Food & Drug Administration v. Brown & Williamson Tobacco Corp.
The Supreme Court ruled that the Food and Drug Administration has no authority to regulate tobacco products, even though the agency found nicotine to be an addictive drug that harms health.
The Court held that Congress, through decades of tobacco-specific laws and the FDA's own long-standing denials of jurisdiction, had made clear it did not want the agency regulating cigarettes and smokeless tobacco, leaving that decision to Congress rather than to unelected regulators.
“Regardless of how serious the problem an administrative agency seeks to address, however, it may not exercise its authority "in a manner that is inconsistent with the administrative structure that Congress enacted into law."”
The majority's core limiting principle on agency power despite the seriousness of the public health problem.
How it got here: A federal trial court partly upheld the FDA's rules; the Fourth Circuit reversed, finding no FDA jurisdiction; the FDA asked the Supreme Court to review that ruling.
The Case in Depth
What happened
The FDA, after decades of saying it had no power over tobacco, reversed course in 1996 and asserted that nicotine is a drug and cigarettes are nicotine-delivery devices. It issued rules restricting sales, advertising, and marketing of tobacco to children and teenagers. Tobacco manufacturers, retailers, and advertisers sued, arguing the FDA had no legal authority to regulate tobacco products this way.
The question before the Court
Could the Food and Drug Administration regulate cigarettes and smokeless tobacco as "drugs" and "devices" under the federal law that governs medicines and medical products?
The Court's answer
No — the Court ruled that the FDA lacks authority to regulate tobacco products as customarily marketed, even though the agency found nicotine to be an addictive drug and cigarettes to be drug-delivery devices under the statute's literal terms. The Court reasoned that applying the law's ordinary safety requirements to a product the FDA itself deemed unsafe would force the agency to ban cigarettes entirely, a result flatly inconsistent with Congress's clear policy choice to keep tobacco legally on the market.
Because Congress passed six tobacco-specific statutes since 1965 regulating labeling and advertising rather than banning tobacco, and did so against the backdrop of the FDA's own consistent, decades-long denials of jurisdiction, the Court concluded Congress had effectively ratified the FDA's no-authority position. A decision of this economic and political magnitude, the Court held, could not have been implicitly delegated to the agency through such general statutory language.
Curious how the Court got there? See the step-by-step legal reasoning →
Why it matters
The decision meant the FDA could not enforce rules limiting tobacco sales, advertising, and marketing to minors that it had adopted in 1996. It left tobacco regulation in the hands of Congress until lawmakers later passed a new law in 2009 explicitly granting the FDA that authority, underscoring that agencies cannot claim sweeping new power without a clear congressional green light.
What changes now
This is a final merits decision, not a temporary order. The FDA's 1996 tobacco regulations were invalidated, and the agency could not regulate tobacco products going forward without new legislation. Congress ultimately responded in 2009 by passing the Family Smoking Prevention and Tobacco Control Act, which expressly gave the FDA authority to regulate tobacco, addressing the gap this decision identified.
What this does not decide
The ruling does not decide whether tobacco products are inherently outside any possible federal regulatory scheme — only that this particular 1938 statute, as later shaped by Congress's tobacco-specific laws, does not give the FDA that power. It leaves open whether new legislation could grant such authority.
Concurrences and dissents
Dissent — Justice Breyer
“The upshot is that the Court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette) that the Court itself finds unsafe.”Breyer's summary of what he sees as the counterintuitive result of the majority's ruling.
Justice Breyer argued that cigarettes plainly fit the statute's literal definition of a drug and device, since nicotine chemically affects the body and manufacturers knew and intended this. He contended the law does not force the FDA to ban a product just because it is dangerous, since the agency has broad remedial discretion short of an outright ban. He also argued the later tobacco-specific statutes never said the FDA lacked jurisdiction and were consistent with leaving the FDA's authority untouched, and that the FDA's policy change was legally insignificant since agencies may revise their views based on new evidence and evolving science.
How the Court got there
The legal reasoning, step by step
- The Court applied the two-step framework from Chevron v. Natural Resources Defense Council, which asks first whether Congress has directly addressed the precise question at issue; if so, that answer controls regardless of the agency's own view.
- Reading the food and drug law as a whole, the Court found its core purpose is to ensure that any regulated drug or device is proven safe and effective for its intended use, with unsafe products subject to removal from the market.
- Because the FDA itself had concluded tobacco products are dangerous and cannot be used safely for their intended effects, applying the statute's ordinary safety provisions to tobacco would require the agency to ban cigarettes and smokeless tobacco entirely.
- The Court found that Congress, through six separate tobacco-specific statutes enacted since 1965 addressing labeling and advertising, had consistently chosen to keep tobacco products on the market rather than ban them, making a required FDA ban squarely inconsistent with Congress's chosen policy.
- The Court also concluded that Congress enacted this tobacco-specific legislation against the backdrop of the FDA's repeated, consistent statements that it lacked jurisdiction over tobacco, which amounted to an implicit ratification of the FDA's no-jurisdiction position.
- Given the economic and political significance of deciding whether to regulate an entire industry, the Court concluded Congress could not have intended to hand such a major policy decision to the FDA through vague, general statutory language.
Doctrinal impact
Cases affected by this decision
Reaffirms Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc. (467 U.S. 837)
The Court applies Chevron's two-step framework to conclude Congress had directly spoken and precluded FDA jurisdiction.
Distinguishes Cipollone v. Liggett Group, Inc. (505 U.S. 504)
The Court treats Cipollone's narrow preemption holding as not by itself resolving whether the FDA can regulate tobacco.