksvarer, C(2022)

4367 findes her:

https://eur-lex.europa.eu/legal-content/DA/TXT/PDF/?uri=CELEX:32022L2100&from=EN

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

I første afsnit forstås ved "opvarmet tobaksvare" en ny kategori af tobaksvarer, der opvarmes

for at frembringe en emission indeholdende nikotin og andre kemikalier, som derefter

inhaleres af brugeren/brugerne, og som afhængigt af deres karakteristika er røgfrie

tobaksvarer eller røgtobak."

1.7

Som følge heraf gør det delegerede direktiv følgende gældende:

1.7.1

1.7.2

Opretter en ny produktkategori, der ikke var forudset i tobaksvaredirektivet og derfor

ikke blev defineret herunder, dvs. et "opvarmet

tobaksprodukt";

Fjerner samtidig for denne nye produktkategori undtagelsen fra forbuddet mod at

markedsføre tobaksvarer med en kendetegnende aroma (artikel 7, stk. 1 i

tobaksvaredirektivet) eller tobaksvarer, der indeholder aromastoffer i deres

bestanddele (artikel 7, stk. 7 i tobaksvaredirektivet).

1.8

Det delegerede direktiv ændrer også artikel 11, stk. 1 i tobaksvaredirektivet, og fjerner

dermed muligheden for, at medlemsstaterne undtager THP'er til rygning fra forpligtelsen til at

bære informationsmeddelelsen og kombinerede sundhedsadvarsler (artikel 9, stk. 2 og 10 i

tobaksvaredirektivet). Med andre ord fordrer det delegerede direktiv, at medlemsstaterne

stiller disse krav for THP'er til rygning.

Det delegerede direktiv blev vedtaget på grundlag af delegerede beføjelser, som er tildelt

Kommissionen i artikel 7, stk. 12, og artikel 11, stk. 6 i tobaksvaredirektivet for at fjerne

ovennævnte undtagelser for etablerede kategorier af tobaksvarer, når der indtræffer en

"væsentlig

ændring i forholdene".

Eksistensen af denne "væsentlige

ændring i forholdene"

beror på, at Kommissionen kan påvise, at visse økonomiske fakta/betingelser er til stede,

herunder at markedsandelen for THP'er er over 2,5 % af det samlede salg af tobaksvarer i

EU. I rapporten, der blev vedtaget den 15. juni 2022 ("Kommissionens

rapport"),

hævder

Kommissionen, at den har fastslået, at disse økonomiske fakta/betingelser er til stede.

Den 16. november 2022 indgav Nicoventures og andre BAT-enheder en ansøgning om

ophævelse af det delegerede direktiv ved EU-Domstolen ("EU-Domstolen").

Den 13.

december 2022 anfægtede Nicoventures og andre BAT-forretningsenheder også indirekte

det delegerede direktiv over for High Court of Ireland og indgav en anmodning om at få sagen

indbragt ved EU-Domstolen.

Begge disse sager er igangværende.

Lovforslaget

Lovforslaget foreslår implementering af det delegerede direktiv ved:

1.12.1

1.12.2

Indsættelse af en ny definition af THP'er i § 2, stk. 31 i loven om tobaksvarer m.v.

Ændring af §§ 14, 15 og 16 i loven om tobaksvarer m.v. for at inkludere THP'er i de

eksisterende forbud mod markedsføring af tobaksvarer med en kendetegnende

aroma eller tobaksvarer, der indeholder aromastoffer i deres bestanddele.

1.9

1.10

1.11

1.12

1.13

Som forklaret nærmere i dette svar mener vi, at det delegerede direktiv er ugyldigt i henhold

til EU-lovgivningen og derfor ikke bør implementeres i den danske lovgivning

–

og bestemt

ikke så længe de ovennævnte igangværende retssager vedr. det delegerede direktiv endnu

ikke er afgjort ved domstolene. Vi mener også, at de forslag, der implementerer det

delegerede direktiv, med større sandsynlighed vil skade folkesundheden end at gavne den.

Rapporten fra Kommissionen, der fastslår en væsentlig ændring af forholdene for opvarmede tobaksvarer

i overensstemmelse med direktiv 2014/40/EU, COM(2022) 279 af 15. juni 2022, findes her:

https://ec.europa.eu/transparency/documents-register/detail?ref=COM(2022)279&lang=en=en

Sag T-706/22, offentliggjort i EU-Tidende den 16. januar 2023, se her:

https://eur-lex.europa.eu/legal-

content/EN/TXT/?uri=CELEX%3A62022TN0706&qid=1673874316710

Fortegnelse nr. 2022/1085 JR

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

1.14

Lovforslaget indeholder også tydeliggørelse af kravene til alderskontrol ved salg af

tobaksvarer og nikotinprodukter både på fysiske salgssteder og online. Som forklaret

nedenfor støtter vi disse tiltag fuldt ud.

SAMMENFATNING

BAT er imod den foreslåede implementering af det delegerede direktiv af følgende grunde:

2.1.1

Kommissionen har ulovligt overskredet omfanget af de delegerede beføjelser, som

den er blevet tillagt. I særdeleshed:

(A)

Ved at regulere en ny kategori af tobaksvarer, dvs. THP'er, som aldrig er

blevet taget i betragtning af EU-lovgiveren, behandler det delegerede

direktiv et "væsentligt

element"

i betydningen jf. artikel 290, stk. 1, i traktaten

om Unionens funktionsmåde ("TEUF"), som ikke kunne været blevet

delegeret til Kommissionen. Bekymringen blev rejst af fire medlemslande,

da Kommissionen første gang kom med et udkast til det delegerede

direktiv,

og det indrømmes i al væsentlighed i Kommissionens

Begrundelse, der ledsager det delegerede direktiv.

Det delegerede direktiv introducerer en ny "særlig

produktkategori"

henhold til tobaksvaredirektivet, dvs. THP'er, det overskrider

Kommissionens delegerede beføjelser og krænker de generelle EU-

lovprincipper om retssikkerhed og legitime forventninger. Kommissionen

har kun beføjelse til at ændre reglerne for en eksisterende produktkategori.

Den kan ikke oprette en ny produktkategori.

Den nye "særlige

produktkategori",

der introduceres af det delegerede

direktiv, er ikke i overensstemmelse med systemet for tobaksvaredirektivet.

Det er ikke muligt, at THP'er på samme tid er en "ny

kategori af tobaksvarer"

"særlig

produktkategori"

og omfatter både "røgfri

tobaksvarer"

"røgtobak", da disse er gensidigt udelukkende.

Kommissionens tilgang til vurdering af tilstedeværelsen af en "væsentlig

ændring i forholdene"

er behæftet med fejl og overskrider den tekniske

opgave, der er delegeret til den, især fordi den vurderer markedsandele på

"antal

cigaretter"

i modsætning til tobaksvægten, til trods for at en enkelt

opvarmet tobakspind kun indeholder ca. halvt så meget tobak som en

cigaret.

2.1

(B)

(C)

(D)

2.1.2

Det delegerede direktiv er derfor ugyldigt i henhold til EU-lovgivningen og bør ikke

overføres til den danske lovgivning,da enhver lov der implementerer det Delegerede

directiv ind i gældende dansk lov, vil være ugyldig. Især ikke givet de forhold, hvor

det delegerede direktiv er genstand for igangværende retssager.

2.2

Såfremt Sundhedsministeriet

–

uanset ovenstående

–

mener, at det bør fortsætte med at

overføre det delegerede direktiv til dansk lovgivning, mener vi

–

uden at det berører

ovenstående punkter

–

at Sundhedsministeriet bør anvende et passende sprog til at definere

THP'er og anerkender forskellen mellem røgfri tobaksvarer og røgtobak, og at de skærpede

mærkningskrav i artikel 9, stk. 2 og artikel 10 i tobaksvaredirektivet alene gælder for THP'er

det omfang, de er røgtobak".

18. møde i gruppen af eksperter i tobakspolitik den 9. februar 2022 kan ses her

https://ec.europa.eu/transparency/expert-groups-

Stk. 2 i Begrundelsen, der ledsager Europa-Parlamentets og Rådets direktiv (EU) .../... om ændring af

Europa-Parlamentets og Rådets direktiv 2014/40/EU om ophævelse af visse undtagelser for opvarmede

tobaksvarer, C(2022) 4367 endelig udgave af 29. juni 2022, findes her:

https://data.consilium.europa.eu/doc/document/ST-10815-2022-INIT/en/pdf

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

2.3

Implementering af det delegerede direktiv i lovforslag vil sandsynligvis have en negativ

indvirkning på folkesundheden. I særdeleshed:

2.3.1

2.3.2

De førende sundhedsmyndigheder har anerkendt den reducerede risikoprofil for

THP'er sammenlignet med brændbare tobaksvarer.

De foreslåede aromabegrænsninger vil påvirke voksne rygere negativt og vil

sandsynligvis medføre utilsigtede konsekvenser, da en reduktion af

forbrugerudvalget af ikke-brændbare produkter kan føre til, at voksne genoptager

rygning eller opsøger det uregulerede ulovlige marked, hvis deres foretrukne

smagsstoffer ikke længere er til rådighed.

Ved at anvende regler på THP'er, der er møntet på brændbare tobaksvarer,

formidles det vildledende budskab, at de risici, der er forbundet med THP'er, er de

samme som dem, der er forbundet med indtagelse af brændbare tobaksvarer. Det

har den virkning, at brugen af mere farlige brændbare tobaksvarer bibeholdes, og

det undergraver deres potentiale til at reducere skader som følge af tobaksrygning.

I sidste ende vil en ubalanceret lovgivning forhindre THP'er i at opnå deres

potentiale for at reducere tobaksskader.

2.3.3

2.3.4

2.4

På baggrund af ovenstående, og hvis Sundhedsministeriet vælger at overføre det delegerede

direktiv til dansk lovgivning, bør det vente med at gøre det til den senest mulige dato (dvs. 23.

juli 2023).

BAT støtter de foreslåede præciseringer af kravene til alderskontrol ved salg af tobaksvarer

og nikotinprodukter ved køb.

DET DELEGEREDE DIREKTIV OVERSKRIDER PÅ ULOVLIG VIS DE DELEGEREDE

BEFØJELSER

Lovvalg

Artikel 290, stk. 1 i TEUF indeholder følgende (understregning tilføjet):

"Kommissionen

kan i en lovgivningsmæssig retsakt få delegeret beføjelse til at vedtage

almengyldige ikke-lovgivningsmæssige retsakter, der supplerer eller ændrer visse ikke-

væsentlige bestemmelser i den lovgivningsmæssige retsakt.

De lovgivningsmæssige retsakter afgrænser udtrykkeligt delegationens formål, indhold,

omfang og varighed. De væsentlige bestemmelser på et område er forbeholdt den

lovgivningsmæssige retsakt og kan derfor ikke være omfattet af delegation."

2.5

3.1

3.2

3.3

I henhold til EU-Domstolens retspraksis er et element "væsentligt" i betydningen af den anden

sætning i artikel 290, stk. 1 i TEUF, såfremt det fordrer politiske valg der falder inden for EU-

lovgivningens ansvarsområder, fordi det kræver, at de pågældende modstridende interesser

skal afvejes ud fra en række vurderinger. Der skal endvidere tages hensyn til det pågældende

felts karakteristika og særlige egenskaber.

EU-domstolens retspraksis fastslår endvidere, at de delegerede beføjelser skal være præcist

afgrænset i den lov, der tildeler de delegerede beføjelser, og at afgrænsningerne ikke kan

overlades til Kommissionens eget skøn. Dette princip er formuleret således i Kommissionens

egne retningslinjer om delegerede love:

"Lovgiveren skal udtrykkeligt og præcist beskrive de

beføjelser, den har til hensigt at delegere til Kommissionen"

"upræcise formuleringer [...]

er ikke mulige.

" Derfor skal Kommissionens beføjelser fastslås og fortolkes præcist, ikke

upræcist, og fortolkes på omfattende vis.

3.4

Delegerede love

–

Vejledning til Kommissionens tjenester, 24. juni 2011, SEC(2011) 588, stk. 52 findes

her:

https://ec.europa.eu/transparency/documents-register/detail?ref=SEC(2011)855&lang=en

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

3.5

3.6

Ved at regulere ny kategori af tobaksvarer regulerer Kommissionen et "væsentligt

element" og træffer ulovlige politiske valg

Som det fremgår af selve det delegerede direktiv, er THP'er "nye

kategorier af tobaksvarer"

henhold til artikel 2, stk. 14 i tobaksvaredirektivet, hvilket betyder, at de er markedsført efter

den 19. maj 2014. THP'er kan derfor ikke betragtes som en af de eksisterende

"produktkategorier" i henhold til artikel 7, stk. 12 og artikel 11, stk. 6 i tobaksvaredirektivet.

EU-lovgiveren kunne ikke på lovlig vis have delegeret beføjelser til Kommissionen til at

regulere en ny kategori af tobaksvarer. Lovgiveren ville i den forbindelse have delegeret

beføjelserne til at regulere et nyt produkt, som EU-lovgiveren aldrig havde taget i betragtning,

og som havde en helt anden risikoprofil end de etablerede tobaksvarekategorier (se

yderligere i afsnit [4.16-4.20] nedenfor). Ifølge enhver analyse omfatter dette politiske valg

hinsides de "ikke-væsentlige

elementer",

der kan behandles via delegeret lovgivning.

Fire medlemsstater gjorde tobaksekspertgruppen opmærksom på dette, da Kommissionen

udgav første udkast til det delegerede direktiv.

I henhold til disse medlemsstater gælder der

følgende for det delegerede direktiv:

3.8.1

3.8.2

"har en dybdegående indvirkning på området med opvarmede tobaksvarer"

introducerer en

"kompleks og omfattende reform";

"overskrider den delegerede beføjelse i henhold til direktiv 2014/40/EU og omfatter

væsentlige elementer, der er forbeholdt de europæiske lovgivere".

3.7

3.8

3.9

3.10

Kommissionen har aldrig reageret på denne bekymring

–

hverken i tobaksekspertgruppen

eller i Begrundelsen, der ledsager det delegerede direktiv.

Som nævnt ovenfor fordrer den etablerede retspraksis, at der ved vurderingen af, om et

element er "væsentligt", skal tages hensyn til det "pågældende

felts karakteristika og særlige

egenskaber".

I den forbindelse skal det bemærkes, at artikel 168, stk. 5, i TEUF udtrykkeligt

udelukker

"nogen form for harmonisering"

med hensyn til

"beskyttelse af folkesundheden i

forbindelse med tobak",

hvilket tydeligt påpeger nye kategorier af tobaksvarers "væsentlige"

karakter. Denne begrænsning af EU's beføjelser kræver, at delegerede beføjelser på dette

område ikke kan fortolkes i bredt omfang. Selvom vi har forståelse for, at artikel 114 i TEUF

er det retsgrundlag, der anvendes for tobaksvaredirektivet, ville det være højst

bemærkelsesværdigt, hvis Kommissionen i kraft af en delegeret lov kunne påvirke en

medlemsstats evne til at godkende salg af visse tobaksvarer med nedsatte risikoprofiler (i

forhold til cigaretter) som et instrument i en folkesundhedspolitik. Hvis dette var muligt, ville

en sådan traktats sikkerhedsforanstaltning i henhold til medlemsstaternes kompetence være

værdiløs.

Konklusionen om, at indførelsen af nye regler for nye produkter ikke kan ske ved delegeret

handling, fremgår ligeledes af ordlyden af artikel 7, stk. 12, og artikel 11, stk. 6 i

tobaksvaredirektivet, der fastslår, at de delegerede beføjelser kan benyttes til "en

bestemt

produktkategori".

Begrebet "bestemt

produktkategori",

som anvendes i artikel 7 i tobaksvaredirektivet, svarer til

de veletablerede "kategorier", der er anført i artikel 2, stk. 14, litra a), i tobaksvaredirektivet.

Denne bestemmelse definerer "ny

kategori af tobaksvarer"

som ethvert tobaksprodukt:

3.12.1

3.12.2

bortset fra "cigaretter,

rulletobak, pibetobak, vandpibetobak, cigarer, cigarilloer,

tyggetobak, tobak der indtages nasalt eller tobak der indtages oralt",

som

også er "nyt", dvs. det er første gang markedsført efter 19. maj 2014.

3.11

3.12

3.13

I medfør af tobaksvaredirektivets klare ordlyd skal begrebet "bestemt

produktkategori"

derfor

opfattes særskilt fra begrebet "ny

kategori af tobaksvarer".

Disse er gensidigt udelukkende

18. møde i gruppen af eksperter i tobakspolitik den 9. februar 2022

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

produktgrupper, da artikel 2, stk. 14 udtrykkeligt definerer "ny kategori af tobaksvarer" som

modsætningen til "særlige

produktkategorier".

3.14

Dette bekræftes yderligere af artikel 28, stk. 2 i tobaksvaredirektivet, som opremser de

elementer, som Kommissionen skal være særlig opmærksom på i sin rapport om

anvendelsen af tobaksvaredirektivet. Artikel 28, stk. 2 skelner mellem markedsudviklinger

vedrørende nye kategorier af tobaksvarer (artikel 28, stk. 2, litra b)) og markedsudviklinger,

der udgør en væsentlig ændring i forholdene (artikel 28, stk. 2, litra c)). Dette understreger

igen tydeligt, at nye kategorier af tobaksvarer adskiller sig fra produktkategorierne i artikel 7,

stk. 12 og artikel 11, stk. 1 i tobaksvaredirektivet, og som er underlagt de delegerede

beføjelser.

Det bekræftes yderligere af prøven i artikel 28, stk. 2 i tobaksvaredirektivet på, om der er sket

en "væsentlig

ændring i forholdene".

Den første alternative betingelse for at tale om en

væsentlig ændring i forholdene er, at salgsmængderne for produktkategorien er steget med

mindst 10 % i mindst fem medlemslande. Men for nye kategorier af tobaksvarer som f.eks.

THP'er vil startniveauet pr. definition være nul, hvilket gør det matematisk umuligt at fastslå

en stigning på 10 %. Selv hvis man ignorerer denne matematiske virkelighed ved at tage

udgangspunkt i et tidspunkt kort efter lanceringen af den nye kategori af tobaksvarer på

markedet, vil enhver beregning, der tager udgangspunkt i et meget lavt grundtal, resultere i

enorme procentstigninger, selv om stigningen i absolutte tal er meget begrænset. Det gør

denne betingelse praktisk talt ubrugelig. Dette fremgår af Kommissionens rapport, der

angiveligt viser stigninger på over 999 % i salget af THP i visse medlemslande beregnet ud

fra meget lave grundværdier i 2018.

Det er absurd, og det kan ikke have været hensigten

med EU-lovgivningen.

Denne fortolkning bekræftes også af tobaksvaredirektivets lovhistorik. I Begrundelsen til

Kommissionens forslag til tobaksvaredirektivet står der:

"Nye kategorier af tobaksvarer er produkter, der indeholder tobak, som ikke falder inden for

nogen af de etablerede produktkategorier (f.eks. cigaretter, rulletobak, pibetobak,

vandpibetobak, cigarer, cigarilloer, tyggetobak, tobak der indtages nasalt eller tobak der

indtages oralt), og som introduceres på markedet efter direktivets ikrafttræden. [...]

(understregning tilføjet)

3.17

Konklusionen er klar. Den delegerede beføjelse i artikel 7, stk. 12, og artikel 11, stk. 6,

påtænker, at Kommissionen kan fjerne visse undtagelser, hvis nogle af de etablerede

kategorier skulle nå et vist salgsniveau hos forbrugere, som udløser tærsklen

for

"væsentlig

ændring i forhold"

som defineret i artikel 2, stk. 28 i tobaksvaredirektivet, f.eks. cigarilloer eller

cigarer. Som fordret af artikel 290, stk. 1 i TEUF blev den politiske beslutning om at fjerne

disse undtagelser i tilfælde af øget salg af disse etablerede kategorier i forhold til andre

tobaksvarer (dvs. det væsentlige element) taget af EU-lovgiveren ved optagelse af

tobaksvaredirektivet. Den delegerede beføjelse defineres også præcist af lovgiveren som

fordret af artikel 290, stk. 1 i TEUF. Denne delegerede beføjelse kan dog ikke anvendes til at

regulere nye produkter, som lovgiveren aldrig specifikt har taget i betragtning

–

som ikke er

en "særlig

produktkategori"

i henhold til artikel 7, stk. 12, og artikel 11, stk. 6 i

tobaksvaredirektivet

–

og som har en fundamentalt forskellig risikoprofil fra de etablerede

tobaksvarekategorier.

Begrundelsen, der ledsager det delegerede direktiv, indeholder meget lignende argumenter:

"Artikel

7, stk. 12, og artikel 11, stk. 6, i direktiv 2014/40/EU giver ikke Kommissionen

nogen skønsmargen, men giver Kommissionen den tekniske opgave at fastslå, om der er

3.15

3.16

3.18

Kommissionens rapport, tabel 1.

Punkt 3.6 i Begrundelse til forslag til Europa-Parlamentets og Rådets direktiv om tilnærmelse af

medlemsstaternes love, forordninger og administrative bestemmelser vedrørende fremstilling,

præsentation og salg af tobak og relaterede produkter, KOM(2012)788 endelig udgave af 19.12.2012

findes her:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014L0040

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

sket en væsentlig ændring i forholdene for en bestemt produktkategori, [...]. Den politiske

beslutning om at forbyde markedsføring af tobaksvarer med kendetegnende aromaer med

henblik på at opnå et højt sundhedsbeskyttelsesniveau, især for unge, er allerede foretaget

i medfør af EU-lovgiveren i selve direktiv 2014/40/EU (se også punkt 19 og 26 i

direktivet)."

(understregning tilføjet)

3.19

Det er korrekt, at artikel 7, stk. 12, og artikel 11, stk. 6 ikke tildeler Kommissionen nogen

skønsmargen, men udelukkende den tekniske opgave at fastslå, om der foreligger en

væsentlig ændring i forholdene hvad angår eksisterende produktkategorier. Det er endvidere

korrekt, at eventuelle relevante politiske beslutninger bør anses for at være foretaget af

lovgiveren, navnlig at der for visse kategorier af eksisterende tobaksvarer var mulighed for en

mindre restriktiv ordning.

Dette bekræftes af punkt 19 og 26, som Kommissionens begrundelse, der ledsager det

delegerede direktiv, henviser til, og som siger følgende:

"(19) I betragtning af dette direktivs fokus på unge mennesker, andre tobaksvarer end

cigaretter og rulletobak bør der gøres en undtagelse fra visse krav vedrørende

indholdsstoffer, så længe der ikke sker væsentlige ændringer i forholdene hvad angår

salgsvolumen eller forbrugsmønstre blandt unge mennesker."

"(26) For anden røgtobak end cigaretter og rulletobak, der hovedsageligt forbruges af ældre

forbrugere og mindre dele af befolkningen, bør det være muligt fortsat at gøre en undtagelse

fra visse mærkningskrav, så længe der ikke er væsentlige ændringer i forholdene hvad angår

salgsvolumen eller forbrugsmønstre blandt unge mennesker. [...] For så vidt angår

vandpibetobak, der ofte opfattes som mindre skadelig end traditionel røgtobak, bør den fulde

mærkningsordning gælde for at undgå vildledning af forbrugerne."

3.21

Begrundelsen, der ledsager det delegerede direktiv og punkt 19 og 26, bekræfter, at de

delegerede beføjelser vedrører lovgiverens politiske beslutning om at behandle visse kendte

produktkategorier mindre strengt end andre. Ifølge Kommissionen blev cigaretter og

rulletobak betragtet som attraktive for unge mennesker, og vandpibetobak blev anset for at

kræve særbehandling på grund af påståede, fejlagtige opfattelser af dens skadelige virkning.

De resterende kategorier blev betragtet som "hovedsageligt

indtaget af ældre forbrugere og

små dele af befolkningen."

I betragtning af listen

over "særlige produktkategorier"

i artikel 2,

stk. 14, litra a), og det faktum, at tobak, der indtages oralt, er forbudt i alle medlemsstaterne

med undtagelse af Sverige, er det klart, at lovgiveren havde følgende for øje: pibetobak,

cigarer, cigarilloer, tyggetobak og tobak, der indtages nasalt.

Lovgiveren indarbejdede derefter en sikkerhedsmekanisme, i fald der skulle ske en ændring

i efterspørgslen fra cigaretter og rulletobak til en af disse produktkategorier (dvs. pibetobak,

cigarer, cigarilloer, tyggetobak eller tobak, der indtages nasalt). En sådan delegeret beføjelse

er faktisk af en rent "teknisk" karakter, nemlig at fastslå, om der var sket en "væsentlig

ændring i forholdene"

hvad angår en af disse kategorier. I så fald måtte Kommissionen fjerne

undtagelsen for den pågældende kategori.

Uanset hvordan sagen analyses, ligger det uden for den "tekniske

opgave"

med at anvende

prøven på væsentlig ændring i forhold, når der oprettes en ny produktkategori, som lovgiveren

aldrig har taget i betragtning, og kategorien derefter pålægges de strengeste regler på trods

af den nedsatte risikoprofil i forhold til cigaretter

–

og det er netop hvad det delegerede direktiv

gør. Det indebærer også en betragtelig skønsmargen, og at der træffes valg ift.

sundhedspolitikken. Ifølge Kommissionens egen indrømmelse overskrider det vedtagne

delegerede direktiv derfor de delegerede beføjelser.

3.20

3.22

3.23

Begrundelse, der ledsager det delegerede direktiv, afsnit 2.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

3.24

Det delegerede direktiv indfører ulovligt en ny "bestemt produktkategori" og krænker

dermed også de generelle EU-lovprincipper om retssikkerhed og legitime

forventninger

Selv om det principelt var muligt for Kommissionen at regulere et nyt produkt med en

delegeret beføjelse (hvilket det ikke er), overskrider det delegerede direktiv i væsentlig grad

den beføjelse, der er delegeret til Kommissionen i medfør af artikel 7, stk. 12, og artikel 11,

stk. 6.

Det delegerede direktiv introducerer den nye kategori "opvarmede

tobaksvarer"

tobaksvaredirektivet. Artikel 7, stk. 12 og artikel 11, stk. 6 i tobaksvaredirektivet giver dog kun

Kommissionen mulighed for at fjerne en undtagelse for eksisterende, veletablerede

produktkategorier. De giver ikke Kommissionen mulighed for at oprette en ny "bestemt

produktkategori".

3.25

3.26

Denne fortolkning understøttes af Kommissionens rapport, der blev vedtaget den 20. maj 2021.

3.27

I denne rapport giver Kommissionen udtryk for, at definitionerne i tobaksvaredirektivet

bør

ændres og forbedres, og at tobaksvaredirektivet ikke giver "fleksibilitet

til at definere nye

produktkategorier."

Som forklaret i afsnit [3.8] herover, blev samme opfattelse gentaget af

flere medlemsstater under processen med at indføre det delegerede direktiv, herunder i de

fire medlemslandes fælles erklæring, hvori der stod: "ved

at introducere en definition af

"opvarmede tobaksvarer" (...) overskrider Kommissionen ifølge os grænserne for de

delegeringskompetencer, den er tildelt".

Desuden ville det være ulogisk, hvis Kommissionen nu kunne oprette nye produktkategorier,

som den

retroaktivt

kunne anvende historiske data på for at fastslå en "væsentlig

ændring i

forholdene".

Uanset hvad, hvis oprettelsen af en ny produktkategori skulle være mulig, ville

den retroaktive anvendelse af prøven i sig selv være et separat grundlag for ugyldigheden af

det delegerede direktiv, da dette ville være i strid med principperne om juridisk sikkerhed og

legitime forventninger. Der er intet i tobaksvaredirektivets tekst eller dets lovgivningsmæssige

historik, der antyder, at Kommissionen kan påberåbe sig artikel 7, stk. 12, og artikel 11, stk.

6 for at ændre reglerne for en ny kategori af tobaksvarer og underminere de

investeringsbeslutninger, der træffes i henhold til disse regler. Den retsusikkerhed, der

forårsages af det delegerede direktiv, blev sågar fremhævet af medlemsstaterne i deres

fælles erklæring som nævnt i afsnit [3.8] ovenfor.

Den retroaktive anvendelse af prøven ville også give Kommissionen mulighed for at tage

højde for de historiske data i forbindelse med tilpasning af definitionen af en ny

produktkategori med henblik på at opfylde kriterierne i prøven på en "væsentlig

ændring i

forholdene".

Sagt på en anden måde kan Kommissionen ved at definere en ny

produktkategori på bredere eller smallere vis

–

set i lyset af historiske data

–

indirekte

kontrollere, om der er sket en væsentlig ændring i forholdene. Faktisk synes Kommissionen

at have gjort netop dette i nærværende tilfælde ved at oprette en ny produktkategori, der

omfatter både produkter til rygning og røgfri produkter. Dette har gjort det muligt for

Kommissionen at skabe og regulere en ny produkttype, nemlig opvarmede tobaksvarer til

rygning, som, så vidt BAT ved, ikke findes på EU-markedet og bestemt ikke i mængder, der

3.28

3.29

Rapport fra Kommissionen til Europa-Parlamentet, Rådet, Det Europæiske Økonomiske og Sociale

Udvalg og Regionsudvalget om anvendelsen af direktiv 2014/40/EU om fremstilling, præsentation og salg

af tobak og relaterede produkter, COM(2021) 249 endelig udgave af 20.5.2021 ("Artikel

28-rapport")

findes her:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0249&from=EN

Artikel 28-rapport, fodnote 43.

Artikel 28-rapport, side 12. Se også

bl.a.

med hensyn til opvarmede tobaksvarer erklæringen om, at

tobaksvaredirektivet "ikke

(...) giver fleksibilitet til at håndtere hurtige produktudviklinger".

(side 12).

18. møde i gruppen af eksperter i tobakspolitik den 9. februar 2022

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

ville kunne betegnes som en "væsentlig

ændring i forholdene".

Dette kan ikke være en korrekt

anvendelse af artikel 7, stk. 12, og artikel 11, stk. 6.

3.30

3.31

3.32

Det delegerede direktiv indfører på ulovlig vis en ny "bestemt produktkategori", der

ikke er i overensstemmelse med systemet i tobaksvaredirektivet

Den nye kategori af opvarmede tobaksvarer, der introduceres i det delegerede direktiv, er

også uforenelig med tobaksvaredirektivets system af to årsager.

For det første harmonerer det ikke, at den nye kategori af opvarmede tobaksvarer både er en

ny kategori af tobaksvarer og en "bestemt

produktkategori"

på én og samme tid. Ifølge

betragtning 4 og artikel 1 i det delegerede direktiv er en "opvarmet

tobaksvare"

en "ny

kategori

af tobaksvarer",

som derfor ligger inden for rammerne af den generelle kategori "ny kategori

af tobaksvarer" i henhold til betydningen i artikel 2, stk. 14 i tobaksvaredirektivet. Men som

omtalt ovenfor i afsnit [3.12] er "bestemt

produktkategori"

og ny kategori af tobaksvarer to

grupper, der udelukker hinanden. Derfor kan et produkt aldrig indgå i begge grupper. Det

delegerede direktiv udvisker derfor de forskelle, som lovgiver har fastlagt mellem disse

begreber og produktgrupper, ved uretmæssigt at behandle en ny kategori af tobaksvarer som

en etableret produktkategori.

For det andet omfatter den nye kategori "opvarmede tobaksvarer", som defineret i det

delegerede direktiv, både tobaksvarer, der er "røgfri", og "røgtobak". I tobaksvaredirektivet

skelnes der dog klart mellem røgfri tobaksvarer og røgtobak,

og der opstilles meget

anderledes og mere vægtige mærknings- og emballageregler for sidstnævnte,

hvilket

afspejler deres grundlæggende forskelligartede karakter. Tobaksvaredirektivet indeholder

endvidere udtrykkeligt bestemmelser om, at nye kategorier af tobaksvarer er omfattet af den

ene eller den anden kategori, og i artikel 19, stk. 4, forklares det, at: "Hvilke

bestemmelserne i dette direktiv, der finder anvendelse på nye kategorier af tobaksvarer,

afhænger af, om de pågældende produkter falder ind under definitionen af en røgfri

tobaksvare eller af røgtobak",

og forskellen mellem dem er dermed baseret på eksistensen af

"forbrænding" eller den manglende eksistens deraf,

dvs. afbrænding af tobak og den deraf

følgende frembringelse af røg.

Ifølge tobaksvaredirektivet er det derfor ikke juridisk muligt for en enkelt produktkategori at

omfatte både røgfri tobaksvarer og røgtobak i forbindelse med tobaksvaredirektivet.

Af ovennævnte årsager udgør det delegerede direktivs indførelse af den nye kategori THP'er

en væsentlig overtrædelse af tobaksvaredirektivet, hvilket, i medfør af artikel 290 i TEUF,

naturligvis ikke er en beføjelse, der kunne være blevet delegeret til Kommissionen.

Kommissionens tilgang til vurderingen af eksistensen af en "væsentlig ændring i

forholdene" går ud over omfanget af den opgave, som den er blevet tillagt

Som beskrevet ovenfor undersøges det i Kommissionens rapport, hvorvidt der er sket en

"væsentlig

ændring i forholdene"

i henhold til betydningen i artikel 2, stk. 28, i

tobaksvaredirektivet, og der konkluderes, at den første alternative betingelse og den

nødvendige betingelse begge var opfyldt.

Med hensyn til undersøgelsen af den nødvendige betingelse, dvs. at salgsvolumen af den

relevante produktkategori i detailleddet overstiger 2,5 % af det samlede salg af tobaksvarer

Se definitionerne fra artikel 2, stk. 9, i tobaksvaredirektivet, der definerer røgtobak og røgfri tobaksvarer i

afsnit [4.6-4.7] nedenfor.

De specifikke regler for røgtobak er fastlagt i artikel 9-11 i tobaksvaredirektivet, hvorimod de specifikke

regler for røgfri tobaksvarer er fastlagt i artikel 12 i tobaksvaredirektivet.

Se definitionerne af "røgfri tobaksvarer" og "røgtobak" fra artikel 2, stk. 5, og artikel 2, stk. 9, i

tobaksvaredirektivet i afsnit [4.6-4.7], som afhænger af, om der er tale om en "forbrændingsproces". Se

også definitionen af "urtebaseret rygeprodukt" i artikel 2, stk. 15, i tobaksvaredirektivet, hvor der ligeledes

henvises til, hvorvidt der foregår en "forbrændingsproces".

3.33

3.34

3.35

3.36

3.37

3.38

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

på EU-plan, søges det i Kommissionens rapport på upassende vis at vurdere dette på

grundlag af "cigaretter". I den forbindelse udføres der i Kommissionens rapport en række

komplekse datajusteringer og beregninger. Dette omfatter navnlig:

3.38.1

Der foretages justeringer af dataene for rulletobak, pibetobak og tyggetobak med

henblik på at konvertere dataene for disse produktkategorier til "cigaret"-

ækvivalenter for at kunne sammenligne dem med de andre produktkategorier.

(A)

(B)

Rulletobak konverteres til "cigaretter" baseret på den antagelse, at 0,7 gram

af produktet er lig med én cigaret.

Pibe- og tyggetobak konverteres til "cigaretter" ved at tage markedsandel

af denne produktkategoris detailværdi og anvende denne på den samlede

markedsstørrelse i "cigaretter".

3.38.2

Data fra tre forskellige kilder (herunder en med ikke-officielle kommercielle data)

kombineres på forskellige måder, hvilket resulterer i, at salgsvolumen af opvarmede

tobaksvarer skulle udgøre 3,33 % af alle tobaksvarers samlede salgsvolumen i EU

i 2020.

3.39

Ved at udvikle denne fejlbehæftede og komplekse metodologi og basere sine overvejelser

derpå går Kommissionen ud over omfanget af den opgave, som den er tillagt i henhold til

artikel 7, stk. 12, og artikel 11, stk. 6, i tobaksvaredirektivet, og som, som Kommissionen selv

forklarer i den begrundelse, der ledsager det delegerede direktiv, "[ikke giver] Kommissionen

noget skøn, men lader det være en teknisk opgave at fastslå, om der er sket en væsentlig

ændring i forholdene for en bestemt produktkategori".

Det, som Kommissionen rent faktisk

har gjort, rækker langt ud over en teknisk beregning, der ikke indebærer skøn (som den burde

have været). Kommissionen har udviklet en kompleks metodologi, der indebærer forkerte

valg, der tilsyneladende fører til det ønskede resultat, nemlig en overskridelse af

grænseværdien på 2,5 %.

Grundlæggende set er Kommissionens tilgang til undersøgelsen af de forskellige

produktkategorier udelukkende baseret på "cigaretter" tydeligvis upassende, da dette er et

uanvendeligt grundlag for sammenligning af de forskellige produktkategorier. Eksempelvis er

det ganske enkelt ikke korrekt at sige, at en cigaret plus en cigar er lig med "to

cigaretter";

cigar indeholder tydeligvis langt mere tobak end en cigaret. Ligeledes og helt grundlæggende

set indeholder en cigaret meget mere tobak end en THP, dvs. cirka dobbelt så meget.

Tobaksmængden eller -vægten er selvfølgelig det korrekte kriterium med hensyn til

markedsandelen, da hele formålet med aromaforbuddene i artikel 7, stk. 1, og artikel 7, stk.

7, i tobaksvaredirektivet og dermed det delegerede direktiv (som fjerner undtagelsen fra disse

forbud for THP'er) er at reducere tobaksforbruget.

Som sådan svarer Kommissionens

beslutning om at anvende en beregning baseret på en "cigaret" uden at tage højde for

krystalklare forskelle mellem produkterne med hensyn til den tobaksmængde, som hvert

produkt indeholder, til at sammenligne to vidt forskellige ting.

En beregning baseret på tobaksmængden eller -vægten er derfor den korrekte metode. En

sådan metode ville også have undgået behovet for at bruge flere datasæt og komplekse

beregninger, der indebærer betydelige og problematiske justeringer. Nøjagtige vægtbaserede

Kommissionens rapport, tabel 3 asterisk og fodnote 3.

Kommissionens rapport, tabel 3 dobbelt asterisk og tabel 5 asterisk.

Dataene er hentet fra følgende tre kilder: (i) EU-CEG-data og Euromonitor-data om salg af opvarmede

tobaksvarer i EU (Kommissionens rapport, tabel 2), (ii) Euromonitor-data om samlet salg af tobaksvarer i

EU delt op efter produktkategorier (Kommissionens rapport, tabel 3) og (iii) Sporbarhedsproduktionstal for

cigaretter og rulletobak, både tidsjusterede og ikke-tidsjusterede tal (Kommissionens rapport, tabel 4).

Kommissionens rapport, afsnit 2.2.3.

Begrundelse, der ledsager det delegerede direktiv, afsnit 2.

Tobaksvaredirektivet, betragtning 16.

3.40

3.41

3.42

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

data om alle produktkategorier ville også have været let tilgængelige for Kommissionen i form

af EU-CEG-data.

I Kommissionens rapport nævnes der imidlertid intet om den

vægtbaserede metode, og der angives ikke engang, at en opvarmet tobakspind kun

indeholder omtrent halvdelen af den tobak, der er i en cigaret. Da cigaretter udgør langt

størstedelen af tobaksmarkedet

, hvilket er et spørgsmål om simpel og ligetil matematik,

indebærer dette, at THP'ers markedsandel målt efter vægt vil være omtrent halvdelen af

markedsandelen målt efter "cigaret"-princippet, dvs. omkring 1,65 % i stedet for 3,33 %, og

dermed et godt stykke under grænseværdien på 2,5 %.

3.43

Ved ikke på behørig vis at undersøge og drage konklusioner ud fra de let tilgængelige data

på passende faglig vis (og i stedet for foretage uberettigede metodiske valg for at nå frem til

det resultat, den ønskede at opnå), er Kommissionen ulovligt gået ud over omfanget af den

tillagte opgave og har i bund og grund manipuleret betingelserne for sin brug af de delegerede

beføjelser.

Derudover har Kommissionen ikke givet offentligheden adgang til de underliggende data,

hverken da det delegerede direktiv blev offentliggjort, eller efterfølgende efter anmodning.

Dette har gjort det umuligt at foretage en rigtig undersøgelse af Kommissionens beregninger.

BATs juridiske repræsentanter har anmodet om adgang til disse data samt vægtdata fra EU-

CEG i henhold til forordning (EF) nr. 1049/2001. Imidlertid har Kommissionen afvist disse

anmodninger

på baggrund af fuldstændigt usande påskud, herunder at Kommissionen ikke

"ejede" dataene, og at de derfor tilsyneladende ikke kunne udleveres, og at tilvejebringelse

af dataene af en eller anden grund ville omfatte "oprettelse af et nyt dokument", selv om

dataene allerede var blevet anvendt af Kommissionen selv i forbindelse med dens

beregninger.

Endelig bemærker vi, at Kommissionens rapport også indeholder en alternativ beregning

baseret på Euromonitor-data om det samlede salg af tobaksvarer i EU efter værdi, opdelt efter

produktkategorier, og den lander tilsyneladende på 3,51 %.

Der skal under alle

omstændigheder ses bort fra denne beregning, da en sådan tilgang strider mod selve artikel

2, stk. 28, i tobaksvaredirektivet, hvori det fastlægges, at beregningen skal foretages på

baggrund af "salgsvolumen", ikke "salgsværdi". Derfor vil ethvert forsøg på at retfærdiggøre

det delegerede direktiv med henvisning til denne beregning være i strid med de tildelte

uddelegerede beføjelser.

Det delegerede direktiv er ugyldigt og bør ikke omsættes til dansk national ret

Som det tydeligt fremgår af ovenstående, udgør det delegerede direktiv en ulovlig udøvelse

af Kommissionens delegerede beføjelser. Det delegerede direktiv er derfor ugyldigt i henhold

til EU-retten, og eventuel lovgivning om omsætning af det delegerede direktiv til dansk

national ret vil også være ugyldig.

Som anført i afsnit [1.10] ovenfor anfægtes gyldigheden af det delegerede direktiv derudover

i øjeblikket både for EU-Domstolen og for de irske domstole. Selv om Sundhedsministeriet

mener, at det skal implementere det delegerede direktiv uanset ovenstående argumenter, bør

der under disse omstændigheder anvendes en forsigtig tilgang, og gennemførelse bør ikke

hastes igennem. Vi bemærker, at medlemsstaterne har indtil den 23. juli 2023 til at omsætte

det delegerede direktiv til national lovgivning. Vi opfordrer Sundhedsministeriet til at vente til

3.44

3.45

3.46

3.47

3.48

Blandt de oplysninger, der skal oplyses i EU-CEG-systemet, er den "[samlede] vægt af indholdet af tobak i

én produktenhed i mg" (en produktenhed er en pind eller 1 g for løs tobak) (se Kommissionens

gennemførelsesafgørelse (EU) 2015/2186, bilag, afsnit 3).

Kommissionens rapport, tabel 5.

BATs juridiske repræsentanter har indsendt en ansøgning om annullering af Kommissionens afgørelse

om afslag, som i øjeblikket er under behandling for Retten (ansøgning indgivet den 12. september 2022,

Herbert Smith Freehills v Kommissionen, T-570/22).

Kommissionens rapport, afsnit 2.2.4.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

sidste øjeblik med at gennemføre direktivet, således at der muligvis først kan blive afsagt en

EU-dom om det delegerede direktivs gyldighed forud for omsætningen.

4.1

DEFINITION OG KLASSIFICERING AF THP

Som nævnt ovenfor mener vi ikke, at Sundhedsministeriet på nuværende tidspunkt bør

omsætte det delegerede direktiv til dansk ret. Hvis Sundhedsministeriet går videre med

omsætningen, mener vi dog, at det foreslåede sprog i lovforslaget er egnet til at definere

THP'er.

Det delegerede direktiv indsætter følgende i artikel 7, stk. 12, i tobaksvaredirektivet:

første afsnit forstås ved »opvarmet tobaksvare« en ny kategori af tobaksvarer, der

opvarmes for at frembringe en emission indeholdende nikotin og andre kemikalier, som

derefter inhaleres af brugeren/brugerne, og som afhængigt af deres karakteristika er røgfri

tobaksvarer eller røgtobak."

(det understregede er blevet tilføjet).

4.3

4.4

Ifølge det delegerede direktiv findes der to typer THP'er: røgfri og røgtobak, og

klassificeringen af varen som røgfri eller røgtobak afhænger af varens egenskaber.

Lovforslaget gør på behørig vis noget ud af denne skelnen mellem røgfri tobaksvarer og

røgtobak, og det foreslås at indsætte følgende definition i tobaksvarelovens § 2, stk. 31:

"Opvarmet tobaksvare: En ny kategori af tobaksvarer, der opvarmes for at frembringe en

emission indeholdende nikotin og andre kemikalier, som derefter inhaleres af

brugeren/brugerne, og som afhængigt af deres karakteristika er røgfri tobaksvarer eller

røgtobak."

4.5

I lovforslaget anerkendes det endvidere, at det delegerede direktiv ved ændring af artikel 11,

stk. 1, i tobaksvaredirektivet, alene fjerner muligheden for, at THP'er kan undtages fra kravet

om påklæbning af den informationsmeddelelse, der er indeholdt i artikel 9, stk. 2, i

tobaksvaredirektivet og den kombinerede sundhedsadvarsel fra artikel 10 i

tobaksvaredirektivet: "for

så vidt de er røgtobak".

I artikel 2, stk. 5, i tobaksvaredirektivet defineres røgfri tobaksvarer som "en

tobaksvare, der

ikke forbruges via en forbrændingsproces, herunder tyggetobak, tobak, der indtages nasalt,

og tobak, der indtages oralt"

(understregning tilføjet).

I artikel 2, stk. 9, i tobaksvaredirektivet defineres røgtobak som "tobaksvarer,

som ikke er

røgfrie tobaksvarer".

Den væsentligste forskel mellem røgfri tobaksvarer og røgtobak er altså tilstedeværelsen eller

fraværet af en "forbrændingsproces". Med andre ord er de relevante produktkarakteristika ved

klassificeringen som røgfri eller røgtobak, uanset hvordan produktet anvendes, hvorvidt det

indebærer forbrænding eller ej.

Denne konklusion underbygges af en afgørelse fra forvaltningsretten i Stockholm, som

afgjorde, at det eneste kriterium for vurdering af, hvorvidt et THP er "røgtobak" eller et "røgfrit

tobaksprodukt", er, om der foregår forbrænding.

Brugen af BATs THP,

glo™,

indebærer ikke en forbrændingsproces. Tobakken i disse

produkter opvarmes (den forbrændes ikke), og der produceres en nikotinholdig aerosol, der

generelt indeholder langt færre og lavere niveauer af giftige stoffer end almindelig cigaretrøg.

For eksempel opvarmer glo™ tobakken.

Når cigaretter ryges, antændes tobakken, hvilket

resulterer i en eksotermisk proces, der fører til meget højere temperaturer samt kontinuerlig

forbrænding og ulmen.

Konklusionen om, at BATs THP er røgfri, underbygges af retslige kendelser.

Forvaltningsretten i Braunschweig (Tyskland) har f.eks. konkluderet, at THP'er er røgfri, fordi

Forvaltningsdomstolen i Stockholm, sag nr. 3803-22, Philip Morris Products SA v The Public Health

Authority, 26. september 2022.

4.2

4.6

4.7

4.8

4.9

4.10

4.11

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

de ikke indebærer en forbrændingsproces.

Den tyske føderale tilsynsmyndighed

appellerede ikke denne kendelse, der nu er blevet inappellabel.

4.12

Den tyske domstol kom frem til denne konklusion efter at have overvejet ekspertudtalelsen

fra Mitchell Smooke, en internationalt anerkendt ekspert i forbrændingsteori og lektor ved Yale

University School of Engineering and Applied Science. En kopi af Mitchell Smookes råd findes

i appendix (1).

Mitchell Smooke forklarede i sin analyse over for retten, at tobak kun antændes ved

temperaturer på mellem 435 °C og 455 °C, hvilket er langt over driftstemperaturerne for THP-

enheder, og at der uden forbrænding ikke kan være nogen

"forbrændingsproces".

Mitchell

Smooke forklarede yderligere retten, at en opvarmet tobaksvareenhed opererer i en såkaldt

"før-antændingszone", hvor temperaturerne ikke er tilstrækkelige til hverken antændelse eller

forbrænding, og at THP-enheder derfor ikke genererer røg. Mitchell Smooke præciserede

over for retten, at materialer, der opvarmes til en "før-antændingszone" og ikke yderligere,

ikke undergår "forbrænding" eller en "forbrændingsproces".

Dette er i overensstemmelse med den amerikanske fødevare- og lægemiddeladministrations

("FDA") entydige konklusion om, at THP'er ikke indebærer en forbrændingsproces. I sin

seneste godkendelse af markedsføring og salg af en THP på det amerikanske marked (omtalt

nærmere nedenfor) omtalte FDA THP-enheden og relaterede forbrugsvarer som faldende

inden for underkategorien "ikke-forbrændt" produkt. I beskrivelsen af THP-forbrugsvarerne

angav FDA, at de er designet til at blive opvarmet elektrisk med henblik på at frigive

nikotinholdige aerosoler og ikke er beregnet til at blive forbrændt. I sin beskrivelse af THP-

enheden bemærkede FDA, at den elektroniske styring har til formål at opretholde et bestemt

temperaturinterval, der gør det muligt at generere aerosoler og forhindrer, at den når

temperaturer, hvor der kan forekomme forbrænding.

Da BATs glo-THP'er er røgfri tobaksvarer, vil ethvert krav om at påklæbe

informationsmeddelelsen fra artikel 9, stk. 2, i tobaksvaredirektivet og de kombinerede

sundhedsadvarsler fra artikel 10 i tobaksvaredirektivet på glo-THP'er være ugyldigt.

Da der ikke foregår forbrænding, er den reducerede risikoprofil for opvarmede tobaksvarer

sammenlignet med brændbare cigaretter blevet anerkendt af en række offentlige

sundhedsorganisationer. Public Health England har eksempelvis konkluderet, "at

foreliggende beviser tyder på, at opvarmede tobaksvarer kan være betydeligt mindre

skadelige end tobakscigaretter."

På samme måde fandt undersøgelser udført af UK Committee on Toxicology, "at

eksponeringen for problematiske forbindelser ved brug af ikke-forbrændte, opvarmede

tobaksvarer er reduceret i forhold til eksponeringen fra almindelig cigaretrøg, og at det er

sandsynligt, at den samlede sundhedsrisiko reduceres for konventionelle rygere, der skifter

til ikke-forbrændte, opvarmede tobaksvarer."

Senest har det hollandske institut for sundhed og miljø (RIVM) bemærket følgende:

"Overordnet

set synes det at være en begrundet konklusion, at forbrug af THP'er i stedet for

4.13

4.14

4.15

4.16

4.17

4.18

Forvaltningsretten i Braunschweig, 4. kammer, sag nr. 4-A-427/20, British American Tobacco (Tyskland)

GmbH v Forbundsrepublikken Tyskland, repræsenteret af det føderale kontor for forbrugerbeskyttelse og

fødevaresikkerhed, den 23. september 2021.

Den amerikanske fødevare- og lægemiddeladministration, teknisk projektgennemgang af PMTA, s. 15,

den 29. april 2019, tilgængelig på https://www.fda.gov/media/124247/download.

McNeill A, Brose LS, Calder R, Bauld L & Robson D., Evidence review of e-cigarettes and heated tobacco

products 2018, A report commissioned by Public Health England, tilgængelig

her,

s. 220.

UK Committee on Toxicology, Toxicological Evaluation of novel heat-not-burn tobacco products

–

non-

technical summary, 2017,

tilgængelig her,

s. 4.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

cigaretter vil være forbundet med en væsentlig stigning i den forventede levetid for den

undergruppe af rygere, der dør af kræft."

4.19

Disse resultater understøttes af BATs forskning med peer-review, der viser, at niveauet af

giftige stoffer i emissioner fra BATs glo-THP reduceres betydeligt på tværs af adskillige

kemiske klasser i forhold til sammenlignelige brændbare cigaretter.

Nylig klinisk forskning

med peer-review fra BAT har også udpeget væsentlige gunstige ændringer i biomarkører for

potentiel skade over seks måneder og et år, hvor rygere skifter over til udelukkende at bruge

BATs glo-THP, i forhold til fortsat at ryge cigaretter.

Forskningen viser, at mange af de

gunstige ændringer i biomarkører for potentiel skade var af samme størrelsesorden som hos

de deltagere, der ved forsøgets start var holdt op med at ryge uden at begynde at bruge en

opvarmet tobaksvare. Denne forskning bidrager til dokumentationen af, at rygere, der skifter

over til opvarmede tobaksvarer, derfor kan reducere deres relative sundhedsrisici i forhold til

at fortsætte med at ryge.

Desuden viser de tilgængelige beviser, at der ikke er sket nogen betydelig stigning i unge,

der begynder at bruge THP'er, og dermed ingen dokumenteret grund til bekymring over, at

THP'er kunne fungere som gateway til øget brug af brændbar tobak eller øget påbegyndelse

af rygning.

Dette underbygges af Kommissionens egen rapport, der som beskrevet ovenfor

fandt, at der ikke var sket nogen væsentlig stigning i udbredelsen af brugen af disse produkter

i gruppen af forbrugere under 25 år i Europa, og at den anden alternative betingelse for at

påvise en "væsentlig

ændring i forholdene"

dermed ikke er opfyldt.

Markedsføringen af THP'er er derfor i overensstemmelse med princippet om at reducere

skader som følge af tobaksrygning, som er nedfældet i artikel 1, litra d), i WHO-rammeaftalen

om tobakskontrol, da det eliminerer eksponering for tobaksrøg for rygere, der skifter

fuldstændigt over til THP'er. Det delegerede direktiv er dog i strid med dette princip, da det

delegerede direktiv ved at forbyde THP'er, der angiver smagsstoffer eller indeholder

smagsstoffer i deres komponenter, gør opvarmede tobaksvarer mindre acceptable over for

eksisterende rygere og dermed afskrækker dem fra at skifte og viderefører mere skadelig

rygning (se afsnit [5] nedenfor).

EU-lovgiveren har selv anerkendt dette med hensyn til elektroniske cigaretter (et andet nyt

produkt med betydeligt potentiale for at reducere skader som følge af tobaksrygning) ved i

betragtning 47 i tobaksvaredirektivet at anføre, at "[d]et

kunne være nyttigt for

medlemsstaterne at overveje at tillade markedsføringen af produkter med aromaer",

og at

"[f]orbud

mod sådanne produkter med aromaer vil skulle begrundes".

4.20

4.21

4.22

Slob W, Soeteman-Hernández LG, Bil W, Staal YCM, Stephens WE, Talhout R. A Method for Comparing

the Impact on Carcinogenicity of Tobacco Products: A Case Study on Heated Tobacco Versus Cigarettes.

Risk Anal. 2020 Jul;40(7):1355-1366, tilgængelig

her,

s. 1362.

Forster M, Fiebelkorn S, Yurteri C, Mariner D, Liu C, Wright C, McAdam K, Murphy J, Proctor C. Assessment

of novel tobacco heating product THP1.0. Part 3: Comprehensive chemical characterisation of harmful and

potentially harmful aerosol emissions. Regulatory Toxicology and Pharmacology. 2018 Mar;93:14-33,

tilgængelig

her.

Gale, N., McEwan, M., Camacho, O.M. et al. Changes in biomarkers after 180 days of tobacco heating

product use: a randomised trial. Intern Emerg Med (2021) 16:2201–2212, tilgængelig

her;

og Gale, N.,

McEwan, M., Hardie, G, et al. Changes in biomarkers of exposure and biomarkers of potential harm after

360 days in smokers who either continue to smoke, switch to a tobacco heating product or quit smoking.

Intern Emerg Med (2022) 17:2017–2030, tilgængelig

her.

Se f.eks. Jones, Joshua & Adamson, Jason & Kanitscheider, Claudia & Prasad, Krishna & Camacho, Oscar

& Beliaeva, Ekaterina & Bauer, Hans & Keralapura, Yoga & Murphy, James. (2020). A National Cross-

Sectional Survey to Assess Tobacco and Nicotine Product Usage Patterns and Behaviour Since the

Introduction of Tobacco Heating Products in Japan: Wave 1. Tobacco Regulatory Science, bind 7, nr. 3,

May 2021, s. 210-220 (11), tilgængelig

her.

Kommissionens rapport, afsnit 2.1.1.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

5.1

5.2

SUNDHEDSMÆSSIGE

KONSEKVENSER

DELEGEREDE DIREKTIV

VED

IMPLEMENTERING

DET

Lovforslaget og implementeringen af det delegerede direktiv vil med større sandsynlighed

underminere den offentlige sundhed end forbedre den.

Med hensyn til de foreslåede smagsbegrænsninger vil disse have en negativ indvirkning på

voksne rygere og sandsynligvis medføre utilsigtede konsekvenser for den offentlige sundhed.

BAT har bestilt en ekspertrapport fra Sally Satel, M.D., som blev indsendt som svar på

Europa-Kommissionens

høring

vedrørende

tobaksvaredirektivet/evaluering

tobaksreklamedirektivet (en kopi af Sally Satels rapport findes i Appendix [2]). Dr. Satel er

læge med speciale i misbrugspsykiatri og fast lektor ved American Enterprise Institute. Hun

har ekspertise inden for sundhedspolitik, misbrug og skadesreduktion. Dr. Satel beskriver sin

holdning til ikke-brændbare dampprodukters rolle med hensyn til at reducere skader som

følge af tobak. Hun adresserer mange misforståelser vedrørende sundhedsrisiciene ved og

effektiviteten af ikke-brændbare dampprodukter som erstatning for rygning, herunder

vigtigheden af smagsstoffer og potentielle utilsigtede konsekvenser, der ville kunne opstå som

følge af et smagsforbud.

I sin rapport bemærker Sally Satel, at en begrænsning af det, der gør ikke-brændbare

dampprodukter attraktive, ved at begrænse smagsstoffer vil påvirke voksne rygere, dvs. den

gruppe, som disse produkter er rettet mod. Baseret på den videnskabelige litteratur finder

sådanne rygere ikke-brændbare dampprodukter med smag mere acceptable end dem, der

har tobakssmag. Hun mener, at en begrænsning af tilgængeligheden af ikke-brændbare

dampprodukter med smag vil have en række utilsigtede konsekvenser, herunder at brugerne

genoptager rygning eller vender sig mod det uregulerede sorte marked, hvis deres foretrukne

smagsstoffer ikke længere er tilgængelige.

Ved derudover at anvende regler på THP'er, der er møntet på brændbare tobaksvarer,

formidles det vildledende budskab, at de risici, der er forbundet med THP'er, er de samme

som dem, der er forbundet med forbrug af brændbare tobaksvarer. Dette ville afskrække

rygere fra at skifte over til RRP'er (reduced

risk products).

Disse synspunkter underbygges af

den anerkendte professor i jura, økonomi og ledelse, W. Kip Viscusi, ved Vanderbilt University

Law School i Nashville, USA, som også er en anerkendt ekspert i risikoopfattelse, og hvordan

de påvirker forbrugeradfærden. (En kopi af Viscusis rapport findes i appendix [3]).

Viscusi bemærker i sin rapport, at mange mennesker mener, at opvarmede tobaksvarer er

lige så skadelige eller mere skadelige end cigaretter. Cigaretrygere, der ikke mener, at THP'er

er mindre skadelige end cigaretter, "er

ifølge rapporten mindre tilbøjelige til at prøve disse

produkter eller bruge dem for tiden"

, hvorimod "en

tro på, at opvarmede tobaksvarer... er

mindre skadelige end cigaretter, har en positiv sammenhæng med brugen af disse produkter.

De respondenter, der opfatter opvarmede tobaksvarer som mindre skadelige end cigaretter,

er 15 % mere tilbøjelige til at bruge opvarmede tobaksprodukter..."

Han konkluderer, "at

det

er muligt, at den seneste lovgivningsmæssige indsats, der behandler disse alternative

produkter på samme måde som brændbare tobaksvarer, kan have udbredt denne fejlagtige

opfattelse vedrørende ikke-brændbar tobak og nikotinprodukter."

Som sådan er det

påviseligt irrationelt at anvende foranstaltninger, der vil have den virkning, at de undergraver

brugen af alternative tobaksvarer og nikotinprodukter med en reduceret risikoprofil for rygere,

der ellers fortsat ville ryge, og dermed videreføre brugen af mere farlige brændbare

tobaksprodukter og underminere deres potentiale for at reducere skader som følge af

tobaksrygning.

5.3

5.4

5.5

Satels rapport s. VI og 97.

Viscusis rapport s. 73.

Viscusis rapport s. 18.

Viscusis rapport s. 107.

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6.1

ALDERSKONTROL VED KØB

BAT Danmark støtter initiativer der kan understøtte en bedre aldersverificering ved køb af

røgfrie nikotin- eller tobaksprodukter. Ingen unge under 18 skal have et nikotinforbrug eller

have adgang til at købe nikotin- eller tobaksprodukter, og en bedre ID-kontrol ved salg af varer

der er underlagt aldersbegrænsning er et skridt i retning af at forhindre unge under 18 år

adgang til nikotin- og tobaksprodukter.

BAT Danmark ser derfor positivt på forslaget, men efterlyser en konkret model for

aldersverificering f.eks gennem krav om et system med to-faktorgodkendelse, og ønsker

generelt en bedre håndhævelse af reglerne omkring aldersverificering. I den seneste RØG

undersøgelse svarer 54,1% af respondenter mellem 15-17 årige at de køber deres røgfrie

nikotinprodukter i supermarkeder, mens 50,3% svarer at de køber røgfrie nikotinprodukter i

kiosker

. Dette er stærkt bekymrende, da det i mange tilfælde er op til den enkelte ekspedient

at bede om og kontrollere ID, hvilket kan løses gennem krav om elektronisk system med

tofaktorgodkendelse, hvor et køb af en aldersbegrænset vare, kun kan lad sig gøre, hvis

kunden er over 18 år. Køb foretaget med kontantbetaling skal forudsætte aldersverificering,

ved forevisning af gyldigt billedlegitimation.

På samme vis ønsker BAT at sidestille onlinehandel med handel i fysiske butikker, således

at der opnåes en symmetri i reglerne. I dag er der ikke i tilstrækkelig høj grad alderskontrol

ved onlinekøb af røgfrie nikotinprodukter, hvorfor det også her vil være oplagt at sikre en

systematisk aldersverificering gennem et system med to-faktor-godkendelse inden købet kan

gennemføres.

6.2

6.3

7.1

KONKLUSION

Af ovennævnte årsager er det delegerede direktiv ugyldigt ifølge EU-retten, da enhver lov der

implementerer det Delegerede Direktiv i Dansk lov vil være ugyldig. Sundhedsministeriet bør

derfor ikke omsætte det til dansk ret. Hvis Sundhedsministeriet alligevel fortsætter med

gennemførelsen, bør det dog vente til sidste øjeblik med omsætningen, på baggrund af de

igangværende retssager, og beholde den definition af THP, som er foreslået i det aktuelle

lovforslag.

Vi opfordrer på det kraftigste Sundhedsministeriet til at overveje vores kommentarer til

lovforslaget og arbejder gerne yderligere sammen med Sundhedsministeriet om dette.

7.2

Brug af røgfrie nikotinprodukter blandt unge (sst.dk)

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

British American Tobacco, bilag 1

An Assessment of the Combustion Characteristics of Glo

Mitchell D. Smooke

Department of Mechanical Engineering

Yale University

New Haven, CT 06520-8284

1. Introduction

This report seeks to answer the following two questions:

1) During its intended operation, does Glo

undergo the process of combustion?

and

2) Does the aerosol produced by Glo

Neosticks constitute smoke?

To better understand the answers to these questions, this report focuses on a detailed discussion

of the basic concepts of combustion that are necessary to explain my conclusions. These include

chemistry, heat release, ignition, and the corresponding products of combustion with regard to the

behavior of fuels such as gaseous and liquid hydrocarbons and organic materials such as tobacco.

2. Overview

Aside from powering our transportation system and generating electricity for our homes, combustion

has been used in a variety of smaller systems such as gas appliances and small power tools to

recreational uses in camping, cook-outs and in the consumption of tobacco products. The last of

these topics forms the primary focus of this report.

There are a number of devices called

tobacco heating products

(THPs) that utilize tobacco materials

in a cylindrical shaped stick that is an alternative to the consumption of cigarettes. The Glo

device electronically heats cylindrical Neostick rods that contain tobacco and are specially designed

to work only with the Glo

device. THPs di↵er from cigarettes primarily in the mode of operation

for nicotine delivery.

In this report a systematic discussion of the process of combustion is provided and an assessment of

whether THPs and, in particular, British American Tobacco’s product Glo

undergo combustion.

In the next section the importance of chemical reactions, ignition and heat release in the burning

of hydrocarbon fuels is discussed. Section 4 considers the burning of tobacco and the operation

of Glo

. The report concludes with an assessment of whether Glo

undergoes the process of

combustion and whether the aerosol produced by the Glo

device is smoke. Reference material is

provided in the appendices that puts in perspective the fundamental physical and chemical aspects

of combustion.

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3. Chemical Reactions, Ignition and Heat Release

Most combustion processes occur under what is termed forced ignition whereby a heat source is

applied to a fuel-air mixture. Fuel-air mixtures include, for example, wood (fuel) burning in a

ﬁre place or gasoline (fuel) burning in an engine or tobacco (fuel) burning in a cigarette or pipe.

Assuming that the mixture is within the ﬂammability limits (see

Appendix H),

combustion follows

a several step process.

As the system is heated, volatile gases begin to emerge from the fuel (pre-heat zone). As the

temperature of the system continues to increase, the volatile materials in the fuel are vaporized

(pre-ignition zone) which can be followed by a region of pyrolysis. As the temperature rises further

and the ignition temperature of the fuel is reached, combustion begins. Depending upon the organic

molecules being burned, organic nano-particles can be formed (soot) which are either oxidized in

the ﬂame or, in some cases, released into the atmosphere as smoke.

For the purposes of this report, it is worthwhile to distinguish between an aerosol that is composed

of combustion (smoke) versus noncombustion products. From a combustion perspective, smoke

refers to the gaseous products of the burning of organic materials in which small solid and liquid

particles are dispersed [1]. Other deﬁnitions consider smoke to be the aerosol or condensed phase

component of the products of combustion. While particulate formation can occur from pyrolysis,

the temperature needs to be in the 325C-625C range [2]. An aerosol composed of noncombustion

products (e.g., water vapor and other vaporized liquids) is not smoke. Thus, while all smoke is an

aerosol, not all aerosols are smoke.

For any fuel-air system, it is essential to understand the temperature at which the pre-heat, pre-

ignition and ignition stages are reached. Detailed studies of ignition temperatures for a variety

of hydrocarbon fuels have been tabulated over the years and a sample is included in Figure 4 in

Appendix H

[3]. What is clear is that the temperature plays a critical role in the combustion of

fuel-air systems. Irrespective of whether the fuel is a solid, a liquid or a gas, combustion will not

occur until the temperature is above the ignition value.

4. Tobacco, Tobacco Heating Products and the Operation of Glo

Tobacco is a plant from the Solanaceae family, better known as Nicotiana (genus). This family

comprises some 2,000 species, including herbaceous plants, bushes, trees and vines. There are

several varieties of tobacco [4] such as Brightleaf, Burley, Corojo, Dokha, Habano, Latakia, Perique,

Shade, etc. Nicotiana tabacum, or common tobacco, is the primary source of tobacco in cigarette

manufacturing.

Tobacco plants are composed of a variety of chemicals, including: nicotine, chlorophyll, water,

sugars, a variety of minerals etc. For example, nicotine, a chemical naturally present in the tobacco

plant, is composed of carbon, hydrogen and nitrogen atoms with the chemical formula C

Nicotine has a speciﬁc evaporation temperature within the range of the Glo

device operating

temperature [5].

The harvesting of tobacco occurs when it is ripe, i.e., when the leaves begin to turn yellow. The

tobacco leaves are then dried which provides a means of rapidly destroying chlorophyll (the leaf goes

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from green to brown), converting starch into sugars, and reducing the moisture that is naturally

present in the leaves.

Of critical importance to the burning of tobacco is the ignition temperature. Studies that address

the ignition temperature for tobacco date back to the early 1900s ([6] and [7]). Other studies were

carried out in the 1940s ([8] and [9]). Most of these studies focused on leaf tobacco which required

a large number of leaves to minimize the e↵ects of tobacco leaf variability due to di↵ering levels of

moisture, fertilizer, chemical addition etc. To reduce such e↵ects, several studies employing ground

tobacco, which was formed into a pellet and subsequently burned, were undertaken by Weybrew

[10] as well as by Elliot and Vickery [11]. Additional studies were carried out by McKee [12] and

Tibbitts [13] in the late 1950s and early 1960s.

Speciﬁcally, in the results reported in [13], a 15 inch (in length) heating element with a uniform

temperature gradient was used to determine the tobacco ignition temperature. The heating element

consisted of a ceramic tube which was wound with Nichrome V wire. By adjusting spacing from

one turn to the next, it was possible to generate a linear temperature gradient along the tube.

Thermocouples were used to measure the temperature and the entire unit was enclosed to prevent

convective e↵ects from local air currents. The heating element temperature was regulated with a

variable transformer. Ignition temperatures were determined by sifting tobacco onto the heating

element. The sifting process started at the cooler end and continued across the element to the

hottest region of the ceramic element.

The point at which the majority of the ground tobacco ignited was recorded as the ignition tem-

perature of the sample [13]. Multiple tests were undertaken for each sample. The results of the

study were fairly consistent in that the ignition temperatures of the sample ranged from 442C to

488C. The study conﬁrmed earlier results by McKee [12] where ignition temperatures were de-

termined to range between 435C and 455C. In spite of the age of these studies, the results are

consistent with more recent investigations carried out in 2005 and 2007 ([14] and [15]). Thus, these

studies reliably establish the ignition temperature of tobacco between 435C and 455C. Similarly,

peer-reviewed published thermogravimetric analysis indicates that ignition of the tobacco rod in

the Glo

Neostick occurs at temperatures above 400C [16].

Factory made cigarettes are the main form of tobacco used globally. When smoked, the tobacco

is combusted at temperatures that can exceed 800C. In addition to the heat released, cigarette

burning produces smoke that can be composed of over 6500 identiﬁed chemicals [17] (see also [16]

and [18]). A number of these constituents are thought to be toxicants [19]. Prolonged exposure

to these chemicals over time can lead to a variety of health issues such as cardiovascular disease

and cancer [20]. As in the case of hydrocarbon fuels, the primary products of tobacco combustion

include

O, CO

, CO

and the oxides of nitrogen

N O, N O

and, more generally,

N O

British American Tobacco’s Glo

is a smoke free THP that uses an electronic battery-powered

device to heat specially designed tobacco sticks called Neosticks to produce an aerosol consisting

of primarily nicotine, glycerin, ﬂavorings and water (see Figure 1). BAT’s Glo

product di↵ers

from cigarettes in that the tobacco is heated to temperatures in the neighborhood of 242±5C with

an electrical heating device. These temperatures are signiﬁcantly lower than the 800C range of

ordinary cigarettes.

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Figure 1

– Illustration of the Glo

Product. Reprinted with permission from British American Tobacco.

The Neostick contains the tobacco material and a ﬁlter. When heated, the user draws the aerosol

from the Neostick. An electronic battery-powered heating element provides the heat source. When

the Neostick is inserted into the heating element, the tobacco material is heated to approximately

242C and creates an aerosol that the user inhales.

The battery is a lithium-ion battery that can last for 30 sessions. A series of small holes at the

bottom of the device allows air to be brought into the device. The device has a micro USB charging

port and the heating device, Neostick and battery are contained within an aluminum sleeve which

protects the device and helps to maintain the temperature so that the device remains cool to the

touch.

As discussed above, when the temperature is below the ignition temperature of tobacco, combustion

does not take place and smoke is not formed. For the Glo

device, this manifests itself with only

trace levels of toxicants such as

CO, CO

N O

and

N O

. Moreover, such low levels of toxicants

in Glo

aerosol emissions (relative to smoke from traditional cigarettes) similarly compels a con-

clusion that Glo

emissions do not constitute tobacco smoke. In fact, the low levels of reported

toxicants in Glo

emissions result from heating processes occurring at temperatures well below

the ignition temperature required for tobacco combustion and smoke production. The extremely

reduced levels of such toxicants in the Glo

aerosol as compared to cigarette smoke evidences the

absence during Glo

operation of both a combustion process and the smoke formation known to

produce the high numbers and levels of toxicants in cigarette smoke.

5. Conclusion

The previous sections and the subsequent appendices discuss the complex interaction of ﬂuid

mechanics, heat transfer, radiation and chemistry in the process of combustion of hydrocarbon

molecules. The burning of a fuel molecule undergoes a multistep procedure that includes a pre-

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heat, pre-ignition, pyrolysis and ignition zone. For nonspontaneous combustion to take place, the

fuel must be heated with an outside ignition source. Each hydrocarbon molecule has a unique tem-

perature at which ignition occurs depending upon the pressure and ﬂammability region. As noted

above, tobacco ignition takes place at temperatures at or above 435C. Once the fuel is heated above

the ignition temperature, a rapid rise in the temperature is observed and the primary products of

combustion are produced.

If the temperature does not get above the ignition limit, combustion does not take place and the

system operates in the pre-heat, pre-ignition or pyrolysis zone. Based upon the temperature and

heating speciﬁcations of British American Tobacco’s THP Glo

and the fact that tobacco does

not ignite at temperatures below approximately 435C, the Neosticks product does not undergo

combustion.

Instead, Glo

operates in a pre-ignition environment, i.e., in a temperature regime where the

primary products of combustion, such as

CO, CO

, various hydrocarbon molecules and the oxides

of nitrogen are signiﬁcantly reduced to only trace levels. In addition, since a tobacco combustion

process does not take place, the device does not produce an aerosol that can be classiﬁed as tobacco

smoke.

Disclaimer:

This report does not endorse nor discourage the use of tobacco heating products.

The views expressed herein are those of the author.

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Overview of the Appendices

Practical combustion systems are governed by large systems of strongly coupled, highly nonlinear

partial di↵erential equations (PDEs) and algebraic constraints that describe the conservation of

total mass, momentum, and energy, and the evolution of individual species mass under the mech-

anisms of convection, molecular di↵usion, and chemical reaction. In the Appendices that follow,

the various submodels that are inherent to the mathematical modeling of combustion processes are

discussed. The section ends with a discussion of ﬂammability limits and ignition.

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Appendix A

Governing Equations

It is possible to derive the governing equations from control volume considerations, as is often done

in textbooks. A more rigorous derivation is also possible using the Boltzmann equation of kinetic

theory, under the assumption that a continuum approximation is justiﬁable and departures from

local thermodynamic equilibrium are small. This is the case whenever the molecular mean free

path is much shorter than any other relevant length scales in the system, or equivalently, when the

Knudsen number is much less than unity. Statistical mechanics reveals that the mean free path is

directly proportional to temperature and inversely proportional to pressure, and that the Knudsen

number is about 1.5 times the ratio of the Mach number to the Reynolds number. It follows that

at terrestrial (or elevated) pressures and typical ﬂame temperatures, there is no question about the

validity of the classical continuum equations for modeling deﬂagrations. Since their derivation is

presented in many other places (e.g., [21, 22]), they are reproduced here in vector form.

Conservation of total mass:

@⇢

⇢u

= 0

(1)

Conservation of momentum:

@⇢u

⇢uu

Conservation of energy:

@⇢e

⇢ue

(u·S)

“Conservation” of individual species

@⇢Y

⇢Y

(4)

u·f

(3)

(2)

where here, as always, the species index

ranges over the

members of the set of species in the

chemistry model,

To this set of di↵erential equations must be added the equation of state for

an ideal gas, which relates the density to the other thermodynamic variables:

⇢

k2S

(5)

The unknowns in the governing equations are the “primitive variables”:

, which denotes the total

pressure;

ﬂuid velocity vector;

, temperature;

, mass fraction of species

and

⇢,

density.

The other quantities appearing in the equations are

time;

stress tensor;

k2S

, body

force vector, where the force can in theory vary depending on the chemical species (e.g., due to

electromagnetic ﬁelds in a plasma), though in this work it will simply be a constant force due to

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gravity (g);

speciﬁc total energy (chemical, sensible, and kinetic);

di↵usive energy ﬂux vector;

volumetric energy source (e.g., due to an ignition source or a laser), to be ignored in this work;

, di↵usive mass ﬂux of species

, volumetric mass production rate of species

due to chemical

reaction;

universal gas constant; and

, molecular mass of species

The symbol

is the

vector derivative operator. Note that whereas the total mass of each di↵erent chemical

element

conserved, strictly speaking, the mass of each of the species in

is not conserved.

A number of quantities in the governing equations must be deﬁned in terms of the basic thermo-

chemical and ﬂuid dynamic variables, including the stress tensor and the other transport ﬂuxes

with their respective transport coe cients, as well as models for molecular di↵usion, chemical re-

action, and radiation. Experiments show that in a broad class of ﬂuids, known as Newtonian, the

stress-strain relation is approximately linear. For such ﬂuids, the two components of the vector

momentum conservation equation are known as the Navier-Stokes equations. The related transport

ﬂuxes are written in

Appendix B

with mass conservation constraints and di↵usion models discussed

Appendices C,

and

respectively. The evaluation of thermodynamic properties and transport

coe cients is a critical and often time-consuming part of detailed computations of reacting ﬂows.

The thermodynamic properties appearing in the governing equations are the species and mixture

speciﬁc heats, the species enthalpies and, along with the required transport coe cients such as the

dynamic viscosity, the thermal conductivity, and the mixture-averaged di↵usion coe cients, are

discussed in

Appendix E.

In fact, all of the transport coe cients are formed by a kind of averaging

process given the relevant coe cients for each component in the mixture. This mixture-averaged

approach to transport modeling has long been the

de facto

standard in combustion modeling due

to its incorporation in various software packages.

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Appendix B

Transport Fluxes

As discussed in Appendix A, the system of governing equations contains a number of quantities

which must be deﬁned in terms of the basic thermochemical and ﬂuid dynamic variables. Speciﬁ-

cally, the stress tensor has the following familiar form:

u I

(6)

(7)

(ru) + (ru)

i.e., the sum of the isotropic pressure tensor and the viscous stress tensor (T). Here,

is the

dynamic viscosity of the mixture and

the unit tensor. As is common in the study of low speed

ﬂows of dilute gases, the bulk viscosity is assumed to be negligible. The dynamic viscosity is

a function of the thermodynamic state of the mixture, like the other transport coe cients; The

di↵usive ﬂuxes of energy and mass are given by the expressions:

rad

(8)

k2S

⇢Y

(9)

The di↵usion velocities

will be discussed below. The terms in the energy ﬂux relate to conduc-

tion (Fourier’s Law, with the coe cient of thermal conductivity), the transport of enthalpy by

molecular di↵usion (h

, speciﬁc enthalpy of species

k),

and the net e↵ect of radiation (q

rad

). The

divergence of the radiative ﬂux will be treated separately from the other heat transfer phenom-

ena. The Dufour e↵ect, whereby an energy ﬂux arises from concentration gradients, is typically

negligible in high-heat-release combustion processes, and hence is omitted above.

One change of note concerns the energy equation, which is transformed into an equation for temper-

ature using various thermodynamic relationships for energy and enthalpy. Its derivation is tedious

and, since this is sketched elsewhere [23], it is simply quoted here:

⇢c

(

)

⇢

P,k

rT r

rad

T:ru

(10)

k2S

In this equation,

and

P,k

are the speciﬁc heats at constant pressure of the mixture and species

respectively;

k2S

, the heat source due to chemical reaction, with

the molar

production rate of species

and

D/Dt

denotes the material derivative. The term involving the

viscous tensor describes the addition of heat due to viscous e↵ects in the ﬂuid (“friction”); both

it and the material derivative of pressure, related to mechanical work, are negligible for low speed

unconﬁned ﬂows. The term arising from work due to body forces has been suppressed since it is

identically zero for the case of a constant force a↵ecting all species equally. This conclusion follows

from the second of the mass conservation constraints that are presented below.

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Appendix C

Mass Conservation Constraints

From the deﬁnitions of the mixture density and mass-averaged velocity in terms of the (partial)

densities and ﬂow velocities of the individual species, it follows that the

mass fractions and the

di↵usion velocities are not a priori independent but satisfy the following constraints:

= 1

= 0

(11)

k2S

To these one can add another mass conservation constraint that derives from the chemical source

terms:

= 0

(12)

k2S

These constraints give mathematical expression to the physical impossibility of a net creation of

mass or a net di↵usion of mass relative to the mass-averaged bulk ﬂow. With them, it is easy to

show that the total mass conservation equation results from summing up all the species equations.

However, this proves yet again that the equation set is overdetermined, and raises questions about

which equations to include in the model and how to enforce the governing equations and constraints

simultaneously.

The ﬁrst constraint on the sum of the mass fractions can be dealt with in two ways. For strongly

diluted ﬂames burning in air, it is possible to compute

from the constraint and to omit the

equation that governs its transport in the ﬂow ﬁeld. This “asymmetric” treatment of the mass

fractions lumps all the errors into the mass fraction of the (inert) diluent. Clearly, this will not

be satisfactory whenever these errors may be relatively large compared with its typical value, e.g.,

in oxyfuel ﬂames [23, p. 16]. The more general (and perhaps more challenging) approach is to

treat all mass fractions similarly by solving the complete set of species balance laws. In this case,

the constraint cannot be imposed but must rather be “deduced from the governing equations” [24,

p. 8].

The second mass conservation constraint requires that the species di↵usion ﬂuxes sum to zero at

every point in the ﬂow. The calculation of the di↵usion velocities will be discussed shortly; for

now, it is enough to assume that they are available. When computing highly diluted ﬂames with

approximate transport coe cients, a common and accepted approach is to “lump” all the di↵usion

velocity errors into the di↵usion velocity of nitrogen, i.e., to take

(13)

k2S,k6

which indeed satisﬁes the constraint. As with the “asymmetric” treatment of the mass fraction

unknowns above, this approach could be problematic for ﬂames where nitrogen is not present in

excess. A more general way of ensuring this constraint is satisﬁed is to add a correction velocity to

the di↵usion velocity of each species at each point in the ﬂow ﬁeld. This is an established approach

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that was introduced a generation ago [25, 26]. The correction velocity is deﬁned as

k2S

(14)

Note that the problem to which this correction velocity is a solution arises from the mutual incom-

patibility of the di↵usion velocities as calculated from common

approximate

formulas; if the best

known model for these velocities were used to compute them, they would automatically satisfy the

constraint and the correction velocity would vanish.

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Appendix D

Di↵usion Model

The modeling of molecular di↵usion in multicomponent gaseous mixtures is a very complicated

subject in its own right. As commonly formulated, the problem is to compute the di↵usion velocity

of each chemical species

at each point of the ﬂow given the concentrations, concentration

gradients, and other thermodynamic variables throughout the ﬂow ﬁeld. This requires the solution

of linear systems of dimension

at every point of the computational domain. These linear

systems derive from the so-called multicomponent di↵usion equations, which are a generalization

of the Stefan-Maxwell equations for binary di↵usion [21, App. E.2.1]:

X 

✓

T,l

T,k

◆ ✓

◆

) +

+ (Y

)

(15)

⇢D

l2S

The ﬁrst term relates mole fraction gradients to relative di↵usion velocities; the second to ther-

mophoresis, or the Soret e↵ect, which unlike its “reciprocal,” the Dufour e↵ect, is not necessarily

negligible in combustion; and the third to pressure gradients in the ﬂow ﬁeld, this being a di↵eren-

tial e↵ect only felt when the molecular weights of the species vary considerably from the average

molecular weight of the mixture. Here it is assumed that the body forces

acting on each species

are equal, or else yet another term would arise. The mole fractions

are related to the mass

fractions by

(16)

k l2S

where the quantity in parentheses is the inverse of the molecular weight of the mixture.

This typical formulation of the multicomponent di↵usion model is generally applicable when the

governing equations are integrated in time using an explicit method, i.e., when the state variables

are considered to be known at the beginning of each time step; however, when a fully implicit

solver is applied to a ﬂame problem it is no longer strictly possible to ﬁx these variables and solve

for the di↵usion velocities in this fashion [27, p. 15]. In this situation, the recommended approach

is to use a di↵erent (and more esoteric) formalism in which the di↵usion ﬂuxes or, equivalently,

the di↵usion velocities are expressed as linear combinations of di↵usion driving forces. Here, the

di↵usion matrix that deﬁnes these linear combinations is populated by coe cients which must

themselves result from the solution of transport linear systems. The practical development of these

multicomponent transport models is largely the work of Giovangigli and Ern [24, 28]. Thanks to

their EGLIB software library, it is now possible to solve the full multicomponent di↵usion problem

much more e ciently than in the past [29].

This is not to say, however, that these fast transport algorithms are inexpensive, or a realistic option

in typical ﬂame calculations; in general, they still require the approximate iterative solution of a

linear matrix equation for the di↵usion matrix at every point in the domain and at every time step

of a transient calculation. Moreover, the beneﬁt of all this extra work is not always apparent. For

the study of either very light or very heavy fuels where the Soret e↵ect is expected to be signiﬁcant,

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it could be worthwhile and might, in some cases, be necessary for the accurate modeling of sensitive

phenomena, such as thermo-di↵usive instability [30–32]; but for a standard laminar hydrocarbon

ﬂame, a sophisticated multicomponent di↵usion model is generally unnecessary. Instead, a highly

simpliﬁed di↵usion model can often be employed – Fick’s law with the mixture-averaged di↵usion

coe cients:

(17)

where

is an e↵ective average di↵usion coe cient of species

into the mixture. The calculation

of these di↵usion coe cients will be discussed below.

It needs to be clearly stated that this approximation is not the best simple di↵usion model available.

It can be shown that the Hirschfelder and Curtiss approximation with mixture-averaged di↵usion

coe cients, i.e.,

(18)

leads, in conjunction with the correction velocity approach introduced in

Appendix C,

to the best

ﬁrst-order approximation to the solution of the Stefan-Maxwell equations [23, p. 14]. Admittedly,

the di↵erence here with the Fick’s Law approximation appears to be slight. Nevertheless, the

Fickian approach based on mass fractions is often simpler to implement since the

are immediately

available, whereas

must be computed from Equation (16). Note that the two approximations

are equivalent if the spatial gradients of the molecular weight of the mixture vanish.

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Appendix E

Thermodynamic Properties and Transport Coe cients

The evaluation of thermodynamic properties and transport coe cients is a critical and often time-

consuming part of detailed computations of reacting ﬂows. The thermodynamic properties appear-

ing in the governing equations are the species and mixture speciﬁc heats and the species enthalpies.

The required transport coe cients are the dynamic viscosity, the thermal conductivity, and the

mixture-averaged di↵usion coe cients. In fact, all of the transport coe cients are formed by a

kind of averaging process given the relevant coe cients for each component in the mixture. This

mixture-averaged approach to transport modeling has long been the de facto standard in combus-

tion modeling due to its incorporation in the Chemkin software library; the utility of more complete

models, such as those available in the EGLIB software package, is measured against this standard.

The original Chemkin software was written at Sandia and published in two separate packages in

the early 1980s, one dealing with chemical kinetics and thermodynamics and the other with the

calculation of transport properties [33, 34]. In some places, it has been customary to refer to the

ﬁrst package as “Chemkin” and the second as “Transport” (the latter name was not given by the

authors of the software). A second-generation Chemkin, known as Chemkin-II, was disseminated a

decade later, by which time an updated transport package had also been introduced [35, 36]. These

two versions of Chemkin each have their own “interpreter” software for reading specially formatted

chemical species and kinetic information. The versions are mutually incompatible. More recent

versions also exist in the form of commercial software. All the early versions of Chemkin were

written for scalar computers and hence were found to su↵er suboptimal performance on the newer

vector and parallel computers that were starting to be used in the late 1980s. This deﬁciency was

addressed originally by Giovangigli and Darabiha, who extracted many critical subroutines in both

Chemkin packages and vectorized them, leading to considerable speed-ups both in these routines

and, to some extent, in the overall ﬂame solver [37].

The evaluation of the energy equation in the temperature variable requires the three thermodynamic

properties of the mixture mentioned above, as well as the mixture density, which is recovered from

the ideal gas law (also through a Chemkin call). The speciﬁc heat capacity at constant pressure for

the

species depends only on temperature. It is computed e ciently from polynomial ﬁts based

on data in the JANNAF Thermochemical Tables, as found, for example, in the database of the

NASA chemical equilibrium code [38], which is also used by Chemkin. The mixture speciﬁc heat

at constant pressure is then taken as the mass average of the species speciﬁc heats. The species

speciﬁc enthalpies are given mathematically by a deﬁnite integral of the species speciﬁc heats over a

prescribed temperature range; in Chemkin, however, these quantities are computed more e ciently

as simple polynomial ﬁts of the published data.

There is more than one way of deﬁning mixture-averaged transport coe cients. For the thermal

conductivity and the viscosity, semi-empirical formulas are available as well as more complicated

expressions. An example of the latter is the formula for the mixture thermal conductivity due to

Wilke, which involves a double summation and ratios of species properties raised to integer and

non-integer powers (the equations can be found in many references, e.g., [37]). Because of the

expense of calculating Wilke’s formula, the mixture thermal conductivity is often computed from

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the semi-empirical formula:

k2S

(19)

where the species thermal conductivities

are given by polynomial ﬁts valid over a range of

temperatures, or to be precise, by the exponential of a polynomial in powers of the logarithm

of temperature. The mixture viscosity is calculated by a similar semi-empirical formula. The

mixture-averaged di↵usion coe cient is deﬁned by

= (1

)

. X

(20)

l2S,l6

where

is the binary di↵usion coe cient of species

into species

or vice-versa. As

with the other transport coe cients, the building blocks for the mixture-averaged di↵usion coef-

ﬁcient, the binary species di↵usion coe cients, are functions of temperature, with log

being

approximated by a polynomial in powers of log

. Although the mixture-averaged di↵usion model

represents an enormous simpliﬁcation as compared with the full multicomponent di↵usion model,

it is important to stress that even using this simpler model can come at a considerable cost. Since

the computational expense of evaluating all the

scales roughly as the square of the number

of species in

chemistry models with a large number of species can lead to ﬂame calculations in

which a signiﬁcant proportion of the CPU time is spent in the transport module of the code.

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Appendix F

Chemistry Models

One of the remaining frontiers of combustion science is the design of reliable detailed kinetic models

for realistic fuels, e.g., transportation, and the eventual deployment of such models to study chal-

lenging, poorly understood burning regimes in technologically relevant ﬂame systems, for instance,

those characterized by pollutant and particulate formation or by strong interactions between ﬂuid

dynamic and chemical e↵ects. A key requirement for progress on these fronts continues to be the

development of numerical codes that can handle such detailed chemistry models. The challenge

arises both from the size of the models and the amount of computation they demand, and from the

wide disparity of time scales supported by them, which leads to the problem of “sti↵ness.”

The reaction set of an arbitrarily complex, detailed chemistry model can be written in symbolic

form as

k2S

⌫

)

k2S

⌫

(21)

where

and

are the species and reaction indices, respectively;

⌫

and

⌫

, the stoichiometric

coe cients of reactant

in both forward and reverse reaction

, the chemical symbol of species

and

the set of

reac

reactions. A rate of progress

may be deﬁned for each elementary

reaction

according to the law of mass action, and the sum of the rates of progress for all reactions

involving species

multiplied by the appropriate net stoichiometric coe cient, gives the molar

production rate for this species:

Y ✓

⇢Y

◆

⌫

Y ✓

⇢Y

◆

⌫

(T )

k2S

(T )

k2S

⌫

)

(22)

i2R

(⌫

(23)

The forward and reverse rate constants for reaction

are denoted by

and

, respectively.

These “constants” are not constant at all but rather strongly dependent on temperature, and the

relationship for the forward coe cient is modeled by a modiﬁed Arrhenius expression:

(T ) =

exp(

/RT

)

(24)

The pre-exponential factor

, the temperature exponent

, and the activation energy

, all

speciﬁed by the kinetic mechanism, are typically estimated by experimental techniques and tuned

as needed to achieve certain benchmarks, such as the correct prediction of premixed laminar ﬂame

speeds or ignition and extinction criteria. Although it is possible to specify Arrhenius parameters

separately for the reverse reaction, the Chemkin default is to back out the reverse rate constant

from the forward rate constant and the equilibrium constant, with the latter determined from a

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thermodynamic calculation [33]. The empirical nature of the Arrhenius model is one reason for

this reliance on the equilibrium constant, the formula for which is well founded from a theoretical

point of view.

Table I illustrates a sample reaction mechanism for methane-air mixtures. The system includes

16 chemical species and 46 elementary reactions [39]. More complicated mechanisms can contain

hundreds of species and thousands of chemical reactions [40]. Detailed theoretical and experimental

studies have been undertaken to generate high ﬁdelity networks of elementary reactions that can

be used in the prediction of combustion phenomena see, e.g., [41].

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TABLE I

Reaction Mechanism Rate Coe cients In The Form

exp(

/RT

Units are moles, cubic centimeters, seconds, Kelvins and calories/mole.

REACTION

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

45.

46.

1.00E+17

7.90E+13

2.20E+04

1.60E+06

7.53E+12

3.31E+14

3.31E+16

1.81E+13

5.00E+12

1.60E+14

4.00E+13

1.00E+13

3.00E+12

3.20E+13

1.51E+07

1.60E+13

7.00E+12

2.40E+13

2.00E+13

1.00E+13

6.30E+10

5.20E+13

6.80E+13

7.50E+12

5.80E+13

1.70E+13

1.17E+09

2.20E+14

1.80E+10

2.10E+18

6.70E+19

5.00E+13

2.50E+14

4.80E+13

6.00E+08

2.23E+12

1.85E+11

7.50E+23

2.50E+13

2.00E+12

1.30E+17

1.60E+12

1.00E+13

0.000

3.000

2.360

2.100

0.000

1.300

0.000

1.300

0.000

1.000

-1.000

-1.420

0.000

1.300

0.500

-2.600

0.000

86000.

56000.

8750.

7400.

2460.

167.

10500.

81000.

3082.

14700.

-4200.

-758.

41000.

25652.

28812.

2600.

34574.

22934.

47780.

3626.

16800.

8826.

1000.

1900.

1000.

92600.

95560.

700.

45500.

3800.

1800.

)

HCO

)

HCO

)

HCO

)

HCO

)

HCO

)

HCO

)

HCO

)

HCO

)

HCO

)

2OH

)

2OH

)

2OH

)

Third body e ciencies:

= 21k

(Ar),

) = 3.3k

(Ar),

) =

) = 0.

Third body e ciencies:

= 6k

(Ar),

(H) = 2k

(Ar),

) = 3k

(Ar).

Third body e ciency:

= 20k

(Ar).

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Appendix G

Radiation Model

The ﬁnal submodel that needs to be speciﬁed concerns the divergence of the net radiative ﬂux in

the energy equation. In an unconﬁned geometry, gas radiation acts to cool the ﬂame, typically with

non-negligible e↵ects on density, velocity, and reaction rates, as well as a number of other ﬂame

properties. Radiative heat transfer is a complicated process involving emission, reabsorption, and

scattering of photons in a three-dimensional setting. Since the radiation that passes through a given

point in the ﬂow ﬁeld can originate at any other point and be attenuated in transit between them,

the physics must be modeled mathematically by a complicated integral over all space (all directions

of propagation) and all frequencies. However, if the reabsorption and scattering of radiant energy

can be neglected then the modeling is considerably simpliﬁed in what is called the “optically thin”

or emission-dominated limit applies, in which case the nonlocal, anisotropic term in the integrand

vanishes and the formula for the divergence of the radiative ﬂux reduces to

rad

= 4⇡

(⌫)

(⌫,

)

d⌫ ,

(25)

where

⌫

is a wavenumber variable (i.e., inverse wavelength),

is the frequency-dependent ab-

sorption coe cient, and

is the Planck function giving the spectral radiance emitted from a black

body at absolute temperature

The discretization of this integral in wavenumber-space is guided

by the fact that almost all of the radiation absorbed and emitted by molecular gases is associated

with a few narrow regions, or “bands,” in their spectra. The Planck function is evaluated at the

centers of these bands, and is considered to be constant across each of them. The absorption co-

e cient for the

absorption band of species

is modeled by a peaked function of a speciﬁed

bandwidth, whose integral may be expressed as the product of an integrated band intensity and

the partial density of this species in the mixture. Values for these intensities (↵

) and the central

(0)

wavenumbers of the bands (⌫

) are tabulated in [43] for the most optically active species,

, and

CO.

The result is a simple double sum for the radiation term:

rad

= 4⇡

↵

⇢

(⌫

, T

)

(0)

(26)

This quantity is important because it gives an upper bound on radiative losses in a ﬂame. However,

in some conditions, e.g., at high pressures or low strain rates, the gas could be su ciently dense or

the ﬂame su ciently thick that the optically thin approximation is no longer justiﬁable. In that

Here the formalism of [42] is used without completely following its notation. In particular, in keeping with [43],

⌫

is used for the wavenumber rather than

since

is very similar to the symbol introduced previously for the

molar production rate (

!).

As it happens,

⌫

is also a common symbol for frequency, which is proportional to but

not equal to wavenumber. It is important to keep all these things straight when considering the Planck function so

as to avoid confusion. The Planck function is typically expressed in terms of either frequency or wavelength, with

the forms di↵ering in part by large constant factors that arise from the change of variables; however, in this work,

also following [43], it is expressed in terms of wavenumber as:

(⌫,

) = 2hc

⌫

/(exp(hc⌫/k

) 1), where

Planck’s constant,

the speed of light, and

the Boltzmann constant.

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case, a more complicated radiation model would be necessary, an example of which is presented in

[42]. A good general discussion of radiation transport modeling for numerical combustion may be

found in [44].

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Appendix H

Flammability Limits and Ignition

What distinguishes combustion from ﬂuid mechanics is chemistry. When a fuel, e.g., a hydrocarbon

molecule, is heated beyond a given temperature, chemical reactions occur which consumes the fuel

in the presence of an oxidizer such as molecular oxygen. The resulting process can relinquish large

quantities of heat with a corresponding rise in the temperature of the system. While the ultimate

products of complete combustion are carbon dioxide and water, rarely are these the only products

that are formed. Instead, the oxidation of a fuel proceeds through hundreds (even thousands) of

elementary chemical steps with commensurate numbers of chemical species generated during the

process (see

Appendix F).

The combustion of fuels occurs in either a premixed or nonpremixed

mode. In the former, the fuel and oxidizer are mixed prior to combustion and in the latter the

fuel and oxidizer are separated before combustion takes place. Most practical combustion devices

operate (due to safety concerns) in the nonpremixed mode.

On occasion, combustion can occur spontaneously. In such cases combustible matter, such as hay

or coal, stored in bulk begins a slow oxidation process (as bacterial fermentation or atmospheric

oxidation) under conditions not permitting ready dissipation of heat, e.g., in the center of a haystack

or a pile of oily rags. Oxidation gradually raises the temperature inside the mass to the point at

which a ﬁre starts. Crops are commonly dried before storage or, during storage, by forced circulation

of air, to prevent spontaneous combustion by inhibiting fermentation. For the same reason soft

coal is wetted to suppress aerial oxidation.

Arbitrary fuel-air mixtures may or may not burn. The mixture must fall within the ﬂammability

limits for the speciﬁc fuel. The ﬂammability limit deﬁnes the concentrations of fuel vapor that

can be ignited and thus sustain combustion. If the mixture falls outside these limits, combustion

cannot be sustained. This implies that, if there is too much fuel and not enough oxygen, the

mixture will be outside what is termed the rich ﬂammability limit and, if there is too much oxygen

and not enough fuel, the mixture will be outside what is termed the lean ﬂammability limit. These

limits are fuel and pressure dependent. Figure 2 illustrates an example of ﬂammability limits for

methane-air mixtures.

To ignite a fuel-air mixture requires an outside supply of energy. The minimum amount of energy

that is needed for combustion of a fuel-air mixture is called the minimum ignition energy. Each fuel

has a di↵erent minimum ignition energy depending upon the amount of oxygen present. Minimum

ignition energies will vary depending upon where in the ﬂammability region the fuel-air mixture

falls. Mixtures that are near the rich ﬂammability limit will ordinarily require more energy to ignite

than those that fall in between the rich and lean ﬂammability limit. The same concept applies to

mixtures near the lean ﬂammability limit. Figures 3 and 4 list minimum ignition energies and the

minimum ignition temperatures for a variety of hydrocarbon fuels.

From Figure 4 one can see that the ignition temperature of alkanes, alkenes and alkynes generally

occur in the 225C-525C range. Once the temperature of the fuel-air mixture rises above the ignition

temperature, the system experiences a rapid temperature increase. This is a direct result of the

heat of combustion of the speciﬁc fuel. It is deﬁned as the heat released for the complete combustion

of a compound in its standard state to form stable products in their standard state, i.e., hydrogen

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is converted to water (in its liquid state), carbon is converted to carbon dioxide gas, and nitrogen

is converted to nitrogen gas. That is, the heat of combustion,

comb

, is the heat of reaction of

the following process:

(std.) +

(g)

xCO

(g) +

O(l)

(g)

where

x, y, z

and

are used to balance the equation.

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Figure 2

– Flammability limits for Methane. From: Zabetakis, M.G.,

Flammability Characteristics of Com-

bustible Gases and Vapors,

Bulletin 627, U.S. Department of the Interior, Bureau of Mines, 1965.

Figure 3

– Minimum Ignition Energy for a variety of hydrocarbon fuels.

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Figure 4

– Minimum Ignition Temperatures for a variety of hydrocarbon fuels.

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British American Tobacco, bilag 2

Report of Dr. Sally Satel MD

Analysis of the role of non-combustible products in

tobacco harm reduction

14 June 2022

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Sally Satel MD

INTRODUCTION

Almost one billion people around the world smoke cigarettes daily.

Fortunately, smokers who do quit before they reach the age of 40 are very likely

to avoid most of the excess mortality associated with smoking, according to the

seminal British doctors' study.

Indeed, quitting at any age confers a substantial

reduction in disease risk compared to continuing smoking, and the longer the

period of cessation the greater the reduction in disease risks. According to the US

Surgeon General Report on Smoking Cessation, “Although the benefits of quitting

are greater the earlier in life that an individual quits, this report confirms that it is

never too late to quit smoking. Even persons who have smoked for many years or

who have smoked heavily can realize health and financial benefits from quitting

smoking.”

Yet, quit rates are very low, from 3 percent to 12 percent annually,

and relapse rates are also high, from 75 percent to 80 percent in the first six

months and between 30 percent and 40 percent even after one year of

abstinence.

Therefore, reduced risk tobacco and nicotine products that provide an alternative

to conventional cigarettes and can thereby reduce smoking rates, demand serious

attention. Electronic cigarettes (e-cigarettes) and Heat Not Burn (“HNB”) devices

(together “non-combustibles”) present great promise in achieving this goal of

tobacco harm reduction by displacing smoking.

E-cigarettes

By way of background, e-cigarettes are battery-powered devices that heat a

flavored solution containing nicotine and convert it into an inhalable, or "vape-

able," aerosol.

These products show great promise as reduced risk alternatives

for smokers who would not otherwise quit. Because e-cigarettes do not burn

tobacco, they emit a mere fraction of the carcinogens and hazardous gases than

do conventional cigarettes.

Heat Not Burn Products

HNB products are another form of non-combustible cigarette alternatives. Unlike

e-cigarettes, HNB products do contain tobacco, but do not burn it. Instead, they

warm the material enough to create an aerosol the user then inhales. In the

absence of combustion, the aerosol produced by HNB products contains far fewer

and lower levels of toxic chemicals than cigarette smoke.

Tobacco Harm Reduction

The philosophy of "tobacco harm reduction" is centered around the goal of

reducing harm to the health of cigarette smokers who are unwilling to stop using

nicotine through traditional methods (primarily cigarette smoking) by

encouraging the substitution of other non-combustible nicotine products.

II.

BACKGROUND, MANDATE AND SUMMARY CONCLUSIONS

I am a physician specializing in addiction psychiatry and am a resident scholar at

the American Enterprise Institute with expertise in public health policy, addiction,

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and harm reduction. I also serve on the current National Advisory Board of the

Substance Abuse and Mental Health Services Administration and in 2019 I

testified before the US House Labor, Health, and Education Appropriations

Subcommittee on teen vaping and balancing the protection of youth with the

health of smokers. Further details of my qualifications and experience are

contained in my CV which is attached to this report.

I have been asked by British American Tobacco to provide an opinion based on my

medical background, expertise, and review of the scientific literature and

scholarship on the role of non-combustible products in tobacco harm reduction. I

have been closely following the development of e-cigarettes and HNB products as

disruptive technologies in public health. For this expert report, I have been asked

to address five questions.

The first

concerns

the comparative risks of e-cigarettes and HNB products

compared to conventional cigarettes. Although e-cigarettes and HNB products

have not been in use long enough for there to be long-term epidemiological data

concerning any long-term health risks, experts consider e-cigarettes and HNB

products to be much safer than conventional cigarettes. Studies, in fact, show a

dramatic reduction in exposure to toxicants almost to the level of non-smokers or

quitters – accounting for the documented improvements in the health of smokers

who switch to e-cigarettes and HNB products.

The second point of my inquiry is conceptual: why does the advancement of

public health depend upon understanding comparative risk rather than absolute

risk? In this report, comparative risk compares health hazards of non-

combustibles to hazards of combustible tobacco products, whereas absolute risk

evaluates the risk of non-combustibles compared to not using any nicotine

products at all. It is a tenet of sound health policy that people make considered

choices for themselves. This is only possible if experts from the fields of public

health and medicine communicate the most accurate information on the costs

and benefits of alternatives.

The third question is whether non-combustibles are an effective substitute for

conventional smoking. In this report, I show how different types of scientific

evidence coalesce to demonstrate that, while not marketed as smoking cessation

devices, many smokers use non-combustibles to quit smoking. The evidence

includes data derived from large populations, from questionnaires administered

to large groups of people, and from randomized controlled trials (the latter

showing about twice the smoking cessation efficacy compared to nicotine

replacement therapy (“NRT”) in controlled conditions). In particular, vaping is

now the most popular and successful product used for quitting smoking.

The fourth domain of concern is flavors and their role in encouraging smokers to

switch from conventional cigarettes to e-cigarettes and HNB products. Data

consistently show that flavors are crucial to adults’ preference of vaping over

smoking and to easing the transition from combusted tobacco to aerosolized

nicotine. At the same time, surveys of youth who have vaped reveal that flavors

are not the primary attraction of vaping.

Fifth, I address the concern that e-cigarette (and to a lesser extent, HNB products)

use, particularly among young people, serves as an introduction to future

cigarette smoking (the gateway hypothesis). Evidence from the US and the UK

10.

11.

12.

13.

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demonstrates that regular use of e-cigarettes by youth is rare and that the so-

called gateway effect has not materialized. To the contrary, studies show that

teens in the US now smoke cigarettes at the lowest rates in history and have

experienced unprecedented decreases in smoking prevalence precisely during the

period of vaping’s popularity. Thus, far from serving as a gateway to smoking,

teen vaping use where it does occur appears to serve as a substitute for teen

smoking. In this regard, I dispel anxiety surrounding the gateway theory by citing

large-sample studies that find a common vulnerability to both smoking and

vaping. In other words, youth who choose to vape share common risk factors

with youth who smoke, and, if not for e-cigarettes, may have smoked cigarettes

instead. Furthermore, the logic of smoking patterns is inconsistent with a causal

relationship between vaping and smoking. After all, if e-cigarettes led youth to

start smoking, we would have seen an increase in smoking following the

emergence of e-cigarettes. Yet, in reality, the opposite has happened. As

experimentation with e-cigarettes and, to a much lesser extent, regular youth

vaping has increased, smoking has declined. Finally, in response to those who

contend that non-combustible use has “re-normalized” smoking, reassurance is at

hand: data from two countries that have embraced e-cigarettes to varying

degrees, the UK and the US, show youth and adult smoking rates are at their

lowest levels ever.

14.

Lastly, I discuss the implications of this current scientific knowledge for public

health policy. Naturally, there is more to learn about current, and future, lower-

risk products. Quoting Sir Austin Bradford Hill, the late English epidemiologist and

statistician,

“All scientific work is incomplete - whether it be observational or

experimental. All scientific work is liable to be upset or modified by advancing

knowledge. That does not confer upon us a freedom to ignore the knowledge we

already have or postpone the action that it appears to demand at a given time.”

Thus far, we have amassed considerable knowledge about e-cigarettes and HNB

products. Data consistently confirm a relative decrease in harmful exposure to

toxicants associated with non-combustible products compared to continued

smoking in addition to the improvement in users’ pulmonary and cardiovascular

health, combined with the effectiveness of non-combustible products as

substitutes for conventional cigarettes.

Accordingly, it is my confident medical and scientific opinion that policymakers

should make e-cigarettes and HNB products widely accessible to adult smokers so

that the products can fulfill their public health potential. By no means should

they be banned or subject to overly limiting caps on nicotine strength, flavor

bans, restrictive tobacco product regulation, or taxation at the high rates that

apply to combustible cigarettes.

15.

III.

COMPELLING EVIDENCE DEMONSTRATING THAT E-CIGARETTES AND HNB PRODUCTS

ARE SUBSTANTIALLY LESS HARMFUL THAN CONVENTIONAL CIGARETTES

E-cigarettes

16.

Cigarettes contain roughly 7,000 chemicals, including 70 known human

carcinogens, carbon monoxide, nitrogen oxides, and other gaseous constituents.

Several analyses of e-cigarette aerosol show that while it contains some toxins

and carcinogens, they are far fewer in number and are present at much lower

levels than those found in cigarette smoke. The toxicants in conventional

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cigarettes, for example, exceed that of e-cigarette aerosol by two orders of

magnitude.

In other words, some toxicants in conventional cigarettes, for

example, exceed those in e-cigarette aerosol "by 100-fold." As expected, a

growing body of clinical evidence demonstrates that adult smokers’ exposure to

carcinogens and toxicants falls substantially following their transition to vaping.

In fact, those levels are comparable to those measured in unaided, ‘cold-turkey’

quitters.

17.

One of the earliest studies on e-cigarette aerosols appears in the journal

Tobacco

Control

in 2012.

Researchers at Roswell Park Cancer Institute screened the vapor

generated from 12 brands of e-cigarettes, for four groups of potentially toxic and

carcinogenic compounds: carbonyls (such as formaldehyde and acetaldehyde),

volatile organic compounds, and nitrosamines. The study found that heavy

metals, such as cadmium, lead, and nickel may be present but in amounts and

forms considered nontoxic.

“We

found that the e-cigarette vapors contained

some toxic substances,” the authors write, going on to note that, “the levels of

the toxicants were 9–450 times lower than in cigarette smoke and were, in many

cases, comparable with trace amounts found in the reference product.”

In 2015, Public Health England (“PHE”) released a high-profile report on e-

cigarettes estimating that vaping is around 95 percent safer than smoking.

Analysts derived this estimate from data demonstrating that the constituents of

cigarette smoke that harm health – including carcinogens – are either absent in e-

cigarette vapor or, if present, they are mostly at levels much below 5 percent of

smoking doses (mostly below 1 percent and far below safety limits for

occupational exposure).

“While vaping may not be 100 percent safe, most of

the chemicals causing smoking-related disease are absent and the chemicals

which are present pose limited danger,” the agency stated. In 2016, the Royal

College of Physicians echoed the key findings of PHE: "[a]lthough it is not possible

to quantify the long-term health risks associated with e-cigarettes precisely, the

available data suggest that they are unlikely to exceed 5% of those associated

with smoked tobacco products, and may well be substantially lower than this

figure."

In 2018, PHE updated the evidence in a review of both e-cigarettes and HNB

products. “Our new review reinforces the finding that vaping is a fraction of the

risk of smoking, at least 95 percent less harmful, and of negligible risk to

bystanders [save for those with asthma or other respiratory conditions, who are

vulnerable to myriad ambient irritants]. Yet over half of smokers either falsely

believe that vaping is as harmful as smoking or just don’t know,” they

summarize.

Similarly, in 2018, the U.S. National Academies of Sciences, Engineering, and

Medicine, wrote that, “Laboratory tests of e-cigarette ingredients, in vitro

toxicological tests, and short-term human studies suggest that e-cigarettes are

likely to be far less harmful than combustible tobacco cigarettes.”

The UK Committee on Toxicity’s ("COT") 2020 report, which addressed both

exposure to users and ambient exposure, found that in users, constituents such

as propylene glycol and glycerol elicited a “low level of concern.” Regarding

“other constituents,” the report states that, “Data from biomonitoring studies

support the conclusion that exposure to levels of tobacco-related toxicants

18.

19.

20.

21.

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associated with E(N)NDS use is lower than from conventional cigarette smoking,

but not as low as in non-users of tobacco products.” Overall, the COT concluded:

“The use of E(N)NDS products, produced according to appropriate manufacturing

standards and used as recommended, as a replacement for [combustible

cigarette] smoking, is likely to be associated with a reduction in overall risk of

adverse health effects, although the magnitude of the decrease will depend on

the effect in question.”

22.

Evidence also indicates improvements in cardiovascular and pulmonary function

in cigarette smokers who switch exclusively to e-cigarettes, according to a recent

review article in the

American Journal of Public Health.

Other reports show that

tests of lung and vascular function and hypertension

find improvement in

smokers who switch to e-cigarettes.

In terms of perceived wellbeing, exclusive

users of e-cigarette, who were largely former smokers, report fewer respiratory

symptoms than do cigarette smokers and dual users.

Heat Not Burn Products

23.

HNB products are gaining popularity and because they do not burn tobacco, they

do not impose health risks comparable to traditional combustible tobacco

products. In a 2018 “evidence review” by Public Health England,

the authors

stated that, “Compared with cigarette smoke, heated tobacco products are likely

to expose users and bystanders to lower levels of particulate matter and harmful

and potentially harmful compounds. The extent of the reduction found varies

between studies.”

In July 2020, the US Food and Drug Administration (FDA) authorized the

marketing of a HNB product. Makers were allowed to claim that the product

significantly reduces the production of harmful and potentially harmful chemicals,

and that scientific studies have shown that switching completely from

conventional cigarettes to the product significantly reduces the user’s exposure to

harmful or potentially harmful chemicals. Mitch Zeller, J.D., director of the FDA’s

Center for Tobacco Products was quoted as follows in the agency press release:

“Data submitted by the company shows that marketing these particular products

with the authorized information could help addicted adult smokers transition

away from combusted cigarettes and reduce their exposure to harmful chemicals,

but only if they completely switch.”21

HNB products produce higher levels of toxicants than do e-cigarettes, but the

levels are still considerably lower than found in cigarette smoke.22 The published

results of laboratory testing of a HNB product by Japanese researchers, found the

concentration of tobacco-specific nitrosamines (“TSNAs”) was one-fifth and

carbon monoxide (CO) was one-hundredth of those of conventional combustion

cigarettes.23 A toxicological product assessment conducted found levels of

aldehydes at approximately 80 percent–95 percent lower than cigarettes and

volatile organic compounds approximately 97 percent–99 percent lower.24

Another toxicological study using a “margin of exposure” analysis reported that a

HNB product reduced the risks from exposure to 9 out of the 20 most toxic

compounds in tobacco comparing the use of HNB with smoking conventional

tobacco products.25

24.

25.

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26.

Ikonomidis and colleagues 2021

randomized 50 smokers to regular cigarettes

and a HNB product. Users of the HNB product showed less compromise in

endothelial function, arterial stiffness, myocardial deformation, oxidative stress,

and platelet activation both acutely and after 1 month of switching exclusively to

HNB use. In late 2021, an international team of researchers confirmed in

Nature

that almost 80 percent of cytotoxic effects on bronchial epithelial cells are due to

volatile compounds in the vapor phase of smoke and found “no cytotoxicity on

bronchial epithelial cells with any [HNB or e-cigarette] product.”

Examining

separately carbon monoxide in a human subject clinical trial, 12 adult smokers

(6 male, 6 female) experienced no elevation in carbon monoxide levels, a risk

factor for cardiovascular disease, measured at intervals up to 45 minutes post-

use.

In addition, a 2021 randomized control trial performed in the U.K. found that

biomarkers of exposure and potential harm are reduced when smokers switch

from smoking cigarettes to exclusive use of a tobacco heating product.

The

product used in the study was glo THP device and Neostick tobacco consumables.

After 180 days of observation, biological

markers of exposure and harm in the

smoking group remained stable, while glo users’ levels of most biological markers

of exposure, and thus harm, reduced significantly, becoming similar to those in

controls abstaining from cigarette smoking.

27.

IV.

SOUND HEALTH POLICY REQUIRES FOCUS ON COMPARATIVE RISKS, NOT ABSOLUTE

RISKS OF NON-COMBUSTIBLES IN A VACUUM

28.

What are clinicians, policymakers, and smokers to make of claims that e-

cigarettes and HNB products are “not without harm”?

To be sure, vaping and

HNB use are not risk free. Yet, the advancement of public health requires

evaluating the effects of non-combustible products in comparison to the impact

of conventional cigarettes. Analysis of such comparative risk is critical to a harm

reduction framework. Indeed, it is an ethical imperative for the public health and

medical fields to provide smokers information on less hazardous ways of

consuming nicotine and to encourage those smokers who would otherwise

continue to smoke, to try non-combustibles even if these less hazardous forms

are not risk-free.

Unfortunately, a number of high-profile international agencies mislead the public

about non-combustibles by presenting the absolute risks only. Doubtless, health

experts must be transparent about any negative consequences of e-cigarettes

and other non-combustibles, but when they present such information

inaccurately and, in a vacuum, that is, without comparing the comparative risks of

these products to combustible cigarettes, they can do more harm than good.

The World Health Organization ("WHO") prominently displays the following

warnings in its materials for the public: “ENDS [Electronic Nicotine Delivery

Systems] contain varying amounts of nicotine and harmful emissions”; “ENDS

expose non-smokers and bystanders to nicotine and other harmful chemicals";

and “There is a risk of the devices leaking, or of children swallowing the liquid,

and ENDS have been known to cause serious injuries, including burns, through

fires and explosions.”

The

European Union Scientific Committee on Health,

Environmental and Emerging Risks

("SCHEER") likewise only provides an absolute

assessment of harm, in its 2020 report. It warns of a “moderate weight of

29.

30.

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evidence for risks of local irritative damage to the respiratory tract and moderate,

but a growing level of evidence from human data suggesting that electronic

cigarettes have harmful health effects, especially but not limited to the

cardiovascular system.”

31.

These publications stand out for their methodological flaws. Robert Beaglehole,

former director of the Department of Chronic Diseases and Health Promotion at

the WHO, highlighted these flaws and challenged the validity of the WHO’s

statements in a December 2020 keynote speech in the U.K. before an audience of

e-cigarette researchers.

Beaglehole said the WHO had “lost its way” and urged

leadership to stop obstructing harm reduction efforts and recommended an

independent inquiry into the agency’s leadership.

Likewise, the SCHEER report

flouted the tenets of sound public health analysis by focusing solely on absolute

risk, ignoring extensive scientific literature demonstrating that vape aerosols

contain fewer and substantially lower levels of harmful chemicals compared to

cigarette smoke.

Examples of exaggerated risk

32.

Finding the proper risk-benefit balance is crucial to sound public health policy and

harm reduction for smokers, but that evaluation depends upon accurate

estimates of the risks and benefits. With respect to risks, it is important to

recognize that studies purporting to have identified vaping-related harms too

often exaggerate those negative effects. This makes the downside of vaping

appear larger than it actually is, and, inevitably, distorts evaluations of risk-benefit

trade-offs.

Take the example of investigations of cell damage. Experimenters typically

expose cells in laboratory settings and assume those settings resemble human

physiology. Yet our bodies possess protective and regenerative mechanisms that

can minimize the impact of exposure in real life. Thus, naive researchers may

over-interpret the results and conclude that their findings are of actual clinical

relevance. What’s more, such

in vitro

studies sometimes use excessive exposures

that fail to correlate with human experience and/or neglect to expose the cells to

cigarette smoke as a comparison condition.

In the realm of human subject research, the media tend to disseminate

worrisome findings under alarmist headlines. Notable examples of flawed

research include a January 2015 report in the

New England of Medicine

entitled

“Hidden Formaldehyde in E-Cigarette Aerosols.“

The authors detected

formaldehyde in e-cigarette vapour after heating a vaping device to a high voltage

setting. Extrapolating from this finding the authors suggested that long-term

vaping is associated with an incremental lifetime cancer risk of five to 15 times as

high as the risk associated with long-term smoking. However -- and this is key --

no user would ever actually heat an e-cigarette high enough to produce the

recorded levels of formaldehyde in the study. The resultant vapor (known as a

“dry puff”) would be intolerably irritating to the throat. Indeed, when the

NEJM

researchers tested the same device at a voltage level normally used by vapers

they detected no formaldehyde.

In response, two experts made a formal

complaint to the

NEJM

calling for retraction of the paper; forty additional experts

wrote a supporting letter.

The plea for retraction was unsuccessful, but the

journal

Addiction

published the complaint under the title, “Research letter on e-

33.

34.

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cigarette cancer risk was so misleading it should be retracted.”

PHE also

corrected the misinformation surrounding the formaldehyde study in its 2015

“evidence update.”

35.

In February 2020, the

Journal of the American Heart Association

retracted an

article purporting to show that vaping increased the risk of heart attacks

— but

not until other scientists argued strenuously with the journal editors to withdraw

it from the scientific literature because its findings were false and invalid.

A recent report in the

American Journal of Preventive Medicine

sought to

determine a possible association between vaping and chronic lung disease.

Researchers used government data from a cohort of smokers and vapers that

were collected at three intervals over a four-year period. At each interval,

researchers asked subjects whether they had been diagnosed with chronic

pulmonary disease. Many of the vapers who did not report disease at the first

interval went on to report it subsequently, leading the authors to conclude that e-

cigarettes constituted a risk for chronic obstructive pulmonary disease, bronchitis,

and asthma. Confounding the results was the fact that over 99 percent of the

subjects studied were former smokers or dual users (that is, they vaped and

smoked), strongly suggesting that they had chronic lung problems long before the

study began, even if those conditions were not formally diagnosed. A subsequent

analysis of the same data that took into account whether the subjects were never

smokers, former smokers, or current smokers, found that current or former users

of e-cigarettes who had never smoked cigarettes had no greater prevalence of

respiratory disease than those who had never smoked combustible tobacco and

who had never used e-cigarettes.

In short, vaping did not confer added risk for

the studied respiratory illness compared with people who neither vaped nor

smoked.

Lastly, consider an unpublished conference presentation publicized by a press

release in 2021 by the

American Heart Association,

AHA. The study reported a

fifteen percent higher stroke risk at a younger age for e-cigarettes users than for

traditional smokers. Although only an abstract, not a peer-reviewed journal

article, and therefore preliminary, the finding garnered significant media

attention. A number of experts, however, were quick to highlight the

shortcomings based on the abstract, calling attention to three facets of the study:

(1) that a number of e-cigarette users in this cohort – likely a large segment --

were smokers who may have switched to vaping only

after

they suffered a stroke;

(2) that no biologically plausible hypothesis could explain how e-cigarettes could

increase the risk of stroke at young ages but decrease it in the older groups, as

the study found; and (3) that vapers in this study were overall less likely to have

strokes than individuals who continued to smoke – a key, and expected, result

that the authors obscured in the presentation of findings.

The authors

withdrew the abstract and press release, prior to the AHA conference.

36.

37.

Nicotine

38.

Nicotine as a chemical substance deserves attention in the context of risk-benefit

calculus because the public regularly considers it to be a high-risk component of

vaping. Not so. Nicotine is the addictive constituent in tobacco but it is the other

constituents of tobacco smoke, not nicotine itself, that primarily cause disease in

cigarette smokers’ consumption.

Nicotine is not carcinogenic.

In general,

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“nicotine plays a minor role, if any, in causing smoking-induced diseases,”

according to Neal Benowitz MD of the UCSF Center for Tobacco Control,

Research, and Education in the

New England Journal of Medicine.

However, the

public tends to misconstrue the risks of nicotine as being the same or similar to

the risks of smoking tobacco.

39.

Even many physicians do not know these facts. For example, a survey of 826 full-

time faculty members in the schools of medicine, public health, dentistry and

nursing at the University of Louisville (US) found that 38 percent believed that

nicotine, separate from smoking, is a high-risk factor for heart attack and stroke.

Thirty-eight percent ranked nicotine a high-risk factor for cancer of all kinds and

another 37 percent rated the risk of nicotine as moderate; and for oral cancer,

the percentages were 32 percent and 40 percent, respectively. In a 2019 survey

of 256 European Union trainees in public health, the vast majority of respondents

believed nicotine contributes significantly to disease. Over four-fifths (82.2

percent) associated nicotine with all smoking-related diseases, 59.1 percent

indicated that nicotine is an important factor in the development of lung cancer,

62.1 percent thought nicotine was involved in vulnerability to cancer in other

organs, and 72.7 percent considered it responsible for atherosclerosis.

Consequences of Exaggerated Risks

40.

The stock warning issued by critics of tobacco harm reduction is that "vaping is

not safe." This is true but misleading. Relative safety compared to the grave

dangers of smoking is what smokers need to know. Worse, otherwise respected

agencies such as state departments of public health, health non-profits (such as

the American Lung Association and the American Academy of Pediatricians),

and even some medical and public health schools, have disseminated information

that is outright false. Examples include the warning that e-liquid has been shown

to cause a very serious illness called “popcorn lung,” and to raise the risk for heart

attack and chronic obstructive pulmonary disease.

Last January, for example, the American Heart Association posted a page called

“Is vaping safer than smoking?”

Its answer: “many downsides, few potential

upsides.” Among other groundless, contrary-to-data claims it tells readers: “E-

cigarettes’ biggest threat to public health may be this: The increasing popularity

of vaping may “re-normalize” smoking, which has declined for years.” A more

general content analysis of media coverage reveals bias as well. For example, a

content analysis of e-cigarette topics and themes covered in US news articles

from 2015 to 2018 found that 70 percent of articles on vaping mentioned e-

cigarette risks, while only 37 percent noted the potential benefits.

Over time, these presentations of the alleged risks of e-cigarettes have influenced

adult public opinion. In 2012, the Longitudinal Health Information National

Trends Survey conducted by the National Cancer Institute found that 39 percent

of respondents believed that e-cigarettes were "less harmful" or "much less

harmful" than smoking.

The next year, 40 percent held those beliefs.

That

ascendant trajectory, unfortunately, started to turn down in 2014, eventually

declining to 17 percent in 2018 and to 14.8 percent in 2019.

A 2019 Reuters poll

found that 63 percent of Americans disagreed with the statement that "vaping is

healthier than traditional cigarettes," a 16 percentage point increase from the

spring of 2016.

In the U.K., public perception of vaping’s advantage relative to

41.

42.

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smoking began to decline after 2015, according to the Smoking Tool Kit Study,

which tracks national smoking patterns and cessation-related behavior among all

adults. Between 2013 (when tracking on vaping began) and 2015, over half of

respondents endorsed e-cigarettes as “less harmful.” In 2017, 44.2 percent

perceived vaping as less harmful than smoking.

In 2020, 29 percent of current

smokers believed vaping was less harmful than smoking.

43.

PHE’s March 2020 evidence update

found that: “[p]erceptions of harm from

vaping among smokers are increasingly out of line with the evidence. The

proportion who thought vaping was less harmful than cigarettes declined from

45% in 2014 to 34% in 2019. These misperceptions are particularly common

among smokers who do not vape.” The report also concluded that: “increasingly

incorrect perceptions among the public about the harms of vaping could prevent

some smokers using vaping products to quit smoking.” PHE's e-cigarette evidence

update report, published in February 2021, also found that: "[p]erceptions of the

harm caused by vaping compared with smoking are increasingly out of line with

the evidence" and recommended that: "[m]isperceptions of the relative harms of

smoking and vaping should be addressed."

A University College London study

reviewed the association between changes in

harm perceptions and e-cigarette use among current tobacco smokers in England

between 2014 and 2019. The authors found that for every 1 percent decrease in

the mean prevalence of current tobacco smokers who endorsed the belief that e-

cigarettes are less harmful than combustible cigarettes, the mean prevalence of

e-cigarette use decreased by 0.48 percent. The authors' state: “[…] our results

highlight the need for an increase in media portrayals and public health

campaigns focusing on the reduced health harms by switching from combustible

tobacco to e-cigarettes.”

In sum, exaggerating the risks of non-combustible tobacco and nicotine products

undermines public health goals of moving smokers away from conventional

cigarettes to less harmful products including e-cigarettes and HNB products.

44.

45.

COMPELLING EVIDENCE THAT E-CIGARETTES AND HNB PRODUCTS REDUCE SMOKING

46.

A number of esteemed health agencies have attested to the reduced toxicity of

non-combustibles relative to conventional cigarettes. They have also urged

smokers to try non-combustibles when other options to quit smoking

conventional cigarettes have failed. For example, in 2020, New Zealand’s Ministry

of Health announced the following: “Evidence is growing that vaping can help

people to quit smoking,” and that “Stop smoking services must support smokers

who choose to use vaping products to quit.” The Ministry also “considers [that]

vaping products could disrupt inequities and contribute to Smokefree 2025.”

Similarly, last year the Royal College of Physicians issued a forthright statement:

“E-cigarettes are an effective treatment for tobacco dependency and their use

should be included and encouraged in all treatment pathways.”

In addition, in its annual “evidence update” of 2021, Public Health England also

endorses vaping as a means to stop smoking cigarettes. The 2021 PHE update

found that vaping products are the most popular quit aid used by smokers and

reported that vaping is positively associated with quitting smoking successfully.

Similarly, the UK National Health Service in 2017 reported that over 50,000

47.

48.

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smokers in the UK stopped smoking with a vaping product and that “[a]lternative

nicotine delivery devices, such as nicotine vaping products, could play a crucial

role in reducing the enormous health burden caused by cigarette smoking.”

addition, an early 2020 posting from the U.S. National Institutes of Health -- a

research update rather than a report or statement from the agency --

acknowledged that “e-cigarette use may lead some to quit traditional

cigarettes.”

49.

As discussed below, and notwithstanding the e-cigarettes are not marketed as

smoking cessation products, there is wide-ranging scientific support that

demonstrates the value of non-combustibles in reducing smoking.

E-cigarettes

50.

Population studies -- retrospective analyses of large groups of individuals --

analyze changes in rates of smoking or cessation over time. Such analyses are

important in showing the association between e-cigarette use and smoking

cessation. With respect to e-cigarette use, they show dramatic declines in

smoking prevalence that coincide with population uptake of vaping.

For example, research from the CDC published in 2017 found that a greater

percentage of smokers seeking to quit substituted e-cigarettes in place of the

nicotine patch, nicotine gum, or other FDA-approved cessation aids.

Subsequent data discussed below, also suggest that the preference translates into

more successful quitting.

Many studies have examined the impact of e-cigarette use on smoking. A

representative sample follows.

A CDC study published in 2020 found that 15.1 percent of current exclusive users

of e-cigarettes reported recent successful smoking cessation for 6 months or

longer.

Those data, collected in 2018, exceeded both the 3.3 percent quit rate

for people using other non-cigarette tobacco products, and the 6.6 percent quit

rate for those using no tobacco products. Notably, 7.1 percent of US adult

smokers reported recent successful quitting in 2018, thus e-cigarettes use

produced twice the quitting rate of all adult smokers that year.

A 2019 report in

Addiction

used cross-sectional survey data collected in the UK

monthly between 2006 and 2018 to reveal a near doubling of self-reported

cessation among users of e-cigarettes or varenicline compared with other

cessation products. “There was little evidence of benefits of using other cessation

aids,” the authors concluded.

Late in 2021, a report published in

JAMA Network Open,

found that smokers who

started vaping daily were multiple times more likely to quit than those who never

used e-cigarettes.

Specifically, 5.8 percent of adult daily cigarette smokers who

were not using e-cigarettes and had no plans to ever quit smoking were, in fact,

not smoking cigarettes at all at follow-up. By comparison, 28 percent of those

who vaped daily, without the intention to quit, were smoke-free. The data

comprised about 1,600 smokers from the FDA’s Population Assessment of

Tobacco and Health (PATH) Study (2014-2019) who, notably, did not plan to quit.

“These findings call for consideration of smokers who are not planning to quit

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when evaluating the risk-benefit potential of e-cigarettes for smoking cessation in

the population,” the authors summarized.

56.

International findings are comparable and point, as well, to the strong association

between vaping and a higher propensity to quit smoking. The 2017

Eurobarometer survey, for example, recorded the duration of smoking cessation

for former smokers as well as smoking duration for both current and former

smokers across the European Union ("EU"). Farsalinos and colleagues classified

smokers according to quit duration to help overcome the problem of analyzing all

former smokers, many of whom had quit long before e-cigarettes were available,

as one group. Their survey analysis revealed that current daily e-cigarette use in

the EU was rare among former smokers of greater than 10 years and was

positively associated with recent (5 years or fewer) smoking cessation. Former

daily e-cigarette use was also positively associated with recent 2 years or fewer

smoking cessation.

Farsalinos encapsulated the findings: “we found a strong

association between current daily e-cigarette use and being a former (rather than

a current) smoker. Specifically, we found that daily e-cigarette use was

associated with 5-fold higher odds of having quit smoking in 2015-2017, and with

3-fold higher odds of having quit smoking in 2012-2015. Another important

finding of the study was that e-cigarette use was extremely rare among former

smokers who had quit before the availability of e-cigarettes, showing that e-

cigarettes do not result in relapse to an inhalational habit for these former

smokers.”

The 2020 Eurobarometer study shows that 58 percent of European

smokers or ex-smokers who use, or have used, e-cigarettes and/or heated

tobacco products say that these products have helped them to either quit or

reduce smoking.

In Australia, a nationally representative sample of 3,868 adult smokers in

Australia found that daily e-cigarette use was strongly associated with smoking

reduction/cessation, but occasional use was not.

In addition to population studies like those outlined above, a number of

randomized clinical trials also provide further confirmatory evidence of the

effectiveness of e-cigarettes in helping smokers to quit cigarettes. Importantly,

randomized clinical trials give insight into causality – if variable X is manipulated

will outcome Y change? – as opposed to observations made in cross-sections or

over time. For example, a year-long study led by Peter Hajek, director of the

Wolfson Institute of Preventive Medicine's Tobacco Dependence Research Unit at

Queen Mary University of London, randomized 886 smokers to various cessation

methods. All subjects were motivated to quit. Those randomized to e-cigarettes

were 80 percent more likely to abstain from cigarettes for at least a year (18

percent) compared with those who used a range of NRTs (patch, gum, lozenge,

nasal spray, inhalator, mouth spray, mouth strip, and microtabs at 9.9 percent).

The findings appeared in 2019 in the

New England Journal of Medicine

and

garnered considerable scientific and media attention.

The following year, in a six-month trial conducted in New Zealand, researchers

randomized 1,124 people to one of three groups: nicotine patches (21 mg) only,

patches plus a nicotine e-cigarette (18mg/L), or patches plus a nicotine-free e-

cigarette. Half of the participants in the patch only group withdrew or were lost

at follow-up by 6 months, compared to just under one-third of both of the other

groups. At six months, 2 percent of the patch-only group maintained continuous

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abstinence from smoking, as verified by carbon monoxide testing, compared with

4 percent in the patch plus nicotine-free device and 7 percent in the patch plus

nicotine-containing e-cigarette.

60.

In 2021, Jonathan Foulds, a Professor of Public Health Sciences and Psychiatry

Penn State University, and his team published the results of a randomized trial of

520 smokers assigned to one of four 24-week conditions.

The study subjects

received either (1) a vaping device with no nicotine, (2) with 8 mg/ml nicotine, (3)

with 36 mg/ml nicotine, or (4) a cigarette-shaped tube containing no nicotine as a

cigarette substitute. The subjects reported being motivated to reduce nicotine

consumption but were not planning to quit consuming nicotine. At 24 weeks,

significantly more participants in the 36 mg/ml condition (10.8 percent) than in

the 0 mg/ml (.8 percent) condition or the “tube” condition (3.1 percent) were

abstinent from cigarettes. Among the set of subjects in the 8 mg/ml condition,

4.6 percent were abstinent. The authors concluded that if smokers continued to

vape with cigarette-like nicotine delivery, a greater proportion completely

switched to an e-cigarette, as compared with placebo or a cigarette substitute.

A number of reviews of randomized trials have also concluded that e-cigarettes

are more effective in helping smokers quit.

For example, in September 2021, the

Cochrane Collaboration

published an update

to its ongoing review into the effect and safety of using e-cigarettes to help

smokers achieve long-term smoking abstinence. This version of the report

assessed the results of 61 studies, representing 16,759 participants, of which 34

studies are randomized controlled trials. The authors found that “[m]ore people

probably stop smoking for at least six months using nicotine e-cigarettes than

using NRT (4 studies, 1,924 people), or nicotine-free e-cigarettes (5-cigarettes,

1,447 people)." It further noted that, "Nicotine e-cigarettes may help more

people to stop smoking than no support or behavioural support only (6 studies,

2,886 people)." The authors also found no evidence of harm from nicotine e-

cigarettes based on a two year follow up period.

In 2021 an Austrian team reviewed 12 randomized controlled trials studies

encompassing 8,512 participants and found that “pooling current evidence points

toward a potential for e-cigarettes as a smoking cessation tool.”

Across the

studies, e-cigarettes containing nicotine were compared with non-nicotine

versions or with established smoking cessation interventions (NRT and or

counseling) published between January 2014 and June 2020. The results, which

appeared in

Nicotine & Tobacco Research,

indicated that e-cigarettes performed

as well if not better than standard interventions. "The proportion of smokers

achieving abstinence was 1.71 (95 CI: 1.02–2.84) times higher in nicotine EC users

compared with non-nicotine EC users. The proportion of abstinent smokers was

1.69 (95 CI: 1.25–2.27) times higher in EC users compared with participants

receiving NRT. EC users showed a 2.04 (95 CI: 0.90–4.64) times higher proportion

of abstinent smokers in comparison with participants solely receiving counseling."

Another review published last year by a research group in the Centre for Youth

Substance Abuse Research, at the University of Queensland, Australia, included

randomized controlled trials that allocated individuals to use nicotine e-

cigarettes, compared to those that used licensed NRTs, or a nicotine-free control

condition such as receiving placebo (nicotine-free) e-cigarettes or usual

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intervention.

While noting the need for more high quality studies, the authors

found that participants randomised to receive nicotine e-cigarettes were almost

50 percent more likely to remain abstinent from smoking than those who

received NRTs. Those randomised to receive nicotine e-cigarettes were twice as

likely to remain abstinent from smoking than those in control conditions where

no nicotine was supplied.

Heat Not Burn products

65.

While the data on HNB products leading to reductions in smoking rates is limited,

data indicates that these products are displacing combusted cigarettes in the

marketplace. For example, HNB products are becoming very popular in a number

of countries, including Japan (where e-cigarettes are not available) and South

Korea. A particular appeal of HNB products for Japanese smokers is eliminating

the social disapproval of the smell of second-hand smoke.

Japan has 90 percent

of the global market for HNB products.

An analysis by Cummings

et al.

(2020)

found a five-fold increase in the annual percentage decline in cigarette sales in

Japan following the introduction of HNB products in late 2015. The authors

stated: “[b]etween 2011 and 2015, cigarette sales in Japan were declining at a

slow but steady pace. However, the pace of decline in cigarette sales accelerated

beginning in 2016, corresponding to the introduction of [HNB products] into the

marketplace.”

In South Korea, sales of HNB products increased from 79 million packs in 2017 to

332 million packs in 2018

and are expected to increase 21 percent annually.

In other major markets for HNB products, sales increased rapidly from 2017 to

2018 as follows: 30 percent in Italy and over 50 percent in Russia.

What emerges from both the population data, observational studies, and

randomized-controlled experiments described above is strong and consistent

evidence suggesting that non-combustibles improve rates of smoking cessation

and lower overall rates of smoking. From a harm reduction perspective,

therefore, regulations that promote access to and knowledge of non-combustible

products should themselves promote the harm reduction potential of these

products, as they grow in popularity.

66.

67.

VI.

WHY FLAVORS ARE IMPORTANT TO SMOKING CESSATION

68.

The rationale for banning flavors may seem plausible on its face: if teens are

attracted to flavors, banning them will dissuade teens from vaping. However,

the problem is that limiting the appeal of vaping will also affect adult

smokers. These smokers are the very group for whom e-cigarettes are

intended. Such smokers also find e-cigarettes with flavor beyond tobacco

more appealing than e-cigarettes with tobacco flavor. Also, contrary to

popular belief, teens are not primarily drawn to e-cigarettes because of

flavors. According to a CDC survey, among students who ever used e-

cigarettes, the two most common reasons for first use were “a friend used

them” (57.8 percent), and “I was curious about them” (47.6 percent). Flavors

came in seventh, at 13.5 percent.

Surveys routinely report that vapers strongly prefer fruit flavors over tobacco

flavor once they make the shift to e-cigarettes. Classic behavioral theory

would predict as much: to prevent relapse, a smoker trying to quit should

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dissociate from the taste of smoking. A 2018 preference survey of 20,836

adult vapers in the U.S. found that fruit and dessert flavors are the most

popular by far, with only a minority using tobacco flavors – between 10 and

20 percent.

Fruit flavors were preferred by over two-thirds of those who

were using e-cigarettes on a frequent basis (of whom 15,807, 75.9 percent,

had completely switched from smoking cigarettes to using e-cigarettes.)

Results indicated that adults who have completely switched from smoking

cigarettes to using e-cigarettes in the past 5 years are increasingly likely to

have initiated e-cigarette use with vapor products not flavored to taste like

tobacco.

70.

Observational studies also demonstrate the importance of flavors in assisting

smokers to switch to e-cigarettes. A 2020 U.S. cohort study in

JAMA

with

17,929 participants used in waves 1-4 (2013-18) of the Population

Assessment of Tobacco and Health Study (collected from 2013 to 2018) found

that among adults who smoked and began vaping, the odds of smoking

cessation for those using non-tobacco flavors were 2.3 times that of those

who used tobacco-flavored e-cigarettes.

Notably, flavored e-cigarettes

were not associated with greater youth smoking initiation.

“Critically, this

study’s findings suggest that efforts to ban flavored e-cigarettes could

increase smoking,” the authors caution.

A 2021 study published in

Nicotine & Tobacco Research

found that smokers

who use flavored vapes to quit smoking were 43 percent more likely to

succeed than someone using an unflavored or tobacco-flavored vape.

Researchers examined 886 concurrent (at least weekly) users of nicotine-

containing vaping products and cigarettes who were first surveyed in 2016

and then successfully re-contacted in 2018. The participants were part of a

survey project conducted in Australia, Canada, England, and the United

States. Compared with users of tobacco flavors, those vaping “sweet” flavors

were more likely to quit smoking between surveys (13.8 percent vs. 9.6

percent). In addition, there was a net shift away from tobacco flavor among

those who continued to vape at follow-up.

Prohibitions on flavors also have predictable consequences. Users would be

likely to resume cigarettes if their preferred flavors are no longer available.

A 2021 paper published in

Addictive Behaviors

reports on findings from the

2020 ITC Smoking and Vaping Survey wherein researchers collected data from

851 regular vapers (all current or ex-smokers) across the U.S., Canada, and

England. They found that 28.3 percent of respondents reported they would

find a way to get their banned flavor(s) and 17.1 percent would stop vaping

and smoke instead.

A study on teens in the wake of a 2018 San Francisco ban on flavors

published last year in

JAMA Pediatrics

drew data from the 2011-2019 Youth

Risk Behavior Surveillance System school district surveys. Authors found that

San Francisco’s flavor ban was associated with more than doubled odds of

recent smoking among underage high school students relative to concurrent

changes in other districts. “This raises concerns,” the researchers caution,

“that reducing access to flavored electronic nicotine delivery systems may

motivate youths who would otherwise vape to substitute smoking.”

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75.

Similarly, online reports and social media posts describe smokers going back

to cigarettes or patronizing black markets, which are breeding grounds for

the worst manufacturing practices such as tainted nicotine liquids, defective

batteries, and heating coils are accumulating.

HNB products are available in tobacco and a limited number of other flavors,

including menthol and mint.

In light of negligible use of HNB products by

teens -- according to the 2021 U.S. National Youth Tobacco Survey, 1.8

percent of U.S. middle and high school students reported ever use of an HNB

product, and 0.7 percent reported current use

-- concern about motives to

use amongst youth has not attracted much attention.

76.

VII.

E-CIGARETTES AND HNBS DO NOT SERVE AS A GATEWAY TO SMOKING

77.

Understandably, the possibility that non-smoking youth who initiate vaping

will then turn to smoking is of vast concern to public health officials,

politicians, and parents. Hence, the question of whether e-cigarettes serve

as a “gateway” to smoking has been extensively researched, with many

tobacco control advocates routinely suggesting this is in fact the case. The

EU Scientific Committee on Health, Environmental and Emerging Risks

(SCHEER) Final Opinion on Electronic Cigarettes

and the “WHO Report on

the global tobacco epidemic 2021: New and Emerging Products” have

sounded similar notes of caution that allowing vaping will serve as a

“gateway” to initiation to smoking.

As will be discussed below, robust data

analyses show that vaping is more of a “gateway” out of a smoking addiction

for teens than it is a passage into a new smoking habit for those who have

never smoked. Indeed, just as the data suggest that vaping and other non-

combustibles reduce smoking by increasing rates of cessation, so too do the

data suggest that non-combustibles reduce rates of smoking initiation in

adolescents and young adults – the time in life when most smokers start

experimenting with cigarettes for the first time.

Reassuringly, there is little evidence that teens who vape move on to

smoking. Data from the U.S., in fact, shows the exact opposite trend wherein

smoking rates of minors have declined at unprecedented speed in the last

decade. More specifically, current youth smoking dropped more steeply in

the years that teen vaping increased most sharply, between 2013 and 2019,

reaching a record low in 2020 of 4.6 percent.

100

Another analysis shows that

U.S. youth smoking rates fell to 6.0 percent by 2019 (thereby surpassing the

Healthy People 2020 objective of 16 percent by 386 percent).

101

This pattern, and

other analyses, suggest that vaping serves as more of an off-ramp from smoking

or as an alternative for adolescents and young adults who would have otherwise

initiated smoking. In addition, most adolescent and young adult users of vaping

products are infrequent users or experimenters; the minority that use e-

cigarettes frequently (defined as 20 to 30 days in the past month) largely

comprises those who have already used tobacco. In 2018, only 1 percent of teens

who never used tobacco frequently vaped.

102

Furthermore, the most recent data from the U.S. Centers for Disease Control

show that vaping among U.S. teens has decreased since 2019. That year, 10.5

percent of middle school students and 27.5 percent of high schoolers used an e-

cigarette at least once in the past month. In 2020, 4.7 percent of middle and 19.6

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percent high school students reported using e-cigarettes within the past 30 days

(current use), according to the CDC. In 2021, 2.8 percent of middle school

students and 11.3 percent of high school reported current e-cigarette use.

103

For

perspective, 5.4 percent of 12

graders vape daily (while 6.9 percent use

marijuana daily and 16.8 percent report binge drinking (more than five drinks in a

row in the last two weeks.))

104

80.

The situation is similar in the UK, where the evidence shows that "[r]egular use of

electronic cigarettes amongst children and young people is rare and is confined

almost entirely to those who currently or have previously smoked." A 2021

factsheet by UK ASH on the use of e-cigarettes among young people in Great

Britain found that "while some people, particularly those who have tried smoking,

experiment with e-cigarettes, regular use remains low." ASH also found that:

"[u]se of e-cigarettes remains largely confined to current or former smokers. The

overwhelming majority, 95.4% in total, of 11-17 year old never smokers have

either never used an e-cigarette (84.3%) or are not aware of them (10.7%)" and

"[o]f 11-17 year old never smokers, 3.3% have tried e-cigarettes once or twice,

0.5% use them less than weekly, and 0.2% use e-cigarettes more than once a

week. Only 1 single never smoker reported vaping daily, and only 0.3% were

previous users of e-cigarettes."

105

It should also be noted that the gateway claim itself is ambiguous, in part

because commentators use the term "gateway" in various ways. Sometimes

“gateway” simply refers to a sequence (action B came after action A); and at

other times it refers to a predictive, causal statement (a person engaged in

action B because he first engaged in A). It is the latter that policymakers

should care about – that is, but for the use of A would B have happened – but

causality is very hard to prove by examining observational data.

After all, it is possible that action B would have happened independent of

behavior A. For example, a teen with a high tendency toward risk-taking

behavior, such as alcohol and marijuana use, or one who is subject to peer

and familial influences that promote risk-seeking behavior, would be prone to

try or use both e-cigarettes and cigarettes independently of each other. This

phenomenon is known as “the common liability theory” of associated

behaviors.

106

Such a teen, therefore, might well have smoked, whether or

not he first vaped, based on shared innate and experiential factors.

number of large studies confirm this “third-factor” dynamic.

107

It would be

wrong to infer, therefore, that someone who vaped and then went on to

smoke did so because vaping was a causal “gateway” to smoking, when

personal, peer and family influences that correlate with a higher propensity

to vape are similar to the same factors that correlate with a higher propensity

to smoke.

This common liability theory is supported by data from Wave 1 (2013-2014)

of the Population Assessment of Tobacco and Health (PATH) by Nicksic and

others. The researchers found that general interest in vaping, peer

influences, social norms, desirable attributes, and goal-directed reasons

influence e-cigarette uptake in both teens and adults.

108

These same factors

are influential in prompting adolescent smoking initiation. Researchers also

enquired about flavors in the context of “reasons to use” e-cigarettes and

found that “It

comes in flavors I like”

lagged sixth in an array of reasons,

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including the fact that they “might be less harmful to people around me,”

“they do not smell,” and others.

84.

Likewise, researchers in a 2020 study published in

Nicotine & Tobacco

Research,

examined respondents to the 2015–2016 waves of US Monitoring

the Future survey

109

using propensity score methods to robustly adjust for

shared risks in estimating the relationship between e-cigarette use and

conventional smoking. Among those 14 shared risk factors were: disciplinary

problems, current alcohol or marijuana, or lifetime illicit drug consumption,

and the highest level of education completed by the father. After accounting

for the propensity for using e-cigarettes based on these 14 risk factors, both

lifetime and current e-cigarette use did not significantly increase the risk of

current conventional cigarette smoking. The authors state that these findings

do not support “the concerns that e-cigarettes act as a ‘gateway’ to

conventional cigarette smoking….”

These data indicate that e-cigarettes do not exert a causal effect on

concurrent conventional smoking among adolescents and young adults. Such

findings also parallel already well-established predictors of progression from

the first few puffs to daily smoking. As reviewed by Wellman and colleagues

in the

American Journal of Prevention,

these factors include male sex, lower

socio-economic status, poor academic performance, sensation-seeking or

rebelliousness, intention to smoke in the future, receptivity to tobacco

promotion efforts, susceptibility to smoking, family members’ smoking, and

having friends who smoke. Higher self-esteem and high parental

monitoring/supervision of the child appeared to protect against smoking

onset.

110

Consistent with these data, one research team confirmed that associations

between adolescent e-cigarette use and subsequent smoking are more likely to

arise from common risk factors in a 2020 paper entitled, “The Relationship

Between Electronic Cigarette Use and Conventional Cigarette Smoking Is Largely

Attributable to Shared Risk Factor.”

111

Examining cross-sectional data from 8th

and 10th graders drawn from the 2015–2016 waves of U.S. Monitoring the Future

survey, the authors inferred that “the apparent relationship between e-cigarette

use and

current

conventional smoking is fully explained by shared risk factors,

thus failing to support claims that e-cigarettes have a causal effect on concurrent

conventional smoking among youth.” Along those lines, another article entitled,

“High School Seniors Who Used E-Cigarettes May Have Otherwise Been Cigarette

Smokers: Evidence from Monitoring the Future (United States, 2009–2018),”

112

found that among non-smoking youth, vaping is largely concentrated among

those who would have likely smoked prior to the introduction of e-cigarettes.

Furthermore, and strikingly, the introduction of e-cigarettes coincided with an

acceleration in the decline in youth smoking rates, the report revealed.

Reviewing the most recent (2020) longitudinal data from the U.S. Population

Assessment of Tobacco and Health (PATH), a team of epidemiologists integrated

data over six years, expressed in waves (wave 1: 2013–2014; wave 2: 2014–2015;

wave 3: 2015–2016; wave 4: 2016–2017; wave 4.5: 2017–2018; and wave 5:

2018–2019).

113

Notably, this study, which appeared in

Nicotine and Tobacco

Research

in December 2021 included an unprecedented set of dependent

variables (e.g., the adolescents’ exposure to tobacco users (family members who

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use tobacco, secondhand smoke exposure, friends who use tobacco); cigarette

smoking susceptibility; and behavioral risk factors, specifically including

respondents’ previous use of other tobacco products, alcohol, and marijuana as

measures of adolescents’ proclivity for use of psychoactive substances.) The

study aimed to determine whether a more substantial set of covariates affected

the finding of a statistically significant association between vaping at baseline and

subsequent smoking. The answer was 'yes': adjusting for a full set of confounders

weakened substantially the association of ever e-cigarette use with subsequent

smoking and even became non-significant in some waves, using both past 12-

month and past 30-day smoking as outcomes. In brief, the researchers report

having found “no direct association between ever vaping and subsequent

cigarette smoking among adolescents.”

88.

A recent study published in

Addiction

114

which was carried out by researchers

from the Department of Behavioural Science and Health, University College

London, UK, assesses how changes in the prevalence of e-cigarette use among

young adults have been associated with changes in the uptake of smoking in

England between 2007 and 2018. The authors use a time series analysis. The

researchers found that there was evidence for no association between the

prevalence of e-cigarette use and ever-regular smoking among those aged 16–24.

VIII.

IMPLICATIONS FOR PUBLIC HEALTH POLICY

89.

Adverse health consequences of combustible tobacco products are significant.

The WHO estimates that there are 1.3 billion tobacco users worldwide and that

tobacco kills more than 8 million people each year.

The products of combustion of tobacco, such as tar and other toxins and gases,

are the overwhelming source of carcinogens and the cause of hypertension, lung

disease, and cardiovascular pathology associated with smoking. In general,

nicotine products that do not involve combustion, including e-cigarettes and HNB

products, are less hazardous than those that burn tobacco leaves.

In my opinion, current smokers must have access to and be properly informed

about safer options. This imperative is aligned with the WHO FCTC, which

includes tobacco harm reduction within its principles.

In their campaigns against e-cigarettes, many health agencies and advocates

breach two fundamental tenets of public-health practice: dispassionate and

nuanced analysis of risk and honest communication about that risk to the public.

Opponents of vaping often define the problem solely as a matter of teen vaping

while abdicating their responsibility to address the problem of adult smoking.

Youth should not vape, nor should adults smoke. Both imperatives need to be

taken into account and trade-offs made. Unfortunately, a vast swath of the

tobacco-control community seem to forget that the purview of public health is

the nation’s entire population of vulnerable people, not just youth, and

particularly groups that smoke at disproportionately high rates, including people

suffering mental illness, working-class men and women, indigenous people and

LGBT+ adults.

The ultimate loss of perspective, jarring in its significance to anyone who looks

beyond the vaping debate, is that regulation which restricts access or awareness

of safer alternatives is liable to have an adverse impact on public health by

90.

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perpetuating the use of more hazardous combustible cigarettes. In an essay

published in September 2021

115

, fifteen past presidents of a leading professional

academic society in the field of tobacco control, the Society for Research on

Nicotine and Tobacco (SRNT), concluded: "While evidence suggests that vaping is

currently increasing smoking cessation, the impact could be much larger if the

public health community paid serious attention to vaping’s potential to help adult

smokers, smokers received accurate information about the relative risks of vaping

and smoking, and policies were designed with the potential effects on smokers in

mind. That is not happening."

94.

Public health policy should be directed to educating smokers about the

comparative risks of different tobacco and nicotine products and facilitating a

switch to less risky substitutes, and not be such as to discourage or make that

switch more difficult.

However, national and local governments are proposing and implementing a

growing number of restrictive measures on non-combustibles. Product bans, too,

have been implemented. Other restrictions include prohibiting flavors other than

tobacco, restricting nicotine content, applying the same restrictions for tobacco

products to non-combustibles, such as tobacco style large graphic health

warnings, standardized packaging of products, retail display bans, and higher

taxes. In my opinion, these types of restrictive measures are ill-advised.

There is no doubt that these measures will cause many smokers to refrain from

switching to safer alternatives, to lure those who have already switched back to

smoking or to patronize illicit markets. Banning the sale of non-combustibles

outright virtually guarantees that smokers will continue smoking. It also puts

teens — the very stimulus for the ban — at increased risk for smoking.

As noted above, when flavored vapes are no longer available, many nicotine users

won’t just quit. Some will use cigarettes. Others will turn to the unregulated

black market to continue buying flavored e-cigarettes, for which vapers have a

strong preference.

Similarly restricting the nicotine content of alternative products to low levels

would likely discourage switching and increase relapse. As noted above, research

indicates that regulations that unduly restrict the nicotine level in e-cigarettes to

levels that smokers find unsatisfactory undermine the potential for smokers to

switch away from smoking.

Regulating non-combustibles in the same way as combustible products, including

requiring the same style of warnings, requiring the same standardized packaging

as tobacco products, and banning product displays, conveys the message that

these products pose the same health risks as combustible tobacco products. As

noted above, existing misperceptions are likely preventing some smokers from

switching to non-combustibles. Recognized public health experts Lyn Kozlowski

and David Sweanor state that, "[t]he error of presenting products with no

meaningful risk reduction as if they were safer cannot be redressed by

committing the equally life-threatening error of presenting products with large

risk reductions as if they are not safer or by concealing this information." Omitting

health-relevant information for consumers, the duo states, "effectively blindfolds

them and impairs their making informed personal choices."

116

95.

96.

97.

98.

99.

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100.

Policymakers should also make non-combustibles more accessible to smokers

by eschewing hefty taxes. While high cigarette taxation can be justified by

the adverse health effects of smoking, such rationale does not apply to safer

alternatives. Imposing significant taxes on non-combustible products would

make them less accessible as alternatives to smoking and will predictably

perpetuate the demand for combustibles.

As for concerns regarding youth, everyone agrees they should not vape.

However, as discussed above, an extremely small percentage of teenagers

use e-cigarettes regularly, and one of the biggest concerns — namely, that

teen vaping leads to teen smoking through a so-called gateway effect — is

unsubstantiated. There is also evidence that vaping is diverting some youth

away from more dangerous smoking.

Policymakers should require reliable, informative labeling and safe manufacturing

standards for e-cigarettes. They should also allay concerns about potential

gateway use and youth addiction to nicotine by banning the marketing and sale of

e-cigarettes to minors. However, they should not be heavy-handed in restricting

marketing and sales to adults. Instead, promoting electronic cigarettes to

smokers should be a public health priority.

Given the direct medical costs of smoking as well as the productivity losses

from premature deaths, persuading more smokers to switch would result in

significant cost savings — as well as millions of lives saved each year. As

noted by David Abrams of the NYU College of Global Public Health “If

we lose

this opportunity, I think we will have blown the single biggest public health

opportunity we've ever had in 120 years to get rid of cigarettes and replace

them with a much safer form of nicotine for everybody.”

117

101.

102.

103.

IX.

CONCLUSION

104.

The purview of public health is the nation’s entire population. That includes adult

smokers, particularly those who smoke at disproportionately high rates, namely,

people suffering mental illness, working-class men and women, those who live in

rural areas, indigenous people, and LGBT+ adults. Governments and regulators

must not allow the intense focus on teen use – warranted though it is – to divert

all attention from the benefits of vaping for adult smokers, millions of who die

each year from smoking-related diseases.

Intrinsic to the controversy in relation to non-combustibles is the fact that the

benefits of these products to smokers are not widely appreciated. What’s more,

studies purporting to have identified vaping-related harms often exaggerate

those alleged negative effects. Researchers cannot conduct an optimal analysis of

the risks and benefits of vaping to the population as a whole – a public health

imperative –unless they take into account the significant advantages of non-

combustibles to smokers. Finally, when the known realities are considered, it

becomes clear that it is irrational to impose bans or overly restrictive regulations

on non-combustibles which will inhibit the tobacco harm reduction potential of

these products for smokers.

A number of harmful unintended consequences will likely result from bans and

overly restrictive regulation. An outright ban on non-combustibles or overly

restrictive regulation (including overly restrictive caps on nicotine strength, flavor

105.

106.

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for smoking cessation". Addict Behav. 2021 Aug;119:106912. doi: 10.1016/j.addbeh.2021.106912. Epub

2021 Mar 15. PMID: 33798919

Hair, E.C., Bennett, M., Sheen, E., Cantrell, J., Briggs, J., Fenn, Z., Willett, J.G. and Vallone, D. (2018),

“Examining perceptions about IQOS heated tobacco product: consumer studies in Japan and

Switzerland”, Tobacco Control, Vol. 27, pp. s70-s73.;

Tabuchi, T., Gallus, S., Shinozaki, T., Nakaya, T., Kunugita, N. and Colwell, B. (2018), “Heat-not-burn

tobacco product use in Japan: its prevalence, predictors and perceived symptoms from exposure to

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January 29, available at:

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decrease-in-cigarette-sales/

K. Michael Cummings, Georges J Nahhas and David T Sweanor., (2021) “What Is Accounting for the

Rapid Decline in Cigarette Sales in Japan?” Int. J. Environ. Res. Public Health, 17(10), 3570.

Filter Magazine (2019), “Rise of heat-not-burn products coincides with a decrease in cigarette sales”,

January 29, available at:

https://filtermag.org/rise-of-heat-not-burn-products-correlates-with-

decrease-in-cigarette-sales/

Korea Times (2019), “Korea world’s no. 2 heated tobacco market”, July 19, available at:

https://www.koreatimes.co.kr/www/tech/2019/07/693_271976.html

(accessed 15 January 2020).

Passport (2020), “Tobacco, database, Euromonitor international”, available at:

https://go.euromonitor.com/passport.html

Wang TW, Gentzke AS, Creamer MR, et al. (2019) "Tobacco Product Use and Associated Factors Among

Middle and High School Students — United States, 2019". MMWR Surveill Summ 2019;68(No. SS-12):1–

22. DOI: http://dx.doi.org/10.15585/mmwr.ss6812a1. Available at:

https://www.cdc.gov/mmwr/volumes/68/ss/ss6812a1.htm

Russell C, et.al., (2018) "Changing patterns of first e-cigarette flavor used and current flavors used by

20,836 adult frequent e-cigarette users in the USA", Harm Reduction Journal volume 15: 33

Abigail S Friedman and Xu, S. (2020) "Associations of flavored e cigarette uptake with subsequent

smoking initiation and cessation". JAMA Network Open ;3(6):e203826. Available at:

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Lin L, et al., "How Does the Use of Flavored Nicotine Vaping Products Relate to Progression Toward

Quitting Smoking? Findings From the 2016 and 2018 ITC 4CV Surveys", Nicotine & Tobacco Research,

Volume 23, Issue 9, September 2021, Pages 1490–1497,

https://doi.org/10.1093/ntr/ntab033

Gravely, Shannon et. al., (2022) "Responses to potential nicotine vaping product flavor restrictions

among regular vapers using non-tobacco flavors: Findings from the 2020 ITC Smoking and Vaping

Survey in Canada, England and the United States", Addictive Behaviors Volume 125, February 2022,

107152.

Abigail S. Friedman (2021) "A Difference-in-Differences Analysis of Youth Smoking and a Ban on Sales of

Flavored Tobacco Products in San Francisco", California JAMA Pediatr. 2021;175(8):863-865.

doi:10.1001/jamapediatrics.2021.0922

Heat Not Burn.Heets product profile. Available at:

https://heatnotburn.co.uk/product-category/heets/

Gentzke AS, Wang TW, Jamal A, et al. Tobacco Product Use Among Middle and High School Students —

United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1881–1888. DOI:

http://dx.doi.org/10.15585/mmwr.mm6950a1

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), (2021), "Scientific

Opinion on electronic cigarettes", 16 April 2021. Available at:

https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_017.pdf

Geneva World Health Organisation (2021) "WHO report on the global tobacco epidemic 2021:

addressing new and emerging products". Licence: CC BY-NC-SA 3.0 IGO. Available at:

https://www.who.int/publications/i/item/9789240032095

Gentzke AS, Wang TW, Jamal A, et al. Tobacco Product Use Among Middle and High School Students —

United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1881–1888.

DOI:

http://dx.doi.org/10.15585/mmwr.mm6950a1.

Abouk R, et al. (2021) "Intended and Unintended Effects of E-Cigarette Taxes on Youth Tobacco Use",

National Bureau of Economic Research. Available at:

https://www.cdc.gov/mmwr/volumes/70/wr/mm7039a4.htm

Glasser A, Johnson A, Niaura R, et al., (2020) Youth Vaping and Tobacco Use in Context in the United

States: Results from the 2018 National Youth Tobacco Survey, Nicotine Tob Res. 1-7

Abouk R, et al. (2021) "Intended and Unintended Effects of E-Cigarette Taxes on Youth Tobacco Use",

National Bureau of Economic Research. Available at:

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http://monitoringthefuture.org/data/20data/table4.pdf

ASH (2021), "Use of e-cigarettes among young people in Great Britain". Available at:

https://ash.org.uk/wp-content/uploads/2021/07/Use-of-e-cigarettes-among-young-people-in-Great-

Britain-2021.pdf

Kim S and Selya AS (2020) "The relationship between electronic cigarette use and conventional

cigarette smoking is largely attributable to shared risk factors". Nicotine Tob Res. 22(7):1123–1130

Adkison SE, et al. "Electronic nicotine delivery systems: international tobacco control four-country

survey". Am J Prev Med. 2013 Mar;44(3):207-15. doi: 10.1016/j.amepre.2012.10.018. PMID: 23415116;

PMCID: PMC3627474; Nicksic, N. E., Snell, L. M., & Barnes, A. J. (2019), "Reasons to use e-cigarettes

among adults and youth in the Population Assessment of Tobacco and Health (PATH) study". Addictive

behaviors, 93, 93–99.

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Bold KW, Kong G, Cavallo DA,

Camenga DR, & Krishnan-Sarin S (2016). Reasons for trying e-cigarettes and risk of continued use.

Pediatrics, 138(3), e20160895 10.1542/peds.2016-0895; Choi, A. L., Grandjean, P., Sun, G., & Zhang, Y.

(2013). "Developmental fluoride neurotoxicity: Choi et al. Respond". Environmental health

perspectives, 121(3), A70.

https://doi.org/10.1289/ehp.1206192R;

Kong G, Morean ME, Cavallo DA,

Camenga DR, Krishnan-Sarin S, (2015) "Reasons for Electronic Cigarette Experimentation and

Discontinuation Among Adolescents and Young Adults". Nicotine Tob Res. 2015 Jul;17(7):847-54. doi:

10.1093/ntr/ntu257. Epub 2014 Dec 6. PMID: 25481917; PMCID: PMC4674436; Pepper JK, Ribisl KM,

Emery SL, Brewer NT. (2014), "Reasons for starting and stopping electronic cigarette use", Int J Environ

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adults and youth in the Population Assessment of Tobacco and Health (PATH) study", Addict Behav.

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cigarette smoking is largely attributable to shared risk factors" Nicotine Tob Res.2020;22(7):1123–1130

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Longitudinal Population-Based Studies in Youth", Am J Prev Med 2016;51(5):767–778

Sooyong Kim, MD, Arielle S Selya, PhD, (2020), "The Relationship Between Electronic Cigarette Use and

Conventional Cigarette Smoking Is Largely Attributable to Shared Risk Factors", Nicotine & Tobacco

Research, Volume 22, Issue 7, July 2020, Pages 1123–1130,

https://doi.org/10.1093/ntr/ntz157

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Cigarette Smokers: Evidence From Monitoring the Future (United States, 2009-2018)", Nicotine Tob

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Beard E, Brown J, Shahab L. (2022), "Association of quarterly prevalence of e-cigarette use with ever

regular smoking among young adults in England: a time-series analysis between 2007 and 2018".

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Balancing Consideration

of the Risks and Benefits of E-Cigarettes.

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products: The public health ethics of health information quarantines. Int J Drug Policy. 2016 Jun;32:17-

23. doi: 10.1016/j.drugpo.2016.03.014. Epub 2016 Apr 1

E-cigarette panic is ruining "biggest public health opportunity" in 120 years, scientist says,

CBS News,

September 20, 2019.

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Sally L. Satel, M.D.

Curriculum Vitae

Date CV Prepared:

April 19, 2019

Personal Data

Name:

Contact Information:

Sally L. Satel, M.D.

Division of Behavioral Health Services and Policy

Research, New York State Psychiatric Institute

1051 Riverside Drive Box 100

New York, NY 10032

Phone: 202-489-6654

Email:

New York, NY

USA

Birth place:

Citizenship:

Academic Appointments, Hospital Appointments, and Other Work Experience

2019 - Present

Vising Professor of Psychiatry, Department of Psychiatry, Columbia

University Irving Medical Center, Department of Behavioral Health

Services and Policy Research

2018 - Present

2010 - Present

2002 - Present

2000 - Present

1995 - Present

1997 - 2009

1996 - 1997

1995 - 1996

1994 - 1996

1988 – 1995

Clinical Consultant, Ironton-Lawrence Community Action Organization,

Addiction treatment

Psychiatric consultant, Partners in Drug Abuse Rehab and Counseling

(PIDARC)

resident scholar, American Enterprise Institute

Resident Scholar, American Enterprise Institute Project

Lecturer, Yale University School of Medicine

Staff Psychiatrist, Oasis Clinic

Professional Staff, U.S. Senate Veterans' Affairs Committee

Staff Psychiatrist, District of Columbia Superior Court Pretrial Program

Consultant to the U.S. Senate Special Committee on Aging

Visiting Research Scientist, University of Pennsylvania School of

Medicine

Assistant Professor of Psychiatry, Yale University School of Medicine

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1993 – 1994

1990 - 1993

1988 – 1993

Education

8/1982-6/1984

7/1977-6/1982

8/1973-6/1977

Training

1985 – 1988

1984 – 1985

Robert Wood Johnson Health Policy Fellow, Office of Senator Nancy L.

Kassebaum (R-KS)

Member medical school admissions committee

Staff psychiatrist, West Haven VA Medical Center, Yale University

School of Medicine

M.D., Warren Alpert Medical School of Brown University, Boston, MA

M.S. in Anatomy, University of Chicago

B.S. in Biology, Cornell University

Resident in Psychiatry, Yale University School of Medicine

Intern, Flexible Internship, Hospital of St. Raphael, Yale University

School of Medicine

Board Certification

1997

Board of Psychiatry and Neurology

Honors and Awards

1993 - 1994 Laughlin Fellowship (American College of Psychiatrists) for outstanding resident

1988

Robert Wood Johnson Health Policy Fellowship

Academic Services

2018 - 2021 Member, National Advisory Council of the Substance Abuse and Mental Health

Services Administration

2002 – 2006

2003 – 2003

1996 – 2003

Member, Advisory Council, Center for Mental Health Services

Member, Editorial Board, Psychiatric Services

Fellowship and Grant Support

1999 – 2000

Robert Wood Johnson Foundation President's Grant

Co-Investigator; wrote a paper on Drugs in courts

$50,000.00

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Publications

Peer-Reviewed Research Publications in Print or other Media

Satel, S. L.*,

& Lilienfeld, S.O. (2016). If addiction is not best conceptualized a brain

disease, then what kind of disease is it?

Neuroethics

Nov 17.

Satel, S.*,

& Cronin D.C. (2015). Time to test incentives to increase organ donation

(Commentary)

JAMA Intern Med.

175(8):1329-30.

Satel, S.*,

Morrison, J.C., & Jones, R.K. (2014) State organ-donation incentives under

the National Organs Transplant Act.

Law and Contemporary Problems

77:217-252.

Satel, S.*

(2014) Delivering services to individuals with severe mental illness: SAMHSA

Falls Short.

Psychiatr Serv.

65(9):1160-1.

Satel S.*,

& Lilienfeld, S.O. Addiction and the brain-disease fallacy.

Front Psychiatry

3;4:141.

6. Working Group on Incentives for Living Donation. (2012). International guidelines for

organ incentives.

American Journal of Transplantation, 12:

306-312.

Satel, S.*,

& Lilienfeld, S. O. (2010). Singing the brain disease blues.

American Journal

of Bioethics Neuroscience, 1(1):46-54.

Satel, S.*

(2010). The physician’s voice is only one of many.

American Journal of

Transplantation,

July 15.

9. Matas, A.J., Hippen, B., &

Satel, S.

(2008). In defense of a regulated system of

compensation for living donation.

Current Opinion in Organ Transplantation, 13(4):

379-85.

10.

Satel, S. L.*

(2007). 9/11: Mental health in the wake of terrorist attacks.

Psychiatric

Services, 58(February):276-77.

11.

Satel, S. L.*,

& Hippen, B. E. (2007). When altruism is not enough: The worsening

organ shortage and what it means for the elderly.

The Elder Law Journal, 15(1):101-152.

12.

Satel, S.*

(2006). Is caffeine addictive? – A review of the literature.

American Journal of

Drug and Alcohol Abuse, 32(4):

493-502.

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13.

Satel, S.*

(2005). Physician substance abuse.

Journal of the American Medical

Association, 294(4):

426-7; author reply 427.

14.

Satel, S.*

(2005). Posttraumatic Stress Disorder: Issues and Controversies.

Psychiatric

Services, 56:758-759.

15.

Satel, S.*,

& Klick, J. (2005). The Institute of Medicine report: too quick to diagnose

bias.

Perspectives in Biology and Medicine, 48(1

Suppl): S15-25.

16.

Satel, S. L.*

(2003). A war of nerves: Soldiers and psychiatrists in the twentieth century.

Psychiatric Services, 54(3):

405-406.

17.

Satel, S. L.*

(2003) The mental health crisis that wasn’t.

Psychiatric Services,

54(12):1571.

18.

Satel, S. L.*

(2001). Commentary: Who needs trauma initiatives?

Psychiatric Services,

52(6):815.

19.

Satel, S.*

(2000). Addiction is a choice.

Psychiatric Services, 52(4):

539-540.

20.

Caulkins, J., &

Satel, S.

(1999). Methadone patients should not be allowed to persist in

cocaine use.

FAS Drug Policy Analysis Bulletin, 6(January).

21.

Satel, S. L.*,

& Aeschbach, E. (1999). The Swiss heroin trials. Scientifically sound?

Journal of Substance Abuse Treatment, 17(4):331-5.

22.

Satel, S. L.*

(1999). What should we expect from drug abusers?

Psychiatric Services,

50(7):861.

23. Gelernter, J., Kranzler, H., &

Satel, S. L.

(1999). No association between D2 dopamine

receptor (DRD2) alleles or haplotypes and cocaine dependence or severity of cocaine

dependence in European- and African-Americans.

Biological Psychiatry, 45(3):340-5.

24.

Satel, S. L.*

(1998). Are women’s health needs really “special”?

Psychiatric Services,

49(5):565.

25.

Satel, S.*

(1997). Drug addicts and disability payments.

FAS Drug Policy Analysis

Bulletin, 3(September).

26.

Satel, S.*,

Reuter, P., Hartley, D., Rosenheck, R., & Mintz, J. (1997). Influence of

retroactive disability payments on recipients' compliance with substance abuse treatment.

Psychiatric Services, 48(6):796-9.

27. Freimer, M., Kranzler, H.,

Satel, S.,

Lacobelle, J., Skipsey, K., Charney, D., & Gelernter,

J. (1996). No association between D3 dopamine receptor (DRD3) alleles and cocaine

dependence.

Addiction Biology, 1(3):281-7.

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28.

Satel, S. L.*

(1995). When disability benefits make patients sicker.

New England Journal

of Medicine, 333(12):794-6.

29.

Satel, S. L.*,

Krystal, J. H., Delgado, P. L., Kosten, T. R., & Charney, D. S. (1995).

Tryptophan depletion and attenuation of cue-induced craving for cocaine.

American

Journal of Psychiatry, 152(5):778-83.

30. Gelernter, J., Kranzler, H. R.,

Satel, S. L.,

& Rao, P. A. (1994). Genetic association

between dopamine transporter protein alleles and cocaine-induced paranoia.

Neuropsychopharmacology, 11(3):195-200.

31. Kranzler, H. R.

Satel, S.,

& Apter, A. (1994). Personality disorders and associated

features in cocaine-dependent inpatients.

Comprehensive Psychiatry, 35(5):335-40.

32.

Satel, S.*

(1994). Health care reform: a reality check.

Hospital and Community

Psychiatry,45(9):849.

33.

Satel, S. L.*,

Becker, B. R., & Dan, E. (1993). Reducing obstacles to affiliation with

alcoholics anonymous among veterans with PTSD and alcoholism.

Hospital and

Community Psychiatry, 44(11):1061-5.

34.

Satel, S. L.*,

& Glazer, W. M. (1993). Supporting addiction with public funds.

Hospital

and Community Psychiatry, 44(10):913.

35.

Satel, S. L.*

(1993). The diagnostic limits of "addiction".

Journal of Clinical Psychiatry,

54(6):237-8.

36. Hoffman, R. E., &

Satel, S. L.

(1993). Language therapy for schizophrenic patients with

persistent ‘voices’.

British Journal of Psychiatry, 162:755-8.

37.

Satel, S. L.*,

Kosten, T. R., Schuckit, M. A., & Fischman, M. W. (1993). Should

protracted withdrawal from drugs by included in the DSM-IV?

American Journal of

Psychiatry, 150(5):695-704.

38.

Satel, S. L.*,

& Swann, A. C. (1993). Extrapyramidal symptoms and cocaine abuse.

American Journal of Psychiatry, 150(2):347.

39. Seibly, J. P.,

Satel, S. L.,

Anthony, D., Southwick, S. M., Krystal, J. H., & Charney, D.

S. (1993). Effects of cocaine on hospital course in schizophrenia.

Journal of Nervous and

Mental Disease, 181(1):31-7.

40.

Satel, S. L.*,

& Howland, F. C. (1992). Multiple personality disorder presenting as

postpartum depression.

Hospital and Community Psychiatry, 43(12):1241-3.

41.

Satel, S. L.*,

Price, L. H., Palumbo, J. M., McDouble, C. J., Krystal, J. H., Gawin, F.,

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Charney, D. S., Heninger, G. R., Kleber, H. D. (1991). Clinical phenomenology and

neurobiology of cocaine abstinence: a prospective inpatient study.

American Journal of

Psychiatry, 148(12):1712-6.

42.

Satel, S. L.*,

& Edell, W. S. (1991). Cocaine-induced paranoia and psychosis proneness.

American Journal of Psychiatry, 148(12):1708-11.

43.

Satel, S. L.*,

Seibyl, J. P., & Charney, D. S. (1991). Prolonged cocaine psychosis implies

underlying major psychopathy.

Journal of Clinical Psychiatry, 52(8):349-50.

44.

Satel, S. L.*,

& Seibyl, J. P. (1991). DSM-III-R criteria for cocaine disorders.

American

Journal of Psychiatry, 148(8):1088.

45.

Satel, S. L.*,

& McDougle, C. J. (1991). Obsessions and compulsions associated with

cocaine abuse.

American Journal of Psychiatry, 148(7):947.

46.

Satel, S. L.*,

Southwick, S. M., & Gawin, F. H. (1991). Clinical features of cocaine-

induced paranoia.

American Journal of Psychiatry, 148(4):495-8.

47.

Satel, S. L.*,

& Kosten, T. R. (1991). Designing drug efficacy trials in the treatment of

cocaine abuse.

Journal of Nervous and Mental Disease, 179(2):89-96.

48.

Satel, S. L.*,

Southwick, S. M., & Gawin, F. H. (1990). Clinical features of cocaine

induced paranoia.

NIDA Research Monographs, 105:371.

49.

Satel, S. L.*

(1990). Mental status changes in children receiving glucocorticoids. Review

of the literature.

Clinical Pediatrics, 29(7):383-8.

50. Southwick, S. M., &

Satel, S. L.

(1990). Exploring the meanings of substance abuse: an

important dimension of early work with borderline patients.

American Journal of

Psychotherapy, 44(1):61-67

51.

Satel, S. L.*

(1989). Audiotape playback as a technique in the treatment of schizophrenic

patients.

American Journal of Psychiatry, 146(8):1012-6.

52.

Satel, S. L.*,

& Nelson, J. C. (1989). Stimulants in the treatment of depression: a critical

overview.

Journal of Clinical Psychiatry, 50(7):241-9.

53.

Satel, S. L.*,

& Gawin, F. H. (1989). Migrainelike headache and cocaine use.

Journal of

the American Medical Association, 261(20):2995-6.

54.

Satel, S. L.*,

& Gawin, F. H. (1989). Seasonal cocaine abuse.

American Journal of

Psychiatry, 146(4):534-5.

55.

Satel, S.*,

Southwich, S., & Denton, C. (1988). Use of imipramine for attention deficit

disorder in a borderline patient.

Journal of Nervous and Mental Disease, 176(5):305-7.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Reviews, Chapters, Monographs, Editorials

Satel, S.*

(2019, April 14). Pain patients get relief from regulation.

Wall Street Journal.

Satel, S.*

(2019, March 7). Chronic pain patients are unwitting casualties in the push to

limit opioids — The CDC could change that.

AEIdeas.

Satel, S.*

(2019, February 13). Vaping Is Harm Reduction: The surgeon general is right

on opioids, but wrong on tobacco.

Wall Street Journal.

Satel, S.*

(2019, January 18). Psychologists want to change how they treat men. That’s a

problem.

Washington Post.

5. Hale, C., &

Satel S.

(2018, November 18). From Basketball to Overdose Capital: The

Story of Rural America, Schools, and the Opioid Crisis. In McShane, M. & Smarick, S.

(Eds.). No Longer Forgotten: The Triumphs and Struggles of Rural Education in

America. Lanham: Rowman & Littlefield.

Satel, S.*

(2018, November 7). The FDA was wise to approve a new opioid: The use of

Dsuvia is limited, and wounded soldiers need it.

Wall Street Journal.

Satel, S.*,

& Kertesz, S. (2018, August 17). Oregon overshoots on opioids.

Wall Street

Journal.

Satel, S.*

(2018, August 8). ‘Dopesick’ and ‘The Addiction Solution’ review: Examining

an epidemic.

Wall Street Journal.

Satel, S.*

(2018, May 15). Vapin’ in the boys’ room.

Wall Street Journal.

10. Rich, J., &

Satel, S.*

(2018, May 8). Access to maintenance medications for opioid

addiction is expanding. Prisons need to get on board.

Slate.

11.

Satel, S.*

(2018, April 11). Why the panic over JUUL and teen vaping may have deadly

results.

Forbes.

12.

Satel, S.*,

& Kertesz, S. (2018, March 30). Pill limits are not a smart way to fight the

opioid crisis.

Slate.

13.

Satel, S.*

(2018, March 19). Naloxone, yes, but 3 other drugs are essential to fight the

opioid epidemic.

Forbes.

14.

Satel, S.*

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Politico.

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15. Kertesz, S., Gordon, A. J., &

Satel, S.*

(2018, January 19). Opioid prescription control:

When the corrective goes too far.

Health Affairs Blog.

16.

Satel, S.*

(2018, January 17). Does it take a shrink to evaluate Trump?

Wall Street

Journal.

17.

Satel, S.*,

& Bentley, G. (2017, December 4). Feds owe the public ‘corrective

statements’ on vaping.

RealClear Health.

18.

Satel, S.*

(2017, November 27). Study shows two addiction medications similar but

dropout rates high: three possible remedies.

Forbes.

19.

Satel, S.*,

& Morse, S. J. (2017, October 27). May court send drug-using thief to jail for

violating no-drugs probation condition?

Washington Post.

20.

Satel, S.*,

& Morse, S. J. (2017, October 2). Addiction shouldn’t excuse criminal acts.

The Wall Street Journal.

21.

Satel, S.*

(2017, September 25). Why I admire Anthony Weiner.

New York Times.

22.

Satel, S.*

(2017, September 20). What the new surgeon general should do about e-

cigarettes.

Forbes.

23.

Satel, S.*,

& Kramer, P. (2017, August 29). Who decides whether trump is unfit to

govern?

New York Times.

24.

Satel, S.*,

& Kertesz, S. (2017, August 17). Some people still need opioids.

Slate.

25.

Satel, S.*

(2017, Summer). Taking on the scourge of opioids.

National Affairs.

26.

Satel, S.*

(2017, June 22). Calling it ‘brain disease’ makes addiction harder to treat.

Boston Globe.

27.

Satel, S.*,

& Viard, A. D. (2017, June 12). The kindest (tax) cut: a federal tax credit for

organ donations.

Tax Notes.

28.

Satel, S.*

(2017, May 31). Senators’ letter to FDA commissioner Gottlieb perpetuates

misconceptions about e-cigarettes.

Forbes.

29.

Satel, S.*

(2017, May 31). Fighting the opioid epidemic: A Q&A with Sally Satel.

AEI.

30.

Satel, S.*

(2017, April 20). What the New York Times gets wrong on vaping regulation.

Forbes.

31.

Satel, S.*

(2017, April 9). Saving lives is the first imperative in the opioid epidemic.

Wall

Street Journal.

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32.

Satel, S.*,

& Schuler, K. (2017, February 9). Organs for the mentally disabled.

National

Review.

33.

Satel, S.*

(2017, March 23). A defense department hotline that keeps smokers hooked.

Forbes.

34.

Satel, S.*

(2017, February 21). Right to try, right to buy, right to test.

Washington Post.

35.

Satel, S.*

(2017, February 9). Her damaged brain forgot new experiences but she still

improved on the viola.

Washington Post.

36.

Satel, S.*,

& Hendrickson, K. (2017, January 18). Use disabilities law to avoid violent

confrontations with mentally disabled people.

San Francisco Chronicle.

37.

Satel, S.*

(2017, January 13). How to treat an opioid epidemic.

Wall Street Journal.

38.

Satel, S.*

(2016, December 31). The year in e-cigarettes: the good, the bad, and some

reasons for optimism.

Forbes.

39.

Satel, S.*

(2016, December 27). Advocacy from the edge: Carrie Fisher spent decades

advocating for mental health treatment and against stigma. Here’s how we should honor

her.

Slate.

40.

Satel, S.*,

& Sweanor, D. (2016, December 19). Dear surgeon general and public health

agencies, anti-vaping polices are bad for public health.

RealClearHealth.

41.

Satel, S.*

(2016, December 8). Big tobacco is giving away money: Researchers should

take it.

Forbes.

42.

Satel, S.*

(2016, December 7). Shortcuts to addiction.

Wall Street Journal.

43.

Satel, S.*,

& Lilienfeld, S.O. (2016, November 30). What the surgeon general gets wrong

about addiction.

RealClear Health.

44.

Satel, S*.

(2016, November 20). The addiction doctor isn’t in.

RealClearHealth.

45.

Satel, S*.

(2016, November 15). You’ve heard of trump steaks, now trump kidneys.

Forbes.

46.

Satel, S.*,

& Bates, C. (2016, November 8). Could changes to a global tobacco treaty

harm health?

Slate.

47.

Satel, S.*

(2016, October 17). California ballot choices: to protect porn stars but not

smokers?

Forbes.

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48.

Satel, S.*

(2016, October 13). It’s ok to speculate about trump’s mental health.

Slate.

49.

Satel, S.*

(2016, September 26). Shameless campaign for tobacco-free kids tries to

censor researchers.

Forbes.

50.

Satel, S.*

(2016, September 15). What to do about heroin addicts who keep OD’ing.

New

York Post.

51.

Satel, S.*

(2016, September 13). Vouchers and incentives can increase kidney donations

and save lives.

Stat News.

52.

Satel, S.*

(2016, September 13). A college tuition payment for your spare kidney?

Slate.

53.

Satel, S.*

(2016, September 11). The Ritalin generation.

Wall Street Journal.

54.

Satel, S.*

(2016, August 16). Vapers wary of FDA deeming rules.

Forbes.

55.

Satel, S.*

(2016, August 9). Obamacare is hazardous to smokers’ health.

Forbes.

56.

Satel, S.*

(2016, July 15). What’s the best way to battle the expanding Zika epidemic?

Washington Post.

57.

Satel, S.*

(2016, June 27). The dearth of donors: In-kind compensation for organs would

save lives.

National Review.

58.

Satel, S.*

(2016, June 8). Mental Health Reform Desperately Needed To Pass House And

Senate.

Forbes.

59.

Satel, S.*

(2016, June). Getting Meds: Why does government make it so hard?

Washington Monthly.

60.

Satel, S.*

(2016, May 10). Is addiction a brain disease?

The Conversation.

61.

Satel, S.*

(2016, May 9). What the U.S. should learn from the UK’s wisdom on e-

cigarettes.

Forbes.

62.

Satel, S.*

(2016, April 29). When our reason is hijacked by an uncontrollable urge.

Washington Post.

63.

Satel, S.*

(2016, April 25). What’s really killing India’s smokers: Misinformation about

e-cigarettes and vaping presents a growing threat to public health.

Wall Street Journal.

64.

Satel, S.*

(2016, April 11). Congress, save e-cigarettes from the FDA.

Forbes.

65.

Satel, S.*

(2016, April 11). What smart folk snort coke.

Wall Street Journal.

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66.

Satel, S.*,

& Fuller Torrey, E. (2016, Spring). A prescription for mental-health policy.

National Affairs.

67.

Satel, S.*

(2016, March 29). You won’t believe the government is supporting this

crackpot mental health therapy.

Forbes.

68.

Satel, S.*

(2016, March 24). When harm reduction harms heroin addicts.

Forbes.

69.

Satel, S.*

(2016, March 4). Precision psychiatry: Hype or promise?

Los Angeles Review

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70.

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(2016, February 29). What government researchers get wrong about addiction.

Forbes.

71.

Satel, S.*

(2016, February 5). Exploring the mind’s power over the body.

Washington

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72.

Satel, S.*

(2016, January 23). Can shame be useful?

New York Times.

73.

Satel, S.*

(2015, December 31). The year in e-cigarettes: The good, the bad, the reason

for optimism.

Forbes.

74.

Satel, S.*

(2015, December 28). Generosity won’t fix our shortage of organs for

transplants.

Washington Post.

75.

Satel, S.*

(2015, December 14). What drug czar Botticelli got wrong on ’60 minutes’.

Forbes.

76.

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& Fuller Torrey, E. (2015, December 11). How bad can a federal agency be?

National Review.

77.

Satel, S.*

(2015, November 17). Why HUD should allow vaping in public housing.

Forbes.

78.

Satel, S.*

(2015, November 13). Treatment alone won’t stop heroin epidemic.

Bloomberg.

79.

Satel, S.*

(2015, November 11). Should drug addicts be forced into treatment?

Compelled drug addiction treatment works because of retention.

New York Times.

80.

Satel, S.*

(2015, November 4). In fight against opioid crisis, civil commitment can save

lives.

Boston Globe.

81.

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(2015, October 30). Diagnosing the urge to run for office.

Politico.

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82.

Satel, S.*

(2015, October 21). Keep vaping China, don’t listen to the World Health

Organization on e-cigarettes.

Forbes.

83.

Satel, S.*

(2015, October 6). How vapers can help smokers quit.

Forbes.

84.

Satel, S.*

(2015, September 15). The bioethics dilemma.

Pacific Standard Magazine.

85.

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(2015, September 9). Why public health advocates care more about heroin

addicts than smokers.

Forbes.

86.

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& Volokh, E. (2015, August 6). Dr. Sally Satel on why James Holmes (the

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Washington Post.

87.

Satel, S.*

(2015, July 30). Double standard: E-cigarettes vs. medical marijuana.

Forbes.

88.

Satel, S.*

(2015, July 21). Why heroin use is surging among women–and what to do

about it.

Forbes.

89.

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mad, sick and defective. If it’s a failure of will, users are bad, immoral and weak.

Wall

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90.

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Forbes.

91. Fuller T. E., &

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National Review.

92.

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(2015, June 1). The tarring of e-cigarettes.

National Review.

93.

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& Lilienfeld, S. O. (2015, May 18). The adolescent brain defense: The

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Washington Post.

94.

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& Yeh, S. (2015, May 14). Smokeless China.

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95.

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96.

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97.

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Forbes.

98.

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Forbes.

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99.

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(2015, April 1). People who get paid by big tobacco should be able to advise

the FDA.

Forbes.

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(2015, March 12). The case for compensating kidney donors.

Pacific

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101.Satel,

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(2015, March 4). Breakthrough on e-cigarette bans: how British adoption

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102.Satel,

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Pacific Standard.

103.Satel,

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104.Satel,

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(2015, January 12). New Surgeon General should prescribe scientific honesty

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Forbes.

105.Satel,

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(2015, January 19). It’s getting better all the time. Review of Shermer’s “The

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Wall Street Journal.

106.Satel,

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107.Satel,

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Forbes.

108.Satel,

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(2014, December 1). Why anti-smoking groups should endorse snus and e-

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109.Satel,

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Bloomberg Opinion.

110.Satel,

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Forbes.

111.Satel,

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Washington

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112.Satel,

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Forbes.

113.Satel,

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114.Satel,

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115.Frueh, B. C., &

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Time.

116.Satel,

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Boston Globe.

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117.Satel,

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New

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118.Satel,

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New York Times.

119.Satel,

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The New Republic.

120.Satel,

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121.Satel,

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Bloomberg Opinion.

122.Satel,

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123.Satel,

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124.Satel,

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125.Satel,

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126.Satel,

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127.Satel,

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Bloomberg

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128.Satel,

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The Atlantic.

129.Satel,

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130.Lilienfeld,

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131.Satel,

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132.Satel,

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133.Raine, A., &

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donors so patients like Sarah Murnaghan can live.

USA Today.

135.Lilienfeld, S.O., &

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Slate.

136.Lilienfeld,

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137.Satel,

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138.Satel,

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139.Satel,

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140.

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Slate.

141.Satel,

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142.Satel,

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Time.

143.Satel,

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144.Satel,

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145.Satel,

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146.Satel,

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147.Satel,

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Bloomberg.

148.Satel,

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Wall Street Journal.

149.Satel,

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Wall Street

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150.Satel,

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Wall Street

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151.Satel,

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New York Times.

152.Satel,

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Wall Street Journal.

153.Satel,

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the status quo. That’s a good thing.

Slate.

154.Satel,

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The New Republic.

155.Satel,

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156.Satel,

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USA Today.

157.

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158.Satel,

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Wall Street

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159.Satel,

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Slate.

160.Satel,

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The New Republic.

161.Satel,

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New Internationalist

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162.Satel,

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Wall Street Journal.

163.Satel,

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Wall Street Journal.

164.Satel,

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New York Times

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165.Satel,

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The Times

166.Satel,

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New York Times Room for

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167.Satel,

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The New Republic

168.Satel,

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169.Satel,

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170.Satel,

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Policy Review.

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171.Satel,

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Slate.

172.Satel,

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The New Republic.

173.Satel,

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174.Satel,

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175.Satel,

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176.Satel,

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Forbes.

177.Satel,

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Wall Street Journal.

178.Satel,

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179.Satel,

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Wall Street Journal.

180.Satel,

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New York Post.

181.Satel,

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Forbes.

182.Satel,

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183.Satel,

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184.Satel,

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Wall Street Journal.

185.Satel,

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186.Satel,

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187.Satel,

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188.Satel,

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Forbes.

189.Satel,

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190.Satel,

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191.Satel,

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192.Satel,

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193.Satel,

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194.Satel,

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195.Satel,

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196.Satel,

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197.Satel,

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Wall Street Journal.

198.Satel,

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National Review Online.

199.Satel,

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200.Satel,

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201.Satel,

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202.Satel,

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203.Satel,

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Wall Street Journal.

204.Satel,

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205.Satel,

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206.Satel,

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207.Satel,

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208.Satel,

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New York Times.

209.Satel,

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210.Satel,

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211.Satel,

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212.Satel,

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Weekly Standard.

213.Satel,

S.*

(2007, May 15). Oxy morons.

Wall Street Journal.

214.Kushner, H. I., &

Satel, S.*(reviewers).

(2007, May). Health gulf: Medical apartheid by

Harriet A. Washington.

Commentary Magazine.

215.Satel,

S.*

(2007, April 30). Paying for kidneys.

Washington Post.

216.Satel,

S.*

(2007, April 8). Mismanaged care.

New York Times.

217.Satel,

S.*

(2007, April 3). One harsh prescription: A doctor vs. cyber humanitarianism.

National Review Online.

218.Satel,

S.*

(2007, March 16). Doing well by doing good.

Wall Street Journal.

219.Satel,

S.*

(2007, February 19). The trouble with traumatology.

Weekly Standard.

220.Satel,

S.*

(2007, February 5). First, Do Harm.

Weekly Standard.

221.Satel,

S.*

(2007). In praise of stigma. In Henningfield, J. E., Santora, P. B., & W. K.

Bickel (Eds.), Addiction treatment: science and policy for the twenty-first century.

Baltimore, MD: Johns Hopkins University Press.

222.Satel,

S.*

(2006, December 19). Sometimes, the Why Really Isn't Crucial.

New York

Times.

223.Satel,

S.*

(2006, November/December). Organs for Sale.

The American

224.Satel,

S.*

(2006, October 25). Organ donations in the USA: Recipient: A living donor let

me live on.

USA Today.

225.Satel,

S.*

(2006, August 29). Measuring the psychic pain of war.

Slate.

226.Satel,

S.*

(2006, August 21). Stressed out vets: Believing the worst about post-traumatic

stress disorder.

The Weekly Standard.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

227.Satel,

S.*

(2006, August 15). For addicts, firm hand can be the best medicine.

New York

Times.

228.Humphrey, K., &

Satel, S.*

(2006, August 11). Think Before You Drink: Talking under

the influence? They’re still your words.

National Review Online.

229.Satel,

S.*

(2006, June 5). Pharmutopia: Antidepressants and the numbing-down of

America.

Weekly Standard.

230.Satel,

S.*

(2006, May). The waiting game: The struggle to find organ donors is more

difficult with a less-than-generous public policy.

In Character.

231.Satel,

S.*

(2006, May 29). The kindness of strangers: And the cruelty of some medical

ethicists.

Weekly Standard.

232.Satel,

S.*

(2006, May 15). Death's waiting list.

New York Times.

233.Satel,

S.*

(2006, April 19). Patients adrift in a sea of clinical trials.

Medical Progress

Today.

234.Satel,

S.*(

(2006, April 5). A statement of madness.

National Review.

235.Satel,

S.*,

& Klick, J. (2006, April & May). Are Doctors Biased?

Policy Review,

136:40-54.

236.Satel,

S.*

(2006, March 1). For some, the war won't end.

New York Times.

237.Satel,

S.*

(2006, February 26). A better breed of American.

New York Times.

238.Satel,

S.*

(2006, February 23). Biased doctors? Don’t rush to pull out the race card.

National Review.

239.Satel,

S.*

(2006, February 14). A pill to treat your addiction? Don't bet the rent.

New

York Times.

240.Satel,

S.*

(2006, February 2). Smoking out cliches about race.

Medical Progress Today.

241.Satel,

S.*

(2006, January 12). Suicide risks and SSRIs: New data should change the

equation.

Medical Progress Today.

242.Klick, J., &

Satel, S.*

(2006). The health disparities myth: Diagnosing the treatment gap.

Washington, DC: AEI Press.

243.Satel,

S.*

(2005, November 22). An internet lifeline, in search of a kidney.

New York

Times.

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244.Satel,

S.*

(2005, November 4). Much ado about meth?

Tech Central Station.

245.Satel,

S.*

(2005, October 31). Political science: Is the GOP the elephant in the

laboratory?

Weekly Standard.

246.Satel,

S.*

(2005, September 27). Prescription: Flexibility.

National Review.

247.Satel,

S.*

(2005, August 22). Where's the choice?

National Review.

248.Satel,

S.*

(2005, August 16). A whiff of 'reefer madness' in U.S. drug policy.

New York

Times.

249.Satel,

S.*

& Sommers, C. (2005, August 14). Defining down mental illness.

Washington

Post.

250.Satel,

S.*

(2005, June 19). ‘The Ethical Brain': Mind over gray matter.

New York Times.

251.Satel,

S.*

(2005, June 15). Veterans: Beware of the disability trap.

The Record,

pp. L11.

252.Sommers,

H. C., &

Satel, S.*

(2005, June 19). Therapy nation: Really, we’re ok.

Orlando Sentinel.

253.Satel,

S.*

(2005, June 14). A cautionary tale.

Tech Central Station.

254.Satel,

S.*

(2005, June 13). Saving our vets once they're home: The right kind of mental

health treatment is vital.

Los Angeles Times.

255.Satel,

S.*

(2005, June 10). Marijuana as RX is a worthy goal.

The Seattle Post-

Intelligencer,

pp. B7.

256.Satel,

S.*

(2005, June 8). Good to grow.

New York Times.

257.Satel,

S.*

(2005, June 7). An infantile policy.

Tech Central Station.

258.Satel,

S.*

(2005, May 12). The children of Ground Zero.

New York Post.

259.Satel,

S.*

(2005, April 12). Just the facts, ma’am.

National Review Online.

260.Satel,

S.*

(2005, April 11). Data do not support ban on silicone breast implants.

USA

Today.

261.Satel,

S.*

(2005, March 29). Bread and shelter, yes. Psychiatrists, no.

New York Times.

262.Satel,

S.*

(2005, March 29). An infamy of one’s own.

Wall Street Journal.

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263.Sommers, C. H., &

Satel, S.*

(2005, March 29). Where were you on 1/14?

Wall Street

Journal.

264.Satel,

S.*

(2005, February 25). Should our TV programs be “quick-acting” or “long-

lasting”?

Advertising Age,

pp. 28.

265.Satel,

S.*

(2005, February 20). Brain-based leniency would give teen killers a pass.

USA

Today.

266.Satel,

S.*

(2005, February 16). TCS Convention on Biodiversity coverage: Diminishing

biodiverse returns.

Tech Central Station.

267.Humphreys, K., &

Satel, S.*

(2005, January 18). Some gene research just isn't worth the

money.

New York Times.

268.Satel,

S.*

(2005, January 14). The therapy reflex.

National Review Online.

269.Eberstadt, N., &

Satel, S.*

(2004). Health, inequality, and the scholars.

Public Interest,

157:100-118.

270.Satel,

S.*

(2004, December 10). Race and medicine can mix without prejudice.

Medical

Progress Today.

271.Satel,

S.*

(2004, October 19). Doctors behind bars: Treating pain is now risky business.

New York Times.

272.Satel,

S.*

(2004, October 10). Are you normal? Think again.

New York Times.

273.Satel,

S.*

(2004, September 20). The rush to black label (or blackball) SSRIs.

Medical

Progress Today.

274.Satel,

S.*

(2004, September 12). Bad medicine? The data on anti-depressants and child

suicide aren't conclusive.

National Review Online.

275.Satel,

S.*

(2004, September 10). Drugged and confused.

Wall Street Journal.

276.Satel,

S.*

(2004, September 6). Painful correction.

Forbes Magazine.

277.Satel,

S.*

(2004, August 6). A case of colorblind care.

Wall Street Journal.

278.Satel,

S.*

(2004, July 13). Blind rush toward AIDS therapy may prove disastrous.

Los

Angeles Times,

pp. A7.

279.Satel,

S.*

(2004, July 7). Unproved AIDS medicines risk lives.

Newsday,

pp. A35.

280.Satel,

S.*

(2004, July 1). WHO's dubious bag of HIV medicines.

Los Angeles Times.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

281.Satel,

S.*

(2004, June 29). The perils of putting national leaders on the couch.

New York

Times.

282.Satel,

S.*

(2004, May 25). Two countries, two views on antidepressants.

New York

Times.

283.Satel,

S.*

(2004, May 7). Where there's smoke.

Wall Street Journal.

284.Satel,

S.*

(2004, April 20). Do less harm? Use of an alternative smokeless tobacco

should be encouraged to reduce the damage of nicotine addiction.

Pittsburgh Post-

Gazette,

pp. F5.

285.Satel,

S.*

(2004, April 12). Science fiction.

Weekly Standard.

286.Satel,

S.*

(2004, April 6). A smokeless alternative to quitting.

New York Times.

287.Satel,

S.*

(2004, March 5). Returning from Iraq, still fighting Vietnam.

New York Times.

288.Satel,

S.*,

& Klick, J. (2004, March 1). Don't despair over disparities.

Weekly Standard.

289.Eberstadt, N., &

Satel, S.*

(2004, January). Health and the income inequality

hypothesis:

A doctrine in search of data. Washington, DC: AEI Press.

290.Satel,

S.*

(2003, November 4). The worst place for them.

Plain Dealer,

S11.

291.Satel,

S.*

(2003, November 1). Out of the asylum, into the cell.

New York Times.

292.Satel,

S.*

(2003, October 26). OxyContin half-truths can cause suffering.

USA Today.

293.

Satel, S.*,

& Humphreys, K. (2003). Mind games: The Senate’s mental health parity

bill is ill-conceived.

Weekly Standard.

294.Satel,

S.*,

& Zdanowicz. (2003, July 29). Commission’s omission: The president’s

mental health commission in denial.

National Review Online.

295.Satel,

S.*

(2003, July 24). Symptoms of modern life or ADD.

National Post,

A16.

296.Satel,

S.*

(2003, July 23). ADD overdose?

Wall Street Journal.

297.Satel,

S.*

(2003, May 19). The trauma society.

New Republic.

298.Satel,

S.*

(2003, May 2). Talk about trauma!

Wall Street Journal.

299.Satel,

S.*

(2003, March 11). Fast food ‘addiction’ feeds only lawyers.

USA Today.

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300.Satel,

S.*

(2003, March 3). Insanity goes back on trial.

New York Times.

301.Satel,

S.*

(2003, February 3). OxyMorons.

Tech Central Station.

302.Satel,

S.*

(2002, October 18). Kumbayah medicine: Why is the government paying for

research into wacky alternative treatments?

Forbes.

303.Satel,

S.*

(2002, July 26). New Yorkers don’t need therapy.

Wall Street Journal.

304.Satel,

S.*

(2002, May 5). I am a racially profiling doctor .

New York Times.

305.Satel,

S.*

(2002, April 4). Racist doctors? Don't believe the media hype.

Wall Street

Journal.

306.Satel,

S.*

(2002, March 14). It's crazy to execute the insane.

Wall Street Journal.

307.Satel,

S.*

(2002, Winter). Menopause envy: Not all guys have changed since September

11.

Women’s Quarterly

308.Satel,

S.*

(2002). Is drug addiction a brain disease? In Musto, D. F. (Ed.). One hundred

years of heroin. Westport, CT: Auburn House.

309.Satel,

S.*

(2001, December 13). Public health? Forget it; Cosmic issues beckon.

Wall

Street Journal.

310.Satel,

S.*

(2001, December 11). ‘You dirty rats’: Activists jeopardize biomedical

research.

Tech Central Station.

311.Satel,

S.*

(2001, December 7). The sorry CSAP flap: It’s worse than it looks.

Tech

Central Station.

312.Satel,

S.*

(2001, December). Medicine’s Race Problem.

Policy Review, 110.

313.Satel,

S.*

(2001, November). In focus: Guest editorial: Affirmative action.

Medscape.

314.Satel,

S.*,

& Sommers, C. H. (2001, October 15). Manager's journal: Good grief: Don't

get taken by the trauma industry.

Wall Street Journal.

315.Satel,

S.*

(2001, September 11). The newest feminist icon -- a killer mom.

Wall Street

Journal.

316.Entine, J., &

Satel, S.*

(2001, September 9). Race belongs in the stem cell debate.

Washington Post.

317.Satel,

S.*

(2001, August 29). Crazed and confused.

Slate.

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318.Satel,

S.*

(2001, August 11). Keeping OxyContin out of the wrong hands.

Boston Globe.

319.Satel,

S.*,

& Marmor, T. R. (2001, July 16). Does inequality make you sick?: The

dangers of the new public health crusade.

Weekly Standard.

320.Satel,

S.*

(2001, July 3). Mommy undearest.

Slate.

321.Satel,

S.*

(2001, May 10). When shedding pounds meant courting danger.

Wall Street

Journal.

322.Satel,

S.*

(2001, May 7). It’s all in her head.

American Prospect,

pp. 49.

323.Satel.

S.*

(2001, April 27). Drugs: A decision, not a disease.

Wall Street Journal.

324.nSatel,

S.*

(2001, April 23). When quackery kills.

National Review Online.

325.Satel,

S.*

(2001, April 1). A misguided medical entanglement.

Orlando Sentinel,

pp. G1.

326.Satel,

S.*

(2001, March 6). A critic takes on psychiatric trauma.

New York Times,

pp.

F5.

327.Satel,

S.*

(2001, March 3). Feminism is bad for women's health care.

Wall Street

Journal.

328.Satel,

S.*,

& Stolba, C. (2001, February). Who needs medical ethics?

Commentary.

329.Satel,

S.*

(2001, January 31). How racial preferences refuse to die.

New York Post.com

330.Satel,

S.*,

& O’Mathuna, D. P. (2000, January 31). New age nurses: Forget Florence

Nightingale.

Women’s Quarterly,

pp. 22.

331.Satel,

S.*

(2001, January). The indoctrinologists are coming.

The Atlantic Online.

332.Satel,

S.*

(2000, October). The truth about anti-depressants will cheer you up.

Femina.

333.Satel,

S.*

(2000, July 14). Learning to say ‘I've had enough.’

New York Times.

334.Satel,

S.*

(2000, April 24). Isn't a commando raid ‘psychologically abusive’?

Wall

Street Journal.

335.Satel,

S.*

(2000, April 3). Prime-time psychosis.

New York Times.

336.Satel,

S.*

(2000, January 1). Baseball is off its rocker.

Wall Street Journal.

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337.Satel,

S.*

(2000). The role of coercion in treating and curing addictions. In Furton, E. J.,

& Dort, V. M. (Eds.). Addiction and compulsive behaviors: Proceedings of the seventh

workshop for bishops. Philadelphia, PA: National Catholic Bioethics Center.

338.Satel,

S.*(1999).

The fallacies of no-fault addiction.

Public Interest, 134

(Winter):52-67.

339.Satel,

S.*

(1999, December 15). Mentally ill or just feeling sad?

New York Times,

pp.

A23.

340.Satel,

S.*

(1999, August 15). Perspective on hate; Badness or madness?

Los Angeles

Times.

341.Satel,

S.*

(1999, June 11). ‘Parity’ isn't charity.

Wall Street Journal.

342.Satel,

S.*

(1999, April 23). An overabundance of counseling?

New York Times.

343.Satel,

S.*

(1999, January 7). Real help for the mentally ill.

New York Times,

pp. A31.

344.Satel,

S.*

(1998, Winter). The abuse excuse.

Women’s Quarterly.

345.Satel,

S.*

(1998, October 12). Bookshelf: A battle plan for the drug war.

Wall Street

Journal.

346.Satel,

S.*

(1998, September 21). Is Clinton out of control?

Wall Street Journal.

347.Satel,

S.*

(1998, August 18). The war on drugs.

Slate.

348.Satel,

S.*

(1998, August 5). Bookshelf: Addicted to abolition.

Wall Street Journal.

349.Satel,

S.*

(1998, Summer). Do drug courts really work?

City Journal.

350.Satel,

S.*

(1998, July 22). Methadone works, usually.

New York Times,

pp. A19.

351.Satel,

S.*

(1998, July 20). Can this stick win the drug war?

New York Post,

pp. 21.

352.Satel,

S.*,

& Jaffe, D. J. (1998, July 20). Psychobabble, violent fantasies.

National

Review.

353.Satel,

S.*

(1998, June 13). Battle of the drug warriors.

Globe and Mail,

pp. D9.

354.Satel,

S.*

(1998, June 8). Opiates for the masses.

Wall Street Journal.

355.Satel,

S.*

(1998, May 2). Refurbishing Sigmund Freud.

Ottawa Citizen,

pp. B7.

356.Satel,

(1998, April 4). Don't forget the addict's role in addiction.

New York Times.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

357.Satel,

S.*

(1998, January 6). For addicts, force is the best medicine.

Wall Street Journal.

358.Satel,

S. L.*,

(1998). There is no women’s health crisis.

National Affairs, 130:21-33.

359.Satel,

S.*

(1998) Drug Treatment: The Case for Coercion. Washington, DC: AEI Press.

360.Satel,

S.*,

& Goodwin, F. K. (1998) Is drug addiction a brain disease? Washington, DC:

Ethics and Public Policy Center.

361.Satel,

S.*

(1997, November 17). Letters to the editor: Those who really need marijuana.

Wall Street Journal.

362.Satel,

S.*

(1997, October 30). Medical marijuana: Research, don’t legalize.

Wall Street

Journal,

pp. A22.

363.Satel,

S.*

(1997, July 11). NOW's time is past.

Wall Street Journal.

364.Satel,

S.*

(1997, May 10). When work is the cure.

New York Times.

365.Satel,

S.*

(1996, December 12). The politicization of public health.

Wall Street Journal.

366.Satel,

S.*

(1996, September 26). Is your kid on drugs? The FDA makes it hard to know.

Wall Street Journal.

367.Satel,

S.*

(1996, July 16). Where there's smoke, there's ire.

Wall Street Journal.

368.Satel,

S.*

(1996, May 5). Psychiatric apartheid.

Wall Street Journal.

369.Satel,

S.*

(1996, February 20). The madness of deinstitutionalization.

Wall Street

Journal.

370.Satel,

S.*

(1995, Summer). Yes, drug treatment can work.

City Journal.

371.Satel,

S.*

(1995, July 17). The wrong fix.

Wall Street Journal.

372.Satel,

S.*

(1995, Winter). Treating insanity reasonably.

City Journal.

373.Satel,

S. L.*

(1995, February 27). Science by quota: P. C. medicine.

The New Republic,

212(9):14,

16.

Books

1. Lilienfeld, S. O., &

Satel, S.

(2013).

Brainwashed: The seductive appeal of mindless

neuroscience.

New York, NY: Basic Books.

Satel, S.

(ed.). (2009).

When altruism isn’t enough: The case for compensating kidney

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

donors.

Washington, DC: AEI Press.

3. Hoff Sommers, C., &

Satel, S.

(2005).

One nation under therapy: How the helping

culture is eroding self-reliance.

New York, NY: St. Martin’s Press.

Satel, S.*,

& Farabee, D. J. (2004) The role of coercion in drug treatment. In Lowinson,

J. H., Ruiz, P., Millman, R. B., & Langrod, J. G. (Eds.). Substance abuse: A

comprehensive textbook (4

ed.). Philadelphia, PA: Lippincott Williams & Wilkins.

Satel, S.

(2001).

PC, M.D. How political correctness is corrupting medicine.

New York,

NY: Basic Books.

Congressional Testimony

Satel, S.*

(2013, May 22).

Examining SAMHSA’s role in delivering services to the

severely mentally ill.

Testimony before House Committee on Energy and Commerce’s

Subcommittee on Oversight and Investigations.

Satel, S.*

(2011, June 14).

Bridging the gap between care and compensation for

veterans.

Testimony before the House Committee on Veterans’ Affairs.

Satel, S.*

(2009, June 12).

Health disparities.

Testimony before the Commission on Civil

Rights.

Satel, S.*

(2008, June 24).

Health Equity and Accountability Act of 2007.

Testimony

before the House Committee on Energy and Commerce.

Satel, S.*

(2008, June 10).

Addressing disparities in health and health care: Issues for

reform.

Testimony before the House Committee on Ways and Means.

Satel, S.*

(2008, May 21).

Veterans’ Mental Health Treatment First Act.

Testimony

before the Senate Committee on Veterans’ Affairs.

Satel, S.*

(2007, July 25).

PTSD and personality disorders: Challenges for the VA.

Testimony before the House Committee on Veterans’ Affairs.

Satel, S.*

(2004, March 11).

Post-traumatic stress disorder and Iraq veterans.

Testimony

before the House Committee on Veterans’ Affairs.

Amicus Briefs

1. Heyman, G. M., Morse, S. J., Lilienfeld, S. O.,

Satel, S. L.,

Commonwealth v. J

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

British American Tobacco, bilag 3

Analysis of Risk Beliefs and Usage of E-Cigarettes and other Potentially Reduced Risk Nicotine

Products in Europe

W. Kip Viscusi

December 17, 2020

University Distinguished Professor of Law, Economics, and Management, Vanderbilt Law School, 131 21st Ave.

South, Nashville, TN, 37203.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

INTRODUCTION

I am the University Distinguished Professor of Law, Economics, and Management at

Vanderbilt University. I hold a bachelor’s

degree in Economics, two master’s degrees,

and a Ph.D. in economics, all from Harvard University. I have published almost 400

articles and over 30 books dealing primarily with health and safety risks, and I have been

ranked among the top 25 economists in the world based on citations in economics

journals. I worked extensively with the U.S. Environmental Protection Agency (“EPA”)

on a continuous basis from 1983 to 2012, where much of my work was focused on the

development of guidelines for hazard warnings for dangerous pesticides and chemicals.

In addition to my extensive work for EPA, I have consulted for several other

governmental entities on a variety of issues, including the U.S. Department of

Transportation, the U.S. Department of Labor, the U.S. Department of Justice, the U.S.

General Accounting Office, the U.S. Department of Health and Human Services, the U.S.

Office of Management and Budget, and the National Oceanic and Atmospheric

Administration. I have also taught courses about risk, uncertainty, risk analysis, and

hazard warnings to hundreds of Food and Drug Administration officials, congressional

staff, and federal and state judges. I served as the Associate Reporter on The American

Law Institute Study on Enterprise Responsibility for Personal Injury and co-wrote the

chapter on Product Defects and Warnings. I have also testified before the U.S. Congress

on nine occasions as an expert in economics and risk analysis. This testimony addressed

such topics as, for example, alcoholic beverage warnings.

Apart from my academic and governmental work, I have consulted on matters such as

risk perception, hazard warnings design, and safety devices for large companies,

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

including Bic, DuPont, Becton Dickinson, R.J. Reynolds, Bristol-Meyers Squibb,

Anheuser-Busch, Black & Decker, and Medline Industries. I have submitted several

expert reports on behalf of British American Tobacco group companies in relation to

proposed tobacco regulation, including the introduction of graphic health warning

requirements and legal challenges to such regulation. I have also served as a

consultant/expert witness for the United States Department of Justice in a variety of

cases. These include an analysis of natural resource damages issues in connection with

the Exxon Valdez oil spill. I have also testified on behalf of the Province of Quebec on

risks and warnings for video lottery terminals.

I am a founding editor of two journals: the Journal of Risk and Uncertainty, which

publishes peer reviewed articles on issues relating to risk perception and analysis; and

Foundations and Trends: Microeconomics. I am currently on the board of several other

academic journals, including Regulation; Journal of Law, Economics and Policy; Journal

of Tort Law; Contemporary Economic Policy; Regulation and Governance; Managerial

and Decision Economics; Journal of Risk and Insurance; Journal of Benefit-Cost

Analysis; and The Geneva Risk and Insurance Review. I have also held editorial

positions with such journals as American Economic Review, which is the official journal

of the American Economic Association; Review of Economics and Statistics, a journal

specializing in quantitative applied economics and based at Harvard University; Journal

of Environmental Economics & Management; Public Policy; International Review of

Law and Economics; and Journal of Regulatory Economics. I have served as a peer

reviewer for dozens of other publications and for government agencies in countries

throughout the world.

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I have won several awards for my books and articles. These include the “Article of the

Year” award from the Western Economic Association

for an article on the valuation of

life; the “Article of the Year” award from the Royal Economic Society, an international

economic society based in England, for an analysis of how ambiguous risk information

influences decision-making;

the “Article of the Year” award from the American Risk and

Insurance Association for an article on automobile insurance regulation;

and two “Article

of the Year” awards from the Society for Benefit-Cost

Analysis. I am also a five-time

winner of the Kulp-Wright Award

for “Book of the Year,” given out by the American

Risk and Insurance Association. Other recent professional awards include being named

an Honorary Member of the Academy of Economics and Finance; winning the University

of Chicago Law School’s Ronald H. Coase

Prize for an article on risk perception; and

winning the 2019 Vanderbilt University Earl Sutherland prize, which is the

school’s most

prestigious university-wide award for scholarly accomplishment.

Much of my scholarly research and writing has focused on issues of risk and health

relating to smoking. My work on risk analysis, risk perception, consumer behavior, and

regulation as it relates to smoking has included extensive research into the history of the

tobacco industry and the related public health discussions, as well as current events as

they pertain to these issues. These articles have been widely disseminated and subject to

peer review.

I have also written two books exclusively related to smoking. The first,

Smoking:

Making the Risky Decision

(Oxford University Press, 1992) is about smoking and

smoking risks, and analyzes how the available information about smoking has changed

over time, how people have assessed the risks of smoking, and how those risk perceptions

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affect smoking behavior. The book also explains how changes in the price of cigarettes

affect cigarette consumption. The second book,

Smoke-Filled Rooms: A Postmortem on

the Tobacco Deal

(University of Chicago Press, 2002), includes chapters on risk

perceptions and addiction, youth smoking, environmental tobacco smoke, the promotion

of potentially safer cigarettes, the settlement of the U.S. state litigation against the

tobacco industry, the U.S. Master Settlement Agreement, and the financial costs of

smoking. Both books were subject to peer review. A full copy of my Curriculum Vitae is

available at

https://law.vanderbilt.edu/phd/faculty/w-kip-viscusi/ViscusiCV.pdf.

I have been asked by British American Tobacco to provide a report that examines the

evidence on e-cigarette risk beliefs and the relationship of these beliefs to e-cigarette

usage, as well as presenting an analysis of data from a new survey conducted in selected

European markets. I assisted in the design of this survey, which examines the e-cigarette

risk beliefs of a sample of smokers, dual users, and exclusive e-cigarette users, as well as

their risk beliefs for heated tobacco products and oral nicotine pouch products. In this

report, I present an analysis of the risk beliefs regarding these different products and the

impact of those beliefs on product usage. I also consider the implications of current risk

beliefs for informed consumer choice and the potential public health benefits that these

alternative potentially reduced risk products offer. Drawing on the implications of these

empirical results, I propose several policy recommendations for Governments/regulators.

II.

EXECUTIVE SUMMARY

Numerous studies and comprehensive reviews by public health authorities have stated

that e-cigarettes are less harmful than conventional tobacco cigarettes. Nevertheless,

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surveys in the UK and the US report that many people believe that e-cigarettes are as

harmful or more harmful than cigarettes. Failure to understand the lower estimated risks

associated with e-cigarettes will discourage e-cigarette use.

10.

The trend in survey reports indicating beliefs that e-cigarettes are as harmful or more

harmful than cigarettes is not favorable. The percentage of the population who regard e-

cigarettes as being as harmful or more harmful than cigarettes has been increasing over

time, particularly in recent survey waves.

11.

This report analyzes data from a survey in 2020 of adults who currently smoke cigarettes

exclusively, currently smoke cigarettes and use e-cigarettes, or use e-cigarettes but do not

currently smoke cigarettes. The countries included in the sample are the United

Kingdom, Belgium, Denmark, the Netherlands, France, Germany, and Italy.

12.

The focus of the survey was on

respondents’ perceptions of the estimated harm of e-

cigarettes compared to conventional cigarettes, and their usage of e-cigarettes. In

addition, the survey also obtained information on other potentially reduced risk

alternatives to cigarettes, specifically heated tobacco products,

and oral nicotine

pouches.

Heated tobacco products (also known as

‘heat-not-burn’ tobacco products)

are devices that heat tobacco to

generate a nicotine-containing aerosol which the user inhales. Because the tobacco is only heated and not burned,

the resulting aerosol can potentially contain substantially lower levels of the toxicants found in the smoke produced

when tobacco is burned. In a review of the available evidence carried out for Public Health England in 2018, the

authors, while noting the need for further research, concluded that "[t]he

available evidence suggests that heated

tobacco products may be considerably less harmful than tobacco cigarettes."

and that "[c]ompared

with cigarettes,

heated tobacco products are likely to expose users and bystanders to lower levels of particulate matter and harmful

and potentially harmful compounds (HPHC). The extent of the reduction found varies between studies."

McNeill A,

Brose LS, Calder R, Bauld L & Robson D (2018). Evidence review of e-cigarettes and heated

tobacco products 2018. A report commissioned by Public Health England. London: Public Health England.

Oral nicotine pouches are pre-portioned porous pouches containing nicotine (but no tobacco). The user puts a

pouch between the upper lip and gum and leaves it there while the nicotine and taste are released. No combustion is

involved. As oral nicotine pouches do not contain any tobacco, they contain far fewer and lower levels of toxicants

than cigarettes and other tobacco products like snus.

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13.

Beliefs that e-cigarettes are less harmful than tobacco burning cigarettes are positively

correlated with e-cigarette use. Those who consider e-cigarettes to be less harmful than

cigarettes are 33% more likely to currently use e-cigarettes. For nonsmokers who

formerly smoked, those who consider e-cigarettes to be less harmful than cigarettes are

9% more likely to currently use e-cigarettes and not smoke conventional cigarettes.

14.

Respondents in the UK, a market that has taken a more progressive approach to the

regulation of e-cigarettes than many of the other European countries analyzed in this

study, are significantly more likely to believe that e-cigarettes are less harmful than

respondents in any other country other than Italy, for which the difference in the levels of

beliefs compared to the UK is not statistically significant.

15.

Controlling for personal characteristics and the respondents’ country, e-cigarette use is

negatively related to being a cigarette smoker, with e-cigarette users being 48% less

likely to also be a current smoker.

16.

Not knowing enough about e-cigarettes and not believing that they are less harmful are

the two principal reasons that people cite for not using e-cigarettes, while beliefs that they

will help cut down or stop smoking are the main reasons given for using e-cigarettes.

17.

A substantial number of the survey respondents were unfamiliar with heated tobacco

products and oral nicotine pouches, with 35% of respondents stating that they had not

heard of a heated tobacco product and 53% of respondents stating that they had not heard

of oral nicotine pouches.

18.

Beliefs that heated tobacco products and nicotine pouches are less harmful than cigarettes

are positively correlated with usage of these products. Respondents who perceive heated

tobacco products as being less harmful than cigarettes are 15% more likely to currently

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use heated tobacco products, while the comparable increase in the use of oral nicotine

pouches for those who perceive them as being less harmful is 4%.

19.

The use of heated tobacco products and oral nicotine pouches is also negatively related to

being a current smoker. Users of heated tobacco are 4% less likely to also be a current

smoker, and users of oral nicotine pouches are 9% less likely to also be a current smoker.

20.

Substantial opportunities remain for more effective risk communication efforts. The

current failure by consumers to appreciate the estimated lower risk of these alternative

products compared to cigarettes is a major shortfall of consumer knowledge. These

beliefs in turn play an instrumental role in consumer decisions regarding the use of these

products.

21.

Recommended policy changes include both a more vigorous role for informational

initiatives by governments as well as framing warnings information so that they facilitate

informed consumer choices. Reducing the restrictions that manufacturers face in

communicating the comparative estimated risks of these products would also facilitate

efforts to inform consumers about the product risks.

III.

22.

THE ESTIMATED RISKS OF E-CIGARETTES

A principal driver of interest in e-cigarettes (EC) is their estimated risk levels compared

to conventional cigarettes that burn tobacco. Because e-cigarettes have been available for

a relatively short time compared to cigarettes and other traditional tobacco products, there

are no epidemiological studies that have assessed their possible long-term health

consequences. There is, however, a substantial literature that has analyzed the chemical

composition of e-cigarette vapors and assessed the possible short-term health effects.

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The general consensus is that e-cigarettes are estimated to be much less risky than

conventional cigarettes.

23.

Public Health England has commissioned reviews of the literature in 2015

and 2018,

each of which provided an extensive assessment of the literature. The 2015 report

provided an update of Public Health England’s earlier reports on e-cigarettes in the light

of new evidence, stating (p.

12): “It has been previously estimated that

EC are around

95% safer than smoking.

This appears to remain a reasonable estimate.”

Public Health

England (2018, p. 150)

reiterated the principal conclusion of the 2015 report: “Since the

2015 Public Health England report, the Royal College of Physicians (RCP) has also

reviewed evidence on the safety

of EC and concluded that they were ‘unlikely to exceed

5% of the harm from smoking to tobacco.’” With respect to the cancer risks posed by e-

cigarettes, Public Health England (2018, p. 157) report concluded:

“In summary, a study

of cancer potencies of EC emissions suggested that these are largely less than 0.4% of

smoking.” The

Public Health England (2018, p. 162) report similarly noted that there was

no evidence of significant health risks from passive vaping.

24.

The 2018 Public Health England report also included a discussion of what is known at

this point about the risks posed by heated tobacco products. While noting that the current

evidence for heated tobacco products was limited, the report concluded that compared to

conventional cigarettes, heated tobacco products are likely to expose users and bystanders

to lower levels of particulate matter and harmful compounds, but pose more risk than e-

cigarettes (p. 23). Their overall assessment (p. 24) is that heated tobacco products

Ann McNeill, et al. Evidence Review of E-Cigarettes and Heated Tobacco Products 2015: A Report

Commissioned by Public Health England. London: Public Health England, 2015.

Ann McNeill, et al., Evidence Review of E-Cigarettes and Heated Tobacco Products 2018: A Report

Commissioned by Public Health England. London: Public Health England, 2018.

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“…may be considerably less harmful than tobacco cigarettes and more harmful than e-

cigarettes.”

25.

The 2020 Public Health England evidence update

included some cautionary information

regarding the absolute risk of e-cigarettes along with the lower comparative risk message

from its previous reports (p. 27), noting that

“vaping

regulated nicotine products has a

small fraction of

the risks of smoking, but this does not mean it is ‘safe’.”

26.

The US National Academies of Sciences, Engineering, and Medicine (NASEM)

undertook a large-scale systematic review of the scientific literature for the US Food and

Drug Administration in 2018.

While noting the need for studies of the long-run effects

of e-cigarettes, the report concludes (p.1) that the current evidence, based on laboratory

tests of e-cigarette ingredients, in vitro toxicological tests, and short-term human studies,

suggests that e-cigarettes are likely to be far less harmful than combustible tobacco

cigarettes. The report also concluded (p. 11): "The evidence about harm reduction

suggests that across a range of studies and outcomes, e-cigarettes pose less risk to an

individual than combustible tobacco cigarettes."

27.

Other prominent studies have reached similar conclusions. Farsalinos and Polosa (2014)

also undertook a systematic review of the literature and concluded that the currently

available evidence indicates that electronic cigarettes are by far a less harmful alternative

to smoking and significant health benefits are expected in smokers who switch from

tobacco to electronic cigarettes.

A. McNeill, L.S. Brose, R. Calder, L. Bauld, and D. Robson. Vaping in England: An Evidence update Including

Mental Health and Pregnancy March 2020: A Report Commissioned by Public Health England. London: Public

Health England, 2020

National Academies of Sciences, Engineering, and Medicine. 2018. Public Health Consequences of E-Cigarettes.

Washington, D.C.: National Academies Press.

K. E. Farsalinos, and R. Polosa. 2014. “Safety Evaluation and Risk

Assessment of Electronic Cigarettes as

Tobacco Substitutes: A Systematic Review,”

Therapeutic Advances in Drug Safety,

5(2), 67-86.

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28.

A more recent study by Stephens (2018) found that the cancer potencies of e-cigarettes

were less than 1% of tobacco smoke.

Heat-not-burn devices were found to have an

order of magnitude lower level of potency than tobacco cigarettes but had a higher level

of potency than e- cigarettes.

29.

Estimates of the health benefits that may result by switching from conventional tobacco

cigarettes to e-cigarettes are substantial. Abrams et al. (2018, p. 205) provided the

following estimates for the United States smoking population: “Replacement of most

cigarette use by e-cigarette use over a 10-year period yields up to 6.6 million fewer

premature deaths with 86.7 million fewer life

years lost.”

30.

Recently, the UK Committee on Toxicity of Chemicals in Food, Consumer Products and

the Environment (COT) concluded that the current evidence indicates that electronic

cigarettes are substantially reduced risk compared with combustible cigarettes. COT,

which is made up of independent experts, was commissioned by the UK Department of

Health and Social Care and Public Health England to review the potential toxicological

risks from electronic cigarettes.

The review concluded that, although the magnitude of

the decrease will depend on the effect in question, the relative risk of adverse health

effects would be expected to be substantially lower from e-cigarettes for smokers who

completely switch to e-cigarettes, or if e-cigarettes are taken up instead of combustible

cigarettes.

William E. Stephens, “Comparing the Cancer Potencies of Emissions from Vapourised Nicotine Products

Including E-Cigarettes

with Those of Tobacco Smoke,”

Tobacco Control,

Vol. 27, 2018, pp. 10-17.

David B. Abrams, et al. 2018. “Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine

Use to Rapidly Save Lives,”

Annual Review of Public Health,

Vol. 39, pp. 193-213.

The review included electronic nicotine delivery systems and devices that use an e-liquid that does not contain any

nicotine, collectively abbreviated as E(N)NDS

The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment.,

Statement on the

potential toxicological risks from electronic nicotine (and non-nicotine) delivery systems (E(N)NDS

–

e-cigarettes)

July 2020 - A report commissioned by the Department of Health and Social Care and Public Health England.

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IV.

31.

PREVIOUS STUDIES OF THE PERCEPTION OF E-CIGARETTE RISKS

There has been an extensive analysis of the perceived harm of e-cigarettes based on

surveys of beliefs in the UK and the US. These studies have framed this assessment on a

comparative basis using tobacco-burning cigarettes as the reference point. The wording

used has usually been in terms of whether e-cigarettes are less harmful, more harmful, or

just as harmful as conventional cigarettes. A couple of studies have framed the question

in terms of whether e-cigarettes pose less risk, more risk, or just as much risk as

conventional cigarettes. For both survey wordings, a substantial segment of the

population either does not know whether e-cigarettes pose less harm or believes that e-

cigarettes are either just as harmful or more harmful than conventional cigarettes. There

has also been evidence of an increase over time in the fraction of the population who

regard e-cigarettes as just as harmful or more harmful than conventional cigarettes.

Comparison of the survey results in the different studies is sometimes hindered by the

fact that some respondents may not be familiar with e-cigarettes, which would lead to a

“don’t know” response

in many surveys. Such

“don’t know”

responses are quite

different than that of informed respondents who are not willing to make a judgment on

whether e-cigarettes are less harmful. These

“don’t know”

respondents may be similar to

viewing the products as being equally harmful.

E-Cigarette Perceptions in the UK

32.

Assessing the degree to which the population regards e-cigarettes as less harmful is

potentially important from the standpoint of the number of smokers who might switch to

e- cigarettes. In a study in England from 2014 to 2019 that followed the behavior of 300

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smokers who were surveyed monthly, Perski et al. (2020)

found that declines in the

belief among current smokers that e-cigarettes are less harmful than combustible

cigarettes were strongly associated with declines in the use of e-cigarettes among current

tobacco smokers. For every 1% decrease in the mean prevalence of current tobacco

smokers who endorsed the belief that e-cigarettes are less harmful than combustible

cigarettes, the mean prevalence of e-cigarette use decreased by 0.48%. The authors state:

“The

reduction in the proportion of tobacco smokers who perceive e-cigarettes to

be less harmful than combustible cigarettes from 2014 to 2019 and the associated

reduction in the use of e-cigarettes

may reflect smokers’ concerns about the

uncertainty about the long-term health effects of e-cigarettes. These concerns may

have been amplified by frequent media reports focusing on the absolute (as

opposed to relative) health risks of e-cigarettes or graphic, highly emotive

depictions of e-cigarette explosions or e-cigarette or vaping product use-

associated lung injury (EVALI) in the US. In line with Huang and colleagues’ call

for an increase in the availability of accurate risk information about e-cigarettes

in mainstream media, our results highlight the need for an increase in media

portrayals and public health campaigns focusing on the reduced health harms by

switching from combustible tobacco to e-cigarettes and a reduction in alarmist

media coverage of events such as EVALI.”.

33.

Some studies of beliefs in the UK also include more than one country in the sample. The

summaries below present them in rough chronological order of the survey years. The

Olga Perski, Emma Beard, and Jamie Brown. 2020. “Association between Changes in Harm Perceptions and E-

Cigarette Use among Current Tobacco Smokers in

England: A Time Series Analysis,”

BMC Medicine,

18:98, pp. 1-

10. In this study, each 1% decrease in the belief that e-cigarettes are less harmful is associated with a 0.5% decrease

in e-cigarette use.

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article by Adkinson et al. (2013) used a sample of current and former smokers from mid-

2010 to mid-2011 and found that the percentage of respondents who viewed e-cigarettes

as being less harmful than conventional cigarettes was 82% in the UK, 71% in Australia,

66% in the US, and 64% in Canada.

The average percentage across these studies was

70%. Most respondents--80%-- indicated that they used e-cigarettes because they were

less harmful than conventional cigarettes, 75% said that they did so to reduce their

smoking, and 85% said it was to help them quit smoking.

34.

Another result from UK samples over two years reported that, excluding

“don’t know”

responses, the percentage of the population who viewed e-cigarettes as less harmful than

cigarettes decreased from 86.4% in 2013 to 78.2% in 2014.

35.

Public Health England (2015) reported the results of a series of surveys for the UK and

Europe, noting that the trend in risk beliefs displayed a disturbing pattern

(p. 6): “There

has been an overall shift towards the inaccurate perception of e-cigarettes being as

harmful as cigarettes over the last year in contrast to the current expert estimate that using

e-cigarettes

is around 95% safer than smoking.”

The Internet Cohort Great Britain

Surveys reported by Public Health England (2015) covered the years from 2012 to 2014.

The percentage who viewed e-cigarettes as less harmful than cigarettes was 67% in 2012,

67% in 2013, and 60% in 2014. The beliefs that the products are equally harmful rose

from 9% in 2012 to 11% in 2013 and to 17% in 2014. The percentage who viewed e-

cigarettes as more harmful than cigarettes remained at 2% throughout that period, while

the

“don’t know”

percentage declined from 23% in 2012 and to 21% in 2013 and 2014.

Sarah E. Adkinson, et al. 2013. “Electronic Nicotine

Delivery Systems: International Tobacco Control Four-

Country Survey,”

Am. J. Prev. Med.,

Vol. 44, No. 3, pp. 207-215.

Leonie S. Brose, et al. 2015. “Perceived Relative Harm of Electronic Cigarettes over Time and Impact on

Subsequent Use. A Survey with 1-Year and 2-Year Follow-ups,”

Drug and Alcohol Dependence,

Vol. 157, 106-111.

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The ASH Smokefree Great Britain Surveys reported by Public Health England (2015)

show somewhat different levels of harm beliefs. The percentage who viewed e-cigarettes

as less harmful than cigarettes rose from 52% in 2013 to 54% in 2014 and 2015. The

equally harmful beliefs rose from 6% in 2013 to 14% in 2014 and 20% in 2015. The

percentage who viewed e-cigarettes as more harmful than cigarettes remained low at 1%

in 2013 and 2% in 2014 and 2015. There was a decline over time in the

“don’t know”

percentage from 40% in 2013 to 30% in 2014 and 23% in 2015. However, the ASH

Smokefree Great Britain Youth Surveys reported a decline in the belief that e-cigarettes

are less risky than cigarettes from 74% in 2013 to 66% in 2014 and 67% in 2015, coupled

with an almost doubling of the equally-risky beliefs from 12% in 2013 to 21% in 2015.

36.

Action on Smoking and Health (ASH 2019) reported survey results among adults in

Great Britain who have heard of e-cigarettes.

Those who viewed e-cigarettes as equally

harmful or more harmful rose from 7% in 2013 to 15% in 2014, and subsequently to 26%

in 2019. Among adult smokers, the percent who viewed e-cigarettes as equally harmful

or more harmful was 8% in 2013 and 10% in 2014, rising to the much higher value of

22% in 2019.

37.

The Public Health England (2020) report by A. McNeill et al. presented survey results for

2019 and compared them with results for an adult sample in 2014 (p. 97). The

percentage of respondents who regarded e-cigarettes as less harmful than cigarettes

dropped from 45% in 2014 to 34% in 2019. The report stated these misperceptions are

particularly common among smokers who do not vape. The response group exhibiting

the greatest change was that in which e-cigarettes and conventional tobacco-burning

Action on Smoking and Health (ASH). 2020.

“Use of E-Cigarettes

(Vapes) among Adults in Great Britain,

October 2020.”

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cigarettes are viewed as being equally harmful, as that fraction rose from 26% in 2014 to

42% in 2019. The remaining categories in 2019 consisted of 14% who viewed e-

cigarettes as more harmful than cigarettes and 10% who indicated that they did not know.

Similar changes in harm beliefs were also evident for the ASH-Y data for youths, as two-

thirds of respondents viewed e-cigarettes as less harmful than cigarettes in 2014 and just

over one-half did so in 2019 (p. 53).

38.

An article by Wilson, et al. (2019) reported perception of harm results for a longitudinal

UK sample interviewed in 2017. Overall, 57% believed that e-cigarettes are less harmful

than cigarettes, 22% believed that e-cigarettes and cigarettes are equally harmful, 3%

believed that e-cigarettes are more harmful than cigarettes, and 18% indicated that they

did not know.

39.

Perhaps influenced in part by the e-cigarette, or vaping, product use associated lung

injury (EVALI) illnesses in the US, respondents to the 2020 Action on Smoking and

Health Survey viewed e-cigarettes even less favorably compared to cigarettes.

Particularly striking is that 37% of adults and 34% of smokers regarded e-cigarettes as

more harmful than or as harmful as cigarettes. Reporting on the Survey, ASH states:

‘[t]he proportion of the adult population thinking that e-cigarettes

are more or equally

harmful as smoking is five times higher than in 2013, increasing from 7% in 2013 to 37%

in 2020’ and ‘… in 2020 perceptions have shifted markedly with the highest proportion

of people reporting inaccurate misperceptions that e-cigarettes are more harmful than

smoking (37%) and the lowest proportion reporting that e-cigarettes are less or a lot less

harmful (39%).’

Action on Smoking and Health (ASH). 2020.

“Use of E-Cigarettes

(Vapes) among Adults in Great Britain,

October 2020.”

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E-Cigarette Perceptions in the US

40.

The pattern of harm beliefs in the United States also indicates that a substantial part of the

population is not aware of the estimated comparative harm of e-cigarettes and

conventional cigarettes. Richardson, et al. (2014) reported that in a 2011 survey of

current and former smokers, the percentage distribution of comparative beliefs regarding

harms of e-cigarettes

was 21% don’t know, 65% less harmful, 10% about the same harm,

and 3% more harmful.

The less harmful belief percentages were lower for snus (12%),

chewing tobacco, snuff, and dip (10%), and dissolvables (17%).

41.

Results reported by Kiviniemi and Kozlowski (2015) using data from the US Health

Information National Trends Survey (HINTS), a population-representative survey of US

adults, for 2012-2013 were that 11% viewed e-cigarettes as much less harmful than

cigarettes, 40% viewed them as less harmful than cigarettes, 46% viewed them as just as

harmful as cigarettes, 1.6% viewed them as more harmful than cigarettes, and 1.2%

viewed them to be much more harmful than cigarettes.

Combining the as harmful and

more harmful groups, 49% believed that e-cigarettes are as harmful as or more harmful

than cigarettes.

42.

Persoskie, et al. (2019) reported trends of declining beliefs that e-cigarettes are less

harmful than cigarettes from 45% in 2012 to 34% in 2017.

In wave two of the US

National Population Assessment of Tobacco and Health (PATH) Study, 59% of those

Amanda Richardson, et al. 2014. “Prevalence, Harm Perceptions, and Reasons for Using Noncombustible

Tobacco Products Among Current and Former Smokers,”

Am. J. of Public Health,

Vol. 104, No. 8, pp. 1437-1444.

Marc T. Kiviniemi and Lynn T. Kozlowski. 2015. “Deficiencies in Public Understanding about Tobacco Harm

Reduction: Results from a United States National Survey,”

Harm Reduction Journal,

Vol. 12, No. 21, pp. 1-7.

Alexander

Persoskie, Erin Keely O’Brien, and Karl Poonai. 2019. “Perceived Relative Harm of Using E-

Cigarettes Predicts Future Product Switching among U.S. Adult Cigarette and E-Cigarette

Dual Users,”

Addiction,

Vol. 114, pp. 2197-2205.

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who used both e-cigarettes and cigarettes perceive the former as being less harmful, 35%

considered the harms to be about the same, 4% viewed e-cigarettes as more harmful than

cigarettes, and 1% did not know.

Compared with those with other perceptions of e‐

cigarette harm, dual users who perceived e-cigarettes as less harmful were more likely to

switch to exclusive e-cigarette use and were less likely to switch to exclusive cigarette

use one year later.

43.

Majeed, et al. (2017) considered results in 2012 and 2015 for both non-smokers and an

over-sampled group of smokers.

The percentage of adults who viewed e-cigarettes as

less harmful than cigarettes was 39% in 2012 and 31% in 2015, and for smokers these

percentages were 45% in 2012 and 36% in 2015. There was a large change in the

percentage of adults who believed the risks to be about the same, from 12% in 2012 up to

36% in 2015. For smokers, that increase was from 11% in 2012 to 31% in 2015. There

was a drop in the

“don’t know”

percentages from 48% to 30% overall, and from 44% to

29% for smokers. The percentage of those who believed that e-cigarettes cause more

harm than cigarettes remained low at 1% in 2012 and 4% in 2015 for both the full sample

and for smokers.

44.

Huang et al. (2019) found that in two nationally representative multiyear cross-sectional

surveys of US adults, the percentage who viewed e-cigarettes as being as harmful as or

more harmful than cigarettes increased from 2012 to 2017.

In the Tobacco Products

and Risk Perceptions Survey (TPRPS) data, the proportion of adults who perceived e-

Ban A. Majeed, et al. 2017.

“Changing Perceptions of Harm of E-Cigarettes

Among U.S. Adults, 2012-2015,”

J. Prev. Med.,

Vol 52, No. 3, pp. 331-338.

Jidong Huang, et al. 2019. “Changing Perceptions of Harm of E-Cigarette

vs. Cigarette Use Among Adults in 2

US National Surveys from 2012 to 2017, Tobacco Products and Risk Perceptions Survey and Health Information

National Trends Survey,”

JAMA Network Open,

Vol. 2, No. 3, pp. 1-12.

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cigarettes to be as harmful as cigarettes increased from 11.5% in 2012 to 36.4% in 2017

and the percentage of those who perceived e-cigarettes to be more harmful than cigarettes

increased from 1.3% in 2012 to 4.3% in 2017. For the Health Information National

Trends Survey (HINTS) data, the proportion of adults who perceived e-cigarettes to be as

harmful as cigarettes increased from 46.4% in 2012 to 55.6% in 2017; and those who

perceived e-cigarettes to be more harmful than cigarettes increased from 2.8% in 2012 to

9.9% in 2017. One difference in the surveys is that there is a

“don’t know”

option in

TPRPS but not in HINTS.

45.

Nyman (2019) reported harm beliefs in 2017 and 2018 based on the U.S. Tobacco

Products and Risk Perceptions Survey (TPRPS).

Between 2017 and 2018, the

percentage of adults perceiving e-cigarettes to be as harmful as cigarettes increased from

36.4% to 43.0%. The percentage of adults perceiving e-cigarettes to be more harmful

than cigarettes also increased from 2.4% to 4.4% and the percentage perceiving e-

cigarettes to be much more harmful than cigarettes increased from 1.9% to 3.7%.

46.

Malt, et al. (2020) provide a review of the harm beliefs of US adults for e-cigarettes in

three waves of the nationally representative Population Assessment of Tobacco and

Health (PATH) study data.

In wave 1 from September 2013 to December 2014, 54%

regarded e-cigarettes as being as harmful as or more harmful than cigarettes, and 41%

viewed them as less harmful than cigarettes. In wave 2 from October 2014 to October

2015, 65% regarded e-cigarettes as being as harmful as or more harmful than cigarettes,

Amy L. Nyman. 2019. “Perceived Comparative Harm of Cigarettes and Electronic Nicotine Delivery Systems,”

JAMA Network Open, Vol. 2, No. 11, pp. 1-4.

Layla Malt, et al. 2020. “Perception of the Relative Harm of Electronic Cigarettes Compared to Cigarettes

Amongst US Adults from 2013 to 2016: Analysis of the Population Assessment of Tobacco and Health (PATH)

Study Data,”

Harm Reduction Journal,

Vol. 17, No. 65, pp. 1-12.

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and 32% considered them to be less harmful than cigarettes. The degree of beliefs that e-

cigarettes are less harmful than cigarettes continued to decline to 25% in wave 3 from

October 2015 to October 2016, with the percentage considering e-cigarettes as being as

harmful as or more harmful than cigarettes increasing to 73% in October 2015. The

“don’t know”

responses constituted the residual for each of these surveys. The authors

conclude: “in

this study, the proportion of US adults who incorrectly perceived e-

cigarettes as equal to, or more, harmful than cigarettes increased steadily regardless of

smoking or vaping status. Current adult smokers appear to be poorly informed about the

relative risks of e-cigarettes yet have potentially the most to gain from transitioning to

these products. The findings of this study emphasize the urgent need to accurately

communicate the reduced relative risk of e-cigarettes compared to continued cigarette

smoking and clearly differentiate absolute and relative harms. Further research is required

to elucidate why the relative harm of e-cigarettes is misunderstood and continues to

deteriorate.”

47.

Viscusi (2016, 2020) framed the question in terms of whether e-cigarettes pose lower

risks than conventional cigarettes rather than lower levels of harm.

The results in both

2014 and 2019 were that 52% viewed e-cigarettes as being somewhat less risky or much

less risky. The fraction who believed that e-cigarettes are more risky rose from 2% in

2014 to 11% in 2019, and the fraction who viewed e-cigarettes as just as risky was 44%

in 2014 and 34% in 2019. In each case there was strong dependence of risk beliefs for e-

cigarettes on respondents’ risk assessment for

conventional cigarettes. In particular,

W. Kip Viscusi. 2016. “Risk Beliefs and Preferences for E-Cigarettes,”

American Journal of Health Economics,

Vol. 2, No. 2, pp. 213-240.

W. Kip Viscusi. 2020. “Electronic Cigarette Risk Beliefs and Usage after the Vaping

Illness Outbreak,”

Journal of Risk and Uncertainty,

Vol. 60, No. 3, pp. 259-279.

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consumers’ beliefs reflected a weight of about

two-thirds on their cigarette risk beliefs

when forming their e-cigarette risk beliefs.

Implications of the UK and US E-Cigarette Perception Studies

48.

The percentage of the respondents who perceive e-cigarettes as being less harmful than

cigarettes depends on the time period, the sample group, and the structure of the survey

question.

Including a “don’t know” response decreases the percentage of respondents

who commit to making a comparison. Surveys that are restricted to those who are

familiar with e-cigarettes generate higher levels of comparative responses.

49.

There are three principal implications of the survey results. First, a substantial segment

of the population view e-cigarettes as posing equivalent risks to conventional cigarettes

or even greater risks, which is inconsistent with the current scientific evidence and the

prevailing public health opinions. Second, both in the UK and in the US, the proportion

of the population who consider e-cigarettes to be as harmful or more harmful than

conventional cigarettes has been increasing over time. Third, there is evidence that these

continued misperceptions of the estimated risk of e-cigarettes are negatively correlated

with e-cigarette use, with respondents who have these views being less likely to use e-

cigarettes.

50.

NEW EVIDENCE ON E-CIGARETTE PERCEPTIONS

A series of surveys were commissioned by British American Tobacco in 2020 to analyze

the current level of harm beliefs in selected European markets. The principal objectives

of the surveys were to ascertain the harm beliefs regarding e-cigarettes and the

relationship of these beliefs to e-cigarette usage. In addition, the survey also asked

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respondents’ questions regarding their

awareness, use and perceptions of heated tobacco

products and oral nicotine pouches. I assisted in the design of the survey questions. The

samples consisted of adult members of online survey panels. The countries included

were the UK, Belgium, Denmark, the Netherlands, France, Germany, and Italy.

51.

To be included in the sample, the respondent had to answer affirmatively to all of the

following: (1) that they had smoked more than 100 cigarettes in their lifetime; (2) that

they had heard of e-cigarettes; and (3) that they were either a current smoker, a current

smoker and vaper, or a former smoker that currently vapes. As noted above, while not

included as part of the screening of the sample (so as to avoid potentially limiting the

sample size, given that these products are newer to the market and generally less used

than e-cigarettes),

the survey also asked questions regarding respondents’ awareness, use

and perceptions of heated tobacco products and oral nicotine pouches. After limiting the

multi-country sample to those who passed these sample screens, the sample consisted of

1,073 respondents in Denmark, 1,477 respondents in Germany, and 1,500 respondents in

each of the other five countries. The analysis below focuses on the pooled sample.

Appendix A presents the demographic characteristics of the sample.

52.

Table 1 provides overview statistics regarding product use and harm beliefs. Almost

two-thirds of the sample use e-cigarettes currently, and 88% have either tried or currently

use e-cigarettes. This high rate of product usage is a consequence of the sample screen.

The harm perceptions reflect the beliefs of these groups. As also indicated in Figure 1,

57% of the sample view e-cigarettes as less harmful than cigarettes, and 43% consider

them to be the same as or more harmful than cigarettes. For simplicity, all figures below

will have numbers that correspond to the table of results that they are illustrating.

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Table 1.

Product use and relative harm belief percentage

E-Cigarettes

Ever heard of the product *

Description of use **

- Never tried the product

- Tried, but never use now

- Use the product currently

- Tried, regardless of current use

Harm relative to cigarettes ***

- Less harmful than cigarettes

- About the same as cigarettes

- More harmful than cigarettes

- Same or more harmful

100

11.5

22.3

66.2

88.5

56.8

35.5

7.7

43.2

* Knowledge of e-cigarettes was required to participate in the survey.

** Those who have never heard of the product are assumed never to have tried it.

*** Harm beliefs are percentages of the subset of respondents who have heard of

the product.

53.

Table 1 indicates that a substantial portion of respondents perceive e-cigarettes to be the

same as or more harmful than cigarettes. Since the sample consists of a disproportionate

share of e-cigarette users, who would be expected to choose this behavior based on

perceived lower levels of harm of the product, these results are likely to understate these

perceptions for the general population.

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Figure 1.

Estimated harm of e-cigarettes

compared to cigarettes

60%

50%

40%

30%

20%

10%

Less harmful than cigarettes

About the same or more harmful than

cigarettes

56.8%

43.2%

54.

The relationship between product use and harm beliefs is examined in Table 2. The first

two columns pertain to the beliefs of cigarette smokers. Half of the smokers in the sample

use e-cigarettes and half of them do not. For cigarette smokers who consider e-cigarettes

to be less harmful than cigarettes, 65% currently use e-cigarettes and 35% do not. In

contrast, for current cigarette smokers who consider the harm levels from e-cigarettes to

be the same or more harmful compared to cigarettes, 37% currently use e-cigarettes and

63% do not. Figure 2 also summarizes these harm belief results. The results for current

non-smokers in the final two columns of Table 2 are less instructive, as all those who are

non-smokers necessarily use e-cigarettes regardless of their harm beliefs or they will not

be included in the sample.

Table 2.

Current or former cigarette smokers and their e-cigarette use percentage

Results for

Current cigarette smokers

Does not

Currently

use product uses product

50.0

35.2

64.8

63.4

36.6

Results for

Current non-smokers

Does not

Currently

use product uses product

100

E-Cigarette users

- Less harmful than cigarettes

- Same or more harmful

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Figure 2.

Harm Beliefs of Current Cigarette

Smokers

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

36.6%

64.8%

63.4%

35.2%

E-cigarettes are less harmful than

cigarettes

Does not use e-cigarettes

E-cigarettes are the same as or more

harmful than cigarettes

Currently uses e-cigarettes

55.

Table 3 and Figure 3 present the distribution of usage of cigarettes for e-cigarette users

based on their level of harm beliefs. Overall, 51% of e-cigarette users in the sample

currently smoke cigarettes, and 49% do not. For those who use e-cigarettes, having low

levels of comparative harm beliefs is associated with not smoking cigarettes. The largest

harm belief category among e-cigarette users is the less harmful group, for which 54% do

not smoke cigarettes and 46% do. The pattern is strongly reversed for those who

consider the risks to be just as harmful or more harmful, as 63% of this group currently

smoke cigarettes and 37% do not smoke cigarettes.

Table 3.

Current or former cigarette smokers percentage, by use and harm perceptions of

e-cigarettes

Observations

E-Cigarette users

- Less harmful than cigarettes

- About the same as cigarettes

- More harmful than cigarettes

6,650

4,573

1,634

443

Currently

smokes cigarettes

51.1

45.8

73.3

24.4

Does not

smoke cigarettes

48.9

54.2

26.7

75.6

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E-Cigarette non-users

Distribution for all respondents

3,400

10,050

100

67.6

32.4

Figure 3.

Harm beliefs of current and former cigarette

smokers

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

37.1%

54.2%

62.9%

45.8%

E-cigarettes are less harmful than

cigarettes

Currently smokes cigarettes

E-cigarettes are same or more harmful

than cigarettes

Does not smoke cigarettes

56.

An alternative perspective on these relationships is the distribution of harm beliefs shown

in Table 4 and Figure 4, conditional on different levels of e-cigarette usage. Those who

currently use e-cigarettes are most likely to perceive that they are less harmful than

cigarettes, with 69% of current e-cigarette users perceiving them to be less harmful than

cigarettes and 31% of current e-cigarette users perceiving e-cigarettes to be just as

harmful or more harmful than cigarettes. The least favorable assessments of the

harmfulness of e-cigarettes are by those who have never tried the product, with only 31%

of this group of those who have never used e-cigarettes considering e-cigarettes to be less

harmful than cigarettes, and 69% considering e-cigarettes to be just as harmful or more

harmful than cigarettes.

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Table 4.

Harm beliefs relative to cigarettes percentage, by e-cigarette use

Observations

E-Cigarettes

- Never tried the product

- Tried, but never use now

- Use the product currently

- Tried, regardless of current use

10,050

1,155

2,245

6,650

8,895

Less

harm

31.3

34.4

68.8

60.1

Same

harm

55.8

57.5

24.6

32.9

harm

12.8

8.1

6.7

7.0

Same

or More

68.7

65.6

31.2

39.9

Figure 4.

Estimated harm of e-cigarettes compared to cigarettes by use

of product

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

Never tried e-cigarettes

Tried e-cigarettes but never use now

Less Harm

Same or more harm

Use e-cigarettes currently

31.3%

34.4%

68.8%

68.7%

65.6%

31.2%

57.

The linkage of harm beliefs to more measures of product usage is examined in Table 5

and Figures 5a, 5b, and 5c. Among those who smoke cigarettes but do not use e-

cigarettes, 67% view e-cigarettes as the same as or more harmful than cigarettes.

However, 76% of those who use e-cigarettes but not cigarettes consider e-cigarettes to be

less harmful than cigarettes. By comparison, among those who both smoke cigarettes

and use e-cigarettes, 62% consider e-cigarettes to be less harmful than cigarettes.

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Cigarette smokers who do not use e-cigarettes are more likely to believe that e-cigarettes

are at least as harmful as cigarettes, by a two-to-one margin.

Table 5.

Percentage distribution of harm beliefs for different groups of usage of cigarettes

and e-cigarettes

E-Cigarettes are:

Product use:

- Smokes cigarettes, not e-cig

- E-Cigarettes, not cigarettes

- Both e-cigarettes and cigarettes

Less harmful

than cigarettes

33.4

76.3

61.6

Same or

more harmful

than cigarettes

66.6

23.7

38.4

Observations

3,400

3,252

3,398

Figure 5A.

Estimated comparative harm beliefs of smokers of

cigarettes and/or e-cigarette users

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

23.7%

38.4%

66.6%

76.3%

61.6%

33.4%

Smokes but does not use e-

cigarettes

Smokes and uses e-cigarettes

Uses e-cigarettes but does not

smoke

Less harmful than cigarettes

Same or more harmful than cigarettes

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Figure 5B.

Harm beliefs of those who use e-cigarettes

but do not smoke cigarettes

23.7%

76.3%

E-cigarettes are less harmful than cigarettes

E-cigarettes are the same as or more harmful than cigarettes

Figure 5C.

Harm beliefs of those who smoke

cigarettes and do not use e-cigarettes

33.4%

66.6%

E-cigarettes are less harmful than cigarettes

E-cigarettes are the same as or more harmful than cigarettes

58.

The implication of Tables 1-5 and their figure counterparts is that beliefs that e-cigarettes

are less harmful than cigarettes are correlated with e-cigarette usage, as well as with the

combination of e-cigarette usage and not smoking cigarettes.

59.

To better analyze the impact of risk perceptions on current e-cigarette use, Table 6

presents regression results in which the dependent variable is a 0-1 indicator for current

product use, and the explanatory variables consist of harm beliefs, countries, and

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demographic factors. These regressions in effect analyze factors that affect the

probability that the respondent currently uses e-cigarettes. For some demographic

variables, such as income and gender, a small number of respondents did not answer the

question (Appendix A lists the missing data percentages for each variable). For these

observations for which the respondent did not answer the question, I followed the

standard statistical practice of including these responses in the statistical analysis but

creating a 0-1 indicator variable to address the fact that an observation on this particular

variable is missing for the particular respondent.

60.

Controlling for the variables included in the regression in Table 6, those who consider e-

cigarettes to be less harmful than cigarettes are 33% more likely to currently use e-

cigarettes. This relationship is statistically significant with a 95% confidence level, a test

that is noted by at least two asterisks in the regression results in this report (three asterisks

reflect a 99% level). There are no statistically significant country effects. For this and in

subsequent regressions, the UK is the excluded country, which means that any country

effects are measured relative to the UK. Usage of e-cigarettes rises with age, but then

declines for those age 60+.

Table 6.

Regressions predicting the probability that respondent CURRENTLY USES e-

cigarettes, based on harm beliefs, country, and demographics

E-Cigarette

yes use

0.3260***

(0.0090)

0.0066

(0.0170)

0.0090

(0.0177)

-0.0210

E-cigarette less harmful

Belgium

Denmark

Netherlands

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France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Asian

Other

Female

Married

Widowed

Divorced

Separated

Partner

Missing income

Missing education

Missing race

Missing female

Missing relationship

Constant

(0.0163)

0.0213

(0.0161)

0.0174

(0.0161)

0.0014

(0.0162)

0.0011**

(0.0005)

-0.0360**

(0.0159)

0.0010***

(0.0002)

0.1087***

(0.0242)

0.0127***

(0.0020)

-0.1276***

(0.0300)

-0.0440

(0.0294)

-0.0098

(0.0268)

-0.0255***

(0.0091)

0.0114

(0.0128)

-0.0175

(0.0296)

-0.0301

(0.0186)

-0.0042

(0.0279)

0.0217

(0.0147)

0.0187

(0.0177)

0.2332***

(0.0511)

0.0714*

(0.0399)

-0.1824*

(0.1065)

-0.0283

(0.0438)

0.1959***

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(0.0373)

Observations

10,050

R-squared

0.15

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

61.

Given the pivotal role of whether the respondent believes that e-cigarettes are less

harmful than cigarettes, the regressions in Table 7 analyze the relationship of the 0-1

variable for whether the respondent perceives e-cigarettes as less harmful than cigarettes.

Also included are the variables for the different countries and demographic groups.

Relative to the UK sample, respondents in Belgium, Denmark, the Netherlands, France,

and Germany are significantly less likely to believe that e-cigarettes are less harmful than

cigarettes. Given the efforts by Public Health England and other public health

organizations in the UK to communicate the relative risk profile of e-cigarettes as

compared to cigarettes, this pattern is consistent with a possible impact of these efforts on

harm beliefs. The greatest disparity is for respondents in Belgium, as they are 25% less

likely to regard e-cigarettes as less harmful. Respondents also are more likely to regard

e-cigarettes as less harmful if they are age 60+ or have high income but are not in the top

income group.

Table 7.

Regressions predicting the probability that the respondent believes e-cigarettes

are LESS HARMFUL than cigarettes, based on country and demographics

E-Cigarettes

less harmful

-0.2596***

(0.0188)

-0.1356***

(0.0197)

-0.0862***

(0.0182)

-0.0513***

(0.0179)

-0.1216***

Belgium

Denmark

Netherlands

France

Germany

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Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Asian

Other

Female

Married

Widowed

Divorced

Separated

Partner

Missing income

Missing education

Missing race

Missing female

Missing

relationship

Constant

Observations

R-squared

(0.0179)

-0.0029

(0.0181)

-0.0009*

(0.0005)

0.0813***

(0.0177)

0.0008***

(0.0002)

-0.0903***

(0.0269)

-0.0031

(0.0022)

-0.0528

(0.0335)

-0.1280***

(0.0327)

-0.0394

(0.0299)

-0.0723***

(0.0101)

-0.0034

(0.0143)

-0.0228

(0.0330)

0.0154

(0.0208)

0.0072

(0.0311)

0.0393**

(0.0164)

0.0126

(0.0197)

-0.0386

(0.0570)

-0.0138

(0.0445)

-0.3318***

(0.1187)

0.0619

(0.0489)

0.7316***

(0.0409)

10,050

0.04

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Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

62.

Whether e-cigarette use is related to smoking status is examined in the regressions in

Table 8, where the dependent variable is the 0-1 indicator variable for whether the

respondent is a current smoker. If the respondent currently uses e-cigarettes, he or she is

48% less likely to also be a current smoker. These results are consistent with e-cigarettes

serving as an alternative for conventional cigarettes given the sample screens that

required all people to be a current or former smoker. Given the cross-sectional nature of

the data, the timing of the transition to use of e-cigarettes cannot be determined.

Table 8.

Regressions predicting the probability that the respondent is a CURRENT

CIGARETTE SMOKER, based on e-cigarette USE, country, and demographics

E-cigarette yes use

Belgium

Denmark

Netherlands

France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Smoker

-0.4814***

(0.0085)

0.0337**

(0.0153)

0.0730***

(0.0161)

0.0064

(0.0148)

0.0024

(0.0146)

0.0014

(0.0146)

-0.0217

(0.0147)

-0.0054***

(0.0004)

-0.0612***

(0.0144)

0.0000

(0.0002)

-0.2013***

(0.0219)

0.0095***

(0.0018)

-0.0229

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(0.0273)

Asian

0.0611**

(0.0267)

Other

0.0207

(0.0244)

Female

-0.0101

(0.0083)

Married

0.0212*

(0.0116)

Widowed

0.0295

(0.0269)

Divorced

0.0021

(0.0169)

Separated

-0.0180

(0.0254)

Partner

-0.0544***

(0.0133)

Missing income

-0.0569***

(0.0160)

Missing education

0.1229***

(0.0465)

Missing race

-0.0077

(0.0363)

Missing female

0.0037

(0.0968)

Missing relationship

-0.0539

(0.0398)

Constant

1.1053***

(0.0336)

Observations

10,050

R-squared

0.29

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

63.

Table 9 reports a regression on a closely related matter regarding exclusive e-cigarette

usage. The dependent variable is a 0-1 variable for whether the respondent currently uses

e-cigarettes and also does not smoke cigarettes. The principal variable of interest is

whether the respondent considers e-cigarettes to be less harmful than cigarettes. Those

who have this belief are 9% more likely to be an e-cigarette user and not smoke

conventional cigarettes. The country effects relative to the UK are also interesting. All

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effects that are statistically significant are negative. The four statistically significant

relationships are for Belgium, the Netherlands, Germany, and Italy, all of which have a

lower likelihood of respondents using e-cigarettes and not also smoking compared to the

UK. Together with the earlier results on risk beliefs, these findings indicate that in the

UK people are more likely to perceive e-cigarettes as less harmful than cigarettes and are

also more likely to use e-cigarettes and not also smoke even after controlling for this

difference in beliefs, compared to these other countries.

Table 9.

Regressions predicting the probability that the respondent CURRENTLY USES

e-cigarettes for the subsample that DOES NOT SMOKE CIGARETTES, for exclusive use

of product

E-Cigarette

yes only

0.0935***

(0.0167)

-0.1904***

(0.0264)

0.0200

(0.0259)

-0.0758***

(0.0232)

-0.0268

(0.0215)

-0.1053***

(0.0221)

-0.2933***

(0.0220)

-0.0017**

(0.0007)

-0.0018

(0.0206)

-0.0029***

(0.0002)

-0.2022***

(0.0334)

-0.0078***

(0.0029)

0.0990**

(0.0485)

E-cig less harmful

Belgium

Denmark

Netherlands

France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

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Asian

Other

Female

Married

Widowed

Divorced

Separated

Partner

Missing income

Missing education

Missing race

Missing female

Missing

relationship

-0.0035

(0.0554)

-0.0314

(0.0431)

-0.0090

(0.0130)

-0.0076

(0.0191)

-0.0163

(0.0421)

-0.0304

(0.0261)

-0.0469

(0.0393)

-0.0239

(0.0208)

-0.0631***

(0.0238)

-0.0754

(0.0698)

-0.0323

(0.0527)

-0.5457

(0.3379)

-0.0459

(0.0594)

Constant

1.1903***

(0.0560)

Observations

3,252

R-squared

0.37

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

64.

The surveys also elicited respondents’ reasons for never trying

e-cigarettes. For the

sample of respondents in Table 10 who have never tried the product, the main reasons

given are that they do not know enough about e-cigarettes or do not think that e-cigarettes

are any less harmful than cigarettes, each of which were mentioned by 27% of the

respondents. Just under 17% of the sample indicate that they do not want to quit

smoking, and 16% believe that e-cigarettes will not help them quit. Cost is a minor

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concern voiced by 10% of respondents. Figure 10 summarizes the most prominent main

reasons for never trying e-cigarettes.

Table 10.

Percentage distribution of the main reason for decision to have NEVER TRIED

e-cigarettes

What is the main reason for you not trying

I do not know enough about them

I do not want to quit smoking

I do not think that they are any less harmful than

cigarettes

They cost too much

I do not think that they would help me to quit or

cut down smoking

Other

Number of observations

E-Cigarette

27.2

16.9

27.1

9.7

15.8

3.3

1,155

Figure 10.

Main reason given by respondents for never

having tried e-cigarettes

27.2%

27.1%

I do not know enough about them

I do not think they are any less harmful than

cigarettes

65.

The stated reasons for currently using e-cigarettes shown in Table 11 are consistent with

e-cigarettes serving as an alternative for conventional cigarettes. A combined total of

62% of the current users indicate that they are using e-cigarettes to either help them stop

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smoking cigarettes (40%) or to cut down on the number of cigarettes smoked (22%).

Figure 11 illustrates these key results. Saving money and the availability of a variety of

flavors rank next in importance. Lower on the list are responses more closely related to

exposure to others and acceptability of using e-cigarettes, as 8% indicate that e-cigarettes

can be used in more places and 6% reference the absence of environmental tobacco

smoke.

Table 11.

Percentage distribution of the main reason for decision to CURRENTLY USE e-

cigarettes

What is the main reason for you using

To help me stop smoking cigarettes

To cut down on the amount of cigarettes that I

smoke

[To help me stop or to cut down]

To save money

Because they are available in better flavors than

cigarettes

Convenience, e-cigarettes can be used in more

places

To not expose people nearby me to cigarette

smoke

Other

Number of observations

E-Cigarette

39.8

22.3

62.0

11.6

10.2

8.1

5.5

2.6

6,650

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Figure 11.

Main reason for decisions to currently

use e-cigarettes

39.8%

22.3%

To help me stop smoking cigarettes

To cut down on the amount of cigarettes

I smoke

VI.

NEW EVIDENCE ON HARM PERCEPTIONS FOR HEATED TOBACCO

PRODUCTS AND ORAL NICOTINE POUCHES

66.

The respondents to the surveys also answered questions regarding heated tobacco

products and oral nicotine pouches. Both because of the sample screens and the lower

overall usage of these products, the results often pertain to a subset of the overall sample.

Table 12.

Product use and relative harm belief percentage, for each of two products

Heated tobacco

products

Ever heard of the product*

Description of use **

- Never tried the product

- Tried, but never use now

- Use the product currently

- Tried, regardless of current use

64.8

61.9

21.2

16.9

38.1

Oral nicotine

pouches

47.2

75.3

15.7

9.0

24.7

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Harm relative to cigarettes ***

- Less harmful than cigarettes

- About the same as cigarettes

- More harmful than cigarettes

- Same or more harmful

43.6

48.7

7.7

56.4

48.7

40.3

11.0

51.3

* Knowledge of e-cigarettes was required to participate in the survey.

** Those who have never heard of the product are assumed never to have tried it.

*** Harm beliefs are percentages of the subset of respondents who have heard of the product.

67.

As indicated in Table 12, 66% of respondents had heard of heated tobacco products, and

only 47% had heard of oral nicotine pouches. The data in Table 12 and Figures 12A and

12B

regarding the respondent’s use of the product and harm perceptions only pertain to

the subsample of respondents who indicated that they had heard of each of the products.

Among these groups, 38% had tried heated tobacco products, and 25% had tried oral

nicotine pouches. Beliefs are roughly evenly divided between perceptions that the

product is less harmful than cigarettes and perceptions that the product is just as harmful

or more harmful. For heated tobacco products, 44% view them as less harmful than

cigarettes, and 56% consider them to be the same or more harmful than cigarettes. For

oral nicotine products, 49% consider them to be less harmful than cigarettes, and 51%

consider them to be the same or more harmful than cigarettes.

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Figure 12A.

Estimated harm of heated tobacco

products compared to cigarettes

60%

50%

40%

30%

43.6%

56.4%

20%

10%

Less harmful than cigarettes

About the same or more harmful than

cigarettes

Figure 12B.

Estimated harm of oral nicotine

pouches compared to cigarettes

60%

50%

40%

30%

48.7%

20%

10%

Less harmful than cigarettes

About the same or more harmful than

cigarettes

51.3%

68.

The distribution of harm perceptions varies depending on product usage, as indicated in

Table 13 and Figures 13A and 13B. The product usage statistics are at the top of each

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panel of Table 13. Overall, 14% of current cigarette smokers currently use heated

tobacco products, and 22% of former smokers currently use heated tobacco products.

Among those who believe that heated tobacco products are less harmful than cigarettes,

67% of current smokers currently use heated tobacco products, and 33% do not, while for

former smokers who believe that heated tobacco products are less harmful than

cigarettes, 51% currently use heated tobacco products and 49% do not. Usage among

those who believe that heated tobacco products are the same as or more harmful than

cigarettes is much lower—only 15% among smokers and 16% among former smokers in

this belief group use heated tobacco products. Only 7% of current smokers currently use

oral nicotine pouches and 14% of former smokers currently use oral nicotine pouches.

For those who believe that oral nicotine pouches are less harmful than cigarettes, the rate

of usage is 19% for current smokers and 42% for former smokers. For those who believe

that oral nicotine pouches are the same as or more harmful than cigarettes, the rate of

product usage is 10% among current smokers and 16% among former smokers.

Table 13.

Current or former cigarette smokers and their alternative product use

percentage, by product and harm belief for that product

Results for

Current cigarette smokers

Does not

Currently

use product uses product

85.6

14.4

67.4

32.6

84.8

15.2

93.2

80.8

90.1

6.8

19.2

9.9

Results for

former smokers

Does not

Currently

use product uses product

78.0

22.0

48.7

51.3

84.0

16.0

86.4

58.0

84.5

13.6

42.0

15.5

Heated tobacco users

- Less harmful than cigarettes

- Same or more harmful

Oral nicotine users

- Less harmful than cigarettes

- Same or more harmful

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Figure 13A.

Harm Beliefs of Current Cigarette

Smokers

100%

80%

60%

40%

20%

HTPs are less harmful than cigarettes

Does not use HTPs

HTPs are the same as or more

harmful than cigarettes

Currently uses HTPs

67.4%

84.8%

32.6%

15.2%

Figure 13B.

Harm Beliefs of Current Cigarette

Smokers

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

19.2%

9.9%

80.8%

90.1%

Oral nicotine pouches are less

harmful than cigarettes

Does not use oral nicotine pouches

Oral nicotine pouches are the same

as or more harmful than cigarettes

Currently uses oral nicotine pouches

69.

To explore the linkage between usage of these products and whether the respondent

currently smokes cigarettes, Table 14 reports these statistics both overall as well as

conditional on harm beliefs. The table and the Figures 14A and 14B illustrate the key

results. Users of heated tobacco products and oral nicotine pouches are more likely to be

former smokers. Among heated tobacco product users 42% do not currently smoke

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cigarettes, as compared to 30% of non-users of heated tobacco products who do not

currently smoke cigarettes; and 49% of oral nicotine pouch users do not currently smoke

cigarettes, as compared to 31% of non-users of oral nicotine pouches who do not smoke

cigarettes. Similarly, users of both heated tobacco and oral nicotine products have a 57%

non-smoking rate.

70.

For those who use heated tobacco products and oral nicotine pouches, perceiving these

products as being less harmful than cigarettes is also associated with not smoking

cigarettes. Among heated tobacco product users who believe that heated tobacco is less

harmful than cigarettes, 49% do not currently smoke cigarettes; and 55% of oral nicotine

pouch users who believe that the product is less harmful than cigarettes do not currently

smoke cigarettes. This effect is diminished for those who believe that these products are

the same or more harmful than cigarettes, such that 28% do not currently smoke

cigarettes if they believe this about heated tobacco products and 36% do not currently

smoke cigarettes if they believe this about nicotine pouches, as shown in Figure 14B.

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Table 14.

Current or former cigarette smokers percentage, by use and harm perceptions of

products, including multiple product users

Observations

Heated tobacco users

- Less harmful than cigarettes

- About the same as cigarettes

- More harmful than cigarettes

Heated tobacco non-users

Oral nicotine users

- Less harmful than cigarettes

- About the same as cigarettes

- More harmful than cigarettes

Oral nicotine non-users

Users of multiple products

- Heated & Pouches

Distribution for all respondents

1,696

1,130

438

127

8,354

906

629

172

104

9,144

709

10,050

Currently

smokes cigarettes

57.9

50.6

80.6

44.1

69.6

51.2

45.5

84.3

30.8

69.3

43.4

67.6

Does not

smoke cigarettes

42.1

49.4

19.4

55.9

30.4

48.8

54.5

15.7

69.2

30.7

56.6

32.4

Figure 14A.

Harm beliefs of current and former

cigarette smokers

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

27.6%

49.4%

72.4%

50.6%

HTPs are less harmful than cigarettes

Currently smokes cigarettes

HTPs are about the same or more harmful

Does not smoke cigarettes

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Figure 14B.

Harm beliefs of current and former

cigarette smokers

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

35.9%

54.5%

64.1%

45.5%

Oral nicotine pouches are less harmful

than cigarettes

Currently smokes cigarettes

Oral nicotine pouches are about the same

or more harmful

Does not smoke cigarettes

71.

Table 15 and Figures 15A and 15B show the distribution of harm beliefs conditional on

different levels of heated tobacco and oral nicotine products usage. In the case of heated

tobacco products, 67% of those who use the product perceive that they are less harmful

than cigarettes and 33% perceive that they are the same as or more harmful than

cigarettes. In the case of oral nicotine pouches, 69.5% of those who use the product

perceive that they are less harmful than cigarettes and 30.5% perceive that they are the

same as or more harmful than cigarettes.

Table 15.

Harm beliefs relative to cigarettes percentage, by product use for each product

Observations

Heated tobacco products

- Never tried the product

- Tried, but never use now

- Use the product currently

- Tried, regardless of current use

Oral nicotine pouches

6,511

2,685

2,131

1,695

3,826

4,739

Less

harm

34.7

36.6

66.7

49.9

Same

harm

57.7

55.7

25.8

43.4

harm

7.6

7.9

7.5

7.7

Same

or More

65.3

63.4

33.3

50.1

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- Never tried the product

- Tried, but never use now

- Use the product currently

- Tried, regardless of current use

2,256

1,578

905

2,483

46.9

39.4

69.5

50.4

43.4

48.3

19.0

37.6

9.8

12.3

14.5

12.0

53.1

60.6

30.5

49.6

Figure 15A.

Estimated harm of heated tobacco

products compared to cigarettes by use of

product

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

33.3%

65.3%

63.4%

66.7%

34.7%

36.6%

Never tried heated

tobacco products

Tried heated tobacco

products but never use

now

Use heated tobacco

products currently

Less harm

Same or more harm

Figure 15B.

Estimated harm of oral nicotine

pouches compared to cigarettes by use of product

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

30.5%

53.1%

60.6%

69.5%

46.9%

39.4%

Same or more harm

Less harm

Never tried oral

nicotine

pouches

Tried oral

nicotine

pouches but

never use now

Use oral

nicotine

pouches

currently

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72.

The final set of overall harm belief statistics in Table 16 analyzes the product use groups

in conjunction with the harm beliefs. In the case of heated tobacco products, the

percentage who believe that they are as harmful as or more harmful than cigarettes is

66% for those who smoke cigarettes and do not use heated tobacco products, 22% for

those who use heated tobacco products and do not smoke cigarettes, 42% if they use both

heated tobacco products and cigarettes, and 61% if they use neither heated tobacco

products nor cigarettes. The remainder in each group believe that heated tobacco

products are less harmful than cigarettes. In the case of oral nicotine products, the

percentage who believe that they are as harmful as or more harmful than cigarettes is

57% for those who smoke cigarettes but do not use oral nicotine pouches, 22% for those

who use oral nicotine pouches but do not smoke cigarettes, 38% for those who use both

oral nicotine pouches and smoke cigarettes, and 53% for those who use neither oral

nicotine pouches nor cigarettes.

Table 16.

Percentage distribution of harm beliefs for different groups of usage of cigarettes

and other products

Heated products are:

Product use:

- Smokes cigarettes, not heated

- Heated, not cigarettes

- Both heated and cigarettes

- Neither heated nor cigarettes

Oral nicotine pouches are:

Product use:

- Smokes cigarettes, not pouches

- Pouches, not cigarettes

Less harmful

than cigarettes

34.1

78.2

58.3

39.2

Less harmful

than cigarettes

42.8

77.6

Same or

more harmful

than cigarettes

65.9

21.8

41.7

60.8

Same or

more harmful

than cigarettes

57.2

22.4

Observations

3,467

714

981

1,349

Observations

2,821

442

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- Both pouches and cigarettes

- Neither pouches nor cigarettes

61.8

46.7

38.2

53.3

463

1,013

73.

Given the nature of the sampling screens, usage of heated tobacco products and oral

nicotine pouch products is less common than is e-cigarette usage in this sample.

Nevertheless, the patterns regarding the usage of these products and the relationship of

product usage to perceptions of their degree of harm are instructive. Each of the products

faces substantial barriers with respect to accurate understanding of the estimated risks

that these alternative products pose as compared to the risks posed by conventional

cigarettes that burn tobacco. Just over half of all respondents believe that these products

pose risks of harm that are the same as or greater than those posed by cigarettes. The

perceptions of harm are correlated with product usage in the expected manner, as

respondents who believe that the products are less harmful than cigarettes are more likely

to use them than are respondents who believe that they are just as harmful as cigarettes or

more harmful. People who do not believe that these products pose less harm are less

likely to try these products or to currently use them. This relationship also holds for

cigarette smokers, as the failure to understand the comparative risk reduction that

scientists estimate is provided by these products may deter their usage as an alternative to

smoking cigarettes.

74.

Table 17 presents regression results in which the dependent variable is a 0-1 indicator for

current product use, and the explanatory variables consist of harm beliefs, country, and

demographic factors. Those who perceive that heated tobacco products are less harmful

than cigarettes are 15% more likely to be using heated tobacco products, while those who

perceive nicotine pouches as being less harmful than cigarettes are 4% more likely to be

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using them. There are several differences across countries in the usage of these products.

All statistically significant effects reflect higher levels of usage than in the UK. Higher

income and better educated respondents are also more likely to use each of these

products.

Table 17.

Regressions predicting the probability that respondent CURRENTLY USES

each of the products, based on harm beliefs, country, and demographics

Heated

yes use

0.1473***

(0.0102)

0.1755***

(0.0211)

0.0132

(0.0216)

0.0242

(0.0181)

0.0264

(0.0184)

0.1023***

(0.0170)

0.1550***

(0.0167)

-0.0002

(0.0005)

-0.0328*

(0.0191)

0.0017***

(0.0002)

0.1976***

(0.0247)

0.0160***

(0.0022)

-0.0932***

(0.0309)

-0.0162

(0.0304)

0.0063

(0.0291)

0.0080

Pouch

yes use

0.0390***

(0.0098)

0.2034***

(0.0179)

0.0251

(0.0186)

0.0464***

(0.0172)

0.0339**

(0.0167)

0.0322*

(0.0168)

-0.0138

(0.0174)

0.0006

(0.0005)

-0.0295

(0.0198)

0.0015***

(0.0002)

0.3044***

(0.0218)

0.0122***

(0.0021)

-0.0866***

(0.0260)

0.0566**

(0.0267)

0.0202

(0.0243)

0.0134

Heated less harmful

Pouch less harmful

Belgium

Denmark

Netherlands

France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Asian

Other

Female

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(0.0101)

(0.0099)

Married

0.0370***

0.0076

(0.0141)

(0.0142)

Widowed

-0.0268

-0.0126

(0.0334)

(0.0317)

Divorced

0.0144

-0.0350

(0.0221)

(0.0223)

Separated

0.0032

0.0825***

(0.0317)

(0.0310)

Partner

-0.0039

-0.0160

(0.0168)

(0.0165)

Missing income

0.0412*

0.0191

(0.0232)

(0.0241)

Missing education

0.2838***

0.1371**

(0.0670)

(0.0639)

Missing race

-0.0028

-0.0074

(0.0475)

(0.0434)

Missing female

0.0782

-0.0535

(0.1170)

(0.0825)

Missing relationship

-0.0405

-0.0301

(0.0585)

(0.0525)

Constant

-0.2442***

-0.2289***

(0.0412)

(0.0384)

Observations

6,511

4,739

R-squared

0.23

0.36

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

75.

The regression results in Table 18 analyze the determinants of whether the respondent

believes that the product is less harmful than cigarettes. The results of greatest interest

are the differences across countries, all of which are relative to the UK. With a few

exceptions, all country effects are negative and statistically significant, meaning that

relative to the UK, the residents of these countries are less likely to perceive these two

products as being less harmful than cigarettes.

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Table 18.

Regressions predicting the probability that the respondent believes the product is

LESS HARMFUL than cigarettes, based on country and demographics

Heated

less harmful

-0.0313

(0.0256)

-0.0470*

(0.0262)

-0.1482***

(0.0219)

-0.0928***

(0.0223)

-0.0350*

(0.0206)

0.1513***

(0.0202)

0.0023***

(0.0006)

-0.0409*

(0.0231)

0.0008***

(0.0002)

0.3189***

(0.0298)

-0.0042

(0.0027)

-0.1196***

(0.0375)

-0.0148

(0.0369)

-0.0031

(0.0353)

-0.0736***

(0.0123)

0.0266

(0.0171)

0.0432

(0.0405)

-0.0156

(0.0268)

-0.0077

(0.0385)

-0.0478**

(0.0204)

-0.0293

Pouch

less harmful

-0.0076

(0.0267)

-0.1190***

(0.0277)

-0.2388***

(0.0253)

-0.1621***

(0.0248)

-0.1541***

(0.0249)

-0.1238***

(0.0258)

0.0020***

(0.0007)

-0.0763***

(0.0295)

0.0000

(0.0002)

0.3249***

(0.0322)

-0.0041

(0.0032)

-0.1056***

(0.0387)

-0.0563

(0.0397)

-0.0928**

(0.0362)

-0.0570***

(0.0147)

0.0128

(0.0212)

0.0666

(0.0473)

0.0142

(0.0332)

-0.0880*

(0.0461)

-0.0252

(0.0246)

-0.0300

Belgium

Denmark

Netherlands

France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Asian

Other

Female

Married

Widowed

Divorced

Separated

Partner

Missing income

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Missing education

Missing race

Missing female

Missing

relationship

(0.0281)

0.0243

(0.0813)

-0.0833

(0.0576)

-0.2186

(0.1419)

-0.0226

(0.0359)

-0.1074

(0.0951)

0.0607

(0.0646)

-0.0328

(0.1230)

-0.0066

(0.0710)

(0.0783)

Constant

0.3762***

0.5648***

(0.0498)

(0.0567)

Observations

6,511

4,739

R-squared

0.12

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

76.

Whether the respondent is a current smoker is the dependent variable in the regression

results in Table 19. These results for the full sample find that users of both heated

tobacco products and oral nicotine pouches are less likely to be a current smoker, whether

these products are included in the regression results individually or jointly. When both

products are included in the final regression, heated tobacco users are 4% less likely to be

a current smoker and users of oral pouches are 9% less likely to be a current smoker.

Table 19.

Regressions predicting the probability that the respondent is a CURRENT

CIGARETTE SMOKER, based on alternative product USE, country, and demographics

Heat yes use

Pouch yes use

Belgium

Denmark

Netherlands

0.0758***

(0.0176)

0.0893***

(0.0184)

0.0296*

Smoker

-0.0685***

(0.0137)

Smoker

-0.1162***

(0.0195)

0.0827***

(0.0176)

0.0908***

(0.0184)

0.0304*

Smoker

-0.0438***

(0.0148)

-0.0926***

(0.0211)

0.0833***

(0.0176)

0.0902***

(0.0184)

0.0300*

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France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Asian

Other

Female

Married

Widowed

Divorced

Separated

Partner

Missing income

Missing education

Missing race

Missing female

Missing relationship

Constant

(0.0170)

0.0004

(0.0167)

0.0180

(0.0168)

-0.0094

(0.0171)

-0.0058***

(0.0005)

-0.0593***

(0.0165)

-0.0005***

(0.0002)

-0.2171***

(0.0256)

0.0048**

(0.0021)

0.0420

(0.0313)

0.1020***

(0.0306)

0.0321

(0.0280)

0.0125

(0.0095)

0.0186

(0.0134)

0.0417

(0.0308)

0.0148

(0.0194)

-0.0164

(0.0291)

-0.0721***

(0.0153)

-0.0664***

(0.0184)

0.0307

(0.0533)

-0.0401

(0.0416)

0.1488

(0.1109)

-0.0517

(0.0457)

0.8847***

(0.0170)

0.0012

(0.0167)

0.0120

(0.0167)

-0.0236

(0.0169)

-0.0058***

(0.0005)

-0.0586***

(0.0165)

-0.0005***

(0.0002)

-0.1912***

(0.0264)

0.0048**

(0.0021)

0.0405

(0.0313)

0.1073***

(0.0306)

0.0346

(0.0279)

0.0131

(0.0095)

0.0184

(0.0133)

0.0431

(0.0308)

0.0134

(0.0194)

-0.0118

(0.0291)

-0.0720***

(0.0153)

-0.0667***

(0.0184)

0.0273

(0.0533)

-0.0397

(0.0416)

0.1466

(0.1108)

-0.0515

(0.0456)

0.8832***

(0.0170)

0.0012

(0.0167)

0.0158

(0.0168)

-0.0152

(0.0171)

-0.0058***

(0.0005)

-0.0599***

(0.0165)

-0.0004**

(0.0002)

-0.1867***

(0.0264)

0.0052**

(0.0021)

0.0387

(0.0313)

0.1061***

(0.0306)

0.0343

(0.0279)

0.0125

(0.0095)

0.0195

(0.0133)

0.0430

(0.0308)

0.0140

(0.0194)

-0.0125

(0.0291)

-0.0726***

(0.0153)

-0.0660***

(0.0184)

0.0341

(0.0533)

-0.0398

(0.0415)

0.1493

(0.1108)

-0.0523

(0.0456)

0.8785***

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(0.0383)

Observations

10,050

R-squared

0.06

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

77.

Table 20 reports a regression on the use of heated tobacco products, the use of oral

nicotine pouches, or the use of both heated tobacco products and oral nicotine pouches,

for those respondents that do not smoke cigarettes. The dependent variable is a 0-1

variable for whether the respondent currently uses a heated tobacco product, an oral

nicotine pouch product, or both heated tobacco products and oral nicotine pouches and

also does not smoke cigarettes. The principal explanatory variable of interest is whether

the respondent considers heated tobacco products or oral nicotine pouches to be less

harmful. Those who believe heated tobacco products are less harmful than cigarettes are

19% more likely to use a heated tobacco product and not smoke conventional cigarettes.

Those who believe oral nicotine pouch products are less harmful than cigarettes are 5%

more likely to use an oral nicotine pouch product and not smoke conventional cigarettes

78.

In the third regression in Table 20, beliefs regarding whether the product is less harmful

than cigarettes are included for both products. In this case, respondents are 15% more

likely to be using heated tobacco products or oral nicotine pouches if they perceive

heated tobacco products as being less harmful than cigarettes; while the effect of oral

nicotine pouch beliefs is not statistically significant once the heated tobacco beliefs

variable is included.

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Table 20.

Regressions predicting the probability that the respondent CURRENTLY USES

product for subsample that DOES NOT SMOKE CIGARETTES, for each or any of two

products, based on harm beliefs, country, and demographics

Heated

yes use

0.1905***

(0.0186)

0.4872***

(0.0443)

0.0087

(0.0434)

0.1335***

(0.0342)

0.0820**

(0.0348)

0.1361***

(0.0310)

0.2760***

(0.0301)

0.0010

(0.0010)

-0.0073

(0.0307)

0.0030***

(0.0003)

-0.0049

(0.0448)

0.0040

(0.0043)

-0.0604

(0.0634)

-0.0785

(0.0805)

0.0543

(0.0624)

0.1010***

(0.0188)

0.0090

(0.0274)

-0.0378

(0.0586)

0.0646*

(0.0389)

Pouch

yes use

0.0500***

(0.0182)

0.4440***

(0.0358)

-0.0053

(0.0379)

0.1453***

(0.0329)

0.0616**

(0.0303)

0.0889***

(0.0320)

-0.0004

(0.0326)

0.0059***

(0.0010)

-0.0785**

(0.0314)

0.0029***

(0.0003)

0.0885**

(0.0380)

0.0127***

(0.0042)

-0.2043***

(0.0495)

0.1553**

(0.0633)

-0.0322

(0.0468)

0.0721***

(0.0187)

-0.0511*

(0.0285)

-0.0098

(0.0578)

-0.0017

(0.0401)

Heated or Pouch

yes use

0.1502***

(0.0285)

-0.0390

(0.0290)

0.5754***

(0.0558)

0.0499

(0.0604)

0.1360***

(0.0482)

0.1377***

(0.0488)

0.1645***

(0.0463)

0.3390***

(0.0462)

0.0033**

(0.0015)

0.0659

(0.0460)

0.0042***

(0.0005)

-0.1687***

(0.0523)

0.0097

(0.0064)

-0.0879

(0.0698)

0.0887

(0.0868)

0.1181*

(0.0707)

0.1886***

(0.0282)

-0.0009

(0.0422)

-0.0531

(0.0808)

0.0789

(0.0571)

Heated less harmful

Pouch less harmful

Belgium

Denmark

Netherlands

France

Germany

Italy

Age

Age 60+

Income

Income €150,000+

Years education

Black

Asian

Other

Female

Married

Widowed

Divorced

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Separated

Partner

Missing income

Missing education

Missing race

Missing female

Missing

relationship

0.0255

(0.0560)

0.0484

(0.0304)

0.1009***

(0.0382)

-0.0283

(0.1199)

0.0501

(0.0844)

0.7447**

(0.3717)

0.0809

0.0858

(0.0574)

0.0863***

(0.0308)

0.0528

(0.0413)

0.2184*

(0.1217)

0.0836

(0.0756)

0.1060

(0.2917)

0.0329

0.1316

(0.0853)

0.0551

(0.0467)

0.0714

(0.0663)

0.0381

(0.1930)

0.4845***

(0.1288)

0.6967*

(0.3692)

0.0873

(0.0971)

(0.1004)

(0.1705)

Constant

-0.3044***

-0.5862***

-0.5370***

(0.0796)

(0.0750)

(0.1163)

Observations

2,063

1,455

1,195

R-squared

0.40

0.61

0.48

Standard errors in parentheses; * significant at 10%; ** significant at 5%; *** significant at 1%

Country effects are relative to the United Kingdom, the excluded country variable.

79.

Table 21 and Figures 21A and 21B summarize the reported reasons for not using heated

tobacco products and oral nicotine pouches. The most important reason given is that they

do not know enough about the products, which is cited by 44% of respondents who had

not tried heated tobacco products and by 46% of respondents who had not tried oral

nicotine pouches. Belief that the products are not less harmful than regular cigarettes or

not believing that the products will be effective in helping the respondent quit smoking

are also common responses.

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Table 21.

Percentage distribution of the main reason for decision to have NEVER TRIED

product for each product

What is the main reason for you not trying

I do not know enough about them

I do not want to quit smoking

I do not think that they are any less harmful than

cigarettes

They cost too much

I do not think that they would help me to quit or

cut down smoking

Other

Number of observations

Heated

43.5

8.1

17.8

11.7

12.9

6.0

2,685

Pouch

45.7

11.8

12.3

6.3

16.6

7.2

2,256

Figure 21A.

Main reason given by respondents

for never having tried heated tobacco products

43.5%

17.8%

I do not know enough about them

I do not think they are any less harmful

than cigarettes

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Figure 21B.

Main reason given by respondents

for never having tried oral nicotine pouches

45.7%

12.3%

I do not know enough about them

I do not think they are any less harmful

than cigarettes

80.

The reasons that respondents gave for currently using heated tobacco products and oral

nicotine pouches are summarized in Table 22 and Figures 22A and 22B. The dominant

response for 58% of heated tobacco users and 70% of pouch users is that the product

would help them stop or cut down on their smoking.

Table 22.

Percentage distribution of the main reason for decision to CURRENTLY USE

product for each product

What is the main reason for you using

To help me stop smoking cigarettes

To cut down on the amount of cigarettes that I

smoke

[To help me stop or to cut down]

To save money

Because they are available in better flavors than

cigarettes

Convenience, e-cigarettes can be used in more

places

To not expose people nearby me to cigarette

smoke

Other

Number of observations

Heated

41.1

16.5

57.5

8.4

12.3

11.9

7.8

2.1

1,696

Pouch

59.4

11.0

70.4

7.0

8.2

9.6

4.2

0.7

906

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Figure 22A.

Main reason for decisions to

currently use heated tobacco products

41.1%

16.5%

To help me stop smoking cigarettes

To cut down on the amount of cigarettes

I smoke

Figure 22B.

Main reason for decisions to

currently use oral nicotine pouches

59.4%

11.0%

To help me stop smoking cigarettes

To cut down on the amount of cigarettes

I smoke

81.

The demographic characteristics of the sample used in the analysis of heated tobacco

products and oral pouches are identical to Appendix A, Table Full Sample Characteristics

below, since the sample is the same.

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VII.

82.

COUNTRY-SPECIFIC RESULTS

Although a comprehensive discussion of the specific country effects is not included in

this report, there are some results that were particularly striking, in addition to the effects

of the country variables in the regressions above.

83.

The data in Table 23 regarding current product usage and those who do not use cigarettes

reflect the influence of the sample screens. The first two columns reflect how

respondents were recruited to participate in the survey, where two-thirds were intended to

be smokers and two-thirds were intended to be e-cigarette users, with an overlap such

that one-third of respondents currently use both cigarettes and e-cigarettes.

84.

The last two columns show product usage by country for heated tobacco products and

oral nicotine pouches, which were not part of whether the respondent would be included

for the sample or screened. As a result of the screening process, the usage of all products

in Table 23 is unlikely to be representative of the entire population. Amongst the sample

there are significant differences in the use of these products across the different countries.

Table 23.

Percentage who currently use product.

Cigarettes

E-Cigarettes

66.7

62.7

66.7

66.1

66.7

66.2

Heated

Tobacco

Products

30.0

6.3

16.3

8.7

8.1

18.8

26.9

16.9

Oral Nicotine

Pouches

28.6

3.7

12.4

4.3

4.7

5.1

2.7

9.0

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

Total

66.7

74.5

66.7

67.6

66.7

67.6

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85.

The distribution of the percentage of those who currently use the product and do not use

cigarettes appears in Table 24. The first column again reflects how the sample was

recruited, so all respondents who do not currently smoke cigarettes currently use e-

cigarettes. In this sample, Belgium and the Netherlands have higher rates of use for

heated tobacco products and nicotine pouches. Germany and Italy also have

comparatively higher rates of use for heated tobacco products, but this distribution may

be a consequence of the sampling procedure.

Table 24.

Percent who currently use product and do not use cigarettes

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

Total

86.

500

274

500

478

500

3,252

E-Cigarettes

100

Heated Tobacco

Products

60.6

3.6

23.8

3.6

5.8

15.5

32.2

22.0

Oral Nicotine

Pouches

59.6

1.1

20.2

1.0

2.8

3.8

0.6

13.6

The pivotal measure of risk beliefs is whether the respondent believes that the product is

less harmful. This variable is summarized for the different countries in Table 25. The

UK and Italy have a comparatively higher proportion of respondents who regard e-

cigarettes to be less harmful than cigarettes. Beliefs vary for the other products, but

across all countries there is a significant proportion of respondents that do not perceive

these products as being less harmful than cigarettes.

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Table 25.

Percent who believe product less harmful than cigarettes

E-Cigarettes

Less Harmful than

Cigarettes

40.0

52.0

58.5

65.7

60.0

54.5

65.4

56.8

Heated Tobacco

Products

Less Harmful

61.8

35.5

33.0

41.9

31.8

39.0

56.8

43.6

Oral Nicotine

Pouches

Less Harmful

73.5

43.4

37.0

56.0

39.2

40.8

44.3

48.7

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

Total

87.

Table 26 reports for each of the three products, the percentage of current cigarette

smokers who believe that the product is the same or more harmful than cigarettes, by

country. The perceptions across countries are relatively consistent, where most often at

least half of current smokers believe the other products to be as harmful or more harmful

compared to cigarettes.

Table 26.

Percent who believe product the same or harmful than cigarettes, current

smokers

E-Cigarettes

Same or More

Harmful than

Cigarettes

54.9

59.3

53.2

47.7

53.6

55.8

44.5

52.5

Heated Tobacco

Products

Same or More

Harmful

60.5

65.0

64.2

59.9

69.6

62.6

48.4

60.5

Oral Nicotine

Pouches

Same or More

Harmful

41.0

59.1

52.2

48.3

63.5

60.1

58.4

54.6

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

Total

88.

Table 27 reports, for each of the products, the percentage of those who do not use that

product who believe that the product is just as harmful or more harmful than cigarettes,

by country. A high percentage among non-users of each product regard it as just as

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harmful or more harmful than conventional cigarettes. The average across all countries is

greater than half for each product. This is the case for each product in every country with

the exception of oral nicotine pouches in the United Kingdom.

Table 27.

Percent who believe product same or more harmful than cigarettes, among those

who do not currently use the product

E-Cigarettes

Same or More

Harmful than

Cigarettes

75.6

74.8

66.6

60.8

65.6

67.4

57.2

66.6

Heated Tobacco

Products

Same or More

Harmful

77.0

67.3

69.4

59.5

71.7

66.3

51.7

64.5

Oral Nicotine

Pouches

Same or More

Harmful

53.9

57.5

63.1

43.9

60.9

60.4

56.8

56.2

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

Total

89.

Table 28 summarizes the country differences in the percentage who give as their reason

for not using the product that they do not know enough about the product or they do not

think that the product is less harmful. These perceptions are relatively consistent across

surveyed countries, where lack of information or a belief that the products are at least as

harmful as cigarettes account for between 46% and 71% of respondents’ primary reasons

for not using the product.

Table 28.

Percent whose main reasons for not using product is do not know enough about

them or do not think that they are any less harmful than cigarettes

E-Cigarettes

Belgium

Denmark

Netherlands

56.8

55.7

50.6

Heated

Tobacco

Products

59.5

59.2

62.9

Oral Nicotine

Pouches

53.7

45.7

68.1

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United Kingdom

France

Germany

Italy

Total

90.

49.3

48.4

58.1

68.1

54.3

67.9

67.3

51.9

57.1

61.3

55.9

58.9

54.2

70.7

58.1

The country analyses in the appendices also yielded regression estimates for several key

relationships of interest. The coefficients summarized in the first column of Table 29

correspond to the effect of harm beliefs on e-cigarette usage. On average, the belief that

e-cigarettes are less harmful than cigarettes increases that the probability of e-cigarette

usage by 33%. For all countries, e-cigarette usage is negatively related to being a current

smoker, as shown in the second column 2. While the linkage between e-cigarettes being

perceived as less harmful than cigarettes and exclusive e-cigarette usage is not

statistically significant for the individual countries, it is for the entire sample.

Table 29.

E-cigarettes, comparative country regressions by product use and harm beliefs

Table A6

E-cigarette

less harmful

*Predicting*

Yes

e-cigarette use

0.2864***

0.3772***

0.2955***

0.3932***

0.3514***

0.2976***

0.3182***

0.3260***

Table A8

E-cigarette

yes use

*Predicting*

Smoker

-0.3803***

-0.4181***

-0.4406***

-0.4891***

-0.4946***

-0.5034***

-0.5041***

-0.4814***

Table A9

E-cigarette

less harmful

*Predicting*

Only

e-cigarette use

0.0092

-0.0254

0.0263

0.0364

0.0578*

0.0082

0.0317

0.0935***

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

Total

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VIII.

91.

DISCUSSION

Understanding of the attributes of products is an essential input to consumers being able

to make efficient decisions with respect to using the product. One such attribute is the

potential health risk that the product poses to users of the product. The number of

alternative nicotine products on the market has grown to include e-cigarettes, heated

tobacco products, and oral nicotine pouches. Available scientific evidence indicates that

each of these products offers potential risk reductions as compared to conventional

cigarettes. As a result, policies that lead consumers to switch from smoking cigarettes to

these products offer potential public health gains.

92.

Consumers must make the decision whether to switch from cigarettes to these products.

These are individual consumer choices made on a decentralized basis. Understanding of

the risks of these alternative products as compared to cigarettes is essential for consumers

to make informed decisions with respect to using these alternative products.

Understanding of the risk is not only important from the standpoint of potential health

consequences but also in terms of matching the product choice to the consumer’s

preferences.

93.

In recognition of the importance of understanding the comparative risks, Public Health

England in particular has taken a prominent role in communicating its conclusion that e-

cigarettes provide a risk reduction compared to tobacco burning cigarettes of at least

95%.

94.

Unfortunately, the available evidence indicates that many consumers have not grasped

the extent of the estimated risk reduction provided by alternatives to conventional

cigarettes.

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95.

This study provides new survey results from respondents in seven European countries.

The current study provides further evidence, consistent with a number of other studies,

that a substantial portion of the public believes that e-cigarettes and other potentially

reduced risk nicotine products, are just as harmful or more harmful than cigarettes. This

gap in consumer knowledge is consequential, as the results in this report and other studies

demonstrate that these risk perceptions are strongly correlated with the non-use of these

products. These findings suggest that more needs to be done to improve consumers

understanding of the comparative risks of these products.

96.

Foregoing consumption of a product that the consumer would choose if adequately

informed of the risk of the product, produces a loss for consumers. Consumers would be

better off if they understood the potentially lower risks of the alternative products and

then made product decisions that matched their preferences. Even if informed of the risk

attributes, some consumers may choose to smoke conventional cigarettes than switch to

e-cigarettes. But some smokers may be deterred from switching because they do not

realize the potential risk reductions that such products offer. These consumers will be

worse off than if they had the information to be able to make a more informed choice.

97.

The gaps in consumer knowledge, also may lead to a public health loss to the extent that

people who would have switched from conventional cigarettes to e-cigarettes or other

potentially reduced risk nicotine products are discouraged from doing so because of a

misunderstanding of the risks.

98.

These misperceptions exist notwithstanding the generally held view by many public

health experts and public health authorities that e-cigarettes and other non-combustible

tobacco and nicotine products are likely to pose substantially reduced risks compared to

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

combustible cigarettes. However, some opponents to these products continue to raise

concerns regarding the absolute risk of e-cigarettes and the absence of long-term

epidemiological evidence regarding these products. A particular example of this

approach is that of the World Health Organization (WHO), which emphasizes that e-

cigarettes are not safe, and continues to advocate in favor of bans on e-cigarettes, or, if

they are not banned, that these products should be regulated in a similar way to traditional

tobacco products.

The WHO also takes a similar approach to heated tobacco

products.

However, this approach to communicating the risk of these products, denies

current smokers accurate information on the risk of these products compared to cigarettes

and contributes to existing misperceptions.

99.

Risk perceptions can also be heavily influenced by inaccurate media reporting regarding

these products and related research. This misinformation phenomenon was an issue

highlighted in the 2018 PHE report, where the authors noted the problem with inaccurate

reporting and stated:

“The

consequences of this inaccurate or inadequate reporting are that the general

public is misled. This could induce smokers to carry on smoking rather than

switching and EC users to relapse to smoking. While such inaccurate reporting is

not confined to the tobacco harm reduction and EC field, the impact is rarely as

large. Smoking is uniquely dangerous and each year in England around 80,000

smokers die because of tobacco use (2) . There are few other scientific areas

where the gains and losses to public health are so high. It is very likely that these

See World Health Organization,

E-Cigarettes, Q&A,

29 January 2020.

See World Health Organization,

Heated tobacco products: a brief

(2020).

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

reports and headlines are playing a key role in the persistent misperceptions that

the public have about the relative risks of EC and tobacco cigarettes.”

100.

A particular example of this is in the case of the reporting of the EVALI cases in the US.

While most of the cases in the U.S. have been associated with inhalation of vitamin E

acetate, an additive found in some tetrahydrocannabinol

(‘THC’)

vaping products, news

reports often failed to distinguish THC vaping products from standard nicotine-based e-

cigarettes.

There is some evidence suggesting that this inaccurate reporting has

contributed to increasing misperceptions regarding the risk of e-cigarettes.

101.

The regulatory regime for these alternative nicotine products is a critical factor for

communicating risk and facilitating awareness and trial of these products. Research

shows that regulation can affect awareness and use of nicotine vaping products. For

example, Gravely, et al (2019) found that:

"[w]ith

a few exceptions, awareness and use of nicotine vaping products varied by

the strength of national regulations governing nicotine vaping product

sales/marketing, and by country income" and

"[i]n

contrast to many of the

[less

restrictive policies]

and

[restrictive policies]

countries, rates of use were quite low

in the

[most restrictive policies]

countries (Australia, Uruguay and Brazil),

indicating that strict regulation and enforcement of

[nicotine vaping products]

McNeill A, Brose LS, Calder R, Bauld L & Robson D (2018). Evidence review of e-cigarettes and heated tobacco

products 2018. A report commissioned by Public Health England. London: Public Health England, at p173.

See Wayne Hall, Billie Bonevski,

Coral Gartner, Policy‐based evidence on e‐cigarette, or vaping product, use–

associated lung injury, Drug and Alcohol Review, 10.1111/dar.13072,

39,

4, (426-427), (2020).

Tattan-Birch H, Brown J, Shahab L, Jackson SE. Association of the US Outbreak of Vaping-Associated Lung

Injury With Perceived Harm of e-Cigarettes Compared With Cigarettes.

JAMA Netw Open.

2020;3(6):e206981.

doi:10.1001/jamanetworkopen.2020.6981.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

laws in these countries may have limited

smokers’ access to these products and/or

discouraged smokers from using them".

102.

Regulating potentially reduced risk alternative tobacco and nicotine products in the same

way as combustible products conveys the message that these products pose the same

potential health risks as combustible tobacco products and undermines the

communication of the comparative risks of products. The anchoring of the presentation

and communication regarding new potentially reduced products with existing more risky

products has more general implications for the performance of consumer markets for

potentially reduced risk products. If new, potentially reduced risk products become

available, these products will encounter the hurdle of overcoming consumers’ prior risk

beliefs associated with the product class to the extent that consumers are reluctant to alter

their high risk beliefs. The dominant market failure may involve overestimation of the

new product’s riskiness. This influence will impede consumers’ response to new,

potentially less risky alternative products introduced in the market.

103.

For example, requiring e-cigarettes and other potentially reduced risk products to carry

the same style warnings and look the same as combustible tobacco products (for example

by imposing the same plain or standardized packaging requirements); and applying the

same restrictions on product display, will reinforce current beliefs that the risks of these

products are comparable in character and magnitude to the risks of cigarettes. The

particular challenge for informational policies is to convey the properties of e-cigarettes

or and other smoking non-combustible tobacco and nicotine alternatives like heated

Gravely, et al (2019) Prevalence of awareness, ever‐use and current use of nicotine vaping

products (NVPs)

among adult current smokers and ex‐smokers in 14 countries with differing regulations on sales and marketing of

NVPs: cross‐sectional findings from the ITC Project, Addiction. doi: https://doi.org/10.1111/add.14558.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

tobacco products and oral nicotine pouches, which are estimated to pose significantly

lower health risks than conventional cigarettes but are more comparable in terms of the

nicotine levels. Cigarette style warnings and packaging policies are not designed to

foster lower risk beliefs with respect to e-cigarettes or to promote accurate comparative

risk beliefs. Warnings should frame risk information that allows users to make informed

choices.

104.

Advertising bans and prohibitions on comparative risk claims prevent manufactures from

communicating the attributes of these products and potential benefits for smokers,

thereby impeding informed consumer decision making. Imposing advertising bans may

also have negative consequences in increasing demand for traditional cigarettes.

IX.

105.

CONCLUSION

Analysis of the survey results for seven European countries yields differences across

countries in terms of the public’s

perception of alternative nicotine delivery devices.

Four conclusions are most noteworthy. First, the perceptions of a substantial segment of

the population are not in line with the estimated lower levels of harm posed by e-

cigarettes and other non-combustible tobacco and nicotine alternatives like heated

tobacco products and oral nicotine pouches, based on prevailing public health opinions.

Second, the evidence is strongly consistent with e-cigarettes and other non-combustible

tobacco and nicotine products serving as an alternative for conventional cigarettes.

Third, the main reasons given by respondents for not using e-cigarettes and other

potentially reduced risk products are that they do not know enough about them or they do

See Tuchman, Anna

E. 2017. “Advertising and Demand for Addictive Goods: The Effects of E-Cigarette

Advertising.” Working Paper, Northwestern University Kellogg School of Management

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

not think that they are less harmful than cigarettes. Fourth, the decisions to use e-

cigarettes and other potentially reduced risk products are strongly correlated with

perceptions that these products pose less harm than smoking conventional cigarettes, so

that continued misperceptions of the estimated harms from non-combustible tobacco and

nicotine products have adverse implications for informed consumer decision making.

106.

These findings, in combination with the studies reviewed in this report, lead to the

following observations and policy recommendations for governments and regulators:

a. The results of the European surveys discussed in this report and other studies, find

that consumers are misinformed about the estimated reduced harms of non-

combustible tobacco and nicotine products compared to combustible tobacco

products.

b. The policy challenge is to address the shortfall in consumer knowledge so that

current cigarette smokers can make a comparison between cigarettes and these

alternative products that reflects the estimated substantial reduction in the risk of

harm that they are expected to provide. Improving the perceptions of harm for

non-combustible tobacco and nicotine products in line with their estimated

reduced harm compared to conventional cigarettes will likely lead to more

smokers switching to these products as an alternative to smoking.

c. To reduce the continued misperception of the estimated harm posed by non-

combustible tobacco and nicotine products compared to conventional cigarettes,

governments and regulators should treat these products differently than cigarettes

and should undertake sustained efforts to communicate the estimated lower risk

that they pose compared to cigarettes.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

d. Such policies might include efforts along the following lines:

i. Undertaking risk communication efforts that credibly convey to

consumers accurate information about the estimated lower risk posed by

these non-combustible products.

ii. Adopting warnings for these products that are not patterned on cigarette

warnings but rather are reflective of the lower degree of estimated risk that

they pose and providing information that facilitates informed consumer

decision making. Warnings and other information efforts should not be

policies of persuasion designed to discourage smokers’ usage of non-

combustible tobacco and nicotine products.

iii. Allowing marketing freedoms for companies selling alternative tobacco

and nicotine products so that they can create awareness of these products

and the estimated risk reduction that they offer to smokers who choose

these products instead of cigarettes.

107.

The underlying principle of these recommendations, which is that non-combustible

tobacco and nicotine products merit quite different treatment than conventional

cigarettes, should be carried over across all dimensions of government and regulatory

policies. These efforts include, among others, advertising bans and limitations, retail

display bans, and requirements regarding the use of plain or standardized packaging as

well as restrictions on ingredients and the imposition of taxes. Efforts that adopt the same

regulatory approach as is used for tobacco cigarettes will continue to reinforce

consumers’ misperceptions regarding the comparative

estimated risk of these products.

There is evidence that consumer beliefs have become more out of line with the estimated

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

risk that these products pose compared to cigarettes. Given the increase in risk beliefs for

e-cigarettes that has been observed in several recent surveys, it is possible that recent

regulatory efforts that treat these alternative products in the same way as combustible

tobacco products may have even increased the degree of misperception regarding non-

combustible tobacco and nicotine products.

____________________

W. Kip Viscusi

17 December 2020

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Appendix A. Sample Characteristics and Survey Text

Appendix Table Full Sample Characteristics.

Full sample demographic percentages

Age

Gender

Male

52.7

Female

46.4

Black

2.2

Asian

2.3

Other

0.7

Multiple

2.1

No Answer

0.2

Other

0.6

Never

Married

18.9

No Answer

1.3

Live-in

Partner

17.4

Answer

1.1

Answer

1.1

18-20

2.3

21-29

138

30-39

27.8

40-49

21.6

50-59

20.7

60+

13.8

Race or ethnicity

White

Race

91.4

Relationship

Married

Relationship

Education

Less than

High

School

7.1

10-30

48.6

Widowed Divorced Separated

2.6

High

School

25.3

30-49

8.6

Trade /

Tech /

Vocational

23.4

50-75

2.8

Bachelor

23.9

Post-

Graduate

19.1

Education

Income in Euros*

0-10

100-

125-

150+

125

150

Answer

Income

7.1

25.6

24.3

13.9

10.4

0.7

2.2

7.2

8.6

* United Kingdom and Denmark respondents

were adjusted based on their currencies’ exchange

rate relative to the euro on July 22, 2020 which is the date when half of all surveys were

complete. Top income for the United Kingdom is the equivalent of

€165,000 or more in pounds.

Top income for Denmark is the equivalent €167,500 or more in kroner.

Country

Belgium

Denmark

Netherlands

United Kingdom

France

Germany

Italy

1,500

1,073

1,500

1,477

1,500

Percentage

14.9

10.7

14.9

14.7

14.9

75-100

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Anna Dunø Madsen

Fra:

Sendt:

Til:

Emne:

Camilla Friborg Madsen

16. marts 2023 14:00

Anna Dunø Madsen

VS: Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til

personer under 18 år og lov om røgfri miljøer - intern frist den 24. februar 2023

Signature-20230207083241.txt

Vedhæftede filer:

Fra:

BOH-FP-Direktion <[email protected]>

Sendt:

7. februar 2023 09:32

Til:

Camilla Friborg Madsen <[email protected]>

Emne:

VS: Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter

m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer - intern frist den

24. februar 2023

Kære Camilla,

På vegne af Bornholms Hospital.

Vi har ingen bemærkninger til fremsendte materiale.

Med venlig hilsen

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Direktionssekretær

Bornholms Hospital

Direktionen

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Fra:

Camilla Friborg Madsen <[email protected]>

Sendt:

3. februar 2023 09:26

Til:

Advoksamfundet <[email protected]>;

Arbejdstilsynet <[email protected]>; Astma-Allergi Forbundet <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

Danske Læskedrik Fabrikanter (info) <[email protected]>; Børnerådet <[email protected]>;

[email protected]; [email protected]; [email protected];

Danmarks Apotekerforening

Danmarks Restauranter og Cafeer <[email protected]>;

Dansk Erhverv (info)

<[email protected]>; Emballageindustrien <[email protected]>;

Helen Gerdrup Nielsen

RHP-ADM - Region Hovedstadens Psykiatri

[email protected]; [email protected]; [email protected]; [email protected];

Dansk

Transport og Logistik (DTL) <[email protected]>;

[email protected]; [email protected]; [email protected];

Danske Regioner <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected];

Datatilsynet

Det Etiske Råd kontakt

<[email protected]>; Diabetesforeningen <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

Faglig Fælles Forbund 3F <[email protected]>;

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[email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected];

1 - KFST Forbrugerombudsmanden (KFST) <[email protected]>; 1

- KFST Forbrugerombudsmanden (KFST) <[email protected]>; Forbrugerrådet <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

Gigtforeningen <[email protected]>; Hjerteforeningen <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected];

Kommunernes

Landsforening <[email protected]>; Kræftens Bekæmpelse <[email protected]>;

[email protected]; [email protected]; [email protected];

Lægeforeningen <[email protected]>; Brancheforeningen for Lægemiddelvirksomheder i Danmark (LIF) <[email protected]>;

[email protected]; [email protected]; [email protected];

NVK Kontakt <[email protected]>; DKetik

Institutionspostkasse <[email protected]>;

Nærbutikkernes Landsforening <info@nbl-

landsforening.dk>; [email protected];

Offentligt Ansattea Organisationer <[email protected]>;

[email protected]; [email protected]; [email protected];

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[email protected]; [email protected]; [email protected];

Rådet for Socialt Udsatte <[email protected]>;

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[email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]

Emne:

Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v.,

lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer

Til alle høringsparter

Se venligst vedhæftede høring over udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri

miljøer (Implementering af dele af delegeret direktiv vedrørende opvarmede tobaksvarer samt andre præciseringer

og tekniske justeringer)

Indenrigs- og Sundhedsministeriet skal anmode om at modtage eventuelle bemærkninger til udkastet

senest

mandag d. 6. marts 2023 kl. 12.

Bemærkninger bedes sendt til

og til

Camilla Friborg Madsen

Fuldmægtig, Kontor for Forebyggelse og Strålebestyttelse

M 21 67 75 18

Indenrigs- og Sundhedsministeriet

Tlf. 7226 9000

Læs ministeriets datapolitik

her

www.sum.dk

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Sagsnummer 2213653

Den 6. marts 2023

Høring over udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske

cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri

miljøer

Bryggeriforeningen takker for muligheden for at afgive bemærkninger til lovforslaget.

Bryggeriforeningens bemærkninger vedrører den del af lovforslaget, der præciserer kravene til

alderskontrol.

I høringsbrevet er det oplyst, at der i forbindelse med flere domstolsprøvelser ikke er tilstrækkelig klar

lovhjemmel til at stille krav om, at erhvervsdrivende skal etablere et generelt alderskontrolsystem ved

online salg af varer underlagt salgsaldersgrænse. Det er i tilknytning hertil Bryggeriforeningens vurdering, at

det er essentielt, at lovgivningen virker, hvilket bl.a. betyder, at lovhjemmelen skal være tilstrækkelig ved

domstolsprøvelser.

Det er vigtigt og relevant, at der med det konkrete lovforslag implementeres en effektiv lovhjemmel, der

kan sikre optimale domstolsprøvelser, men den eksisterende udfordring med håndhævelsen af

salgsaldersgrænserne bør også søges løst.

Håndhævelsen af salgsaldersgrænserne har i mange år været en stor udfordring, hvilket afspejles i en

række undersøgelser fra Sundhedsstyrelsen m.fl. Grunden til at håndhævelsen ikke fungerer i praksis i den

fysiske handel kan sandsynligvis henføres til, at det alene er den enkelte kassemedarbejder, der er ansvarlig

for at vurdere kundens alder, hvilket resulterer i mange fejl. For så vidt angår online håndhævelse er det

nærliggende, at grunden primært skyldes muligheden for omgåelse. Sådan som løsningen er i dag ved

online salg, kan mindreårige i de fleste situationer indtaste en hvilken som helst alder ved køb af varer (pop

up, afkrydsning eller andet), der er underlagt salgsaldersgrænse.

Som en del af løsningen på den mangeårige håndhævelsesudfordring foreslår Bryggeriforeningen, at

Sundhedsministeriet nedsætter arbejdsgruppe, der skal afsøge hvilke tilgængelige løsninger for

alderskontrol, der i væsentligt og tilfredsstillende omfang kan forbedre håndhævelsen af de nuværende

salgsaldersgrænser. Dette arbejde kan f.eks. ske i forlængelse af de drøftelser som Sundhedsministeriet

igangsatte i foråret 2022 med deltagelse af en række organisationer. Som repræsentant for bryggerierne

deltager Bryggeriforeningen gerne i dette videre arbejde.

Det er Bryggeriforeningens vurdering, at der er behov for at få udviklet et digitalt alderskontrolsystem, der

kan sikre en forbedring af såvel håndhævelsen i den fysiske detailhandel som ved online salg. Et digitalt

alderskontrolsystem skal forhindre, at kunder kan gennemføre køb af produkter, som de ikke er gamle nok

til at købe.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Et digitalt alderskontrolsystem kræver udvikling af en løsning, der ikke er tilgængelig i dag, men som ifølge

flere af de relevante og naturligt involverede parter, herunder også fx MasterCard, er realistisk, da der til

hvert elektroniske betalingsmiddel er knyttet en konkret kontohaver. Ved at indhente samtykke fra

kontohaver med accept til at foretage alderskontrol, er det muligt digitalt at verificere alderen ved køb i

detailhandlen, når forbrugeren gennemfører sin betaling elektronisk, hvad enten det er med kort eller

telefon ved terminalen

–

såvel fysisk som online.

Giver høringssvaret anledning til spørgsmål, står vi naturligvis til rådighed.

Med venlig hilsen

Lea Kholghi Frederiksen

Erhvervspolitisk chef

Mobil (+45) 29 27 26 23

BRYGGERIFORENINGEN

Danish Brewers’ Association

Faxehus, Gamle Carlsberg Vej 16

1799 København V, Denmark

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

DANSK ERHVERV

Børsen

1217 København K

www.danskerhverv.dk

T. + 45 3374 6000

Indenrigs- og Sundhedsministeriet

Att.: Camilla Friborg Madsen

Den 6. marts 2023

Høring: udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov

om elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol

til personer under 18 år og lov om røgfrie miljøer

Dansk Erhverv har modtaget ovenstående udkast til lovforslag i høring. Lovforslaget gennemfører

dele af delegeret direktiv vedrørende opvarmede tobaksvarer samt en præcisering af lovgivning

vedr. alderskontrol og skiltning, som baserer sig på eksisterende praksis på området og med for-

målet at skabe lovhjemmel for, at erhvervsdrivende kan pålægges straf, såfremt de ikke overhol-

der kravene. Dansk Erhverv har følgende bemærkninger til udkastet:

Generelle bemærkninger

Dansk Erhverv støtter formålet med forslaget og deler ønsket om at sætte ind mod unges rygning.

Dansk Erhverv er medlem af partnerskabet for Røgfri fremtid.

For så vidt angår første del af lovforslaget vedrørende gennemførelse af dele af delegeret direktiv

om opvarmede tobaksvarer, bakker Dansk Erhverv op om forslaget, der vurderes at kunne bi-

drage til at begrænse forbruget af de opvarmede tobaksprodukter.

Ligeledes bakker Dansk Erhverv op om lovforslagets præcisering af lovgivning vedrørende alders-

kontrol og skiltning, da denne præcisering allerede er eksisterende praksis og alene har til formål

at skabe tilstrækkelig lovhjemmel.

Metode til alderskontrol ved online salg

Dansk Erhverv noterer sig, at der i lovforslaget fortsat er lagt op til metodefrihed for alderskontrol

ved online salg (pop up, afkrydsning eller andet). Dette bakker Dansk Erhverv fuldt op om og det

vil også fremadrettet være et opmærksomhedspunkt for Dansk Erhverv, da vi mener, det er vig-

tigt, at de erhvervsdrivende ikke bebyrdes med krav til specifikke metoder til alderskontrol mv.

Med venlig hilsen,

Stine Sjølund Blok

Chefkonsulent

stsb/STSB

Side 1/1

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Fremsendt pr. e-mail til

28. februar 2023

Høringssvar fra Dansk Selskab for Folkesundhed vedr.:

”Lov om ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v., lov om forbud

mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer”

DSFF hilser det meget velkommen at opvarmede tobaksvarer fremover ikke kan undtages fra

bestemmelserne i artikel 7, stk. 1 og 7. DSFF støtter fuldt ud op om at det skal være forbudt at

markedsføre opvarmede tobaksvarer med en kendetegnende aroma, og at det skal være forbudt at

markedsføre opvarmede tobaksvarer, der indeholder aromastoffer i deres bestanddele såsom filtre,

papir, emballage, kapsler eller enhver teknisk funktion, der gør det muligt at ændre opvarmede

tobaksvarers duft eller smag eller deres røgudviklingsintensitet. DSFF støtter også at opvarmede

tobaksvarer, der består af filtre, papir eller kapsler med indhold af tobak eller nikotin, ikke må

markedsføres her i landet og at opvarmede tobaksvarer skal have samme kombinerede

sundhedsadvarsler som cigaretter.

DSFF finder det meget vigtigt, at smagsstoffer ikke kun forbydes som ”kendetegnende aromaer”,

men som ingredienser, så der ikke er tvivl om, hvor meget smag, der må/ikke må tilsættes et

produkt. DSFF vil dog gerne opponere imod at opvarmet tobak fremover kun vil være omfattet af

bestemmelserne i artikel 7, stk. 1 og 7, i tobaksvaredirektivet

for så vidt opvarmet tobak er

røgtobak.

DSFF vil gerne opponere imod at opvarmet tobak både kan defineres som røgtobak og røgfri tobak

jf. følgende definition af opvarmet tobak:

§ 2

indsættes som

nr. 31:

»31) Opvarmet tobaksvare: En ny kategori af tobaksvarer, der opvarmes

for at frembringe en emission indeholdende nikotin og andre kemikalier,

som derefter inhaleres af brugeren/brugerne, og

som afhængigt af deres karakteristika

er røgfrie tobaksvarer eller røgtobak. «

Udtrykket ”som afhængigt af deres karakteristika er røgfrie tobaksvarer eller røgtobak” er yderst

uheldig, da det ikke specificeres hvad der menes med karakteristika. Denne unøjagtige formulering

vil uden tvivl blive udnyttet af tobaksproducenterne, der har en stærk interesse i at markedsføre

opvarmet tobak som et ”uskadeligt alternativ” til almindelige cigaretter. De amerikanske

sundhedsmyndigheder, FDA, har konkluderet “data failed to show consistently lower risks of harm

in humans using IQOS (et opvarmet tobaksprodukt) compared with conventional cigarettes.”

WHO anbefaler at opvarmet tobak lovgives som andre tobaksvarer. Opvarmet tobak er små

cigaretter lavet af tobaksblade, og udover at være stærkt afhængighedsskabende, dannes der

mange stærkt sundhedsskadelige stoffer ved opvarmning. Det bør ikke være til forhandling om

tobak er tobak, uanset om det opvarmes, puttes under læben, brændes eller indtages på anden vis.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

DSFF anbefaler derfor at al opvarmet tobak fremover defineres som røgtobak og at al opvarmet

tobak således fremover vil være omfattet af bestemmelserne i artikel 7, stk. 1 og 7 i

tobaksvaredirektivet.

DSFF hilser det meget velkommen at pligten til at drive et alderskontrolsystem fremover

vil påhvile alle detailforhandlere af tobaksvarer, tobakssurrogater og urtebaserede rygeprodukter,

der markedsfører via fjernsalg, og ikke kun dem, der markedsfører via fjernslag over landegrænser.

Ved markedsføring af produkterne online foreslås det, at der skal etableres og drives et generelt

alderskontrolsystem. Dette skal bl.a. gøres via en app-funktion, for at sikre et system, der effektivt

verificerer køberens alder.

Når man læser lovteksten, fremstår den dog ikke så stærk som ønsket.

Stk. 3.

Den, der erhvervsmæssigt markedsfører elektroniske cigaretter eller genopfyldnings-

beholdere med eller uden nikotin online, skal kræve, at

kunden inden salget gennemføres utvetydigt

tilkendegiver, om kunden er fyldt 18 år.«

Ansvaret lægges altså hos kunden, ikke den erhvervsdrivende. Når en 15-årig ønsker at købe tobak

eller e-cigaretter online skal vedkommende så bare sætte et hak ved ”ja, jeg er over 18 år”? Dette

har i DSFFs øjne intet med alderskontrol at gøre. Det svarer til at man i fysiske butikker bare skal

nikke ja til at man er over 18 år, uden legitimation. Unge, kan med få klik få tilsendt store mængder

tobak/tobakssurrogater via onlinekøb. DSFF opponerer stærkt imod dette. Som udgangspunkt

mener DSFF, ligesom WHO, at online salg af tobak og tobakssurrogater ikke skal være tilladt.

Såfremt denne anbefaling fra WHO ikke følges, vil vi opfordre til at man strammer lovteksten, så

onlinesalg af tobaksprodukter og tobakssurrogater kun kan finde sted ved brug af fx MitID, så der

sikres en reel alderskontrol. DSFF anbefaler at man suspenderer muligheden for at forhandle

tobaksvarer indtil en tilfredsstillende og sikker løsning vedr. alderskontrol er etableret.

DSFF vil til sidst gerne gøre opmærksom på at vi er meget uenige i tobaksvaredirektivets artikel 7,

stk. 12, hvor det fremgår, at andre tobaksvarer end cigaretter og rulletobak er undtaget fra

forbuddene i stk. 1 og 7. Disse undtagelser er allerede blevet udnyttet at tobaksproducenterne. I

USA sælges små cigarer der til forveksling ligner almindelige cigaretter, men har brunt rullepapir. De

sælges med søde smagsstoffer, de sælges i farvestrålende pakninger, der reklameres kraftigt for

dem, og de ligger ved kassen i børns øjenhøjde – fordi de kan omgå tobaksvarelovgivningen. Flere

unge i USA bruger små cigarer end almindelige cigaretter.

På vegne af Dansk Selskab for Folkesundhed

Helle Terkildsen Maindal

Forperson

Nina Krogh Larsen

Bestyrelsessuppleant

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Holbergsgade 6

1057 København K

E-mail:

[email protected],

cc:

Høringssvar vedr. udkast til forslag til lov om ændring af lov om

tobaksvarer m.v., lov om elektroniske cigaretter m.v., lov om

forbud mod salg af tobak og alkohol til personer under 18 år og

lov om røgfri miljøer (Implementering af dele af delegeret

direktiv vedrørende opvarmede tobaksvarer samt andre

præciseringer og tekniske justeringer)

Danske Patienter takker for muligheden for at afgive høringssvar til det

fremsendte lovforslag. I Danmark er der mange børn og unge, der

begynder at ryge og bliver afhængige af nikotin

–

og det sker i takt med,

at der kommer flere og flere tobaks- og nikotinprodukter på markedet. I

Danske Patienter bakker vi derfor op om øget regulering af opvarmede

tobaksvarer.

Danske Patienter mener, at opvarmede tobaksvarer skal reguleres på

linje med cigaretter og anden tobak. Vi er derfor positive over for, at der

lægges op til, at opvarmede tobaksvarer omfattes af samme forbud

mod aromastoffer som cigaretter. Mentol og andre aromaer gør

produkterne mere tiltrækkende for særligt børn og unge og bør derfor

forbydes i opvarmede tobaksvarer. Vi mener desuden, at forbuddet

mod aromastoffer bør udvides til at gælde for alle typer af tobaksvarer.

Vi finder det også positivt, at der indføres lovhjemmel til at stille krav om

alderskontrol ved online salg af tobak, urtebaserede rygeprodukter,

tobakssurrogater og e-cigaretter. Vi frygter dog, at det i sig selv ikke er

tilstrækkeligt, idet forhandlere blot kan vælge at lade forbrugere krydse

af, at de er over 18 år. Vi mener derfor, at det er mere oplagt helt at

forbyde salg af tobak og lignende produkter online, hvilket WHO

ligeledes anbefaler. Det mener vi vil gøre tobak mindre tilgængeligt for

særligt børn og unge.

Med venlig hilsen

Dato:

6. marts 2023

Danske Patienter

Kompagnistræde 22, 1. sal

1208 København K

Tlf.: 33 41 47 60

www.danskepatienter.dk

E-mail:

Cvr-nr: 31812976

Side 1/1

Morten Freil

Direktør

Danske Patienter er paraply for patient- og pårørendeforeninger i Danmark. Danske Patienter har 23 medlemsforeninger, der repræsenterer 104

patientforeninger og 900.000 medlemmer: Alzheimerforeningen, Astma-Allergi Danmark, Bedre Psykiatri, Colitis-Crohn Foreningen, Diabetesforeningen,

Epilepsiforeningen, Fibromyalgi- og Smerteforeningen, Foreningen Spiseforstyrrelser og Selvskade, Gigtforeningen, Hjerneskadeforeningen,

Hjerteforeningen, Kræftens Bekæmpelse, Patientforeningen Fertilitet og Tab, Lungeforeningen, Muskelsvindfonden, Nyreforeningen,

Osteoporoseforeningen, Parkinsonforeningen, Polioforeningen, Scleroseforeningen, Sjældne Diagnoser, UlykkesPatientForeningen og Øjenforeningen.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

NOTAT

Danske Regioners bemærkninger til høring af Udkast til for-

slag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af to-

bak og alkohol til personer under 18 år og lov om røgfri mil-

jøer

21-02-2023

EMN-2023-00263

1610034

Sofie Vennike

Indenrigs- og Sundhedsministeriet har d. 3. februar 2023 anmodet om Danske

Regioners bemærkninger til lovforslag vedrørende lov om tobaksvarer og alko-

hol.

Med lovforslaget udvides forbuddet mod markedsføring af tobaksvarer nu til

også at omfatte opvarmede tobaksvarer. Lovforslaget skal gøre opvarmede to-

baksvarer mindre attraktive, og gøre forbrugere mere opmærksomme på de

sundhedsrisici, der er forbundet med at anvende opvarmede røgtobaksvarer.

Direktivet forventes således at bidrage til at begrænse forbruget af opvarmede

tobaksvarer, herunder at børn og unge indleder et forbrug. Lovforslaget har til

formål at rette op på, at der ikke er tilstrækkelig klar lovhjemmel til at stille krav

om, at erhvervsdrivende skal etablere et generelt alderskontrolsystem ved on-

line salg af disse produkter.

Danske Regioner går ind for en målrettet og koordineret forebyggende indsats

på tobaks- og alkoholområdet, og på den baggrund bakker Danske Regioner der-

for op om lovforslaget.

På vegne af Danske Regioner

Thomas I. Jensen

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

E-mail:

og [email protected].

23. februar 2023

Danske Tandplejere

Rosenborggade 1a

1130 København K

T: 8230 3540

E: [email protected]

www.dansketandplejere.dk

Høringssvar vedr. Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske

cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri

miljøer

Danske Tandplejere takker for muligheden for at komme med bemærkninger til ovennævnte høring.

Danske Tandplejere støtter generelt op om alle tiltag og lovændringer, som mindsker brugen af

nikotinholdige produkter af alle slags, da nikotin og indtaget heraf har en yderst skadelig effekt på borgerens

generelle sundhed, herunder også borgernes tandsundhed. Der er blandt andet en markant og signifikant

sammenhæng mellem parodontitis og brug af tobaksprodukter. Parodontitis udvikler sig hurtigere hos

rygere, og succesraten ved behandling er langt ringere hos rygere end hos ikke-rygere. Disse

helbredsmæssige konsekvenser er også gældende for børn og unge, der bruger tobaks- og nikotinholdige

produkter, hvor eksempelvis brugen af snusprodukter har fået antallet af skader på tandkød og den

generelle mundsundhed til at udvikle sig negativt for et stort antal børn og unge.

Danske Tandplejere støtter derfor op om de foreslåede lovændringer og står naturligvis til rådighed, hvis

ovenstående ønskes uddybet.

Venlig hilsen,

Elisabeth Gregersen

Formand, Danske Tandplejere

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Sagsnummer 2213653

København, den 21. februar 2023

Høring over udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske

cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om

røgfri miljøer

De Samvirkende Købmænd, DSK, har den 3. februar 2023 modtaget ovennævnte forslag i hø-

ring.

Medlemskredsen omfatter godt 1.500 supermarkeder, discountbutikker, nærbutikker og conveni-

ence. DSK har også samtidig et tæt samarbejde med de to grossister i den frie sektor: Dagrofa

og Reitan Distribution.

DSK’s medlemmer beskæftiger

samlet set ca. 35.000 ansatte.

Vi takker for muligheden for at afgive kommentarer.

DSK har alene bemærkninger til den del af lovforslaget, der omhandler alderskontrol i fysiske bu-

tikker. Alderskontrol i de fysiske butikker er baseret på, at der skal kræves billedlegitimation, hvis

sælgeren er i tvivl om, hvorvidt kunden er fyldt 16 år hhv. 18 år afhængig af den pågældende

vare.

I praksis er det alene den enkelte kassemedarbejder, der vurderer kundens alder og det medfører

for mange fejl, hvor for unge kunder køber varer som de ellers ikke bør.

En undersøgelse fra HK Handel 2022 viser, at hele 80% af de adspurgte butiksansatte har ople-

vet at blive talt grimt eller nedsættende til af kunder. Når kunderne ikke i tilstrækkelig grad re-

spekterer, at de butiksansatte varetager en jobfunktion med at sikre overholdelse af lovgivning,

får de butiksansatte ikke altid bedt om fremvisning af gyldig billedlegitimation.

Det afspejles da også i adskillige undersøgelser

–

herunder branchens egne - der konkluderer, at

det lykkes for en stor andel unge at købe alkohol og tobak mv., som de ikke er gamle nok til at

købe.

Det skal der rettes op på. De politisk fastsatte aldersgrænser skal naturligvis overholdes.

Hos DSK vil vi gerne opfordre til, at der udarbejdes et alderskontrolsystem, der ikke kun skal be-

nyttes ved fjernsalg, men som også kan benyttes ved fysisk handel.

I Danmark er vi rigtig gode til brug af nye IT-løsninger. Danmark er faktisk blandt de mest digitali-

serede lande i verden. Det bør vi udnytte ved alderskontrollen, så effektiviteten af lovgivningen

ikke alene afhænger af kassemedarbejderens vurdering, når den butiksansatte er face-to-face

med forbrugeren.

Der er endnu ikke udviklet en 100% effektiv digital løsning, men det er vigtigt, at ”hullerne i osten”

ikke længere får lov til at skygge for de fremskridt som brugen af teknologi kan medvirke til.

De Samvirkende Købmænd

Islands Brygge 26 | DK-2300 København S |Tlf. +45 39 62 16 16 | [email protected] | www.dsk.dk

CVR nr.15232013 | Danske Bank 4180-4110212313

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Digital alderskontrol kan f.eks. ske automatisk, når forbrugeren gennemfører sin betaling elektro-

nisk, hvad enten det er med kort eller telefon ved terminalen. Stregkoden på varen fortæller, hvis

varen er underlagt en salgsaldersgrænse, og hvis forbrugeren ikke er gammel nok til at købe va-

ren, bliver betalingen automatisk afvist.

Det kræver udvikling af en løsning, der ikke er tilgængelig i dag, men som bør være realistisk, da

hvert eneste elektroniske betalingsmiddel er knyttet til en konkret kontohaver.

En digitaliseret løsning bør godkendes af Datatilsynet inden den lanceres. Der må på ingen som

helst måde skabes tvivl om forbrugerbeskyttelsen og en digitaliseret løsning bør udelukkende for-

holde sig til, hvorvidt kunden er gammel nok. Ja eller nej.

Prissætningen

–

en elektronisk løsning vil ikke være gratis - bør vurderes af Konkurrence- og For-

brugerstyrelsen på lige fod med f.eks. styrelsens overvågning af prissætningen på Dankortet.

Andre digitaliserede kontrolmuligheder end via betalingsmidlet bør ikke udelukkes på forhånd.

Visionen må være, at der tilvejebringes et effektivt alderskontrolsystem, der ikke kun finder an-

vendelse ved markedsføring via fjernsalg, men ligeledes ved fysisk handel. Løsningen er ikke til-

gængelig i dag, men arbejdet bør igangsættes hurtigst muligt under politisk ledelse.

På den baggrund vil vi opfordre til, at der gøres et helhjertet forsøg på at forene såvel dagligvare-

handlen, de butiksansatte, producenterne af de berørte varer, NGO’ere med naturlig interesse for

børn og unges sundhed samt den finansielle sektor til drøftelser om, hvordan alderskontrollen i

de fysiske butikker kan forbedres mærkbart ved brug af en form for digitaliseret løsning.

Supplerende forslag, der skal medvirke til øget beskyttelse af børn og unge:

- Ved handel online, skal kunden inden salget gennemføres utvetydigt tilkendegive, om

kunden er fyldt 16 år hhv. 18 år. En lignende løsning bør tænkes ind i den fysiske handel.

Her kan man f.eks. forestille sig, at det ikke kun er forbudt at sælge til for unge kunder -

det krav skal naturligvis fortsat gælde

–

men at det også bliver forbudt at erhverve sig pro-

dukter med salgsaldersgrænse, hvis man som kunde ikke er gammel nok. Købsforbuddet

foreslås markedsført med krav om tydelig skiltning, så unge overtræder købsforbuddet,

hvis salgsstedet efterlever krav om tydelig skiltning efter myndighedernes anvisning.

Der bør indføres et forbud mod såkaldt proxysalg, så man fremadrettet kan få en bøde,

hvis man for eksempel køber tobak eller alkohol på vegne af en mindreårig, hvor der er

sket en økonomisk transaktion, hvor den myndige tager betaling for at købe tobak eller

alkohol mv på vegne af den mindreårige.

Giver vores høringssvar anledning til yderligere, er vi naturligvis til rådighed.

Med venlig hilsen

Claus Bøgelund Nielsen

Vicedirektør

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Anna Dunø Madsen

Fra:

Sendt:

Til:

Emne:

David Luxhøj-Pedersen <[email protected]>

9. februar 2023 12:19

Camilla Friborg Madsen; DEP Sundhedsministeriet

SV: Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til

personer under 18 år og lov om røgfri miljøer

Signature-20230209111926.txt

Vedhæftede filer:

Kære Camilla

Finanssektorens Arbejdsgiverforening (FA) takker for høringsmuligheden og har ingen bemærkninger til

lovforslagene.

Med venlig hilsen

David Luxhøj-Pedersen

Advokatfuldmægtig

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

+45 33 38 16 23

Amaliegade 7

1256 København K

Fra:

Camilla Friborg Madsen <[email protected]>

Sendt:

3. februar 2023 09:26

Til:

Advoksamfundet <[email protected]>; [email protected]; [email protected]; [email protected];

Arbejdstilsynet <[email protected]>; Astma-Allergi Forbundet <[email protected]>;

Danske Læskedrik Fabrikanter (info) <[email protected]>; Børnerådet <[email protected]>; [email protected];

[email protected]; [email protected]; [email protected]; Danmarks Apotekerforening

<[email protected]>; [email protected]; [email protected];

Danmarks Restauranter og Cafeer <[email protected]>; [email protected]; [email protected]; Dansk Erhverv (info)

<[email protected]>; Emballageindustrien <[email protected]>; [email protected];

[email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; Dansk Transport og Logistik (DTL) <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected]; Danske Regioner

<[email protected]>; [email protected]; [email protected]; [email protected]; info@danske-

aeldreraad.dk; [email protected]; Datatilsynet <[email protected]>; [email protected];

[email protected]; Det Etiske Råd kontakt <[email protected]>; Diabetesforeningen

<[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; Faglig Fælles Forbund 3F <[email protected]>; [email protected]; Finanssektorens Arbejdsgiverforening

<[email protected]>; 1 - KFST Forbrugerombudsmanden (KFST) <[email protected]>; 1 - KFST

Forbrugerombudsmanden (KFST) <[email protected]>; Forbrugerrådet <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; Gigtforeningen <[email protected]>; Hjerteforeningen <[email protected]>;

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected]; Kommunernes

Landsforening <[email protected]>; Kræftens Bekæmpelse <[email protected]>; [email protected]; [email protected]; [email protected];

Lægeforeningen <[email protected]>; Brancheforeningen for Lægemiddelvirksomheder i Danmark (LIF) <[email protected]>;

[email protected]; [email protected]; [email protected];

[email protected]; [email protected]; NVK Kontakt <[email protected]>; DKetik

Institutionspostkasse <[email protected]>; [email protected]; Nærbutikkernes Landsforening <info@nbl-

landsforening.dk>; [email protected]; Offentligt Ansattea Organisationer <[email protected]>; [email protected];

[email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; Rådet for Socialt Udsatte <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]

Emne:

Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v.,

lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer

Til alle høringsparter

Se venligst vedhæftede høring over udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri

miljøer (Implementering af dele af delegeret direktiv vedrørende opvarmede tobaksvarer samt andre præciseringer

og tekniske justeringer)

Indenrigs- og Sundhedsministeriet skal anmode om at modtage eventuelle bemærkninger til udkastet

senest

mandag d. 6. marts 2023 kl. 12.

Bemærkninger bedes sendt til

og til

Camilla Friborg Madsen

Fuldmægtig, Kontor for Forebyggelse og Strålebestyttelse

M 21 67 75 18

Indenrigs- og Sundhedsministeriet

Tlf. 7226 9000

Læs ministeriets datapolitik

her

www.sum.dk

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

______________________________________________________________________________________

Galten, d. 1. marts 2023

Til Indenrigs- og Sundhedsministeriet

Høringssvar vedr.: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske

cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer

(Implementering af dele af delegeret direktiv vedrørende opvarmede tobaksvarer samt andre

præciseringer og tekniske justeringer)

Først og fremmest ønsker GEjSER at takke for muligheden for at kommentere på fremsendte lovforslag.

Det glæder os, at Indenrigs- og Sundhedsministeriets har et ønske om at tydeliggøre hvilke krav der skal

stilles til alderskontrol, henholdsvis på fysiske salgssteder og ved salg online i forbindelse med salg af

elektroniske cigaretter og tilbehør. Vi mener dog, at der bør foretages ensrettede og mere konkrete

ændringer, som tydeliggør hvilke specifikke krav der stilles i forbindelse med aldersverificering, og særligt

for online-salgssteder.

I GEjSER bakker vi op om De Samvirkende Købmænds forslag om elektronisk aldersverificering via.

betalingskort

, og vi er overbeviste om, at denne løsning især vil kunne forhindre salg af nikotinprodukter til

børn og unge via. online-salgssteder. Derfor har vi naturligvis et håb om, at Indenrigs- og

Sundhedsministeriet vil have løsningen med i overvejelserne, så ensretning for samtlige online-salgskanaler

opnås. Vi mener der er behov for konkrete løsninger og yderligere præcisering på området, og her er

elektronisk aldersverificering via. betalingskort et godt bud.

Vi anerkender, at der kan opstå tvivl i forbindelse med kontant-betalinger i forbindelse med salg på fysiske

salgssteder, og derfor er det også glædeligt, at præciseringen vedr. krav om anmodning om fremvisning af

gyldig billedlegitimation, hvis en ekspedient er i tvivl om en kundes alder, fremgår i lovforslaget.

Vi håber at Indenrigs-

og Sundhedsministeriet vil tage GEjSER’s

forslag og betragtninger med i

viderebehandlingen af lovforslaget, og vi takker endnu engang for muligheden for at få lov til at dele dem

med jer.

Med venlig hilsen

Jeanett Andersen

Kommunikationsansvarlig

GEjSER ApS

Erhvervsparken Klank 3, DK-8464 Galten

CVR / VAT DK32337260

+45 25 63 14 14

www.gejser.dk

https://www.berlingske.dk/danmark/koebmaend-alderstjek-via-kreditkort-kan-hindre-salg-af-nikotinprodukter

GEjSER ApS - Erhvervsparken Klank 3 - 8464 Galten | Tlf. 26 22 07 07 | www.gejser.dk | CVR 32 33 72 60

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Slotsholmsgade 10-12

–

1216 København K

E-mail: [email protected]

Dato:

01. 03. 2023

Direkte tlf.: 51 28 22 43

E-mail:[email protected]

Indenrigs- og Sundhedsministeriet har den 3. februar 2023 fremsendt udkast til:

Forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v., lov om

forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer (Implementering

af dele af delegeret direktiv vedrørende opvarmede tobaksvarer samt andre præciseringer og tekniske

justeringer)

Hjerteforeningen takker for muligheden for at kommentere forslaget om tilbagetrækning af undtagelser vedr.

forbud mod smagsstoffer for opvarmet tobak samt andre præciseringer herunder lovhjemmel til aldersgrænser

ved onlinesalg af tobak og alkohol.

Smagsstoffer til opvarmet tobak

Hos Hjerteforeningen er vi positivt indstillede over for, at der ikke må tilsættes smagsstoffer til opvarmet

tobak. Tobak udgør den største enkeltstående risikofaktor for udviklingen af hjertesygdomme. Vidensråd for

Forebyggelse konkluderer i en rapport fra 2022 om nikotinbrug blandt børn og unge, at der er stærk evidens

for nikotins skadelige virkning på hjerte og kar, samt at der er større risiko for død ved eksisterende

hjertesygdom/blodprop ved brug af nikotinholdige produkter. I litteraturen finder Vidensråd for Forebyggelse

at en sammenhæng mellem tidlig udsættelse for nikotin og senere hjerte-kar-sygdom er sandsynlig. Det

konkrete niveau for den øgede risiko for udvikling af hjerte-kar-sygdom kan ikke angives. Udviklingen af nye

tobaks- og nikotinprodukter går hurtigt, og derfor er det nødvendigt at lovgivningen bliver tilpasset den

udvikling, vi ser på markedet.

Ifølge WHO er der ikke evidens for, at opvarmet tobak er mindre skadeligt end andre former for tobak. Derfor

er anbefalingerne, i henhold til WHO’s rammekonvention

om tobakskontrol, som Danmark og EU har

ratificeret, at opvarmet tobak reguleres på samme måder som cigaretter.

Vi mener, at forbuddet mod smagsstoffer skal udvides, så det dækker alle typer af tobaksprodukter. Dertil er

det også vigtigt,

at smagsstofferne bliver forbudt som ingredienser, og ikke som ”kendetegnende aromaer”, så

der ikke opstår usikkerhed om, hvor meget smag der må indgå i produktet.

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Hjerteforeningen støtter, at opvarmet tobak fremover omfattes af samme forbud mod smagsstoffer, som gør

sig gældende for cigaretter, og det er særligt vigtigt, da smagsstofferne gør produkterne mere tiltrækkende for

børn og unge.

Onlinesalg af tobak og lignende produkter skal ikke være lovligt

Ved online salg af tobak, urtebaserede rygeprodukter, tobakssurogater og e-cigaretter, vil der med lovforslaget

blive indført lovhjemmel til at stille krav om alderskontrol. Det er vi positivt indstillede overfor, men det er

ikke tilstrækkeligt. Det er alt for nemt for forhandlere at indføre et skema, hvor forbrugeren siger ja til, at

vedkommende er over 18. Som det fremgår af lovforslaget, bliver der først stillet krav til forhandlerne om at

sikre et system, der effektivt verificerer køberens alder, når det kan sikres, ”at den rette tilgængelige løsning

til et effektivt alderskontrolsystem kan implementeres hos forhandlerne”.

Vi mener, at det ikke skal være tilladt at sælge tobak og lignende produkter online, da vi den vej igennem kan

mindske tilgængeligheden og markedsføring af de skadelige produkter for børn og unge.

Effektiv alderskontrol ved onlinesalg af alkohol

Det er en god udvikling, at der med lovforslaget bliver rettet op på den manglende lovhjemmel ift.

aldersgrænser for onlinesalg af alkohol. Men da der heller ikke her stilles krav om, at kontrolsystemet for alder

skal være effektivt, godkender lovgivningen på en måde den nuværende fremgangsmåde, hvor forbrugeren

kan afkrydse, om vedkommende er fyldt hhv. 16 eller 18 år. Det nuværende alderskontrolsystem er derfor ikke

tilstrækkeligt, da det stadig muliggør onlinesalg af alkohol til børn og unge.

Hjerteforeningen mener desuden, at der bør indføres en aldersgrænse på 18 år for køb af alle typer af alkohol.

Det er også i overensstemmelse med Sundhedsstyrelsens anbefalinger, hvori børn og unge under 18 år frarådes

at drikke alkohol.

Med venlig hilsen

Anne Kaltoft

Adm. direktør

Side 2 af 2

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Side 2

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Holbergsgade 6

1057 København K

Høringssvar vedr. implementering af direktiv vedr. opvarmede tobaksvarer samt andre præciseringer,

herunder alderskrav ved online salg af tobak og alkohol

Lungeforeningen takker for muligheden for at kommentere på lovforslaget.

Opvarmet tobak skal reguleres på linje med cigaretter og anden tobak

Vi er i Lungeforeningen positive over for, at der lægges op til, at opvarmet tobak omfattes af samme forbud

mod smagsstoffer som cigaretter. Mentol og andre aromaer gør produkterne mere tiltrækkende for særligt

børn og unge og bør derfor forbydes. Vi mener også, at smagsstofferne fremover bør udvides til at gælde

for alle typer af tobaksprodukter.

Tobak er hvert år årsag til mere end 13.600 dødsfald i Danmark, og for flere lungesygdomme er rygning

årsagen til hovedparten af tilfældene, herunder lungesygdommen KOL, hvor ca. 9 ud af 10 tilfælde skyldes

rygning. Der kommer hele tiden nye tobaks- og nikotinprodukter på markedet, og derfor er det vigtigt, at

lovgivningen hele tiden tilpasses. WHO anbefaler, at opvarmet tobak reguleres på samme måde som

cigaretter og anden tobak og derfor er det godt, at loven tilpasses i overensstemmelse hermed.

Onlinesalg bør helt forbydes

Med lovforslaget indføres lovhjemmel til at stille krav om alderskontrol ved onlinesalg af tobak,

urtebaserede rygeprodukter, tobakssurrogater og e-cigaretter.

Vi finder det positivt, at der indføres lovhjemmel, men vi kan godt frygte om det er nok, da forhandlerne

blot kan vælge at lade forbrugere krydse af, at de er over 18 år. Langt mere oplagt ville det være at forbyde

onlinesalg af tobak og lignende produkter, som WHO anbefaler. Det vil gøre tobak mindre tilgængeligt for

især børn og unge.

Vi bidrager gerne yderligere

Skulle vores høringssvar medføre spørgsmål eller ønske om yderligere drøftelse, står vi naturligvis til

rådighed.

Med venlig hilsen

Anne Brandt

Direktør i Lungeforeningen

Strandboulevarden 49, B-8

DK-2100 København Ø

T +45 38 74 55 44

www.lunge.dk

www.facebook.com/lungeforeningen

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Sagsnr.: 2213653

Dok. nr.: 2523532

marts 2023

Udkast til forslag til lov om ændring af lov om tobaksvarer (Implementering af dele

af delegeret direktiv vedrørende opvarmede tobaksvarer m.m.)

Nikotinbranchen kvitterer for muligheden for at kommentere "Udkast til forslag til lov om ændring

af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v., lov om forbud mod salg af tobak og

alkohol til personer under 18 år og lov om røgfri miljøer (Implementering af dele af delegeret

direktiv vedrørende opvarmede tobaksvarer samt andre præciseringer og tekniske justeringer)” –

herefter benævnt ”forslaget”.

Nikotinbranchens medlemmer producerer ikke opvarmet tobak

– herefter benævnt ”THP”

(tobacco heating products), men vi finder det aktuelt at kommentere på forslaget, da det

overordnet vedrører regulering af røgfrie nikotinprodukter per se og i sammenligning med

reguleringen for cigaretter/røgtobak.

Forslagets indhold

Dette delegerede direktiv rummer disse for Nikotinbranchen relevante elementer:

Der lægges op til, at sælgere af tobak og alkohol skal kunne kræve forevisning af billedlegitimation,

hvis der er tvivl om købers alder. Denne del af forslaget er relevant for Nikotinbranchen, fordi salg

af røgfrie nikotinprodukter til mindreårige er et problem.

Det vil fjerne den hidtil gældende undtagelse for THP i forhold til forbuddet om brug af

”kendetegnende aromaer” i produkterne.

Kommenterede delelementer

ID-kontrol

Det er positivt, at man med forslaget sikrer en tilstrækkelig tydelig hjemmel for krav om

alderskontrolsystem ved salg fra hjemmesider, men det er efter Nikotinbranchens opfattelse

bekymrende at der endnu ikke er taget konkrete skridt for indførsel af krav om ID-kontrol både ved

salg fra fysiske butikker og hjemmesider.

Dels ved vi, at alt for mange børn og unge har adgang til at købe nikotinprodukter i butikker trods

eksisterende aldersgrænse og skiltning herom, dels bliver det i for stort omfang alene den

●

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

individuelle ekspedients ansvar at bede om og kontrollere ID, og det er ikke en rimelig opgave at

pålægge personalet i detailhandlen.

En del nikotinprodukter forhandles via nettet, og vi finder det derfor oplagt, at man har

symmetriske regler online såvel som i fysiske butikker. Det kunne f.eks. ske ved, at man ved online

køb ikke alene skal klikke af, at man er over 18 år, men også mødes af tofaktorgodkendelse i form af

krav om aldersverifikation med digital ID.

I fysiske butikker kunne løsningen bestå af automatisk data i elektronisk betalingssammenhæng.

Nikotinbranchen foreslår, at man fra myndighedernes side etablerer en samlet plan for at

nedbringe salget af nikotinprodukter til personer under 18 år såvel i fysiske butikker som på

internettet. Nikotinbranchen bidrager gerne med input og viden om det illegale salg fra

medlemmernes complianceindsats.

Kendetegnende aromaer og manglende differentiering mellem produktkategorier

Nikotinbranchen betragter forslaget om forbud mod kendetegnende aromaer i THP som

problematisk i sin principielle tilgang, da det sidestiller THP og cigaretter for så vidt angår kravet

om, at kendetegnende aromaer ikke må findes i såvel THP som cigaretter/røgtobak.

Det er grundlæggende problematisk at regulere cigaretter og traditionelle tobaksvarer på samme

vis som røgfrie nikotinprodukter

–

herunder THP

–

idet produkterne er væsensforskellige for så

vidt angår skadesvirkninger for den enkelte, gener og potentielle sundhedsrisici for omgivelserne

og samfundsomkostningerne i forlængelse af brugen af produkterne.

Kendetegnende aromaer og smag er en for mange brugere afgørende forskel og incitament til at

skifte fra cigaretter til røgfrie produkter som THP, e-cigaretter og nikotinposer.

Skadesreduktion

Rygning koster hvert år 13.600 danske liv. Antallet af rygere ligger stabilt med en let opadgående

tendens trods års indsats i form af oplysning, forbud og stigende afgifter.

Med nikotinposers entré på det danske marked i 2019 faldt antallet af rygere, og det understøtter

opfattelsen af røgfrie nikotinprodukters rolle som en realistisk vej væk fra cigaretterne for mange

rygere.

I Sverige har man kendt til snus som røgfrit nikotinprodukt i årtier, og her er man tæt på at nå den

fælles europæiske målsætning om maks. 5 pct. daglige rygere. Det er på tide i Danmark at tage ved

lære af Sverige, men også lande som Storbritannien og New Zealand, hvor man regulerer røgtobak

hårdt, men går på to ben og anerkender røgfrie nikotinprodukters skadesreducerende potentiale.

Reguleringen af cigaretter/røgtobak og røgfrie nikotinprodukter bør afspejle væsensforskellene

mellem kategorierne og give incitament for rygere til at skifte fra røg til røgfri. Det kan bl.a. ske ved

at fastholde, at forbuddet mod kendetegnende aromaer gælder for cigaretter men ikke for røgfrie

alternativer.

Indstilling

●

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Nikotinbranchen forstår Danmarks forpligtelse til at implementere EU-lovgivningen i dansk ret,

men vil alligevel opfordre til, at Danmark i EU-regi fordrer en evidensbaseret tilgang til

skadesreduktion og de folkesundhedsmæssige gevinster, der er at hente i anerkendelsen heraf.

Nikotinbranchen står til rådighed for drøftelser med myndigheder og lovgivere.

Med venlig hilsen

Inger Schroll-Fleischer, direktør

Nikotinbranchen

●

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Udkast til forslag til lov om ændring af lov om tobaksvarer (Implementering af dele af delegeret

direktiv vedrørende opvarmede tobaksvarer m.m.)

Vi skal hermed afgive høringssvar om ændring af lov om tobaksvarer med henblik på at implementere det

delegerede direktiv vedrørende opvarmede tobaksvarer.

Vi synes det et en dårlig ide at forbyde smage i opvarmede tobaksvarer. Smagene er vigtige elementer i at

få rygere til at kvitte cigaretter og vælge et mindre skadeligt produkt, såsom opvarmet tobak. Dermed

mener vi, at det nye forbud vil få skadelige konsekvenser for folkesundheden, idet færre rygere vil have

incitament til at forlade cigaretterne til fordel for røgfri tobaksprodukter.

Vi konstaterer dog, at implementeringen af det delegerede direktiv holder sig inden for de rammerne af

vedtagelserne på EU-niveau. Og vi lægger vægt på, at man sondrer mellem tobaksvarer, der er

røgprodukter (med forbrænding) og tobaksvarer, der er røgfri (uden forbrænding).

Med venlig hilsen

Jesper Lundberg

formand

Orøvej 8

3400 Holbæk

Mobil: + 45 2889 1017

E-mail: [email protected]

Website: www.nbl-landsforening.dk

Følg os på Facebook og LinkedIn

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Anna Dunø Madsen

Fra:

Sendt:

Til:

Emne:

Niels Jørgen Langkilde - Patientforeningen <[email protected]>

15. februar 2023 20:48

Camilla Friborg Madsen; DEP Sundhedsministeriet

SV: Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til

personer under 18 år og lov om røgfri miljøer

Til Indenrigs- og Sundhedsministeriet

Att: Camilla Friborg Madsen

Alene sendt på

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

Patientforeningen takker for muligheden for at kommentere på lovforslaget om ændring af Lov om tobaksvarer

mmm.

Patientforeningen har ingen kommentarer til lovforslaget, og Patientforeningen kan anbefale, at det fremsættelse.

De bedste hilsener

Mag. art. Niels Jørgen Langkilde, fhv. MF,

Formand,

Patientforeningen,

Rishøjvej 2, 2. sal th

5672 Broby

For at besk y tte dine personlige oply sninger har Microsoft Office forhindret automatisk hentning af dette billede fra internettet.

Tlf. +45 20 96 70 00

www.patientforeningen.dk

CVR.nr.: 30011538

For et frit læge- og sygehusvalg

Fra:

Camilla Friborg Madsen <[email protected]>

Sendt:

3. februar 2023 09:26

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Til:

Advoksamfundet <[email protected]>; [email protected]; [email protected]; [email protected];

Arbejdstilsynet <[email protected]>; Astma-Allergi Forbundet <[email protected]>;

Danske Læskedrik Fabrikanter (info) <[email protected]>; Børnerådet <[email protected]>; [email protected];

[email protected]; [email protected]; [email protected]; Danmarks Apotekerforening

<[email protected]>; [email protected]; [email protected];

Danmarks Restauranter og Cafeer <[email protected]>; [email protected]; [email protected]; Dansk Erhverv (info)

<[email protected]>; Emballageindustrien <[email protected]>; [email protected];

[email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; Dansk Transport og Logistik (DTL) <[email protected]>;

[email protected]; [email protected]; [email protected]; [email protected]; Danske Regioner

<[email protected]>; [email protected]; [email protected]; [email protected]; info@danske-

aeldreraad.dk; [email protected]; Datatilsynet <[email protected]>; [email protected];

[email protected]; Det Etiske Råd kontakt <[email protected]>; Diabetesforeningen

<[email protected]>; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; Faglig Fælles Forbund 3F <[email protected]>; [email protected]; [email protected]; 1 - KFST

Forbrugerombudsmanden (KFST) <[email protected]>; 1 - KFST Forbrugerombudsmanden (KFST)

<[email protected]>; Forbrugerrådet <[email protected]>; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; Gigtforeningen

<[email protected]>; Hjerteforeningen <[email protected]>; [email protected]; info@oliver-

twist.dk; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; Kommunernes Landsforening <[email protected]>;

Kræftens Bekæmpelse <[email protected]>; [email protected]; [email protected]; [email protected]; Lægeforeningen

<[email protected]>; Brancheforeningen for Lægemiddelvirksomheder i Danmark (LIF) <[email protected]>;

[email protected]; [email protected]; [email protected];

[email protected]; [email protected]; NVK Kontakt <[email protected]>; DKetik

Institutionspostkasse <[email protected]>; [email protected]; Nærbutikkernes Landsforening <info@nbl-

landsforening.dk>; [email protected]; Offentligt Ansattea Organisationer <[email protected]>; [email protected]; Medlem -

Patientforeningen <[email protected]>; Niels Jørgen Langkilde - Patientforeningen

<[email protected]>; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected]; [email protected];

[email protected]; Rådet for Socialt Udsatte <[email protected]>; [email protected];

[email protected]; [email protected]; [email protected]; [email protected]; benny.husted@ssp-

samraadet.dk; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected];

[email protected]; [email protected]; [email protected]; [email protected]

Emne:

Høring: Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v.,

lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer

Til alle høringsparter

Se venligst vedhæftede høring over udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov om

elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri

miljøer (Implementering af dele af delegeret direktiv vedrørende opvarmede tobaksvarer samt andre præciseringer

og tekniske justeringer)

Indenrigs- og Sundhedsministeriet skal anmode om at modtage eventuelle bemærkninger til udkastet

senest

mandag d. 6. marts 2023 kl. 12.

Bemærkninger bedes sendt til

og til

Camilla Friborg Madsen

Fuldmægtig, Kontor for Forebyggelse og Strålebestyttelse

M 21 67 75 18

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Tlf. 7226 9000

Læs ministeriets datapolitik

her

www.sum.dk

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Sagsnr.: 2213653

Dok. nr.: 2523532

København den 21. februar 2023

Udkast til forslag til lov om ændring af lov om tobaksvarer (Implementering af dele af delegeret direktiv

vedrørende opvarmede tobaksvarer m.m.)

Vi takker for muligheden for at kommentere "Udkast til forslag til lov om ændring af lov om tobaksvarer

m.v., lov om elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til personer under 18

år og lov om røgfri miljøer (Implementering af dele af delegeret direktiv vedrørende opvarmede

tobaksvarer samt andre præciseringer og tekniske justeringer)”

– herefter omtalt som “Forslaget”.

Med dette forslag gennemfører Danmark Kommissionens delegerede direktiv (EU) 2022/2100 af 29. juni

2022 om ændring af Europa-Parlamentets og Rådets direktiv 2014/40/EU (TPD) med hensyn til

tilbagetrækning af visse undtagelser for opvarmede tobaksvarer (det delegerede direktiv).

Lovens indhold

Gennemførelsen af dette delegerede direktiv vil fjerne den undtagelse, som har været gældende for

opvarmede tobaksvarer, i forhold til forbuddet mod at bruge kendetegnede aromaer.

Desuden vil det påbyde brugen af kombinerede sundhedsadvarsler og den generelle

informationsmeddelelse i henhold til art. 9 og 10 i TPD for de opvarmede tobaksprodukter, der er blevet

klassificeret som tobaksvarer til rygning i overensstemmelse med art. 2(5) TPD.

Vigtige juridiske hensyn

Gennemførelse af det delegerede direktiv skal ske i overensstemmelse med art. 114 TEUF og må ikke

resultere i en forvridning af det indre marked eller en krænkelse af Acquis Communautaire generelt. Dette

indebærer, at den nationale lovgivning klart skal skelne mellem mærkningsreglerne for opvarmede

tobaksprodukter, der ikke involverer en forbrændingsproces, og dem, der er klassificeret som tobak til

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

rygning. Førstnævnte vil skulle anvende sundhedsadvarsler i henhold til art. 12 TPD, mens sidstnævnte skal

overholde art. 9 og 10 i TPD i denne henseende.

Vi noterer os Danmarks hensigt om at gennemføre det delegerede direktiv inden for de retlige rammer for

Acquis Communautaire og derfor alene kræve kombinerede sundhedsadvarsler for de opvarmede

tobaksprodukter, der er klassificeret som rygetobak og involverer en forbrændingsproces:

”Endvidere

medfører det delegerede direktiv en ændring af artikel 11, stk. 1, i tobaksvaredirektivet, således

opvarmede tobaksvarer, for så vidt de er røgtobak, fremover ikke kan undtages fra bestemmelserne om

påføring af den informationsmeddelelse, der er fastsat i artikel 9, stk. 2, i tobaksvaredirektivet og de

kombinerede sundhedsadvarsler, der er fastsat i artikel 10 i tobaksvaredirektivet (Forslagets side 7)

Forslaget fremmer desværre ikke folkesundheden

Med hensyn til tilsætningsstoffer vil gennemførelsen af det delegerede direktiv føre til en sidestilling af

reguleringen for opvarmede tobaksprodukter med brændbare tobaksprodukter såsom cigaretter og

finskårne tobaksprodukter.

Selvom denne regulering er resultatet af et krav i TPD efter en "væsentlig ændring i forholdene" i

betydningen af art. 2 (28) TPD, er det imidlertid en udvikling, der ikke vil gavne folkesundheden.

Sundhedsministeriet giver udtryk for, at det delegerede direktivs gennemførelse vil gøre

"opvarmede

tobaksvarer mindre attraktive og, for så vidt de opvarmede tobaksvarer er røgtobak, at gøre forbrugere

mere opmærksomme på de sundhedsrisici, der er forbundet med at anvende opvarmede tobaksvarer. Det

vurderes, at direktivet således vil bidrage til at begrænse forbruget af opvarmede tobaksvarer, herunder at

børn og unge indleder et forbrug.” (Forslagets side 7)

I den forbindelse vil vi gerne påpege, at der ifølge Eurobarometer-data stort set ingen, der påbegynder et

nikotinforbrug via opvarmede tobaksvarer

–

ligesom kun få påbegynder nikotinforbrug via e-cigaretter

Nationale undersøgelser i EU bekræfter dette resultat

Vi henviser i øvrigt til præsentationen af

”Vidensråd for Forebyggelse” i Folketingets sundhedsudvalg den

10. juni 2021, hvor det blev oplyst, at kun 0,7 pct. af unge rygere er blevet introduceret til nikotin gennem

opvarmet tobak

For opvarmede tobaksvarer understøttes denne vurdering af den seneste rapport fra Europa-

Kommissionen om en væsentlig ændring i forholdene for opvarmede tobaksvarer. Rapporten:

"did not

identify an increase of the level of prevalence of use in the under 25 years of age consumer group by at least

five percentage points in at least

five Member States for heated tobacco products”

Eurobarometer Special Report 506, p. 97.

I Tyskland er andelen af unge, der bruger opvarmede tobaksprodukter 0,3 %, ifølge tal fra det tyske føderale center

for sundhedsuddannelse (BZgA), se:

https://www.bzga.de/fileadmin/user_upload/PDF/pressemitteilungen/daten_und_fakten/Info-

Blatt_01._Juli_2020.pdf

For e-cigaretter er denne andel 0,5 % i Tyskland, ifølge de seneste tal fra DEBRA-undersøgelsen fra Kölns Universitet,

se:

https://www.debra-study.info/wp-content/uploads/2022/02/Factsheet-07-v5.pdf

(https://www.ft.dk/samling/20201/almdel/SUU/bilag/475/2415957.pdf

COM(2022) 279 final: Report from the Commission on the establishment of a substantial change of circumstances for

heated tobacco products in line with Directive 2014/40/EU

–

se:

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Dette viser, at alternativer til cigaretter for det meste anvendes af voksne rygere og ikke af mindreårige

eller ikke-rygere. Desværre vil forbuddet mod kendetegnende aromaer i opvarmede tobaksvarer

sandsynligvis gøre det mindre oplagt for voksne rygere at skifte til disse produkter, hvilket vi vil uddybe

yderligere nedenfor.

Brug for tobaksskadereduktion og differentieret regulering

Den bedste måde at undgå skaderne ved rygning er, at man aldrig begynder, eller at eksisterende rygere

holder op. Men virkeligheden er, at mange ikke opfører sig sådan.

Det er vores opfattelse, at de mennesker, som ellers ville fortsætte med at ryge, fortjener en pragmatisk

tilgang og en fornuftig løsning, der flytter dem væk fra brugen af cigaretter, som er den mest skadelige

måde at forbruge nikotin på ifølge videnskaben.

Europa-Kommissionen påpeger, at 700.000 europæere dør for tidligt af rygning årligt

. I Danmark er dette

tal 13.600.

Den eneste måde at nedbringe dette tal er at gennemføre regulering, der fremskynder ophøret af rygning.

Der er stærke uafhængige internationale beviser for skadesreduktion indenfor tobak. Derfor bør rygestop

fremskyndes ved at gøre brug af de positive erfaringer med skadesreduktion.

Tilskyndelser til rygestop fremmes bedst ved hjælp af en differentieret regulering baseret på

skadevirkningerne forårsaget af tobaks- og nikotinholdige produkter i forhold til deres toksicitet.

Her må det være tilsynsmyndighedernes primære mål at reducere cigaretternes tiltrækningskraft (ved at

fremme ikke-initiering og tilskynde til ophør), idet cigaretterne er den mest skadelige måde at levere

nikotin på.

Samtidig bør voksne rygere, som ellers ville fortsætte med at ryge , have mulighed for at vælge bedre,

røgfri alternativer såsom opvarmede tobaksvarer.

Sådanne politikker bør indebære differentierede regler, både med hensyn til kommunikation og med

hensyn til emballage, mærkning og ingredienser. Det vil sikre, at bedre alternativer skal være korrekt

mærkede i overensstemmelse med deres egenskaber. Desuden skal de være kendte og accepterede i

forhold til voksne rygere.

Smagenes rolle for tobaksskadereduktion

Forbuddet mod kendetegnende aromaer i opvarmede tobaksvarer indebærer desværre, at disse produkter

nu reguleringsmæssigt de facto bliver ligestillet med de langt mere skadelige produkter såsom cigaretter og

rulletobak.

Forskellige smagsvarianter spiller en væsentlig rolle for voksne rygere i forhold til at få dem til at skifte væk

fra cigaretter. Et forbud mod kendetegnende aromaer reducerer dermed rygeres incitamenter til at skifte

til skadesreducerende produkter. Det vil tilmed kunne få brugere, som anvender mindre skadelige

opvarmede tobaksprodukter til at skifte tilbage til cigaretter.

Background document on the Call For Evidence to Evaluate the Tobacco Control Framework Ref. Ares(2022)3824008,

- se:

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13481-Evaluation-of-the-legislative-

framework-for-tobacco-control_en

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Det er kendt fra rygestop, at andre smage end tobak i røgfri alternativer til cigaretter støtter rygere i at

holde op

Empiriske data tyder på, at et forbud mod smag i røgfri alternativer endda kan have den utilsigtede

konsekvens at øge rygefrekvensen ved at modvirke skift: En undersøgelse udført i San Francisco viste, at

rygestop for voksne og skift til røgfri produkter var mere effektivt for de voksne, der brugte e-cigaretter

uden tobakssmag. Undersøgelsen konkluderer:

“Critically, this study’s findings suggest that efforts to ban flavored e-cigarettes

could increase smoking:

nontobacco flavors were no more strongly associated with youth smoking initiation than tobacco flavors but

were more strongly associated with adult cessation. Given limited sample sizes, further work is needed”

Anbefaling

Selvom PMI forstår, at Danmark er nødt til at gennemføre EU-lovgivningen, anbefaler vi kraftigt, at

Danmark arbejder konstruktivt for at modernisere EU's tobakskontrolramme og forholde sig positivt til den

evidensbaserede tilgang til tobaksskadereduktion. På den måde kunne Danmark demonstrere sit lederskab

globalt med henblik på at bidrage til at skabe en røgfri verden. En sådan tilgang vil også fremme

transformationen af tobaksindustrien, som har en afgørende rolle at spille i at fremskynde denne overgang

til en røgfri fremtid. Det skyldes industriens evne til at udvikle bedre røgfri alternativer, der kan erstatte

rygning.

Vi står til rådighed for en åben og gennemsigtig dialog om fremtidens tobaksregulering i Danmark.

Med venlig hilsen

Christopher Arzrouni

Philip Morris ApS

Copenhagen Towers

Ørestads Boulevard 108, 3. sal

2300 København S

Romijnders et al (2019): E-Liquid Flavor Preferences and Individual Factors Related to Vaping: A Survey among Dutch

Never-Users, Smokers, Dual Users, and Exclusive Vapers, in Int J Environ Res Public Health, 4661

Friedman 2020 Associations of Flavored e-Cigarette Uptake With Subsequent Smoking Initiation and Cessation

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Att. Camilla Friborg Madsen

Høring: Udkast til forslag til lov om ændring af lov om

tobaksvarer m.v., lov om elektroniske cigaretter m.v., lov om

forbud mod salg af tobak og alkohol til personer under 18 år og

lov om røgfri miljøer (Implementering af dele af delegeret

direktiv vedrørende opvarmede tobaksvarer samt andre præciseringer og tekni-

ske justeringer)

SSP-Samrådet

Benny Husted

Formand

Tlf.: 2325 8547

Pernille Ødegaard Skovsted

Næstformand

Tlf.: 4053 3006

www.ssp-samraadet.dk

Skanderborg den 06.03.2023

SSP-Samrådet takker for muligheden for at kommentere

”Udkast

til forslag til lov om

ændring af lov om tobaksvarer m.v., lov om elektroniske cigaretter m.v., lov om

forbud mod salg af tobak og alkohol til personer under 18 år og lov om røgfri miljøer

(Implementering af dele af delegeret direktiv vedrørende opvarmede tobaksvarer

samt andre præciseringer og tekniske justeringer)”.

SSP-Samrådet har følgende bemærkninger til det fremsatte lovforslag:



Det er positivt, at opvarmede tobaksvarer omfattes af de eksisterende regler

om forbud mod markedsføring af produkter med kendetegnende aroma eller

aromastoffer.

Det er ligeledes positivt, at lovgivningen omkring alderskontrol præciseres,

særligt i forhold til online-salg. Det er dog en svaghed, at man ikke pt. har et

tilgængeligt system, der entydigt kan identificere køber som værende over 18

år.

SSP-Samrådet har ikke tiltro til at et alderskontrolsystem, der er baseret på en

tilkendegivelse af alder, vil have den ønskede effekt. Der bør fortsat arbejdes

på et alderskontrolsystem der er baseret på en teknisk hindring af muligheden

for at gennemføre et online køb, såfremt man ikke kan dokumentere, at man er

over 18 år.

På vegne af SSP-Samrådet

Benny Husted

Formand

Pernille Ødegaard Skovsted

Næstformand

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

6. marts 2023

Høringssvar fra Sund By Netværket

Vedr. høring til Udkast til forslag til lov om ændring af lov om tobaksvarer m.v., lov

om elektroniske cigaretter m.v., lov om forbud mod salg af tobak og alkohol til

personer under 18 år og lov om røgfri miljøer.

Sund By Netværket har gennem sin temagruppe med fokus på forebyggelse af brugen

af tobak, damp, snus og nikotinprodukter, kigget på lovforslaget. Temagruppens

medlemmer, der repræsenterer 52 danske kommuner, har følgende bemærkninger:

Generel kommentar om strukturelle rammer

Tobak- og nikotinprodukter finder desværre vej til vores børn og unge, i mange af de

miljøer de befinder sig i, i hverdagen

–

fx i skolen og foreningslivet. I kommunerne i

Danmark arbejdes der hver dag med forebyggelse af udfordringerne, men både

Sygdomsbyrderapporten (Sundhedsstyrelsen, 2023) og rapporten Nikotinbrug blandt

børn og unge (Vidensråd for Forebyggelse, 2022), viser behovet for at vi har et

yderligere fokus her. Og her har de strukturelle greb en afgørende betydning. Med

afsæt i viden om de kendte skadevirkninger, og udfordringen med særligt børn og

unges stigende forbrug af nikotinprodukter, kunne vi således ønske, at det blev langt

sværere for børn og unge at begynde på produkterne, hvorfor vi som fagligt netværk

savner et langt større fokus på:



Håndhævelse af allerede eksisterende lovgivning

–

18års grænsen skal

overholdes (nikotinens skadelige virkning for unge helt op til 25-30års

alderen kunne endda tale for at grænsen skulle hæves yderligere)

Der skal afsættes tilstrækkelige økonomiske ressourcer og kapacitet til at

fastholde eller ligefrem øge kontrollen på tobaks- og nikotinområdet, så

nærværende lovgivning som minimum håndhæves. Det er desuden ikke

lykkes med håndhævelse af nikotinfrie miljøer i fx skoletiden (på trods af

–

men muligvis pga. ikke tydelig

–

lovgivning på området)



Der skal være flere røgfrie- og nikotinfrie miljøer hvor børn og unge færdes

Gerne i foreningslivet, i biografen, på diskoteker og i byens rum. Alt sammen

med det formål at indskrænke de rum og miljøer i hverdagslivet, hvor børn

og unge disponeres for produkterne

Priserne på tobak- og nikotinprodukter skal sættes op

Endelig vil vi gerne appellere til

højere prissætning på tobaks- og

nikotinprodukter

i tillæg til det strukturelle greb med røg- og nikotinfrie

miljøer. En flerstrenget lovgivning, som skruer på alle knapperne til gavn for

folkesundheden nu og her, såvel som for kommende generationer.



Sund By Netværket

c/o KL-huset

Weidekampsgade 10

2300 København S

3370 3580

www.sund-by-net.dk

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Ønske om ulovliggørelse

Det ultimative ønske

til gavn for folkesundheden

er et egentlig forbud mod tobaks-

og nikotinprodukter. Den netop offentliggjorte sygdomsbyrde rapport bakker i høj

grad op om dette

–

i tillæg til nyeste viden om nikotinprodukternes skadelig virkning

på børn og unge.

Strukturelle greb som lovgivning og forbud understøtter forebyggelsesarbejdet i

kommunerne hvorfor vi hilser forslag om lovændringer på dette område velkommen,

med følgende bemærkninger til lovteksten:

Skildring mellem medicinsk nikotin og nydelses nikotin

Det er et stærkt ønske om at

produkter der går under betegnelsen

’nikotinprodukter’

(bortset fra nikotinprodukter der er godkendt til medicinsk

forbrug, herunder rygestopmedicin eller behandlingsnikotin)

gennem lovteksten

underlægges samme lovgivning, som tobaksprodukter

(i teksten omtalt som

tobaksvarer, tobakssurrogater eller urtebaserede rygeprodukter). Det betyder, at vi

meget gerne ser produkterne omtalt, så det er tydeligt, at disse produkter er

omfattet af loven som et

’nydelses nikotinprodukt’.

Med den nuværende betegnelse ’røgfri tobak’, der bruges i nærværende lovtekst

åbnes en mulighed for producenterne om at omgå lovgivningen så blandt andet

produkter som nikotinposer, der ikke indeholder tobak, kommer på markedet uden

yderligere kontrol.

Der ønskes desuden en

grænseværdi for nikotinindholdet

’nydelsesnikotinprodukterne,

hvor vi ligeledes gerne ser en

tydelig

produktinformation på produkterne.

Det undrer os, at vi som sundhedsfaglige (kommunalt) ansatte, er underlagt

delegeret ansvar fra Lægemiddelstyrelsen når vi vejleder borgere, der skal købe

hjælpemidler til rygestop

–

når borgere kan gå i enhver kiosk eller supermarked og

købe et nikotinprodukt (hvor vi ikke altid kender indholdet af nikotin), som pga.

manglende lovgivning på området, findes i utrolig mange afskygninger.

På vegne af Sund By Netværket

Lene Bruun og Ditte Kirkegaard Madsen

Formandskabet for Sund By Netværkets bestyrelse

L 123 - 2022-23 (2. samling) - Bilag 1: Høringssvar og høringsnotat, fra indenrigs- og sundhedsministeren

Indenrigs- og Sundhedsministeriet

Sagsnr.: 2213653

Dok. nr.: 2523532