Top Takeaways:

• A federal judge in Georgia struck down the FDA’s rule requiring graphic cigarette health warnings, handing a victory to Philip Morris USA and state retailers.
• The court said the FDA violated administrative law by failing to release all raw data used in developing the rule, depriving stakeholders of meaningful input.
• The decision is the latest setback for the FDA’s efforts to implement warning labels under the 2009 Tobacco Control Act and is expected to be appealed to the 11th Circuit.

A federal judge in South Georgia has vacated the U.S. Food and Drug Administration’s rule requiring graphic health warnings on cigarette packs and advertising, siding with Philip Morris USA and Georgia retailers in a closely watched case.

U.S. District Judge Lisa Godbey Wood ruled that the FDA failed to disclose all of the raw data it relied on when developing the 2020 regulation, a procedural error that violated the Administrative Procedure Act. That failure, she said, denied affected parties the ability to provide meaningful feedback during the rulemaking process.

“The Court is cognizant of the time, resources, and effort that goes into rulemaking… its decision to vacate the FDA’s rule for an error that ultimately might not lead to a different outcome is not made lightly,” Wood wrote in her opinion.

The plaintiffs—including Philip Morris USA, the Georgia Association of Convenience Stores, and two distribution companies—argued the rule would impose heavy compliance costs, force retailers to “speak against their own products,” and deter customers by making stores unwelcoming. They also said the agency cherry-picked health risks while ignoring contrary evidence from its own research.

The FDA countered that its process was sound and that the graphic images were necessary to more effectively convey the risks of smoking, in line with mandates under the 2009 Family Smoking Prevention and Tobacco Control Act.

The ruling adds to a string of legal defeats for the FDA’s graphic-warning initiative. In Texas, a judge has already blocked enforcement of the same regulation, and both cases are expected to wind through the appellate courts.

The matter now moves to the 11th U.S. Circuit Court of Appeals, prolonging an already years-long battle over the future of cigarette warning labels in the United States. For retailers and manufacturers, the ruling delays costly new requirements. For the FDA, it marks yet another setback in its decade-plus struggle to update tobacco packaging with graphic health messages.