FDA’s Cigarette Health Warning Rule Postponed to April 2023

Court has pushed back deadline several times
Cigarette health warning example
Photograph courtesy of the FDA

SILVER SPRING, Md. — The U.S. District Court for the Eastern District of Texas postponed the effective date of the U.S. Food and Drug Administration’s (FDA) graphic cigarette health warning rule to April 9, 2023. It was previously Jan. 9, 2023, and has been pushed back several times already.

The court’s order, provided to CSP by the National Association of Tobacco Outlets (NATO), also stated any additional requirements associated with the rule would also be postponed for an additional 90 days, implying that retailers also have until June 13 to submit their cigarette health warning rotational plans.

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 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.

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 on April 3 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 Feb. 10.

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