FDA Nicotine Regulation and the Courts
History of the Food and Drug Administration's Tobacco Rule
On August 28, 1996, the Food and Drug Administration (FDA) issued its final rule regulating cigarettes and smokeless tobacco, titled "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents." In general, these regulations restricted the sale and distribution of cigarettes and smokeless tobacco to minors and limited the advertising and promotion of tobacco products. Specifically, the final rule prohibited the sale of nicotine-containing cigarettes and smokeless tobacco to individuals under the age of 18; required manufacturers, distributors, and retailers to comply with certain conditions regarding the sale and distribution of these products; and…