The U.S. Food and Drug Administration’s latest rule requiring graphic warnings on cigarette packaging and advertising has been tossed out by a federal judge in South Georgia.
In a written order Friday, U.S. District Judge Lisa Wood said the FDA failed to publicly disclose all the raw data it relied on when creating the 2020 rule. She said that prejudiced Georgia retailers and tobacco giant Philip Morris USA as they couldn’t meaningfully comment on the rule during the feedback period.
Wood said she had to vacate the rule because the FDA violated the federal Administrative Procedures Act, even though timely public disclosure of all the raw data might not have made any difference.
“The Court is cognizant of the time, resources, and effort that goes into rulemaking,” Wood wrote. “Thus, its decision to vacate the FDA’s rule for an error that ultimately might not lead to a different outcome is not made lightly.”
It is a win for Philip Morris and the Georgia retailers, including the Georgia Association of Convenience Stores, which sued the FDA and the U.S. Department of Health and Human Services in December 2024.
Representatives for the plaintiffs did not immediately respond to questions about the case. A spokesperson for the federal government declined to comment.
Credit: handout
Credit: handout
The FDA has been trying since 2009 to implement graphic warnings under the Family Smoking Prevention and Tobacco Control Act, but its attempts keep getting thwarted in court.
Though Wood ultimately gave the plaintiffs what they wanted, she rejected almost all their arguments in the Georgia case, which is likely to now go before the U.S. Court of Appeals for the 11th Circuit. It was 11th Circuit precedent that Wood relied on in part to reach her decision.
A separate suit by tobacco companies also challenging the rule is pending in a different federal appeals court, after a judge in Texas barred the rule’s enforcement until a final decision in that case.
In their complaint, the Georgia retailers and Philip Morris alleged the FDA rule would cost them millions of dollars and unfairly force them to “speak against their own products via provocative images that may mislead consumers.” They said the rule would render convenience stores “unwelcoming, especially to children.”
“This is a clear case of administrative rulemaking gone awry,” the plaintiffs said in the suit. “Cigarette packaging and advertisements have long featured text-only Surgeon General’s warnings about the health consequences of smoking, but FDA’s rule would represent a sea change that would revolutionize cigarette packaging and advertisements.”
The new rule requires cigarette manufacturers to display one of 11 warnings across 50% of every cigarette package and 20% of every advertisement. It also requires convenience stores to display the warnings on in-store advertisements for cigarette products.
In creating the rule, the FDA arbitrarily focused on certain smoking-related risks over others without explanation, the plaintiffs in the Georgia case alleged. They also claimed the FDA ignored countless red flags in its studies.
Credit: handout
Credit: handout
Through court filings, the FDA defended its rulemaking process and said the plaintiffs had failed to show they were injured by it.
Apart from the data disclosure issue, Wood agreed the agency had acted appropriately under the relevant federal laws. She found nothing wrong with the FDA’s decision to implement 11 new graphic warnings to better inform consumers about risks associated with tobacco products.
“The FDA examined the pertinent data, provided an adequate explanation for its decisions, and made a rational connection between its reported findings and the statements included in the Final Rule,” she wrote.
The FDA is supported in the case by several medical and public health organizations.
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