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., No. 6:20-cv-00176, 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. 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 16, 2021.
FDA has revised the “Submission of Plans for Cigarette Packages and Cigarette Advertisements” guidance and “Required Warnings for Cigarette Packages and Advertisements” small entity compliance guide to include the rule’s new effective date and updated the recommended date for submission of cigarette plans. For questions about the effective date or cigarette plans, please contact CTP.
Required Health Warnings
The Family Smoking Prevention and Tobacco Control Act (TCA) granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products. The TCA also amended Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), directing FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The TCA amends the FCLAA to require each cigarette package and advertisement to bear one of the new required warnings.
In March 2020, FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings, consisting of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. These new required warnings depict some of the lesser-known, but serious health risks of smoking.
U.S. Food and Drug Administration – January 12, 2021.