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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

tion against the background of the FDA repeatedly and con-
sistently asserting that it lacks jurisdiction under the FDCA
to regulate tobacco products as customarily marketed. Fur-
ther, Congress has persistently acted to preclude a meaning-
ful role for any administrative agency in making policy on
the subject of tobacco and health. Moreover, the substance
of Congress’ regulatory scheme is, in an important respect,
incompatible with FDA jurisdiction. Although the super-
vision of product labeling to protect consumer health is a
substantial component of the FDA’s regulation of drugs and
devices, see 21 U. S. C. § 352 (1994 ed. and Supp. III), the
FCLAA and the CSTHEA explicitly prohibit any federal
agency from imposing any health-related labeling require-
ments on cigarettes or smokeless tobacco products, see 15
U. S. C. §§ 1334(a), 4406(a).

Under these circumstances,

it is clear that Congress’
tobacco-speciﬁc legislation has effectively ratiﬁed the FDA’s
previous position that it lacks jurisdiction to regulate to-
bacco. As in Bob Jones Univ. v. United States, 461 U. S. 574
(1983), “[i]t is hardly conceivable that Congress—and in this
setting, any Member of Congress—was not abundantly
aware of what was going on.”
Id., at 600–601. Congress
has afﬁrmatively acted to address the issue of tobacco and
health, relying on the representations of the FDA that it had
It has created a distinct
no authority to regulate tobacco.
scheme to regulate the sale of tobacco products, focused on
labeling and advertising, and premised on the belief that the
FDA lacks such jurisdiction under the FDCA. As a result,
Congress’ tobacco-speciﬁc statutes preclude the FDA from
regulating tobacco products as customarily marketed.

Although the dissent takes issue with our discussion of the
FDA’s change in position, post, at 186–189, our conclusion does
not rely on the fact that the FDA’s assertion of jurisdiction
represents a sharp break with its prior interpretation of the
FDCA. Certainly, an agency’s initial
interpretation of a
statute that it is charged with administering is not “carved