FDA v. R. J. REYNOLDS VAPOR CO.

SUPREME COURT OF THE UNITED STATES

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No. 23–1187

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FOOD AND DRUG ADMINISTRATION, et al., PETITIONERS v. R. J. REYNOLDS  VAPOR CO., et al.

on writ of certiorari to the united states court of appeals for the fifth circuit

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 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. 21 U. S. C. §387j. In deciding who falls within the zone of interest of that statute, the Court largely ignores this context. Instead, the Court directs all attention to the language of the statute’s cause of action—and then essentially nullifies the zone-of-interest test by reducing it to the near-meaningless proposition that anyone affected, or even arguably affected, by the FDA’s marketing denial can sue.

 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 21 U. S. C. §§387a, 393(d)(2). The Act expressly applies to many tobacco products that were popular when the Act was enacted in 2009, such as cigarettes. See §387a(b). But recognizing that markets evolve, Congress provided that the Act would also apply to “any other tobacco products” that the FDA “by regulation deems to be subject to” the Act. Ibid. Within that covered-product category, the Tobacco Control Act prohibits manufacturers from marketing without FDA authorization any “new tobacco product,” defined as a product not generally available on the market as of February 15, 2007. §§387j(a)(1), (a)(2)(A). The statute also prohibits any retailer from selling a “new tobacco product” unless that product has been authorized by the FDA. See §§387b(6)(A), 331(a).

 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); §387j(b). That application must include “full reports of all information” the manufacturer is (or should be) aware of “concerning investigations which have been made to show the health risks of ” the product. §387j(b)(1)(A). It must also include a list of the product’s “components, ingredients, additives, and properties,” along with a description of the manufacturing methods and facilities. §§387j(b)(1)(B), (C). And the man ufacturer must produce any “samples of such tobacco product” that the agency “may reasonably require.” §387j(b)(1)(E).

 “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 §387j(c)(2)(A)). Congress has thus placed the burden on the applicant (the manufacturer) to persuade the FDA that its product would help—not hurt—public health.

 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.” §387l(a)(1).

 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 15 U. S. C. §1125(a)(1)). Applying the zone-of-interest test, we held that, despite the statute’s broad “any person” language, contextual clues—including the statute’s expressed purpose—demonstrated that Congress intended to permit suit only by persons who suffered a particular type of injury (specifically, “an injury  to a commercial interest in reputation or sales”). 572 U. S., at 131–132.

 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 basis for his complaint.’ ” Bennett v. Spear, 520 U. S. 154, 175–176 (1997) (quoting Lujan v. National Wildlife Federation, 497 U. S. 871, 883 (1990); emphasis deleted). Although one would not know it from reading the majority’s opinion, this is blackletter law. See, e.g., Clarke, 479 U. S., at 396–397; Air Courier Conference v. Postal Workers, 498 U. S. 517, 523–524 (1991); Thompson v. North American Stainless, LP, 562 U. S. 170, 178 (2011).

 Respondents here allege that the FDA improperly denied a marketing application filed by R. J. Reynolds Vapor Co. (RJR Vapor) in violation of 21 U. S. C. §387j(c). So, it is that statutory provision, not the cause of action itself, that is the proper focus of the zone-of-interest inquiry.

 Analyzing that provision (as the majority fails to do) reveals that §387j(c) is part of a statutory scheme that establishes an adjudicatory process between a manufacturer and the FDA—and no one else. Per that process, after the FDA receives a manufacturer’s marketing application and reviews it, the statute requires a particular agency response: The FDA “shall” “issue an order that the new product” either may be, or may not be, “introduced . . . into interstate commerce.” §387j(c)(1)(A).

 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 §§387j(b), (c). I touched on those details above, see supra, at 2, but it bears repeating here that, by law, a manufacturer’s application must contain a “full statement of the components, ingredients, additives, and properties” of the proposed tobacco product; a “description of the methods used in, and the facilities and controls used for, the manufacture, processing, and . . . packing” of the product;  and, in some instances, samples of the product itself. §387j(b)(1). The manufacturer gathers all of that information and submits it directly to the FDA. That is it—the agency does not solicit any information from interested third parties, such as potential consumers or retailers who wish to sell the product, and manufacturers are not required to submit any information to the FDA on their behalf.

 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 §387j(c)(2)(B). The FDA must also deny an application if the manufacturer fails to show “that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.” §387j(c)(2)(A).

 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 has been submitted to the FDA at all, let alone that one was denied. See §387j(e)(2) (requiring the FDA to serve denial notices on applicants, but not retailers); see also §387f(c) (providing  that the agency may not disclose confidential information to nonapplicants); 86 Fed. Reg. 55398 (2021) (recognizing that “the intent to market a tobacco product that is not currently marketed is often considered confidential commercial information”).¹

 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. §§331(c), 387b(6)(A) (clarifying that a new tobacco product may not be sold before the FDA approves it). A retailer may desire to sell an upcoming (not-yet-approved) product—it may even expect to profit handsomely, if the manufacturer’s application were to be approved and the product deemed marketable. But that kind of forward-looking interest is different in kind from the manufacturer’s backward-looking one. If the FDA denies a manufacturer’s marketing application, a retailer might well be disappointed, but it will not lose an investment; it can stock its shelves with something else. Thus, Congress could have rationally intended to protect manufacturers’ reliance interests by affording them a layer of judicial review if the FDA denies a marketing application, while feeling no need to extend similar protection to retailers.

 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 §387j that enables the FDA to withdraw its prior approval of a tobacco product in certain situations. See §387j(d). That provision states that the agency’s decision to withdraw its approval of a tobacco product may be challenged in court by only the “holder of [the] application subject to” the withdrawal order—in other words, the manufacturer alone. §387j(d)(2). To me, this is the single most significant piece of textual evidence bearing on Congress’s intent regarding the protection of retailers.

 Under the majority’s view, even though a retailer cannot challenge the FDA’s decision to withdraw its prior approval per §387j(d), it can file a lawsuit to challenge the FDA’s denial of a manufacturer’s application in the first instance due to the “any person adversely affected” language of the cause of action. But as I see it, the fact that a retailer cannot  challenge a withdrawal order makes it much more likely that Congress did not intend to permit it to challenge the agency’s initial denial of an application either—a consistent and reasonable result since, as I have explained, retailers generally lack any financial stake or reliance interests in the application’s approval.

 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: §387l(a)(1). In its view, retailers fit within that provision’s scope because, by permitting suit by “ ‘any person adversely affected,’ ” the statute’s text “suggests an intent to cover more than one party.” Ante, at 9. But as I have already noted, fixating on the broad text of a judicial-review provision substantially similar to the ones that prompted us to birth the zone-of-interest test gets us nowhere—at least, nowhere remotely resembling the traditional inquiry and what it was designed to do. This observation is fundamental; as our foundational zone-of-interest precedents recognized, a literal reading of capacious cause-of-action language renders the provision far broader than it is typically reasonable to conclude Congress intended. Cf. Thompson, 562 U. S., at 176–177 (observing that “absurd consequences” about who was entitled to sue would follow if the Court were to interpret literally a similarly worded cause of action).

 In any event, even pure textualists would have to acknowledge that §387l(a)(1)’s seemingly infinite terminology can be adequately explained by a linguistic quirk that has little to do with Congress’s “choice” to allow any arguably affected person to sue. Carefully examined, the text of this provision permits suit by “any person adversely affected by” either “the promulgation of a regulation” or the “denial of an application.” §387l(a)(1). One way to use a single subject to describe two different types of plaintiffs (those who may seek to challenge an FDA regulation and also those who may seek to challenge the FDA’s denial of a manufacturer’s application) is to use a generic term, such as “any person.” By design, that generic phrasing relates to “more than one party” and does not explain or suggest  who is included in either category. Ante, at 9. So, ultimately, the “any person” phrasing the majority puts so much stock in might just be a product of Congress’s desire to use a single statutory provision to cover both situations.

 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 §387l(a)(1)’s cause of action also fails to fully appreciate the reasoning of our zone-of-interest precedents. The zone-of-interest analysis here is substantially similar to that of Block, 467 U. S. 340. There, the Court held that the Agricultural Marketing  Agreement Act of 1937 permitted only milk handlers and producers—not consumers—to seek judicial review of the Secretary of Agriculture’s milk pricing orders, even though the orders affected (indeed, harmed) consumers by increasing the price of milk. Consumers were not in the zone of interest (and thus were not “adversely affected” persons under the relevant cause of action, id., at 345), the Court reasoned, because of the structure of the underlying administrative scheme. Milk market orders were promulgated via a “cooperative venture” between the agency, milk handlers, and milk producers; “[n]owhere in the Act” was there any “provision for participation by consumers.” Id., at 346–347. The Court recognized that “[i]n a complex scheme of this type, the omission of such a provision is sufficient reason to believe that Congress intended to foreclose consumer participation in the regulatory process.” Ibid.

 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. In Thompson, for example, we had no trouble concluding that an employee injured by his employer’s unlawful retaliation fell within the zone of interests of a statute whose purpose was “to protect employees from their employers’ unlawful actions.” 562 U. S., at 178. And in Bank of America Corp. v. Miami, 581 U. S. 189 (2017), the statute had specifically defined “ ‘aggrieved person’ ” to include “ ‘any person who . . . claims to have been injured by a discriminatory housing practice,’ ” when the plaintiff there had made that claim. Id., at 193.

 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 §387j but never articulates how retailers are protected by this statute—not arguably, and certainly not actually. See ante, at 8, and n. 7, 9. That’s because they can’t. No matter how long you stare at §387j, you will not find anything looking out for retailers. They are simply not protected by the provision at all.

IV

 Finally, when evaluating Congress’s intent regarding the scope of the cause of action it established in §387l(a)(1), we should keep in mind, too, that this provision does not merely authorize judicial review of agency determinations at the behest of “any person adversely affected.” Congress also specifically prescribed where that review must be sought. Again, the text states 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.” §387l(a)(1).

 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 §387l(a)(1)’s venue restrictions—RJR Vapor needed another party to bring its legal challenge to court.

 It is not hard to see where this is going. RJR Vapor teamed up with a Texas-based retailer that sold the relevant e-cigarettes—respondent Avail Vapor Texas, LLC—and, together, they filed a joint petition in the Fifth Circuit, challenging the FDA’s denial of RJR Vapor’s application.⁴  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 §387l(a)(1)’s venue restrictions and steer this case to the preferred—but unauthorized—forum.

 This is, of course, precisely the kind of manipulation that the pesky zone-of-interest test operates to prevent, insofar as it requires §387l(a)(1) to be interpreted consistent with what Congress cared about when it crafted that statute (including, presumably, its venue-related policies), rather than with undue adherence to whatever might be necessary to advance a party’s litigating interests. And, ultimately, for present purposes, the distinction between what Congress wanted when it enacted §387l(a)(1) and what some tobacco manufacturers want to do now is particularly acute.

 As we consider who can sue under §387l(a)(1), it is important to acknowledge that the statute Congress enacted  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 §387l(a)(1) of the Tobacco Control Act implicates our well-established zone-of-interest test. All agree, too, that, under the zone-of-interest test, the watchword is congressional intent. But I would proceed to determine Congress’s intent as normal, by applying the traditional tools of statutory interpretation to investigate the scope of §387j(c)—the provision that respondents argue the FDA violated. Every available indicator reveals that Congress intended to permit manufacturers—not retailers—to challenge the denial of a manufacturers’ marketing application (and to do so only in the designated courts). In concluding otherwise, the majority not only opens up an avenue for judicial review that Congress did not intend, it also allows manufacturers like RJR Vapor to evade the statute’s venue requirements.