WASHINGTON—Due to the COVID-19 pandemic and its disruptive impacts on both regulated industry and government, the U.S. District Court for the Eastern District of Texas has postponed the effective date of the “Required Warnings for Cigarette Packages and Advertisements ” final rule by 120 days. The new effective date is Oct. 16, 2021. NACS Daily first reported on the requested delay by the Food and Drug Administration (FDA) earlier this month.
Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The FDA has updated the 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 recommended timing for submission of cigarette plans.
The FDA said it remains fully committed to the rule and strongly encourages entities to submit cigarette plans as soon as possible, and in any event by Dec. 16, 2020, to facilitate timely review. Regulated industry may contact CTP at AskCTP@fda.hhs.gov for more details.