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 FDA’s Premarket Tobacco Product Application (PMTA) marketing denial orders (MDOs) for each manufacturer petitioner’s electronic nicotine delivery system (ENDS) products, and remanding the PMTAs back to the agency for
Keller and Heckman Partner Eric Gotting was interviewed on the recent episode of Regulator Watch (RegWatch), “Major Win | Court Ruling Could Dismantle FDA’s Flavored Vape Ban.” The episode discusses the recent Fifth Circuit ruling that FDA violated the Administrative Procedure Act when it imposed its comparative-efficacy standard without notice-and-comment rulemaking.
To watch the full
