Overview
(U.S. Court of Appeals for the 3rd Circuit, October 19, 2023): The Third Circuit Court of Appeals found that the Food and Drug Administration (FDA) did not violate the Administrative Procedures Act (APA) and did not act arbitrarily or capriciously in rejecting a vape manufacturer’s Pre-Market Tobacco Product Application for a menthol-flavored vape product. Logic Technology alleged that the FDA violated the APA and acted arbitrarily and capriciously by applying the same standard to menthol products as applied to candy and fruit flavored products; establishing a rule against authorization of menthol vapes through informal decision rather than the formal rulemaking process; and not giving the manufacturer a post-denial transition period to wind down sales of the denied products. Rejecting each argument, the Court found that the FDA properly applied a regulatory decision-making framework that was consistent with the Family Smoking Prevention and Tobacco Control Act and provided a reasoned explanation for the denial. The Court explained that the FDA made scientific judgments in decision making and that the Court would not second guess those determinations. Read the full Opinion here.
View all cases in the Judicial Trends in Public Health – November 20, 2023.