FDA Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
标准简介
Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco[附网盘链接]由Food&Drug Administration于之前发布,适用于美国。标准截图
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标准文档说明
标准文档类型为Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco[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
Compliance Policy for Certain Labeling and
Warning Statement Requirements for Cigars and Pipe Tobacco
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 or pipe tobacco with respect to the labeling requirements in sections 903(a)(2) and 920(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387c(a)(2), 387t(a)) and the warning statement requirements in Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143). This guidance document discusses, among other things: • Certain statutory requirements for pipe tobacco and cigar labeling • The regulatory requirements for cigar and pipe tobacco warning statements • Definitions • FDA’s compliance policy for certain labeling and warning statement requirements for cigars and pipe tobacco 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 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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