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GUIDANCE DOCUMENT

Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Guidance for Industry and FDA Staff May 2010

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0189
Issued by:
Guidance Issuing Office
Center for Tobacco Products

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. 

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0189.

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