Master The Supreme Court held that the FDA lacked authority under the FDCA to regulate tobacco products as customarily marketed absent clear congressional authorization. with this comprehensive case brief.
FDA v. Brown & Williamson is a landmark administrative law decision defining the limits of agency power in the face of ambiguous statutes and significant policy questions. Confronted with the FDA’s 1996 assertion of jurisdiction over tobacco—classifying nicotine as a “drug” and cigarettes and smokeless tobacco as “drug delivery devices” under the Food, Drug, and Cosmetic Act (FDCA)—the Supreme Court rejected the agency’s claim. The Court emphasized that the FDCA’s text, structure, and purpose, together with a complex body of tobacco-specific statutes enacted by Congress, demonstrate that Congress did not intend to give the FDA such sweeping authority without an express delegation.
The case is frequently taught as a precursor to the modern “major questions” doctrine and as a careful example of Chevron’s limits. It teaches that courts read statutes holistically, looking beyond isolated definitional provisions to the statute’s regulatory scheme and to the broader statutory context. Brown & Williamson underscores that when an agency’s interpretation would carry vast economic and political significance or would yield outcomes Congress has foreclosed, courts require a clear statement from Congress before allowing the agency to proceed.
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)
For decades, the FDA had disclaimed authority to regulate tobacco products as such, asserting jurisdiction only when tobacco was marketed with therapeutic claims. In 1996, after compiling an extensive administrative record, the FDA reversed course, concluding that nicotine is a “drug” because manufacturers intend it to affect the structure or function of the body, and that cigarettes and smokeless tobacco are “drug delivery devices” under the FDCA. The FDA promulgated rules to curb youth access and restrict advertising and promotion, while stopping short of an outright ban. Tobacco companies, advertising firms, and retailers sued in the Middle District of North Carolina, arguing that the FDA lacked statutory authority. The district court largely upheld the FDA’s jurisdiction but invalidated parts of the advertising restrictions. On appeal, the Fourth Circuit reversed, holding the FDA had no authority to regulate tobacco under the FDCA. The Supreme Court granted certiorari and affirmed, concluding that Congress had precluded the FDA from exercising such authority absent clear authorization.
Does the Food, Drug, and Cosmetic Act authorize the FDA to regulate tobacco products as “drugs” and “devices” based on nicotine’s physiological effects, notwithstanding Congress’s tobacco-specific legislation and the FDCA’s overall scheme?
An agency may not assume regulatory authority of vast economic and political significance without clear congressional authorization. Statutory terms must be interpreted in light of the statute’s text, structure, purpose, and the broader legislative scheme, including later-enacted, related statutes. Under the FDCA, the FDA’s mandate requires it to ensure that drugs and devices are safe and effective; if a product cannot be made safe for its intended use, the FDA must remove it from the market. Where Congress has enacted a distinct regulatory framework for an industry (here, tobacco) that presupposes the product’s continued availability and has declined to grant FDA regulatory authority, courts will not infer such authority from general definitional provisions.
No. The FDCA does not authorize the FDA to regulate tobacco products as customarily marketed. Reading the FDCA in light of its structure, purpose, and Congress’s tobacco-specific legislation, Congress clearly precluded FDA jurisdiction over tobacco in the absence of explicit authorization.
The Court began with the FDCA’s definitions of “drug” and “device,” which, read in isolation, could encompass nicotine and tobacco products because they affect the body’s structure and function. But statutory interpretation requires a holistic approach. The FDCA empowers the FDA to ensure that drugs and devices are safe and effective for their intended uses and to remove from the market products that cannot be rendered safe. Because conventional tobacco products pose severe health risks and offer no therapeutic benefit, accepting the FDA’s interpretation would compel the agency to ban cigarettes and smokeless tobacco. The Court concluded that Congress could not have intended to allow the FDA to effectuate a de facto ban through the FDCA, given Congress’s separate policy choices. The Court stressed that Congress had enacted a comprehensive, tobacco-specific statutory scheme—the Federal Cigarette Labeling and Advertising Act of 1965 and its amendments, the Public Health Cigarette Smoking Act of 1969, the Comprehensive Smoking Education Act (1984), and the Comprehensive Smokeless Tobacco Health Education Act (1986)—that presupposed tobacco’s continued availability while imposing labeling, advertising, and education requirements. These statutes reflect Congress’s decision to regulate tobacco differently and to reserve broader regulatory choices to itself. Moreover, for decades the FDA had consistently disclaimed jurisdiction over tobacco absent therapeutic claims, and Congress legislated against that backdrop, repeatedly declining to confer FDA authority expressly despite considering such proposals. Against this context, the Court was unwilling to read the FDCA’s general language to cover an issue of “extraordinary economic and political significance” without a clear statement from Congress. The Court treated the question as beyond ordinary Chevron deference: even if the definitional terms were textually capacious, the overall statutory scheme and subsequent legislation made clear that the FDA lacked authority. Thus, the Fourth Circuit’s judgment was affirmed. Justice Breyer dissented, arguing that the FDCA’s broad definitions comfortably included nicotine and that the FDA could regulate without necessarily banning tobacco; he viewed the tobacco-specific statutes as complementary rather than preclusive.
Brown & Williamson is a foundational administrative law case for understanding the limits of Chevron deference and the emergence of the major questions principle. It teaches that agencies cannot bootstrap sweeping regulatory authority from generalized statutory terms where Congress has crafted a separate policy framework or where the agency’s interpretation would produce consequences Congress has rejected. The decision also models holistic statutory interpretation, the use of subsequent related legislation to inform meaning, and the relevance of longstanding agency practice. For students, it foreshadows later cases such as Utility Air Regulatory Group v. EPA, King v. Burwell, and West Virginia v. EPA, which further entrench the requirement of clear congressional authorization for major policy shifts.
The Court framed its analysis within Chevron’s paradigm but effectively declined to defer, emphasizing that the question involved issues of deep economic and political significance and that the FDCA’s structure and later tobacco-specific statutes made Congress’s intent clear. Brown & Williamson is often cited as an early expression of the major questions principle limiting Chevron’s reach.
Under the FDCA, the FDA must ensure that drugs and devices are safe and effective. Because conventional tobacco products carry substantial health risks and provide no therapeutic benefits, they could not be found safe for their intended use. The FDCA would therefore obligate the FDA to remove them from the market, a result Congress had foreclosed through tobacco-specific legislation presupposing tobacco’s continued sale.
Congress enacted a separate regulatory framework for tobacco—imposing warnings, advertising restrictions, and education mandates—without conferring FDA jurisdiction. These statutes assume tobacco remains on the market and reflect deliberate regulatory choices by Congress. The Court read these enactments as evidence that Congress did not intend the FDA to regulate tobacco under the FDCA absent express authorization.
Justice Breyer’s dissent contended that the FDCA’s broad definitions of “drug” and “device” clearly encompass nicotine and tobacco products. He argued that the FDA could regulate to mitigate harms—especially to minors—without necessarily banning tobacco, and that the tobacco-specific statutes complemented, rather than displaced, FDA authority.
In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, expressly granting the FDA authority to regulate tobacco products (including manufacturing, marketing, and distribution) while prohibiting the agency from banning cigarettes outright. This statute confirms the Court’s premise that Congress, not the FDA, must make the foundational policy choice to delegate tobacco regulation.
Courts cite Brown & Williamson to require clear congressional authorization when agencies claim power over significant economic and political issues. It informed decisions like Utility Air Regulatory Group v. EPA (2014), King v. Burwell (2015), NFIB v. OSHA (2022), and West Virginia v. EPA (2022), where the Court rejected expansive agency interpretations absent a clear statement from Congress.
FDA v. Brown & Williamson draws a clear line around agency authority: broad, consequential regulatory claims cannot rest on general statutory language divorced from a statute’s structure and from Congress’s related enactments. The Court insisted on a clear congressional statement before permitting the FDA to regulate tobacco products under the FDCA, especially where such regulation would lead to outcomes Congress had deliberately avoided.
For law students, the case is essential for understanding the interplay between Chevron deference, holistic statutory interpretation, and the major questions principle. It emphasizes congressional primacy in setting major policy and signals that agencies must operate within the bounds of clear legislative authorization when attempting to regulate industries of profound economic and political importance.