FDA v. Brown & Williamson Tobacco Corp.
Citation: 529 U.S. 120 (2000)
Facts
The FDA asserted authority to regulate tobacco products as “drug delivery devices” under the Food, Drug, and Cosmetic Act. If tobacco were a drug delivery device, the FDA would have been required to remove it from the market as unsafe.
Issue
Does the FDA have authority under the FDCA to regulate tobacco products?
Holding
No. Congress had not granted the FDA authority over tobacco products. The FDCA’s text, structure, and context — particularly the existence of separate tobacco-specific statutes — demonstrated that Congress did not intend the FDA to have jurisdiction. Chevron deference did not apply to so momentous a decision.
Rule
Major questions principle: When an agency claims to discover in a statute authority over a major question of economic and political significance, courts should be skeptical. It is “highly unlikely” that Congress would hide such authority in broadly worded statutory text. The Court will not defer to an agency’s interpretation of its own expansive power when the question is of enormous consequence.
Significance
- Early application of what later became the “major questions doctrine” (West Virginia v. EPA, 2022)
- A significant limit on Chevron deference for questions of great significance
- Congress later gave the FDA explicit tobacco authority in the Family Smoking Prevention and Tobacco Control Act (2009)
- Precursor to the Court’s scaling back of administrative deference