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Case 15.2
FOOD AND DRUG ADMINISTRATION V. BROWN & WILLIAMSON TOBACCO CORP.
Supreme Court of the United States
529 U.S. 120; 120 S. Ct. 1291; 2000 U.S. LEXIS 2195 [March 21, 2000]
FACTS:
In 1996, the Food and Drug Administration (FDA) asserted jurisdiction to regulate tobacco products
(after having expressly rejected any such authority since its inception).
The FDA concluded that nicotine is a “drug” within the meaning of the Food, Drug, and Cosmetic
Act (FDCA), and that cigarettes and some smokeless tobacco are “combination products” that
deliver nicotine to the body.
The FDA promulgated regulations governing tobacco products’ advertising, promotion, labeling,
and accessibility to children and adolescents.
The access regulations prohibited the sale of cigarettes or smokeless tobacco to persons younger
than 18; required retailers to verify through photo identification the age of all purchasers younger
than 27; prohibited the sale of cigarettes in quantities smaller than 20; prohibited the distribution
of free samples; and prohibited sale through self-service displays and vending machines, except in
adult only locations.
By reducing tobacco use by minors, the regulations aimed to substantially reduce the prevalence of
addiction, and thus, the incidence of tobacco-related death and disease.
A group of tobacco manufacturers, retailers, and advertisers filed suit challenging the regulation.
PROCEDURE: The District Court upheld the FDA’s authority, and the United States Court of Appeals
reversed.
ISSUE: Whether the FDA has authority under the FDCA to regulate tobacco products?
RULE: Under Chevron, a reviewing court must first ask “whether Congress has directly spoken to the
precise question at issue. If Congress has done so, the inquiry is at an end; the court must give effect
to the unambiguously expressed intent of Congress.”
REASONING:
1. In this case, the Court believed that Congress clearly precluded the FDA from asserting jurisdiction
to regulate tobacco products.
2. Such authority is inconsistent with the intent that Congress has expressed in the FDCA’s overall
regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the
FDCA.
3. The Court could not give deference to any administrative agency’s interpretation of the law it is
responsible for administering. The Court noted that tobacco has a “unique political history.”
4. No matter how “important, conspicuous, and controversial” the issue, and regardless of how likely
the public is to hold the Executive Branch politically accountable an administrative agency’s power
to regulate in the public interest must always be grounded in a valid grant of authority from
Congress.
ADDITIONAL INFORMATION:
Since 1965, Congress has enacted six separate statutes addressing the problem of tobacco use and
human health. Those statutes, among other things, require that health warnings appear on all
packaging and in all print and outdoor advertisement.
The Court was confident that Congress did not intend to delegate a decision of such economic and
political significance to any agency in so cryptic a fashion. To find that the FDA has the authority to
regulate tobacco products, one must not only adopt an extremely strained understanding of
“safety” as it is used throughout the Act – a concept central to the FDCA’s regulatory scheme – but
