Number: RL32619
Title: FDA Regulation of Tobacco Products: A Historical, Policy and Legal Analysis
Authors: C. Stephen Redhead, Domestic Social Policy Division; Vanessa Burrows, American Law Division 
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.
Pages: 52
Date: July 30, 2008