Supreme Court: Food and Drug Administration Has No Authority to Regulate Tobacco-Food & Drug Admin. V. Brown & Williamson Tobacco Corp

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Supreme Court: Food and Drug Administration Has No Authority to Regulate Tobacco-Food & Drug Admin. v. Brown & Williamson Tobacco Corp. 1-The Supreme Court of the United States held that Congress has not granted the Food and Drug Administration (FDA) the authority to regulate tobacco products as customarily marketed.2

In 1996, the FDA concluded that under The Food, Drug, and Cosmetic Act (FDCA), nicotine is a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body. Under the FDCA, the FDA has the authority to regulate items classified as "drugs" or "devices." Pursuant to this authority, the FDA promulgated regulations governing tobacco products' promotion, labeling and accessibility to children and adolescents.3 Respondents, a group of tobacco manufacturers, retailers and advertisers, filed suit in United States District Court for the Middle District of North Carolina challenging the FDA's 1996 assertion of jurisdiction to regulate tobacco products. The district court held that the FDCA authorizes the FDA to regulate tobacco products as customarily marketed and that the FDA's access and labeling regulations are permissible, but the agency's advertising and promotion restrictions exceeded its authority. The Court of Appeals of the Fourth Circuit reversed this ruling, holding that there has been no Congressional grant of jurisdiction to the FDA to regulate tobacco products.4

The Supreme Court noted that in cases involving an agency's statutory construction it must first be determined whether Congress has directly spoken on the exact question at issue. The Court must examine the statute in context, "interpreting the statute to create a symmetrical and coherent regulatory scheme" with regard to other actions that Congress has taken.5 If Congress has spoken regarding the matter at issue, then the Court is obligated to give effect to such Congressional intention. Hence, the Court found that by considering the FDCA as a whole, it was clear that Congress intended to exclude tobacco products from the FDA's jurisdiction. Specifically, internal inconsistencies would be created if Congress granted the FDA authority to regulate tobacco. The FDA has extensively documented the dangerous and unsafe nature of tobacco products resulting in adverse health effects. A fundamental precept of the FDCA is that any product regulated by the FDA must be "safe and effective for its intended use" and the therapeutic benefit outweighs the risk of harm.6 Based on the findings of the harmful effects of tobacco, therefore, the FDA would be required to ban tobacco products from the market because it would be impossible to prove that they were safe for their intended use and there exists no therapeutic benefit from using such products. …