The question
Whether retailers who would sell a new tobacco product but for the FDA's denial order fall within the class of persons "adversely affected" who may seek judicial review of that order under 21 U.S.C. § 387l(a)(1).
FDA v. R. J. Reynolds Vapor Co.
What the Court decided
Retailers who would sell a new tobacco product if not for the FDA's denial order may seek judicial review of that order under 21 U.S.C. § 387l(a)(1). The Court held that "adversely affected" is a term of art that it reads broadly, covering anyone arguably within the zone of interests the statute protects, and that the FDA's narrower reading limiting review to the applicant does not hold. The Court rejected the FDA's argument that the broad zone-of-interests standard is unique to the Administrative Procedure Act.
How the justices split
7-2The Court's opinion
Barrett, joined by Roberts, Thomas, Alito, Kagan, Gorsuch, Kavanaugh
The opinion held that retailers who would sell a new tobacco product but for the FDA's denial order may seek judicial review under § 387l(a)(1). It reasoned that a plaintiff invoking a statutory cause of action must fall within the zone of interests the statute protects, and that 'adversely affected' is a term of art with a long history in federal administrative law that the Court reads broadly to cover anyone arguably within the statute's zone of interests. It rejected the FDA's position that the broad zone-of-interests standard is unique to the APA and that only the applicant is aggrieved, noting the Court has borrowed the APA formulation when interpreting variations of 'adversely affected or aggrieved' in other statutes.
Dissenting
Jackson, joined by Sotomayor
The dissent disagreed with the majority's conclusion that retailers may seek judicial review of the FDA's denial order under § 387l(a)(1).
How we know · 5 sourced claims
The Court held that retailers who would sell a new tobacco product if not for the FDA's denial order may seek judicial review of that order under 21 U.S.C. § 387l(a)(1).
Source: syllabus, Held
The TCA permits 'any person adversely affected' by an FDA denial order to petition for judicial review, and the Court read 'adversely affected' as a term of art covering anyone arguably within the statute's zone of interests.
Source: syllabus, Held
The Court rejected the FDA's argument that the broad zone-of-interests understanding is unique to the Administrative Procedure Act and that only the applicant is actually aggrieved by a denial.
Source: syllabus, Held
Justice Barrett delivered the opinion of the Court, joined by Roberts, Thomas, Alito, Kagan, Gorsuch, and Kavanaugh.
Source: syllabus, lineup
Justice Jackson filed a dissenting opinion, joined by Justice Sotomayor.
Source: syllabus, lineup