目录
I.引言 1
II.背景 3
III.定义 6
A.配件 6
B.添加剂 6
C.组件或部件 6
D.涵盖的烟草制品 7
E.电子烟 7
F.电子烟液 7
G.成品烟草制品 8
H.新型烟草制品 8
I.烟草制品 8
IV.讨论 9
A.本指南适用的产品? 9
B.什么时候需要PMTA以及适用哪些强制性政策？ 10
C.ENDS PMTA审查的一般程序 11
D.ENDS产品的公共卫生考虑 12
V.如何提交PMTA 17
VI.ENDS PMTA的内容及格式 19
A.一般信息 20
B.目录 21
C.描述性信息 21
D.产品样品 23
E.标签 24
F.环境评估 24
G.所有研究结果摘要 24
H.科学研究和分析 26
VII.电子烟液PMTA的补充建议 40
A.组件、成分和添加剂 40
B.香味物质 40
VIII.电子烟PMTA的补充建议 42
A.电子烟设计应考虑的因素 42
B.电子烟组件或部件子类别可能的设计参数 43
IX.对电子烟液和电子烟包装在一起的ENDS产品的补充建议 46
X.科学研究和分析的其他考虑因素 47
A.在美国进行随机对照临床试验的替代方案 47
B.文献综述? 48
C.对已发表文献和公共数据集的分析 49
D.主文件 49
E.与其他产品的桥接研究 50
XI.上市后要求 51
XII.与FDA的会面请求 52
XIII.小企业援助办公室 54
Contents
I.Introduction 55
II.Background 58
III.Definitions 61
A.Accessory 61
B.Additive 62
C.Component or Part 62
D.Covered Tobacco Product 62
E.E-cigarette 63
F.E-liquids 63
G.Finished Tobacco Product 64
H.New Tobacco Product 64
I.Tobacco Product 64
IV.Discussion 66
A.Products to Which This Guidance Applies 66
B.When Are PMTAs Required and What Enforcement Policies Apply? 67
C.General Procedures for ENDS PMTA Review 69
D.Public Health Considerations for ENDS Products 71
V.How to Submit a PMTA 79
VI.Content and Format of a Premarket Tobacco Product Application for ENDS Products 81
A.General Information 83
B.Table of Contents 84
C.Descriptive Information 84
D.Product Samples 87
E.Labeling 87
F.Environmental Assessment 88
G.Summary of All Research Information 89
H.Scientific Studies and Analyses 91
VII.Additional Recommendations for Premarket Tobacco Product
Applications for E-Liquid Products 112
A.Components， Ingredients， and Additives 112
B.Flavors 112
VIII.Additional Recommendations for Premarket Tobacco Product
Applications for E-Cigarettes 114
A.E-cigarette Design Factors to Consider 114
B.Possible Design Parameters for Subcategories of E-cigarette Components and Parts 115
IX.Additional Recommendations for ENDS Products that Package E-Liquids and E-Cigarettes Together 120
X.Additional Considerations for Scientific Studies and Analyses 121
A.Alternatives to U.S.-Conducted Randomized Controlled Clinical Trials 122
B.Literature Reviews 122
C.Analysis of Published Literature and Public Datasets 124
D.Master Files 124
E.Bridging 125
XI.Postmarket Requirements 127
XII.Requesting Meetings With FDA 128
XIII.Office of Small Business Assistance 130
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