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Page Number: 206.0

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Unit: $U36

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Cite as: 529 U. S. 120 (2000)

131

Opinion of the Court

several tobacco-speciﬁc statutes fully cognizant of the FDA’s
In fact, the court reasoned,
position. See id., at 168–176.
Congress has considered and rejected many bills that would
have given the agency such authority. See id., at 170–171.
This, along with the absence of any intent by the enacting
Congress in 1938 to subject tobacco products to regulation
under the FDCA, demonstrates that Congress intended to
withhold such authority from the FDA.
Id., at 167–176.
Having resolved the jurisdictional question against the
agency, the Court of Appeals did not address whether the
regulations exceed the FDA’s authority under 21 U. S. C.
§ 360j(e) or violate the First Amendment. See 153 F. 3d, at
176, n. 29.

We granted the federal parties’ petition for certiorari, 526
U. S. 1086 (1999), to determine whether the FDA has author-
ity under the FDCA to regulate tobacco products as custom-
arily marketed.

II

The FDA’s assertion of jurisdiction to regulate tobacco
products is founded on its conclusions that nicotine is a
“drug” and that cigarettes and smokeless tobacco are “drug
delivery devices.” Again, the FDA found that tobacco prod-
ucts are “intended” to deliver the pharmacological effects
of satisfying addiction, stimulation and tranquilization, and
weight control because those effects are foreseeable to any
reasonable manufacturer, consumers use tobacco products
to obtain those effects, and tobacco manufacturers have de-
signed their products to produce those effects. 61 Fed. Reg.
44632–44633 (1996). As an initial matter, respondents take
issue with the FDA’s reading of “intended,” arguing that it
is a term of art that refers exclusively to claims made by the
manufacturer or vendor about the product. See Brief for
Respondent Brown & Williamson Tobacco Corp. 6. That is,
a product is not a drug or device under the FDCA unless the
manufacturer or vendor makes some express claim concern-
ing the product’s therapeutic beneﬁts. See id., at 6–7. We