Amicus Curiae Brief — Food and Drug Administration, Petitioner v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al.

No. 23-1038

IN THE

Supreme Court of the United States

UNITED STATES FOOD AND DRUG ADMINISTRATION,

Petitioner,

v.

WAGES AND WHITE LION INVESTMENTS, L.L.C., DBA

TRITON DISTRIBUTION, ET AL.,

Respondents.

_____________________________________________

On Writ of Certiorari to the United States

Court of Appeals for the Fifth Circuit

_____________________________________________

BRIEF OF THE VAPOR TECHNOLOGY

ASSOCIATION AS AMICUS CURIAE IN

SUPPORT OF RESPONDENTS

_____________________________________________

ANTHONY L. ABBOUD

Counsel of Record

LAW OFFICES OF

TONY ABBOUD

950 Hawthorne Lane

Northbrook, IL 60062

(312) 498-6060

tony@abboudlegal.com

Counsel for Amicus Curiae

i

Page

TABLE OF CONTENTS………………………………...i

TABLE OF

AUTHORITIES………………………………………….iii

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

SUMMARY OF ARGUMENT.....................................3

ARGUMENT ...............................................................5

I.

II.

LOPER REQUIRES THAT FDA’S DENIAL

ORDERS BE SET ASIDE BECAUSE THEY

VIOLATE THE BEST READING OF THE

TOBACCO CONTROL ACT. ..............................5

A.

The Various Courts Of Appeals That

Have Considered This Issue All

Failed To Analyze Whether FDA’s

Denial Orders Conformed With The

Best Reading Of The Tobacco Control

Act. ...............................................................7

B.

The Fifth Circuit’s Decision To Set

Aside FDA’s Denial Orders Is

Consistent With Loper Because The

FDA’s Denial Orders Violate The Best

Reading Of The Tobacco Control Act. ........7

THE BEST READING OF THE TOBACCO

CONTROL ACT DOES NOT ALLOW FDA

TO ISSUE DENIAL ORDERS BASED ON

THE POST-HOC COMPARATIVE

EFFICACY TEST. .............................................11

ii

TABLE OF CONTENTS

(continued)

Page

A.

The Tobacco Control Act Requires

FDA To Consider The Population As

A Whole, But FDA Used The

Comparative Efficacy Test To Only

Consider Two Segments Of The

Population. ................................................11

B.

The Tobacco Control Act Requires

FDA To Evaluate New Tobacco

Products On An Individual Basis, But

FDA Failed to Do So. ................................14

C.

FDA Improperly Used Its Application

Review Process to Implement a De

Facto Tobacco Product Standard

While Unlawfully Evading Notice and

Comment Rulemaking Requirements. .....17

III. FDA PROCESS FOR REVIEWING PMTAS

WAS HEAVILY CRITICIZED BY AN

INDEPENDENT TOBACCO EXPERT

PANEL WHICH CALLED OUT THE FDA’S

FAILURE TO CONSISTENTLY APPLY

THE APPH TEST..............................................20

CONCLUSION ..........................................................23

iii

Page(s)

CASES

21 U.S.C. §387j (c)(2)(A) ............................................. 6

Azar v. Allina Health Servs., 587 U.S. 566, 575

(2019) .................................................................... 19

Chevron U.S.A. Inc. v. Natural Resources Defense

Council, Inc., 467 U. S. 837, 842 (1984)................. 5

General Motors Corp. v. Ruckelshaus, 742 F. 2d

1561, 1565 (D.C. Cir. 1984) .................................. 20

Loper Bright Enterprises v. Raimondo, et al. 144 S.

Ct. 2244, 603 U.S. ___ (2024) ........................ passim

Motor Vehicle Mfrs. Ass'n v. State Farm Mutual

Automobile Ins. Co., 463 U.S. 29, 42 (1983) ... 6, 14,

20

NLRB v. Wyman–Gordan Co., 394 U.S. 759, 764

(1969) .................................................................... 19

Safari Club Int’l v. Zinke, 878 F.3d 316, 331-333

(D.C. Cir. 2017) ..................................................... 20

Wages & White Lion Investments, LLC v. Food &

Drug Administration, 90 F.4th 357, 388 (en banc)

(2024) ................................................................ 8, 18

Wages & White Lion Invs. LLC v. U.S. Food & Drug

Administration, 14 F.4th 1130, 1134 (5th Cir.

2021)........................................................................ 1

Yesler Terrace Cmty. Council v. Cisneros, 37 F.3d

442, 449 (9th Cir. 1994) ........................................ 20

STATUTES

21 U.S.C. § 387j (c)(4)......................................... 13, 16

21 U.S.C. § 387j(c)(2)................................................ 16

iv

TABLE OF AUTHORITIES

(continued)

Page(s)

21 U.S.C. § 387j(c)(5)................................................ 16

21 U.S.C. §387g(a)(1)(A) .......................................... 17

21 U.S.C. §387g(a)(4)(B)(i) ....................................... 17

21 U.S.C. §387g(c)-(d) ........................................ 17, 19

21 U.S.C. §387g(e)(1)................................................ 17

21 U.S.C. §387g. ....................................................... 17

21 U.S.C. §387j (c)(4)................................................ 12

21 U.S.C. §387j(b)(1)(D) ..................................... 18, 19

5 U.S.C. §706(2)(A) ..................................................... 6

Family Smoking Prevention and Tobacco Control Act

of 2009, 123 Stat. 1776, 1777, codified at 21 U.S.C.

§ 387 .................................................................... 3, 4

Food, Drug & Cosmetic Act, 21 U.S.C. §387j ............ 4

Further Consolidated Appropriations Act, 2020 Pub.

L. No. 116-94, 133 Stat. 2534 ................................. 2

Id. § 387j(c)(4) ........................................................... 12

OTHER AUTHORITIES

Operational Evaluation of Certain Components of

FDA's Tobacco Program: A Report of the Tobacco

Independent Expert Panel, Silvis, et. al; 2022. .. 21,

22, 23

U.S. Public Health Service, U.S. Dep’t of Health and

Human Services, E-Cigarette Use Among Youth

and Young Adults: A Report of the Surgeon

General 49 (2016) ................................................. 14

v

TABLE OF AUTHORITIES

(continued)

Page(s)

Yagi, Dr. Brian, et al., Appropriate for the Protection

of Public Health: Why We Need Electronic Nicotine

Delivery System Product Standards, Food and

Drug Law Journal, vol. 78 (2023) ........................ 13

REGULATIONS

Advance Notice of Proposed Rule Making,

Regulation of Flavors in Tobacco Products,

83Fed.Reg.12,294 (Mar. 21, 2018) ................... 1, 18

FDA, Enforcement Priorities for Electronic Nicotine

Delivery Systems (ENDS) and Other Deemed

Products on the Market Without Premarket

Authorization, January 2020 ................................. 2

Proposed Tobacco Product Standard for Menthol in

Cigarettes, 87 Fed. Reg. 26454 (May 4, 2022) ..... 18

Tobacco Product Standard for Characterizing

Flavors in Cigars, 87 Fed. Reg. 26396 (May 4,

2022)...................................................................... 18

OTHER MATERIALS

The Economic Impact of a Ban on Flavored Vapor

Products, John Dunham & Associates, November

21, 2019 ................................................................... 2

1

INTEREST OF AMICUS CURIAE

The Amicus Curiae1 Vapor Technology Association

(VTA) is a national non-profit industry trade

association whose members are dedicated to

developing and selling high quality electronic nicotine

delivery systems (ENDS), also known as e-cigarettes

or vapor products2, that provide adult consumers with

an alternative to smoking combustible cigarettes.

Since its founding, VTA has been engaged on critical

regulatory issues confronting the vapor industry,

advocating for science-based regulations to protect

against youth access to and appeal of vapor products.

VTA has engaged with Congress and federal

regulators, including the U.S. Food & Drug

Administration (FDA), on myriad issues and

specifically on the issue of flavored ENDS regulation.

In 2018, when the FDA published its Advance Notice

of Proposed Rulemaking, Regulation of Flavors in

Tobacco Products, 83 Fed. Reg. 12294 (Mar. 21, 2018)

(hereafter, “Flavor ANPRM”), VTA submitted

substantive comments to the FDA detailing all of the

scientific studies at that time demonstrating the role

that flavors play in smoking cessation amongst other

issues.

No counsel for any party authored this brief in whole or in

part, and no person or entity other than amicus, its members, or

its counsel made a monetary contribution intended to fund the

preparation or submission of this brief. Petitioners are not and

have not been members of VTA.

1

Herein we refer to ENDS products as e-cigarettes and

vapor products as those terms are used interchangeably. See,

Wages & White Lion Invs. LLC v. U.S. Food & Drug

Administration, 14 F.4th 1130, 1134 (5th Cir. 2021) (discussing

the interchangeability of the terms).

2

2

In 2019, when the FDA in the Trump

Administration announced a ban all flavored vapor

products through a modification of its deferred

enforcement policy (which it later elected not to do),

VTA shared information with the Administration on

the role that flavored vaping products play in

assisting adult smokers quit, and presented the

economic impact analysis of John Dunham &

Associates (JDA), which showed that the proposed

national flavor ban would shut down 13,000 small

businesses whose adult customers relied on flavored

vaping.3

The Administration ultimately elected not to ban

open-system flavored vaping products (like

Respondents’ at issue) and, instead, modified its

deferred enforcement policy to limit FDA’s flavor ban

only to pod and cartridge closed system products that

the FDA had tied directly to the problem of youth

vaping. FDA, Enforcement Priorities for Electronic

Nicotine Delivery Systems (ENDS) and Other

Deemed Products on the Market Without Premarket

Authorization, January 2020. VTA also championed

raising the age to purchase all tobacco products to 21

as a common sense way to address the issue of youth

vaping, which the Administration endorsed and

Congress passed in December 2019. See Further

Consolidated Appropriations Act, 2020 Pub. L. No.

116-94, 133 Stat. 2534, 3123.

In 2024, VTA’s Executive Director testified before

the Senate Judiciary Committee regarding the

myriad problems with FDA’s regulatory process,

3 The Economic Impact of a Ban on Flavored Vapor Products,

John Dunham & Associates, November 21, 2019, p. 6, available

at

https://vaportechnology.org/wpcontent/uploads/2022/11/Dunham-Economic-Impact-of-FlavorBan-11-21-19.pdf (the “JDA 2019 Report”).

3

including its violations of law. With this extensive

background and involvement on the issue of vaping

product regulation, Amicus Curiae offers this

additional context that may assist the Court in

assessing the importance of denying the relief sought

by the U.S. Food & Drug Administration in its brief

(the “Brief”).

SUMMARY OF ARGUMENT

After Loper Bright Enterprises v. Raimondo, et al.

144 S. Ct. 2244, 603 U.S. ___ (2024) (“Loper”) the

jurisprudence in the United States for reviewing

administrative agency actions has changed. No

longer is it acceptable for federal agencies to throw up

any reasonable justification to support its actions.

Now, it is essential that every agency action be

evaluated in the context of the best reading of the

statute empowering the agency in the first place. In

this case, the FDA’s denial orders not only in conflict

with the best reading Family Smoking Prevention

and Tobacco Control Act of 2009, 123 Stat. 1776, 1777,

codified at 21 U.S.C. § 387 (hereafter, the “Tobacco

Control Act” or “Act”), they undermine the Act

altogether.

First, the denial orders were all issued based on

the absence of a specific study – a long term

comparative

efficacy

study

which

required

Respondents to prove that its non-tobacco flavored ecigarettes were more efficacious at helping adults to

quit smoking than its tobacco-flavored e-cigarettes

(hereafter, the “Comparative Efficacy Test”) – which

the FDA had never stated was a requirement before

Respondents’ applications were filed. FDA only

announced this Comparative Efficacy Test after

Respondents’ PMTAs had been filed. Retroactively

requiring Respondents to have included a specific

4

piece of information, failing to give Respondents an

opportunity to provide such information, and then

denying Respondents’ application solely based on the

absence of that information contradicts any

reasonable conception of what a fair application

process should look like, much less what Congress

required in the Act.

Second, the demand for the Comparative Efficacy

Test undermines the central purpose of the Act of

ensuring

that

new

tobacco

products

are

comparatively less harmful than cigarettes. What

FDA referred to as a “fatal flaw” justifying its denials

was in fact the fatal flaw in its post-hoc attempt to

justify its actions as lawful. Not only does this

misapprehend the Tobacco Control Act’s intent for

each new tobacco product be evaluated on its own

merit, but it also undermines the fundamental

purpose of the Tobacco Control Act to provide a

pathway to market for products less harmful than

combustible cigarettes. See, e.g., Tobacco Control Act

§3(4) (stating that a purpose of the Tobacco Control

Act is to facilitate the marketing of less harmful

tobacco products); see generally Food, Drug &

Cosmetic Act, 21 U.S.C. §387j (providing pathways to

market for products that are less harmful than

combustible cigarettes).

Third, no section of the Tobacco Control Act

empowers the FDA to create a de facto tobacco

product standard through a series of denial orders for

e-cigarette flavors without FDA first adopting a

tobacco product standard—as laid out expressly in the

Tobacco Control Act by Congress—through the

required notice and comment process. Here again,

FDA flouted the terms of the Tobacco Control Act by

retroactively imposing a tobacco product standard

against non-tobacco flavors with giving applicants

5

prior notice of this standard, much less an

opportunity to comment on it, before PMTAs were

due.

Thus, while Loper was decided after the Fifth

Circuit’s decision below, and as Respondents correctly

note does not preclude in any way the Fifth Circuit’s

finding that they were not given fair notice, it is clear

that post-Loper jurisprudence aligns with the Fifth

Circuit’s criticisms and findings regarding the FDA’s

actions. What is equally clear is that FDA’s attempt

to wrap itself in Loper is folly. The very notion that

FDA plucks one word – “appropriate” – out of its

context in the Tobacco Control Act to claim that this

one word gives it “significant flexibility” is not only

the epitome of cherry-picking but demonstrates the

highly tenuous ground on which it knows it is

standing. See, FDA Brief, p. 16. Accordingly, the

decision of the Fifth Circuit should be upheld based

on Respondents’ arguments but particularly so when

viewed through the prism of this Court’s Loper

jurisprudence.

ARGUMENT

I.

LOPER REQUIRES THAT FDA’S DENIAL ORDERS

BE SET ASIDE BECAUSE THEY VIOLATE THE

BEST READING OF THE TOBACCO CONTROL ACT.

The Court’s decision in Loper requires that every

agency action derive from the best reading of the

statute empowering the agency in the first place. No

longer can a court allow an agency to justify its

actions simply because they are “based on a

permissible construction of the statute.” Chevron

U.S.A. Inc. v. Natural Resources Defense Council, Inc.,

467 U. S. 837, 842 (1984) (“Chevron”). Instead,

“[c]ourts must exercise their independent judgment in

deciding whether an agency has acted within its

6

statutory authority, as the APA requires.” Loper, 144

S.Ct. at 2273.

It is “the will of Congress” that

matters, not the will of the agency. See Id. at 2263.

This case concerns the question: “Whether the

[Fifth Circuit] erred in setting aside FDA's denial

orders as arbitrary and capricious.” FDA Brief I.

These denial orders were made under 21 U.S.C. §387j

(c)(2)(A), which provides FDA shall issue a denial

order if “[t]here is a lack of a showing that permitting

such tobacco product to be marketed would be

appropriate for the protection of the public health”

(the “APPH Test”). See Id. The APPH Test is set

forth in 21 U.S.C. §387j, which describes what is

required for a PMTA approval. Thus, whether FDA

acted in an arbitrary and capricious manner when

issuing denial orders necessarily requires the Court

“to ‘interpret … statutory provisions’” in relation to

the PMTA process and specifically the APPH Test.

See Loper, 144 S.Ct. at 2270 (quoting 5 U.S.C. §706

and 5 U.S.C. §706(2)(A)); see also Id. at 2269 (“[T]he

APA[] demand[s] that courts exercise independent

judgment in construing statutes administered by

agencies.”)

Thus, the “question that matters” is: “Does the

statute authorize the challenged agency action?” Id.

It does not; FDA’s denial orders resulted from a

decision making process so disconnected from the text

of the Tobacco Control Act as to render the denial

orders arbitrary and capricious. See Motor Vehicle

Mfrs. Ass'n v. State Farm Mutual Automobile Ins. Co.,

463 U.S. 29, 42 (1983) (“State Farm”) (To survive

arbitrary and capricious review an agency action

must be “based on consideration of the relevant

factors, and within the scope of the authority

delegated to the agency by the statute.”); 5 U.S.C.

§706(2)(A). Accordingly, the Fifth Circuit’s decision

7

to set the denial orders aside as arbitrary and

capricious should be upheld because FDA has failed

to act in accordance with the best reading of the

Tobacco Control Act.

A.

The Various Courts Of Appeals That

Have Considered This Issue All Failed

To Analyze Whether FDA’s Denial

Orders Conformed With The Best

Reading Of The Tobacco Control Act.

While Chevron was not directly raised in the case

below or any of the parallel circuit court cases, its

ghost haunts them all. See Loper, 144 S.Ct. at 2275

Concurring (Gorsuch, J.) (“Today, the Court places a

tombstone on Chevron no one can miss.”). While none

of the cases which upheld FDA actions expressly

relied on Chevron, Chevron still reigned supreme as

those courts readily demurred to FDA’s broad

deference arguments allowing it to change its position

from pre-application guidance through postapplication decision making, a course of conduct

which was presumed to be “permissible.” 467 U. S. at

843. However, since this Court declared that “[i]n the

business of statutory interpretation, if it is not the

best, it is not permissible,” decisions deferentially

approving FDA actions are now, at best, wholly

incomplete. See Loper, 144 S.Ct. at 2266.

B.

The Fifth Circuit’s Decision To Set Aside

FDA’s Denial Orders Is Consistent With

Loper Because The FDA’s Denial Orders

Violate The Best Reading Of The

Tobacco Control Act.

Of all of the prior cases on this issue, the Fifth

Circuit’s decision is the only one that aligns with the

post-Loper jurisprudence.

Essentially, the Fifth

Circuit found PMTA applicants could not fairly

8

deduce the decision making criteria of FDA’s denial

orders based on the guidance documents and other

communications FDA provided before applications

were due (collectively, the “Guidance”). Pet. A 2a-4a.

As a result, the Fifth Circuit found:

In sum, FDA’s denials of petitioners’ PMTAs were

arbitrary and capricious. The agency did not give

manufacturers fair notice of the rules; the agency

did not acknowledge or explain its change in

position; the agency ignored reasonable and

serious reliance interests that manufacturers had

in the pre-MDO guidance; and the agency tried to

cover up its mistakes with post hoc justifications

at oral argument.

Wages & White Lion Investments, LLC v. Food & Drug

Administration, 90 F.4th 357, 388 (en banc) (2024).

Analysis of the relevant statutory provisions

fortifies the Fifth Circuit’s decision.

The preapplication Guidance accorded with the best reading

of the statute; FDA’s later decision making criteria for

the denial orders did not. Accordingly, it is not hard

to see why thousands of applicants submitted PMTAs

for more than a million proposed products that were

all denied without the benefit of a full review:

applicants could not predict that FDA’s decision

making would ignore the actual requirements of the

Tobacco Control Act.

FDA’s shift in position from its Guidance to its

extra-statutory decision making criteria is exactly the

sort of problem Chevron enabled and which Loper

now rejects. See Loper, 144 S.Ct. at 2272 (“Chevron

thus allow[ed] agencies to change course even when

Congress has given them no power to do so” […]

“Under Chevron, a statutory ambiguity . . . bec[ame]

a license authorizing an agency to change positions as

9

much as it likes” […] “Chevron foster[ed]

unwarranted instability in the law, leaving those

attempting to plan around agency action in an eternal

fog of uncertainty”).

Thus, the Fifth Circuit’s

decision, which directly calls out the FDA for its

changing requirements and post-hoc justifications, is

in full alignment with post-Loper jurisprudence

because it invalidates FDA’s shift in position away

from the best reading of the Tobacco Control Act. See

Pet. A. 2a.

The specific details of the FDA’s Guidance are

described at length in the Fifth Circuit’s opinion and

need not be fully recounted here. See Pet. A. 6a-14a.

What is important to note is the fact that while the

Guidance was full of “recommendations” as to what

information FDA would like to see in a PMTA,

nowhere in this Guidance did the FDA ever state it

would unequivocally require any specific study. See

J.A. 5.

Yet, FDA issued denial orders for PMTAs of nontobacco flavored e-cigarette products if they did not

include “robust and reliable evidence,” newly defined

after the fact as a “randomized controlled trial” or a

“longitudinal cohort study,” comparing use of nontobacco flavored products with that of tobacco

flavored products “over time” in order to show that the

non-tobacco flavored products have an “added benefit

relative to that of tobacco flavored [e-cigarettes] in

facilitating smokers completely switching away from

or significantly reducing their smoking” – the

Comparative Efficacy Test. See Pet. A. 180a-82a.

The oddity of such a contrived post-hoc

requirement cannot be overlooked. Because neither

non-tobacco flavored e-cigarettes nor tobacco flavored

e-cigarettes were authorized at the time applications

10

were due, the Comparative Efficacy Test only

involved a comparison between one type of not-yetauthorized e-cigarette product with another type of

not-yet-authorized e-cigarette product, but utterly

failed to compare the proposed e-cigarette products to

the existing authorized combustible cigarettes on the

market. This failing strikes at the core of the Tobacco

Control Act, which Congress intended to facilitate the

introduction of new, novel and less harmful tobacco

products into the market as alternatives to cigarettes.

See, e.g., Tobacco Control Act §3(4) (Congress stating

that a purpose of the Act is “to provide new and

flexible enforcement authority to ensure that there is

effective oversight of the tobacco industry's efforts to

develop, introduce, and promote less harmful tobacco

products” such as e-cigarettes).

Instead of reviewing the full applications which

Respondents submitted, FDA chose instead to only

perform a cursory review of non-tobacco flavored

product PMTAs in search of the Comparative Efficacy

Test which were never previously required. See J.A.

615-638. Pet. A. 182a. If a PMTA did not include the

Comparative Efficacy Test – which FDA knew was

likely given FDA’s failure to previously make such

studies a requirement – then the PMTA was

summarily denied without the benefit of a full review.

J.A. 243; Pet. A. 182a. As described in more detail

below, FDA had no statutory basis to establish what

the FDA called a “Fatal Flaw” Comparative Efficacy

Test prerequisite after applications were due, and

then use that retroactive prerequisite to justify its

refusal to conduct a full PMTA review. Accordingly,

the Fifth Circuit’s holding that FDA must re-do its

evaluations of applicants’ PMTAs in a comprehensive

manner should be upheld—with the added caveat

that these reevaluations must fully comply with the

11

best reading of the Tobacco Control Act. See Pet. A.

4a; Loper, 144 S.Ct. at 2266.

II. THE BEST READING OF THE TOBACCO CONTROL

ACT DOES NOT ALLOW FDA TO ISSUE DENIAL

ORDERS

BASED

ON

THE

POST-HOC

COMPARATIVE EFFICACY TEST.

A.

The Tobacco Control Act Requires FDA

To Consider The Population As A Whole,

But FDA Used The Comparative Efficacy

Test To Only Consider Two Segments Of

The Population.

FDA claims it denied Respondents’ PMTAs

because it found they did not meet the APPH Test.

See Pet. A. 182a, 236a, 290a. However, FDA’s

imposition of the Comparative Efficacy Test

prerequisite improperly ignored the statutory

requirement that it assess the “risks and benefits to

the population as a whole,” choosing instead to only

consider two discrete sub-segments of the population

in isolation.

The APPH Test reads in full:

For purposes of this section, the finding as to

whether the marketing of a tobacco product for

which an application has been submitted is

appropriate for the protection of the public health

shall be determined with respect to the risks and

benefits to the population as a whole, including

users and nonusers of the tobacco product, and

taking into account-A. the increased or decreased likelihood that

existing users of tobacco products will stop using

such products; and

12

B. the increased or decreased likelihood that

those who do not use tobacco products will start

using such products.

21 U.S.C. §387j (c)(4). Here, the primary directive of

Congress is that FDA assess the “risks and benefits to

the population as a whole.” Id.

Then, using

conjunctive “and, taking into account” language, the

Tobacco Control Act requires that two subgroups be

considered: existing users and new users. Id. at

(c)(4)(A)-(B). Accordingly, the new tobacco product’s

net public health benefit must be assessed as it

pertains to the whole population and “taking into

account” both new and existing tobacco product users.

See Id. § 387j(c)(4).

In its review process and in its Brief, FDA

completely skips over the primary objective Congress

laid out and inaccurately states that the APPH Test

only “requires FDA to weigh (1) the likelihood that the

new product will help existing smokers (generally

adults) completely switch to less dangerous

alternatives, or significantly reduce the amount they

smoke, against (2) the risk that the new product will

entice new users (generally youth) to begin using

tobacco products.” Pet. Brief 3; see also Pet. A. 182a,

236a, 290a. In framing its argument in this way, FDA

entirely discounts the main body of 21 U.S.C. §

387j(c)(4) in favor of its (A) and (B) subparts. Only by

ignoring the plain language of the Act can FDA assert

that the APPH analysis is limited to adults on the one

hand (i.e., use cessation) and youth on the other hand

(i.e., use initiation). “FDA’s proposed analysis above

oversimplifies the APPH analysis into an X-Y

equation (combustible cessation – youth uptake),

which is not how the statute constructs the APPH

framework.” Yagi, Dr. Brian, et al., Appropriate for

the Protection of Public Health: Why We Need

13

Electronic Nicotine Delivery System Product

Standards, Food and Drug Law Journal, vol. 78

(2023), p. 59.

Perhaps FDA’s truncated interpretation was

“permissible” under Chevron, but it is no longer. See

467 U. S. at 843. The “best” – and therefore only

permissible – interpretation of 21 U.S.C. § 387j (c)(4)

puts the focus of the APPH Test squarely on “the risks

and benefits to the population as a whole” with

existing adult smokers and potential youth users

being mere factors FDA must “tak[e] into account” as

part of this whole population analysis. See Loper, 144

S.Ct. at 2266.

To be sure, FDA’s “X-Y equation” is wrong from the

start because it: (1) ignores new adult users; (2)

ignores existing youth cigarette users who quit

smoking using e-cigarettes; (3) ignores nonusers who

benefit from reduced secondhand smoke; and (4)

never considers the impact of new users (adult or

youth) choosing to initiate tobacco use with ecigarettes instead of cigarettes. See, e.g., J.A. 361

(Respondents’ evidence that: “In the underage

nonsmoking group, 57% of frequent vapers had

previously smoked.”); J.A. 465-66 (Respondents’

evidence that: “Universally, any study that compared

combustible cigarettes and e-cigarettes found greatly

increased effects on the indoor air quality and

bystander

concentrations

from

combustible

cigarettes.”); Yagi, et al, at 60 (“ENDS [e-cigarette]

product authorizations can still be considered future

harm-reducing when considering that any new

initiator would be better served by selecting an ENDS

product over a combustible product in the first

instance. Indeed, while youth use of ENDS products

was rising over the past two decades, it was

accompanied by a concomitant decline in exclusive

14

combustible use.”) U.S. Public Health Service, U.S.

Dep’t of Health and Human Services, E-Cigarette Use

Among Youth and Young Adults: A Report of the

Surgeon General 49 (2016) at iii (stating that youth ecigarette use has increased “[a]s cigarette smoking

among those under 18 has fallen”) and at 49 (finding

that between 2011 and 2015 last 30-day high school

e-cigarette only use rose from 0% to 7% while last 30day high school combustible cigarette only use fell

from 16% to 7%).

Failing to even consider entire segments of the

population in the manner FDA did when it adopted a

two-factor test only relating to two subgroups of the

population is plainly inconsistent with the holistic,

whole population analysis Congress required FDA to

conduct when it adopted the APPH Test. See Loper,

144 S.Ct. at 2263 (“[T]he role of the reviewing court …

is … to … effectuate the will of Congress.”).

Therefore, because the FDA’s actions “entirely failed

to consider … important aspect[s]” of the Act in

accordance with its congressionally delegated

authority, FDA’s denial orders must be found to be

arbitrary and capricious. See Id.; Motor Vehicle Mfgs.

Assn., 463 U.S. 43.

B.

The Tobacco Control Act Requires FDA

To Evaluate New Tobacco Products On

An Individual Basis, But FDA Failed to

Do So.

Not only did FDA improperly truncate whole

population analysis to only involve a two-factor test of

risks and benefits, but FDA also never actually

evaluated the risks and benefits of Respondents’

specific products. Instead, relying only on generalized

data FDA made sweeping declarations that all

flavored ENDS products (not Respondents’ specific

15

products) are attractive to youth to satisfy its review

of one prong of the APPH test (i.e., use initiation) and

then used that generalized conclusion as the agency’s

justification to impose never-before announced

requirements of a heightened standard of productspecific evidence on another prong of the APPH

balancing test (i.e., use discontinuation).

In its denial orders, FDA did not find Respondents’

non-tobacco flavored e-cigarettes provided no benefit;

it simply generally determined—without reference to

Respondents’ specific products—that “the literature

does not establish that [non-tobacco] flavors

differentially promote switching” from combustible

cigarettes better than tobacco flavor does. J.A. 266;

Pet. A. 202(a), 256(a), 310(a). FDA then issued denial

orders for applicants’ products solely because it

believed all “tobacco-flavored [e-cigarettes] may offer

the same type of public health the same type of public

health benefit as flavored [e-cigarettes] … but do not

pose the same degree of risk of youth uptake.” J.A.

248; Pet. A. 181a, 235a, 289a (emphasis added).

Importantly, FDA did not determine that

Respondents’ specific flavored products posed any

unique risks or concerns regarding youth initiation,

and it did not evaluate any of the information

contained in the PMTAs when it conducted its

analysis. Thus, FDA did not issue denial orders for

non-tobacco flavored products because FDA found

such non-tobacco flavored products failed a

risk/benefit analysis on the products’ own merit, but

solely because it thought another product may

perform better on a risk/benefit assessment. See Pet.

A. 182a, 236a, 290a.

This type of comparative product analysis is not

consistent with the best reading of the Act. See Loper,

144 S.Ct. at 2266 (“[S]tatutes … have a single, best

16

meaning.”). Instead, the APPH Test sets forth an

evaluation of the “risks and benefits” of “the tobacco

product” “for which an application has been

submitted.” 21 U.S.C. § 387j(c)(4). Investigations and

scientific evidence about “the tobacco product” that is

the subject of an application is used to evaluate an

application. 21 U.S.C. § 387j(c)(5). A denial order can

only be issued based on information “with respect to

such tobacco product” that is the subject of an

application. 21 U.S.C. § 387j(c)(2). Thus, the text of

the Tobacco Control Act provides that the analysis of,

required evidence for, and decision on an application

concern the product that is actually the subject of the

application.

Accordingly, the best reading of the APPH Test is

that FDA must individually analyze each product for

which an application has been submitted to

determine if such a product can demonstrate a net

public health benefit (i.e., whole population health

benefits outweigh whole population health risks). See

21 U.S.C. § 387j (c)(4).

The FDA’s belief that tobacco flavored e-cigarettes

may provide greater net public health benefits does

not necessarily mean that non-tobacco flavored ecigarettes do not provide net public health benefits.

Non-tobacco flavored e-cigarettes could still provide a

net public health benefit, albeit maybe a smaller one.

However, FDA never even attempted to individually

analyze the benefits of Respondents’ products; it just

demanded that Respondents needed to show more

benefits than other products.

As for the risk side (i.e., youth) of FDA’s “X-Y

equation”, FDA failed to individually assess the risks

associated with Respondents’ specific products.

17

C.

FDA Improperly Used Its Application

Review Process to Implement a De Facto

Tobacco Product Standard While

Unlawfully

Evading

Notice

and

Comment Rulemaking Requirements.

By requiring that PMTAs for non-tobacco flavored

e-cigarettes include the Comparative Efficacy Test,

FDA has imposed a de facto tobacco product standard

prohibiting non-tobacco flavored e-cigarettes—

without following the notice and comment process

Congress required in the Tobacco Control Act.

Accordingly, FDA’s denial orders conflict with the

best reading of the Tobacco Control Act for another

reason and, therefore, must be set aside.

FDA’s authority to establish tobacco product

standards is set forth in the Tobacco Control Act. 21

U.S.C. §387g. The section of the Tobacco Control Act

that concerns tobacco product standards specifically

references flavors. 21 U.S.C. §387g(a)(1)(A), 21 U.S.C.

§387g(e)(1). This section also provides for tobacco

product standards in relation to “ingredients” and

“additives.” 21 U.S.C. §387g(a)(4)(B)(i). Since ecigarettes are naturally unflavored, a flavoring

additive is necessary to impart tobacco or non-tobacco

flavor. Thus, these provisions make clear that ecigarette flavors are subject to tobacco product

standard regulations. Critically, the Tobacco Control

Act expressly provides that all tobacco product

standards be subject to notice and comment

rulemaking over and above the requirements of the

APA. 21 U.S.C. §387g(c)-(d).

FDA is well aware of the fact that the proper way

to regulate e-cigarette flavors is through adopting a

tobacco product standard subject to a notice and

comment requirement. In 2018, FDA published an

18

Advance Notice of Proposed Rulemaking (“ANPRM”)

regarding e-cigarette flavors. In the ANPRM, the

FDA expressly referenced 21 U.S.C. §387g as its

statutory authority for regulating flavors in tobacco

products. 83 Fed. Reg. 12,294, 12,295 (March 21,

2018). Since then, FDA has moved forward with two

tobacco product standards related to flavors. On May

4, 2022, FDA published its Proposed Tobacco Product

Standard for Menthol in Cigarettes, 87 Fed. Reg.

26454 (May 4, 2022). And, FDA published its Tobacco

Product Standard for Characterizing Flavors in

Cigars, 87 Fed. Reg. 26396 (May 4, 2022).

However, FDA abandoned the rulemaking process

for e-cigarette flavors. Instead of proceeding through

the required notice and comment process, FDA

imposed a de facto tobacco product standard for nontobacco e-cigarette flavors during adjudication of

PMTAs. See Pet. Brief 27. This is why the Fifth

Circuit properly noted that “FDA unquestionably

failed to follow § 387g's notice-and-comment

obligations before imposing its de facto ban on

flavored e-cigarettes.” Wages & White Lion, 90 F. 4th

at 384, n. 5.

There is simply no difference whatsoever between

the

FDA’s

adjudication

process

and

the

implementation of a tobacco product standard

prohibiting non-tobacco flavors. Under 21 U.S.C.

§387j(b)(1)(D), a PMTA must identify any relevant

tobacco product standard and provide “either

adequate information to show that such aspect of such

tobacco product fully meets such tobacco product

standard or adequate information to justify any

deviation from such standard.” The Comparative

Efficacy Test FDA imposed on non-tobacco flavored ecigarettes is the functional equivalent of a tobacco

product standard prohibiting non-tobacco flavors and

19

providing that the Comparative Efficacy Test can

serve as the “adequate information to justify any

deviation from such standard.”

Indeed, FDA’s PMTA adjudication process used

the Comparative Efficacy Test in the exact same

manner as a tobacco product standard prohibiting

non-tobacco flavors would be used. If a PMTA doesn’t

meet a tobacco product standard and doesn’t include

the required “information to justify any deviation

from such standard,” the application can be

summarily denied on that basis alone. See 21 U.S.C.

§387j(b)(1)(D). This is precisely how FDA used the

Comparative Efficacy Test for non-tobacco flavored

products despite the fact FDA claimed it was using

the Comparative Efficacy Test to conduct whole

population analysis under the APPH Test.

FDA’s decision to implement a de facto tobacco

product standard prohibiting non-tobacco flavored ecigarettes in the manner it did is illegal because it was

done without the required notice and comment

procedures laid out in the Tobacco Control Act. See

21 U.S.C. §387g(c)-(d). An agency cannot evade notice

and comment requirements simply by labeling its

decisions as adjudication, particularly when Congress

has expressly directed an issue be subject to notice

and comment requirements. See Azar v. Allina

Health Servs., 587 U.S. 566, 575 (2019) (“Agencies

have never been able to avoid notice and comment

simply

by

mislabeling

their

substantive

pronouncements. On the contrary, courts have long

looked to the contents of the agency's action, not the

agency's self-serving label, when deciding whether

statutory notice-and-comment demands apply.”);

NLRB v. Wyman–Gordan Co., 394 U.S. 759, 764

(1969) (plurality opinion) (agency cannot avoid

rulemaking requirements by making rule in course of

20

adjudication); Safari Club Int’l v. Zinke, 878 F.3d 316,

331-333 (D.C. Cir. 2017) (finding enhancement

determinations under Endangered Species Tobacco

Control Act to be a rule, not an adjudication); Yesler

Terrace Cmty. Council v. Cisneros, 37 F.3d 442, 449

(9th Cir. 1994) (“An agency cannot avoid the

requirement of notice-and-comment rulemaking

simply by characterizing its decision as an

adjudication.”); General Motors Corp. v. Ruckelshaus,

742 F. 2d 1561, 1565 (D.C. Cir. 1984) (en banc) (“[T]he

agency's own label, while relevant, is not

dispositive.”).

Despite Congress providing FDA with clear

requirements and authority to implement a tobacco

product standard, FDA ignored them in the case of

flavored e-cigarettes. FDA’s decision to regulate such

flavoring

additives through

adjudication is

particularly unwarranted given the fact Congress

deliberately wrote additional notice and comment

requirements for tobacco product standards into the

Act—above and beyond the notice and comment

requirements of the APA. See Loper, 144 S.Ct. at

2263 (“[T]he role of the reviewing court … is … to …

effectuate the will of Congress.”). Therefore, because

FDA acted outside the boundaries of its

congressionally delegated authority by imposing a de

facto tobacco product standard without notice and

comment, FDA’s denial orders must be set aside as

arbitrary and capricious. See Id. at 14 (The APA

“requires courts to ‘hold unlawful and set aside

agency action. . . not in accordance with law.’”)

(quoting 5 U.S.C. §706(2)(A)); Motor Veh. Mfgs. Assn.,

463 U.S. 42-43.

III. FDA PROCESS FOR REVIEWING PMTAS WAS

HEAVILY CRITICIZED BY AN INDEPENDENT

TOBACCO EXPERT PANEL WHICH CALLED OUT

21

THE FDA’S FAILURE TO CONSISTENTLY APPLY

THE APPH TEST.

The very concerns raised by Respondents have been

echoed by an independent review of FDA’s tobacco

regulatory process. On December 19, 2022, just two

weeks before the Fifth Circuit issued its order, an

Independent Tobacco Expert Panel – convened at the

request of FDA Commissioner Robert Califf under the

auspices of the Congressionally-created ReaganUdall Foundation to advise the FDA – released its

report which laid bare the FDA’s mishandling of,

among other things, PMTAs.4 Not only do the

Independent Tobacco Expert Panel’s findings

buttress Respondents’ claim that FDA’s requirements

for establishing what products are “appropriate for

the protection of public health” are unclear, the Panel

also concurred that FDA was not transparent in

explaining how it was evaluating what products are

appropriate for the protection of public health and

that FDA didn’t even have a clearly articulated basis

for making its determinations.

The Independent Tobacco Expert Panel called out

the FDA for its lack of clarity in what Respondents,

and every other applicant, should submit to FDA to

satisfy an APPH determination:

“Applicants, however, will struggle to

address the issues necessary to meet the

APPH

standard

unless

FDA

clearly

articulates its expectations. A lack of clarity

results in extraneous work on both sides--for

4

Operational Evaluation of Certain Components of FDA's

Tobacco Program: A Report of the Tobacco Independent Expert

Panel,

Silvis,

et.

al;

2022

available

at

https://reaganudall.org/sites/default/files/202212/Tobacco%20report%20210pm.pdf

22

applicants and for the Agency. CTP has a

responsibility to clearly identify application

requirements, if for no other reason than to

reduce the burden on the Agency itself and

improve efficiency.”

Id. at 20. (emphasis supplied). The Independent

Tobacco Expert Panel also concurred with

Respondents’ argument regarding the lack of clear

rules, finding that, “While CTP has issued some

foundational regulations and guidances, many gaps

remain.” Id. As a result, the Independent Tobacco

Expert Panel expressed the urgent need for FDA to

create a strategic plan “now” and demanded that “the

plan must … explain how FDA is interpreting the

APPH standard.” Id. at 15. FDA’s recalcitrance, even

when confronted by criticism levied by an

independent review it asked for itself, was best

evidenced by FDA ignoring the admonitions of the

Independent Tobacco Expert Panel by issuing a

strategic plan one year later that failed to even

address its concerns about the opacity of the PMTA

process and FDA’s approach to APPH. See generally,

Id.

Respondents rightly raise the concern that FDA

implemented a policy of banning all flavored vaping

products under the guise of its scientific review of

Respondents’ application. This concern was also

supported by the Independent Tobacco Expert Panel

which cited FDA’s inability to separate policy

decisions, at the core of Respondents’ denials, and

scientific decisions:

“One such question that scientific analysis alone

will not resolve is how to weigh the public health

benefits of the percentage of adults who use ENDS

that will completely quit smoking combustible

tobacco products against the potential public

23

health harms that youth who use ENDS will

acquire a lifelong addiction to nicotine or proceed to

use combustible tobacco products. At times, a lack

of clarity about the distinction between, and the

intersection between, policy and science has

created controversy within CTP and may lead to a

perception that the Center’s scientific integrity is

being challenged when, in fact, policy decisions that

transcended the science are being made.”

Id.

Finally, the Independent Tobacco Expert Panel also

offered its support for Respondents’ complaint that

FDA inappropriately failed to consider all aspects of

its application (i.e., its plan to restrict youth access

and appeal) in making its APPH determination:

“To the extent that CTP intends to review certain

critical sections of an application first, and if

deficient, not proceed to other sections, such a

policy should be reflected in a public guidance that

explains to applicants how CTP will triage its

substantive reviews.”

Id. at 20.

Thus, every element of FDA’s failures to honestly

and lawfully administer its regulatory duties as

argued by Respondents and as found by the Fifth

Circuit, has been buttressed by the FDA’s own

independent review of its process; processes which, to

date, FDA has declined to fix.

CONCLUSION

For the foregoing reasons, the decision below

should be upheld and FDA should be required to

conduct a “full and fair regulatory proceeding”

24

consistent with the best reading and purposes of the

Tobacco Control Act.

October 14, 2024

Respectfully submitted,

ANTHONY L. ABBOUD

Counsel of Record

LAW OFFICES OF

TONY ABBOUD

950 Hawthorne Ln

Northbrook, IL 60062

(312) 498-6060

tony@abboudlegal.com

Counsel for Amicus

Curiae