US Sup.Ct. Slip Op. of June 20, 2025
Ruling: When the federal Food and Drug Administration (the “FDA”) denies an application for legal authorization to sell a new kind of e-cigarette to consumers, a retail merchant who did not file the application but who wants to lawfully sell that kind of e-cigarette to his customers, is nevertheless a “person adversely affected” by the FDA’s denial of someone else’s application under 21 U.S.C. §387l(a)(1)(B). Accordingly, that statute authorizes such a retailer to demand judicial review of the FDA’s denial from the federal Court of Appeals that covers his or her home territory, regardless of where the home territory of the applicant may be located.
The vote on the Court for this ruling was 7-2, with Justices Jackson and Sotomayor arguing in dissent that the broader context of 21 U.S.C. §3871l points to the actual applicant for the FDA’s authorization as the only “person adversely affected” by the FDA’s denial.
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