FDA v. R. J. Reynolds Vapor Co.

Summary

Retailers who would sell a new tobacco product if not for the FDA’s denial order may seek judicial review of that order under 21 U. S. C. §387l(a)(1).

Text

PRELIMINARY PRINT 
Volume 606 U. S. Part 1 
Pages 226–258 
OFFICIAL REPORTS 
OF 
THE SUPREME COURT 
June 20, 2025 
REBECCA A. WOMELDORF 
reporter of decisions 
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226 OCTOBER TERM, 2024 
Syllabus 
FOOD AND DRUG ADMINISTRATION et al. v. R. J. 
REYNOLDS V APOR 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 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 manu-
facturers and retailers while the manufacturers sought FDA appro-
val. 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 
RJR Vapor had failed to demonstrate that marketing Vuse Alto prod-
ucts 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 Va-
por's state of incorporation and principal place of business). RJR Vapor 
instead combined forces with a Texas-based retailer and a Mississippi-
based 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.

Cite as: 606 U. S. 226 (2025) 227 
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., 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, Offce of Workers' Compensation Programs v. 
Newport News Shipbuilding & Dry Dock Co ., 514 U. S. 122, 126. Many 
statutes use the term, most notably the Administrative Procedure Act 
(APA), which entitles anyone “adversely affected or aggrieved by 
agency action within the meaning of a relevant statute . . . to judicial 
review.” 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 interests. 
And, as the FDA sees it, under the TCA the only person actually ag-
grieved 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 for-
mulation 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, 581 U. S. 189, 193 (interpreting 
“aggrieved person” in the Fair Housing Act); Thompson v. North Amer-
ican Stainless, LP , 562 U. S. 170, 177 (interpreting “person claiming to 
be aggrieved” in Title VII); Newport News, 514 U. S., at 123 (interpret-
ing “person adversely affected or aggrieved” in the Longshore and Har-
bor 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 ad-
versely 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-
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228 FDA v. R. J. REYNOLDS V APOR 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). Ac-
cordingly, 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 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 
“person adversely affected” to mean “the applicant.” Cf. Thompson, 
562 U. S. 170 (rejecting analogous argument that Title VII's use of “per-
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 ad-
versely 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 ar-
gument raised frst to the Court, see OBB Personenverkehr AG v. 
Sachs, 577 U. S. 27, 38, and prudence counsels against doing so here. 
Pp. 240–241. 
Affrmed and remanded. 
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Cite as: 606 U. S. 226 (2025) 229 
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 Dep-
uty Assistant Attorney General Boynton, Deputy Solicitor 
General Gannon, Joshua M. Koppel, Catherine Padhi, Sam-
uel 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. Ver-
gonis, Andrew J. M. Bentz, Charles E. T. Roberts, and An-
drew 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 ap-
proval from the Food and Drug Administration (FDA) before 
marketing any “new tobacco product.” 123 Stat. 1807, 21 
U. S. C. § 387j. Companies that manufacture or sell new to-
bacco 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 Ben-
jamin 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 Stres-
senger; 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. 
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230 FDA v. R. J. REYNOLDS V APOR CO. 
Opinion of the Court 
review under the standards of the Administrative Procedure 
Act (APA). §§ 387l(a)–(b). We must decide whether retail-
ers 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 pur-
poses of the TCA. See FDA v. Wages & White Lion Invest-
ments, LLC , 604 U. S. 542, 553–556 (2025). They could 
therefore be sold without the FDA's approval, and over the 
years, a large market developed. See ibid. But in 2016, 
the FDA changed direction: It announced that e-cigarettes 
and related products are subject to the TCA after all. 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 
them would have been disruptive. To mitigate the disrup-
tion, the FDA announced that it would defer enforcement of 
the TCA against e-cigarette manufacturers and retailers 
while the manufacturers sought FDA approval. Id., at 
29009–29015. 
R. J. Reynolds Vapor Co. (RJR Vapor) manufactures e-
cigarettes, including the popular menthol- and mixed-berry-
favored Vuse Alto products. It timely applied for authori-
zation 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 per-
son adversely affected” by the denial may petition for judi-
cial review in either the D. C. Circuit or “the circuit in which 
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Cite as: 606 U. S. 226 (2025) 231 
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 Petro-
leum Marketers and Convenience Stores Association, a trade 
association of gas stations and convenience stores; and an-
other 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 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 fle 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. 948 (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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232 FDA v. R. J. REYNOLDS V APOR CO. 
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., 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, Offce 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 (claim-
ing that 124 statutes use variations of “adversely affected”). 
Most notably, the term appears in the APA, which entitles 
anyone “adversely affected or aggrieved by agency action 
within the meaning of a relevant statute . . . to judicial re-
view.” 
4 5 U. S. C. § 702. We have interpreted “adversely 
Madison, 1 Cranch 137, 175 (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 argu-
ment 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, 581 U. S. 189, 196–197 (2017). As we have ex-
plained, 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 
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Cite as: 606 U. S. 226 (2025) 233 
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, 397 U. S. 150, 153 
(1970) (emphasis added). A plaintiff may sue under the APA 
unless her “interests are so marginally related to or incon-
sistent with the purposes implicit in the statute that it can-
not 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 demanding.” 
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-review 
provision . . . permits suit for violations of numerous statutes 
of varying character that do not themselves include causes 
of action for judicial review.” Ibid.; see also, e. g., Bennett 
v. Spear, 520 U. S. 154, 163 (1997). For statutes other than 
the APA, the FDA argues, a person must “actually”—not 
“arguably”—fall within the statute's zone of interests. 
Brief for Petitioners 12–13. And as the FDA sees it, the 
person actually aggrieved by the denial of permission to 
market a tobacco product is the one with the closest relation-
ship 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, includ-
ing their broad formulation of the zone-of-interests test. 
For instance, in Bank of America Corp. v. Miami, we inter-
preted 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 artic-
acted. See Association of Data Processing Service Organizations, Inc. 
v. Camp, 397 U. S. 150, 153 (1970).

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234 FDA v. R. J. REYNOLDS V APOR 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. 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 
include only the person claiming to be the victim of discrimi-
nation nor so broad as to encompass every person with Arti-
cle 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 fred in retaliation 
for the protected activity of his fancée (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 Offce of Workers' Compensation Programs 
in the Department of Labor was “[a] person adversely af-
fected or aggrieved by a fnal 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 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 , 
397 U. S., at 153; emphasis added). Considering the “long 
lineage” of this language, we found it telling that neither

Cite as: 606 U. S. 226 (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 policy-
making capacity, is `adversely affected' or `aggrieved.' ” 
Newport News, 514 U. S., at 127. 
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 interpret-
ing each statute, we borrowed principles from cases describ-
ing the APA's cause of action. The FDA cannot explain 
why—repeatedly and without regard for their differing stat-
utory purposes—we have interpreted other causes of action 
with variations of “adversely affected or aggrieved” consist-
ently 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 
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 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, Offce 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 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 , 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). 
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236 FDA v. R. J. REYNOLDS V APOR CO. 
Opinion of the Court 
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; alteration omitted). The retailers ft the bill. 
If the FDA denies an application, the retailers, like the man-
ufacturer, 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 21 U. S. C. 
§§ 331, 333(a), 387b(6)(A), 387j(a)–(c). Given this signifcant, 
direct impact on retailers, their interests are not “so margin-
ally related to or inconsistent with the purposes implicit in 
the statute that it cannot reasonably be assumed that Con-
gress intended to permit the suit.” Clarke, 479 U. S., at 399. 
Accordingly, the retailers are “adversely affected” by a de-
nial 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 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 incon-
sistent 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. 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 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 permit-
ted to “weigh in on” the agency's disposition of an application—it author-
izes suit for those “adversely affected” by the denial of an application. 
The retailers meet that description. 
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Cite as: 606 U. S. 226 (2025) 237 
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 manufac-
turer: Only the manufacturer may ask the FDA to refer its 
application to a scientifc committee, receive notice of a de-
nial 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. 
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 manu-
facturer—could use. “Read naturally, the word `any' has an 
expansive meaning, that is, `one or some indiscriminately of 
whatever kind.' ” United States v. Gonzales, 520 U. S. 1, 5 
(1997) (quoting Webster's Third New International Diction-
ary 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 ad-
versely affected” suggests an intent to cover more than one 
party. Thompson is probative. In that case, the respond-
ent 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 artifcially 
narrow meaning, and if that is what Congress intended,” 
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238 FDA v. R. J. REYNOLDS V APOR CO. 
Opinion of the Court 
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 Congress intended to convey the FDA's reading, it 
would more naturally have said “applicant” rather than “per-
son 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. 
665, 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. 
See also post, at 251 (Jackson, J., dissenting). The provi-
sion's breadth, the FDA says, accommodates the latter con-
text: Regulations affect more than one person, even if a de-
nial 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 
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] applica-
tion” and “any person adversely affected” is conspicuous. 
When Congress uses “one term in one place, and a materially

Cite as: 606 U. S. 226 (2025) 239 
Opinion of the Court 
different term in another, the presumption is that the differ-
ent term denotes a different idea.” A. Scalia & B. Garner, 
Reading Law 170 (2012); see also, e. g., Southwest Airlines 
Co. v. Saxon, 596 U. S. 450, 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 inter-
ests) 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 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 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, ar-
guing 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 “ad-
versely affected” by the denial order, not whether a peti-
tioner 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 , 
467 U. S. 340 (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 
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240 FDA v. R. J. REYNOLDS V APOR 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 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 “ad-
versely 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 in-
dependently establish venue. RJR Vapor and the RJR-
affliated 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. 
No court, including the Fifth Circuit in this case, has ana-
lyzed whether every petitioner in a joint petition must inde-
pendently satisfy the TCA's venue provisions. We rarely 
address an argument raised for the frst 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 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, 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 frst 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. 
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Jackson, J., dissenting 
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 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 manufac-
turers to receive permission from the Food and Drug Admin-
istration (FDA) before new tobacco products may be mar-
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 atten-
tion to the language of the statute's cause of action—and 
then essentially nullifes the zone-of-interest test by reduc-
ing it to the near-meaningless proposition that anyone af-
fected, 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 di-
rection: Congress established a detailed scheme for manufac-
turers to obtain authorization to market new tobacco prod-
ucts—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 manu-
facturers' statutorily created interests. Because nothing in 
this statute suggests that Congress meant to authorize 
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242 FDA v. R. J. REYNOLDS V APOR CO. 
Jackson, J., dissenting 
retailers to sue to challenge the FDA's denial of a manufac-
turer's marketing application, much less bring that legal 
challenge in a venue that is otherwise unavailable, I respect-
fully dissent. 
I 
The Family Smoking Prevention and Tobacco Control Act 
empowers the Secretary of Health and Human Services, act-
ing 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 without 
FDA authorization any “new tobacco product,” defned as a 
product not generally available on the market as of February 
15, 2007. §§ 387j(a)(1), (a)(2)(A). The statute also prohibits 
any retailer from selling a “new tobacco product” unless that 
product has been authorized by the FDA. See §§ 387b(6) 
(A), 331(a). 
When a manufacturer seeks FDA authorization to market 
a new tobacco product, it must submit an application to the 
agency. See FDA v. Wages & White Lion Investments, 
LLC, 604 U. S. 542, 551–552 (2025); § 387j(b). That applica-
tion must include “full reports of all information” the manu-
facturer is (or should be) aware of “concerning investigations 
which have been made to show the health risks of” the prod-
uct. § 387j(b)(1)(A). It must also include a list of the prod-
uct'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). 
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Jackson, J., dissenting 
“There are many reasons why the FDA may deny market-
ing 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 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 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 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). 
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 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 
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244 FDA v. R. J. REYNOLDS V APOR 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, 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 alter-
ations 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 stat-
utory interpretation, whether a legislatively conferred cause 
of action encompasses a particular plaintiff's claim.” Lex-
mark, 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)). 
Applying the zone-of-interest test, we held that, despite the 
statute's broad “any person” language, contextual clues—in-
cluding the statute's expressed purpose—demonstrated that 
Congress intended to permit suit only by persons who suf-
fered a particular type of injury (specifcally, “an injury to a 
commercial interest in reputation or sales”). 572 U. S., at 
131–132. 
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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, 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 232. It also goes to 
great lengths to emphasize that the zone-of-interest test op-
erates 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 mean-
ing of the congressionally enacted provision creating a cause 
of action,” which we do by “apply[ing] traditional principles 
of statutory interpretation.” Lexmark, 572 U. S., at 128. 
Sometimes, as with the APA, those contextual clues 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 prece-
dents 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, en-
tirely circular. Instead, because the zone-of-interest test is 
premised on the idea that interpreting a seemingly un-
bounded cause of action requires exploration into what Con-
gress wanted in the context of that particular statute, we 
look to “the particular provision of law upon which the plain-
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246 FDA v. R. J. REYNOLDS V APOR CO. 
Jackson, J., dissenting 
tiff relies” for his legal claim—that is, “ `the statutory provi-
sion 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 Confer-
ence v. Postal Workers, 498 U. S. 517, 523–524 (1991); Thomp-
son v. North American Stainless, LP , 562 U. S. 170, 178 
(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) 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 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 com-
merce.” § 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 particulars. 
See §§ 387j(b), (c). I touched on those details above, see 
supra, at 242, but it bears repeating here that, by law, a manu-
facturer'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 
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Jackson, J., dissenting 
directly to the FDA. That is it—the agency does not solicit 
any information from interested third parties, such as poten-
tial 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 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 produc-
tion, processing, or packing facilities fail to conform to regu-
latory 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 confdentiality, so third-party 
retailers may not even know that an application for the mar-
keting of a particular new tobacco product has been submit-
ted 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); 86 Fed. Reg. 55398 (2021) (recognizing that 
“the intent to market a tobacco product that is not currently 
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248 FDA v. R. J. REYNOLDS V APOR CO. 
Jackson, J., dissenting 
marketed is often considered confidential commercial 
information”).1 
Thus, the text of the statutory provisions that create the 
premarketing-approval scheme Congress adopted does not 
support the conclusion that Congress promulgated this stat-
ute with retailers' interests in mind. 
C 
Nor does the purpose of the Tobacco Control Act's 
premarketing-approval or judicial-review provisions. In -
stead, the statute's judicial-review mechanism operates to 
ensure that those most invested in a new product's authoriza-
tion can enlist a court to double check the FDA's work. 
Manufacturers plainly fall within that category: At the time 
a manufacturer applies for authorization to market a new 
tobacco product, it has already expended considerable time, 
money, and effort to develop that product. 
But retailers are differently situated. As a general mat-
ter, when a manufacturer applies for authorization to market 
a new product, retailers are mere bystanders—they do not 
yet have any skin in the game. Cf. §§ 331(c), 387b(6)(A) 
(clarifying that a new tobacco product may not be sold before 
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 applica-
tion. 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 this page and 249. So, 
although retailers may hope that the FDA will grant a particular appli-
cation, 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. 
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Jackson, J., dissenting 
the FDA approves it). A retailer may desire to sell an up-
coming (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 re-
tailers—and protected only the former in the instant con-
text—is confrmed 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 to-
bacco 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 protec-
tion 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 de-
nial 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 rea-
sonable result since, as I have explained, retailers generally 
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250 FDA v. R. J. REYNOLDS V APOR CO. 
Jackson, J., dissenting 
lack any fnancial stake or reliance interests in the applica-
tion'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 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 man-
ufacturers can fle suit to challenge such withdrawal. Why 
would Congress have wanted retailers to be able to seek ju-
dicial review of the agency's initial denial (at which point 
they generally lack reliance interests), but not when the 
agency withdraws its approval (at which point they generally 
will have such interests)? 
The majority offers no explanation, stating only that this 
differential treatment was Congress's “choice.” Ante, at 
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 accom-
plished.” Advocate Christ Medical Center v. Kennedy, 605 
U. S. 1, 29 (2025) (Jackson, J., dissenting). The more logical 
inference by far is that Congress excluded retailers from pro-
tecting 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 mar-
keting scheme. Instead, it zeroes in on the language of the 
provision supplying the cause of action: § 387l(a)(1). In its 
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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. Thompson, 562 U. S., at 176–177 (observing 
that “absurd consequences” about who was entitled to sue 
would follow if the Court were to interpret literally a simi-
larly worded cause of action). 
In any event, even pure textualists would have to acknowl-
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 provi-
sion 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 sub-
ject 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 manufactur-
er's application) is to use a generic term, such as “any per-
son.” By design, that generic phrasing relates to “more 
than one party” and does not explain or suggest who is in-
cluded 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 interpre-
tation is that it draws almost exclusively from what this 
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252 FDA v. R. J. REYNOLDS V APOR 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 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 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 manufac-
turers wish to market a new tobacco product. Third parties 
are entirely excluded from that back-and-forth. And, nota-
bly, that is so even when circumstances develop that do, in 
fact, implicate third-party interests (such as when a retailer 
has already begun marketing the product). There really is 
no material similarity between the premarketing-approval 
scheme Congress has constructed in the Tobacco Control 
Act, on the one hand, and the various interests that the APA 
protects, on the other. Consequently, the zones of interest 
those two statutes create are completely different, making it 
diffcult to understand why the majority fnds the APA paral-
lel so persuasive. 
B 
The majority's take on the scope of § 387l(a)(1)'s cause of 
action also fails to fully appreciate the reasoning of our zone-
of-interest precedents. The zone-of-interest analysis here is 
substantially similar to that of Block, 467 U. S. 340. There, 
the Court held that the Agricultural Marketing Agreement 
Act of 1937 permitted only milk handlers and producers— 
not consumers—to seek judicial review of the Secretary of 
Agriculture's milk pricing orders, even though the orders af-
fected (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 rele-
vant cause of action, id., at 345), the Court reasoned, because

Page Proof Pending Publication
Cite as: 606 U. S. 226 (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 pro-
ducers; “[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 omis-
sion of such a provision is suffcient reason to believe that 
Congress intended to foreclose consumer participation 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 program con-
templates collaboration between the agency and manufactur-
ers—but not retailers. Therefore, here, just as in Block, the 
absence of any mechanism for retailers to participate in that 
collaborative premarketing-approval process on the front 
end is a strong signal that Congress did not intend to protect 
any interests retailers may have on the back end, if premar-
keting approval is denied. 
Moreover, as with the would-be plaintiff-consumers in 
Block, “preclusion of [retailer] suits will not threaten realiza-
tion 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 statute's 
objectives will not be frustrated.” Ibid.; cf. Joint Anti-
Fascist Refugee Comm. v. McGrath, 341 U. S. 123, 153–154 
(1951) (Frankfurter, J., concurring) (recognizing that the like-
lihood 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 V APOR CO. 
Jackson, J., dissenting 
that certain industry participants could seek judicial review 
only “after first exhausting administrative remedies.” 
Ante, at 240, 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 “suf-
fcient reason” to believe that Congress intended to exclude 
consumers from using the statutory cause of action to seek 
judicial review of the relevant agency action. 467 U. S., at 
347.
2 
Applying the plainly analogous reasoning of Block to the 
question presented in this case gets us to the most 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 
issue here. Ante, at 232–235. 
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 statu-
tory 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 manufac-
turer of agency over its own application, and risks manufacturers and re-
tailers 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. 
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Cite as: 606 U. S. 226 (2025) 255 
Jackson, J., dissenting 
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 specifcally defned “ `ag-
grieved 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 any-
one whose interests were at least “ ` “ arguably . . . protected 
by the statute.” ' ” Ante, at 236 (quoting Thompson, 562 
U. S., at 178; emphasis added). But the retailers here cannot 
even satisfy that formulation of the standard. The majority 
explains how retailers may be affected by § 387j but never 
articulates how retailers are protected by this statute—not 
arguably, and certainly not actually. See ante, at 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 
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 be-
hest of “any person adversely affected.” Congress also spe-
cifcally 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 “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 
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256 FDA v. R. J. REYNOLDS V APOR 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 re-
jected on the merits similar challenges that other favored e-
cigarette manufacturers had fled. See Avail Vapor, LLC v. 
FDA, 55 F. 4th 409, 413, 422 (CA4 2022); Prohibition Juice 
Co. v. FDA, 45 F. 4th 8, 12, 20–21 (CADC 2022). It thus 
became (perhaps) imperative from RJR Vapor's perspective 
that its own lawsuit challenging the FDA's denial of its fa-
vored 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— 
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, to-
gether, they fled a joint petition in the Fifth Circuit, chal-
lenging the FDA's denial of RJR Vapor's application.
4 The 
possibility that the courts would allow venue to be estab-
lished 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 princi-
pal 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-and-
capricious challenge levied against the FDA's denial of a similar applica-
Page Proof Pending Publication

Cite as: 606 U. S. 226 (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 Con-
gress 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 partici-
pate 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 (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 Congress 
wanted when it enacted § 387l(a)(1) and what some tobacco 
manufacturers want to do now is particularly acute. 
As we consider who can sue under § 387l(a)(1), it is impor-
tant to acknowledge that the statute Congress enacted also 
articulates a clear venue mandate: Thwarted tobacco manu-
facturers have a cause of action to challenge the FDA's denial 
of their marketing applications in court, but they must liti-
gate their interests in the designated venues and, presum-
ably, 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, 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 fled 
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. 542, 592 (2025). 
Page Proof Pending Publication

258 FDA v. R. J. REYNOLDS V APOR 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 interpreta-
tion to investigate the scope of § 387j(c)—the provision that 
respondents argue the FDA violated. Every available indi-
cator reveals that Congress intended to permit manufac-
turers—not retailers—to challenge the denial of a manufac-
turers' 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 Con-
gress did not intend, it also allows manufacturers like RJR 
Vapor to evade the statute's venue requirements. 
Page Proof Pending Publication

Page Proof Pending Publication
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 
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

Retrieval chunks

• #1

  PRELIMINARY PRINT Volume 606 U. S. Part 1 Pages 226–258 OFFICIAL REPORTS OF THE SUPREME COURT June 20, 2025 REBECCA A. WOMELDORF reporter of decisions Page Proof Pending Publication NOTICE: This preliminary print is subject to formal revision before the bound volume is published. Users are requested to noti…

• #2

  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 a…

• #3

  the Court has borrowed from its APA cases, including their broad for- mulation 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, 581 U. S. 189, 193 (interpreting “aggrieved person” in the …

• #4

  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 withd…

• #5

  U. S. C. § 387j. Companies that manufacture or sell new to- bacco 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…

• #6

  cigarettes, including the popular menthol- and mixed-berry- favored Vuse Alto products. It timely applied for authori- zation 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 …

• #7

  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 “origin…

• #8

  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 its…

• #9

  acted. See Association of Data Processing Service Organizations, Inc. v. Camp, 397 U. S. 150, 153 (1970). Page Proof Pending Publication 234 FDA v. R. J. REYNOLDS V APOR 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 beca…

• #10

  making capacity, is `adversely affected' or `aggrieved.' ” Newport News, 514 U. S., at 127. 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 …

• #11

  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; alteration omitted). The retailers ft the bill. If the FDA denies an application, the retailers, like the man- ufacturer, lose …

• #12

  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 co…

• #13

  here. If Congress intended to convey the FDA's reading, it would more naturally have said “applicant” rather than “per- son 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 …

• #14

  ests) 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 chal- lenges. Plainly, the FDA wishes that Congress had written the review provision differently. As we have explained be- fore, however, …

• #15

  affliated 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. No court, including the Fifth Circuit in this case, has ana- lyzed whether every petitioner in a joint petition mu…

• #16

  tion to the language of the statute's cause of action—and then essentially nullifes the zone-of-interest test by reduc- ing it to the near-meaningless proposition that anyone af- fected, or even arguably affected, by the FDA's marketing denial can sue. The actual zone-of-interest inquiry, however, requires us to…

• #17

  facturer is (or should be) aware of “concerning investigations which have been made to show the health risks of” the prod- uct. § 387j(b)(1)(A). It must also include a list of the prod- uct's “components, ingredients, additives, and properties,” along with a description of the manufacturing methods and facilities…

• #18

  244 FDA v. R. J. REYNOLDS V APOR 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, 572 U. S., at 129 (quoting Allen v. Wright, 468 U. S. 737, 751 (1984)). We cal…

• #19

  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, 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…

• #20

  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) re- veals that § 387j(c) …

• #21

  § 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 s…

• #22

  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 applica- tion. After all, it is not Congress's decision to deny a manufacturer's marketing applica…

• #23

  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 protec- tion of retailers. Under the majority's view, even though a retailer cannot challenge the FDA's decision to withdraw its prior approval…

• #24

  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 mar- keting scheme. Instead, it zeroes in on the language of the provision supplying the cause of action: § 387l(a)(1). In its Page Proof …

• #25

  tation is that it draws almost exclusively from what this Page Proof Pending Publication Page Proof Pending Publication 252 FDA v. R. J. REYNOLDS V APOR 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 t…

• #26

  venture” between the agency, milk handlers, and milk pro- ducers; “[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 omis- sion of such a provision is suffcient reason to believe that Congress intende…

• #27

  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 ca…

• #28

  those cases that the statutes at issue permitted suit by any- one whose interests were at least “ ` “ arguably . . . protected by the statute.” ' ” Ante, at 236 (quoting Thompson, 562 U. S., at 178; emphasis added). But the retailers here cannot even satisfy that formulation of the standard. The majority explains…

• #29

  that its own lawsuit challenging the FDA's denial of its fa- vored 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— RJR Vapor needed another party to bring its legal challenge to court. It is…

• #30

  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 impor- tant to acknowledge that the statute Congress enacted also articulates a clear venue mandate: Thwarted tobacco manu- facturers have a cause of a…

• #31

  makes available the offcial United States Reports citation in advance of 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 …