Keller and Heckman Secures Significant Fifth Circuit Victory Challenging FDA PMTA Denials

On August 19, 2026, the U.S. Court of Appeals for the Fifth Circuit issued a published opinion granting petitions for review in seven consolidated cases, vacating the U.S. Food and Drug Administration's (FDA) marketing denial orders (MDOs) for numerous electronic nicotine delivery system (ENDS) products, and remanding the matters to the agency for further proceedings. Keller and Heckman Partner Eric Gotting represented the petitioners in the challenge, with important contributions from Partner Azim Chowdhury, Counsel Neelam Gill and LieAnn Van-Tull, and Associate Victoria Tinker.

The court held that FDA violated the Administrative Procedure Act (APA) by applying a broadly applicable "comparative-efficacy" evidentiary standard during PMTA reviews without first adopting that standard through the APA's required notice-and-comment rulemaking process. The Fifth Circuit found that FDA effectively imposed a binding rule across PMTA adjudications while bypassing procedural safeguards designed to provide affected parties with notice and an opportunity to participate.

Importantly, the court did not prohibit FDA from considering comparative evidence when evaluating PMTAs, nor did it require FDA to authorize any products. Rather, the decision reinforces a fundamental administrative law principle: agencies may not create broadly applicable regulatory requirements through informal adjudication when formal rulemaking procedures are required.

The ruling represents a significant procedural victory for the petitioners and may have broader implications for FDA's future regulation of ENDS products and PMTA review practices. Keller and Heckman will continue to monitor developments as FDA considers its next steps on remand.

To learn more, see the Continuum of Risk blog post, “Fifth Circuit Vacates FDA PMTA Denials, Reinforces APA Limits on Informal Adjudication.”