Food and Drug Administration v. Brown & Williamson Tobacco Corporation

PETITIONER: Food and Drug Administration
RESPONDENT: Brown & Williamson Tobacco Corporation

DOCKET NO.: 98-1152
DECIDED BY: Rehnquist Court (1986-2005)
LOWER COURT: United States Court of Appeals for the Fourth Circuit

CITATION: 529 US 120 (2000)
ARGUED: Dec 01, 1999
DECIDED: Mar 21, 2000

Richard M. Cooper - Argued the cause for respondents
Seth P. Waxman - on behalf of the Petitioners

Facts of the case

The Food, Drug, and Cosmetic Act (FDCA) grants the Food and Drug Administration (FDA) the authority to regulate, among other items, "drugs" and "devices." In 1996, the FDA asserted jurisdiction to regulate tobacco products, concluding that, under the FDCA, nicotine is a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body. Accordingly, the FDA promulgated regulations governing tobacco products' promotion, labeling, and accessibility to children and adolescents. Brown & Williamson Tobacco Corporation, and a group of tobacco manufacturers, retailers, and advertisers, filed suit challenging the FDA's regulations. Brown moved for summary judgement on the ground that the FDA lacked the jurisdiction to regulate tobacco products as customarily marketed, or without manufacturer claims of therapeutic benefit. The District Court ruled that the FDA had jurisdiction over tobacco as a device, but that the agency had overstepped its authority in attempting to restrict tobacco advertising. In reversing, the Court of Appeals held that Congress had not granted the FDA jurisdiction to regulate tobacco products. The court found that the FDA's definition of tobacco as a device was flawed because the agency could not prove that the impact of tobacco products on the body was "intended" under the act.


Does the Food and Drug Administration have the authority to regulate tobacco products as "drugs" and "devices" under the Food, Drug, and Cosmetic Act?

Media for Food and Drug Administration v. Brown & Williamson Tobacco Corporation

Audio Transcription for Oral Argument - December 01, 1999 in Food and Drug Administration v. Brown & Williamson Tobacco Corporation

Audio Transcription for Opinion Announcement - March 21, 2000 in Food and Drug Administration v. Brown & Williamson Tobacco Corporation

William H. Rehnquist:

The opinion of the Court in No. 98-1152, Food and Drug Administration versus Brown & Williams Tobacco Corporation will be announced by Justice O’Connor.

Sandra Day O'Connor:

This case comes to us on writ of certiorari to the Court of Appeals for the Fourth Circuit.

In August 1996, the Food and Drug Administration published a final rule imposing regulations on the sale and marketing of tobacco products.

The FDA found that nicotine is a drug and that cigarettes and smokeless tobacco are devices that deliver nicotine to the body.

It concluded that it had jurisdiction to regulate tobacco products under the Food, Drug and Cosmetic Act.

A group of tobacco manufacturers, retailers and advertisers filed suit claiming among other things that the FDA lack the authority to regulate tobacco.

The Federal District Court rejected this contention, but the Fourth Circuit Court of Appeals reversed.

In an opinion file with the Clerk of the Court today, we affirm the judgment of the Court of Appeals.

Tobacco is perhaps the single most troubling public health problem our nation faces today, according to the FDA’s findings more than 400,000 Americans die each year from tobacco related illnesses such as cancer, respiratory illnesses and heart disease.

Indeed tobacco use is the leading cause of preventable death in the United States resulting in more deaths annually than Aids, car accidents, alcohol, homicides, illegal drug, suicides and fires combined.

But no matter how important the issue a federal administrative agency seeks to address, its power to regulate in a public interest must always be grounded in a valid grant of authority from Congress.

And in examining the Act as a whole as well as Congress’ more specific efforts to address the problem of tobacco and health it is clear that Congress never intended to delegate to the FDA the authority to regulate tobacco.

First, FDA jurisdiction over tobacco is incompatible with the Food, Drug and Cosmetic Act's over all regulatory scheme.

A fundamental precept of the Act is that all drugs or devices must be safe and effective for their intended use to obtain FDA approval.

The FDA’s findings concerning the health hazards of tobacco demonstrate however, that tobacco products are not safe and effective for any use.

Accordingly, were tobacco products with in the FDA’s jurisdiction, they would have to be removed form the market entirely, but Congress’ tobacco-specific statutes are expressly premised on the continued sale of tobacco products.

They therefore foreclose a ban.

To avoid this dilemma, the FDA has found that tobacco products are actually safe under the Act because in its opinion banning them would cause greater harm then leaving them on the market.

But the Act requires the FDA to conclude that the drug or device is safe, not that one remedial measure taken by the agency is less dangerous than another, that is to permit a product to be sold, the FDA must determine that at least for some consumers the therapeutic benefits from using it outweigh its risks to health.

The FDA cannot make such a finding for tobacco products, because according to its own findings cigarettes and smokeless tobacco are an unsafe means to obtaining any benefit or pharmacological effect.

The inescapable conclusion is that they are not devices within the meaning of the Act.

If tobacco products cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they just don’t fit within the FDA’s jurisdiction.

Moreover, Congress has specifically addressed the problem of tobacco and health in a manner that precludes any role for FDA regulation.

Since 1965, Congress has enacted six separate statutes addressed to the marketing and sale of tobacco products.

That legislation establishes a distinct scheme for the regulation of cigarettes and smokeless tobacco that focuses on product labeling and advertising.

As Congress enacted this legislation each time the FDA consistently, repeatedly, and resolutely stated that it had no authority to regulate tobacco.

Indeed from the enactment of the first Pure Food and Drug Act in 1908 until this rule making preceding, the FDA never want stated it had such jurisdiction and in passing these tobacco-specific statutes Congress several times explicitly considered and rejected bills that would have granted the FDA this authority.

In fact Congress consistently evidence its intent to preclude any agency from exercising significant policy-making authority in this area.

Congress has expressly preempted any other regulation of tobacco product labeling even though the regulation of labeling is a central aspect of FDA oversight.

Under these circumstances, it is evident that Congress never intended the FDA to have the power to regulate tobacco and instead ratify the FDA’s long-held position that it lacks such jurisdiction.