FDA v. Brown & Williamson Tobacco Corp.
Facts
The FDA concluded that nicotine is a "drug" and that cigarettes and smokeless tobacco are "drug delivery devices" because the products are intended to deliver pharmacological effects such as satisfying addiction, stimulation, tranquilization, and weight control. The Court assumed arguendo that products can be "intended" to affect the body even without therapeutic claims by manufacturers. In its rulemaking, the FDA found tobacco products to be unsafe, dangerous, and a leading cause of preventable death. At the same time, Congress had enacted several tobacco-specific statutes regulating labeling and advertising while allowing tobacco products to remain on the market.
Issue
Whether the FDCA authorizes the FDA to regulate tobacco products as customarily marketed, based on the agency's determination that nicotine is a drug and cigarettes and smokeless tobacco are drug-delivery devices. More specifically, whether Congress had directly spoken to that question so as to preclude FDA jurisdiction under Chevron.
Rule
Under Chevron, a court first asks whether Congress has directly spoken to the precise question at issue, and that inquiry requires reading statutory terms in context, as part of a coherent regulatory scheme, and in light of later, more specific statutes. An agency may not claim jurisdiction where its interpretation conflicts with the statute's core structure and with Congress's clear policy choices, especially on a question of great economic and political significance.
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