In the News

Proposed Bill Would Give FDA Jurisdiction Over Tobacco

Apr 9, 2009

The U.S. House of Representatives passed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) on April 2, 2009. (For a complete copy of the bill, see http://energycommerce.house.gov/Press_111/20090304/hr1256.pdf.) H.R. 1256, sponsored by Rep. Henry Waxman (D-CA), would amend the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration (FDA) authority to regulate the advertising, marketing, and manufacturing of tobacco products. The new tobacco program would be funded entirely through user fees imposed upon manufacturers of cigarettes, cigarette tobacco, and smokeless tobacco products sold in the United States, based on their respective shares of the entire U.S. market.

The FSPTCA would subject tobacco products to FDA labeling supervision. The legislation addresses "reduced harm" products by prohibiting the use of misleading terms such as "light," "low-tar," and "mild." The FSPTCA also would require larger and/or specific health warnings that cover the top 30% of the front and rear panels of the package.

Under the Act, tobacco companies would be required to disclose the ingredients in tobacco products to FDA. The Agency would have the authority to impose changes to current and future tobacco products to protect the public health. Such changes may include the reduction or elimination of harmful ingredients, additives, and flavorants, such as menthol. While the FSPTCA would grant FDA authority to reduce the levels of nicotine in tobacco products, FDA may not require the overall removal of nicotine from a tobacco product or impose a ban on an entire class of tobacco products.

The FSPTCA would require the prompt reinstatement of a 1996 FDA final rule aimed at reducing underage smoking. (See "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents," 61 Fed. Reg. 44396 (Aug. 28, 1996).) In this respect, the legislation would ban outdoor advertising of tobacco within 1,000 feet of schools and playgrounds and all remaining tobacco-brand sponsorships of sports and entertainment events, and would restrict vending machines to adult-only facilities. FDA is granted the authority under the proposed bill to develop regulations that restrict advertising and promotion of tobacco products to the extent permitted by the First Amendment.

The bill has been placed on the Senate's Legislative Calendar and may be addressed later this month. The White House supports the legislation, a shift from the Bush administration, which threatened to veto a similar House-passed measure last year.