This is an interesting date: Oct. 16, 2021
POSTPONED: Cigarette Health Warnings Effective Date
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. 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 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 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 update the recommended timing for submission of cigarette plans.
FDA strongly encourages entities to submit cigarette plans as soon as possible, and in any event by Dec. 16, 2020. Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner.
Regulated industry may contact CTP with questions about the effective date.
