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Administrative Law Keyed to Breyer
Food and Drug Administration v. Brown & Williamson Tobacco Corp.
Citation:
529 U.S. 120, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000)Facts
The FDA, after decades of disclaiming jurisdiction over tobacco products, reversed its position in 1996 and determined that nicotine is a “drug” and cigarettes are “drug delivery devices” under the FDCA. The FDA found that nicotine affects the structure and function of the body by causing addiction and other physiological effects, and that these effects were “intended” by tobacco manufacturers. Based on this determination, the FDA issued regulations restricting the sale, distribution, and advertising of tobacco products to minors. The FDA acknowledged that tobacco products are unsafe but concluded that an outright ban would be dangerous due to the potential for black market products and widespread withdrawal symptoms among addicted users. Tobacco companies challenged the FDA’s jurisdiction, arguing that Congress never intended to give the FDA authority over tobacco products and that subsequent tobacco-specific legislation confirmed this understanding.
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