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Health Effects of Smokeless Tobacco Products Preliminary Report

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Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR Health Effects of Smokeless Tobacco Products Preliminary Report The SCENIHR approved this opinion for public consultation at the 19th plenary on 21-22 June 2007 Health Effects of Smokeless Tobacco Products About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Products (SCCP), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Evaluation Agency (EMEA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCENIHR Questions concerning emerging or newly-identified risks and on broad, complex or multi- disciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk- assessment bodies. In particular, the Committee addresses questions related to potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields and methodologies for assessing new risks. Scientific Committee members Anders Ahlbom, James Bridges, Wim De Jong, Jana Hajslová, Philippe Hartemann, Thomas Jung, Mats-Olof Mattsson, Jean-Marie Pagès, Konrad Rydzynski, Dorothea Stahl, Mogens Thomsen, David Williams Contact: European Commission Health & Consumer Protection DG Directorate C: Public Health and Risk Assessment Unit C7 - Risk Assessment Office: B232 B-1049 Brussels [email protected] © European Commission 2007 The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/ph_risk/risk_en.htm 2 Health Effects of Smokeless Tobacco Products ACKNOWLEDGMENTS Members of the working group are acknowledged for their valuable contribution to this opinion. The members of the working group are: SCENIHR members: Dr. Mogens Thomsen (Chair and Rapporteur) Prof. Anders Ahlbom1 Prof. James Bridges Prof. Konrad Rydzynski2 External experts: Tony Axéll2, PhD, Professor, Senior Consultant, Maxillofacial Unit, Halmstad Hospital, Halmstad, Sweden. John Britton3, Professor of Epidemiology and Honorary Consultant in Respiratory Medicine, University of Nottingham, UK Erik Dybing4, MD, PhD, Division Director and Professor, Division of Environmental Medicine, Norwegian Institute of Public Health, Oslo, Norway Hans Gilljam2, MD, Associate Professor and Lecturer in Public Health, Karolinska Institutet, Stockholm, Sweden. Jacques Le Houezec2,5 , PhD, Consultant in Public Health, Rennes, France and Special Lecturer, Department of Epidemiology & Public Health, University of Nottingham, Nottingham, UK. Marcus R. Munafò4, PhD, Reader in Biological Psychology, Department of Experimental Psychology, University of Bristol, Bristol, United Kingdom. Jagadeesan Nair, PhD, Group Leader, Division of Toxicology and Cancer Risk Factors, German Cancer Research Center (DKFZ), Heidelberg, Germany Kurt Straif, MD, MPH, PhD, Scientist, International Agency for Research on Cancer (IARC), Lyon, France Saman Warnakulasuriya2, PhD, FDSRCS, DSc, Professor in Oral Medicine & Experimental Pathology, King's College London Dental Institute, University of London, London, UK The additional contribution from the following experts is gratefully acknowledged: Harri Vainio, MD, PhD, Director General, Finnish Institute of Occupational Health, Helsinki, Finland (member of the Working Group until December 2006) Paolo Boffetta, MD, MPH, Head of the Lifestyle, Environment and Cancer Group, Coordinator of the Genetics and Epidemiology Cluster, International Agency for Research on Cancer (IARC), Lyon, France (member of the Working Group until October 2006) 1 Declared interest (see the minutes of the SCENIHR Plenary http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_014.pdf) 2 Declared interest (see the minutes of the SCENIHR Plenary http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_011.pdf) 3 Declared interest (see the minutes of the SCENIHR Plenary http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_009.pdf) 4 Declared interest (see the minutes of the SCENIHR Plenary http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_012.pdf) 5 Declared interest (see the minutes of the SCENIHR Plenary http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_mi_017.pdf) 3 Health Effects of Smokeless Tobacco Products ABSTRACT The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has been asked to evaluate the health effects of smokeless tobacco products (STP) with particular attention to tobacco for oral use, moist snuff, which is called “snus” in Sweden. In addition to tobacco for oral use, STP include chewing tobacco, dry snuff and nasal snuff. The EC Tobacco Products Directive (2001/37/EC) defines tobacco for oral use as “…all products for oral use, except those intended to be smoked or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms”. Synonyms for “tobacco for oral use” are moist snuff (snus) and oral tobacco. Marketing of oral tobacco is banned in all EU-countries except Sweden while other STP are allowed in EU. Adverse health effects of smokeless tobacco products All STP contain nicotine, a potent addictive substance. They also contain carcinogenic tobacco-specific nitrosamines, albeit at differing levels. STP are carcinogenic to humans and the pancreas has been identified as a main target organ. All STP cause localised oral lesions and a high risk for development of oral cancer has been shown for various STP but has not been proven for Swedish moist snuff (snus). There is some evidence for an increased risk of fatal myocardial infarction among STP users. Some data indicate reproductive effects of smokeless tobacco use during pregnancy but firm conclusions cannot be drawn. Addiction potential of smokeless tobacco products Smokeless tobacco is addictive and withdrawal symptoms are similar to those seen in smokers. Use of STP as smoking cessation aid compared to pharmaceutical nicotine replacement products Due to insufficient evidence it is not possible to draw conclusions as to the relative effectiveness of smokeless tobacco as an aid to smoking cessation in comparison with established therapies. Impact of smokeless tobacco use on subsequent initiation of smoking There is some evidence from the USA that smokeless tobacco use may lead to subsequent cigarette smoking. The Swedish data, with its prospective and long-term follow-up do not support the hypothesis that smokeless tobacco (i.e. Swedish snus) is a gateway to future smoking. Social, cultural and product differences between North America and Europe and within Europe suggest caution in translating findings across countries. Extrapolation of the information on the patterns of smokeless tobacco use, smoking cessation and initiation from countries where oral tobacco is available to EU-countries where oral tobacco is not available. It is not possible to extrapolate future patterns of tobacco use across countries. In particular, it is not possible to extrapolate the trends in prevalence of smoking and oral tobacco use if it were made available in an EU-country where it is now unavailable due to societal and cultural differences. General conclusion STP are addictive and their use is hazardous to health. STP contain various levels of toxic substances. Evidence for the role of STP as a smoking cessation aid is insufficient, while data on progression from STP into smoking are inconsistent. It is not possible to extrapolate the patterns of tobacco use from one country where oral tobacco is available to other countries due to societal and cultural differences. Keywords: carcinogenic, health effects, moist snuff, nicotine, nitrosamines, oral tobacco, SCENIHR, smokeless tobacco, smoking, snus, STP Opinion to be cited as: 4 Health Effects of Smokeless Tobacco Products TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 3 ABSTRACT .......................................................................................................... 4 EXECUTIVE SUMMARY........................................................................................... 9 1. BACKGROUND ........................................................................................... 12 2. TERMS OF REFERENCE................................................................................ 12 3. SCIENTIFIC RATIONALE .............................................................................
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