FDA Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (Revised)
标准简介
Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (Revised)[附网盘链接]是Food&Drug Administration于不久之前发布的FDA标准，适用于美国。标准截图
![Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (Revised)[附网盘链接]](/img/20210914103616yw46j.jpg)
标准文档说明
标准文档类型为Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (Revised)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
1 Civil Money Penalties and No-Tobacco-Sale 2 Orders For Tobacco Retailers 3 4 1
5 Guidance for Industry 6 7 8 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 9 this topic. It does not establish any rights for any person and is not binding on FDA or the public. You 10 can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 11 To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 12 title page. 13 14 15 16 17 I. INTRODUCTION 18 19 This guidance document is intended to describe CTP’s current policies with respect to civil 20 money penalties and no-tobacco-sale orders for retailers who violate Federal Food, Drug, and 21 Cosmetic Act (“FD&C Act”) (21 U.S.C. 301 et seq.) requirements relating to tobacco products, 22 including the requirement that tobacco products may not be sold or distributed in violation of the 2
23 restrictions on the sale and distribution of cigarettes, smokeless tobacco, and covered tobacco 24 products, which are codified at title 21 of the Code of Federal Regulations (CFR) part 1140. 25 When this guidance document was finalized in March 2011, several provisions in the Family 26 Smoking Prevention and Tobacco Control Act (“Tobacco Control Act” or “TCA”) (Public Law 27 111-31) that relate to civil money penalties and no-tobacco-sale orders went into effect. Section 28 103(q)(3) of the TCA. 29 30 The guidance document discusses: 31 32 • Definitions 33 • How does CTP intend to identify violations of the FD&C Act relating to tobacco 34 products? 1
This guidance was prepared by the Office of Compliance and Enforcement and Office of Regulations in the Center for Tobacco Products (CTP) at FDA. 2
Unless otherwise stated, the requirements applicable to cigarettes also apply to cigarette tobacco (section 900(4) of the FD&C Act and 21 CFR § 1140.3). Additionally, the definition of “cigarette” includes roll-your-own tobacco (Section 900(3) of the FD&C Act; 21 C.F.R. § 1140.3).
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