Update: The new effective date of the final rule is Oct. 6, 2023, the U.S. Food and Drug Administration announced Aug. 17. Any obligation to comply with a deadline tied to the effective date is similarly postponed, the agency said, meaning retailers have until Dec. 7, 2022, to submit cigarette plans.
SILVER SPRING, Md. — A judge has again postponed the effective date of the U.S. Food and Drug Administration’s graphic cigarette health warning rule. It is now July 8, 2023, and advertisement plans—which may apply to some convenience-store retailers—should be filed by Sept. 8.
The FDA finalized the rule in March 2020 that requires 11 new cigarette health warnings consisting of textual warning statements accompanied by color graphics depicting the negative health consequences of cigarette smoking.
Manufacturers, wholesalers and retailers that create their own cigarette advertisements must file a plan with the FDA that includes the schedule for rotating the 11 warnings on cigarette packages or advertisements. Web-based or printed order guides or catalogs for retailers to order cigarettes are not considered advertisements.
The rule has been challenged by several lawsuits.
Winston-Salem, N.C.-based R.J. Reynolds, along with other manufacturers and retailers, filed a lawsuit in the U.S. District Court for the Eastern District of Texas to invalidate the FDA’s rule and Congress’ requirement that the FDA mandate the warnings. New York-based Philip Morris USA Inc. and Sherman Group Holdings LLC, owned by Richmond, Va.-based Altria Group Inc., filed a lawsuit in the District of Columbia against the FDA seeking the same resolution.
The U.S. District Court for the Eastern District of Texas issued the postponement in the case of R.J. Reynolds Tobacco Co. et al vs. United States FDA et al on May 10. This is the second postponement this year, following one announced in February.
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