A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit on Friday ruled 3-0 to deny Lotus Vaping Technologies’ petition for review of a marketing denial order (MDO) for its flavored e-liquid products. The company could now ask for an en banc rehearing with all Ninth Circuit judges
The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.
The panel held that the text of the Family Smoking Prevention and Tobacco Control Act (TCA) authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids, the judges wrote in the denial that is not considered an opinion.
The panel also held that the FDA did not arbitrarily or capriciously deny Lotuss’ applications and that “any error the agency committed by failing to comparisons of flavored e-liquids to tobacco-flavored e-liquids.” The panel also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless