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On Aug. 18, 2021, the U.S. District Court for the Eastern District of Texas issued an order 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.
The new effective date of the final rule is Oct. 11, 2022. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, FDA strongly encourages entities to submit cigarette plans as soon as possible but no later than Dec. 12, 2021.
Additional details on the rule, as well as the new effective date and recommended date for submission of cigarette plans, can be found on FDA’s website.
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