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GUIDANCE DOCUMENT

Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) September 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-5364
Issued by:
Guidance Issuing Office
Center for Tobacco Products

The FDA is issuing this guidance to assist persons submitting cigarette plans for cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention and Tobacco Control Act (TCA), amending the Federal Cigarette Labeling and Advertising Act (FCLAA). This guidance provides recommendations related to 21 CFR 1141 and the FCLAA requirements regarding the submission of cigarette plans for cigarette packages and cigarette advertisements. This guidance document discusses, among other things:

  • The regulatory requirements to submit cigarette plans 
  • Definitions  
  • Who submits a cigarette plan 
  • The scope of a cigarette plan 
  • When to submit a cigarette plan 

For information regarding the current status of the final rule, visit “Cigarette Labeling and Health Warnings Requirements.”

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-2019-D-5364.

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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