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FDA v. Wages and White Lion Investments, LLC | Date Decided: 4/2/25 | Case No. 23-1038
The question presented in this case is: Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious.
The Supreme Court held: The Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in its adjudication of manufacturers’ premarket tobacco product applications is vacated because the FDA’s denial orders were sufficiently consistent with its predecisional guidance—as to scientific evidence, comparative efficacy, and device type—and thus did not run afoul of the change-in-position doctrine.
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By SCOTUS Oral ArgumentsThe question presented in this case is: Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious.
The Supreme Court held: The Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in its adjudication of manufacturers’ premarket tobacco product applications is vacated because the FDA’s denial orders were sufficiently consistent with its predecisional guidance—as to scientific evidence, comparative efficacy, and device type—and thus did not run afoul of the change-in-position doctrine.