On April 9, 2026, Philip Morris USA Inc. (PM USA) filed its brief with the U.S. Circuit Court of Appeals for the 11th Circuit in response to the U.S. Food and Drug Administration’s (FDA) appeal of a lower federal district court decision vacating (i.e., overturning) the FDA’s graphic cigarette health warning regulation. The federal district court decision was issued in a lawsuit brought against the FDA by PM USA, Dhaliwal & Associates, Inc., Stewart Candy Company d/b/a Stewart Distribution, and the Georgia Association of Convenience Stores, Inc.

In its appeal brief, PM USA advances several key arguments as to why the Circuit Court of Appeals should affirm the lower federal district court ruling overturning the FDA’s graphic cigarette health warning regulation. These key arguments include the following:

1. The FDA failed to disclose raw data underlying the studies the agency relied on to adopt the graphic cigarette health warning regulation. Withholding of the raw study data violates the Administrative Procedures Act, the law which sets forth the required procedures that federal agencies must follow to propose and adopt regulations.
2. The delay in providing raw study data prevented PM USA, the other plaintiffs, and industry members from raising critical points in comments submitted on the proposed graphic cigarette health warning regulation that the data supported different conclusions than those reached by the FDA.
3. The FDA exceeded its authority by requiring eleven rewritten cigarette health warnings instead of the nine cigarette health warnings that Congress approved.

The Circuit Court of Appeals for the 11th Circuit will now schedule an oral argument on the case. Read the PM USA brief here.