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SMALL ENTITY COMPLIANCE GUIDE

Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide Guidance for Industry March 2012

Final

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Tobacco Products

March 2012

This guidance is intended to help small businesses understand and comply with FDA’s amendments to certain of its regulations to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products. Parties must be in compliance with that final rule beginning on April 2, 2012.  


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)