On October 27, FDA appealed a decision of the U.S. District Court for the Southern District of Georgia that vacated the agency’s 2020 rule requiring graphic health warnings on cigarette packaging and advertisements. This appeal to the U.S. Court of Appeals to the Eleventh Circuit, along with a separate challenge pending before the Fifth Circuit, may determine whether FDA’s second attempt to impose graphic health warnings on cigarettes will be successful.[1]
In 2009, Congress directed the FDA, through the Family Smoking Prevention and Tobacco Control Act (TCA), to require nine new cigarette health warnings that include “color graphics depicting the negative health consequences of smoking,” allowing FDA to “adjust the format, type size, color graphics, and text of any of the label requirements … if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products.” The FDA’s first attempt, in 2011, ultimately failed when the D.C. Circuit vacated the graphic health warning requirements for violating the First Amendment. The agency’s second attempt, in 2020, has so far survived a First Amendment challenge but now faces statutory challenges.
A central issue on appeal to the Eleventh Circuit is whether the 2020 rule complied with the Administrative Procedure Act (APA)’s rulemaking requirements. The U.S. District Court held that the FDA violated the APA by failing to disclose underlying raw study data during the notice-and-comment process. That failure, the court said, prevented opponents of the rule from submitting competing analyses that could have challenged the FDA’s efficacy claims for the revised warnings.
After obtaining the raw data through litigation, for example, the plaintiffs provided an analysis showing “‘there was no statistically significant difference’ between the FDA’s final revised warnings and the Surgeon General’s carbon monoxide warning.” The court found that this evidence contradicted one of the primary bases for the rulemaking—namely “that the current 1984 Surgeon General’s warnings do not effectively promote greater public understanding of the negative health consequences of smoking and that there are better approaches to cigarette health warnings.” Although providing the public an opportunity to comment on this raw data “may not have changed the FDA’s ultimate decision,” the court could not conclude that it “would clearly have no bearing on the procedure used.” Because the FDA failed to disclose the raw data on which it relied and the plaintiffs were prejudiced during the rulemaking process, the court determined that vacatur was the proper remedy.
Notably, the U.S. District Court rejected several other attacks on the FDA’s rulemaking process. It found that the FDA’s methodology was reasonable and that the agency examined the relevant data, provided an adequate explanation for its decisions, and made a rational connection between its reported findings and the Final Rule in a manner that was not arbitrary and capricious. The court also rejected claims that the FDA exceeded its statutory authority.
The latter conclusion stands at odds with a parallel challenge in Texas. There, the U.S. District Court for the Eastern District of Texas concluded in January that the plaintiffs were likely to succeed on their argument that the FDA lacked statutory authority to increase the TCA’s number of required warnings from nine to eleven, and it preliminarily enjoined the FDA from enforcing the rule while the litigation continues. The FDA appealed to the Fifth Circuit, and the appeal remains pending.
What’s next? For now, no graphic health warnings are required on cigarette packaging or advertisements. That is likely to remain the case unless both the Fifth Circuit and Eleventh Circuit reverse the lower courts’ rulings that the FDA likely exceeded its statutory authority or failed to comply with APA rulemaking requirements in a manner that prejudiced opponents of the rule.
The vacatur of the FDA’s graphic health warnings rule also means that the original Surgeon General’s health warnings for cigarette packages and advertisements remain in effect. The TCA’s amendments to the Federal Cigarette Labeling and Advertising Act (FCLAA), which requires the Surgeon General’s warnings, only take effect fifteen months after the FDA issues the necessary implementing regulations—namely, the graphic health warning rule.
If the FDA ultimately prevails, the agency would likely exercise enforcement discretion to allow a transition period for manufacturers to come into compliance, as it did the last time it appeared the rule would take effect. If FDA is unsuccessful and the rule is vacated, it may take years for the agency to finalize a new rule addressing any deficiencies identified by the courts. Stay tuned for further updates.
[1] The cases are R.J. Reynolds Tobacco Co. v. FDA, No. 6:20cv176 (E.D. Tex.), appeal pending No. 25-40137 (5th Cir.), and Philip Morris USA Inc. v. FDA, No. 2:24cv143 (S.D. Ga.), appeal pending No. 25-13863 (11th Cir.).