SUU, Alm.del - 2017-18 - Endeligt svar på spørgsmål 964: Spm. om oversendelse af al kommunikation i form af e-mails, notater fra telefonsamtaler m.v., der i indeværende valgperiode har været mellem på den ene side tobakslobbyister fra Philip Morris, British American Tobacco og andre tobaksproducenter og på den anden side medarbejdere i Sundheds- og Ældreministeriets departement og styrelser, til sundhedsministeren

Sundheds- og Ældreudvalget 2017-18
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Sundhedsstyrelsen

Islands Brygge 67

2300 København S

Sendt per e-mail til [email protected] og [email protected]

København 20. juni 2016

Høringssvar vedrørende udkast til bekendtgørelse om undersøgelse af konkrete tilsætningsstoffer i tobaksva-

rer og nærmere krav til mærkning og emballering af cigaretter og rulletobak mv.

Kære Hanne Vibjerg

Vi kan konstatere, at hverken Philip Morris ApS eller resten af tobaksbranchen har været inviteret til at afgive

høringssvar på bekendtgørelsen, men vi tillader os dog at indsende et høringssvar.

Vi konstaterer, at Sundhedsstyrelsen med dette udkast har gennemført en 1-1 implementering af

EU’s tobaks-

varedirektiv, og vi mener den ligger på linje med den vedtagne lovs beskrivelser af, hvorledes området skal

reguleres.

Vi håber, at Sundhedsstyrelsen i fremtiden også vil invitere tobaksbranchen til at afgive et høringssvar, idet vi

mener det altid vigtigt at høre den branche for hvem en specifik lovgivning vedrører.

Jeg står naturligvis til rådighed, såfremt ovenstående måtte give anledning til spørgsmål eller behøver yderli-

gere uddybning.

Med venlig hilsen

Thomas Aarestrup Jepsen

Manager Corporate Affairs

Philip Morris ApS

Weidekampsgade 14A, 3.

2300 København S

Mobil: +45 31 15 48 71

[email protected]

Swedish Match.

Date

2016-12-07

Sundhedsstyrelsen

Forebyggelse

Islands Brygge 67

DK2300 København $

Dear Mrs Jette Jul Bruun

RE: Health effects of Swedish snus

We have understood from information in the medla1 that Sundhetsstyrelsen is conducting a scientific

evaluation of snus and 1 would like to offer you some important scientific information and information

about toxilogical assessment recently prepared by the US Food and Drug Administration (FDA).

Swedish Match is currently involved in a process with FDA. The company has applied for a so called

Modified Risk Tobacco Status (MRTP) for our General products, and we are waiting for a decision. You

can read our application, including the 848 page summary on:

hffxI/www.

accessdata.fda.gov/Static/widgets/tobacco/SM NA M RTPA FDA-20 1 4-N- 1051. htm 1. This

application covers significant amount of scientific evidence on snus and its use.

We have applied for the PMTA-pathway under the current US regulation, and on 15 November 2015, our

products were granted PMTA status. The decision from the FDA can be found via this link:

http://www.fda. gov/downloadsrrobaccoProducts/Labelinc,rrobaccoProductReviewEvaluation/UcM472 12

By granting Swedish Match’s products PMTA status, FDA concluded that our applications where of high

quality, and demonstrated protection of public health. The scientific evidence presented demonstrated

that our General snus is lower in harmful constituents, leading to substantial risk reduction when

compared to other smokeless products and cigarettes.

ln its toxicological assessment, the FDA concluded:

•

The proposed products have significantly lower levels of NNN and NNK compared to over 97% the

ST products currently on US market.

Since NNN and NNK are among the most carcinogenic constituents in tobacco products, reduction of

NNN and NNK levels

ST products could reduce the cancer risk for consumers.

Assuming that the only users of these products are persons who would have used other ST products

currently on the US market, individuals using these products with lower NNN levels could decrease

their excess cancer risk by 90% compared use of moist snuff (market share: 82%), 67% compared to

use of chewing tobacco (market share: 15%), 38% compared to use of US-style snus, and 92%

compared to use of dry snuff.

-hovedstadens-une, httv://www.mx.dk/nvheder/danmarklstory/268 1051

Swedish Match AB (pubi)

Visiting address: Sveavägen 44,8

tt.,

Stockholm

Postal address: SE-118 85 Stockholm

Telephone: 08-6580200

Corporate Identity Number: 556015-0756

Country: Sweden

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Swedish Match.

In view of your evaluation, 1 would also like to draw your affention to the following report by

Environ//Ram boll: http://www. accessdata.fda.gov!Static/widgets/tobacco/M RTP/1 8%2oappendix-6a-

environ-snus-monograph-201 3.pdf. This report covers all research on snus up to 2013, none of this

research is funded by Swedish Match.

The comparative lower risk with Swedish snus compared to other tobacco products can be attributable to

the manufacturing process regulated by the Swedish Food Act2, which only allows food approved

additives. Sweden has recently introduced legislation for maximum levels of unwanted constituents in line

with the recommendation of WHO Tobacco Regulatory Committee3. ln essence, this regulation sets strict

limits when it comes to NNN, NNK & BaP as weil as imposing maximum levels of aflatoxin and mercury.

ln a recent statement from the Swedish Food Authority it was concluded that with their proposed

maximum levels of contaminants in snus products there is likely “no increased risk for the average

consumer”4.

In addition, all snus manufactured in Sweden is subject to an industry standard, based on our standard

GOTHIATEK® that Swedish Match introduced in 2001.

The relative low risk associated with snus has been confirmed by a large number of researchers, NGOs,

and government bodies, such as the Royal College of Physicians 2002, 20076, 201 2, the Swedish

National Board of Health 20068, SIRUS (Norway) in several reports9lOH New Zealand Heath Technology

Assessment 200712 and in an Institute of Medicine report from 201113

Because use of snus does not involve inhalation of tobacco smoke, snus is also unassociated with

chronic Iung disease e g COPD including chronic bronchitis and emphysema.These three groups of

diseases (cancer, cardiovascular disease, chronic lung disease) account for c. 90% of the excess

mortality associated with cigarette smoking. This circumstance forms the basis for the scientific

discussion about the role of Swedish snus (and possibly other reduced harm tobacco products such as

electronic cigarettes) for tobacco harm reduction at both the individual as weil as the societal level.

3 WHO Tob. Reg. Report 955, Scientific Hasis of Tobacco Product Regulation. (20t0)

4 httpUssv,

w.dn.se/ekonomi/nya-rcc)er-for-cancerframkallande-amnen-i-snus/

5 Tobacco Advisory Group of the Royal College of Physicians (2002). Protecting smokers, saving lives: The case for a Tobacco and Nicotine Authority, London.

6 Tobacco Advisorv Group of the Royal College of Physicians (2007). Harm rednction in nicotine addiction, Hetping people who can’t qnit. London

7 Royal College of Physicians (2012). Fifty Years Since Smoking and Health: Progress. Lessons and Priorities for a Smoke-Free tiK. London

$ Public Health Status Report: 2005, (2006) Report of the Swedish National Board of Health and Welfare, Stockholm

9 A Tohacco-Free Society or Tobacco Harm Reduction? Which Objective is Best for the Remaining Smokers in Scandinavia? (2009) Report by the Norwegian Institute for

Alcohol and Dt-ng Research (SIRLS Report No. 6/2009), Oslo

10 Scheffels. Janne, Lund, Karl E., McNeill, Ann, Contrasung snus and NRT as methods to quit smoking. An observational study (2012), Harm Reduction Journal,

Il Lund, K.-E.. McNeill, A., Scheffels, J. (2010). The use of snus for qnitting smoking compared with medicinal products. Nicotine & Tobacco Research, 12:$t7-822

12 Systematic Review of the Health Effects of Modifled Smokeless Tobacco Products (2007), Marita Broadstock, New Zealand Health Technology Assessment

13 Scientific Standards for Stndies on Modifled Risk Tobacco Products (2011), Institnte of Medicine Committee on Scientific Standards for Stndies on Modified Risk Tobacco

Prodncts, Washington, DC.

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