Supreme Court Upholds FDA’s Denial of Marketing Authorization for Flavored Tobacco Products

On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS), otherwise known as e-cigarettes or “vapes.” The Court vacated and remanded the Fifth Circuit’s decision that FDA had acted arbitrarily and capriciously under the Administrative Procedure Act (APA) by issuing marketing denial orders (MDOs) to the respondents for their premarket tobacco product applications (PMTAs).