FDA Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry

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Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry[附网盘链接]是于当前发布的FDA标准,适用于U.S。

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Compliance Policy for Required Warning Statements on Small-Packaged Cigars  Guidance for Industry[附网盘链接]
Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry[附网盘链接](截图)

 

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标准部分原文

Compliance Policy for Required Warning

Statements on Small-Packaged Cigars

1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance document is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143) for product packaging. This guidance document discusses, among other things: • The regulatory requirements to place specific warnings on cigar packaging • Definitions • FDA’s compliance policy for cigars in small packaging FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1 This guidance was prepared by the Office of Regulations and the Office of Compliance and Enforcement in the Center for Tobacco Products at FDA. 1

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