On Feb. 25, 1994, the U.S. Food and Drug Administration (FDA) announced it could consider regulating regulating tobacco products under the authority of the Federal Food, Drug, and Cosmetic Act.

On August 10, 1995, President Bill Clinton announced that the agency’s evidence and analysis supported a finding, subject to public comment, that the nicotine in cigarettes and smokeless-tobacco products is a drug and that these products are drug-delivery devices under the terms of the act.