This report examines the legislative debate over giving FDA the authority to regulate tobacco products and provides some analysis of S. 2461/H.R. 4433. 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 …
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Description
This report examines the legislative debate over giving FDA the authority to regulate tobacco products and provides some analysis of S. 2461/H.R. 4433. 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, 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 provisions in S. 2461/H.R. 4433 and discusses some of the key issues, including preemption and the regulation of reduced-risk products.
This report is part of the following collection of related materials.
Congressional Research Service Reports
The Congressional Research Service (CRS) is the public policy research arm of Congress. This legislative branch agency works exclusively for Members of Congress, their committees and their staff. This collection includes CRS reports from the mid-1960's through 2018—covering a variety of topics from agriculture to foreign policy to welfare.
Redhead, C. Stephen & Feder, Jody.FDA Regulation of Tobacco Products: A Policy and Legal Analysis,
report,
December 3, 2004;
Washington D.C..
(https://digital.library.unt.edu/ark:/67531/metacrs8198/:
accessed April 19, 2024),
University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu;
crediting UNT Libraries Government Documents Department.