FDA’s Cigarette Labeling Regulations Vacated by Georgia Judge

Philip Morris USA Inc. convinced a federal judge to strike down FDA rules on cigarette labeling and advertising, the latest setback for a long-running government effort to force the tobacco industry to more clearly communicate the health risks of smoking.

The agency failed to disclose the raw data of the studies it relied on during rulemaking, which prejudiced the cigarette manufacturer and other plaintiffs during the process, Judge Lisa G. Wood of the US District Court for the Southern District of Georgia wrote in an Aug. 29 order granting summary judgment to the plaintiffs.

A federal judge in Texas temporarily barred enforcement of the regulations in January after finding the FDA likely violated the Administrative Procedure Act, which the government appealed to the Fifth Circuit.

The 2009 Family Smoking Prevention and Tobacco Control Act made it unlawful to distribute or sell any cigarettes without at least one of nine warnings outlined in the statute, and directed the FDA to come up with graphics depicting the negative health consequences to accompany the statements.

The FDA’s initial regulations issued in 2011 were vacated by the DC Circuit because they violated the First Amendment. The agency in 2020 issued a new final rule that included 11 graphics to accompany corresponding text warnings on cigarette packaging and advertisements. The FDA said it reviewed the public’s general awareness of health risks associated with smoking and conducted two quantitative studies to assess whether any of 15 revised statements created by the agency would promote greater public understanding of the health risks tied to smoking.

Philip Morris, along with Georgia-based convenience stores and a cigarette distribution company, alleged the FDA’s rulemaking process violated the TCA and the APA.

Although the rule isn’t arbitrary or in violation of the TCA, the FDA’s failure to disclose the raw data of the studies it relied on prejudiced the plaintiffs’ ability to engage in the notice-and-comment process, Wood said. The judge was unable to conclude whether the disclosure of that data would clearly have had no impact on the rulemaking process, given the plaintiffs’ argument that “after obtaining access to the raw data during litigation Plaintiffs identified that the data supports different conclusions than those reached by the agency.”

The “plain language” of the TCA provides that the agency isn’t limited to the nine statements included in the statute, so long as the FDA follows rulemaking procedures and makes adequate findings that the changes “promote greater public understanding” of cigarette risks, Wood said.

The FDA’s reliance on “new information” and “self-reported learning” to measure whether the warnings promote public understanding also complies with the TCA, since they “account for individuals’ ‘understanding’ of a topic, at least in the early stages of comprehension.” The agency’s use of those metrics also supports a finding that the final rule wasn’t arbitrary and capricious, the judge said.

The agency’s methodology also shows it compared the original warnings in the statute with the revised statements and found the changes promoted greater public understanding of tobacco use risks. Only the statements that outperformed the original TCA warnings “to a statistically significant degree” were included in the final rule. And the agency “examined the pertinent data, provided an adequate explanation for its decisions, and made a rational connection” between its findings and the final warning statements, Wood said.

Williams & Connolly LLP and Hunter Maclean Exley & Dunn PC represent the plaintiffs.

The case is Philip Morris USA Inc. v. US Food and Drug Admin., 2025 BL 308757, S.D. Ga., No. 2:24-cv-00143, 8/29/25.