The FDA attempted to regulate tobacco products by classifying nicotine as a drug under the FDCA, but Congress has explicitly prohibited the FDA from regulating tobacco products. The Court of Appeals for the Fourth Circuit held that Congress did not grant the FDA jurisdiction to regulate tobacco products. The Supreme Court is considering whether the FDA has the authority to regulate tobacco products as drug delivery devices, but a ban of tobacco products by the FDA would contradict congressional policy and the provision of the United States Code that recognizes the marketing of tobacco as one of the greatest basic industries of the United States. Congress has expressed a clear intent to exclude tobacco products from the FDA's jurisdiction through tobacco-specific legislation, but subsequent tobacco-specific legislation suggests that the FDA may have the authority to regulate tobacco. Despite evidence of tobacco's health effects and addictiveness, Congress rejected three bills that would have granted the FDA jurisdiction to regulate tobacco products. The lower court should take note of Congress's rejection of bills granting the FDA jurisdiction over tobacco and the FDA's consistent position that it lacks jurisdiction over tobacco products.

The passage discusses the dissenting opinion of Justice Breyer, who argues that the FDA has the authority to regulate tobacco products under the FDCA. The majority opinion rejects the proposal to limit the definition of "drug" or "device" in the FDCA to exclude certain products. The chemical effects of nicotine on the body establish it as a drug, and the cigarette that delivers it as a drug-delivery device under the FDCA. The FDA can regulate products that affect the body if the manufacturer wants and knows that consumers use the product for a particular purpose, even in the absence of express claims. The passage suggests that the FDA's interpretation of the Delaney Amendment was too rigid and did not allow for a level of "safe use" or a judgment of whether the benefits of continued use outweighed the risks involved. The argument suggests that the FDCA should be interpreted flexibly to allow the FDA to choose from its arsenal of remedies in appropriate cases. The passage also disputes the majority's view that laws enacted since 1965 require the denial of FDA jurisdiction over tobacco products. Finally, the passage argues that the FDA Modernization Act of 1997 did not intend to limit the FDA's jurisdictional authority over tobacco products.