SILVER SPRING, Md. — A judge has once again postponed the effective date of the U.S. Food and Drug Administration’s graphic cigarette health warning rule—but this time, a final decision is in sight.
The U.S. District Court for the Eastern District of Texas on Nov. 7 postponed the effective date another 31 days to Nov. 6, 2023, a court order, provided by the National Association of Tobacco Outlets (NATO), showed. With that, the court also postponed the preferred filing deadline for manufacturers and retailers to submit cigarette health warning rotational plans to the FDA—that deadline is now Jan. 6, 2023. This marks at least the fourth postponement of the effective dates this year.
In the Nov. 7 order, Judge J. Campbell Barker also said the court expects to rule on the cross motions for the summary judgement within 31 days, meaning he will decide whether the graphic cigarette health warning rule will ultimately be allowed to be implemented.
The motion for summary judgement, used to seek a decision by the court on the merits of a case without a full trial, was filed by R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co. and ITG Brands against the FDA, and the FDA also filed a motion for a summary judgement, NATO said.
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.
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