Kealani Distribution v. FDA - Tobacco Control Act Rule Challenge

The Fifth Circuit Court of Appeals affirmed the FDA's Final PMTA Rule, finding that the agency complied with the Regulatory Flexibility Act (RFA). The lawsuit was brought by small-business manufacturers of e-liquids and a trade association, who argued that the FDA's certification that the rule would not have a significant economic impact on small entities was arbitrary and capricious. The court's decision upholds the FDA's regulatory authority over new tobacco products not commercially marketed before February 15, 2007, requiring premarket authorization.

This ruling means that the requirements of the Final PMTA Rule remain in effect, impacting small-business manufacturers and retailers of vapor products. While the court found no violation of the RFA, regulated entities should ensure their compliance with the FDA's premarket application process for new tobacco products. The decision reinforces the FDA's comprehensive scheme for tobacco product regulation established by the Tobacco Control Act.