FDA faces legal setback over flavored e-cigarette reviews

A federal appeals court has issued a significant ruling against the Food and Drug Administration (FDA) regarding its oversight of flavored e-cigarette applications. The U.S. Court of Appeals for the Fifth Circuit ruled that the agency unlawfully applied a comparative-efficacy standard to reject flavored electronic nicotine delivery system (ENDS) products without following the required public notice-and-comment process mandated by the Administrative Procedure Act.

The court vacated marketing denial orders and sent the cases back to the agency. While the ruling does not force the FDA to authorize specific products or strip it of its authority to weigh the risks to youth against benefits for adult smokers, it challenges the procedural method used to establish the evidentiary standard. The court noted that the FDA has issued marketing denial orders for over 1.2 million flavored ENDS products, suggesting the standard functioned as a generally applicable rule rather than an individualized scientific review.