Guidance for Industry and FDA Staff: Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
This guidance is intended to provide information related to certain provisions of the regulations restricting the sale and distribution of cigarettes and smokeless tobacco. See 75 Federal Register 13225 (March 19, 2010). These regulations are effective June 22, 2010.1 More specifically, this guidance provides clarifying information related to FDA’s enforcement policy concerning 21 CFR sections 1140.16(a) and 1140.32(a) of the final rule.
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.