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In another win for ALF's top-ranked Amicus Program, the Supreme Court's June 20 opinion in Food and Drug Administration v. R. J. Reynolds Vapor Co. (23-1187) reaffirms that statutory provisions affording a right of judicial review to "any person adversely affected" (or "aggrieved") by a final agency action should be construed broadly. This is an important precedent for companies that are affected by, and wish to challenge, final decisions or actions by federal regulatory agencies.
The case involved a challenge to FDA's denial of the application of R. J. Reynolds Vapor Co. ("RJR Vapor") for authorization to continue marketing Vuse "Alto" e-cigarettes, which contain nicotine and FDA regulates as a "new tobacco product" under the Family Smoking Prevention and Tobacco Control Act (“TCA”). The TCA states that “any person adversely affected by such . . . denial may file a petition for judicial review of such . . . denial." 21 U.S.C. § 387l(a)(1). RJR Vapor, along with a Texas retailer of Vuse e-cigarettes and a Mississippi-based gasoline station/convenience store assocation, jointly filed a judicial review petition in the U.S. Court of Appeals for the Fifth Circuit challenging FDA’s marketing authorization denial.
FDA sought to block the Fifth Circuit from hearing the appeal, arguing in part that the retailers are not “adversely affected” by, and thus lack statutory standing (as distinct from Article III constitutional standing) to challenge, FDA's marketing denial. A divided Fifth Circuit panel held that the retailers, as well as RJR Vapor, have "statutory standing to challenge FDA decisions that affect them."
FDA appealed to the Supreme Court. ALF filed an amicus brief on the merits, arguing that the TCA judicial review provision at issue should be broadly construed because it entitles “any person adversely affected” by an FDA marketing denial to seek judicial review (emphasis added).
The Supreme Court agreed. Its 7 to 2 opinion, authored by Justice Barrett, explains that "[w]e have interpreted 'adversely affected' broadly, as covering anyone even 'arguably within the zone of interests to be protected or regulated by the statute . . . in question.'" The opinion further indicates that this broad interpretation applies to statute-specific judicial review provisions (such as in the TCA) as well as to the federal Administrative Procedure Act (APA). Rejecting FDA's argument that only the applicant (i.e., RJR Vapor) has statutory standing to challenge an FDA denial, the Court observed that "Congress’s use of 'any' suggests that a denial order can adversely affect multiple persons." It would be an "oddity" for the phrase "any person adversely affected to describe a cause of action that only one person—the applicant manufacturer—could use."
As ALF discussed in its amicus brief, maintaining a broad interpretation of "any person adversely affected" is important since numerous federal regulatory statutes, as well as the APA, afford a right of judicial review to any person adversely affected or aggrieved by a final agency action.
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