Kealani Distribution v. FDA: Affirming the Final PMTA Rule

This episode details a ruling from the Fifth Circuit Court of Appeals that upholds the FDA’s regulatory framework for electronic nicotine delivery systems. Several small-business manufacturers challenged the Final PMTA Rule, arguing that the agency failed to properly assess the economic burden on minor entities as required by the Regulatory Flexibility Act. The court determined that the FDA acted reasonably by attributing major compliance costs to a previous 2016 mandate rather than the newer procedural updates. Furthermore, the judges found that the agency appropriately considered regulatory alternatives while maintaining strict statutory requirements for public health protection. Ultimately, the court affirmed the lower court's decision, confirming that the FDA met its procedural obligations in regulating the vapor industry.