Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 195

529US1

Unit: $U36

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120

OCTOBER TERM, 1999

Syllabus

FOOD AND DRUG ADMINISTRATION et al. v. BROWN
& WILLIAMSON TOBACCO CORP. et al.

certiorari to the united states court of appeals for
the fourth circuit

No. 98–1152. Argued December 1, 1999—Decided March 21, 2000

The Food, Drug, and Cosmetic Act (FDCA or Act), 21 U. S. C. § 301 et seq.,
grants the Food and Drug Administration (FDA), as the designee of the
Secretary of Health and Human Services (HHS), the authority to regu-
late, among other items, “drugs” and “devices,” §§ 321(g)–(h), 393.
In
1996, the FDA asserted jurisdiction to regulate tobacco products, con-
cluding that, under the FDCA, nicotine is a “drug” and cigarettes and
smokeless tobacco are “devices” that deliver nicotine to the body. Pur-
suant to this authority, the FDA promulgated regulations governing
tobacco products’ promotion, labeling, and accessibility to children and
adolescents. The FDA found that tobacco use is the Nation’s leading
cause of premature death, resulting in more than 400,000 deaths annu-
ally, and that most adult smokers begin when they are minors. The
regulations therefore aim to reduce tobacco use by minors so as to sub-
stantially reduce the prevalence of addiction in future generations, and
thus the incidence of tobacco-related death and disease. Respondents,
a group of tobacco manufacturers, retailers, and advertisers, ﬁled this
suit challenging the FDA’s regulations. They moved for summary
judgment on the ground, inter alia, that the FDA lacked jurisdiction
to regulate tobacco products as customarily marketed, that is, without
manufacturer claims of therapeutic beneﬁt. The District Court upheld
the FDA’s authority, but the Fourth Circuit reversed, holding that Con-
gress has not granted the FDA jurisdiction to regulate tobacco prod-
ucts. The court concluded that construing the FDCA to include to-
bacco products would lead to several internal inconsistencies in the Act.
It also found that evidence external to the FDCA—that the FDA con-
sistently stated before 1995 that it lacked jurisdiction over tobacco, that
Congress has enacted several tobacco-speciﬁc statutes fully cognizant of
the FDA’s position, and that Congress has considered and rejected many
bills that would have given the agency such authority—conﬁrms this
conclusion.

Held: Reading the FDCA as a whole, as well as in conjunction with Con-
gress’ subsequent tobacco-speciﬁc legislation, it is plain that Congress
has not given the FDA the authority to regulate tobacco products as
customarily marketed. Pp. 131–161.