Contents
WHO Study Group on Tobacco Product Regulation Preface
1. Advisory note on smokeless tobacco products: health effects, implications for harm reduction and research
1.1 Purpose 1.2 Background
1.3 Types of smokeless tobacco product 1.4 Health effects
1.5 Regional and global patterns of use
1.6 Reducing harm due to use of smokeless tobacco 1.7 Conclusions
1.8 Recommendations
1.9 Gaps in knowledge and research needs References
2. Advisory note on ‘fire-safer’ cigarettes: approaches to reduced ignition propensity
2.1 Purpose
2.2 Background and history 2.3 Regulatory responses
2.3.1 Effectiveness of regulatory measures in populations 2.3.2 Regulatory considerations
2.4 Research needs 2.4.1 Techniques 2.4.2 Testing methods
2.4.3 Surveillance and monitoring
2.4.4 Exposure to emissions and smoking behaviour 2.5 Findings and recommendations
References
Annex 2.1 Model legislation
3. Mandated lowering of toxicants in cigarette smoke:
tobacco-specific nitrosamines and selected other constituents 3.1 Executive summary and recommendations
3.2 Introduction 3.3 Background
3.4 First report on mandated lowering of tobacco-specific nitrosamines
3.5 Use of mandated lowering of toxicant levels in a product regulatory strategy
3.5.1 Selection of machine testing method 3.5.2 Sources of data on toxicants
3.5.3 Criteria for selecting toxicants for mandatory lowering regulation
3.6 Recommended toxicants for reporting and regulation
vii ix
1 1 2 3 5 7 7 10 12 12 15
17 17 17 20 23 24 27 27 27 2 28 29 30 33
45 45 48 52 53 57 61 66 66 78
iii 8
3.6.1 Toxicity of the selected constituents 3.6.2 Methods for measuring the toxicants
3.6.3 Existing techniques to reduce specific toxicant emissions in cigarette smoke
3.6.4 Considerations in applying mandatory lowering to multiple toxicants
3.7 Recommended toxicants and recommended mandated limits 3.8 Implementing mandatory reductions in toxicant yields
3.8.1 Considerations for modified cigarettes and potential reduced exposure products
3.8.2 Communication of regulatory values and testing results to the public
3.9 Issues for regulators mandating lower levels of toxicants 3.10 Recommendations for follow-up and future work
3.10.1 Toxicants in tobacco smoke 3.10.2 Smokeless tobacco products References
Annex 3.1. Levels of toxicants per milligram of nicotine for international Philip Morris brands, Canadian brands and Australian brands
Annex 3.2. Basis for calculation of toxicant animal carcinogenicity index and toxicant non-cancer response index Annex 3.3. Calculation of toxicant animal carcinogenicity index
and toxicant non-cancer response index for International Philip Morris brands, Canadian brands and Australian brands
Annex 3.4. Correlation of toxicant yields from international brands, Canadian brands and Canadian brands with less than 100 ng/mg nicotine in the modified intense smoking regimen with machine measurement
80 87 93 104 111 113 114 115 117 119 119 121 125
137 199
213
229
iv
Annex 3.5. Variation in yield of selected toxicants by brand 4. Recommendation on cigarette machine smoking regimens 5. Overall recommendations
5.1 Harm reduction and smokeless tobacco products: regulatory recommendations and research needs
5.2 ‘Fire-safer’ cigarettes: approaches to reducing ignition propensity
5.3 Mandated lowering of toxicants in cigarette smoke: tobacco- specific nitrosamines and selected other constituents 5.4 Cigarette machine smoking regimens
260
269
273 273 274 275 277
