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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

biguously expressed intent of Congress.” Chevron U. S. A.
Inc. v. Natural Resources Defense Council, Inc., 467 U. S.
837, 842–843 (1984).
In this case, we believe that Congress
has clearly precluded the FDA from asserting jurisdiction
to regulate tobacco products. Such authority is inconsistent
with the intent that Congress has expressed in the FDCA’s
overall regulatory scheme and in the tobacco-speciﬁc legisla-
tion that it has enacted subsequent to the FDCA.
In light
of this clear intent, the FDA’s assertion of jurisdiction is
impermissible.

I

The FDCA grants the FDA, as the designee of the Secre-
tary of Health and Human Services (HHS), the authority to
regulate, among other items, “drugs” and “devices.” See 21
U. S. C. §§ 321(g)–(h), 393 (1994 ed. and Supp. III). The Act
deﬁnes “drug” to include “articles (other than food) intended
to affect the structure or any function of the body.” 21
U. S. C. § 321(g)(1)(C).
It deﬁnes “device,” in part, as “an
instrument, apparatus, implement, machine, contrivance, . . .
or other similar or related article, including any component,
part, or accessory, which is . . . intended to affect the struc-
ture or any function of the body.” § 321(h). The Act also
grants the FDA the authority to regulate so-called “combi-
nation products,” which “constitute a combination of a drug,
device, or biological product.”
§ 353(g)(1). The FDA has
construed this provision as giving it the discretion to regu-
late combination products as drugs, as devices, or as both.
See 61 Fed. Reg. 44400 (1996).

On August 11, 1995, the FDA published a proposed rule
concerning the sale of cigarettes and smokeless tobacco to
children and adolescents. 60 Fed. Reg. 41314–41787. The
rule, which included several restrictions on the sale, distribu-
tion, and advertisement of tobacco products, was designed to
reduce the availability and attractiveness of tobacco products
to young people.
Id., at 41314. A public comment period
followed, during which the FDA received over 700,000 sub-