5th Circuit Says FDA’s Vape Application Rule Violated APA

( September 4, 2026, 7:51 AM EDT) -- NEW ORLEANS — A Fifth Circuit U.S. Court of Appeals panel granted several electronic nicotine delivery systems (ENDS) companies’ consolidated petitions for review, vacated the Food and Drug Administration’s marketing denial orders (MDOs) banning sales of their products in the United States and remanded the cases after finding that the FDA violated the Administrative Procedure Act (APA) by adopting a substantive “comparative efficacy” rule without notice-and-comment rulemaking....