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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 2023

Download the Final Small Entity Compliance Guide Read the Federal Register Notice
Final
Docket Number:
FDA-2014-N-0189
Issued by:
Guidance Issuing Office
Center for Tobacco Products

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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2014-N-0189.

Questions?

Contact Point
Contact CTP
Center for Tobacco Products
Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
AskCTP@fda.hhs.gov
(9 a.m. - 4 p.m. Eastern) 1-877-CTP-1373 (1-877-287-1373)
Twitter: https://twitter.com/FDATobacco
FDA Tobacco Education Resource Library: https://digitalmedia.hhs.gov/tobacco
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