WASHINGTON—On December 2, 2020, the U.S. District Court for the Eastern District of Texas granted a motion by the plaintiffs in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by an additional 90 days.
The new effective date of the final rule is January 14, 2022. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The U.S. Food and Drug Administration (FDA) strongly encourages entities to submit cigarette plans as soon as possible, and in any event by March 16, 2021. The FDA intends to revise its relevant guidance documents related to the rule with the new effective date. For questions about the effective date, please contact CTP.
This marks the second time the agency won a delay in the rule’s effective date. In May 2020, the U.S. District Court for the Eastern District of Texas agreed to a postponement until October 16, 2021, because of the COVID-19 pandemic. The new requirement for graphic warning labels on cigarette packs was initially slated to take effect June 18, 2021.