FDA Regulation of Tobacco Products: A Policy and Legal Analysis
Publication Date: April 2007
Publisher(s): Library of Congress. Congressional Research Service
On October 6, 2004, congressional conferees for the American Jobs Creation Act of 2004 (H.R. 4520, P.L. 108-357) rejected a Senate amendment that would have given the Food and Drug Administration (FDA) broad new authority to regulate cigarettes and smokeless tobacco products. The amendment incorporated the text of FDA tobacco legislation (S. 2461) introduced by Senators DeWine (R-OH) and Kennedy (D-MA). Identical legislation (H.R. 4433) had been introduced in the House by Representatives Tom Davis (R-VA) and Henry Waxman (D-CA). On October 10, 2004, following its rejection by the conference committee, the Senate passed the DeWine-Kennedy FDA tobacco bill by voice vote.
S. 2461/H.R. 4433 was the product of months of negotiations in which lawmakers sought to balance the competing interests of public health groups and Philip Morris, the nation's leading cigarette company. Both sides supported the legislation, which would create a new Chapter IX in the Federal Food, Drug, and Cosmetic Act (FFDCA) solely for the regulation of tobacco products. Among its many provisions, S. 2461/H.R. 4433 would authorize FDA to: restrict tobacco advertising and promotions, especially to children; develop standards that require changes in tobacco product composition and design, such as the reduction or elimination of toxic chemicals; and require manufacturers to obtain agency approval in order to make reduced-risk and reduced-exposure claims for their products.
In the mid-1990s, FDA claimed authority under the FFDCA to regulate cigarettes and smokeless tobacco products as delivery devices for nicotine, an addictive drug. The agency's 1996 tobacco regulation was invalidated by the U.S. Supreme Court in March 2000. The Court concluded that Congress had clearly intended to preclude FDA from regulating tobacco products. It found that because the FFDCA prohibits the marketing of products that have not been found to be safe and effective, the statute would have required FDA to ban such manifestly harmful products as cigarettes and smokeless tobacco if the agency had jurisdiction over them. Such a ban, argued the Court, would plainly contradict congressional intent.
The Supreme Court's decision made it clear the Congress would have to enact legislation giving FDA statutory authority over tobacco products in order for the agency to assert jurisdiction. Lawmakers first drafted such language in the 105th Congress as part of legislation to implement the 1997 proposed national tobacco settlement. Several FDA tobacco bills were introduced in the 107th Congress following the Supreme Court's decision, though none saw any legislative action.
Under S. 2461/H.R. 4433, FDA would be authorized to regulate tobacco product marketing and impose mandatory design changes on tobacco products if it determined that such actions were appropriate for the protection of public health, based on a consideration of the risks and benefits to individual consumers and to the population as a whole. But the legislation would also place certain restrictions on that authority, permitting most existing products to remain on the market (at least in the near term) and reserving for Congress the power to ban tobacco products.