Small Entity Compliance Guide on Regulations to Restrict the Sale andDistribution of Cigarettes and Smokeless Tobacco in Order to Protect Children and Adolescents (21 CFR Part 897) (Revised)

摘要

In the Federal Register of August 28, 1996, the Food and Drug Administration(FDA) published a final rule to restrict the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents. This rule is intended to decrease the number of children and adolescents who use cigarettes and smokeless tobacco and, by doing so, to reduce the death and disease caused by tobacco products. FDA took this step after reviewing thousands of scientific and medical studies, reports, recommendations, and other documents, including materials received as comments on the proposed rule. FDA also studied many domestic and foreign tobacco control laws and regulations, reviewed industry documents, and received evidence and statements from former industry employees. Collectively, the evidence persuaded the agency that cigarettes and smokeless tobacco are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the act) and that regulation is necessary to restrict the sale and distribution of these products to people under 18. This guide is designed to help one understand the rule and to explain what you should do to comply with the rule.