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 civil money penalties and no-tobacco-sale orders 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 regulations issued under section 906(d) of the FD&C Act, including restrictions on the sale and distribution of cigarettes, smokeless tobacco, and covered tobacco products in title of the Code of Federal Regulations (CFR) part 1140 and about procedures CTP follows when it initiates administrative enforcement actions. Additional information on civil money penalties and no-tobacco-sale orders can be found in FDA's guidance for FDA and tobacco retailers Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers (CMP and NTSO Guidance).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.