Amicus Curiae Brief — Food and Drug Administration, et al., Petitioners v. R.J. Reynolds Vapor Co., et al.

No. 23-1187

IN THE

Supreme Court of the United States

_______________________________

FOOD AND DRUG ADMINISTRATION; ET AL.,

Petitioners,

v.

R.J. REYNOLDS VAPOR COMPANY; RJR VAPOR

COMPANY, L.L.C.; AVAIL VAPOR TEXAS, L.L.C.; AND

MISSISSIPPI PETROLEUM MARKETERS AND

CONVENIENCE STORES ASSOCIATION,

Respondents.

_______________________________

On Writ of Certiorari to the

United States Court of Appeals

for the Fifth Circuit

BRIEF AMICUS CURIAE OF THE

NEW CIVIL LIBERTIES ALLIANCE

IN SUPPORT OF RESPONDENTS

Andrew J. Morris

Counsel of Record

Daniel Kelly

Mark Chenoweth

NEW CIVIL LIBERTIES ALLIANCE

4250 N. Fairfax Dr., Suite 300

Arlington, VA 22203

Phone: (202) 869-5210

andrew.morris@ncla.legal

Counsel for Amicus Curiae

i

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................ i

TABLE OF AUTHORITIES ...................................... ii

INTEREST OF AMICUS CURIAE ........................... 1

INTRODUCTION AND SUMMARY ......................... 2

STATEMENT ............................................................. 5

ARGUMENT .............................................................. 6

I.

II.

FDA’S DENIAL ORDERS “ADVERSELY AFFECT”

THE RETAILER RESPONDENTS .............................. 6

FDA’S ARGUMENTS CONTRADICT THE

STATUTE’S TEXT AND THE COURT’S ZONE-OFINTERESTS TEST ................................................. 13

A.

FDA’s Arguments Dodge Rather Than

Explain the Governing Phrase “Any

Person Adversely Affected” ....................... 14

B.

FDA’s Arguments Attempt to Narrow

the Review Provision by Rewriting

This Court’s Zone-of-Interests Test .......... 18

III. FDA’S ARGUMENTS WOULD NARROW THE

SCOPE OF JUDICIAL REVIEW PROVISIONS IN

MANY OTHER STATUTES .................................... 21

A.

FDA’s Categorical “Party”

Requirement .............................................. 22

B.

The Danger of Unintended

Consequences ............................................ 25

CONCLUSION ......................................................... 31

ii

TABLE OF AUTHORITIES

Page(s)

Cases

Abbott Lab’y v. Gardner,

387 U.S. 136 (1967) ........................................... 9, 15

Bank of Am. Corp. v. City of Miami,

581 U.S. 189 (2017) ....................................... 6, 8, 18

Bd. of Trade of Chicago v. SEC,

883 F.2d 525 (7th Cir. 1989) ................................. 28

Center for Reproductive Law & Policy v. Bush,

304 F.3d 183 (2d Cir. 2002) .................................. 20

Clarke v. Sec. Indus. Ass’n,

479 U.S. 388 (1987) ................................7, 11, 18, 19

Corner Post, Inc. v. Bd. of Governors of Fed.

Rsrv. Sys.,

603 U.S. 799 (2024) ........................................... 9, 15

Darby v. Cisneros,

509 U.S. 137 (1993) ............................................... 16

Dep't of State v. Muñoz,

602 U.S. 899 (2024)............................................. 20

Dir., Off. of Workers’ Comp. Programs v.

Newport News Shipbuilding & Dry Dock Co.,

514 U.S. 122 (1995) ........................................... 8, 26

Horizons Int’l, Inc. v. Baldrige,

811 F.2d 154 (3d Cir. 1987) ............................ 28, 29

Kucana v. Holder,

558 U.S. 233 (2010) ................................................. 9

iii

Lexmark Int’l, Inc. v. Static Control

Components, Inc.,

572 U.S. 118 (2014) ..............................7, 8, 9, 10, 20

Lujan v. Defs. of Wildlife,

504 U.S. 555 (1992) ............................................... 20

Match-E-Be-Nash-She-Wish Band of

Pottawatomi Indians v. Patchak,

567 U.S. 209 (2012) ............................................... 19

Nat’l Credit Union Admin. v. First Nat’l

Bank & Tr. Co.,

522 U.S. 479 (1998) ..................................... 7, 18, 19

O’Bannon v. Town Court Nursing Center,

447 U.S. 773 (1980) .............................................. 19

Russello v. United States,

464 U.S. 16 (1983) ................................................. 16

SAS Inst., Inc. v. Iancu,

584 U.S. 357 (2018) ................................................. 9

Thompson v. N. Am. Stainless, LP,

562 U.S. 170 (2011) ........................................... 8, 15

United States v. Soul Vapor, LLC,

No. CV 1:22-00458, 2024 WL 3258211

(S.D. W. Va. July 1, 2024)..................................... 12

Statutes

05 U.S.C. § 702 ..................................................... 8, 28

07 U.S.C. § 136n ....................................................... 30

07 U.S.C. § 3804 ....................................................... 27

07 U.S.C. § 6912 ...................................................... 15

15 U.S.C. § 1710 ....................................................... 27

iv

15 U.S.C. § 2615 ....................................................... 30

15 U.S.C. § 4015 ................................................. 27, 29

15 U.S.C. § 6762 ....................................................... 27

15 U.S.C. § 77i .......................................................... 27

15 U.S.C. § 78y ................................................... 27, 28

16 U.S.C. § 824k ....................................................... 27

16 U.S.C. § 825l ........................................................ 30

20 U.S.C. § 7905 ....................................................... 27

21 U.S.C. § 331 ............................................5, 6, 10, 19

21 U.S.C. § 333 ......................................................... 11

21 U.S.C. § 360g ....................................................... 27

21 U.S.C. § 387 ........................................................... 3

21 U.S.C. § 387b ............................................... 5, 6, 19

21 U.S.C. § 387f ........................................................ 24

21 U.S.C. § 387j ....................... 5, 10, 13, 16, 17, 23, 30

21 U.S.C. § 387l ........... 3, 5, 6, 9, 13, 14, 18, 21, 26, 29

21 U.S.C. § 877 ......................................................... 27

28 U.S.C. § 2344 ....................................................... 15

30 U.S.C. § 816 ......................................................... 27

33 U.S.C. § 1516 ....................................................... 30

42 U.S.C. § 5405 ....................................................... 27

42 U.S.C. § 6306 ....................................................... 27

42 U.S.C. § 7622 ....................................................... 27

47 U.S.C. § 252 ......................................................... 27

v

49 U.S.C. § 5127 ....................................................... 27

52 U.S.C. § 30109 ..................................................... 17

Regulations

81 Fed. Reg. 28,974 (May 10, 2016).................. 6, 10

Other Authorities

Jonathan R. Siegel,

2022 Sourcebook of Federal Judicial Review

Statutes, Administrative Conference of the

United States ........................................................ 25

1

INTEREST OF AMICUS CURIAE

The New Civil Liberties Alliance (“NCLA”) is a

nonpartisan, nonprofit civil rights organization and

public-interest law firm devoted to defending

constitutional freedoms from the administrative

state’s depredations. Professor Philip Hamburger

founded NCLA to challenge multiple constitutional

defects in the modern administrative state through

original litigation, amicus curiae briefs, and other

advocacy.1

The “civil liberties” of the organization’s name

include rights at least as old as the U.S. Constitution

itself, such as jury trial, due process of law, and the

right to have laws made by the nation’s elected

lawmakers through constitutionally prescribed

channels (i.e., the right to self-government). These

selfsame civil rights are also very contemporary—and

in dire need of renewed vindication—precisely

because Congress, the President, federal agencies,

and even sometimes the Judiciary, have neglected

them for so long.

NCLA aims to defend civil liberties—primarily by

asserting

constitutional

constraints

on

the

administrative state. Although the American People

still enjoy the shell of their Republic, there has

1 No counsel for any party to this case authored this brief in

whole or part, and no party or counsel other than amicus curiae

and its counsel made a monetary contribution intended to fund

the preparation or submission of this brief. Counsel for amicus

curiae notified the parties of its intention to file this brief on

December 12 , 2024.

2

developed within it a very different sort of

government—a type, in fact, that the Constitution

was designed to prevent. This unconstitutional state

within the Constitution’s United States is the focus of

NCLA’s concern.

NCLA therefore has a strong interest in the first

question presented and the judicial review provision

it addresses. NCLA believes it can assist the Court by

discussing the effect a decision for the FDA would

have on judicial review provisions in many statutes.

The key language, “adversely affected,” appears in

many judicial review provisions. FDA asks this Court

to give that language a vanishingly narrow reading

that disregards the language chosen by Congress. But

NCLA has a strong interest in ensuring that Courts

apply all judicial review provisions as Congress wrote

them, to give effect to these important checks on

agencies and to provide parties access to the courts to

challenge unlawful agency actions.

INTRODUCTION AND SUMMARY

Amicus submits this brief to highlight the damage

FDA’s arguments would do to many judicial review

provisions across the United States Code. Congress

has enacted hundreds of such provisions, typically

using the same “adversely affected” language at issue

here. In this case, FDA attempts to narrow a typical

provision to a fraction of the scope Congress enacted.

FDA’s arguments, if successful, would narrow similar

provisions in other statutes. But Congress enacts

these provisions precisely to place a check on

agencies’ compliance with the law. These provisions

also codify the important principle that citizens

3

injured by agency action are entitled to their day in

court. So, it is important that courts respect

Congress’s legislative authority by giving these

provisions the broad scope Congress chose to give

them.

FDA seeks to narrow the judicial review provision

in the Family Smoking Prevention and Tobacco

Control Act (“TCA”), 21 U.S.C. § 387 et seq. The TCA

makes it illegal to sell certain tobacco products unless

FDA authorizes their sale. It also subjects FDA’s

denial of an application to judicial review upon the

petition of “any person adversely affected” by the

denial order. 21 U.S.C. § 387l(a)(1). FDA contends

that Congress chose that broad phrase to limit the

right of review to only one “person”—the

manufacturer whose application was denied. FDA

argues that retailers who also want to sell the covered

products—the same goal as the applicant

manufacturer—are not adversely affected by the

denial order.

FDA’s narrow reading cannot be reconciled with

the statute, either with the broad review provision

itself or with other provisions that directly contradict

FDA’s arguments. FDA’s reading also conflicts with

this Court’s zone-of-interests test. This Court

describes the test as “lenient,” reflecting the strong

presumption that citizens injured by agency action

should have access to a court to challenge that action.

Applying the test here shows that the retailers fall

well within the TCA’s zone of interests. Like the

manufacturer whose application FDA denied,

4

retailers want to sell products the FDA has approved,

and they want to refrain from selling products it has

declined to approve. If they act in violation of a denial

order, they can be prosecuted. Indeed, even if FDA

isn’t willing to say retailers are within the TCA’s zone

of interests, it acts as though they are; it has compiled

a substantial record of vigorous enforcement against

many retailers for selling unauthorized products in

violation of the TCA.

FDA’s arguments would transform this lenient

zone-of-interests test into a roadblock that bars relief

for many persons injured by agency actions. In

particular, FDA’s argument construes this test as a

requirement to exhaust administrative remedies

before petitioning for judicial review, a requirement

not imposed by this Court’s precedents nor the TCA.

Because the zone-of-interests test is a background

principle for interpreting all judicial review

provisions, such a newly stringent test could also

narrow the scope of hundreds of other judicial review

provisions. That change would insulate many

agencies from judicial scrutiny Congress directed

them to face, and it would bar many citizens and

small businesses injured by agency actions from

obtaining the day in court that Congress instructed

them to have.

The Fifth Circuit properly avoided these

damaging consequences by rejecting FDA’s

arguments, ruling that retailers were “adversely

affected” by the FDA denial orders. This Court should

affirm.

5

STATEMENT

This case arises from a petition to the Fifth

Circuit for review of FDA’s denial of applications by

R.J. Reynolds Vapor Co. (“Reynolds”) for

authorization to sell certain e-cigarette products. See

C.A. Pet. for Review (Oct. 12, 2023). In addition to

Reynolds, Respondents include retailers RJR Vapor

Company, LLC, Avail Vapor Texas, LLC, and an

association that includes retailers, the Mississippi

Petroleum Marketers and Convenience Stores

Association. These retailers wish to continue selling

products addressed by the denial orders

Reynolds submitted the applications to comply

with the TCA. Enacted in 2009, this statute requires

manufacturers to obtain FDA authorization before

introducing certain products to market. See 21 U.S.C.

§ 387j(a)(2). If FDA denies an application, the TCA

prohibits sale of the product by the applicant or

anyone else. 21 U.S.C. §§ 331(a), 387b(6). The TCA

also provides that, if FDA denies an application, “any

person adversely affected by” the denial has the right

to petition for judicial review. 21 U.S.C. § 387l(a)(1).

After FDA denied Reynolds’s applications, Pet.

App. 9a–23a, Reynolds and the retailers petitioned for

review by the Fifth Circuit, Pet. App. 3a. Since before

Reynolds submitted its application, the retailers have

been selling products now covered by FDA’s denial.

Pet. App. 3a-4a. (FDA has permitted sales of certain

6

products while their manufacturers were applying for

FDA approval. See 81 Fed. Reg. 28,974, 28,977,

29,001 (May 10, 2016)) . The denial order currently

is stayed, Pet. Br. 7, but if it takes effect the retailers

will be prohibited from selling those products. See 21

U.S.C. §§ 331(a), 387b(6).

In response to the petition, FDA moved to dismiss

or transfer. It contended (among other arguments)

that the retailers lacked standing because they were

not “adversely affected” by the denial orders. Pet.

App. 2a–3a. The court denied FDA’s motion, correctly

holding that the Respondents are “adversely affected”

by the denial. Pet. App. 3a–5a. This Court then

granted interlocutory review of the court’s order

denying FDA’s motion.

ARGUMENT

I.

FDA’S DENIAL ORDERS “ADVERSELY AFFECT”

THE RETAILER RESPONDENTS

The TCA says “any person adversely affected” by

a marketing denial order “may file a petition for

judicial review.” 21 U.S.C. § 387l(a)(1). This provision

does not specifically state whom it includes, but the

Court’s zone-of-interests test shows that it

encompasses the applicant manufacturer and the

retailers who want to sell products covered by a denial

order. See Bank of Am. Corp. v. City of Miami, 581

U.S. 189, 194, 197 (2017) (stating that this Court

applies the zone-of-interests test to determine

whether a person is “adversely affected”). This test is

7

a background limitation that, this Court assumes,

Congress incorporates into judicial review provisions.

Lexmark Int’l, Inc. v. Static Control Components,

Inc., 572 U.S. 118, 129, 130 n.5 (2014). The test is

rooted in the venerable “harm within the risk”

principle, id. at 130 n.5, and it focuses on whether an

injured person’s interests “arguably” align with the

interests the statute advances, Nat’l Credit Union

Admin. v. First Nat’l Bank & Tr. Co., 522 U.S. 479,

492 (1998).

The test has two steps. The first “discern[s] the

interests ‘arguably ... to be protected’ by the statutory

provision at issue,” and the second “inquire[s]

whether the plaintiff’s interests affected by the

agency action in question are among them.” Nat’l

Credit Union Admin., 522 U.S. at 492. This Court has

“conspicuously included the word ‘arguably’ in the

test to indicate that the benefit of any doubt goes to

the plaintiff.” Lexmark, 572 U.S. at 130 (cleaned up).

Because it gives plaintiffs the benefit of any doubt, the

test does not “foreclose[] suit” unless “a plaintiff’s

interests are so marginally related to or inconsistent

with the purposes implicit in the statute that it

cannot reasonably be assumed that Congress

authorized that plaintiff to sue.” Id. (cleaned up). See

also Clarke v. Sec. Indus. Ass’n, 479 U.S. 388, 403

(1987) (requiring only a “plausible relationship”

between the statute’s zone of interests and the

complainant’s asserted interest).

This lenient “benefit of the doubt” approach is not

limited to cases decided under the Administrative

8

Procedure Act, as FDA contends. This Court has

applied the same approach to challenges arising

under other statutes, including the Fair Housing Act,

Bank of Am. Corp., 581 U.S. at 194 (stating that it

suffices if the plaintiff’s interest is “arguably within

the zone of interests”), the Lanham Act, Lexmark, 572

U.S. at 130–31, 137–38 (applying the “lenient

approach” developed in APA cases), and the Civil

Rights Act of 1964, Thompson v. N. Am. Stainless, LP,

562 U.S. 170, 178 (2011) (stating that the plaintiff is

within the zone of interests unless “the plaintiff's

interests are so marginally related to or inconsistent

with the purposes implicit in the statute that it

cannot reasonably be assumed that Congress

intended to permit the suit”).

The same lenient approach applies here. Lexmark

states that this approach depends on “the provisions

of law at issue,” 572 U.S. at 130. TCA’s review

provision uses the same language as the APA,

referring to “any person adversely affected.” See 5

U.S.C. § 702 (granting a right of judicial review to “a

person … adversely affected or aggrieved by agency

action”). 2 Nothing suggests Congress meant this

This Court also has equated “adversely affected” and

“aggrieved.” See Dir., Off. of Workers’ Comp. Programs v.

Newport News Shipbuilding & Dry Dock Co., 514 U.S. 122, 126

(1995) (stating that “[t]he phrase ‘person adversely affected or

aggrieved’ is a term of art used in many statutes to designate

those who have standing to challenge or appeal an agency

decision,” and “‘adversely affected’ and ‘aggrieved,’ alone or in

combination, have a long history in federal administrative law”).

2

9

language to describe a different category in the TCA

than in the APA. In fact, the TCA expressly

incorporates the APA’s review standards, 21 U.S.C. §

387l(b) (referencing U.S. Code Title 5, Ch. 7).

This lenient approach also reflects the

presumption that everyone directly injured by agency

action should have access to judicial review. See, e.g.,

Corner Post, Inc. v. Bd. of Governors of Fed. Rsrv.

Sys., 603 U.S. 799, 824 (2024); Abbott Labs. v.

Gardner, 387 U.S. 136, 140 (1967). This presumption

is strong, governing absent “‘clear and convincing

indications’ that Congress meant to foreclose review.”

SAS Inst., Inc. v. Iancu, 584 U.S. 357, 370 (2018). This

“presumption

favoring

judicial

review

of

administrative action” is a “familiar principle of

statutory construction.” Kucana v. Holder, 558 U.S.

233, 251 (2010). Because of it, “[w]hen a statute is

reasonably susceptible to divergent interpretation,

[courts] adopt[] the reading that accords with … basic

principles: that executive determinations generally

are subject to judicial review.” Id. (citation omitted).

Nothing in the TCA provides any basis to overcome

this strong presumption.

The zone-of-interests test identifies those who

may bring a claim by comparing the challenger’s

interests to the interests protected by the statute.

Lexmark illustrates its application. There, a company

sued a competitor under the Lanham Act, alleging

that the competitor’s false advertising had caused the

plaintiff to lose sales. 572 U.S. at 122. The Court

identified the “interests protected by the Lanham Act”

10

as “protecting persons engaged in commerce against

unfair competition.” Id. at 131 (cleaned up). It held

that the plaintiff was in the statute’s zone of interests

because it had “allege[d] an injury to a commercial

interest in reputation or sales.” Id. at 131–32; see also

id. at 137. But, the Court noted, this statutory zone of

interests did not extend beyond the injured

competitor, for example to “a consumer who is

hoodwinked into purchasing a disappointing

product.” Id. at 132.

Like the Lexmark plaintiff who had lost sales, the

retailers in this case lie well inside the zone of

protected interests. The TCA permits the sale of

products that meet its public-health standard, and

prohibits the sale of products FDA has concluded do

not. 21 U.S.C. § 331(a). The TCA requires FDA to

approve products that meet the statutory standards.

21 U.S.C. § 387j(c)(a)(A)(i). These statutory

provisions directly affect an e-cigarette retailer’s

interests every bit as much as those of a

manufacturer—they are both interested in selling

permitted products and in complying with the TCA by

not selling products the TCA prohibits. Retailers and

the manufacturer were already selling the very

products that FDA’s denial orders would take off the

market. (As noted above, FDA has permitted sales of

certain products while their manufacturers were

applying for FDA approval. 81 Fed. Reg. a t 28,977,

29,001). The denial order would put one of the

retailers out of business altogether. Pet. App. 4a. The

close match between the interests the TCA protects

11

and the retailers’ interests easily satisfies the lenient

“plausible relationships” threshold set by the zone-ofinterests test. Clarke, 479 U.S. at 403.

FDA’s own actions confirm this conclusion. Its

extensive efforts to enforce the TCA against retailers

establish that, in its view, retailers are near the

bullseye of the TCA’s zone of interests. The TCA

subjects retailers to severe sanctions for violations.

Retailers that sell unauthorized products can be

penalized as much as $1 million per “proceeding.” 21

U.S.C. § 333(f)(9)(A). They can be criminally

prosecuted and imprisoned for years. 21 U.S.C.

§ 333(a) (authorizing imprisonment of one year for the

first violation and three years for every subsequent

violation).

Against this background of stiff regulatory

penalties, FDA maintains a vigorous program of

enforcement against tobacco retailers. FDA

specifically provides retailers extensive guidance

about compliance with the TCA. 3 It conducts routine

physical inspections of retailers’ stores, checking for

violations. 4 It sends warning letters to many retailers

See FDA, Retailer Regulations and Guidance, available at

https://tinyurl.com/5b2926dx.

3

See FDA, About Warning and Close-Out Letters, “Tobacco

Retail

Warning

Letters”

available

at

https://tinyurl.com/5fuad8t2.

4

12

it believes have violated the TCA. 5 So far this month

alone, it has issued letters warning more than 100

“brick-and-mortar retailers” to comply with the TCA. 6

FDA has sought civil money penalties against at least

177 retailers, in each case seeking the “maximum

statutory amount.” 7 It also has obtained injunctive

relief against retailers. E.g., United States v. Soul

Vapor, LLC, No. CV 1:22-00458, 2024 WL 3258211,

*2–7, *14–16 (S.D.W. Va. July 1, 2024) (entering

injunction against retailer for selling unapproved ecigarette and other products in violation of the TCA).

Actions speak louder than words. FDA’s history of

enforcement actions, if not its brief, demonstrates

that it believes the retailers fall within the TCA’s zone

of interests.

The conclusion that the TCA’s zone of interests

encompasses retailers does not, as FDA contends,

expand the zone of interests without a “stopping

point.” Pet. Br. 17–18. It would not, for example,

See FDA, Advisory and Enforcement Actions Against Industry

for

Unauthorized

Tobacco

Products,

available

at

5

https://tinyurl.com/3sru29nw.

See FDA, Working with States, FDA Warns More than 100

Retailers for Illegal Sale of Youth Appealing E-Cigarettes, Dec.

5, 2024, available at https://tinyurl.com/yex52kes.

6

See FDA, Advisory and Enforcement Actions Against Industry

for Unauthorized Tobacco Products, “Which Retailers Have

7

Received CMP Complaints for Violations Related

Unauthorized

Tobacco

Products?”

available

https://tinyurl.com/3sru29nw.

to

at

13

extend the zone of interests to include retail

customers. Unlike the retailers, those customers do

not sell vaping products, do not suffer an economic

injury from FDA’s application denials, and are not

targets of FDA warnings or enforcement actions. This

distinction between, on one hand, retail businesses

that lost revenue because of the denial order and, on

the other, customers who had no such losses, draws

the same kind of line the Court drew in Lexmark.

There, the zone of interests included companies that

had lost sales because of the legal violation, but it did

not extend to their consumers. 572 U.S. at 132.

II.

FDA’S ARGUMENTS CONTRADICT THE

STATUTE’S TEXT AND THE COURT’S ZONE-OFINTERESTS TEST

FDA argues that the review provision’s phrase

“any person adversely affected,” 21 U.S.C.

§ 387l(a)(1), despite its apparent breadth, in fact

refers to only one “person”: the applicant whose

application FDA denied. Pet. Br. 7. The key to FDA’s

argument is its effort to avoid this governing broad

language altogether. Rather than address the

meaning of “any person adversely affected,” FDA

shifts the focus away from that language to a different

statutory subsection, “Action on application,” which

describes the intra-agency procedure for marketing

applications and denials, 21 U.S.C. § 387j(c). Pet. Br.

14. Then, having shifted the focus, FDA points out

that this subsection refers only to the applicant. 21

U.S.C. § 387j(c). And, FDA also notes, this subsection

“does not grant [retailers] any procedural rights,” Pet.

14

Br. 7–8; see also id. at 14–15, nor does it “require FDA

to account for their substantive interests,” Pet. Br. 8.

“In fact,” FDA summarizes, this “Action on

application” subsection “does not mention retailers at

all.” Pet. Br. 17. FDA then concludes with an abrupt

non sequitur, stating that only the applicant referred

to in the “Action on application” subsection can be a

“person adversely affected” by a denial order. Pet. Br.

7, 14.

FDA does acknowledge, though briefly, that

denial orders affect retailers. It concedes that the

orders prevent retailers from selling products, but it

assures the Court that this effect is only “indirect.”

Pet. Br. 7, 14–15. In FDA’s view, this means that the

retailers were not “adversely affected” under the

judicial review section.

A. FDA’s Arguments Dodge Rather Than

Explain the Governing Phrase “Any Person

Adversely Affected”

FDA’s arguments never confront the key

statutory language and conflict with other textual

evidence. FDA also distorts the zone-of-interests test

beyond recognition. From the start, FDA’s attempt to

shift the focus away from the governing language

misreads the text.

Nothing in the judicial review provision, 21

U.S.C. § 387l(a)(1), suggests that “any person

adversely affected” refers only to the applicant in the

underlying agency proceeding. To the contrary,

Congress chose the broad adjective “any.” It then

15

chose “person,” not “party,” which is the term used in

some other review provisions. See, e.g., Hobbs Act, 28

U.S.C. § 2344 (referring to “any party aggrieved”).

Congress again expanded the scope of the review

provision beyond the party to the order by referring to

a person “affected,” not just to the party participating

in the agency proceeding. If the “artificially narrow

meaning” proposed by FDA “is what Congress

intended[,] it would more naturally have said” person

who was a party to the marketing application, rather

than the person adversely affected. Thompson, 562

U.S. at 177 (rejecting an effort to insert a scope

limitation Congress had not inserted). Congress chose

the broader language, not the narrower, and FDA

does not even try to explain why.

FDA’s efforts to narrow this provision also collide

with the strong presumption in favor of judicial

review of final agency actions. Corner Post, Inc., 603

U.S. at 799; Abbott Labs., 387 U.S. at 140. FDA tries

to brush that key presumption aside but cannot

reconcile its novel arguments with that presumption.

At bottom, FDA’s argument attempts to read an

administrative exhaustion requirement into the

TCA’s review provision. Under FDA’s reading of the

review provision, a potential challenger must

intervene in the agency proceeding to secure the right

to subsequently petition for review. But Congress

inserted no such requirement in the statute, and it

obviously knows how to do so. See, e.g., 7 U.S.C.

§ 6912(e) (requiring that “a person shall exhaust all

administrative appeal procedures” before bringing an

16

action against the Secretary or Department of

Agriculture). Nor has the zone-of-interests test ever

been understood to include it. And it is not given to

courts to create such prerequisites when Congress

has chosen not to impose them. See Darby v. Cisneros,

509 U.S. 137, 154 (1993) (where judicial review

provision did not require it, agency could not require

plaintiff to exhaust administrative remedies before

seeking judicial review).

FDA’s arguments conflict more directly with

other textual evidence, which rules out its proposed

narrow reading of the judicial review provision. The

TCA contains a separate review provision that

addresses FDA orders withdrawing previously

approved applications, 21 U.S.C. § 387j(d)(2), one that

contains precisely the limitation FDA wants to read

into the review provision for denial orders. With

respect to withdrawal orders, only the “holder of” the

previously approved “application” may file a petition

for review. 21 U.S.C. § 387j(d)(2). The different

language in these two provisions shows that, when

Congress meant to limit the right to seek review to

the person who made the marketing application, it

said so. “Where Congress includes particular

language in one section of a statute but omits it in

another section of the same Act, it is generally

presumed that Congress acts intentionally and

purposely in the disparate inclusion or exclusion.”

Russello v. United States, 464 U.S. 16, 23 (1983). That

presumption dictates that, in contrast with the review

provision for withdrawal orders, Congress did not

17

limit the right to petition for review of denial orders

to the applicant.

Comparing the TCA judicial review provision for

denial orders with judicial review provisions in

various other statutes further confirms this textual

conclusion. In certain review provisions, Congress did

include specific limitations on the persons who could

seek judicial review, even limiting the right of review

to the party to the agency proceeding. See, e.g., 52

U.S.C. § 30109(a)(4)(C)(iii) (Federal Campaign

Finance Enforcement) (providing the right to seek

judicial review to “Any person against whom an

adverse determination is made under this

subparagraph”). Congress knows how to limit the

scope of a judicial review provision when it wants to.

FDA’s argument offers one final conflict with the

relevant text. FDA misdescribes the application

process as an “adjudication,” Pet. Br. 7 (citing 21

U.S.C. § 387j(c)), see also id. at 14, and it even equates

the process with a “court proceeding[],” Pet. Br. 14

(emphasis added). FDA then notes that “only the

parties to an adjudication may challenge its outcome

in court.” Id. at 25. But the subsection FDA cites does

not use the word “adjudicate” or anything like it. 21

U.S.C. § 387j(c). The marketing application process is

a simple paper review. There are no competing

evidentiary submissions, no hearings, and no

resulting findings of fact or conclusions of law. The

FDA just reviews the application and either grants or

denies it. 21 U.S.C. §§ 387j(c)(1)–(2); see also Pet.

App. 10a (denial order stating that it is “[b]ased on

our review of your” applications). Because there is no

18

hearing to which a person could be a party, it makes

perfect sense for § 387l(a)(1) to make judicial review

available to those who are “adversely affected” by a

denial order.

B. FDA’s Arguments Attempt to Narrow the

Review Provision by Rewriting This Court’s

Zone-of-Interests Test

FDA’s attempt to direct the focus solely to the

party to the underlying agency proceeding brings us

to its misreading of the zone-of-interests test. This

test provides the proper framework to determine

whether the retailers were “adversely affected” by the

denial order. See Bank of Am. Corp., 581 U.S. at 194,

197. As summarized above, the test focuses on the

substantive “interests” advanced by the relevant

statute and by the challenger. See Nat’l Credit Union

Admin., 522 U.S. at 492. The test does not, as FDA

contends, limit the statutory zone of interests to the

person named in the agency order at issue, nor to

those whom the statute permitted to participate in

the underlying agency proceeding.

One leading zone-of-interests case illustrates

FDA’s error. Clarke, 479 U.S. at 390–92, 403. There,

the Comptroller of the Currency had granted

applications by certain banks for authority to provide

brokerage services. Id. at 390–91, 399. A group of

securities brokers and similar entities challenged the

order. Id. at 392–93. Like the retailers in this case,

they had played no role in the agency application

process that had led to the order they were

challenging. Id. Yet, the Court held that they were in

19

the zone of interests of the governing National Bank

Act and thus could challenge the order granting the

banks’ applications. 479 U.S. at 390–94, 397. (See also

id. at 403, concluding that the securities brokers’

“interest … has a plausible relationship to the policies

underlying” the National Bank Act.)

Similarly, the zone-of-interests test does not

require a showing that the relevant statute expressly

protects the challenger. To the contrary, this Court

already has rejected that argument: “We do not

require any indication of congressional purpose to

benefit the would-be plaintiff.” Match-E-Be-NashShe-Wish Band of Pottawatomi Indians v. Patchak,

567 U.S. 209, 225 (2012) (cleaned up). See also Clarke,

479 U.S. at 399 (same); Nat’l Credit Union Admin.,

522 U.S. at 492 (same).

Finally, FDA’s assertion that the denial order

“affects retailers only indirectly,” Pet. Br. 7, ignores

the direct effects that denial orders have on them.

Most obviously, they lose sales as a direct effect of the

denial order. And as documented above, FDA

penalizes retailers for selling unauthorized tobacco

products. See, e.g., 21 U.S.C. §§ 331(a), 387b(6). FDA

cites no authority suggesting these tangible economic

effects do not satisfy the zone-of-interests test. 8

8 FDA cites authorities addressing takings and other due process

claims, but those cases do not discuss proximate cause or even

any judicial review statute. See Pet. Br. 15. O’Bannon v. Town

Court Nursing Center, 447 U.S. 773, 788 (1980), addresses a

due process claim based on an asserted property interest in

remaining in a nursing home. Department of State v. Muñoz,

20

Equally telling, FDA does not challenge the retailers’

standing under Article III—which it surely would

have done if it could show that the effect on retailers

was only “indirect.” See Lujan v. Defs. of Wildlife, 504

U.S. 555, 560 (1992) (stating that Article III standing

requires “a causal connection between the injury and

the conduct complained of”). But FDA has not

advanced that argument.

Overall, FDA attempts to transform the zone-ofinterests test into an arbitrary barrier that would

narrow the scope of judicial review provisions. This

Court’s test inquires into the “interests” of the

petitioner and those protected by the governing

statute, but FDA substitutes a test that asks only

whether (i) the petitioner participated in the

underlying agency proceeding, or (ii) the statute

specifically identifies the plaintiffs as a beneficiary.

FDA’s proposed alternative test bears no resemblance

to the Court’s zone-of-interests test. See, e.g.,

Lexmark, 572 U.S. at 129–30; see also id. at 130 n.5

(discussing the harm-within-the-risk).

By reducing the scope of persons who are

“adversely affected,” FDA would eliminate the

ability of many “adversely affected” persons to seek

602 U.S. 899, 917–919 (2024), addresses a wife’s assertion of a

liberty interest in her husband’s visa application. Similarly,

Center for Reproductive Law & Policy v. Bush, 304 F.3d 183,

186 (2d Cir. 2002), holds that the “plaintiffs’ alleged harm does

not fall within the zone of interests protected by the Due Process

Clause.”

21

redress for the FDA’s injurious actions. If

successful, FDA’s arguments also would generate

significant new uncertainty about the content of

the well-established zone-of-interests test. This

uncertainty would, in turn, cast doubt on the

meaning of the many judicial review provisions

that authorize those who are “adversely affected”

to obtain judicial review of agency actions.

III.

FDA’S ARGUMENTS WOULD NARROW THE

SCOPE OF JUDICIAL REVIEW PROVISIONS IN

MANY OTHER STATUTES

In some instances, the Venn diagram of those who

are both “adversely affected” and “parties” to an

agency proceeding could, given the right

circumstances and statutory language, completely

overlap. But that is not the argument FDA is making.

FDA says an entity that was not a party to an agency

proceeding may not, as a categorical matter, be

“adversely affected.” That cannot be correct. Congress

regularly addresses itself to the question of whether

“party” status should be a prerequisite to seeking

judicial review. Sometimes it says it’s necessary, quite

often it doesn’t. FDA, impatient with these prudential

judgments, asks the Court to make uniform what

Congress did not. But judicially imposing a “party”

status requirement in this case would affect not just

21 U.S.C. § 387l(a), but all statutes that condition the

right to judicial review on being “adversely affected”

or “aggrieved.”

22

A. FDA’s Categorical “Party” Requirement

Although couching its proposition in terms of the

zone-of- interests test, FDA focuses almost

exclusively on factors that relate to what it means to

be a party to an agency proceeding. Here is FDA’s own

summary of its argument:

A retailer’s interests fall outside the zone of

interests protected by the provision at issue—

the provision that requires FDA to adjudicate

an application for marketing authorization.

See 21 U.S.C. 387j(c). The order that FDA

issues at the end of that adjudication speaks to

the applicant alone (always or nearly always a

manufacturer of the product) and affects

retailers only indirectly. And while the

provision grants procedural rights to the

applicant itself, it shows no similar solicitude

for retailers. It does not allow retailers to

participate in the proceedings, does not grant

them any procedural rights, and does not

require FDA to account for their substantive

interests.

Pet. Br. 7–8.

According to FDA, unless an entity partakes of

the listed characteristics, it cannot qualify as

“adversely affected” for purposes of filing a petition for

review. All but two of those characteristics (more

about the exceptions in a moment) describe attributes

associated with “party” status in the agency

proceeding. Thus, the fact that the FDA’s order

addresses the applicant and no one else is not only to

23

be expected but could hardly be otherwise. An

administrative agency has no authority to adjudicate

the rights of anyone not a party to the proceeding, so

there would be no reason for FDA to address itself to

anyone else. Similarly, “procedural rights” have no

meaning outside the context of participation in the

agency proceeding. And, naturally, FDA’s observation

that 21 U.S.C. § 387j contains no mechanism for

retailers to participate in the application process is

just another way of saying retailers cannot be parties.

The two characteristics not addressing party

attributes do not detract from the categorical nature

of FDA’s argument. First, whether the retailers are

“indirectly” affected is simply a conclusory

characterization by which FDA tries to drive a wedge

between the retailers’ and Reynolds’s interests. But

there’s little light between them. Reynolds’s interest

is in selling its product at wholesale, while the

retailers’ interest is selling that same product at

retail. The effect of FDA’s order doesn’t differentiate

between the retailers’ and Reynolds’s interests: They

are all prohibited from selling the product. The

retailers may be downstream in the supply chain, but

the order’s impact on their interests is every bit as

direct as it is on Reynolds’s.

The second non-party characteristic is as

inapplicable to parties as it is to retailers. FDA says

the statute indicates Congress did not allow retailers

to file petitions for review because it “does not require

FDA to account for their substantive interests.” Pet.

Br. 8. Perhaps there are circumstances in which that

24

is relevant, but here, the Act doesn’t account for any

of the applicant’s substantive interests either. Unless,

that is, FDA is referring to its duty not to broadcast

proprietary information used in the application

process. 21 U.S.C. § 387f(c). And, if that is the interest

to which FDA adverts, it’s merely incidental to the

only substantive question the statutory application

process addresses, to wit, whether the product may be

offered for sale.

Because the two extraneous characteristics do

nothing to distinguish the retailers from Reynolds,

they can be dropped without affecting the substance

of FDA’s argument. With that adjustment, FDA’s

ultimate position boils down to this: An entity cannot

be “adversely affected” unless it was a party to the

agency proceeding. FDA helpfully said that very thing

in the tightest summary of its argument: “[T]his case

involves judicial review of an adjudication. It is

particularly natural to infer that only the parties to

an adjudication may challenge its outcome in court.”

Pet. Br. 25.

Congress, however, did not include the categorical

restriction the FDA wants the Court to impose, even

though it has been legislatively included in many

other statutory programs. Accepting the FDA’s

argument would thus require the Court to supplant

Congress’s prudential judgment with its own and

venture into the legislative realm. Moreover, the

likely unintended consequences attendant on such a

venture are far-reaching. So, there is more than

25

adequate reason to leave this question in Congress’s

hands where it belongs.

B. The Danger of Unintended Consequences

Although FDA may be asking the Court to impose

a categorical “party” requirement on just one judicial

review provision, it offers no limiting principle to

prevent it from becoming instantly applicable to all

other statutes that use similar language. If the Court

were to grant FDA’s request, the risk of unintended

consequences with respect to the scope of a host of

other judicial review statutes would be enormous.

The Administrative Conference of the United

States (“ACUS”) counts 652 statutes that grant a

right to judicial review of agency actions. 9 At least

that was true upon completion of the research that

went into the 2022 Sourcebook of Federal Judicial

Review Statutes. 10 The number might be, and likely

is, higher today. As part of its study, ACUS examined

who the statutes’ text authorizes to file such petitions.

It found that Congress uses at least four different

categories to identify authorized petitioners,

including the following:

9 The Administrative Conference compiled a list of the statutes

into a spreadsheet (the “ACUS Spreadsheet”), which is available

here: https://tinyurl.com/4kvfyz47.

10 Jonathan R. Siegel, 2022 Sourcebook of Federal Judicial

Review Statutes, Administrative Conference of the United

States, available at https://tinyurl.com/2ptp6tdz.

26

1.

Aggrieved or adversely affected; 11

2.

Those against whom the agency has

acted; 12

3.

Any interested person; 13 and

4.

States or political subdivisions. 14

ACUS also noted that some statutes grant a right to

judicial review to specifically named agencies or

entities, while others contain no textually defined

category of proper petitioners at all. ACUS’s study is

instructive at the most general level because it

reveals the multiplicity of approaches Congress has

taken in expressing who should have a right to file a

petition for judicial review.

Of all these categories, the first is of greatest

interest here, of course, inasmuch as such statutes

use the same phrase (or an indistinguishable cognate)

as 21 U.S.C. § 387l(a). ACUS identified 124 statutory

See ACUS Spreadsheet, column W (“Who May Seek Review”).

ACUS coded the statutes according to the language describing

who has the right to petition for review. Those coded as “B.1”

through “B.3” use the term “aggrieved” or “adversely affected.”

There has been no suggestion that these terms identify

materially different groups of people. See, e.g., Dir., Off. of

Workers’ Comp. Programs, 514 U.S. at 126 (“‘adversely affected’

and ‘aggrieved,’ alone or in combination, have a long history in

federal administrative law”).

12 Id. ACUS coded the statutes falling into this category as “C.1”

through “C.5.”

13 Id. Statutes in this category are coded “A.”

14 Id. Statutes in this category are coded “F.”

11

27

provisions that use that language, alone or in

combination with other descriptors, to identify the

class of people who may file a petition for review. With

respect to those using “aggrieved” or “adversely

affected” as the only descriptor, the following is just a

representative sample: 7 U.S.C. § 3804(b) (“[a]ny

person aggrieved by an order”); 15 U.S.C. § 77i(a)

(“[a]ny person aggrieved by an order”); 15 U.S.C.

§ 78y(a) & (b)(1) (“[a] person aggrieved by a final

order”; “[a] person adversely affected by a rule”); 15

U.S.C. § 1710(a) ([a]ny person, aggrieved by an order

or determination”); 15 U.S.C. § 4015(a) (“any person

aggrieved by such determination”); 15 U.S.C.

§ 6762(a) (“[a]ny person aggrieved by a decision or

action”); 16 U.S.C. § 824k(f)(1) (“any aggrieved

person”); 20 U.S.C. § 7905(c)(3) (“[a]ny person

aggrieved by the action”); 21 U.S.C. § 360g(a) (“any

person adversely affected by such regulation or

order”); 21 U.S.C. § 877 (“any person aggrieved by a

final decision”); 30 U.S.C. § 816(a)(1) (“[a]ny person

adversely affected or aggrieved by an order”); 42

U.S.C. § 5405(a)(1) (“any person who may be

adversely affected by such order”); 42 U.S.C.

§ 6306(b)(1) (“[a]ny person who will be adversely

affected by a rule”); 42 U.S.C. § 7622(c)(1) (“[a]ny

person adversely affected or aggrieved by an order”);

47 U.S.C. § 252(e)(6) (“any party aggrieved by such

determination”); 49 U.S.C. § 5127(a) (“a person

adversely affected or aggrieved by a final action”).

And, of course, there is the APA provision making

review available to any person who is “adversely

28

affected or aggrieved by agency action within the

meaning of a relevant statute ….” 5 U.S.C. § 702.

Not all of these statutes have received judicial

treatment on the question of whether a petitioner

must first have been a party to the agency proceeding.

But some have. As mentioned above, this Court in the

Clarke case did not require “party” status in an

agency proceeding as a prerequisite to being

“adversely affected” within the meaning of the APA’s

judicial review provision. 479 U.S. at 390-93. Other

courts have come to the same conclusion when

addressing the same language in the context of nonAPA judicial review statutes.

For example, in Bd. of Trade of Chicago v. SEC,

883 F.2d 525 (7th Cir. 1989), business rivals of a

newly-authorized clearing house filed a petition to

review the SEC’s authorization under a provision that

granted such right to “person[s] aggrieved by a final

order of the Commission.” 15 U.S.C. § 78y(a)(1). The

question was whether business competitors fell

within the statute’s zone of interests governing the

authorization process. Notwithstanding the fact that

the rivals had not been parties to the clearing house’s

application process before the SEC, the court

concluded the competitors were “aggrieved” and

entitled to file their petition.

Nor were the petitioners in Horizons Int’l, Inc. v.

Baldrige, 811 F.2d 154 (3d Cir. 1987), stymied by the

fact they had not participated in the agency

proceeding. The case addressed “certificates of

29

review” that give applicants “limited antitrust

immunity to engage in specified concerted export

activity” if “the proposed activity meets statutory

requirements.” Id. at 156. The application process

requires publication in the Federal Register so that

interested parties may file comments. A consortium of

interests filed an application for such a certificate,

which the Commerce Secretary granted. The relevant

review statute says “any person aggrieved by such

determination” may file a petition for review. 15

U.S.C. § 4015. The petitioners, who were business

competitors of the applicants, petitioned for review of

the certificate without first filing comments during

the agency application process. The court concluded

that “failure to comment did not affect plaintiffs’

standing to seek judicial review.” 811 F.2d at 168.

FDA does not account for the effect of its

argument on these opinions, nor on all the other

statutes that use “aggrieved” or “adversely affected”

to identify those who are entitled to file a petition for

review. But if the Court accepts FDA’s contra-textual

argument that “party” status in the agency

proceeding is a sine qua non to being “adversely

affected” for purposes of 21 U.S.C. § 387l(a), there is

no limiting factor that would preclude imposition of

this restriction across this entire category of statutes.

Not only would FDA’s argument, if accepted,

represent the imposition of a condition Congress did

not adopt, but the rejection of a distinction Congress

must be presumed to have deliberately created. Even

as it rejected “party” status in the category of statutes

30

identified above, it affirmatively required that status

in others. So, when Congress considered it was not

enough to be “aggrieved” or “adversely affected,” it

added the further requirement that the petitioner

must have been a party to the agency proceedings.

See, e.g., 7 U.S.C. § 136n(b) (“any person who will be

adversely affected by such order and who had been a

party to the proceedings”); 15 U.S.C. § 2615(a)(3)

(“Any person who requested in accordance with

paragraph (2)(A) a hearing respecting the assessment

of a civil penalty and who is aggrieved by an order”);

16 U.S.C. § 825l(a) (“Any person, electric utility,

State, municipality, or State commission aggrieved by

an order issued by the Commission in a proceeding

under this chapter to which such person, electric

utility, State, municipality, or State commission is a

party”); 33 U.S.C. § 1516 (“A person shall be deemed

to be aggrieved by the Secretary’s decision within the

meaning of this chapter if he—(A) has participated in

the

administrative

proceedings

before

the

Secretary ….”). And then, of course, there is the

judicial review provision governing an FDA order that

withdraws a prior approval of an application.

Congress saw fit to limit review in such circumstances

to the applicant alone. 21 U.S.C. § 387j(d)(2).

The Court should reject FDA’s argument not just

because it finds no support in statutory text or the

history of the zone-of-interests test, but also because

it would unsettle the meaning of a distressingly large

number of judicial review provisions, impose

requirements that Congress did not create, and erase

31

distinctions that it did. The U.S. Code’s array of

judicial review provisions may not create the uniform

“party” requirement FDA wants, but it does reflect

Congress’s prudential judgment about when that

status should be a prerequisite to judicial review.

And that is a judgment the Constitution reserves to

the first branch of government.

CONCLUSION

The Court should hold that the retailer

Respondents are persons “adversely affected” by

FDA’s denial order within the meaning of 21 U.S.C.

§ 387l(a)(1).

December 23, 2024

Respectfully submitted,

/s/ Andrew J. Morris

Andrew J. Morris

Counsel of Record

Daniel Kelly

Mark Chenoweth

NEW CIVIL LIBERTIES ALLIANCE

4250 N. Fairfax Dr., Suite 300

Arlington, VA 22203

Phone: (202) 869-5210

andrew.morris@ncla.legal

Counsel for Amicus Curiae

New Civil Liberties Alliance