FDA

Majority — Barrett

Joined by: Roberts, Thomas, Alito, Kagan, Gorsuch, Kavanaugh

The majority held that the phrase "any person adversely affected" in the Tobacco Control Act carries the same broad meaning it has across federal administrative law, including under the Administrative Procedure Act (APA — the general law that allows people to challenge federal agency decisions in court). The Court reasoned that in prior cases involving the Fair Housing Act, Title VII, and the Longshore and Harbor Workers' Compensation Act, it had consistently borrowed the APA's broad "zone of interests" standard — meaning a plaintiff can sue if their interests are at least arguably within what the statute was meant to protect — when interpreting similar "adversely affected" language in other statutes. Applying that standard here, the Court found that retailers clearly qualify: when the FDA denies a marketing application, retailers lose the opportunity to profit from selling the product, and if they sell it anyway they face criminal penalties. The majority also pointed to the statute's own text, noting that Congress used the word "any" before "person adversely affected," which signals that more than one type of person can be harmed by a denial order; and that elsewhere in the same law Congress used the narrower phrase "holder of the application" when it wanted to limit a cause of action to manufacturers alone, showing Congress knew how to write a narrow cause of action when it wanted to.

Dissent reasoning

The dissent argued that the majority focused almost entirely on the broad language of the cause-of-action provision itself, which is precisely the kind of literal reading that the zone-of-interests test was designed to prevent. In the dissent's view, the proper inquiry requires looking at the specific statutory provision the plaintiffs claim was violated — here, the section of the Tobacco Control Act governing the FDA's review of marketing applications — and that provision reveals a scheme designed exclusively for manufacturers, with no role, no rights, and no notice for retailers at any stage of the process. The dissent contended that the withdrawal provision — which explicitly limits challenges to the "holder of the application" — is the most telling piece of evidence: if retailers cannot challenge the FDA's decision to take away an already-granted approval (when they may have already stocked shelves and invested in the product), it makes no sense to say Congress intended to let them challenge an initial denial (when they have no investment at all). The dissent also drew a parallel to Block v. Community Nutrition Institute, where the Court held that milk consumers could not challenge milk pricing orders because they had no role in the administrative process that produced those orders — just as retailers here had no role in the manufacturer's application process. Finally, the dissent raised a practical concern: the retailers' participation in this lawsuit appeared designed to allow the manufacturer, RJR Vapor, to file its challenge in the Fifth Circuit after the D.C. Circuit and Fourth Circuit had already ruled against similar manufacturers, effectively using retailers as a vehicle to reach a more favorable venue.