Facts of the Case

Provided by Oyez

These cases arise from the Food and Drug Administration’s (FDA) denial of R.J. Reynolds Vapor Co.’s applications to market various e-cigarettes, including menthol- and berry-flavored “Alto” e-cigarettes. R.J. Reynolds, along with retail entities like Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association, challenged this denial in the U.S. Court of Appeals for the Fifth Circuit.

The FDA filed a Motion to Dismiss or Transfer, arguing that the petitioners do not meet the venue requirements set forth in the Family Smoking Prevention and Tobacco Control Act for filing their petition in the Fifth Circuit. The case was consolidated with previous related cases, and the court had previously ruled that venue was proper in the Fifth Circuit in a related matter. In the present matter, the Fifth Circuit stood by its prior decision that venue was proper.

Questions

  1. May a manufacturer file a petition for review in a circuit where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer’s products that is located within that circuit?

Conclusions

  1. 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.