Download Locations

• Open CRS (User submitted)

Summary

The 111th Congress is considering legislation that would give the Food and Drug Administration (FDA) broad new statutory authority to regulate the manufacture and marketing of cigarettes and smokeless tobacco products under the Federal Food, Drug, and Cosmetic Act (FFDCA). On April 2,2009, the House passed the Family Smoking Prevention and Tobacco Control Act (H.R. 1256; H.Rept. 111-58, part 1 and 2). On May 20, the Senate Committee on Health, Education, Labor and Pensions approved an almost identical bill (S. 982). Similar legislation was first introduced in the 10Sth Congress and passed the Senate in 2004 and the House in 200S with strong bipartisan support. The Administration strongly supports H.R. 1256/S. 982. H.R. 1256/S. 982 would create a new FFDCA Chapter IX solely for the regulation of tobacco products. While the bill's language draws extensively on the FFDCA's existing provisions for regulating pharmaceutical products and medical devices, tobacco products would be regulated under new legal authority based on a public health standard rather than the safety and effectiveness standard by which the FDA regulates drugs and devices. Under the new language, FDA would have to demonstrate that any proposed tobacco product regulation was appropriate for the protection of public health, taking into consideration the risks and benefits to the population as a whole. Among its many provisions, H.R. 1256/S. 982 would require all tobacco product manufacturers to register with FDA. All registered facilities would be inspected every two years. H.R. 1256/S. 982 would require the FDA to reissue its 1996 tobacco rule, which was struck down by the U.S. Supreme Court in 2000. The rule would place new restrictions on youth access to tobacco products, end all remaining brand-name sponsorship of sporting and other entertainment events, and limit tobacco advertising in publications with a significant youth readership to black-on-white text only. In addition, the existing health warnings on tobacco product packaging and advertising would be replaced with more explicit and conspicuous health warnings. H.R. 1256/S. 982 would give FDA the authority to develop regulations restricting the sale, distribution, advertising, and promotion of tobacco products, to the extent permitted by the First Amendment. The agency also would have the authority to require changes in the design and characteristics of current and future tobacco products, such as the reduction or elimination of harmful ingredients and additives. FDA would not have the authority to reduce nicotine yields to zero or ban tobacco products. Under H.R. 1256/S. 982, manufacturers would have to obtain FDA approval in order to market a new tobacco product, unless FDA determined that it was substantially equivalent to a product already on the market, or a minor modification of an existing product. The bill would prohibit the use of descriptors such as "light" and "mild" and require manufacturers seeking FDA approval to market a product for which they intend to make a reduced-risk claim to provide evidence substantiating that claim. H.R. 1256/S. 982 would require FDA to develop new requirements for testing and reporting tobacco product ingredients and smoke constituents, and to issue new recordkeeping requirements to help counter the illicit trade of tobacco products. FDA's new regulatory activities would be paid for by user fees assessed on the manufacturers. This report provides a detailed summary of the provisions in H.R. 1256/S. 982 and discusses some of the public health and legal issues it raises. A companion report, CRS Report R40196, FDA Tobacco Regulation: History ofthe 1996 Rule and Related Legislative Activity, 1998-2008, by C. Stephen Redhead and Vanessa K. Burrows, provides more background on the FDA rule and past efforts to give the agency the authority to regulate tobacco products.

Related Legislation:
• H.R.1256
• S.982
• S.1996

Related Reports:
• R40475

XML