Supreme Court Decision Syllabus (scotus)

Send us a textIn 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 consid