Food and Drug Administration v. Brown & Williamson
In 1996, the U.S. Food and Drug Administration (FDA) issued regulations to limit the sale, distribution, and advertisement of tobacco products, especially to minors. The FDA argued it had jurisdiction to regulate tobacco products as “drug delivery devices” under the Food, Drug, and Cosmetics Act (FDCA). A group of tobacco companies, retailers, and advertisers sued the FDA arguing that the regulations exceeded the FDA’s authority. The U.S. Supreme Court ruled that the FDA did not have jurisdiction to regulate tobacco products. The Court found that Congress intended to exclude tobacco products from the FDA’s jurisdiction because if the FDA were to regulate tobacco products then the agency would have to ban such products as unsafe, which clearly contradicted Congressional policy. The Court also looked at multiple laws to regulate tobacco products enacted by Congress over a 35-year period (such as limits on tobacco advertising and requiring warning labels on tobacco products) and found that these laws preclude any role for the FDA in regulating tobacco products. The Court also noted that the FDA has repeatedly taken the position in the past that it did not have jurisdiction to regulate tobacco products under the FDCA. (Note that nine years after this decision -- in 2009 -- Congress explicitly gave the FDA authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act.)
Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging.
(See FCTC Art. 11)
Measures restricting tobacco sales to or by minors, as well as other retail restrictions relating to point-of-sale, candy and toys resembling tobacco products, vending machines, or free distribution.
(See FCTC Art. 16)
Any violation of a law designed to ensure fair trade, competition, or the free flow of truthful information in the marketplace. For example, a government may require businesses to disclose detailed information about products—particularly in areas where safety or public health is an issue.
The legislative branch, through its tobacco control legislation, may have granted too much authority to the executive branch to implement measures administratively.
Subsequent regulations exceed the scope of the originating law.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"The majority nonetheless reaches the "inescapable conclusion" that the language and structure of the FDCA
as a whole "simply do not fit" the kind of public health problem that tobacco creates. Ante, at 143. That is
because, in the majority's view, the FDCA requires the FDA to ban outright "dangerous" drugs or devices
(such as cigarettes); yet, the FDA concedes that an immediate and total cigarette-sale ban is inappropriate.
Ibid.
This argument is curious because it leads with similarly "inescapable" force to precisely the opposite
conclusion, namely, that the FDA does have jurisdiction but that it must ban cigarettes. More importantly,
the argument fails to take into account the fact that a statute interpreted as requiring the FDA to pick a more
dangerous over a less dangerous remedy would be a perverse statute, causing, rather than preventing,
unnecessary harm whenever a total ban is likely the more dangerous response. And one can at least imagine
such circumstances."
"Thus, the Act generally requires the FDA to prevent the marketing of any drug or device where the "potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit." United States v. Rutherford, 442 U. S. 544, 556 (1979). In its rulemaking proceeding, the FDA quite exhaustively documented that "tobacco products are unsafe," "dangerous," and "cause great pain and suffering from illness." 61 Fed. Reg. 44412 (1996). It found that the consumption of tobacco products presents "extraordinary health risks," and that "tobacco use is the single leading cause of preventable death in the United States." Id., at 44398. It stated that "[m]ore than 400,000 people die each year from [tobacco-related] illnesses, such as cancer, respiratory illnesses, and 135*135 heart disease, often suffering long and painful deaths," and that "[t]obacco alone kills more people each year in the United States than acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides, illegal drugs, suicides, and fires, combined." Ibid. Indeed, the FDA characterized smoking as "a pediatric disease," id., at 44421, because "one out of every three young people who become regular smokers . . . will die prematurely as a result," id., at 44399.These findings logically imply that, if tobacco products were "devices" under the FDCA, the FDA would be required to remove them from the market. Consider, first, the FDCA's provisions concerning the misbranding of drugs or devices. The Act prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded." 21 U. S. C. § 331(a). In light of the FDA's findings, two distinct FDCA provisions would render cigarettes and smokeless tobacco misbranded devices. First, § 352(j) deems a drug or device misbranded "[i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." The FDA's findings make clear that tobacco products are "dangerous to health" when used in the manner prescribed. Second, a drug or device is misbranded under the Act "[u]nless its labeling bears . . . adequate directions for use . . . in such manner and form, as are necessary for the protection of users," except where such directions are "not necessary for the protection of the public health." § 352(f)(1). Given the FDA's conclusions concerning the health consequences of tobacco use, there are no directions that could adequately protect consumers. That is, there are no directions that could make tobacco products safe for obtaining their intended effects. Thus, were tobacco products within the FDA's jurisdiction, the Act would deem them misbranded devices that could not be introduced into interstate 136*136 commerce. Contrary to the dissent's contention, the Act admits no remedial discretion once it is evident that the device is misbranded."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
In 1996, the U.S. Food and Drug Administration (FDA) issued regulations to limit the sale, distribution, and advertisement of tobacco products, especially to minors. The FDA argued it had jurisdiction to regulate tobacco products as “drug delivery devices” under the Food, Drug, and Cosmetics Act (FDCA). A group of tobacco companies, retailers, and advertisers sued the FDA arguing that the regulations exceeded the FDA’s authority. The U.S. Supreme Court ruled that the FDA did not have jurisdiction to regulate tobacco products. The Court found that Congress intended to exclude tobacco products from the FDA’s jurisdiction because if the FDA were to regulate tobacco products then the agency would have to ban such products as unsafe, which clearly contradicted Congressional policy. The Court also looked at multiple laws to regulate tobacco products enacted by Congress over a 35-year period (such as limits on tobacco advertising and requiring warning labels on tobacco products) and found that these laws preclude any role for the FDA in regulating tobacco products. The Court also noted that the FDA has repeatedly taken the position in the past that it did not have jurisdiction to regulate tobacco products under the FDCA. (Note that nine years after this decision -- in 2009 -- Congress explicitly gave the FDA authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act.)