WASHINGTON — A Texas court pushed back the date new cigarette health warnings will be required by the U.S. Food and Drug Administration (FDA) to Jan. 14, 2022.
The deadline was previously postponed to Oct. 16, 2021, by the Federal District Court for the Eastern District of Texas. In that case, Winston-Salem, N.C.-based R.J. Reynolds Tobacco Co., along with several other manufacturers and five retailers, and the FDA jointly asked the court on May 6 for a 120-day extension of the effective date of the warnings because of the disruptive effects of the COVID-19 outbreak on manufactures, retailers and the FDA.
As part of the most recent extension, which the court issued on Dec. 2, any other deadline related to the graphic cigarette health warnings were also delayed.
Previously, the FDA had asked manufacturers, wholesalers and retailers to file graphic cigarette health warning rotational plans with the agency by Dec. 16 if they create or produce cigarette advertisements. A statement on the FDA’s website following the Dec. 2 order, however, said to submit plans as soon as possible.
“[The] FDA strongly encourages entities to submit cigarette plans (as required by 21 CFR 1141.10(g)) as soon as possible, and in any event by March 16, 2021,” the statement reads. “[The] FDA intends to revise its relevant guidance documents related to the rule with the new effective date.”
The new rule, which several lawsuits have challenged, requires 11 new health warnings to be implemented on cigarette packs, cartons and ads. The warnings include text statements as well as graphic color images.
R.J. Reynolds, along with other manufacturers and retailers, filed a lawsuit in the Eastern District of Texas on April 3 to invalidate the FDA’s rule and Congress’s 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.