A recent U.S. Supreme Court opinion in favor of the Food and Drug Administration in an e-cigarette case has implications for drugs and other medical products regulated by the agency, according to a Pink Sheet article by McGuireWoods’ Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody and Allyson Maur.
In FDA v. Wages and White Lion Investments, the high court unanimously reversed a ruling by the U.S. Court of Appeals for the Fifth Circuit that the FDA unlawfully issued denial orders to two vape manufacturers looking to sell new flavored products in the U.S. market. The court’s ruling indicates a deferential approach to the FDA’s expertise on scientific and regulatory issues, the authors wrote in the May 19, 2025, article. “The Wages decision impacts mostly small- to medium-sized vape manufacturers, as well as other companies bringing new FDA-regulated products to market,” the authors wrote. “The decision is critical for the e-cigarette and vaping industry because it reinforces the FDA’s power to regulate the industry without guardrails. For other regulated products, Wages is a sign of an increasingly complex administrative landscape, especially for introducing new products into the marketplace. It can be harder for applicants to discern patterns and make predictions with changing guidance