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

_________

FOOD AND DRUG ADMINISTRATION,

Petitioner,

v.

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

D/B/A TRITON DISTRIBUTION, ET AL.,

Respondents.

_________

On Petition for Writ of Certiorari to the

United States Court of Appeals

For the Fifth Circuit

_________

BRIEF OF VAPING INDUSTRY

STAKEHOLDERS AS AMICI CURIAE IN

SUPPORT OF RESPONDENTS

_________

J. GREGORY TROUTMAN

Counsel of Record

TROUTMAN LAW

OFFICE, PLLC

4205 Springhurst Blvd,

Suite 201

Louisville, KY 40241

(502) 412-9179

jgtatty@yahoo.com

Attorney for Amici Curiae

i

TABLE OF CONTENTS

TABLE OF CONTENTS……………………..…………….…i

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

INTERESTS OF AMICI CURIAE....................................... 1

SUMMARY OF THE ARGUMENT ..................................... 2

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

I.

THE EN BANC FIFTH CIRCUIT EXPOSED THE

INHERENT LEGAL DEFECTS OF FDA’S PMTA

REVIEW PROCESS FOR FLAVORED ENDS

PRODUCTS ....................................................... 5

A. FDA’S POST HOC RATIONALIZATIONS

ARE AN ATTEMPT TO JUSTIFY AND

RESCUE ITS FLAWED PMTA PROCESS ... 5

B. FDA’S ACTIONS VIOLATE THE FAIR

NOTICE STANDARD. .................................. 8

C. FDA FAILED TO EXPLAIN ITS POLICY

SWITCH REGARDING FLAVORED ELIQUIDS. ................................................. 10

D. FDA FAILED TO GIVE ACCORD TO

RESPONDENTS’ RELIANCE INTERESTS .. 13

II.

THE COURT SHOULD ADDRESS THE

CONSTITUTIONALITY OF THE TCA’S DEEMING

PROVISION UNDER THE MAJOR QUESTIONS

DOCTRINE ..................................................... 15

III. FDA’S REGULATORY TACT CANNOT EXIST IN

A POST-LOPER/RELENTLESS WORLD .......... 18

CONCLUSION ............................................................... 22

APPENDIX: LIST OF AMICI CURIAE...…………………A-1

ii

TABLE OF AUTHORITIES

CASES

Amer. Acad. of Pediatrics v. FDA,

399 F. Supp.3d 479 (D. Md. 2019)......................... 7

Biden v. Nebraska,

600 U.S. 477, 143 S.Ct. 2355 (2023) ................... 15

Christopher v. SmithKline Beecham Corp.,

567 U.S. 142 (2012) ..................................... 8, 13, 21

Department of Homeland Security v. Regents of the

University of California,

591 U.S. ___, 140 S. Ct. 1891 (2020) .................... 13

Encino Motorcars, LLC v. Navarro,

579 U.S. ___, 136 S. Ct. 2117 (2016) ...................... 7

ETSI Pipeline Project v. Missouri,

484 U.S. 495 (1988) ............................................... 21

FCC v. Fox Television Stations, Inc.,

556 U.S. 502 (2009) ............................... 8, 10, 13, 21

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) ......................... 4, 15, 16, 18, 21

J.W. Hampton, Jr. & Co. v. U.S.,

276 U.S. 394 (1928) ............................................... 17

Morton v. Ruiz,

415 U.S. 199 (1974) ................................................. 8

Nicopure Labs, LLC v. FDA,

266 F. Supp.3d 360 (D. D.C. 2017) ....................... 17

iii

Panama Refining Co. v. Ryan,

293 U.S. 388 (1935).............................................. 17

SEC v. Chenery Corp.,

318 U.S. 80 (1943) ................................................. 5

SEC v. Chenery Corp.,

332 U.S. 194 (1947).............................. 4, 20, 21, 22

Wages & White Lion Invs., LLC v. FDA,

16 F.4th 1130 (5th Cir. 2021) .......................... 7, 19

Wages & White Lion Invs., LLC v. FDA,

90 F.4th 357 (5th Cir. 2024) ........................ passim

West Virginia v. EPA,

597 U.S. ____, 142 S.Ct. 2587 (2022) .................. 15

STATUTES

15 U.S.C. § 1331 ......................................................... 16

21 U.S.C. § 321(rr)(1) ................................................. 16

§ 387 notes ............................................................... 2

§ 387a(b) ................................................ 4, 16, 17, 18

§ 387g(a)(4)(B)(i) ................................................... 21

§ 387g(c)............................................................. 3, 21

§ 387j(c)…………………………………………………8

§ 387j(c)(4) ............................................................... 3

H.R. 2248, 89th Congress (1966) ............................... 16

iv

Regulatory Flexibility Act,

5 U.S.C. §§ 601, et seq ................................................ 18

REGULATIONS

61 FED. REG. 44,619, et. seq. (Aug. 28, 1996) ............. 15

81 FED. REG. 28,974 (May 10, 2016) ........................... 18

82 FED. REG. 37,459, et seq. (Aug. 10, 2017)............... 11

RULES

SUPREME COURT RULE 37.2 .......................................... 1

SUPREME COURT RULE 37.6 .......................................... 1

OTHER AUTHORITIES

Agriculture, Rural Development, Food and Drug

Administration,

and

Related

Agencies

Appropriations for 2020: Hearings Before a

Subcomm. of the H. Comm. on Appropriations,

116th CONG. 35 (2019) ......................................... 11

Antonin Scalia, The Rule of Law as a Law of Rules, The

Univ. of Chicago L. Rev. 56:4 1175 (Fall 1989) .. 21

Donald F. McGahn, Federalist Society National

Lawyers Convention, Barbara K. Olson Memorial

Lecture (Nov. 17, 2017) ....................................... 21

FDA Announces Comprehensive Regulatory Plan to

Shift Trajectory of Tobacco-Related Disease, Death

(Jul. 27, 2017) ...................................................... 11

v

FDA, Enforcement Priorities for Electronic Nicotine

Delivery Systems (ENDS) and Other Deemed

Products on the Market Without Premarket

Authorization (Revised)*: Guidance for Industry

(Apr. 2020) ............................................................. 9

FDA, Final Regulatory Impact Analysis Final

Regulatory

Flexibility

Analysis

Unfunded

Mandates Reform Act Analysis, Table 9

(May 2016) ........................................................... 11

FDA, Statement from FDA Comm’r Scott Gottlieb (Mar.

14, 2018) ............................................................... 11

Klebe, E.R., Actions of the Congress and the Federal

Government

on

Smoking

and

Health,

Congressional Research Serv., Report No. 79-219

(Sept. 26, 1979). ................................................... 16

Reagan-Udall Foundation, Operational Evaluation of

Certain Components of FDA’s Tobacco Programs

(Dec. 19, 2022) ....................................................... 7

The Pink Panther Strikes Again,

United Artists (1976) ........................................... 12

William Shakespeare, Romeo and Juliet,

act 2, sc. 4………………………………………….12

1

INTERESTS OF AMICI CURIAE

Amici are businesses and trade associations which

represent a diverse cross-section of manufacturers,

distributors, and retailer of flavored Electronic

Nicotine Delivery Systems (ENDS) products

(colloquially “e-cigarettes”).1 Millions of smokers have

used them to transition away from cigarettes and

many of them started businesses to help promote this

novel and beneficial technology. Amici thus share a

common mission to advocate for a reasonably

regulated marketplace that allows consumer access to

less harmful products. FDA’s regulatory regime has

been anything but reasonable.

The ENDS products industry finds itself at a

crossroads given FDA’s decision to impose a de facto

ban on flavored e-liquids through its adjudication of

Pre-Market Tobacco Product Applications (PMTA).

Amici have a substantial interest in the outcome of this

and the other industry cases now pending before the

Court.2 Amici are keenly interested in how the Court

decides the circuit split arising from the U.S. Food and

Drug Administration’s (FDA) decision to reach far

beyond any reasonable interpretation of the Family

Smoking Prevention and Tobacco Control Act (TCA) by

instituting a de facto ban on all non-tobacco flavored

1 Pursuant to S. CT. R. 37.6, counsel for amici curiae

state that no counsel for any party authored this brief in

whole or in part or made any monetary contribution.

Pursuant to S. CT. R. 37.2, notice of intent to file was

provided to counsel for all parties more than 10 days in

advance of the filing deadline. Amici are listed in the

attached appendix.

2 Magellan Technology, Inc. v. FDA, No. 23-799; Lotus

Vaping Technologies, LLC v. FDA, No. 23-871; and Logic

Technology Development LLC v. FDA, No. 23-1125.

2

products. The “wild goose chase” described by the en

banc Fifth Circuit in Wages & White Lion Invs., LLC v.

FDA, 90 F.4th 357 (5th Cir. 2024) is common to all

prior and pending industry appeals. The Court should

thus grant review in this case, as well as the Magellan,

Lotus and Logic cases, to resolve the existing circuit

split to bring certainty to the industry.

SUMMARY OF THE ARGUMENT

The TCA’s preamble evidences a clear

congressional intent that FDA have authority to

ensure addicted, adult smokers have access to lower

risk products which help them move away from

cigarettes. See 21 U.S.C. § 387 notes. The scientific

community, and FDA itself, now firmly recognize that

ENDS products are an important smoking risk

reduction tool.

The TCA requires that product manufacturers

obtain premarket authorization from FDA through the

submission of a PMTA for each product. The TCA’s

plain language requires FDA to evaluate all

information and data included in a PMTA when

determining whether a given product is “appropriate

for the protection of the public health” (APPH). This is

not a one-size-fits-all process as the evidence

warranting the marketing of one product may not

justify the approval of another.

For example, the APPH standard requires that

FDA evaluate whether each ENDS product appeals to

minors, and that manufacturers ensure youth access

and marketing are restricted. This standard, however,

requires that FDA must balance any concerns about

youth (under age 21) access against all other evidence

contained in the PMTA warranting a grant of

marketing authorization. The TCA reflects a

congressional policy choice mandating that FDA

3

consider, inter alia, both the benefits and risks of a

tobacco product across the population as a whole. 21

U.S.C. § 387j(c)(4). This represented Congress’ first

ever population-level health standard which required

that FDA account for all stakeholder interests by

conducting a complete review of each PMTA.

Unfortunately, FDA has ignored the TCA’s plain

language by applying a one-size-fits-all approach

which swung the PMTA review pendulum far to one

side. The effect has been a de facto ban of all nontobacco flavored (e.g., mint and fruit) ENDS products.

FDA’s myopic view of the APPH standard caused a

disproportionate skewing of its attention by focusing

on underage use at the expense of adult smokers. FDA

did not either ask Congress to amend the TCA to adopt

a tobacco product standard which banned flavored

ENDS products or promulgate a tobacco product

standard via public notice and comment rulemaking,

as required by 21 U.S.C. § 387g(c). Rather, FDA chose

to initiate this policy initiative through the PMTA

adjudication process in a manner not grounded in the

TCA’s plain text, structure, and context. The en banc

Fifth Circuit accurately found FDA’s review process

was fatally flawed.

First, the en banc Fifth Circuit correctly found that

FDA acted arbitrarily in denying the Respondents’

PMTAs by: (1) relying upon post hoc justifications to

justify its PMTA rejections; (2) failing to provide fair

notice when applying its comparative efficacy

standard; (3) changing a substantive position without

displaying an awareness of the change and explaining

it; and (4) ignoring the Respondents’ reliance interests.

Amici discuss each of the en banc Fifth Circuit’s

particular findings in showing that it reached the

correct conclusions.

4

Second, the amici argue that FDA’s regulatory

efforts are unconstitutional because Congress violated

the major question doctrine and this Court’s holding in

FDA v. Brown & Williamson Tobacco Corp., 529 U.S.

120 (2000). The Court therein held that the regulation

of tobacco products was a major question and FDA

lacked regulatory authority absent specific enabling

legislation. Congress permissibly identified four

product subsets in the TCA for which it granted

regulatory authority to FDA. 21 U.S.C. § 387a(b).

Congress, however, impermissibly delegated FDA with

legislative authority to determine which tobacco

products would be regulated under the TCA beyond the

four initial product subsets. Review is necessary to

consider the underlying constitutionality of Congress’

delegated grant of legislative authority to FDA vis-àvis ENDS products.

Finally, any change to the agency deference

standard resulting from Loper/Relentless necessitates

the Court consider the future viability of the type of ad

hoc regulatory adjudications permitted by SEC v.

Chenery Corp., 332 U.S. 194 (1947) (Chenery II). A

continued adherence to Chenery II is inconsistent with

this Court’s recent administrative law jurisprudence.

It is appropriate to review this case and the other

pending cases to determine whether Loper/Relentless

bring that adherence to an end.

___________________

5

ARGUMENT

I.

THE EN BANC FIFTH CIRCUIT EXPOSED THE

INHERENT LEGAL DEFECTS OF FDA’S

PMTA REVIEW PROCESS FOR FLAVORED

ENDS PRODUCTS.

The facts here evidence that FDA’s PMTA review

process is fundamentally flawed for the following

reasons: (1) FDA invented post hoc justifications to

justify its rejection of Respondents’ PMTAs; (2) FDA

failed to provide fair notice when applying its

comparative efficacy standard; (3) FDA changed a

substantive position without displaying an awareness

of the change and explaining it; and (4) FDA ignored

Respondents’ reliance interests.

A. FDA’S POST HOC RATIONALIZATIONS

ARE AN ATTEMPT TO JUSTIFY AND

RESCUE ITS FLAWED PMTA PROCESS.

The Respondents fleshed out the significant legal

flaws with FDA’s after-the-fact, disguised tobacco

product standard for flavored ENDS products. FDA

responded by resorting to post hoc rationalizations to

justify its position. The en banc Fifth Circuit

accurately deduced FDA’s post hoc rationalizations

and adjudged their illegitimacy based on the basic

proposition that the:

“grounds upon which an administrative

order must be judged are those upon

which the record discloses that its

action was based.”

90 F.4th at 371, citing SEC v. Chenery Corp. (Chenery

I), 318 U.S. 80, 87 (1943).

The administrative record reflects that FDA had

many interactions with ENDS product stakeholders

6

over several years in which it made affirmative

representations that PMTAs would not need the

support of long-term studies. FDA certainly never

informed stakeholders that they needed studies which

compared the efficacy of flavored ENDS products to

that of tobacco-flavored products. Instead, FDA

focused on the importance of stakeholders’ marketing

plans, including specific details about the contents of

such plans. 90 F.4th at 372. That should have framed

the scope of FDA’s PMTA review. It did not.

The en banc Fifth Circuit noted that FDA

predicated Respondents’ marketing denial order on a

determination that:

“the mere existence of flavor was

sufficient to justify denial of a PMTA

because flavor standing alone was

enough to prove that youth would use the

proposed product and that youth use

would outweigh any countervailing

benefit to adults.

90 F.4th at 372. See also Pet. App. at 200a – 201a n.

xix. Despite numerous representations about the

importance of marketing plans, FDA admitted in its

marketing denial order that “it did not even read the

marketing plans it previously said were critical.” 90

F.4th at 372. See also Pet. App. at 201a n. xix

(acknowledging FDA’s failure to review Respondents’

marketing plans). FDA defended this failure by

pointing to an evolved mindset based on what claimed

to have it “learned” from “review[ing] PMTAs for

flavored ENDS.”3 See Pet. App. 181a, n. vi.

3 FDA employed this same explanation in its marketing

decisions for all other flavored open-system ENDS products

adjudicated to date.

7

It was reasonable for FDA to adopt a changed

mindset as its experiences evolved. The law, however,

required that FDA both acknowledge such evolution

and articulate a “detailed justification” before the

PMTA deadline if it desired to abandon its stated and

existing expectations. Encino Motorcars, LLC v.

Navarro, 579 U.S. ___, 136 S. Ct. 2117, 2125 (2016)

(quotation omitted).

What likely happened is that FDA realized it could

not comply with an artificial court-imposed4 review

deadline.5 It was thus incumbent upon FDA to seek

judicial relief from such constraint instead of making

up a new evidentiary rule as a matter of expediency.

FDA’s hasty change of position was indeed the

“surprise switcheroo” initially found by the Fifth

Circuit stay panel. Wages and White Lion Invs. v. FDA,

16 F.4th 1130, 1138 (5th Cir. 2021). The en banc Fifth

Circuit did not err in refusing to give deference to FDA

on the merits because it arbitrarily sprung a new and

unexpected evidentiary requirement on Respondents

after it was too late to comply.

A legitimate regulatory adjudication process

should be able to stand the crucible of scrutiny without

the need for post hoc rationalizations. FDA’s

marketing denial order to Respondents was rife with

post hoc rationalizations which speak for themselves.

FDA, as the en banc Fifth Circuit recognized, doubled

down by advancing even more post hoc rationalizations

The Maryland District Court in Amer. Acad. of

Pediatrics v. FDA, 399 F. Supp.3d 479, 487 (D. Md. 2019)

set a new May 9, 2020 PMTA deadline, later extended to

September 9, 2020.

4

5 See Reagan-Udall Foundation, Operational Evaluation

of Certain Components of FDA’s Tobacco Programs, 11 (Dec.

19, 2022).

8

in the proceedings on the merits. See 90 F.4th at 373,

388.

B. FDA’S ACTIONS VIOLATE

NOTICE STANDARD.

THE

FAIR

This Court’s administrative law jurisprudence

premises that agency regulatory processes must be

fair, open and transparent. See Christopher v.

SmithKline Beecham Corp., 567 U.S. 142, 156 (2012)

(agencies must “provide regulated parties fair

warning” of what it “prohibits or requires” before

punishing noncompliance) and FCC v. Fox Television

Stations, Inc., 556 U.S. 502, 515 (2009) (agencies

cannot “depart from a prior policy sub silentio or

simply disregard[ ] rules that are still on the books”).

Thus, an agency cannot announce a particular

position, create an “unfair surprise” by pivoting to a

new position, and then penalize the reliance on such

prior position. Christopher at 156-57 (quotation

omitted). This principle applies to agency regulatory

actions based upon informal guidance. See e.g., Morton

v. Ruiz, 415 U.S. 199, 235 (1974).

The en banc Fifth Circuit’s opinion laid bare that

the FDA PMTA review process was anything but fair,

open, and transparent vis-à-vis flavored ENDS

products. The opinion discussed in detail the timeline

of numerous FDA interactions with ENDS product

stakeholders. FDA’s actions commenced with its

August 2017 extension of the PMTA deadline so it

could clarify the mechanics of the APPH standard

provided by 21 U.S.C. § 387j(c) and allow itself time to

“promulgate application instructions.” 90 F.4th at 363.

FDA then provided “instructions on five relevant

occasions,” namely FDA’s October 2018 stakeholder

presentation; a lengthy June 2019 guidance document;

an October 2019 public stakeholder meeting; a

9

September 2019 proposed PMTA rule; and a January

2020 guidance document in which FDA prioritized its

enforcement against non-tobacco and non-menthol

“flavored, cartridge-based ENDS products.” 90 F.4th at

363 – 366. The crux of the en banc Fifth Circuit’s

“dizzying detail” in its analysis was that:

“[n]ever in this long, winding, and

byzantine regulatory process of meetings,

PowerPoint decks, proposed rules,

comment periods, guidance documents,

and enforcement priorities did FDA ever

say that it was contemplating an acrossthe-board ban on flavored products.”

Id. at 368. The en banc Fifth Circuit thus found FDA

never gave “fair notice that flavored product

manufacturers had to submit robust scientific studies

on flavored” open-system products.6 Id. at 368-9.

Instead, the en banc Fifth Circuit noted that FDA

focused its regulatory sights on flavored closed-system

pods

and

cartridges7

based

upon

specific

characteristics which enhanced their youth appeal. 90

F.4th at 367-69, citing FDA, Enforcement Priorities for

Electronic Nicotine Delivery Systems (ENDS) and

Other Deemed Products on the Market Without

Premarket Authorization (Revised)*: Guidance for

Industry (Apr. 2020) at 5, 16, 17. The Court noted

FDA’s contrast of open-system products which

Open system devices are typically larger in size than

closed system devices, are operating using interchangeable

and refillable e-liquid tanks (referred to as atomizers).

6

Closed-system products refer to a distinct market

segment of ENDS products which are fully disposable or

operate using a disposable pre-filled cartridge or pod which

offer e-liquid in a limited variety of flavor choices.

7

10

characteristics that lessened their youth appeal. 90

F.4th at 367, citing FDA Guidance at 17.

FDA’s Guidance, as evidenced by its numerous

pre-PMTA dealings with ENDS product stakeholders,

signaled a plan to treat flavored open-system products

like those made by the Respondents less strictly than

flavored closed-system products. FDA, however, did an

about face after the PMTA deadline without notice or

an opportunity for stakeholders to amend their

PMTAs. The en banc Fifth Circuit’s characterizations

of a “surprise switcheroo” and a “wild goose chase”

were not wrong.

The en banc Fifth Circuit’s discussion evidences

that FDA made a mockery of the fair notice principles.

FDA took its mockery a step further by imposing a

threshold evidentiary standard which required specific

proof that flavored ENDS products were more effective

at causing smoking cessation than a tobacco-flavored

product without either identifying a comparator

tobacco-flavored product or defining how many

smokers must quit smoking for a flavored ENDS

product to be deemed “effective.” It begs the question

that stakeholders could never conduct a comparative

efficacy comparison without knowing this critical

information. This is a textbook example of arbitrary

regulatory regime which lacks basic elements of

fairness, openness, and transparency. This issue

makes the case worthy of review.

C. FDA FAILED TO EXPLAIN ITS POLICY

SWITCH REGARDING FLAVORED ELIQUIDS.

This Court prohibits agencies from “depart[ing]

from a prior policy sub silentio” or simply disregarding

existing rules. Fox Television, 556 U.S. at 515. An

agency must “display awareness” of a position change

11

and support it with a “detailed justification” if the new

policy rests upon facts different than those underlying

the prior policy if that prior policy has “engendered

serious reliance interests.” Id.

The Court should put itself in the shoes of ENDS

product

stakeholders

when

considering

the

reasonableness of FDA’s post-PMTA departure from

its pre-PMTA guidance and assurances. For example,

FDA announced plans in 2017 to issue “regulations

outlining what information” it expected in PMTAs.8

This was part of a larger policy shift which included a

4-year extension of the PMTA deadline.9 FDA

acknowledged in early 2018 that it had yet to

“delineate key requirements” of the PMTA process.10

By early 2019, FDA still had not determined the PMTA

“rules of the road.”11 FDA ostensibly saw no urgency

since it had extended the PMTA deadline, and believed

very few manufacturers would file a PMTA.12 The en

FDA Announces Comprehensive Regulatory Plan to

Shift Trajectory of Tobacco-Related Disease, Death (Jul. 27,

2017),

https://tinyurl.com/4e4xutd5.

8

9

82 FED. REG. 37,459, et seq. (Aug. 10, 2017).

FDA, Statement from FDA Comm’r Scott Gottlieb

(Mar. 14, 2018), https://tinyurl.com/22zuh3b4.

10

Agriculture, Rural Development, Food and Drug

Administration, and Related Agencies Appropriations for

2020: Hearings Before a Subcomm. of the H. Comm. on

Appropriations, 116th CONG. 35 (2019) (statement of FDA

Comm’r Gottlieb).

11

FDA, Final Regulatory Impact Analysis Final

Regulatory Flexibility Analysis Unfunded Mandates Reform

Act

Analysis,

Table

9

(May

2016).

https://www.fda.gov/media/97875/download

12

12

banc Fifth Circuit noted that FDA’s numerous prePMTA representations disclaimed the need for specific

studies or long-term studies. 90 F.4th at 363. FDA not

only radically changed its position after the PMTA

deadline, it attempted to justify such change by

arguing its pre-PMTA guidance were merely “nonbinding recommendations” and it “never promised or

committed itself to doing any particular thing.” 90

F.4th at 383.

The en banc Fifth Circuit’s comparison of such

regulatory tact to a wild good chase, Act 2, Scene 4 of

Romeo and Juliet,13 was appropriate. A more modern

analogy is the hotel scene in The Pink Panther Strikes

Again. In this scene, Peter Sellers, playing Inspector

Clouseau, sees a dog in the hotel lobby and, assuming

it belongs to the innkeeper, asks him if his dog bites to

which the innkeeper responds in the negative. The dog

bites Clouseau when he tries to pet it. Clouseau then

indignantly queries the innkeeper “I thought you said

your dog did not bite” to which the innkeeper responds,

“that is not my dog.”14 FDA responds similarly when

asked to stand behind its pre-PMTA guidance and

representations.

Indeed, FDA’s pre-PMTA assurances lulled

thousands of flavored open-system ENDS product

manufacturers to spend millions of dollars each to

prepare and timely file a PMTA. These stakeholders

did everything FDA said needed to be done in its prePMTA guidance. They also did so in the face of both an

arbitrarily court-imposed PMTA deadline change

which significantly shortened the filing period and the

13 William Shakespeare, Romeo and Juliet, act 2, sc. 4.

14

(1976).

The Pink Panther Strikes Again, United Artists

13

many business restrictions resulting from the Covid

pandemic. FDA attempts to justify its radical position

change by shrugging its shoulders and saying it was

not bound by anything contained in the pre-PMTA

dealings with the ENDS product industry. This tact is

wholly inconsistent with Fox Television.

D. FDA FAILED TO GIVE ACCORD TO

RESPONDENTS’ RELIANCE INTERESTS.

Finally, review is appropriate to consider whether

FDA sufficiently give accord to the reliance interests of

Respondents and other manufacturers of flavored

open-system ENDS products. FDA’s regulatory flipflop after the PMTA deadline was wholly inconsistent

with this Court’s jurisprudence.

The final point of the en banc Fifth Circuit’s

analysis focused on FDA’s failure to give accord to the

reliance interests resulting from its pre-PMTA

assurances. 90 F4th at 384. This Court held in

Christopher, supra. at 156-57, that agencies cannot

penalize a regulated party for a “good faith reliance”

upon a prior regulatory position and in Fox Television,

supra., at 515, that agencies must take “serious

reliance interests” into account. An agency must even

take reliance interests into account when the

regulatory policy it seeks to reverse was not enacted

according to law. Department of Homeland Security v.

Regents of the University of California, 591 U.S. ___,

140 S. Ct. 1891 (2020).

The en banc Fifth Circuit recognized that FDA’s

pre-PMTA guidance could be interpreted to say that

flavored ENDS product manufacturers were on notice

of the need to perform long-term scientific studies. 90

F.4th at 385. The court recognized such guidance could

also be reasonably interpreted to say that a

manufacturer’s PMTA did not need “specific studies”,

14

“[y]outh behavioral data”, or “long-term studies.” Id.

citing FDA’s October 2018 Guidance at 18, 26. The

former interpretation is weakened by the fact that:

“not a single sentence anywhere in the

voluminous

record”

said

that

“manufacturers should submit long-term

scientific studies on the differences

between their new flavored e-cigarette

products and other nonflavored e-cigarette

products.”

90 F.4th at 385. Implicit in the en banc Fifth Circuit’s

ruling is the proposition that ambiguities in the FDA

guidance documents were to be interpreted against it

in finding the agency could not send ambiguous

instructions and then penalize Respondents for

obeying the wrong one. Id. This is a sound proposition

which further supports review.

Respondents find themselves in the same shoes as

thousands of other open-system flavored ENDS

product manufacturers. These stakeholders relied

upon a reasonable interpretation of the substance and

scope of FDA’s many pre-PMTA assurances and

representations. It would be one thing if Respondents’

interpretation and claimed reasonable reliance

occurred in isolation. It is a completely different thing

when flavored ENDS manufacturers from all corners

of the nation reached the same interpretation. The

Court should grant review if it reaches the same

interpretation as the Respondents and other flavored

ENDS product manufacturers.

___________________

15

II.

THE COURT SHOULD ADDRESS THE

CONSTITUTIONALITY

OF

THE

TCA’S

DEEMING PROVISION UNDER THE MAJOR

QUESTIONS DOCTRINE.

This

Court’s

recent

administrative

law

jurisprudence has signaled a significant reliance upon

the separation of powers subset principle embodied in

the “major questions doctrine.” Such doctrine is

implicated when an agency adopts a policy which has

a broad national effect in the absence of specific

congressional authorization. See e.g., West Virginia v.

EPA, 597 U.S. ____, 142 S.Ct. 2587 (2022) (holding that

EPA’s regulation of emissions from existing plants

based on generation shifting mechanisms was a major

question for which Congress had not granted

authority) and Biden v. Nebraska, 600 U.S. 477, 143

S.Ct. 2355 (2023) (holding the scale of the Department

of Education’s student loan debt cancellation plan was

a major question for which Congress had not granted

authority).

This Court has rooted its recent major question

doctrine jurisprudence in Brown & Williamson,

another case of FDA overreach. Brown & Williamson

concerned FDA’s adoption of a regulation which

classified tobacco products as a drug under the Federal

Food Drug and Cosmetic Act (FFDCA). See 61 FED.

REG. 44,619, et. seq. (Aug. 28, 1996).

Brown & Williamson considered Congress’ various

efforts to regulate tobacco products after the 1964

Surgeon General’s report; all of which Congress

constrained to labeling and advertising restrictions.

529 U.S. at 137-38. In fact, Congress considered 75

bills between 1965 and 1978 regarding problems

16

associated with smoking.15 Among such bills was one

to amend the FFDCA to grant FDA regulatory

authority.16 Ultimately, however, Congress took a

lesser step: enacting the first federal cigarette labeling

act.17

This Court noted in Brown & Williamson that

Congress made the policy choice embodied in 15 U.S.C.

§ 1331 that the “commerce and the national economy

may be . . . protected to the maximum extent consistent

with” the principle of consumers “being adequately

informed about any adverse health effects.” Id. at 13839. Based upon these observations, the Court held that

FDA lacked regulatory authority in the absence of

enabling legislation because the regulation of tobacco

products was a major question which required

Congressional imprimatur because tobacco products

concerned a “significant portion of the American

economy,” which had a “unique place in American

history and society.” Id. at 159-60.

Congress and FDA were bound by this Court’s

major question finding vis-à-vis any future regulation

of tobacco products. Congress, however, did not take

this to heart when enacting the TCA. Congress

predicated the TCA’s operative provisions upon the

extant definition of “tobacco product” which in relevant

part includes:

“any product made or derived from tobacco

that is intended for human consumption,

15 Klebe, E.R., Actions of the Congress and the Federal

Government on Smoking and Health, Congressional

Research Serv., Report No. 79-219 (Sept. 26, 1979).

16 See H.R. 2248, 89th Congress (1966).

17

Klebe, supra.

17

including any

accessory....”

component,

part,

or

21 U.S.C. § 321(rr)(1). Congress, however, chose to not

immediately subject all tobacco products to the TCA’s

requirements. Instead, Congress only subjected only

four specific subsets of tobacco products (cigarettes,

cigarette tobacco, roll-your-own tobacco, and

smokeless tobacco) to immediate regulation by FDA

under the TCA. See 21 U.S.C. § 387a(b).

Congress then delegated plenary authority to the

Health and Human Services Secretary to subject all

other tobacco products to the TCA through a

regulatory deeming process. 21 U.S.C. § 387a(b).

Congress, however, “did not provide standards for

when and how the agency [FDA] was to exercise its

discretion to deem[.]” Nicopure Labs, LLC v. FDA, 266

F. Supp.3d 360, 392 (D. D.C. 2017). FDA acknowledged

the lack of standards governing any deeming in

Nicopure (“Congress’s choice of the deferential word

‘deems’ and the absence of any standard—beyond the

requirement that the product meet the definition of a

‘tobacco

product’—demonstrate

that

Congress

committed the exercise of this authority to the agency’s

broad discretion”).18 Id.

FDA exercised its deeming authority in May 2016

as to all other products which satisfied the “tobacco

products” definition, including ENDS products, by way

Such lack of guiding standards arguably also

presents a non-delgation doctrine question. See Panama

Refining Co. v. Ryan, 293 U.S. 388, 430 (1935); J.W.

Hampton, Jr. & Co. v. U.S., 276 U.S. 394, 409 (1928).

18

18

of its “Deeming Rule.”19 See 81 FED. REG. 28,974 (May

10, 2016). FDA’s claim of broad regulatory discretion

under the Deeming Rule wholly begged the question

because the TCA’s deeming provision was itself

constitutionally defective.

Brown & Williamson required that Congress, and

only Congress, construct any regulatory framework for

tobacco products. The letter and spirit of Brown &

Williamson stands for the proposition that the specific

identification of any tobacco products to be regulated

was part and parcel of Congress constructing any

regulatory framework. Thus, Brown & Williamson

prohibited Congress from delegating the authority to

FDA to determine which specific tobacco products

would be subjected to its regulation under the TCA.

The Court should accordingly accept review of this case

to consider whether the TCA’s deeming provision set

forth in 21 U.S.C. § 387(a)(b) is an ultra vires action

which violates the separation of powers doctrine as to

ENDS products.

III. FDA’S REGULATORY TACT CANNOT EXIST

IN A POST-LOPER/RELENTLESS WORLD.

This case and the three other pending ENDS

product cases come before the Court as its

administrative law jurisprudence is at a critical

crossroads. This Court’s recent administrative law

jurisprudence has significantly evolved during recent

terms, including frequent invocation of the “major

questions” doctrine. This evolution is ongoing with the

19 The validity of FDA’s Deeming Rule fiscal analysis is

presently being challenged under the Regulatory Flexibility

Act, 5 U.S.C. §§ 601, et seq. See Kealani Distrib, LLC v. FDA,

No. 22-cv-856 (E.D. Tx.).

19

cases like Loper/Relentless20 which will impact the

deference to be afforded agencies such as FDA. A grant

of certiorari in this case and the other pending ENDS

products industry cases is crucial for the Court to

address whether FDA’s on-the-fly regulatory tact

concerning the adjudications of flavored open-system

e-liquids places it on the wrong side of the

jurisprudential crossroads.

The en banc Fifth Circuit addressed how FDA

repeatedly articulated clear and unambiguous

expectations in its written guidance to ENDS product

manufacturers. At no time during FDA’s many prePMTA dealings with the industry did it mention any

intention to apply a comparative efficacy standard

when reviewing flavored ENDS product PMTAs. To

the contrary, FDA specifically disclaimed the need for

any specific type of study, including long-term studies.

90 F.4th at 363, citing FDA’s October 2018

presentation. FDA then flipped the script when

adjudicating these ENDS product PMTAs—adopting

an ad hoc policy of requiring a showing that a flavored

ENDS product has a “magnitude of the potential

benefit to adult smokers” which is “adequate to

outweigh the risks to youth.” Pet. App. at 167a. This

was what the Fifth Circuit’s stay panel characterized

as a “surprise switcheroo” in Wages & White Lion, 16

F.4th at 1138, and its en banc panel later characterized

as a “wild goose chase.” 90 F.4th at 362.

FDA believes the Court should countenance this

type of regulatory practice. The Court has seen this

before as what FDA wants looks like the Securities and

Exchange Commission’s regulatory tact countenanced

20 See Loper Bright Enterprises, Inc. v. Raimondo, No.

22-451 and Relentless, Inc. v. Dept. of Commerce, No. 221219.

20

in Chenery II. Chenery concerned the propriety of the

SEC creating a substantive legal standard during the

process of adjudicating a regulated party’s

reorganization plan. The Court countenanced the

SEC’s authority to regulate informally on an ad hoc

basis by rationalizing that promulgating rules through

a quasi-legislative process is preferred to the extent

possible but:

“any rigid requirement to that effect

would make the administrative process

inflexible and incapable of dealing with

many of the specialized problems which

arise.”

332 U.S. at 202. The Court felt that agencies should be

able to adjust the rulemaking process on-the-fly “to

meet particular, unforeseeable situations” and thus

“must be equipped to act either by general rule or by

individual order.” Id.

Chenery II, however, is inconsistent with basic

notions of due process because it has:

“empowered agencies to issue retroactive

regulations through adjudication, a

doctrine that has empowered agencies . . .

to

announce

new

rules

during

enforcement actions without any fair

notice to the parties being regulated.”21

Empowering agencies in this manner is inconsistent

with the basic concept of fair notice. As the late Justice

Scalia observed, “[r]udimentary justice requires that

those subject to the law must have the means of

Donald F. McGahn, Federalist Society National

Lawyers Convention, Barbara K. Olson Memorial Lecture

(Nov.

17,

2017)

at

29:20

–

29:31.

https://fedsoc.org/conferences/2017-national-lawyersconvention#agenda-item-barbara-k-olson-memorial-lecture

21

21

knowing what it prescribes.”22 FDA’s serial application

of its post-PMTA comparative efficacy standard to all

flavored open-system ENDS products is an illegitimate

“subregulatory action.”23

Chenery II is inconsistent with this Court’s opinion

in Brown & Williamson which held that “[r]egardless

of how serious the problem an administrative agency

seeks to address” it cannot “exercise its authority ‘in a

manner that is inconsistent with the administrative

structure that Congress enacted into law.’” 529 U.S. at

125, citing ETSI Pipeline Project v. Missouri, 484 U.S.

495, 517 (1988). In this instance, FDA’s marketing

denial pointed to the “known risks to youth of

marketing flavored [ENDS],” Pet. App at 167a, as the

justification for its actions.

Yet, Congress specifically told FDA how to address

this risk: adopting a formal tobacco product standard

through notice-and-comment rulemaking, 21 U.S.C. §

387g(c), if it desired to regulate a tobacco product’s

“components, ingredients [or] additives,” 21 U.S.C. §

387g(a)(4)(B)(i). FDA essentially applied Chenery II in

making an end run around the requirements of 21

U.S.C. § 387g as to flavored ENDS products. FDA’s

worldview, however, is wholly inconsistent with this

Court’s jurisprudence which has sought to restrain

administrative regulatory authority.

FDA significantly premises its arguments here

upon the proposition that it should be able to adjust its

PMTA review standards in real time as its experiences

and understanding evolves. FDA blithely assumes its

world view must be correct because other circuits have

22 Antonin Scalia, The Rule of Law as a Law of Rules,

The Univ. of Chicago L. Rev. 56:4 1175, 1179 (Fall 1989).

23 McGahn at 24:14 - 24:22.

22

countenanced its ad hoc review process. FDA implicitly

argues for a continued adherence of Chenery II without

directly saying so. That view, however, is contrary to

this Court’s jurisprudence in ETSI Pipeline,

Christopher and Fox Television.

Time has proven the accuracy of Justice Jackson’s

prediction in his Chenery II dissent—the position

countenanced therein “would in practice, put most

administrative orders above the law” by making

judicial review “a hopeless formality for the litigant,

even where granted to him by Congress” thus reducing

“the judicial process in such cases to a mere feint.” 332

U.S. at 210 (Jackson, J, dissenting). One reason for the

Court to accept review here is to address whether

Chenery II still applies in a post-Loper/Relentless

world.

CONCLUSION

Based on the foregoing, amici ask that this Court

grant FDA’s Petition for Writ of Certiorari and those

also pending in Nos. 23-799, 23-871 and 23-1125.

May 15, 2024

Respectfully submitted,

J. GREGORY TROUTMAN

Counsel of Record

TROUTMAN LAW OFFICE, PLLC

4205 Springhurst Boulevard,

Suite 201

Louisville, KY 40241

(502) 412-9179

jgtatty@yahoo.com

Attorney for Amici Curiae

APPENDIX

A-1

APPENDIX

LIST OF AMICI CURIAE

723VAPE, INC. (KY)

BREATHE EASY ALLIANCE OF ALABAMA

DERBECIGS LLC (KY)

DERBECIGS INDIANA LLC (IN)

FLORIDA SMOKE FREE ASSOCIATION, INC.

GEORGIA SMOKE FREE ASSOCIATION, INC.

KANSAS SMOKE FREE ASSOCIATION

KENTUCKY VAPING RETAILERS ASSOCIATION, INC.

D/B/A KENTUCKY SMOKE FREE ASSOCIATION

IOWANS FOR ALTERNATIVES TO SMOKE AND

TOBACCO, INC.

IOWA VAPE ASSOCIATION, INC.

J-VAPOR LLC, D/B/A NORTH SHORE VAPOR (MA)

LOUISIANA VAPING ASSOCIATION, INC.

MARYLAND VAPOR ALLIANCE

MICHIGAN VAPE SHOP OWNERS, INC.

MIDWEST VAPE COALITION, INC.

MINNESOTA SMOKE FREE ALLIANCE

MISSISSIPPI VAPING ADVOCACY ASSOCIATION, INC.

MISSOURI SMOKE FREE, INC.

MONTANA SMOKE FREE ASSOCIATION, INC.

NEBRASKA VAPE VENDORS ASSOCIATION, INC.

NEVADA VAPING ASSOCIATION, INC.

NEW MEXICO SMOKE FREE ALLIANCE, INC.

NEW YORK STATE VAPOR ASSOCIATION, INC.

NORTH CAROLINA VAPING COUNCIL, INC.

OHIO VAPOR TRADE ASSOCIATION, INC.

OP MURSE HOLDINGS, LLC, D/B/A OPMH PROJECT (KY)

A-2

SOUTH CAROLINA VAPOR ASSOCIATION, INC.

VIRGINIA SMOKE FREE ASSOCIATION, INC.

WASHINGTON SMOKE FREE ASSOCIATION, INC.

WEST VIRGINIA SMOKE FREE ASSOCIATION, INC.

UNITED VAPERS ALLIANCE, INC.

VAPOR STOCKROOM, L.L.C. (KY)

VAPOR UNLIMITED, LLC (FL)