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FDA Regulation of Tobacco Products: A Historical, Policy and Legal Analysis

Abstract. This report examines the legislative debate over giving FDA the authority to regulate tobacco
products and provides some analysis of H.R. 1108/S. 625. It begins with an overview of the FDA’s 1996 tobacco
rule that includes a summary of the agency’s arguments for asserting jurisdiction over tobacco products. That is
followed by an analysis of the U.S. Supreme Court decision in FDA v. Brown & Williamson, which overturned
the FDA tobacco rule. The report then reviews the 1997 proposed national tobacco settlement, which would
have codified the FDA rule and given the agency explicit authority to regulate tobacco products as medical
devices. It includes a discussion of the FDA provisions in the McCain tobacco bill (see Table 1), which was
introduced and debated in the 105th Congress in an attempt to implement the proposed settlement. The final
section of the report summarizes the legislative history and provisions of H.R. 1108/S. 625 (see Table 2), and
discusses some of the key issues, including preemption and the regulation of reduced-risk products.

Abstract. This report examines the legislative debate over giving FDA the authority to regulate tobaccoproducts and provides some analysis of H.R. 1108/S. 625. It begins with an overview of the FDA’s 1996 tobaccorule that includes a summary of the agency’s arguments for asserting jurisdiction over tobacco products. That isfollowed by an analysis of the U.S. Supreme Court decision in FDA v. Brown & Williamson, which overturnedthe FDA tobacco rule. The report then reviews the 1997 proposed national tobacco settlement, which wouldhave codified the FDA rule and given the agency explicit authority to regulate tobacco products as medicaldevices. It includes a discussion of the FDA provisions in the McCain tobacco bill (see Table 1), which wasintroduced and debated in the 105th Congress in an attempt to implement the proposed settlement. The finalsection of the report summarizes the legislative history and provisions of H.R. 1108/S. 625 (see Table 2), anddiscusses some of the key issues, including preemption and the regulation of reduced-risk products.

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