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Guidance Issuing OfficeCenter for Tobacco Products
Due to the COVID-19 pandemic and its disruptive impacts on both regulated industry and FDA, on May 8 the U.S. District Court for the Eastern District of Texas granted a joint motion 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 govern proceedings in that case and postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by 120 days. FDA remains fully committed to the rule and would not agree to postpone its effective date but not for the extraordinary disruptions caused by the COVID-19 pandemic.
The new effective date of the final rule is Oct. 16, 2021. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. 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 Dec. 16, 2020. FDA has updated the “Required Warnings for Cigarette Packages and Advertisements” small entity compliance guide and the “Submission of Plans for Cigarette Packages and Cigarette Advertisements” guidance to include the rule’s new effective date and updated timing for submission of cigarette plans. Regulated industry may contact CTP with questions about the effective date.
The Food and Drug Administration 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, 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
- Who submits a cigarette plan
- The scope of a cigarette plan
- When to submit a cigarette plan
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:
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.