United States

In 1996, the U.S. Food and Drug Administration (FDA) issued regulations to limit the sale, distribution, and advertisement of tobacco products, especially to minors. The FDA argued it had jurisdiction to regulate tobacco products as “drug delivery devices” under the Food, Drug, and Cosmetics Act (FDCA). A group of tobacco companies, retailers, and advertisers sued the FDA arguing that the regulations exceeded the FDA’s authority. The U.S. Supreme Court ruled that the FDA did not have jurisdiction to regulate tobacco products. The Court found that Congress intended to exclude tobacco products from the FDA’s jurisdiction because if the FDA were to regulate tobacco products then the agency would have to ban such products as unsafe, which clearly contradicted Congressional policy. The Court also looked at multiple laws to regulate tobacco products enacted by Congress over a 35-year period (such as limits on tobacco advertising and requiring warning labels on tobacco products) and found that these laws preclude any role for the FDA in regulating tobacco products. The Court also noted that the FDA has repeatedly taken the position in the past that it did not have jurisdiction to regulate tobacco products under the FDCA. (Note that nine years after this decision -- in 2009 -- Congress explicitly gave the FDA authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act.)