## Facts

- The Federal Food, Drug, and Cosmetic Act (FDCA) authorizes the Food and Drug Administration (FDA) to regulate “drugs” and “devices,” generally requiring regulated products to be safe and effective for their intended uses.
- In 1996, after investigation, FDA asserted that nicotine is a “drug,” cigarettes and smokeless tobacco are “devices” delivering nicotine, and tobacco products are “combination products” subject to FDCA regulation.
- FDA issued regulations targeting labeling, advertising, promotion, and youth access, aiming to reduce tobacco use by minors and future nicotine addiction.
- For decades before the mid-1990s, FDA had repeatedly stated it lacked jurisdiction to regulate tobacco products as customarily marketed (absent therapeutic claims).
- During that period, Congress enacted multiple tobacco-specific statutes addressing warnings, advertising, and related matters, and it considered but did not enact proposals that would have expressly granted FDA authority over tobacco.

## Issues

1. Whether the FDCA authorizes FDA to regulate tobacco products as “drugs” and “devices” when sold as customarily marketed without therapeutic claims.
2. Whether, considering the FDCA’s structure and subsequent tobacco-specific legislation, Congress clearly delegated to FDA authority over tobacco products of major economic and political significance.
3. Whether FDA’s 1996 assertion of jurisdiction is consistent with the FDCA’s overall statutory scheme and remedial tools.

## Decision

- The Supreme Court affirmed the Fourth Circuit, holding 5–4 that FDA lacks authority under the FDCA to regulate tobacco products as customarily marketed.
- Applying Chevron step one, the Court concluded that Congress had directly addressed the question by withholding FDA jurisdiction when the FDCA is read as a whole and alongside later tobacco-specific statutes.
- The Court reasoned that treating tobacco as an FDCA-regulated drug/device would clash with the FDCA’s safety-based framework because tobacco is harmful when used as intended, implying FDA would be required to remove tobacco from the market—an outcome Congress had repeatedly declined to mandate.
- The Court relied on Congress’s tobacco-specific enactments and repeated rejections of jurisdiction-granting bills as evidence that Congress created a separate regulatory approach for tobacco and did not silently authorize FDA regulation under the FDCA.
- The Court found FDA’s prior, long-standing position disclaiming jurisdiction significant in assessing congressional intent and in rejecting deference for FDA’s later reversal.
- The dissent would have held the FDCA’s definitions were broad enough to cover nicotine and delivery devices and would have sustained FDA’s interpretation as permissible.

## Legal Principles

- Under Chevron, courts first ask whether Congress has directly spoken to the precise question at issue; if congressional intent is clear, the agency’s interpretation receives no deference.
- An agency may not exercise asserted authority in a way that conflicts with the statutory structure Congress enacted, including the statute’s core regulatory requirements and remedies.
- Where an agency claims regulatory authority over a matter of great economic and political significance, courts expect a clear congressional authorization rather than an inference from general statutory terms.
- Subsequent, targeted legislation can inform interpretation of an earlier statute when it shows Congress adopted a distinct regulatory scheme and legislated against an agency’s consistent prior understanding of its own jurisdiction.

## Conclusion

The Court held that FDA could not regulate tobacco products as customarily marketed under the FDCA because the statute’s safety-centered scheme, Congress’s tobacco-specific legislative program, and Congress’s repeated refusal to grant FDA tobacco jurisdiction demonstrated that Congress withheld that authority.


Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)