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SMALL ENTITY COMPLIANCE GUIDE

FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements Guidance for Industry March 2019

Final
Issued by:
Guidance Issuing Office
Center for Tobacco Products

March 2019

This Small Entity Compliance Guide is intended to help small businesses understand and comply with FDA's final rule deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) ( the Deeming Rule). The Deeming Rule extends FDA's tobacco product authorities in Chapter IX of the FD&C Act to include all tobacco products, except accessories of newly deemed tobacco products. The Deeming Rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires warning labels on packages and advertisements.


Additional Resources


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)