Fontem US, LLC v. FDA, No. 22-1076 (D.C. Cir. 2023)
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After the FDA promulgated regulations applying the Act to vaping products, Fontem US, LLC, submitted numerous applications to market its flavored and unflavored vaping products. The FDA denied all of them, concluding Fontem had not shown its products were “appropriate for the protection of the public health.” Fontem petitioned for review, arguing the denial was unlawful.
The DC Circuit denied the petition for review as to Fontem’s flavored products and granted the petition for review with respect to the unflavored products. The court explained that as to Fontem’s flavored products, the FDA reasonably found a lack of evidence that the benefits of such products to adult smokers sufficiently outweighed the potential risks to young non-smokers. The court wrote that as to Fontem’s unflavored products, however, the FDA acted unlawfully by failing to engage in the holistic public health analysis required by the statute. The court concluded that the agency did not take into account the potential benefits of unflavored products or weigh those benefits against risks to public health. Instead, the agency identified highly granular deficiencies but failed to evaluate the potential effects of such deficiencies on public health or to weigh these deficiencies against the potential benefits of Fontem’s products.
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