Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) July 2021

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-5364
• Issued by: Center for Tobacco Products

On Dec. 7, 2022, the U.S. District Court for the Eastern District of Texas issued an order in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, vacating the “Required Warnings for Cigarette Packages and Advertisements” rule. Currently, FDA is not recommending that entities submit cigarette plans. If a firm has already submitted a plan, no further action is needed at this time. FDA will provide further updates regarding submission of cigarette plans as they are available.

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 

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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.

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