On Nov. 12, 2021, 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, to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule. The new effective date of the final rule is Jan. 9, 2023. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, FDA strongly encourages entities to submit cigarette plans (as required by 21 CFR 1141.10(g)) as soon as possible, and in any event by March 12, 2022. 

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 

Questions?