The U.S. Court of Appeals for the Fifth Circuit upheld a 2021 rule issued by the U.S. Food and Drug Administration requiring manufacturers seeking premarket tobacco product authorization to investigate and disclose health effects data, according to Law 360. In a unanimous opinion, the three-judge panel found the agency complied with the Regulatory Flexibility Act by reasonably certifying that the rule would not have a significant economic impact on a substantial number of small entities, affirming a February 2025 summary judgment in FDA’s favor.
Plaintiffs, including e-liquid manufacturers and the United States Vaping Association, argued the FDA improperly relied on economic analysis from its 2016 deeming rule and failed to consider less burdensome alternatives. The court rejected those claims, holding that the 2016 assessment provided an adequate factual basis and that key requirements — such as submitting all known health-risk information — are mandated by the Tobacco Control Act and cannot be waived by regulation. The decision leaves the 2021 PMTA rule intact in Kealani Distribution LLC et al. v. FDA.