This guidance provides information in response to frequently asked questions that the Center for Tobacco Products (CTP) is receiving from retailers and other interested stakeholders regarding the issuance of civil money penalties for violations of Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.) requirements relating to tobacco products in retail outlets. In particular, the guidance provides information about CTP’s enforcement of the requirement that tobacco products may not be sold or distributed in violation of FDA’s regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents (21 CFR part 1140) and about procedures the Agency follows when it initiates enforcement actions.
The penalty schedule mentioned in this document is only for violations of rules issued under section 906(d) of the FD&C Act by a retail outlet. FDA may seek other general or enhanced penalties under section 303(f)(9) of the FD&C Act for other kinds of violations not addressed in this document.