FDA v. Brown & Williamson Tobacco Corp.
529 U.S. 120 (2000)
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Rule of Law:
An administrative agency's authority to regulate is determined by the overall statutory scheme enacted by Congress. When Congress creates a specific and distinct regulatory framework for a particular product, and that framework conflicts with the agency's general statutory mandate, Congress has precluded the agency from asserting jurisdiction over that product.
Facts:
- Historically, the Food and Drug Administration (FDA) consistently stated it lacked jurisdiction under the Food, Drug, and Cosmetic Act (FDCA) to regulate tobacco products unless the manufacturer made express therapeutic claims.
- In 1996, the FDA reversed its long-standing position and asserted jurisdiction over tobacco products.
- The FDA determined that nicotine is a 'drug' and that cigarettes and smokeless tobacco are 'drug delivery devices' within the meaning of the FDCA.
- The agency found that nicotine has significant pharmacological effects on the body, including causing and sustaining addiction, and concluded these effects were 'intended' by manufacturers due to their foreseeability and consumer use.
- Based on these findings, the FDA promulgated regulations aimed at reducing tobacco use among children and adolescents.
- These regulations included prohibiting sales to persons younger than 18, requiring age verification for purchasers under 27, and imposing substantial restrictions on the advertising and promotion of tobacco products.
Procedural Posture:
- A group of tobacco manufacturers, retailers, and advertisers (Respondents) filed suit against the FDA in the U.S. District Court for the Middle District of North Carolina, challenging the agency's regulations.
- The District Court granted summary judgment in part, holding that the FDA had jurisdiction to regulate tobacco and that its access and labeling regulations were permissible, but that its advertising restrictions exceeded its statutory authority.
- Both the FDA and the tobacco companies appealed to the U.S. Court of Appeals for the Fourth Circuit.
- The Court of Appeals reversed the district court's decision, holding that Congress had not granted the FDA jurisdiction to regulate tobacco products as customarily marketed.
- The federal government (Petitioners) petitioned the U.S. Supreme Court for a writ of certiorari, which was granted.
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Issue:
Does the Food, Drug, and Cosmetic Act (FDCA) grant the Food and Drug Administration (FDA) the authority to regulate tobacco products as 'drugs' and 'devices'?
Opinions:
Majority - Justice O'Connor
No, the Food, Drug, and Cosmetic Act (FDCA) does not grant the Food and Drug Administration (FDA) the authority to regulate tobacco products. Reading the FDCA as a whole, along with subsequent tobacco-specific legislation, demonstrates that Congress has clearly precluded the FDA from asserting such jurisdiction. First, the FDCA’s core purpose requires that any regulated product be 'safe and effective' for its intended use. Given the FDA’s own findings that tobacco products are inherently unsafe and dangerous, the only possible outcome under the FDCA’s provisions would be to ban them entirely. However, a total ban would directly contradict congressional intent, as expressed in six separate tobacco-specific statutes passed since 1965, which presuppose the continued marketing of tobacco products. This fundamental conflict shows that tobacco products do not fit within the FDCA's regulatory framework. Second, Congress has enacted a comprehensive, distinct regulatory scheme for tobacco, focusing on labeling and advertising, all while the FDA repeatedly asserted it lacked jurisdiction. This history effectively constitutes a congressional ratification of the FDA's prior position. Finally, the regulation of an industry of such vast economic and political significance is a 'major question' that Congress would not delegate to an agency implicitly or cryptically; it would have done so expressly.
Dissenting - Justice Breyer
Yes, the Food, Drug, and Cosmetic Act (FDCA) grants the Food and Drug Administration (FDA) the authority to regulate tobacco products. The plain language of the statute supports this conclusion, as tobacco products fall squarely within the FDCA’s definition of 'drugs' and 'devices' because they contain a chemical (nicotine) 'intended to affect the structure or any function of the body.' The majority's 'ban-or-nothing' premise is a perverse reading of the statute; the FDCA provides the FDA with flexible remedial powers that allow it to regulate dangerous products without necessarily banning them, especially when a ban could lead to worse public health outcomes like a black market. Subsequent tobacco legislation is ambivalent and does not explicitly or implicitly repeal the FDA's authority; it simply leaves the jurisdictional question where it was. The FDA's change in position is legally permissible, as it was based on new evidence of manufacturer intent and a strengthened scientific consensus, and agencies must be able to adapt their policies to new information and changing circumstances.
Analysis:
This decision established a significant limit on the Chevron deference doctrine and foreshadowed the formal emergence of the 'major questions doctrine.' It demonstrates that a court will not defer to an agency's interpretation of its own statute, even if the text is arguably ambiguous, when the agency asserts control over a major portion of the economy in a way that Congress has not clearly authorized. The ruling emphasizes a holistic approach to statutory interpretation, where subsequent, specific legislation and historical context can effectively override a plausible reading of a broad, earlier statute. This case impacts future administrative law by requiring agencies to show clear congressional authorization before undertaking transformative regulatory actions with vast economic and political significance.
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