11th Circuit Orders 2nd Shot At PMTAs For 6 Flavored Vape Companies

Mealey's (September 1, 2022, 1:15 PM EDT) -- MIAMI — A split 11th Circuit U.S. Court of Appeals panel on Aug. 23 set aside the Food and Drug Administration’s marketing denial orders (MDOs) to six flavored vape companies after finding that it arbitrarily and capriciously denied their premarket tobacco applications (PMTAs) without considering plans to limit youth access to their products, while a dissenting judge predicted that on remand the companies will again receive MDOs....