Two recent rulings by a federal appellate court have stunted the U.S. Food and Drug Administration’s attempts to regulate the marketing of tobacco products, emphasizing restraints on the agency’s power.
In back-to-back August rulings, the U.S. Fifth Circuit Court of Appeals shot down the agency’s warning requirements on cigarette packages and decision-making process in denying applications for marketing new tobacco products.
Warnings on Cigarette Packages
A coalition of tobacco companies—including R.J. Reynolds, Santa Fe Natural, and ITG Brands—filed a federal lawsuit against the FDA; Commissioner Kyle Diamantas; the U.S. Department of Health and Human Services; and Secretary Robert F. Kennedy Jr. for requiring eleven warnings to be posted on cigarette packaging and in advertising.
Plaintiffs argued that Congress had only authorized the FDA to require nine warnings.
U.S. District Judge Campbell Barker agreed and temporarily postponed the rule from taking effect—finding that the plaintiffs had a “substantial likelihood” of success on their claim that the FDA exceeded its statutory authority.
The government appealed this decision to the Fifth Circuit in New Orleans, where it was considered by a three-judge panel of Judges James Ho, Leslie Southwick, and Don Willett.
Finding that the district court did not abuse its discretion in issuing the temporary relief, the panel upheld the decision. The opinion, dated August 18, was written by Judge Willett.
Willett explained that when Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009, it provided a “detailed framework with nine prescribed warning statements that must appear on cigarette packages and advertising.”
The TCA granted the FDA only limited, conditional authority to adjust it. But in 2019, the FDA promulgated a rule requiring cigarette manufacturers and retailers to display a rotating total of eleven warning statements—each paired with a graphic image depicting a smoking-related health harm.
“At this preliminary stage, the statutory text points one way: the FDA may require the nine warnings Congress prescribed—no more,” wrote Judge Willett. “Congress legislated with precision, and an agency treated that precision as optional.”
The rule remains blocked from enforcement while the case proceeds on the merits at the district court—pending an appeal or petition for rehearing.
Marketing New Tobacco Products
The following day—on August 19—another three-judge panel of the Fifth Circuit released a separate ruling related to the FDA’s regulations on marketing tobacco products.
A provision of the TCA prohibits marketing new tobacco products without authorization from the FDA. It provides that the agency “shall deny” a new premarket tobacco product application (PMTA) unless the applicant shows that its product would be “appropriate for the protection of the public health.”
In making its determination, the FDA must evaluate “the risks and benefits to the population as a whole,” taking into account both the “likelihood that those who do not use tobacco products will start using such products” and the “likelihood that existing users of tobacco products will stop.”
However, two internal FDA memoranda reportedly required the agency to apply a “comparative efficacy standard”—effectively forcing the denial of PMTAs if they did not include a comparative efficacy study.
This is a study that evaluates the effect of one product compared to another active alternative under similar conditions.
Multiple tobacco companies were denied for failing to include such a study, leading many of them to file petitions for review in the Fifth Circuit. Seven petitions were consolidated for consideration.
Petitioners included NicQuid, Wood Creek Vapory, Breeze Smoke, Texas Wholesale, Baton Vapor, Max & Zach’s Vapor Shops, White Cloud Cigarettes, Jail Puff Max, Vapermate, Vape Away, Elite Brothers, Cloud Vapors, and American Vapor Company.
They argue that the FDA’s application of a comparative efficacy requirement was arbitrary and did not provide them with fair notice—violating their due process rights.
Petitioners further asserted that the TCA and Administrative Procedures Act required the FDA to pursue a notice-and-comment rulemaking procedure before requiring a comparative-efficacy study, as such constituted a substantive rule.
Notice-and-comment rulemaking required publishing a notice of proposed rulemaking, soliciting comments from interested parties, responding to those comments in the proper manner, then releasing a final rule.
The three-judge panel—consisting of Judges Patrick Higginbotham, Jerry Smith, and Andrew Oldham—agreed.
Judge Smith wrote the opinion, reasoning that “the comparative efficacy standard is a substantive rule that needed to be adopted under the APA’s notice-and-comment requirements so as not to imperil the due-process-protected interests of bound parties.”
The court directed the FDA, on remand, to either “rethink the rule, to re-adopt it consistently with the APA’s information-forcing procedure that permits the many bound parties to have their say and contribute to rational and sound policy, or to undertake other appropriate proceedings consistent with this opinion.”
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