本报告介绍了WHO烟草制品管制研究小组第十次会议的结论和建议。该次会议讨论了新型烟草制品，如电子烟碱传输系统（ENDS）、电子非烟碱传输系统（ENNDS）和加热型烟草制品（HTP）管制科学基础方面的优先事项。研究小组审查了专门为会议编写的九份背景文件和两份补充文件，涉及以下专题：①HTP中的有害物质及其暴露、健康影响和风险降低声明；②HTP的吸引力和致瘾性：对认知和使用的影响及关联效应；③HTP之间的差异：考虑因素和影响；④HTP的使用：产品转换以及双重或多重使用；⑤HTP、ENDS和ENNDS相关法规以及国家措施和监管障碍；⑥电子烟碱传输系统和传统卷烟的烟碱暴露评估；⑦ENDS、ENNDS和HTP相关个体风险的量化方法探索：对人体健康和监管的影响；⑧新型烟草制品的风味；⑨新型烟草制品的全球营销和推广及其影响；⑩烟草中的烟碱形态、化学修饰及其对电子烟碱传输系统的影响；电子烟碱传输系统或雾化产品使用相关肺损伤。研究组关于每个主题的建议在相关章节末尾列出，最后一章为总体建议。

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1986年毕业于南京化工学院（现南京工业大学）获学士学位，1991年获硕士学位，2006年毕业于中国科学院合肥物质科学研究院，获博士学位。1995年—2001年，中国烟草标准化研究中心副主任。 2001年—2011年，国家烟草质量监督检验中心常务副主任。 2011年至今，郑州烟草研究院党组成员、质检中心主任。国家烟草质量监督检验中心主任、世界卫生组织(烟草控制框架公约)第 9、10条工作组中国政府代表。兼任国家实验室认可委员会主任评审员，全国烟草标准化技术委员会委员，全国烟草标准化卷烟分技委委员，国家认可委食品技术委员会副主任等职。

目录
译者序 i
WHO烟草制品管制研究小组第十次会议 iii
致谢 xi
缩略语 xv
1.引言 1
参考文献 3
2.加热型烟草制品中的有害物质及其暴露、健康影响和风险降低声明 5
摘要 5
2.1 背景 5
2.2 加热型烟草制品释放物中的有害物质 7
2.2.1 测量有害物质的实验室方法 7
2.2.2 烟碱 8
2.2.3 其他有害物质 9
2.3 加热型烟草制品的体外暴露和实验动物暴露及影响 15
2.3.1 体外研究 15
2.3.2 实验动物研究 17
2.4 加热型烟草制品中有害物质的人体暴露及健康影响 18
2.4.1 产品用途和使用模式 18
2.4.2 暴露和效应生物标志物 19
2.4.3 被动暴露 22
2.4.4 健康影响 23
2.5 加热型烟草制品风险或危害降低的证据审查 25
2.5.1 烟草制品危害降低 25
2.5.2 风险降低声明 25
2.6 小结和公共卫生影响 28
2.6.1 数据摘要 28
2.6.2 公共卫生影响 29
2.7 研究差距和优先事项 30
2.8 政策建议 31
2.9 参考文献 31
3.加热型烟草制品的吸引力和致瘾性：对认知和使用的影响及关联效应 40
摘要 40
3.1 背景 41
3.2 HTP的吸引力 42
3.2.1 WHO FCTC第9条和第10条中吸引力的定义 42
3.2.2 HTP的吸引力特性 42
3.2.3 了解ENDS和ENNDS并应用到HTP 45
3.3 HTP的致瘾性 46
3.3.1 致瘾性 46
3.3.2 了解ENDS和ENNDS并应用到HTP 49
3.3.3 HTP的总体滥用倾向 49
3.4 ENDS、ENNDS和HTP的吸引力和致瘾性对风险、危害和使用认知的影响 50
3.4.1 吸引力和致瘾性对开始、转换、补偿和戒除传统卷烟的贡献 50
3.4.2 了解ENDS和ENNDS并应用到HTP 51
3.5 讨论 52
3.5.1 不同群体不同使用方式的行为影响 52
3.5.2 公共卫生影响 53
3.5.3 研究差距、优先事项和问题 53
3.5.4 政策建议 54
3.6 结论 54
3.7 参考文献 55
附录 IQOS、卷烟和JUUL产品中的薄荷醇浓度 62
4.加热型烟草制品之间的差异：考虑因素及影响 63
摘要 63
4.1 背景 63
4.1.1 概述 63
4.1.2 缔约方大会FCTC/COP8(22)号决议 64
4.1.3 范围与目标 64
4.2 市场上产品的差异 64
4.2.1 产品类别和类型的概述 64
4.2.2 加热型烟草制品之间的差异 66
4.2.3 产品类型和类别的市场分布 66
4.3 产品特征和设计特点 67
4.3.1 产品的温度分布情况和操作性能 67
4.3.2 电池性能 68
4.3.3 烟草插片、烟棒和胶囊的特性 68
4.4 产品的成分、释放物及总体设计 69
4.4.1 成分和释放物 69
4.4.2 烟碱递送 70
4.4.3 风险概况 71
4.4.4 加热型烟草制品成分的监管意义 72
4.4.5 释放物的监管意义 73
4.5 产品、制造商和销售点的差异 73
4.5.1 制造商和销售点 73
4.5.2 对客户吸引力的影响 74
4.6 讨论 75
4.7 结论 75
4.8 研究差距、优先事项和问题 76
4.9 政策建议 77
4.10 参考文献 77
5.加热型烟草制品的使用：产品转换以及双重或多重使用 82
摘要 82
5.1 概述 82
5.2 关于HTP在人群层面使用的信息 83
5.3 从传统卷烟转向HTP的动态情况：双重或多重产品联用是过渡态还是永久态？ 85
5.4 HTP作为传统卷烟替代品的潜在作用 87
5.5 双重/多重使用者的烟碱暴露及潜在健康风险 88
5.6 动物药代动力学 91
5.7 人体药代动力学 91
5.8 使用HTP和传统卷烟的主观效应 95
5.9 讨论和影响 96
5.10 研究差距 97
5.11 政策建议 97
5.11.1 戒烟政策 97
5.11.2 监督政策 97
5.11.3 研究政策 97
5.11.4 合作政策 98
5.12 参考文献 98
6.加热型烟草制品和电子烟碱/非烟碱传输系统相关法规以及国家措施和监管障碍 106
摘要 106
6.1 背景 106
6.1.1 缔约方大会的介绍和要求（FCTC/COP8(22)） 106
6.1.2 范围和目标 108
6.1.3 来源 108
6.2 新型烟草制品的监管情况 108
6.2.1 HTP的可用性 108
6.2.2 产品分类 109
6.2.3 减少烟草需求的监管框架和措施 113
6.3 监管、实施和执行政策的考虑事项和障碍 118
6.3.1 实施政策时的监管考虑 118
6.3.2 实施和执行政策的障碍 119
6.3.3 其他考虑和意外后果 119
6.4 讨论 120
6.5 结论 121
6.6 研究差距 121
6.7 政策建议 121
6.8 参考文献 122
7.电子烟碱传输系统和传统卷烟的烟碱暴露评估 127
摘要 127
7.1 背景 128
7.2 电子烟碱传输系统的烟碱暴露 129
7.2.1 电子烟碱传输系统的烟碱释放 129
7.2.2 电子烟碱传输系统电功率对烟碱释放的影响 129
7.2.3 电子烟碱传输系统烟油中烟碱和其他化合物浓度对烟碱释放的贡献 130
7.3 伴生物质的暴露概述 131
7.4 电子烟碱传输系统的烟碱递送 131
7.5 与使用有关的暴露行为模式 132
7.5.1 使用者群体和使用者模式的定义 132
7.5.2 影响行为模式的因素 133
7.6 被动暴露于烟碱和其他有害成分 135
7.7 烟碱通量 135
7.8 讨论 137
7.9 结论 138
7.10 研究差距、优先事项和问题 138
7.11 政策建议 139
7.12 参考文献 139
8.电子烟碱/非烟碱传输系统和加热型烟草制品相关个体风险的量化方法探索：对人体健康和监管的影响 148
摘要 148
8.1 背景 148
8.1.1 量化风险的挑战 150
8.2 使用ENDS和ENNDS相关的风险评估与量化 151
8.2.1 与特定成分或无意添加的物质相关的健康风险 152
8.2.2 ENDS和ENNDS的潜在健康影响 154
8.2.3 非使用者的风险 156
8.3 量化风险的方法 156
8.3.1 毒理学关注的阈值 158
8.3.2 基于单个化合物的风险评估 158
8.3.3 相对风险方法 159
8.3.4 暴露边界值法 159
8.3.5 非致癌作用 159
8.3.6 评估框架 160
8.4 加热型烟草制品 162
8.5 对监管的影响 162
8.6 讨论 164
8.7 建议 165
8.8 结论 166
8.9 参考文献 166
9.新型烟草制品的风味 175
摘要 175
9.1 背景和引言 175
9.2 风味电子烟的流行病学（使用频率、模式和原因，按社会人口统计变量） 177
9.2.1 电子烟碱/非烟碱传输系统 178
9.2.2 传统卷烟和无烟烟草制品 179
9.2.3 加热型烟草制品 180
9.3 调味物质对吸引力、尝试使用、使用和持续使用的影响 180
9.3.1 青少年和年轻人 180
9.3.2 成年人 182
9.4 常见调味物质特性、健康效应及其对公众健康的影响 183
9.4.1 电子烟和烟草制品中常见的调味物质 183
9.4.2 风味电子烟中常见调味物质的化学和物理性质 183
9.4.3 调味物质的毒性 184
9.5 风味产品的监管 185
9.5.1 全球风味电子烟监管 185
9.5.2 全球风味烟草制品监管 186
9.5.3 常用方法的优缺点 188
9.5.4 对烟碱产品特定风味监管产生的影响 188
9.5.5 调味物质的未来监管 189
9.6 讨论 191
9.7 研究差距、优先事项和问题 191
9.8 政策建议 192
9.9 参考文献 192
10.新型烟草制品的全球营销和推广及其影响 206
摘要 206
10.1 背景 206
10.2 电子烟碱传输系统和电子非烟碱传输系统 208
10.2.1 引言 208
10.2.2 电子烟市场、产品和营销策略 209
10.2.3 电子烟的全球使用情况和使用流行程度 212
10.2.4 电子烟的广告、促销和赞助趋势 216
10.2.5 控制电子烟的广告、促销和赞助的措施 217
10.2.6 建议 218
10.2.7 电子烟的研究差距 220
10.3 加热型烟草制品 221
10.3.1 引言 221
10.3.2 市场参与者、产品和策略 221
10.3.3 加热型烟草制品的全球使用和流行情况 224
10.3.4 加热型烟草制品的广告、促销和赞助趋势 225
10.3.5 加热型烟草制品广告、促销和赞助的控制措施 227
10.3.6 对监测加热型烟草制品的广告、促销和赞助趋势的建议 227
10.3.7 对监管机构的建议 228
10.3.8 加热型烟草制品研究的研究差距 229
10.4 总结 229
10.5 参考文献 230
11.烟草中的烟碱形态、化学修饰及其对电子烟碱传输系统的影响 241
摘要 241
11.1 背景 241
11.2 烟碱的化学修饰及其对烟碱传输的影响 243
11.2.1 烘烤对烟碱的影响 243
11.2.2 碱改性 244
11.2.3 酸改性 244
11.3 对电子烟碱传输系统产品和多样性的影响 245
11.3.1 电子烟碱传输系统中游离态烟碱与烟碱盐 245
11.3.2 有效浓度和滥用倾向 246
11.3.3 对产品刺激性可能的掩饰 247
11.3.4 健康影响和监管考虑 247
11.4 讨论 248
11.5 研究差距、优先事项和问题 248
11.6 建议 249
11.7 考虑因素 249
11.8 参考文献 249
12.电子烟碱传输系统或雾化产品使用相关肺损伤 258
摘要 258
12.1 背景 258
12.1.1 与电子烟和雾化产品相关的呼吸影响 258
12.1.2 电子烟碱传输系统或雾化产品使用相关肺损伤（EVALI） 259
12.1.3 与EVALI有关的产品和化学制品 259
12.2 EVALI 260
12.2.1 详细说明和历史记录 260
12.2.2 症状 260
12.2.3 临床表现 261
12.2.4 报告病例 261
12.3 EVALI的识别 261
12.4 对EVALI的监测 262
12.4.1 国家监测机制 262
12.4.2 地区监测机制 262
12.4.3 国际监测机制和验证 262
12.5 讨论 262
12.6 考虑事项 263
12.7 建议 263
12.7.1 主要建议 263
12.7.2 其他建议 264
12.8 参考文献 264
13.总体建议 266
13.1 主要建议 267
13.2 对公共卫生政策的意义 268
13.3 对WHO规划的影响 269
13.4 参考文献 269
Contents
Participants in the 10th meeting of the WHO study group on tobacco product regulation vii
Acknowledgements xiii
Abbreviations and acronyms xvii
1.Introduction 273
References 277
2.Toxicants in heated tobacco products, exposure, health effects and claims of reduced risk 278
Abstract 278
2.1 Background 279
2.2 Toxicants in heated tobacco product emissions 281
2.2.1 Laboratory methods for measuring toxicants 281
2.2.2 Nicotine 282
2.2.3 Other toxicants 284
2.3 Exposure and effects of HTPs in vitro and in laboratory animals 291
2.3.1 In-vitro studies 291
2.3.2 Studies in laboratory animals 293
2.4 Exposure of humans to toxicants in HTPs and implications for health 295
2.4.1 Product use and topography 295
2.4.2 Biomarkers of exposure and effect 296
2.4.3 Passive exposure 300
2.4.4 Impact on health outcomes 302
2.5 Review of the evidence for reduced risk or harm with use of HTPs 304
2.5.1 Harm reduction in the context of tobacco products 304
2.5.2 Claims of reduced risk 304
2.6 Summary and implications for public health 308
2.6.1 Summary of data 308
2.6.2 Implications for public health 310
2.7 Research gaps and priorities 311
2.8 Policy recommendations 312
2.9 References 312
3.The attractiveness and addictive potential of heated tobacco products: effects on perception and use and associated effects 320
Abstract 320
3.1 Background 321
3.2 Attractiveness of HTPs 323
3.2.1 Definition of attractiveness in the context of Articles 9 and 10 of the WHO FCTC 323
3.2.2 Attractive features of HTPs 323
3.2.3 What we can learn from studies on ENDS and ENNDS and relevance to HTPs 327
3.3 Addictiveness of HTPs 328
3.3.1 Addictiveness 328
3.3.2 What we can learn from ENDS and ENNDS and relevance to HTPs 332
3.3.3 Overall abuse liability of HTPs 332
3.4 Effects of the attractiveness and addictiveness of ENDS, ENNDS and
HTPs on perceptions of risk and harm and use 333
3.4.1 Contributions of attractiveness and addictiveness to initiation, switching, complementing and quitting conventional tobacco products 333
3.4.2 Learning from ENDS and ENNDS and application to HTPs 334
3.5 Discussion 335
3.5.1 Behavioural implications of different patterns of use in different groups 335
3.5.2 Implications for public health 336
3.5.3 Research gaps, priorities and questions 337
3.5.4 Policy recommendations 338
3.6 Conclusions 339
3.7 References 339
Annex 3.1.Menthol concentrations in IQOS, cigarettes and JUUL products 345
4.Variations among heated tobacco products: considerations and implications 346
Abstract 346
4.1 Background 347
4.1.1 Overview 347
4.1.2 Decision FCTC/COP8(22) of the Conference of the Parties 347
4.1.3 Scope and objectives 347
4.2 Variations among products on the market 348
4.2.1 Overview of product categories and types 348
4.2.2 Variations among heated tobacco products 350
4.2.3 Market distribution of product types and categories 350
4.3 Characteristics and design features of products 352
4.3.1 Temperature profiles of products and operational capabilities 352
4.3.2 Battery characteristics 352
4.3.3 Properties of tobacco inserts, sticks and capsules 352
4.4 Content, emissions and general design of products 353
4.4.1 Content and emissions 353
4.4.2 Nicotine delivery 356
4.4.3 Risk profiles 356
4.4.4 Regulatory implications of the contents of heated tobacco products 357
4.4.5 Regulatory implications of emissions 358
4.5 Variations among products, manufacturers and selling points 359
4.5.1 Manufacturers and selling points 359
4.5.2 Implications for customer pulling power 360
4.6 Discussion 361
4.7 Conclusions 362
4.8 Research gaps, priorities and questions 363
4.9 Policy recommendations 363
4.10 References 365
5.Use of heated tobacco products: product switching and dual or poly product use 369
Abstract 369
5.1 Introduction 370
5.2 Information on HTP use at population level 370
5.3 Dynamics of switching from conventional cigarettes to HTPs: Is dual or poly use a transitional or permanent state? 373
5.4 Potential role of HTPs as a substitute for conventional cigarettes 376
5.5 Exposure to nicotine and potential health risks among poly users 377
5.6 Pharmacokinetics in animals 380
5.7 Pharmacokinetics in people 380
5.8 Subjective effects of use of HTPs and conventional cigarettes 385
5.9 Discussion and implications 386
5.10 Research gaps 387
5.11 Policy recommendations 387
5.11.1 Cessation policy 387
5.11.2 Surveillance policy 387
5.11.3 Research policy 388
5.11.4 Cooperation and partnership policy 388
5.12 References 388
6.Regulations on heated tobacco products, electronic nicotine delivery systems and electronic non-nicotine delivery systems, with country approaches, barriers to regulation and regulatory considerations 395
Abstract 395
6.1 Background 396
6.1.1 Introduction and the request of the Conference of the Parties (FCTC/COP8(22)) 396
6.1.2 Scope and objectives 397
6.1.3 Sources 398
6.2 Regulatory mapping of novel and emerging nicotine and tobacco products 398
6.2.1 Availability of HTPs 398
6.2.2 Product classification 399
6.2.3 Regulatory frameworks and measures to reduce tobacco demand 404
6.3 Considerations and barriers to regulation, implementation and enforcement of policies 411
6.3.1 Regulatory considerations in implementing policies 411
6.3.2 Barriers to implementing and enforcing policies 413
6.3.3 Other considerations and unintended consequences 413
6.4 Discussion 414
6.5 Conclusions 415
6.6 Research gaps 416
6.7 Policy recommendations 416
6.8 References 417
7.Estimation of exposure to nicotine from use of electronic nicotine delivery systems and from conventional cigarettes 421
Abstract 421
7.1 Background 422
7.2 Exposure to nicotine from ENDS 424
7.2.1 ENDS nicotine emission 424
7.2.2 Influence of ENDS electrical power on nicotine emission 424
7.2.3 Contribution of the concentrations of nicotine and other
compounds in ENDS liquids to nicotine emissions 425
7.3 Overview of exposure to accompanying substances 426
7.4 Nicotine delivery from ENDS 427
7.5 Behavioural patterns of exposure according to use 428
7.5.1 Definition of user groups and user patterns 428
7.5.2 Factors that influence behavioural patterns 428
7.6 Passive exposure to nicotine and other toxicants 430
7.7 Nicotine flux 431
7.8 Discussion 433
7.9 Conclusions 434
7.10 Research gaps, priorities and questions 435
7.11 Policy recommendations 436
7.12 References 436
8.Exploration of methods for quantifying individual risks associated with electronic nicotine and non-nicotine delivery systems and heated tobacco products: impact on population health and implications for regulation 444
Abstract 444
8.1 Background 445
8.1.1 Challenges to quantifying risk 447
8.2 Risk assessment and quantification of risks associated with use of ENDS and ENNDS 449
8.2.1 Health risks associated with specific ingredients or unintentionally added substances 450
8.2.2 Potential health effects of ENDS and ENNDS 453
8.2.3 Risks for bystanders 455
8.3 Methods for quantifying risk 455
8.3.1 Threshold of toxicological concern 458
8.3.2 Risk assessment based on individual compounds 458
8.3.3 Relative risk approaches 459
8.3.4 Margin-of-exposure approach 459
8.3.5 Non-carcinogenic effects 460
8.3.6 Evaluation frameworks 460
8.4 Heated tobacco products 463
8.5 Implications for regulation 463
8.6 Discussion 466
8.7 Recommendations 467
8.8 Conclusions 468
8.9 References 469
9.Flavours in novel and emerging nicotine and tobacco products 476
Abstract 476
9.1 Background and introduction 477
9.2 Epidemiology of flavoured products (frequency, patterns and reasons for use by sociodemographic variables) 479
9.2.1 Electronic nicotine and non-nicotine delivery systems 480
9.2.2 Traditional smoked and smokeless tobacco products 481
9.2.3 Heated tobacco products 482
9.3 Effects of flavours on appeal, experimentation, uptake and sustained use 483
9.3.1 Adolescents and young adults 483
9.3.2 Adults 484
9.4 Common flavours, properties, health effects and implications for public health 486
9.4.1 Common flavours in electronic nicotine delivery systems and tobacco products 486
9.4.2 Chemical and physical properties of common flavours in flavoured products 486
9.4.3 Toxicity of flavours 487
9.5 Regulation of flavoured products 488
9.5.1 Global regulation of flavoured ENDS 488
9.5.2 Global regulation of flavoured tobacco products 490
9.5.3 Pros and cons of common approaches 492
9.5.4 Impact of regulation of specific flavoured nicotine products 492
9.5.5 Future regulation of flavours 493
9.6 Discussion 495
9.7 Research gaps, priorities and questions 496
9.8 Policy recommendations 497
9.9 References 497
10.Global marketing and promotion of novel and emerging nicotine and tobacco products and their impacts 509
Abstract 509
10.1 Background 510
10.2 Electronic nicotine delivery systems and electronic non-nicotine delivery systems 512
10.2.1 Introduction 512
10.2.2 Markets, products and strategies used in marketing ENDS and ENNDS 513
10.2.3 Global use of ENDS and prevalence of use 518
10.2.4 Trends in advertising, promotion and sponsorship of ENDS
products 521
10.2.5 Measures to control advertising, promotion and sponsorship of ENDS products 523
10.2.6 Recommendations 524
10.2.7 Research gaps for ENDS and ENNDS 527
10.3 Heated tobacco products 528
10.3.1 Introduction 528
10.3.2 Market players, products and strategies 529
10.3.3 Global use and prevalence of use of HTPs 532
10.3.4 Trends in advertising, promotion and sponsorship of HTPs 533
10.3.5 Measures to control advertising, promotion and sponsorship of HTPs 535
10.3.6 Recommendations for monitoring trends in marketing, advertising, promoting and sponsorship of HTPs 536
10.3.7 Recommendations for regulators 536
10.3.8 Gaps in research on HTPs 538
10.4 Summary 538
10.5 References 539
Supplementary sections 548
11.Forms of nicotine in tobacco plants, chemical modifications and implications for electronic nicotine delivery systems products 549
Abstract 549
11.1 Background 550
11.2 Chemical modification of nicotine and influence on nicotine delivery 553
11.2.1 Brief summary of the effect of curing on nicotine 553
11.2.2 Modification with alkali 553
11.2.3 Modification with acid 554
11.3 Implications for ENDS products and diversity 554
11.3.1 Free-base nicotine vs nicotine salt in ENDS 554
11.3.2 Feasible concentrations and abuse liability 556
11.3.3 Potential masking of the harshness of products 557
11.3.4 Health implications and potential regulations 557
11.4 Discussion 558
11.5 Research gaps, priorities and questions to members regarding further work or a full paper 558
11.6 Recommendation 559
11.7 Considerations 559
11.8 References 560
12.EVALI: e-cigarette or vaping product use-associated lung injury 567
Abstract 567
12.1 Background 568
12.1.1 Respiratory effects associated with e-cigarettes and vaping 568
12.1.2 E-cigarette or vaping product use-associated lung injury (EVALI) 568
12.1.3 Products and chemicals implicated in EVALI 569
12.2 EVALI 569
12.2.1 Detailed description and history 569
12.2.2 Symptoms 570
12.2.3 Clinical presentation 570
12.2.4 Reported cases 571
12.3 Identification of EVALI 571
12.4 Surveillance for EVALI 571
12.4.1 National surveillance mechanisms 571
12.4.2 Regional surveillance mechanisms 572
12.4.3 International surveillance mechanisms and validation 572
12.5 Discussion 572
12.6 Considerations 573
12.7 Recommendations 574
12.7.1 Key recommendations 574
12.7.2 Other recommendations 574
12.8 References 574
13.Overall recommendations 576
13.1 Main recommendations 577
13.2 Significance for public health policies 579
13.3 Implications for the Organization’s programmes 580
13.4 References 581