FDA v. Brown & Williamson Tobacco Corp.

529 U.S. 120, 120 S. Ct. 1291 (2000)



In determining whether Congress has specifically addressed the question at issue, a reviewing court should not confine itself to examining a particular statutory provision in isolation. The meaning, or ambiguity, of certain words or phrases may only become evident when placed in context. The words of a statute must be read in their context and with a view to their place in the overall statutory scheme. A court must therefore interpret the statute as a symmetrical and coherent regulatory scheme, and fit, if possible, all parts into a harmonious whole. Similarly, the meaning of one statute may be affected by other Acts, particularly where Congress has spoken subsequently and more specifically to the topic at hand. In addition, the reviewing court must be guided to a degree by common sense as to the manner in which Congress is likely to delegate a policy decision of such economic and political magnitude to an administrative agency.


The Food, Drug, and Cosmetic Act (FDCA), grants the Food and Drug Administration (FDA), as the designee of the Secretary of Health and Human Services (HHS), the authority to regulate, among other items, "drugs" and "devices”. In 1996, the FDA asserted jurisdiction to regulate tobacco products, concluding that, under the FDCA, nicotine is a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body. Pursuant to this authority, the FDA promulgated regulations governing tobacco products' promotion, labeling, and accessibility to children and adolescents – these regulations aim to reduce tobacco use by minors so as to substantially reduce the prevalence of addiction in future generations, and thus the incidence of tobacco-related death and disease. Respondents, a group of tobacco manufacturers, retailers, and advertisers, filed this suit challenging the FDA's regulations. They moved for summary judgment on the ground, inter alia, that the FDA lacked jurisdiction to regulate tobacco products as customarily marketed, that is, without manufacturer claims of therapeutic benefit. The District Court upheld the FDA's authority, but the Circuit Court reversed, holding that Congress has not granted the FDA jurisdiction to regulate tobacco products. On certiorari, the court affirmed.


Was the FDA authorized by Congress to regulate tobacco products as customarily marketed?




The court stated that, considering the Federal Food, Drug and Cosmetic Act (Act), as a whole, it was clear that Congress intended to exclude tobacco products from the FDA's jurisdiction. If tobacco products were within the FDA's jurisdiction, the Act would require the FDA to remove them from the market entirely. Such a ban would contradict Congress' clear intent as expressed in recent tobacco-specific legislation. Thus, there existed no room for tobacco products within the Act's regulatory scheme. Given the history and the breadth of the authority that the FDA had asserted, the court was obliged to defer not to the agency's expansive construction of the statute, but Congress' consistent judgment to deny the FDA the power to regulate tobacco products. 

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