On May 21, 2021, 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. The new effective date of the final rule is July 13, 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 Sept. 13, 2021. In line with these new dates, FDA today has revised and made available the "Submission of Plans for Cigarette Packages and Cigarette Advertisements" guidance and "Required Warnings for Cigarette Packages and Advertisements" small entity compliance guide. 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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