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FDA Regulation of Tobacco Products: A Historical, Policy and Legal Analysis (CRS Report for Congress)

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Release Date Revised July 30, 2008
Report Number RL32619
Report Type Report
Authors C. Stephen Redhead, Domestic Social Policy Division; Vanessa Burrows, American Law Division
Source Agency Congressional Research Service
Older Revisions
  • Premium   Revised April 30, 2007 (46 pages, $24.95) add
  • Premium   Dec. 3, 2004 (39 pages, $24.95) add
Summary:

This report examines the legislative debate over giving FDA the authority toregulate tobacco products and provides some analysis of H.R. 1108/S. 625. It beginswith an overview of the FDA's 1996 tobacco rule that includes a summary of theagency's arguments for asserting jurisdiction over tobacco products. That is followedby 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 proposednational tobacco settlement, which would have codified the FDA rule and given theagency explicit authority to regulate tobacco products as medical devices. It includesa discussion of the FDA provisions in the McCain tobacco bill (see Table 1), whichwas introduced and debated in the 105th Congress in an attempt to implement theproposed settlement. The final section of the report summarizes the legislativehistory and provisions of H.R. 1108/S. 625 (see Table 2), and discusses some of thekey issues, including preemption and the regulation of reduced-risk products.