Food & Drug Administration v. Brown & Williamson Tobacco Corp.

Background

A federal agency (the FDA) announced rules in 1996 treating nicotine as a drug and cigarettes and smokeless tobacco as devices that deliver nicotine. The agency said those rules would curb underage use by banning certain sales, ads, and promotional practices. Tobacco companies, retailers, and advertisers sued, and lower courts split over whether the FDA had authority to regulate tobacco as it is usually sold.

Reasoning

The Court asked whether the Food, Drug, and Cosmetic Act (the law the FDA enforces) and later tobacco-specific laws give the agency power to regulate tobacco. The majority said no. It explained that the FDCA focuses on ensuring regulated products are safe and effective for their intended use, and that if cigarettes were treated as drugs or devices the Act would require banning them. Because Congress repeatedly enacted separate tobacco laws and limited other agencies from acting, the Court found Congress had effectively left tobacco regulation to those tobacco-specific statutes rather than to the FDA.

Real world impact

As a result, the FDA may not use the FDCA to impose the 1996 rules on cigarettes and smokeless tobacco as customarily marketed. That means the agency cannot enforce the particular sale, advertising, and labeling limits it had adopted under that theory. Tobacco policy and any new federal controls must come from Congress or other specific laws rather than from the FDA’s drug-and-device authorities.

Dissents or concurrances

A dissenting opinion argued the FDCA’s plain language covers nicotine and tobacco, and that the FDA could lawfully regulate them; the dissent disagreed about how safety and remedies should be judged.