In the 1999 case of Food and Drug Administration, et al. v. Brown & Williamson Tobacco Corporation, et al., the U.S Supreme Court ruled that the FDA did not have authority to regulate tobacco products as drugs or devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The court held in a 5-4 decision that Congress had clearly intended to exclude tobacco from the FDA's jurisdiction because it had enacted several industry-specific statutes addressing concerns about tobacco use without amending FDCA to include such regulation. This suggested an intention for these issues to be handled separately from general drug/device regulation by FDA. Therefore, any attempt by FDA to assert jurisdiction over tobacco would contradict this legislative history and exceed its statutory authority.

In the dissenting opinion for the case between FDA and Brown & Williamson Tobacco Corporation, it was argued that Congress had not explicitly denied the Food and Drug Administration (FDA) authority to regulate tobacco products. The dissenters believed that since tobacco products clearly fall under the category of "drugs" and "devices," as defined by Federal Food, Drug, and Cosmetic Act (FDCA), they should be within FDA's regulatory purview. They also pointed out that nicotine is a highly addictive substance with significant effects on human health; thus its regulation falls squarely within FDA’s mandate to protect public health. Furthermore, they disagreed with majority’s interpretation of subsequent tobacco-specific legislation as stripping away any implied authority from FDCA. Instead, these laws were seen as complementing or supplementing existing regulations rather than replacing them entirely.