FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 12 (2000)

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

Opinion of the Court

several tobacco-specific statutes fully cognizant of the FDA's position. See id., at 168-176. In fact, the court reasoned, 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 authority under the FDCA to regulate tobacco products as customarily marketed.


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 products 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 designed 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 concerning the product's therapeutic benefits. See id., at 6-7. We


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