FOOD AND DRUG ADMINISTRATION ET AL. v. R. J. REYNOLDS VAPOR CO. ET AL.
No. 23–1187
SUPREME COURT OF THE UNITED STATES
Argued January 21, 2025—Decided June 20, 2025
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
The Family Smoking Prevention and Tobacco Control Act (TCA) requires manufacturers to apply for and receive approval from the Food and Drug Administration (FDA) before marketing any “new tobacco product.”
The TCA provides that “any person adversely affected” by an FDA denial order can petition for judicial review in either the D. C. Circuit or “the circuit in which such person resides or has their principal place of business.”
Held: Retailers who would sell a new tobacco product if not for the FDA’s denial order may seek judicial review of that order under
(a) To invoke a statutory cause of action, a plaintiff must be within the “zone of interests” that the statute protects. Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U. S. 118, 129. That means a plaintiff must belong to the class of persons to which the statute grants a right to sue, which under the TCA is “any person adversely affected” by the FDA’s “denial.”
“Adversely affected” (and its variations like “adversely affected or aggrieved”) is a term of art with a “long history in federal administrative law.” Director, Office of Workers’ Compensation Programs v. Newport News Shipbuilding & Dry Dock Co., 514 U. S. 122, 126. Many statutes use the term, most notably the Administrative Procedure Act (APA), which entitles anyone “adversely affected or aggrieved by agency action within the meaning of a relevant statute . . . to judicial review.”
The FDA insists that the capacious understanding of “adversely affected” is unique to the APA, and that other statutes require a person to “actually”—not “arguably”—fall within the statute’s zone of interests. And, as the FDA sees it, under the TCA the only person actually aggrieved by the denial of permission to market a tobacco product is the one with the closest relationship to the application—the applicant.
The Court interprets “adversely affected” in the TCA against this backdrop. Echoing the APA, the TCA provides that “any person adversely affected by [the FDA’s] denial” may petition for judicial review.
(b) The FDA argues that the TCA’s text and structure reflect Congress’s choice to offer judicial review only to manufacturers denied permission to market a tobacco product. The FDA’s arguments, which focus almost entirely on
Even without the word “any,” the phrase “person adversely affected” suggests an intent to cover more than one party. If Congress intended to convey the FDA’s reading, it would more naturally have said “applicant.” And there is “no basis in text or prior practice” for limiting “person adversely affected” to mean “the applicant.” Cf. Thompson, 562 U. S. 170 (rejecting analogous argument that Title VII’s use of “person claiming to be aggrieved” refers to a single person). Congress knows how to limit the scope of a cause of action—in fact, it did so elsewhere in the TCA. When the FDA withdraws an existing approval of an application to market a new tobacco product, only the “holder of [the] application” may challenge the withdrawal order.
The retailers had the right to petition for review under the TCA, and the Fifth Circuit denied the FDA’s motion to dismiss or transfer because it correctly concluded that at least one proper petitioner had venue. Pp. 8–12.
(c) The FDA now argues that each petitioner in a joint petition for review must independently establish venue. The
Affirmed and remanded.
BARRETT, J., delivered the opinion of the Court, in which ROBERTS, C. J., and THOMAS, ALITO, KAGAN, GORSUCH, and KAVANAUGH, JJ., joined. JACKSON, J., filed a dissenting opinion, in which SOTOMAYOR, J., joined.
FOOD AND DRUG ADMINISTRATION, ET AL., PETITIONERS v. R. J. REYNOLDS VAPOR CO., ET AL.
No. 23–1187
SUPREME COURT OF THE UNITED STATES
June 20, 2025
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT
JUSTICE BARRETT delivered the opinion of the Court.
The Family Smoking Prevention and Tobacco Control Act (TCA) requires manufacturers to apply for and receive approval from the Food and Drug Administration (FDA) before marketing any “new tobacco product.”
I
When modern e-cigarettes made their American debut, the FDA did not treat them as “new tobacco products” for purposes of the TCA. See FDA v. Wages & White Lion Investments, LLC, 604 U. S. ___, ___–___ (2025) (slip op., at 6–9). They could therefore be sold without the FDA’s approval, and over the years, a large market developed. See ibid. But in 2016, the FDA changed direction: It announced that e-cigarettes and related products are subject to the TCA after all.
R. J. Reynolds Vapor Co. (RJR Vapor) manufactures e-cigarettes, including the popular menthol- and mixed-berry-flavored Vuse Alto products. It timely applied for authorization to market its Vuse Alto products, but three years later, the FDA denied the applications. According to the FDA, RJR Vapor had failed to demonstrate that marketing Vuse Alto products would be “appropriate for the protection of the public health.”
When the FDA denies premarket authorization, “any person adversely affected” by the denial may petition for judicial review in either the D. C. Circuit or “the circuit in which such person resides or has their principal place of business.”
The FDA asked the court to either dismiss the joint petition for lack of venue or transfer it to the D. C. Circuit or Fourth Circuit. It pointed out that under the TCA, only those “adversely affected” by the denial of premarket authorization may petition for review of the FDA’s order. And in the FDA’s view, only a disappointed applicant—in this case, RJR Vapor—is “adversely affected” within the meaning of the TCA. Because the retailers had no right to seek review, the FDA argued, the petition had no basis for being in the Fifth Circuit. RJR Vapor could file in the D. C. Circuit (the default) or the Fourth Circuit (its home).
A divided Fifth Circuit panel denied the FDA’s motion and concluded that venue was proper over the joint petition to review the FDA’s denial order.1 The FDA sought this Court’s review of the Fifth Circuit’s order, and we granted certiorari.2 603 U. S. ___ (2024).
II
A
To invoke a statutory cause of action, a plaintiff must be within the “zone of interests” that the statute protects. Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U. S. 118, 129 (2014).3 Put differently, a plaintiff must belong to the class of persons to which the statute grants a right to sue. Id., at 127. Under the TCA, the relevant class is “any person adversely affected” by the FDA’s “denial.”
“Adversely affected” (and its variations like “adversely affected or aggrieved”) is a term of art with a “long history in federal administrative law.” Director, Office of Workers’ Compensation Programs v. Newport News Shipbuilding & Dry Dock Co., 514 U. S. 122, 126 (1995); see also Brief for New Civil Liberties Alliance as Amicus Curiae 26–27 (claiming that 124 statutes use variations of “adversely affected”). Most notably, the term appears in the APA, which entitles anyone “adversely affected or aggrieved by agency action within the meaning of a relevant statute . . . to judicial review.”4
The FDA, however, attempts to ratchet up the standard. It insists that the capacious understanding of “adversely affected” is unique to the APA, whose “omnibus judicial-review provision . . . permits suit for violations of numerous statutes of varying character that do not themselves include causes of action for judicial review.” Ibid.; see also, e.g., Bennett v. Spear, 520 U. S. 154, 163 (1997). For statutes other than the APA, the FDA argues, a person must “actually”—not “arguably”—fall within the statute’s zone of interests. Brief for Petitioners 12–13. And as the FDA sees it, the person actually aggrieved by the denial of permission to market a tobacco product is the one with the closest relationship to the application—the applicant.
We have not drawn the distinction the FDA proposes. On the contrary, when we have interpreted variations of the phrase “adversely affected or aggrieved” outside the context of the APA, we have borrowed from our APA cases, including their broad formulation of the zone-of-interests test. For instance, in Bank of America Corp. v. Miami, we interpreted the Fair Housing Act’s (FHA) cause of
Thompson v. North American Stainless, LP, runs in the same vein. 562 U. S. 170 (2011). There, we interpreted the scope of Title VII’s cause of action, which permits a “person claiming to be aggrieved” to sue.
Finally, in Newport News, we had to decide whether the Director of the Office of Workers’ Compensation Programs in the Department of Labor was “[a] person adversely affected or aggrieved by a final order” under the Longshore and Harbor Workers’ Compensation Act. 514 U. S., at 123;
Taken together, these cases reflect a presumption that the term “adversely affected” carries the same meaning outside the APA as in it.5 The Fair Housing Act, Title VII, and the Longshore and Harbor Workers’ Compensation Act have different histories, scopes, and purposes. Yet in interpreting each statute, we borrowed principles from cases describing the APA’s cause of action. The FDA cannot explain why—repeatedly and without regard for their differing statutory purposes—we have interpreted other causes of action with variations of “adversely affected or aggrieved” consistently with the
We interpret the phrase “adversely affected” in the TCA against this backdrop. Echoing the APA, the TCA provides that “any person adversely affected by [the FDA’s] denial” may petition for judicial review.
B
Resisting this conclusion, the FDA (followed by the dissent) argues that the TCA’s text and structure reflect Congress’s choice to offer judicial review only to manufacturers denied permission to market a tobacco product. The FDA emphasizes that TCA applications result in an “order,”
These arguments, which focus almost entirely on
Even without the word “any,” the phrase “person adversely affected” suggests an intent to cover more than one party. Thompson is probative. In that case, the respondent similarly argued that the phrase “person aggrieved” referred to only the person who engaged in statutorily protected activity. 562 U. S., at 177. We said that “[w]e know of no other context in which the words carry this artificially narrow meaning, and if that is what Congress intended,” then “it would more naturally have said ‘person claiming to have been discriminated against’ rather than ‘person claiming to be aggrieved.’” Ibid. We saw “no basis in text or prior practice for limiting the latter phrase” to the single person who engaged in protected conduct. Ibid. So too here. If Congress intended to convey the FDA’s reading, it would more naturally have said “applicant” rather than “person adversely affected.” And there is “no basis in text or prior practice” for limiting “person adversely affected” to mean “the applicant”—or, for that matter, the “party” with whom the agency dealt. See NRC v. Texas, 605 U. S. ___, ___ (2025) (slip op., at 9) (distinguishing between statutes that grant a cause of action to a “party” aggrieved, as opposed to the broader any “person” aggrieved).
The FDA tries to explain away the breadth of
Congress knows how to limit the scope of a cause of action—in fact, it did so elsewhere in the TCA. When the FDA issues an order withdrawing an existing approval of an application to market a new tobacco product, only the “holder of [the] application” may challenge the order.
The FDA tries to turn this liability into an asset. See also post, at 9–10 (JACKSON, J., dissenting). It argues that Congress would not have allowed retailers to challenge denial orders (in which they normally have no reliance interests) but not withdrawal orders (in which they usually have significant reliance interests). Yet Congress made this very choice by using different language for the two types of challenges. Plainly, the FDA wishes that Congress had written the review provision differently. As we have explained before, however, “[w]e do not ask whether in our judgment Congress should have authorized” this lawsuit, “but whether Congress in fact did so.” Lexmark, 572 U. S., at 128.
The FDA’s other structural and policy arguments similarly fail. See also post, at 6–8 (JACKSON, J., dissenting). It claims that
III
In addition to contending that the retailers are not “adversely affected,” the FDA advances an argument in this Court that it failed to make in the Fifth Circuit: It maintains that each petitioner in a joint petition for review must independently establish
No court, including the Fifth Circuit in this case, has analyzed whether every petitioner in a joint petition must independently satisfy the TCA’s venue provisions. We rarely address an argument raised for the first time in this Court. OBB Personenverkehr AG v. Sachs, 577 U. S. 27, 38 (2015). In the ordinary course, “[p]rudence . . . dictates awaiting a case in which the issue was fully litigated below, so that we will have the benefit of developed arguments on both sides and lower court opinions squarely addressing the question.” Yee v. Escondido, 503 U. S. 519, 538 (1992). Prudence counsels that course here, because anything we say about the TCA’s venue provisions would inevitably inform debates about similar statutes—including
* * *
We affirm the Fifth Circuit’s denial of the FDA’s motion and remand the case for further proceedings consistent with this opinion.
It is so ordered.
FOOD AND DRUG ADMINISTRATION, ET AL., PETITIONERS v. R. J. REYNOLDS VAPOR CO., ET AL.
No. 23–1187
SUPREME COURT OF THE UNITED STATES
June 20, 2025
JACKSON, J., dissenting
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT
JUSTICE JACKSON, with whom JUSTICE SOTOMAYOR joins, dissenting.
The statute at issue in this case requires tobacco manufacturers to receive permission from the Food and Drug Administration (FDA) before new tobacco products may be marketed or sold.
The actual zone-of-interest inquiry, however, requires us to examine exactly whom Congress intended to protect under the relevant statutory provisions. And, here, all the usual tools of statutory interpretation point in the same direction: Congress established a detailed scheme for manufacturers to obtain authorization to market new tobacco products—a scheme within which retailers have no rights and play no role—and, in the context of that scheme, Congress provided a cause of action for the protection of the manufacturers’ statutorily created interests. Because noth- ing in this statute suggests that Congress meant to authorize retailers to sue to challenge the FDA’s denial of a manufacturer’s marketing application, much less bring that legal challenge in a venue that is otherwise unavailable, I respectfully dissent.
I
The Family Smoking Prevention and Tobacco Control Act empowers the Secretary of Health and Human Services, acting through the FDA, to regulate tobacco products. See
When a manufacturer seeks FDA authorization to market a new tobacco product, it must submit an application to the agency. See FDA v. Wages & White Lion Investments, LLC, 604 U. S. ___, ___ (2025) (slip op., at 5);
“There are many reasons why the FDA may deny marketing authorization to a ‘new tobacco product,’” but it must do so if the manufacturer fails to show “that the product ‘would be appropriate for the protection of the public health.’” Id., at ___ (slip op., at 5) (quoting
If the agency denies a manufacturer’s application for failure to make this showing, or if the application is denied for any other reason, the statute further authorizes judicial review of that FDA decision. The Act specifically provides that “any person adversely affected” by the FDA’s denial “may file a petition for judicial review of such . . . denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.”
The question before us today is what “any person adversely affected” by the FDA’s denial means in the context of this statute.
II
A
“Read literally,” the “broad language” of the Tobacco Control Act’s judicial-review provision “might suggest that an action is available to anyone who can satisfy the minimum requirements of Article III.” Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U. S. 118, 129 (2014). But, as the majority acknowledges, this Court has not read this or similar wording for all it is worth when interpreting causes of action. See ante, at 4. In the administrative-law context, we have long recognized that “adversely affected” is a term of art that can be far more cabined than its literal
meaning suggests. Indeed, we have consistently eschewed reading the “adversely affected” word formulation to apply to anyone in the world who might be affected by an agency‘s action, and have instead interpreted this language to refer “only to plaintiffs whose interests ‘fall within the zone of interests protected by the law invoked.‘” Lexmark, 572 U. S., at 129 (quoting Allen v. Wright, 468 U. S. 737, 751 (1984)).
We call this the zone-of-interest test—and it is, by now, well established. Simply stated, the test “is a guide for deciding whether . . . a particular plaintiff should be heard to complain of a particular agency decision.” Clarke v. Securities Industry Assn., 479 U. S. 388, 399 (1987). “The essential inquiry is whether Congress ‘intended for [this particular] class [of plaintiffs] to be relied upon to challenge agency disregard of the law.‘” Ibid. (quoting Block v. Community Nutrition Institute, 467 U. S. 340, 347 (1984); some alterations in original). We have also explained that, at bottom, “the reviewability question turns on congressional intent, and all indicators helpful in discerning that intent must be weighed.” Clarke, 479 U. S., at 400. In short: “Whether a plaintiff comes within ‘the “zone of interests“’ is an issue that requires us to determine, using traditional tools of statutory interpretation, whether a legislatively conferred cause of action encompasses a particular plaintiff ‘s claim.” Lexmark, 572 U. S., at 127.
Our decision in Lexmark illustrates how the zone-of-interest test works in practice. The statute at issue there authorized a suit brought by “‘any person who believes that he or she is likely to be damaged’ by a defendant‘s false advertising.” Id., at 129 (quoting
The Administrative Procedure Act (APA) is on the other side of the spectrum of outcomes when the zone-of-interest test is applied. We have long recognized that the APA‘s judicial-review provision is particularly capacious. See ante, at 5. Notably, we have observed that such breadth is necessary in the context of that statute in order to “preserv[e] the flexibility” of the APA‘s provisions, which apply in a range of contexts. Lexmark, 572 U. S., at 130.
The majority accepts that the zone-of-interest test is the proper legal framework for assessing the breadth of the cause of action at issue. See ante, at 4. It also goes to great lengths to emphasize that the zone-of-interest test operates identically across all statutes that permit aggrieved persons to sue—be it the APA or a more specific provision. See ante, at 5–7. I wholeheartedly agree. Whatever the underlying statute, our task is “to determine the meaning of the congressionally enacted provision creating a cause of action,” which we do by “apply[ing] traditional principles of statutory interpretation.” Lexmark, 572 U. S., at 128. Sometimes, as with the APA, those contextual clues demonstrate a cause of action‘s breadth. Other times, as was the case in Lexmark, those clues suggest a narrower scope. In each case, the question is one of Congress‘s intent.
B
To properly discern congressional intent about the breadth of a particular cause of action, it is crucial to know where to look. And, unlike the majority‘s opinion here, our precedents do not merely look to the words of the cause-of-action provision that prompted the need to inquire further about what Congress intended. Doing so would be, of course, entirely circular. Instead, because the zone-of-interest test is premised on the idea that interpreting a seemingly unbounded cause of action requires exploration into what Congress wanted in the context of that particular statute, we look to “the particular provision of law upon which the plaintiff relies” for his legal claim—that is, “‘the statutory provision whose violation forms the legal
Respondents here allege that the FDA improperly denied a marketing application filed by R. J. Reynolds Vapor Co. (RJR Vapor) in violation of
Analyzing that provision (as the majority fails to do) reveals that
The FDA makes this marketing-approval decision in accordance with the statute‘s directives, by considering the manufacturer‘s marketing application in all of its particulars. See
Nor do retailers, in particular, have any procedural rights whatsoever after a manufacturer submits its marketing application. Indeed, in many circumstances, the FDA is required to deny an application without regard to the impact that doing so might have on retailers. For example, the FDA must deny an application if the manufacturer‘s production, processing, or packing facilities fail to conform to regulatory standards. See
This all means that, under the premarketing-approval scheme that Congress has crafted, the interests of tobacco retailers are entirely beside the point—they do not factor in at all. It is the manufacturers that have to make the requisite showings, and if they do a poor job, the retailers are simply out of luck. There is no mechanism by which any interested third party (including a retailer excited by the prospect of being able to sell the relevant product) can supplement a manufacturer‘s marketing application. There are also no third-party notice requirements, and Congress has emphasized the importance of confidentiality, so third-party retailers may not even know that an application for the marketing of a particular new tobacco product
Thus, the text of the statutory provisions that create the premarketing-approval scheme Congress adopted does not support the conclusion that Congress promulgated this statute with retailers’ interests in mind.
C
Nor does the purpose of the Tobacco Control Act‘s premarketing-approval or judicial-review provisions. Instead, the statute‘s judicial-review mechanism operates to ensure that those most invested in a new product‘s authorization can enlist a court to double check the FDA‘s work. Manufacturers plainly fall within that category: At the time a manufacturer applies for authorization to market a new tobacco product, it has already expended considerable time, money, and effort to develop that product.
But retailers are differently situated. As a general mat-ter, when a manufacturer applies for authorization to market a new product, retailers are mere bystanders—they do not yet have any skin in the game. Cf.
The intuition that Congress reasonably intended to draw a distinction between the interests of manufacturers and retailers—and protected only the former in the instant context—is confirmed by a provision of
Under the majority‘s view, even though a retailer cannot challenge the FDA‘s decision to withdraw its prior approval per
Indeed, in my view, the provision prohibiting retailers from challenging the withdrawal of an approved application puts the nail in the proverbial coffin of the contention that retailers’ interests are being protected by this statute. When the FDA withdraws its marketing approval, retailers may well have already invested considerably in the new tobacco product—e.g., by purchasing inventory, setting up store displays, or attracting new customers. But Congress did not seem to care; the statute states plainly that only manufacturers can file suit to challenge such withdrawal. Why would Congress have wanted retailers to be able to seek judicial review of the agency‘s initial denial (at which point they generally lack reliance interests), but not when the agency withdraws its approval (at which point they generally will have such interests)?
The majority offers no explanation, stating only that this differential treatment was Congress‘s “choice.” Ante, at 10. But “[t]he illogic of the majority‘s interpretation strongly signals that what the majority believes Congress ‘chose’ is not actually what Congress intended or accomplished.” Advocate Christ Medical Center v. Kennedy, 605 U. S. ___, ___ (2025) (JACKSON, J., dissenting) (slip op., at 10). The more logical inference by far is that Congress excluded retailers from protecting their interests in the withdrawal context precisely because retailers are not within the zone of interest of this statutory scheme.
III
A
Ignoring our past edicts regarding how the zone-of-interest test works, the majority spends very little time evaluating the substantive provisions of the Tobacco Control Act‘s marketing scheme. Instead, it zeroes in on the language of the provision supplying the cause of action:
In any event, even pure textualists would have to acknowledge that
Another noteworthy problem with the majority‘s interpretation is that it draws almost exclusively from what this Court has said about the breadth of the cause of action in an entirely different statute (the APA). It is certainly true that, in the APA context, the zone-of-interest test is “not especially demanding.” Ante, at 5 (internal quotation marks omitted). But, again, we have explained that Congress intended this language to be broadly interpreted as it appears in the APA precisely because of the breadth of the APA itself. See supra, at 5. By contrast, as I have shown, the Tobacco Control Act‘s premarketing-approval scheme is narrow: It involves an exchange between tobacco manufacturers and the FDA that occurs when said manufacturers wish to market a new tobacco product. Third parties are entirely excluded from that back-and-forth. And, notably, that is so even when circumstances develop that do, in fact, implicate third-party interests (such as when a retailer has already begun marketing the product). There really is no material similarity between the premarketing-approval scheme Congress has constructed in the Tobacco Control Act, on the one hand, and the various interests that the APA protects, on the other. Consequently, the zones of interest those two statutes create are completely different, making it difficult to understand why the majority finds the APA parallel so persuasive.
B
The majority‘s take on the scope of
In the same way that the Agricultural Marketing Agreement Act contemplated collaboration between the agency, milk handlers, and milk producers—but not consumers—the Tobacco Control Act‘s premarket-authorization program contemplates collaboration between the agency and manufacturers—but not retailers. Therefore, here, just as in Block, the absence of any mechanism for retailers to participate in that collaborative premarketing-approval process on the front end is a strong signal that Congress did not intend to protect any interests retailers may have on the back end, if premarketing approval is denied.
Moreover, as with the would-be plaintiff-consumers in Block, “preclusion of [retailer] suits will not threaten realization of the fundamental objectives of the statute.” Id., at 352. After all, a retailer‘s interest generally will be aligned with a manufacturer‘s—both want the FDA to approve the application. Manufacturers, then, can “be expected to challenge unlawful agency action and to ensure that the statute‘s objectives will not be frustrated.” Ibid.; cf. Joint Anti-Fascist Refugee Comm. v. McGrath, 341 U. S. 123, 153 (1951) (Frankfurter, J., concurring) (recognizing that the likelihood that a person would be “adequately protected” by the party who is able to challenge the underlying Government action is a “relevant consideration” when determining the scope of judicial review).
The majority dismisses Block in a footnote, arguing that it is “readily distinguishable” because the statute provided that certain industry participants could seek judicial review only “after first exhausting administrative remedies.” Ante, at 11–12, n. 8. But Block is not an exhaustion case. Rather, the Court held that consumers’ inability to participate in the administrative process was in and of itself a “sufficient reason” to believe that Congress intended to exclude consumers from using the statutory cause of action to seek judicial review of the relevant agency action. 467 U. S., at 347.2
Applying the plainly analogous reasoning of Block to the question presented in this case gets us to the most straightforward answer: Like the consumers in Block, the retailers here are beyond the zone of interest and thus cannot invoke the cause of action. But instead of just applying Block, the majority opts to rely on a number of cases interpreting causes of action that are far less similar to the statute at
issue here. Ante, at 4–8.
Those cases are really of no help because, in each of them, the plaintiff was expressly protected by the statute at issue, and thus fit well within the zone of interest.
The majority makes much of the Court‘s statements in those cases that the statutes at issue permitted suit by anyone whose interests were at least “’ “arguably . . . protected by the statute.” ’ ” Ante, at 7 (quoting Thompson, 562 U. S., at 178; emphasis added). But the retailers here cannot even satisfy that formulation of the standard. The majority explains how retailers may be affected by
IV
Finally, when evaluating Congress‘s intent regarding the scope of the cause of action it established in
No one disputes that RJR Vapor itself qualifies as a “person adversely affected” by the FDA‘s denial of its marketing application. Therefore, it is not as though RJR Vapor had no options—it most certainly could have brought a lawsuit challenging the FDA‘s denial in the D.C. Circuit or in the Fourth Circuit, where it has its principal place of business.3 So, stepping back, one wonders: Why does it even matter whether the tobacco retailers RJR Vapor has chosen to pair up with have the ability to sue?
The above-quoted statutory text provides the answer. As it turns out, at the time RJR Vapor filed its application, the D. C. Circuit and the Fourth Circuit had each already rejected on the merits similar challenges that other flavored e-cigarette manufacturers had filed. See Avail Vapor, LLC v. FDA, 55 F. 4th 409, 413, 422 (CA4 2022); Prohibition Juice Co. v. FDA, 45 F. 4th 8, 12, 20–21 (CADC 2022). It thus became (perhaps) imperative from RJR Vapor‘s perspective that its own lawsuit challenging the FDA‘s denial of its flavored e-cigarette marketing applications be filed somewhere else. To accomplish that objective—i.e., to facilitate RJR Vapor‘s end run around
The possibility that the courts would allow venue to be established based on Avail Vapor‘s presence on the petition gave RJR Vapor hope that its substantive legal challenge would move forward in a more applicant-friendly venue.5
From RJR Vapor‘s strategic litigating standpoint, neither Congress‘s intent concerning the scope of the cause of action, nor the fact that retailers were not front of mind for Congress when it crafted the premarketing-approval provisions of the Tobacco Control Act (see Part II, supra) mattered much. Regardless, it was critical for the retailers to participate as plaintiffs if RJR Vapor was going to successfully skirt
This is, of course, precisely the kind of manipulation that the pesky zone-of-interest test operates to prevent, insofar as it requires
As we consider who can sue under
also articulates a clear venue mandate: Thwarted tobacco manufacturers have a cause of action to challenge the FDA‘s denial of their marketing applications in court, but they must litigate their interests in the designated venues and, presumably, not elsewhere—including through proxy suits that third parties file in other places on their behalf.
* * *
The majority correctly acknowledges that the disputed “any person adversely affected” language in