FDA v. R. J. Reynolds Vapor Co.

                   PRELIMINARY PRINT

              Volume 606 U. S. Part 1
                             Pages 226–258




       OFFICIAL REPORTS
                                     OF


   THE SUPREME COURT
                                June 20, 2025


Page Proof Pending Publication


                    REBECCA A. WOMELDORF
                           reporter of decisions




    NOTICE: This preliminary print is subject to formal revision before
  the bound volume is published. Users are requested to notify the Reporter
  of Decisions, Supreme Court of the United States, Washington, D. C. 20543,
  [email protected], of any typographical or other formal errors.
226                     OCTOBER TERM, 2024

                                 Syllabus


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

certiorari to the united states court of appeals for
                  the fth circuit
      No. 23–1187. Argued January 21, 2025—Decided June 20, 2025
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.” 21 U. S. C. § 387j. In 2016, the FDA decided that e-cigarettes
  and related products were new tobacco products subject to the TCA.
  Given the size of the existing e-cigarette market, the FDA announced
  that it would defer enforcement of the TCA against e-cigarette manufacturers and retailers while the manufacturers sought FDA approval. R. J. Reynolds Vapor Co. (RJR Vapor)—a manufacturer of
  e-cigarettes—sought FDA approval to continue marketing its popular
  Vuse Alto products. The FDA denied the applications, fnding that

Page Proof Pending Publication
  RJR Vapor had failed to demonstrate that marketing Vuse Alto products would be “appropriate for the protection of the public health” as
  required by the TCA. § 387j(c)(2)(A). The FDA's order sounded the
  death knell for a signifcant portion of the e-cigarette market, and RJR
  Vapor sought to challenge it.
     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.” § 387l(a)(1). Had RJR Vapor sought judicial review on
  its own, it could have fled a petition in the D. C. Circuit (the statutory
  default) or the Fourth Circuit (which includes North Carolina, RJR Vapor's state of incorporation and principal place of business). RJR Vapor
  instead combined forces with a Texas-based retailer and a Mississippibased trade association of retailers to challenge the FDA's denial order
  in the Fifth Circuit (which includes both Texas and Mississippi). In
  response, 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.
  The FDA argued that only a disappointed applicant—in this case, RJR
  Vapor—is “adversely affected” by an FDA denial order 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.
  A divided Fifth Circuit panel concluded venue was proper and denied
  the FDA's motion.
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                                 Syllabus

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 § 387l(a)(1).
 Pp. 232–241.
    (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., 

. 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.” § 387l(a)(1).
    “Adversely affected” (and its variations like “adversely affected or
 aggrieved”) is a term of art with a “long history in federal administrative law.” Director, Offce of Workers' Compensation Programs v.
 Newport News Shipbuilding & Dry Dock Co., 

. 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 Court has interpreted “adversely affected” broadly, as covering anyone even “arguably within the zone of
 interests to be protected or regulated by the statute . . . in question.”
 Association of Data Processing Service Organizations, Inc. v. Camp,

Page Proof Pending Publication
 

 (emphasis added).
    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. But
 the Court has not drawn the distinction the FDA proposes. Instead,
 the Court has borrowed from its APA cases, including their broad formulation of the zone-of-interests test, when it has interpreted variations
 of the phrase “adversely affected or aggrieved” in other statutes. See,
 e. g., Bank of America Corp. v. Miami, 

 (interpreting
 “aggrieved person” in the Fair Housing Act); Thompson v. North American Stainless, LP, 

 (interpreting “person claiming to
 be aggrieved” in Title VII); Newport News, 

 (interpreting “person adversely affected or aggrieved” in the Longshore and Harbor Workers' Compensation Act). Taken together, these cases refect a
 presumption that “adversely affected” carries the same meaning outside
 the APA as in it.
    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.
 § 387l(a)(1). The retailers ft the bill. If the FDA denies an applica-
228              FDA v. R. J. REYNOLDS VAPOR CO.

                                 Syllabus

  tion, the retailers lose the opportunity to proft from the sale of the new
  tobacco product—or, if they sell the product anyway, risk imprisonment
  and other sanctions. See §§ 331, 333(a), 387b(6)(A), 387j(a)–(c). Accordingly, the retailers are “adversely affected” by a denial order and
  are therefore proper petitioners under § 387l(a)(1). Pp. 232–236.
     (b) The FDA argues that the TCA's text and structure refect 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 § 387j, cannot be squared with § 387l(a)(1)—the
  provision that creates the cause of action. Start with the textual oddity
  of using the phrase “any person adversely affected” to describe a cause
  of action that only one person—the applicant manufacturer—could use.
  Congress's use of “any” suggests that a denial order can adversely affect
  multiple persons.
     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,
  

 (rejecting analogous argument that Title VII's use of “per-

Page Proof Pending Publication
  son 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. § 387j(d)(2).
  Congress's use of materially different terms in the TCA—“holder of
  [the] application” in § 387j(d)(2) and “any person adversely affected”
  in § 387l(a)(1)—raises the presumption that the different terms mean
  different things. This principle is fatal to the FDA's reading of
  § 387l(a)(1). The FDA's other structural and policy arguments likewise
  cannot be squared with Congress's use of the phrase “any person adversely affected.”
     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. 236–240.
     (c) The FDA now argues that each petitioner in a joint petition for
  review must independently establish venue. The FDA did not make
  that argument in the Fifth Circuit. The Court rarely addresses an argument raised frst to the Court, see OBB Personenverkehr AG v.
  Sachs, 

, and prudence counsels against doing so here.
  Pp. 240–241.
Affrmed and remanded.
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                          Opinion of the Court

  Barrett, J., delivered the opinion of the Court, in which Roberts,
C. J., and Thomas, Alito, Kagan, Gorsuch, and Kavanaugh, JJ., joined.
Jackson, J., fled a dissenting opinion, in which Sotomayor, J., joined,
post, p. 241.

  Vivek Suri argued the cause for petitioners. With him on
the briefs were Solicitor General Prelogar, Principal Deputy Assistant Attorney General Boynton, Deputy Solicitor
General Gannon, Joshua M. Koppel, Catherine Padhi, Samuel R. Bagenstos, and Wendy S. Vicente.
  Ryan J. Watson argued the cause for respondents. With
him on the brief were Noel J. Francisco, Christian G. Vergonis, Andrew J. M. Bentz, Charles E. T. Roberts, and Andrew J. Clopton.*

  Justice Barrett delivered the opinion of the Court.
  The Family Smoking Prevention and Tobacco Control Act
(TCA) requires manufacturers to apply for and receive apPage Proof Pending Publication
proval from the Food and Drug Administration (FDA) before
marketing any “new tobacco product.” 

, 21
U. S. C. § 387j. Companies that manufacture or sell new tobacco products without the FDA's approval face signifcant
penalties. See §§ 331, 333(a), 387b(6)(A), 387j(a)–(c). If the
FDA denies an application, the TCA authorizes “any person
adversely affected” by the denial order to petition for judicial

   *William B. Schultz, Andrew N. Goldfarb, and Dennis A. Henigan fled
a brief for Public Health Groups et al. as amici curiae urging reversal.
   Briefs of amici curiae urging affrmance were fled for the American
Center for Law and Justice by Jordan Sekulow, Donn Parsons, and Benjamin P. Sisney; for the Atlantic Legal Foundation by Lawrence S. Ebner;
for Electronic Nicotine Delivery System Trade Associations et al. by Eric
P. Gotting and Azim Chowdhury; for Foreign Ends Manufacturers et al.
by Eric N. Heyer, Joseph A. Smith, James C. Fraser, and Anna Stressenger; and for Vaping Industry Stakeholders by J. Gregory Troutman.
   Briefs of amici curiae were fled for the Chamber of Commerce of the
United States of America by Christopher G. Michel, Jennifer B. Dickey,
and David A. Nabors; and for the New Civil Liberties Alliance by Andrew
J. Morris, Daniel Kelly, and Mark Chenoweth.
230           FDA v. R. J. REYNOLDS VAPOR CO.

                      Opinion of the Court

review under the standards of the Administrative Procedure
Act (APA). §§ 387l(a)–(b). We must decide whether retailers who would sell a new tobacco product if not for the FDA's
denial order have the right to seek judicial review. We hold
that they do.
                              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, 

, 553–556 (2025). They could
therefore be sold without the FDA's approval, and over the
years, a large market developed. See 

 But in 2016,
the FDA changed direction: It announced that e-cigarettes
and related products are subject to the TCA after all. 81
Fed. Reg. 29028–29044 (2016). Given the size of the
e-cigarette market, pulling products from the shelves while
manufacturers sought “premarket” authorization to sell
Page Proof Pending Publication
them would have been disruptive. To mitigate the disruption, the FDA announced that it would defer enforcement of
the TCA against e-cigarette manufacturers and retailers
while the manufacturers sought FDA approval. 

 at
29009–29015.
   R. J. Reynolds Vapor Co. (RJR Vapor) manufactures e-
cigarettes, including the popular menthol- and mixed-berryfavored 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.” § 387j(c)(2)(A). This order sounded
the death knell for a signifcant portion of the e-cigarette
market.
   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
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                          Opinion of the Court

such person resides or has their principal place of business.”
§ 387l(a)(1). RJR Vapor is incorporated and has its principal
place of business in North Carolina; thus, had it fled alone,
its options were the D. C. Circuit and the Fourth Circuit.
Rather than fling alone, however, RJR Vapor combined
forces with retailers of Vuse Alto products: Avail Vapor
Texas, L.L.C., a Texas company that owns and operates the
“Vuse Inspiration Store” in Houston; the Mississippi Petroleum Marketers and Convenience Stores Association, a trade
association of gas stations and convenience stores; and another North Carolina-based RJR corporate affliate that sold
Vuse products online. RJR Vapor and the retailers fled a
joint petition in the Fifth Circuit, where Avail Vapor and the
trade association are located.
   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

Page Proof Pending Publication
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 fle 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 

 (2024).

  1
    In a separate order, the Fifth Circuit also stayed the FDA's denial
order. The Fifth Circuit's stay order is not before us.
  2
    The respondents argue that we lack jurisdiction to decide this case.
Outside of limited circumstances, Article III allows this Court to exercise
only “appellate jurisdiction,” not “original jurisdiction.” Marbury v.
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                            Opinion of the Court

                              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., 

 (2014).3 Put differently, a plaintiff must belong to the class of persons to whom the statute grants a
right to sue. 

. Under the TCA, the relevant class
is “any person adversely affected” by the FDA's “denial.”
21 U. S. C. § 387l(a)(1).
   “Adversely affected” (and its variations like “adversely affected or aggrieved”) is a term of art with a “long history
in federal administrative law.” Director, Offce of Workers'
Compensation Programs v. Newport News Shipbuilding &
Dry Dock Co., 

 (1995); see also Brief for
New Civil Liberties Alliance as Amicus Curiae 26–27 (claiming that 124 statutes use variations of “adversely affected”).
Page Proof Pending Publication
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 

. We have interpreted “adversely
Madison, 

 (1803). The respondents argue that we are
unconstitutionally exercising original jurisdiction because the Court of
Appeals has not yet adjudicated the merits of their petition. This argument is clever but misguided. We are reviewing the Fifth Circuit's order
denying a motion to transfer venue. So, as with any other case in which
we review a lower court order, we are exercising appellate jurisdiction
over that order—not deciding the motion in the frst instance.
   3
     Though we once applied the zone-of-interests test as part of a “prudential
standing” doctrine, we have abandoned that label as “misleading.” Bank
of America Corp. v. Miami, 

, 196–197 (2017). As we have explained, the question is not one of standing, but of “whether the statute
grants the plaintiff the cause of action that he asserts.” 

 The zone-of-interests test is part of the ordinary statutory interpretation analysis
that courts employ to answer that question. Lexmark, 

.
   4
     Because the APA provides an omnibus cause of action for violations of
other statutes, the “relevant statute” for an APA zone-of-interests analysis
is not the APA itself, but the statute under which the relevant agency
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                        Opinion of the Court

affected” broadly, as covering anyone even “arguably within
the zone of interests to be protected or regulated by the
statute . . . in question.” Association of Data Processing
Service Organizations, Inc. v. Camp, 

(1970) (emphasis added). A plaintiff may sue under the APA
unless her “interests are so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress intended to permit
the suit.” Clarke v. Securities Industry Assn., 

 (1987). The inquiry is “not especially demanding.”
Lexmark, 

 (internal quotation marks
omitted).
   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

Page Proof Pending Publication
of action for judicial review.” Ibid.; see also, e. g., Bennett
v. Spear, 

 (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 that 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 action—which
permits any “aggrieved person” to sue. 

(2017); 

(a)(1)(A). Citing our canonical articacted. See Association of Data Processing Service Organizations, Inc.
v. Camp, 

 (1970).
234           FDA v. R. J. REYNOLDS VAPOR CO.

                      Opinion of the Court

ulation of the APA's broad zone-of-interests test in Data
Processing, we held that Miami could sue under the FHA
because the city “arguably” fell within the interests that the
FHA sought to protect. 581 U. S., at 197–201.
   Thompson v. North American Stainless, LP, runs in the
same vein. 

 (2011). There, we interpreted the
scope of Title VII's cause of action, which permits a “person
claiming to be aggrieved” to sue. 42 U. S. C. § 2000e–5(f)(1).
We held that this cause of action is neither so narrow as to
include only the person claiming to be the victim of discrimination nor so broad as to encompass every person with Article III standing. Thompson, 

. Instead,
interpreting the term “aggrieved” consistently with its
“common usage” in the APA context, we held that Title VII
authorized suit by “any plaintiff with an interest `arguably
[sought] to be protected by the statute.' ” 

 at 177–178
(quoting Na tional Credi t Union Admin. v. First Na t.
Page Proof Pending Publication
Bank & Trust Co., 

 (1998)). Under this
test, an employee who had allegedly been fred in retaliation
for the protected activity of his fancée (who was also his
co-worker) was “aggrieved” and could sue. Thompson, 

.
   Finally, in Newport News, we had to decide whether the
Director of the Offce of Workers' Compensation Programs
in the Department of Labor was “[a] person adversely affected or aggrieved by a fnal order” under the Longshore
and Harbor Workers' Compensation Act. 

;

, 

(c). To answer this question,
we considered the history of this “term of art” across administrative law, including our canonical interpretation of it
under the APA: “[A] litigant [must] show . . . that the interest
he seeks to vindicate is arguably within the `zone of interests
to be protected or regulated by the statute.' ” Newport
News, 514 U. S., at 126–127 (quoting Data Processing,

; emphasis added). Considering the “long
lineage” of this language, we found it telling that neither
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 (2025)                     235

                           Opinion of the Court

we nor any court of appeals had ever held, under the APA
or otherwise, that “an agency, in its regulatory or policymaking capacity, is `adversely affected' or `aggrieved.' ”
Newport News, 

.
  Taken together, these cases refect 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 APA's cause of action.6
  We interpret the phrase “adversely affected” in the TCA
against this backdrop. Echoing the APA, the TCA provides
Page Proof Pending Publication
that “any person adversely affected by [the FDA's] denial”
may petition for judicial review. 21 U. S. C. § 387l(a)(1); see

   5
     The FDA invokes Bennett and Lexmark for support, but the statutes
at issue in those cases did not use variations of the phrase “adversely
affected” to create a cause of action. See 

(g) (Bennett v.
Spear, 

 (1997)); 

(a)(1) (Lexmark Int'l, Inc. v.
Static Control Components, Inc., 

 (2014)). So neither case
sheds light on whether “adversely affected” has a unique meaning in the
context of the APA.
   6
     The FDA notes that the phrase “adversely affected or aggrieved” predates the APA. Director, Offce of Workers' Compensation Programs v.
Newport News Shipbuilding & Dry Dock Co., 

 (1995).
But the FDA has not shown that the pre-APA defnition of “adversely
affected or aggrieved” was meaningfully narrower than the version of the
zone-of-interests test articulated in modern APA cases, not to mention
Bank of America and Thompson v. North American Stainless, LP, 

 (2011). Even our pre-APA construction of “adversely affected”
was quite broad. See, e. g., FCC v. Sanders Brothers Radio Station, 

, 475–477 (1940) (holding that competitors of FCC licensees are
“adversely affected” by an order granting a license within the meaning of
§ 402(b)(2) of the Communications Act of 1934).
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                           Opinion of the Court

also 

 (“[a] person . . . adversely affected or
aggrieved by agency action”). The TCA's cause of action
thus extends to any petitioner “with an interest `arguably
sought to be protected by the statute.' ” Thompson, 

 (quoting National Credit Union Admin., 

; alteration omitted). The retailers ft the bill.
If the FDA denies an application, the retailers, like the manufacturer, lose the opportunity to proft from the sale of the
new tobacco product—or, if they sell the product anyway,
risk imprisonment and other sanctions. See 

, 333(a), 387b(6)(A), 387j(a)–(c). Given this signifcant,
direct impact on retailers, their interests are not “so marginally related to or inconsistent with the purposes implicit in
the statute that it cannot reasonably be assumed that Congress intended to permit the suit.” Clarke, 

.
Accordingly, the retailers are “adversely affected” by a denial order and are therefore proper petitioners under

Page Proof Pending Publication
§ 387l(a)(1).7
                               B
  Resisting this conclusion, the FDA (followed by the dissent) argues that the TCA's text and structure refect Con-
  7
    The dissent argues that the zone-of-interests inquiry turns exclusively
on § 387j(c), which governs the FDA's response to a marketing application.
See post, at 246 (opinion of Jackson, J.) This myopic approach is inconsistent with Clarke v. Securities Industry Assn., which explains that the
zone-of-interests analysis must not “focu[s] too narrowly” on the basis for
the violation, but must also consider that provision “in the overall context”
of the relevant Act. 

 (1987). Here, the relevant context
includes not only the application process outlined in § 387j(c), but also the
legal consequences if that process ends with a denial order—namely, the
threat of criminal penalties for retailers who sell the denied products.
According to the dissent, this threat is irrelevant because § 387j(c) does
not enable the retailers to “weigh in on” the FDA's consideration of an
application for premarket authorization. Post, at 248, n. 1 (opinion of
Jackson, J.). But the TCA does not authorize suit only for those permitted to “weigh in on” the agency's disposition of an application—it authorizes suit for those “adversely affected” by the denial of an application.
The retailers meet that description.
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                      Opinion of the Court

gress'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,”
§ 387j(c)(1)(A), and that “orders” may normally be challenged
only by the participants in the proceeding that led to the
order. It also asserts that other provisions of the statute
refect an overriding concern with the applicant manufacturer: Only the manufacturer may ask the FDA to refer its
application to a scientifc committee, receive notice of a denial order, or receive a statement about why the application
was denied. §§ 387j(b)(2)(B), (e)(2), (c)(3). And, the FDA
observes, only the manufacturer is positioned to demonstrate
that a product is “appropriate for the protection of the public
health.” § 387j(c)(2)(A). Putting these provisions together,
the FDA says that the TCA is concerned exclusively with
the interests of the manufacturer. Retailers are outside the
TCA's zone of interests.
Page Proof Pending Publication
   These arguments, which focus almost entirely on § 387j,
cannot be squared with § 387l(a)(1)—the provision that creates the cause of action. Start with the textual oddity of
using the phrase “any person adversely affected” to describe
a cause of action that only one person—the applicant manufacturer—could use. “Read naturally, the word `any' has an
expansive meaning, that is, `one or some indiscriminately of
whatever kind.' ” United States v. Gonzales, 

(1997) (quoting Webster's Third New International Dictionary 97 (1976)). Congress's use of “any” suggests that a
denial order can adversely affect multiple persons.
   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. 

. We said that “[w]e know
of no other context in which the words carry this artifcially
narrow meaning, and if that is what Congress intended,”
238           FDA v. R. J. REYNOLDS VAPOR CO.

                      Opinion of the Court

then “it would more naturally have said `person claiming to
have been discriminated against' rather than `person claiming to be aggrieved.' ” 

 We saw “no basis in text or
prior practice for limiting the latter phrase” to the single
person who engaged in protected conduct. 

 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, 

, 675–676 (2025) (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 § 387l(a)(1)
by stressing that it applies not only to denial orders under
§ 387j(c), but also to regulations promulgated under § 387g.
Page Proof Pending Publication
See also post, at 251 (Jackson, J., dissenting). The provision's breadth, the FDA says, accommodates the latter context: Regulations affect more than one person, even if a denial order affects only the applicant. So, the FDA stresses,
its interpretation does not read the phrase “any person” out
of the provision. Fair enough. But it does read the phrase
“an applicant” into the provision. Congress did not enact a
narrow cause of action for denial orders and a broader one
for regulations. Instead, it brought them under the same
umbrella, using the same language—“any person adversely
affected”—to cover both contexts. The FDA's spin on the
provision proposes to undo that choice.
   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.
§ 387j(d)(2). The difference between “holder of [the] application” and “any person adversely affected” is conspicuous.
When Congress uses “one term in one place, and a materially
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 (2025)                   239

                          Opinion of the Court

different term in another, the presumption is that the different term denotes a different idea.” A. Scalia & B. Garner,
Reading Law 170 (2012); see also, e. g., Southwest Airlines
Co. v. Saxon, 

, 457–458 (2022). That principle
is fatal to the FDA's reading of § 387l(a)(1).
   The FDA tries to turn this liability into an asset. See
also post, at 249–250 (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
signifcant 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, 

.

Page Proof Pending Publication
   The FDA's other structural and policy arguments similarly
fail. See also post, at 246–248 (Jackson, J., dissenting). It
claims that § 387j's statutory structure suggests that only the
applicant has a protected stake in the application process.
In particular, it highlights the confdentiality protections, arguing that they could prevent a retailer from obtaining the
information necessary to mount a successful challenge. See
§ 387f(c) (applying protection to information obtained by the
FDA through § 387j's application process). Maybe—though
the confdentiality provisions did not frustrate this lawsuit.
In any event, § 387l(a)(1) asks whether a petitioner is “adversely affected” by the denial order, not whether a petitioner is the person best positioned to challenge a denial
order. If Congress had wanted only those with the most
information to be able to bring these challenges, it would
have said so.8
  8
    The FDA relies heavily on Block v. Community Nutrition Institute,

 (1984). See also post, at 252–254 (Jackson, J., dissenting).
But Block is readily distinguishable. The question in Block was whether
the Act at issue “preclude[d] judicial review” within the meaning of 5
240              FDA v. R. J. REYNOLDS VAPOR CO.

                          Opinion of the Court

   The retailers had the right to petition for review under
the TCA. Because Avail Vapor and the trade association
have their principal places of business in Texas and Mississippi, respectively, they could both fle in the Fifth Circuit.
So when it denied the FDA's motion to dismiss or transfer,
the Fifth Circuit correctly concluded that at least one proper
petitioner had venue.
                              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 venue. RJR Vapor and the RJRaffliated retailer, standing alone, could not fle in the Fifth
Circuit. Thus, the FDA says, the Fifth Circuit must dismiss
the RJR petitions even if the other retailers may petition for
review there.
Page Proof Pending Publication
  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 frst time in this Court.
OBB Personenverkehr AG v. Sachs, 

 (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 beneft of developed arguments on both sides
and lower court opinions squarely addressing the question.”

U. S. C. § 701(a)(1), such that milk consumers could not invoke the APA's
omnibus cause of action to challenge the Secretary of Agriculture's milk
market orders. Block, 

. We held that consumers
could not sue under the APA, primarily because the Act itself included a
separate cause of action enabling dairy handlers (and not consumers) to
seek judicial review of the orders after frst exhausting administrative
remedies. See 

 at 345–347 (citing 7 U. S. C. § 608c(15)). Allowing consumers to sue under the APA would have frustrated that scheme. Block,
467 U. S., at 345–347. This case—which involves a single cause of action
and no administrative exhaustion requirement—is not analogous.
                   Cite as: 

 (2025)           241

                     Jackson, J., dissenting

Yee v. Escondido, 

 (1992). Prudence counsels that course here, because anything we say about the
TCA's venue provisions would inevitably inform debates
about similar statutes—including 

(e)(1), the
general venue statute for lawsuits against the Government.

                         …
  We affrm 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.

  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 marPage Proof Pending Publication
keted 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 nullifes 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 nothing in
this statute suggests that Congress meant to authorize
242           FDA v. R. J. REYNOLDS VAPOR CO.

                     Jackson, J., dissenting

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,” defned as a
Page Proof Pending Publication
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, 

, 551–552 (2025); § 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 manufacturer must
produce any “samples of such tobacco product” that the
agency “may reasonably require.” § 387j(b)(1)(E).
                   Cite as: 

 (2025)            243

                     Jackson, J., dissenting

  “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.' ” 

at 552 (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 specifcally provides
that “any person adversely affected” by the FDA's denial
“may fle 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).

Page Proof Pending Publication
  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., 

 (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 232–233. 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
244           FDA v. R. J. REYNOLDS VAPOR CO.

                      Jackson, J., dissenting

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, 

 (quoting Allen v. Wright, 

(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., 

 (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.' ” 

 (quoting Block v. Community
Nutrition Institute, 

 (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
Page Proof Pending Publication
weighed.” Clarke, 

. 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, 

.
   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.” 

 at 129 (quoting 

(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 (specifcally, “an injury to a
commercial interest in reputation or sales”). 572 U. S., at
131–132.
                   Cite as: 

 (2025)            245

                     Jackson, J., dissenting

   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 233–234. Notably, we have observed that such
breadth is necessary in the context of that statute in order
to “preserv[e] the fexibility” of the APA's provisions, which
apply in a range of contexts. Lexmark, 

.
   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 232. 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 specifc provision.
See ante, at 233–235. I wholeheartedly agree. Whatever
the underlying statute, our task is “to determine the meaning of the congressionally enacted provision creating a cause

Page Proof Pending Publication
of action,” which we do by “apply[ing] traditional principles
of statutory interpretation.” Lexmark, 

.
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 plain-
246            FDA v. R. J. REYNOLDS VAPOR CO.

                      Jackson, J., dissenting

tiff relies” for his legal claim—that is, “ `the statutory provision whose violation forms the legal basis for his complaint.' ”
Bennett v. Spear, 

, 175–176 (1997) (quoting
Lujan v. National Wildlife Federation, 

(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, 

, 523–524 (1991); Thompson v. North American Stainless, LP, 

(2011).
   Respondents here allege that the FDA improperly denied
a marketing application fled 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 estabPage Proof Pending Publication
lishes 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 242, 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
                   Cite as: 

 (2025)             247

                      Jackson, J., dissenting

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).
Page Proof Pending Publication
   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 confdentiality, 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 confdential information to
nonapplicants); 

 (2021) (recognizing that
“the intent to market a tobacco product that is not currently
248               FDA v. R. J. REYNOLDS VAPOR CO.

                          Jackson, J., dissenting

marketed is of ten 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.

Page Proof Pending Publication
   But retailers are differently situated. As a general matter, 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
   1
     Contrary to the majority's assertion (ante, at 236, n. 7), the fact that
retailers can face criminal penalties for selling a tobacco product that lacks
FDA approval tells us nothing about the scope of the statute's zone of
interest related to the FDA's denial of a manufacturer's marketing application. After all, it is not Congress's decision to deny a manufacturer's
marketing application that subjects a retailer to criminal penalties; a retailer never has a legal right to sell an unauthorized product—before or
after an application is submitted. See infra this page and 249. So,
although retailers may hope that the FDA will grant a particular application, the FDA's failure to do so does not impact the retailer's
rights. What is more, the zone-of-interest inquiry asks us to consider
who Congress intended to weigh in on the FDA's decision to deny the
manufacturer authorization to market the product. Neither Congress's
general prohibition on the sale of unauthorized tobacco products nor the
mechanisms it has provided for the enforcement of that prohibition speaks
to the threshold authorization issue.
                   Cite as: 

 (2025)           249

                     Jackson, J., dissenting

the FDA approves it). A retailer may desire to sell an upcoming (not-yet-approved) product—it may even expect to
proft 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 confrmed by a provision of § 387j that enables the
Page Proof Pending Publication
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 signifcant 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 fle a lawsuit to challenge the FDA's denial of a manufacturer's application in the frst 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
250           FDA v. R. J. REYNOLDS VAPOR CO.

                     Jackson, J., dissenting

lack any fnancial 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 coffn 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 fle 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)?
Page Proof Pending Publication
   The majority offers no explanation, stating only that this
differential treatment was Congress's “choice.” Ante, at
238. 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, 

 (2025) (Jackson, J., dissenting). 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
                   Cite as: 

 (2025)           251

                     Jackson, J., dissenting

view, retailers ft 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 237. But as I have already noted, fxating
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. 

 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 acknowlPage Proof Pending Publication
edge that § 387l(a)(1)'s seemingly infnite 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 237. 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
252           FDA v. R. J. REYNOLDS VAPOR CO.

                      Jackson, J., dissenting

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 233 (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 245. 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

Page Proof Pending Publication
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
diffcult to understand why the majority fnds 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, 

. 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, 

), the Court reasoned, because
                    Cite as: 

 (2025)             253

                      Jackson, J., dissenting

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.” 

 at 346–347. The Court
recognized that “[i]n a complex scheme of this type, the omission of such a provision is suffcient reason to believe that
Congress intended to foreclose consumer participation in the
regulatory process.” 

   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
Page Proof Pending Publication
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.” 

. 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, 

, 153–154
(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
254              FDA v. R. J. REYNOLDS VAPOR CO.

                          Jackson, J., dissenting

that certain industry participants could seek judicial review
only “af ter first exhausting administrative remedies. ”
Ante, at 240, 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 “suffcient 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. 

.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 232–235.
Page Proof Pending Publication
   Those cases are really of no help because, in each of them,
the plaintiff was expressly protected by the statute at issue,
and thus ft 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

  2
    In any event, permitting retailers to sue would “frustrat[e]” the statutory scheme at issue here, too. Ante, at 240, n. 8. When the FDA denies
a manufacturer's application, the manufacturer faces a choice. It can (1)
stand on its initial application and challenge the FDA's denial in court; (2)
attempt to address its application's shortcomings (by, for example, fxing
the part of its manufacturing or processing facilities that the FDA deemed
insuffcient, see 21 U. S. C. § 387j(c)(2)(B)); or (3) give up on the product.
Allowing retailers to challenge the denial in court deprives the manufacturer of agency over its own application, and risks manufacturers and retailers taking inconsistent actions after an application is denied. Of
course, there may be times in which a retailer and a manufacturer are in
lockstep. But, in that situation, one wonders why a retailer needs to be
able to sue at all—beyond, of course, its desire to bring a legal challenge
in a venue unavailable to the manufacturer. See infra, at 257.
                   Cite as: 

 (2025)            255

                     Jackson, J., dissenting

employees from their employers' unlawful actions.” 

. And in Bank of America Corp. v. Miami, 

 (2017), the statute had specifcally defned “ `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. 

.
  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 236 (quoting Thompson, 

; 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 236, and
n. 7. That's because they can't. No matter how long you
stare at § 387j, you will not fnd anything looking out for

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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 specifcally prescribed where that review must be sought.
Again, the text states that “any person adversely affected”
by the FDA's denial “may fle 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 qualifes 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
256              FDA v. R. J. REYNOLDS VAPOR CO.

                         Jackson, J., dissenting

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 fled its application, the
D. C. Circuit and the Fourth Circuit had each already rejected on the merits similar challenges that other favored e-
cigarette manufacturers had fled. See Avail Vapor, LLC v.
FDA, 

 (CA4 2022); Prohibition Juice
Co. v. FDA, 

, 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 favored e-cigarette marketing applications be fled somewhere
else. To accomplish that objective—i. e., to facilitate RJR
Vapor's end run around § 387l(a)(1)'s venue restrictions—

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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 fled 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
  3
    RJR Vapor is incorporated in North Carolina and maintains its principal place of business there too.
  4
    Two other parties were also included on the petition: the Mississippi
Petroleum Marketers and Convenience Stores Association and an RJR
Vapor corporate affliate that sold the relevant product. The presence of
these parties does not affect the legal analysis.
  5
    Although a Fifth Circuit panel had rejected a similar arbitrary-andcapricious challenge levied against the FDA's denial of a similar applica-
                       Cite as: 

 (2025)                    257

                          Jackson, J., dissenting

   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

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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 fle in other places on their behalf.

tion, see Wages & White Lion Investments, L.L.C. v. FDA, 

, 436–439 (2022), the Circuit had vacated that decision and granted
rehearing en banc at the point in which RJR Vapor and Avail Vapor fled
their joint action, see 

 (2023). That vacatur strongly
suggested that the full Fifth Circuit would come out against the FDA—
as, indeed, it eventually did. See 

, 362, 371 (2024) (en banc).
We later vacated the Fifth Circuit's en banc decision, disagreeing with its
primary holding. See FDA v. Wages & White Lion Investments, LLC,

 (2025).
258           FDA v. R. J. REYNOLDS VAPOR CO.

                     Jackson, J., dissenting

                        …
   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.
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                           Reporter’s Note

  The attached opinion has been revised to refect the usual publication
and citation style of the United States Reports. The revised pagination
makes available the offcial United States Reports citation in advance of

Page Proof Pending Publication
publication. The syllabus has been prepared by the Reporter of Decisions
for the convenience of the reader and constitutes no part of the opinion of
the Court. A list of counsel who argued or fled briefs in this case, and
who were members of the bar of this Court at the time this case was
argued, has been inserted following the syllabus. Other revisions may
include adjustments to formatting, captions, citation form, and any errant
punctuation. The following additional edits were made:

None