Food and Drug Administration v. R.J. Reynolds Vapor Co.

The Tobacco Control Act’s provision that “any person adversely affected” by the FDA’s denial of a marketing application may seek judicial review extends to retailers who would sell the new tobacco product, not just the manufacturers who applied for approval. Justice Amy Coney Barrett authored the 7-2 majority opinion of the Court. The phrase “adversely affected” is a term of art in administrative law that the Court has consistently interpreted broadly. When Congress uses variations of this phrase across different statutes, the Court presumes it carries the same meaning as in the Administrative Procedure Act—covering anyone “arguably within the zone of interests to be protected or regulated by the statute.” Congress reinforced this broad interpretation by using “any person” rather than limiting review to “the applicant.” The Court’s precedents from other contexts, including employment discrimination and fair housing cases, confirm that “adversely affected” encompasses more than just the direct recipient of agency action. Retailers face a direct, significant impact from denial orders because they lose the opportunity to profit from selling the product and face criminal penalties if they sell it without authorization. The statutory structure confirms Congress intended different scopes for different provisions. While the Act limits challenges to withdrawal of existing approvals to only “the holder of [the] application,” it uses the broader “any person adversely affected” language for initial denials. This deliberate use of materially different terms creates a presumption that Congress intended different meanings. The FDA’s arguments focusing on the application process and confidentiality provisions cannot override the plain language Congress chose for the judicial review provision. Justice Ketanji Brown Jackson authored a dissenting opinion, joined by Justice Sonia Sotomayor, arguing that retailers fall outside the statute’s zone of interests because the premarket approval scheme involves only manufacturers and the FDA, with no mechanism for retailer participation.