FDA Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to FAQs(Revised)
标准简介
Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to FAQs(Revised)[附网盘链接]是FDA发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to FAQs(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 Responses to Frequently Asked Questions 4 5 1
6 Guidance for Industry 7 8 9 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 10 this topic. It does not establish any rights for any person and is not binding on FDA or the public. You 11 can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 12 To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 13 title page. 14 15 16 17 18 I. INTRODUCTION 19 20 This guidance provides information in response to frequently asked questions that the Center for 21 Tobacco Products (CTP) is receiving from retailers and other interested stakeholders regarding 22 civil money penalties and no-tobacco-sale orders for violations of Federal Food, Drug, and 23 Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.) requirements relating to tobacco products in 24 retail outlets. In particular, the guidance provides information about CTP’s enforcement of the 25 requirement that tobacco products may not be sold or distributed in violation of regulations 26 issued under section 906(d) of the FD&C Act, including restrictions on the sale and distribution 27 of cigarettes, smokeless tobacco, and covered tobacco products in title 21 of the Code of Federal 2
28 Regulations (CFR) part 1140 and about procedures CTP follows when it initiates administrative 29 enforcement actions. Additional information on civil money penalties and no-tobacco-sale 30 orders can be found in FDA's guidance for FDA and tobacco retailers Civil Money Penalties and 31 No-Tobacco-Sale Orders for Tobacco Retailers (CMP and NTSO Guidance). 32 33 The penalty schedule mentioned in this document is only for violations by a retail outlet of rules 34 issued under section 906(d) of the FD&C Act. CTP may seek other general or enhanced 35 penalties under section 303(f)(9) of the FD&C Act for other kinds of violations not addressed in 1
This guidance was prepared by the Office of Compliance and Enforcement and Office of Regulations in the Center for Tobacco Products at FDA. 2
75 FR 13225, March 19, 2010; 81 FR 28973. May 10, 2016 (“Deeming Rule”). 1
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