美国FDA 指导原则小包装雪茄行业指南所要求的警告声明的遵从性政策英文原版.pdfVIP

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美国FDA 指导原则小包装雪茄行业指南所要求的警告声明的遵从性政策英文原版.pdf

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Compliance Policy for Required Warning Statements on Small-Packaged Cigars (Revised)* Guidance for Industry Comments may be submitted at any time for Agency consideration. Electronic comments may be submitted to . Alternatively, submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with FDA-2017 D-0121. For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877 CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. EDT. Additional copies are available online at /TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. You may send an e-mail request to SmallBiz.Tobacco@ to receive an electronic copy of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products August 2018 *This is the first revision to this guidance. The first edition was published in September 2017. Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. DISCUSSION 4 A. What Definitions Apply to This Guidance? 4 B. FDA’s Compliance Policy for Cigars in Small Packaging 4 IV. DOCUMENT HISTORY 5 i Conta