On Aug. 29, 2025, the U.S. District Court in Georgia issued a ruling vacating (i.e., overturning) the U.S. Food and Drug Administration’s (FDA) graphic cigarette health warning regulation. The decision was issued in a lawsuit brought against the FDA by Philip Morris USA Inc., Dhaliwal & Associates, Inc., Stewart Candy Company d/b/a Stewart Distribution, and the Georgia Association of Convenience Stores, Inc.

On Oct. 27, 2025, the FDA filed a Notice of Appeal with the U.S. Court of Appeals for the Eleventh Circuit to appeal the Aug. 29, 2025, district court decision. A copy of the Notice of Appeal filed by the FDA can be found here.

The Aug. 29, 2025, federal district court decision struck down the FDA’s regulation that requires cigarette manufacturers to display graphic cigarette health warnings on the top half of the front and back of cigarette packs and the top 20% of cigarette advertisements. In the decision, the federal judge determined that the FDA failed to disclose the raw data of the studies that the agency relied on during the regulatory rulemaking process, which prejudiced Philip Morris USA and the other plaintiffs during the process that the public is allowed to submit comments on a proposed regulation.