Opinion of the Court
The FDA Cannot Regulate Tobacco Products As Drugs
This case was granted certiorari on April 26, 1999, and was affirmed on March 21, 2000. In a 5-to-4 decision, the Court held that tobacco cannot be regulated by the Food and Drug Administration (FDA) as a drug and cigarettes as drug delivery devices under the Food, Drug, and Cosmetic Act (FDCA). The following is excerpted from the summary of the majority opinion written by Justice O’Connor, as prepared by the Court Reporter of Decisions:Reading the FDCA as a whole, as well as in conjunction with Congress’s subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA…
