“Any Person Adversely Affected” Means What It Says:
FDA v. R. J. Reynolds Vapor Co. (2025) and the Expansion of Statutory Standing Under the Tobacco Control Act

1. Introduction

The United States Supreme Court’s decision in Food & Drug Administration v. R. J. Reynolds Vapor Co., 606 U.S. ___ (2025), resolves a deceptively simple yet deeply consequential question: Who may seek judicial review when the Food and Drug Administration (FDA) denies an application to market a new tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009 (“TCA”)?

After the FDA rejected R. J. Reynolds Vapor Company’s (“RJR Vapor”) applications to sell flavored Vuse Alto e-cigarettes, the manufacturer strategically joined forces with two downstream businesses—a Texas storefront (Avail Vapor Texas, LLC) and a Mississippi trade association—to file a single petition in the U.S. Court of Appeals for the Fifth Circuit. The FDA moved to dismiss or transfer, arguing that only the applicant manufacturer is “adversely affected” within the meaning of 21 U.S.C. § 387l(a)(1).

By a 7-2 majority (Justice Barrett writing; Justices Jackson and Sotomayor dissenting), the Supreme Court affirmed the Fifth Circuit: retailers who would lawfully sell a product but for the FDA’s denial fall within the statute’s zone of interests and may therefore sue. The case simultaneously clarifies statutory standing, refines venue strategy in multi-party petitions, and signals a renewed willingness to read “any person adversely affected” broadly across federal regulatory schemes.

2. Summary of the Judgment

• Holding. The phrase “any person adversely affected” in § 387l(a)(1) includes retailers harmed by the FDA’s denial of a manufacturer’s marketing application. Because at least one proper petitioner (the retailers) resides in the Fifth Circuit, venue was proper and the FDA’s motion to dismiss/transfer was correctly denied.
• Vote. 7-2. Opinion by Justice Barrett (joined by Roberts, Thomas, Alito, Kagan, Gorsuch, Kavanaugh). Dissent by Justice Jackson (joined by Sotomayor).
• Key Doctrinal Move. The Court imports the Administrative Procedure Act’s (APA) “arguably within the zone of interests” test to non-APA causes of action containing the words “adversely affected,” unless Congress clearly says otherwise.
• Issues Left Open. Whether every petitioner in a joint petition must independently satisfy venue was raised too late by FDA; question reserved for future litigation.

3. Analysis

3.1 Precedents Cited and Their Influence

The Court leaned heavily on prior statutory-standing cases that construed similar language:

• Association of Data Processing Service Orgs. v. Camp, 397 U.S. 150 (1970) – coined the modern “zone of interests” test.
• Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U.S. 118 (2014) – clarified that “zone of interests” is a matter of statutory interpretation, not “prudential” standing.
• Bank of America Corp. v. Miami, 581 U.S. 189 (2017) – applied the “arguably within” standard to the Fair Housing Act’s “aggrieved person.”
• Thompson v. North American Stainless, LP, 562 U.S. 170 (2011) – read Title VII’s “person claiming to be aggrieved” broadly.
• Director, OWCP v. Newport News Shipbuilding, 514 U.S. 122 (1995) – acknowledged the decades-long lineage of “adversely affected or aggrieved.”
• Distinguished: Block v. Community Nutrition Institute, 467 U.S. 340 (1984) (explicit statutory design limited review), Bennett v. Spear, 520 U.S. 154 (1997) (different wording), among others.

The majority synthesized these cases to announce a presumption: where Congress employs “adversely affected” (or variants), courts should presume the broader APA meaning unless contradicted by clear contextual evidence.

3.2 The Court’s Legal Reasoning

1. Text. “Any person” is linguistically expansive; pairing it with “adversely affected” signals multiple potential plaintiffs. Congress used narrower wording (“holder of the application”) elsewhere in the TCA (withdrawal proceedings), proving it knew how to cabin review when it wished.
2. History of the Term. Across dozens of statutes, “adversely affected” consistently triggers Data Processing’s liberal test. The Court declines the FDA’s invitation to distinguish between APA and non-APA contexts.
3. Statutory Structure. Section 387j (application mechanics) may focus on manufacturers, but § 387l(a)(1) is a separate remedial provision. Reading the latter to embrace only the applicant would effectively rewrite “person” to “applicant.”
4. Practical Effect on Retailers. Denial of the application deprives retailers of lawful sales and exposes them to criminal penalties if they proceed anyway; that economic and legal harm is direct, not collateral.
5. Venue. Because at least one proper petitioner had its principal place of business in the Fifth Circuit, the joint petition satisfied venue. The Court refused to entertain the FDA’s late-raised argument that every petitioner must individually qualify.

3.3 Impact on Future Litigation and Regulatory Practice

• Broader Applicant Pool. Downstream businesses—wholesalers, retailers, perhaps even consumers’ associations—will likely seek review of FDA denial orders, expanding the universe of challengers.
• Forum Shopping. By anchoring venue in any petitioner’s residence, the decision facilitates strategic coalition-building to reach favorable circuits. Expect agencies to seek early rulings on whether each petitioner must establish venue.
• Trans-Statutory Ripple. Other regulatory schemes using “adversely affected” (e.g., environmental, transportation, banking) may now see an uptick in suits by indirect market participants.
• Agency Rule-Making Sensitivity. Knowing that downstream entities can sue, FDA and peer agencies may craft records and confidentiality processes more defensively, anticipating retailer-driven litigation.
• Legislative Response. If Congress perceives over-liberal review, it may tighten standing language for specific programs (e.g., by mimicking the TCA’s “holder of the application” limitation for withdrawals).

4. Complex Concepts Simplified

• Zone of Interests. Think of a statute as creating a protected neighborhood. Only those whose homes are inside that neighborhood gate can sue to protect it. The Court says retailers’ “homes” are indeed within the TCA’s neighborhood.
• Premarket Tobacco Application (PMTA). A detailed packet a manufacturer must file to prove its new product benefits—or at least does not harm—public health compared to existing tobacco goods.
• Statutory Standing vs. Article III Standing. Article III asks: “Is there a real injury?” Statutory standing (zone-of-interests) asks: “Did Congress want this injured person to sue under this law?”
• Venue. The geographical court location where a case may be filed. The TCA lets a petitioner sue either in D.C. Circuit (default) or the circuit where the petitioner resides.
• Slip Opinion. The preliminary version of a Supreme Court opinion, later subject to typographical corrections before official publication in U.S. Reports.

5. Conclusion

FDA v. R. J. Reynolds Vapor Co. is more than a skirmish over e-cigarettes. It marks a significant doctrinal statement that when Congress uses the capacious phrase “any person adversely affected,” courts should default to the APA’s broad zone-of-interests approach, thereby welcoming suits from a wider array of stakeholders—even those absent from the primary regulatory dialogue.

Practically, agencies must prepare for litigation brought by entities once presumed outside the courthouse door; litigants will experiment with coalition petitions to reach sympathetic venues; and Congress may recalibrate standing language if it deems the courthouse too crowded. The majority’s message is simple yet far-reaching: words matter, and “any person” really does mean any person—at least until Congress says otherwise.