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GUIDANCE DOCUMENT

Prohibition of Distributing Free Samples of Tobacco Products Guidance for Industry March 2023

Final
Docket Number:
FDA-2017-D-0113
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This guidance is intended to help tobacco product manufacturers, distributors, and retailers understand the prohibition of distributing free samples of tobacco products set forth in Title 21 CFR Part 1140 and to explain what you should do in order to comply with the regulations. The document explains, among other things, what activities and which persons are subject to the regulations, as well as how the prohibition of distributing free samples applies to the distribution of tobacco products through:

  • non-monetary exchanges
  • membership and rewards programs
  • contests and games of chance
  • business-to-business exchanges

Submit Comments

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-2017-D-0113.

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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