July 3, 2025
Food and Drug Administration v. R.J. Reynolds Vapor Co., 605 U.S. ____ (2025) (Barrett, J.)
Response by Richard J. Pierce, Jr.
Geo. Wash. L. Rev. On the Docket (Oct. Term 2024)
Slip Opinion | SCOTUSblog
Food and Drug Administration v. R.J. Reynolds: A Standing Decision that is a Major Victory for Corporate Forum Shopping
In Food and Drug Administration v. R.J. Reynolds, 605 U.S. ___ (June 20, 2025), a seven-Justice majority held that retailers have standing to obtain review of any agency action that has an adverse effect on any product or service that the retailers sell or want to sell. The majority opinion is an important addition to the large and difficult-to-understand body of law that governs standing. Its primary effect, however, is to enable most firms that produce products or services to engage in unlimited forum shopping.
The Family Prevention and Tobacco Control Act (“TCA”) requires any manufacturer to apply for and receive approval from the Food and Drug Administration (“FDA”) before it can market any “new tobacco product.” The FDA has taken many actions under the TCA recently. It has received and refused to approve applications to market 6.5 million flavored e-cigarettes in the past five years.1 This case was initiated by a petition to review one of those FDA decisions.
After the FDA issued a final decision in which it denied Reynolds’s application to market a flavored e-cigarette, Reynolds and a trade association—consisting of retailers that sell other Reynolds products and would have sold the new product if FDA had approved Reynolds’s application—filed petitions for review of the FDA decision in the Fifth Circuit. The FDA moved to dismiss the petitions on the basis that the Fifth Circuit had no jurisdiction to consider the petition because the retailers lacked standing to obtain review of the FDA decision.
The TCA provides that “any person adversely affected” by denial of an application to market a new tobacco product may petition for review in either the D.C. Circuit or “the circuit in which such person resides or has their principal place of business.”2 Reynolds has its principal place of business in North Carolina, so it could have filed a petition for review in either the D.C. Circuit or the Fourth Circuit. It did not want to litigate the issue in either of those circuits, however, because both have a well-deserved reputation for being receptive to arguments made by regulatory agencies. Reynolds wanted to litigate the issue in the Fifth Circuit, because it has a well-deserved reputation for being hostile to regulatory agencies.3 Moreover, the D.C. Circuit and the Fourth Circuit had already upheld FDA decisions refusing to grant applications to market flavored e-cigarettes,4 while the en banc Fifth Circuit had already reversed such a decision.5
There was no doubt that Reynolds, as the manufacturer of the product, had standing to obtain review of the action denying its application to market the product. However, there was no clear precedent governing the standing of a retailer to obtain review of an agency action that denies an application to market a product that the retailer would have sold if the application had been approved. The question before the Court was whether such a retailer is “adversely affected” by such an action.
The majority answered that question by describing and applying a body of law that the Court has often characterized as the “zone of interest test.” That legal doctrine has a rich and complicated history. I devote twenty-three pages to discussion of the relevant case law in my Treatise.6 The majority devotes five pages to an accurate description of that body of law and four pages to an application of the zone of interest test to the facts of the case.7
The majority begins by tracing the roots of the test to its 1970 decision in Association of Data Processing Service Organizations v. Camp.8 In that case, the Court interpreted the Administrative Procedure Act (“APA”). The APA provides that anyone who is “adversely affected or aggrieved by agency action within the meaning of a relevant statute [can obtain] judicial review” of the action.9 The “relevant statute” is the statute that authorizes the agency to take the action that is the subject of the review petition.
The Court has long interpreted the “adversely affected” language of the APA to allow review at the behest of anyone who is “arguably” within the zone of interests to be regulated or protected by the relevant statute.10 The Court has often said that this test is “not especially demanding”11 and that review is available to anyone with interests in the outcome of the case unless those “interests are so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress authorized that plaintiff to sue.”12
The FDA argued that the zone of interests test did not apply because the test was based on the APA while the petitions for review filed in the case were based on the TCA. The majority rejected that argument by referring to the long line of cases in which it applied the permissive zone of interests test to many other statutes that used the “adversely affected” language in the APA.13 The Court then held that the association of retailers easily satisfied the zone of interests test because the retailers were adversely affected economically by the FDA decision not to grant Reynolds’s application to market a product that they would have sold if FDA had granted the application.
Justice Jackson filed a dissenting opinion in which Justice Sotomayor joined. She began her discussion with this sentence: “The actual zone-of-interest inquiry, however, requires us to examine exactly whom Congress intended to protect under the relevant statutory provisions.” That is not an accurate description of the test. As I discuss in my Treatise, the Court applied the test in that manner in only one case in 1991.14 The Court rejected that approach in subsequent cases and has since consistently applied the test in the highly permissive way that the majority describes.15
Justice Jackson argues that the majority opinion is inconsistent with the Court’s holding and reasoning in Block v. Community Nutrition Institute.16 But that argument is based on a misunderstanding of the Block opinion. In Block, the Court held that consumers do not have standing to obtain review of a decision of the Secretary of Agriculture under the Agricultural Marketing Agreement Act.17 The Court described the highly permissive zone of interests test and the powerful presumption of reviewability. It went on, however, to conclude that the structure, language, and purpose of the statute rebutted the presumption of reviewability and indicated a congressional intent to preclude review by consumers.18
The purpose of the Agricultural Marketing Agreement Act is to ensure that milk producers receive adequate compensation for the milk that they produce. Allowing consumers to obtain review of orders issued by the Secretary of Agriculture would be inconsistent with the congressional intent to benefit milk producers. The Court has long interpreted the Block decision as being consistent with a permissive version of the zone of interests test subject only to a narrow exception applicable in the rare case of a statute in which Congress clearly indicates that some types of parties should not have standing to obtain review of actions that adversely affect them.19
Justice Jackson’s opinion strongly suggests that she has two broad concerns about the majority opinion. She is concerned about inconsistency in the Court’s standing decisions, and she is concerned about the increased opportunity for forum shopping that the holding creates.20 I am sympathetic to both of her concerns, but I still think the majority used the right reasoning process and got the right answer in the case.
I have long complained that the Supreme Court’s standing decisions are incoherent and inconsistent.21 The permissive version of the zone of interests test is not symptomatic of that problem, however. With the exception of one case decided over thirty years ago, the Court has applied it consistently and with good results for over fifty years.22
I also share Justice Jackson’s concern about forum shopping, but that concern is entirely attributable to the extreme political polarity in the judiciary at present. If you take away that phenomenon, it is good for our legal system to allow different circuits to address an issue so that the Supreme Court will have the benefit of a wide range of views expressed by many judges by the time it addresses an issue. I am not confident that I know how to solve the problem of extreme political polarity, but I know that it cannot be addressed effectively by changing the law of standing.
Richard J. Pierce, Jr. is the Lyle T. Alverson Professor of Law at The George Washington University Law School. He is the author of over twenty books and 130 articles on administrative law, government regulation, and the effects of various forms of government intervention on the performance of markets. His books and articles have been cited in hundreds of judicial opinions, including over a dozen opinions of the U.S. Supreme Court.
Recommended Citation
Richard J. Pierce, Jr., FDA v. R.J. Reynolds Vapor Co., Geo. Wash. L. Rev. On the Docket (July 3, 2025), https://www.gwlr.org/fda-v-rj-reynolds-major-victory-for-corporate-forum-shopping
