01/09/2024
"The decision concluded that FDA changed the evidentiary standards and wholly ignored the Companies’ marketing plans, which were previously characterized by the Agency as “critical.” In doing so, the Court found FDA’s denials of petitioners’ PMTAs to be arbitrary and capricious.This case is highly significant for FDA and the entire regulated va**ng industry. After all, a more pronounced circuit split over the FDA’s handling of va**ng product applications furthers the possibility of a Supreme Court review. This is coupled with the fact that, in this momentous decision, the Fifth Circuit characterizes FDA’s denial of all PMTAs for non-tobacco flavored ENDS products as a de facto flavor ban that circumvents the required notice-and-comment rulemaking process:
Never in this long, winding, and byzantine regulatory process of meetings, PowerPoint decks, proposed rules, comment periods, guidance documents, and enforcement priorities did FDA ever say that it was contemplating an across-the-board ban on flavored products.
This decision will undoubtedly impact the industry and the future regulation and marketing of ni****ne ENDS products in the U.S. "
In a long-anticipated decision, the U.S. Court of Appeals for the Fifth Circuit ruled against FDA on January 3, 2024, criticizing the Agency for its
