Food and Drug Administration v. R.J. Reynolds Vapor Co.

The U.S. Supreme Court resolved a critical challenge to the Food and Drug Administration’s authority over e-cigarettes. The FDA had denied R.J. Reynolds Vapor Company’s premarket applications to sell flavored vaping products, finding that the company failed to demonstrate the products were appropriate for the protection of public health. Reynolds argued the agency acted arbitrarily and capriciously by disregarding its detailed marketing plans designed to limit youth access. The Fifth Circuit Court of Appeals sided with Reynolds, vacating the denial orders. On June 20, 2025, the Supreme Court reversed the lower court, holding that the FDA reasonably assessed the scientific evidence and the predictable behavioral impacts on youth, and that the agency was not required to accept marketing restrictions as a cure-all. The ruling reinforced the FDA’s gatekeeping role in tobacco product authorization.

The Supreme Court, in a decision authored by Chief Justice John Roberts, reversed the judgment of the U.S. Court of Appeals for the Fifth Circuit. The Court ruled 9-0 that the FDA’s denial orders were not arbitrary and capricious. It held that the agency had properly considered the relevant factors, including the significant risk of youth appeal from flavored products, and had provided a reasoned explanation for its decision.

Whether the FDA acted arbitrarily and capriciously, in violation of the Administrative Procedure Act, when it denied R.J. Reynolds’ applications to market flavored e-cigarettes without specifically quantifying the weight given to the company’s proposed youth-access prevention marketing plans.

The decision substantially strengthened the FDA’s ability to block the sale of flavored e-cigarettes, aligning with public health advocacy goals to curb a youth vaping epidemic. Vaping manufacturers face a much narrower path to gain marketing authorization, likely accelerating the decline of disposable and cartridge-based flavored products. The ruling also clarified the deference courts must give to agency scientific judgments on public health risks, setting a precedent that limits judicial second-guessing of technical FDA assessments.