Opinion of the Court
Amy Coney Barrett
(Slip Opinion) OCTOBER TERM, 2024 1
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337 .
SUPREME COURT OF THE UNITED STATES
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 FIFTH 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 prod-
uct.” 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, finding that 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
significant 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 filed 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 Mis-
2 FDA v. R. J. REYNOLDS VAPOR CO.
Syllabus
sissippi-based trade association of retailers to challenge the FDA’s de-
nial order in the Fifth Circuit (which includes both Texas and Missis-
sippi). 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.
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. 3–12.
(a) To invoke a statutory cause of action, a plaintiff must be within
the “zone of interests” that the statute protects. Lexmark Int’l, Inc. v.
Static Control Components, Inc., 572 U. S. 118, 129 . That means a
plaintiff must belong to the class of persons to which the statute grants
a right to sue, which under the TCA is “any person adversely affected”
by the FDA’s “denial.” §387l(a)(1).
“Adversely affected” (and its variations like “adversely affected or
aggrieved”) is a term of art with a “long history in federal administra-
tive law.” Director, Office of Workers’ Compensation Programs v. New-
port News Shipbuilding & Dry Dock Co., 514 U. S. 122, 126 . Many
statutes use the term, most notably the Administrative Procedure Act
(APA), which entitles anyone “adversely affected or aggrieved by
agency action within the meaning of a relevant statute . . . to judicial
review.” 5 U. S. C. §702 . The Court has interpreted “adversely af-
fected” 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,
397 U. S. 150, 153 (emphasis added).
The FDA insists that the capacious understanding of “adversely af-
fected” is unique to the APA, and that other statutes require a person
to “actually”—not “arguably”—fall within the statute’s zone of inter-
ests. 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. In-
stead, 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 stat-
utes. See, e.g., Bank of America Corp. v. Miami, 581 U. S. 189, 193
(interpreting “aggrieved person” in the Fair Housing Act); Thompson
Cite as: 606 U. S. ____ (2025) 3
Syllabus
v. North American Stainless, LP, 562 U. S. 170, 177 (interpreting “per-
son claiming to be aggrieved” in Title VII); Newport News, 514 U. S.,
at 123 (interpreting “person adversely affected or aggrieved” in the
Longshore and Harbor Workers’ Compensation Act). Taken together,
these cases reflect 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 ad-
versely affected by [the FDA’s] denial” may petition for judicial review.
§387l(a)(1). The retailers fit the bill. If the FDA denies an application,
the retailers lose the opportunity to profit from the sale of the new to-
bacco product—or, if they sell the product anyway, risk imprisonment
and other sanctions. See §§331, 333(a), 387b(6)(A), 387j(a)–(c). Ac-
cordingly, the retailers are “adversely affected” by a denial order and
are therefore proper petitioners under §387l(a)(1). Pp. 3–8.
(b) The FDA argues that the TCA’s text and structure reflect Con-
gress’s choice to offer judicial review only to manufacturers denied per-
mission 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 “appli-
cant.” And there is “no basis in text or prior practice” for limiting “per-
son adversely affected” to mean “the applicant.” Cf. Thompson, 562
U. S. 170 (rejecting analogous argument that Title VII’s use of “person
claiming to be aggrieved” refers to a single person). Congress knows
how to limit the scope of a cause of action—in fact, it did so elsewhere
in the TCA. When the FDA withdraws an existing approval of an ap-
plication to market a new tobacco product, only the “holder of [the] ap-
plication” may challenge the withdrawal order. §387j(d)(2). Con-
gress’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 dif-
ferent 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 ad-
versely affected.”
The retailers had the right to petition for review under the TCA, and
4 FDA v. R. J. REYNOLDS VAPOR CO.
Syllabus
the Fifth Circuit denied the FDA’s motion to dismiss or transfer be-
cause it correctly concluded that at least one proper petitioner had
venue. Pp. 8–12.
(c) The FDA now argues that each petitioner in a joint petition for
review must independently establish venue. The FDA did not make
that argument in the Fifth Circuit. The Court rarely addresses an ar-
gument raised first to the Court, see OBB Personenverkehr AG v.
Sachs, 577 U. S. 27, 38 , and prudence counsels against doing so here.
Pp. 12–13.
Affirmed and remanded.
BARRETT, J., delivered the opinion of the Court, in which ROBERTS,
C. J., and THOMAS, ALITO, KAGAN, GORSUCH, and KAVANAUGH, JJ., joined.
JACKSON, J., filed a dissenting opinion, in which SOTOMAYOR, J., joined.
Cite as: 606 U. S. ____ (2025) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the
United States Reports. Readers are requested to notify the Reporter of
Decisions, Supreme Court of the United States, Washington, D. C. 20543,
pio@supremecourt.gov, of any typographical or other formal errors.
SUPREME COURT OF THE UNITED STATES
_________________
No. 23–1187
_________________
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
[June 20, 2025]
JUSTICE BARRETT delivered the opinion of the Court.
The Family Smoking Prevention and Tobacco Control Act
(TCA) requires manufacturers to apply for and receive ap-
proval from the Food and Drug Administration (FDA) be-
fore marketing any “new tobacco product.” 123 Stat. 1807 ,
21 U. S. C. §387j. Companies that manufacture or sell new
tobacco products without the FDA’s approval face signifi-
cant 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 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 In-
vestments, LLC, 604 U. S. ___ , ___–___ (2025) (slip op., at
2 FDA v. R. J. REYNOLDS VAPOR CO.
Opinion of the Court
6–9). They could therefore be sold without the FDA’s ap-
proval, and over the years, a large market developed. See
ibid. But in 2016, the FDA changed direction: It announced
that e-cigarettes and related products are subject to the
TCA after all. 81 Fed. Reg. 29028–29044 (2016). Given the
size of the e-cigarette market, pulling products from the
shelves while manufacturers sought “premarket” authori-
zation to sell them would have been disruptive. To mitigate
the disruption, the FDA announced that it would defer en-
forcement of the TCA against e-cigarette manufacturers
and retailers while the manufacturers sought FDA ap-
proval. Id., at 29009–29015.
R. J. Reynolds Vapor Co. (RJR Vapor) manufactures e-
cigarettes, including the popular menthol- and mixed-
berry-flavored Vuse Alto products. It timely applied for au-
thorization 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 mar-
keting 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 significant portion of the e-
cigarette market.
When the FDA denies premarket authorization, “any per-
son adversely affected” by the denial may petition for judi-
cial 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). RJR Vapor is incorporated and has
its principal place of business in North Carolina; thus, had
it filed alone, its options were the D. C. Circuit and the
Fourth Circuit. Rather than filing alone, however, RJR Va-
por 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 Mis-
sissippi Petroleum Marketers and Convenience Stores As-
sociation, a trade association of gas stations and conven-
ience stores; and another North Carolina-based RJR
Cite as: 606 U. S. ____ (2025) 3
Opinion of the Court
corporate affiliate that sold Vuse products online. RJR Va-
por and the retailers filed a joint petition in the Fifth Cir-
cuit, where Avail Vapor and the trade association are lo-
cated.
The FDA asked the court to either dismiss the joint peti-
tion for lack of venue or transfer it to the D. C. Circuit or
Fourth Circuit. It pointed out that under the TCA, only
those “adversely affected” by the denial of premarket au-
thorization 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 mean-
ing of the TCA. Because the retailers had no right to seek
review, the FDA argued, the petition had no basis for being
in the Fifth Circuit. RJR Vapor could file in the D. C. Cir-
cuit (the default) or the Fourth Circuit (its home).
A divided Fifth Circuit panel denied the FDA’s motion
and concluded that venue was proper over the joint petition
to review the FDA’s denial order.1 The FDA sought this
Court’s review of the Fifth Circuit’s order, and we granted
certiorari.2 603 U. S. ___ (2024).
II
A
To invoke a statutory cause of action, a plaintiff must be
within the “zone of interests” that the statute protects.
——————
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. Mad-
ison, 1 Cranch 137 , 175 (1803). The respondents argue that we are un-
constitutionally exercising original jurisdiction because the Court of Ap-
peals has not yet adjudicated the merits of their petition. This argument
is clever but misguided. We are reviewing the Fifth Circuit’s order deny-
ing 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 first instance.
4 FDA v. R. J. REYNOLDS VAPOR CO.
Opinion of the Court
Lexmark Int’l, Inc. v. Static Control Components, Inc., 572
U. S. 118, 129 (2014).3 Put differently, a plaintiff must be-
long to the class of persons to whom the statute grants a
right to sue. Id., at 127 . Under the TCA, the relevant class
is “any person adversely affected” by the FDA’s “denial.” 21
U. S. C. §387l(a)(1).
“Adversely affected” (and its variations like “adversely af-
fected or aggrieved”) is a term of art with a “long history in
federal administrative law.” Director, Office of Workers’
Compensation Programs v. Newport News Shipbuilding &
Dry Dock Co., 514 U. S. 122, 126 (1995); see also Brief for
New Civil Liberties Alliance as Amicus Curiae 26–27
(claiming that 124 statutes use variations of “adversely af-
fected”). 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 judi-
cial review.”4 5 U. S. C. §702 . We have interpreted “ad-
versely affected” broadly, as covering anyone even “argua-
bly within the zone of interests to be protected or regulated
by the statute . . . in question.” Association of Data Pro-
cessing Service Organizations, Inc. v. Camp, 397 U. S. 150,
153 (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
——————
3 Though we once applied the zone-of-interests test as part of a “pru-
dential standing” doctrine, we have abandoned that label as “mislead-
ing.” Bank of America Corp. v. Miami, 581 U. S. 189 , 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.” Ibid.
The zone-of-interests test is part of the ordinary statutory interpretation
analysis that courts employ to answer that question. Lexmark, 572 U. S.,
at 127 .
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 acted. See Association of Data Processing Service Organizations,
Inc. v. Camp, 397 U. S. 150, 153 (1970).
Cite as: 606 U. S. ____ (2025) 5
Opinion of the Court
it cannot reasonably be assumed that Congress intended to
permit the suit.” Clarke v. Securities Industry Assn., 479
U. S. 388, 399 (1987). The inquiry is “not especially de-
manding.” Lexmark, 572 U. S., at 130 (internal quotation
marks omitted).
The FDA, however, attempts to ratchet up the standard.
It insists that the capacious understanding of “adversely af-
fected” is unique to the APA, whose “omnibus judicial-re-
view provision . . . permits suit for violations of numerous
statutes of varying character that do not themselves in-
clude causes of action for judicial review.” Ibid.; see also,
e.g., Bennett v. Spear, 520 U. S. 154, 163 (1997). For stat-
utes 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 rela-
tionship to the application—the applicant.
We have not drawn the distinction that the FDA pro-
poses. On the contrary, when we have interpreted varia-
tions 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-in-
terests test. For instance, in Bank of America Corp. v. Mi-
ami, we interpreted the Fair Housing Act’s (FHA) cause of
action—which permits any “aggrieved person” to sue. 581
U. S. 189, 193 (2017); 42 U. S. C. §3613 (a)(1)(A). Citing our
canonical articulation 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 inter-
ests that the FHA sought to protect. 581 U. S., at 197–201.
Thompson v. North American Stainless, LP, runs in the
same vein. 562 U. S. 170 (2011). There, we interpreted the
scope of Title VII’s cause of action, which permits a “person
claiming to be aggrieved” to sue. 42 U. S. C. §2000e–5(f )(1).
We held that this cause of action is neither so narrow as to
6 FDA v. R. J. REYNOLDS VAPOR CO.
Opinion of the Court
include only the person claiming to be the victim of discrim-
ination nor so broad as to encompass every person with Ar-
ticle III standing. Thompson, 562 U. S., at 177 . 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.’ ” Id., at 177–178
(quoting National Credit Union Admin. v. First Nat. Bank
& Trust Co., 522 U. S. 479, 495 (1998)). Under this test, an
employee who had allegedly been fired in retaliation for the
protected activity of his fiancée (who was also his co-
worker) was “aggrieved” and could sue. Thompson, 562
U. S., at 178 .
Finally, in Newport News, we had to decide whether the
Director of the Office of Workers’ Compensation Programs
in the Department of Labor was “[a] person adversely af-
fected or aggrieved by a final order” under the Longshore
and Harbor Workers’ Compensation Act. 514 U. S., at 123 ;
44 Stat. 1436 , 33 U. S. C. §921 (c). To answer this question,
we considered the history of this “term of art” across admin-
istrative law, including our canonical interpretation of it
under the APA: “[A] litigant [must] show . . . that the inter-
est he seeks to vindicate is arguably within the ‘zone of in-
terests to be protected or regulated by the statute.’ ” New-
port News, 514 U. S., at 126–127 (quoting Data Processing,
397 U. S., at 153 ; emphasis added). Considering the “long
lineage” of this language, we found it telling that neither
we nor any court of appeals had ever held, under the APA
or otherwise, that “an agency, in its regulatory or policy-
making capacity, is ‘adversely affected’ or ‘aggrieved.’ ”
Newport News, 514 U. S., at 127 .
Taken together, these cases reflect a presumption that
the term “adversely affected” carries the same meaning out-
side the APA as in it.5 The Fair Housing Act, Title VII, and
——————
5 The FDA invokes Bennett and Lexmark for support, but the statutes
Cite as: 606 U. S. ____ (2025) 7
Opinion of the Court
the Longshore and Harbor Workers’ Compensation Act
have different histories, scopes, and purposes. Yet in inter-
preting each statute, we borrowed principles from cases de-
scribing 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
that “any person adversely affected by [the FDA’s] denial”
may petition for judicial review. 21 U. S. C. §387l(a)(1); see
also 5 U. S. C. §702 (“[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, 562
U. S., at 178 (quoting National Credit Union Admin., 522
U. S., at 495 ; alterations omitted). The retailers fit the bill.
If the FDA denies an application, the retailers, like the
manufacturer, lose the opportunity to profit from the sale
——————
at issue in those cases did not use variations of the phrase “adversely
affected” to create a cause of action. See 16 U. S. C. §1540 (g) (Bennett v.
Spear, 520 U. S. 154 (1997)); 15 U. S. C. §1125 (a)(1) (Lexmark Int’l, Inc.
v. Static Control Components, Inc., 572 U. S. 118 (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” pre-
dates the APA. Director, Office of Workers’ Compensation Programs v.
Newport News Shipbuilding & Dry Dock Co., 514 U. S. 122, 126 (1995).
But the FDA has not shown that the pre-APA definition 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, 562
U. S. 170 (2011). Even our pre-APA construction of “adversely affected”
was quite broad. See, e.g., FCC v. Sanders Brothers Radio Station, 309
U. S. 470 , 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).
8 FDA v. R. J. REYNOLDS VAPOR CO.
Opinion of the Court
of the new tobacco product—or, if they sell the product an-
yway, risk imprisonment and other sanctions. See 21
U. S. C. §§331 , 333(a), 387b(6)(A), 387j(a)–(c). Given this
significant, direct impact on retailers, their interests are
not “so marginally related to or inconsistent with the pur-
poses implicit in the statute that it cannot reasonably be
assumed that Congress intended to permit the suit.”
Clarke, 479 U. S., at 399 . Accordingly, the retailers are “ad-
versely affected” by a denial order and are therefore proper
petitioners under §387l(a)(1).7
B
Resisting this conclusion, the FDA (followed by the dis-
sent) argues that the TCA’s text and structure reflect Con-
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 chal-
lenged only by the participants in the proceeding that led
to the order. It also asserts that other provisions of the stat-
——————
7 The dissent argues that the zone-of-interests inquiry turns exclu-
sively on §387j(c), which governs the FDA’s response to a marketing ap-
plication. See post, at 6 (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 over-
all context” of the relevant Act. 479 U. S. 388, 401 (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 de-
nial 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 8,
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 appli-
cation—it authorizes suit for those “adversely affected” by the denial of
an application. The retailers meet that description.
Cite as: 606 U. S. ____ (2025) 9
Opinion of the Court
ute reflect an overriding concern with the applicant manu-
facturer: Only the manufacturer may ask the FDA to refer
its application to a scientific committee, receive notice of a
denial order, or receive a statement about why the applica-
tion 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 protec-
tion of the public health.” §387j(c)(2)(A). Putting these pro-
visions together, the FDA says that the TCA is concerned
exclusively with the interests of the manufacturer. Retail-
ers are outside the TCA’s zone of interests.
These arguments, which focus almost entirely on §387j,
cannot be squared with §387l(a)(1)—the provision that cre-
ates 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 man-
ufacturer—could use. “Read naturally, the word ‘any’ has
an expansive meaning, that is, ‘one or some indiscrimi-
nately of whatever kind.’ ” United States v. Gonzales, 520
U. S. 1, 5 (1997) (quoting Webster’s Third New Interna-
tional Dictionary 97 (1976)). Congress’s use of “any” sug-
gests that a denial order can adversely affect multiple per-
sons.
Even without the word “any,” the phrase “person ad-
versely 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” re-
ferred to only the person who engaged in statutorily pro-
tected activity. 562 U. S., at 177 . We said that “[w]e know
of no other context in which the words carry this artificially
narrow meaning, and if that is what Congress intended,”
then “it would more naturally have said ‘person claiming to
have been discriminated against’ rather than ‘person claim-
ing to be aggrieved.’ ” Ibid. We saw “no basis in text or prior
practice for limiting the latter phrase” to the single person
who engaged in protected conduct. Ibid. So too here. If
10 FDA v. R. J. REYNOLDS VAPOR CO.
Opinion of the Court
Congress intended to convey the FDA’s reading, it would
more naturally have said “applicant” rather than “person
adversely affected.” And there is “no basis in text or prior
practice” for limiting “person adversely affected” to mean
“the applicant”—or, for that matter, the “party” with whom
the agency dealt. See NRC v. Texas, 605 U. S. ___ , ___
(2025) (slip op., at 9) (distinguishing between statutes that
grant a cause of action to a “party” aggrieved, as opposed to
the broader any “person” aggrieved).
The FDA tries to explain away the breadth of §387l(a)(1)
by stressing that it applies not only to denial orders under
§387j(c), but also to regulations promulgated under §387g.
See also post, at 11–12 (JACKSON, J., dissenting). The pro-
vision’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 ac-
tion—in fact, it did so elsewhere in the TCA. When the FDA
issues an order withdrawing an existing approval of an ap-
plication 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 Con-
gress uses “one term in one place, and a materially 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.
Cite as: 606 U. S. ____ (2025) 11
Opinion of the Court
Saxon, 596 U. S. 450 , 457–458 (2022). That principle is fa-
tal to the FDA’s reading of §387l(a)(1).
The FDA tries to turn this liability into an asset. See also
post, at 9–10 (JACKSON, J., dissenting). It argues that Con-
gress 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 sig-
nificant reliance interests). Yet Congress made this very
choice by using different language for the two types of chal-
lenges. Plainly, the FDA wishes that Congress had written
the review provision differently. As we have explained be-
fore, however, “[w]e do not ask whether in our judgment
Congress should have authorized” this lawsuit, “but
whether Congress in fact did so.” Lexmark, 572 U. S., at
128 .
The FDA’s other structural and policy arguments simi-
larly fail. See also post, at 6–8 (JACKSON, J., dissenting). It
claims that §387j’s statutory structure suggests that only
the applicant has a protected stake in the application pro-
cess. In particular, it highlights the confidentiality protec-
tions, arguing that they could prevent a retailer from ob-
taining 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 confidentiality provisions did not frus-
trate 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 chal-
lenge a denial order. If Congress had wanted only those
with the most information to be able to bring these chal-
lenges, it would have said so.8
——————
8 The FDA relies heavily on Block v. Community Nutrition Institute,
467 U. S. 340 (1984). See also post, at 12–14 (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
U. S. C. §701 (a)(1), such that milk consumers could not invoke the APA’s
12 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 Missis-
sippi, respectively, they could both file 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 “ad-
versely affected,” the FDA advances an argument in this
Court that it failed to make in the Fifth Circuit: It main-
tains that each petitioner in a joint petition for review must
independently establish venue. RJR Vapor and the RJR-
affiliated retailer, standing alone, could not file 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.
No court, including the Fifth Circuit in this case, has an-
alyzed whether every petitioner in a joint petition must in-
dependently satisfy the TCA’s venue provisions. We rarely
address an argument raised for the first time in this Court.
OBB Personenverkehr AG v. Sachs, 577 U. S. 27, 38 (2015).
In the ordinary course, “[p]rudence . . . dictates awaiting a
case in which the issue was fully litigated below, so that we
will have the benefit of developed arguments on both sides
and lower court opinions squarely addressing the question.”
——————
omnibus cause of action to challenge the Secretary of Agriculture’s milk
market orders. Block, 467 U. S., at 341, 345 . 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 first exhausting administrative
remedies. See id., at 345–347 (citing 7 U. S. C. §608c(15)). Allowing con-
sumers 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: 606 U. S. ____ (2025) 13
Opinion of the Court
Yee v. Escondido, 503 U. S. 519, 538 (1992). Prudence coun-
sels that course here, because anything we say about the
TCA’s venue provisions would inevitably inform debates
about similar statutes—including 28 U. S. C. §1391 (e)(1),
the general venue statute for lawsuits against the Govern-
ment.
* * *
We affirm the Fifth Circuit’s denial of the FDA’s motion
and remand the case for further proceedings consistent
with this opinion.
It is so ordered.
Cite as: 606 U. S. ____ (2025) 1
JACKSON, J., dissenting
SUPREME COURT OF THE UNITED STATES
_________________
No. 23–1187
_________________
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
[June 20, 2025]
JUSTICE JACKSON, with whom JUSTICE SOTOMAYOR joins,
dissenting.
The statute at issue in this case requires tobacco manu-
facturers to receive permission from the Food and Drug Ad-
ministration (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 un-
der the relevant statutory provisions. And, here, all the
usual tools of statutory interpretation point in the same di-
rection: Congress established a detailed scheme for manu-
facturers 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, Con-
gress provided a cause of action for the protection of the
manufacturers’ statutorily created interests. Because noth-
2 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
ing in this statute suggests that Congress meant to author-
ize retailers to sue to challenge the FDA’s denial of a man-
ufacturer’s marketing application, much less bring that le-
gal 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 rec-
ognizing 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 with-
out 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 mar-
ket 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 inves-
tigations 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-
Cite as: 606 U. S. ____ (2025) 3
JACKSON, J., dissenting
ufacturer must produce any “samples of such tobacco prod-
uct” that the agency “may reasonably require.”
§387j(b)(1)(E).
“There are many reasons why the FDA may deny mar-
keting 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 fail-
ure to make this showing, or if the application is denied for
any other reason, the statute further authorizes judicial re-
view 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 ad-
versely affected” by the FDA’s denial means in the context
of this statute.
II
A
“Read literally,” the “broad language” of the Tobacco Con-
trol 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
4 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
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 de-
ciding whether . . . a particular plaintiff should be heard to
complain of a particular agency decision.” Clarke v. Securi-
ties Industry Assn., 479 U. S. 388, 399 (1987). “The essen-
tial inquiry is whether Congress ‘intended for [this particu-
lar] 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 altera-
tions 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 ad-
vertising.” Id., at 129 (quoting 15 U. S. C. §1125 (a)(1)). Ap-
plying 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
Cite as: 606 U. S. ____ (2025) 5
JACKSON, J., dissenting
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 per-
sons to sue—be it the APA or a more specific provision. See
ante, at 5–7. I wholeheartedly agree. Whatever the under-
lying statute, our task is “to determine the meaning of the
congressionally enacted provision creating a cause of ac-
tion,” 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 demon-
strate 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
6 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
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) re-
veals that §387j(c) is part of a statutory scheme that estab-
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 re-
views it, the statute requires a particular agency response:
The FDA “shall” “issue an order that the new product” ei-
ther may be, or may not be, “introduced . . . into interstate
commerce.” §387j(c)(1)(A).
The FDA makes this marketing-approval decision in ac-
cordance with the statute’s directives, by considering the
manufacturer’s marketing application in all of its particu-
lars. 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 meth-
ods used in, and the facilities and controls used for, the
manufacture, processing, and . . . packing” of the product;
Cite as: 606 U. S. ____ (2025) 7
JACKSON, J., dissenting
and, in some instances, samples of the product itself.
§387j(b)(1). The manufacturer gathers all of that infor-
mation 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 re-
quired to submit any information to the FDA on their be-
half.
Nor do retailers, in particular, have any procedural rights
whatsoever after a manufacturer submits its marketing ap-
plication. Indeed, in many circumstances, the FDA is re-
quired 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 pro-
duction, 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 requi-
site 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 sup-
plement 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
8 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
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 cur-
rently marketed is often considered confidential commer-
cial 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 pre-
marketing-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. Manu-
facturers plainly fall within that category: At the time a
manufacturer applies for authorization to market a new to-
bacco product, it has already expended considerable time,
money, and effort to develop that product.
But retailers are differently situated. As a general mat-
——————
1 Contrary to the majority’s assertion (ante, at 8, 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 ap-
plication. After all, it is not Congress’s decision to deny a manufacturer’s
marketing application that subjects a retailer to criminal penalties; a re-
tailer never has a legal right to sell an unauthorized product—before or
after an application is submitted. See infra, at 9. 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 pro-
vided for the enforcement of that prohibition speaks to the threshold au-
thorization issue.
Cite as: 606 U. S. ____ (2025) 9
JACKSON, J., dissenting
ter, when a manufacturer applies for authorization to mar-
ket 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 be-
fore 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 invest-
ment; it can stock its shelves with something else. Thus,
Congress could have rationally intended to protect manu-
facturers’ reliance interests by affording them a layer of ju-
dicial review if the FDA denies a marketing application,
while feeling no need to extend similar protection to retail-
ers.
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 con-
text—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 de-
nial 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
10 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
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 to-
bacco 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 gen-
erally 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.” Ad-
vocate 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 inter-
est of this statutory scheme.
III
A
Ignoring our past edicts regarding how the zone-of-
Cite as: 606 U. S. ____ (2025) 11
JACKSON, J., dissenting
interest test works, the majority spends very little time
evaluating the substantive provisions of the Tobacco Con-
trol 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 provi-
sion substantially similar to the ones that prompted us to
birth the zone-of-interest test gets us nowhere—at least, no-
where remotely resembling the traditional inquiry and
what it was designed to do. This observation is fundamen-
tal; as our foundational zone-of-interest precedents recog-
nized, a literal reading of capacious cause-of-action lan-
guage 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 conse-
quences” 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 terminol-
ogy can be adequately explained by a linguistic quirk that
has little to do with Congress’s “choice” to allow any argua-
bly affected person to sue. Carefully examined, the text of
this provision permits suit by “any person adversely af-
fected 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
12 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
who is included in either category. Ante, at 9. So, ulti-
mately, 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 inter-
pretation 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 Con-
gress 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 manufac-
turers 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 in-
terest 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
Cite as: 606 U. S. ____ (2025) 13
JACKSON, J., dissenting
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 increas-
ing the price of milk. Consumers were not in the zone of
interest (and thus were not “adversely affected” persons un-
der the relevant cause of action, id., at 345 ), the Court rea-
soned, because of the structure of the underlying adminis-
trative 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 par-
ticipation in the regulatory process.” Ibid.
In the same way that the Agricultural Marketing Agree-
ment Act contemplated collaboration between the agency,
milk handlers, and milk producers—but not consumers—
the Tobacco Control Act’s premarket-authorization pro-
gram contemplates collaboration between the agency and
manufacturers—but not retailers. Therefore, here, just as
in Block, the absence of any mechanism for retailers to par-
ticipate in that collaborative premarketing-approval pro-
cess 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 reali-
zation 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 chal-
lenge unlawful agency action and to ensure that the stat-
ute’s objectives will not be frustrated.” Ibid.; cf. Joint Anti-
Fascist Refugee Comm. v. McGrath, 341 U. S. 123 , 153
14 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
(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 Govern-
ment 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 re-
view 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 partici-
pate in the administrative process was in and of itself a
“sufficient reason” to believe that Congress intended to ex-
clude 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 straight-
forward 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
——————
2 In any event, permitting retailers to sue would “frustrat[e]” the stat-
utory scheme at issue here, too. Ante, at 11–12, 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 ex-
ample, fixing the part of its manufacturing or processing facilities that
the FDA deemed insufficient, 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 appli-
cation 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 17–18.
Cite as: 606 U. S. ____ (2025) 15
JACKSON, J., dissenting
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 pro-
tect 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 an-
yone 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 ex-
plains how retailers may be affected by §387j but never ar-
ticulates how retailers are protected by this statute—not ar-
guably, 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
16 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
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 “per-
son 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 re-
jected 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 per-
spective 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 facil-
itate RJR Vapor’s end run around §387l(a)(1)’s venue re-
strictions—RJR Vapor needed another party to bring its le-
gal 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 rele-
vant 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
——————
3 RJR Vapor is incorporated in North Carolina and maintains its prin-
cipal 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 affiliate that sold the relevant product. The presence of
Cite as: 606 U. S. ____ (2025) 17
JACKSON, J., dissenting
The possibility that the courts would allow venue to be es-
tablished 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 ac-
tion, nor the fact that retailers were not front of mind for
Congress when it crafted the premarketing-approval provi-
sions of the Tobacco Control Act (see Part II, supra) mat-
tered much. Regardless, it was critical for the retailers to
participate as plaintiffs if RJR Vapor was going to success-
fully 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 (in-
cluding, 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 Con-
gress 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 im-
portant to acknowledge that the statute Congress enacted
——————
these parties does not affect the legal analysis.
5 Although a Fifth Circuit panel had rejected a similar arbitrary-and-
capricious challenge levied against the FDA’s denial of a similar applica-
tion, see Wages & White Lion Investments, L.L.C. v. FDA, 41 F. 4th 427,
430 , 436–439 (2022), the Circuit had vacated that decision and granted
rehearing en banc at the point in which RJR Vapor and Avail Vapor filed
their joint action, see 58 F. 4th 233, 234 (2023). That vacatur strongly
suggested that the full Fifth Circuit would come out against the FDA—
as, indeed, it eventually did. See 90 F. 4th 357 , 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,
604 U. S. ___ , ___ (2025) (slip op., at 46).
18 FDA v. R. J. REYNOLDS VAPOR CO.
JACKSON, J., dissenting
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 re-
spondents argue the FDA violated. Every available indica-
tor reveals that Congress intended to permit manufactur-
ers—not retailers—to challenge the denial of a
manufacturers’ marketing application (and to do so only in
the designated courts). In concluding otherwise, the major-
ity not only opens up an avenue for judicial review that Con-
gress did not intend, it also allows manufacturers like RJR
Vapor to evade the statute’s venue requirements.