FDA v. Wages and White Lion Investments, LLC (Administrative Law)

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In FDA v. Wages and White Lion Investments, the Supreme Court unanimously vacated a Fifth Circuit decision that found the Food and Drug Administration acted arbitrarily and capriciously when it denied authorization for flavored e-cigarette products. Under the Tobacco Control Act of 2009, manufacturers must receive FDA approval before marketing “new tobacco products,” including most modern e-cigarettes. The Act permits approval only if the product is “appropriate for the protection of the public health,” requiring the FDA to weigh population-wide risks and benefits, including youth usage.

Respondents, manufacturers of flavored e-liquids, submitted premarket applications but failed to provide robust scientific evidence—such as randomized controlled trials or longitudinal studies—showing their products posed fewer risks than tobacco-flavored alternatives. The FDA denied their applications. The Fifth Circuit, sitting en banc, held the FDA improperly departed from its own guidance and failed to consider the applicants’ marketing plans, which had been labeled “critical.”

Justice Alito, writing for a unanimous Court, rejected the Fifth Circuit’s findings. The Court held that the FDA’s denials were consistent with its guidance and did not violate the change-in-position doctrine. The FDA had made clear that strong scientific evidence would be necessary and that fruit- and dessert-flavored products were likely to appeal to youth. The Court also found that the Fifth Circuit misread Calcutt v. FDIC in concluding that the FDA’s failure to review the marketing plans required automatic remand. Instead, the harmless-error rule applies in administrative cases, and remand is not always necessary. The case was remanded for further consideration under the correct standard.

Justice Sotomayor filed a concurring opinion.