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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

ing restrictions violated the First Amendment. Second
Brief in Support of Plaintiffs’ Motion for Summary Judgment
in No. 2:95CV00591 (MDNC), in 3 Rec. in No. 97–1604 (CA4),
Tab No. 40; Third Brief in Support of Plaintiffs’ Motion
for Summary Judgment in No. 2:95CV00591 (MDNC), in 3
Rec. in No. 97–1604 (CA4), Tab No. 42. The District Court
granted respondents’ motion in part and denied it in part.
966 F. Supp., at 1400. The court held that the FDCA au-
thorizes the FDA to regulate tobacco products as custom-
arily marketed and that the FDA’s access and labeling regu-
lations are permissible, but it also found that the agency’s
advertising and promotion restrictions exceed its author-
Id., at 1380–1400. The court stayed im-
ity under § 360j(e).
plementation of the regulations it found valid (except the
prohibition on the sale of tobacco products to minors) and
certiﬁed its order for immediate interlocutory appeal.
Id.,
at 1400–1401.

The Court of Appeals for the Fourth Circuit reversed,
holding that Congress has not granted the FDA jurisdiction
to regulate tobacco products. See 153 F. 3d 155 (1998). Ex-
amining the FDCA as a whole, the court concluded that the
FDA’s regulation of tobacco products would create a number
of internal inconsistencies.
Id., at 162–167. Various provi-
sions of the Act require the agency to determine that any
regulated product is “safe” before it can be sold or allowed to
remain on the market, yet the FDA found in its rulemaking
proceeding that tobacco products are “dangerous” and “un-
Id., at 164–167. Thus, the FDA would apparently
safe.”
have to ban tobacco products, a result the court found clearly
contrary to congressional intent.
Ibid. This apparent
anomaly, the Court of Appeals concluded, demonstrates that
Congress did not intend to give the FDA authority to regu-
Id., at 167. The court also found that evi-
late tobacco.
dence external to the FDCA conﬁrms this conclusion.
Im-
portantly, the FDA consistently stated before 1995 that it
lacked jurisdiction over tobacco, and Congress has enacted