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,

v.

Petitioner,

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 Boulevard,

Suite 201

Louisville, KY 40241

(502) 412-9179

jgtatty@yahoo.com

Attorney for Amici Curiae

-iTABLE OF CONTENTS

TABLE OF CONTENTS……………………..…………….…i

TABLE OF AUTHORITIES……………………..………….iii

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

INTRODUCTION ............................................................. 1

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

ARGUMENT.................................................................... 7

I. FDA’S IMPOSITION OF A DE FACTO PRODUCT

STANDARD

THROUGH

ITS

PMTA

ADJUDICATION

PROCESS

IMPERMISSIBLY

IGNORED THE TCA’S RULEMAKING PROCESS.. 7

II. THIS CASE WAS TAILOR-MADE FOR REVIEW

UNDER THE NEW LOPER STANDARD............... 12

III. THE EN BANC PANEL ACCURATELY FOUND

THAT FDA’S PMTA REVIEW PROCESS FOR

FLAVORED ENDS PRODUCTS WAS FRAUGHT

WITH LEGAL DEFECTS. ................................... 21

A. FDA’S POST HOC RATIONALIZATIONS; AN

ATTEMPT TO JUSTIFY ITS FLAWED PMTA

PROCESS. ................................................... 21

B. FDA’S ACTIONS VIOLATE THE FAIR NOTICE

STANDARD. ................................................ 24

C. FDA FAILED TO EXPLAIN ITS POLICY

SWITCH REGARDING FLAVORED E-LIQUIDS

................................................................... 27

- ii D. FDA FAILED TO GIVE ACCORD TO

APPELLEES’ RELIANCE INTERESTS. ......... 28

IV. THE TCA’S DEEMING PROVISION VIOLATES

THE MAJOR QUESTIONS DOCTRINE………...…30

CONCLUSION ............................................................... 34

APPENDIX ................................................................. A-1

- iii TABLE OF AUTHORITIES

CASES

Ala. Ass’n of Realtors v. HHS,

594 U.S. 758 (2021)................................................. 30

Amer. Acad. of Pediatrics v. FDA,

399 F. Supp.3d 479 (D. Md. 2019) .......................... 23

Biden v. Nebraska,

600 U.S. 477, 143 S.Ct. 2355 (2023)................. 30, 31

Christopher v. SmithKline Beecham Corp.,

567 U.S. 142 (2012)......................................... passim

Department of Homeland Security v. Regents of the

University of California,

591 U.S. ___, 140 S. Ct. 1891 (2020) ...................... 29

Encino Motorcars, LLC v. Navarro,

579 U.S. ___, 136 S. Ct. 2117 (2016) ................ 23, 34

ETSI Pipeline Project v. Missouri,

484 U.S. 495 (1988)........................................... 10, 11

FCC v. Fox Television Stations, Inc.,

556 U.S. 502 (2009)......................................... passim

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000)......................................... passim

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

276 U.S. 394 (1928)................................................. 33

Loper Bright Enterprises vs. Raimondo,

603 U.S. ___, 144 S.Ct. 2244 (2024) ............... passim

- iv Cases—continued:

Morton v. Ruiz,

415 U.S. 199 (1974)................................................. 24

Nicopure Labs, LLC v. FDA,

266 F. Supp.3d 360 (D. D.C. 2017) ......................... 33

Panama Refining Co. v. Ryan,

293 U.S. 388 (1935)................................................ 33

SEC v. Chenery Corp.,

318 U.S. 80 (1943)................................................... 22

SEC v. Chenery Corp.,

332 U.S. 194 (1947)......................................... passim

Skidmore v. Swift & Co.,

323 U.S. 134 (1944)................................................. 13

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

16 F.4th 1130 (5th Cir. 2021) ............................. 8, 24

Wages & White Lion Inv. LLC v. FDA,

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

West Virginia v. EPA,

597 U.S. ____, 142 S.Ct. 2587 (2022) ..................... 30

STATUTES AND CONGRESSIONAL ACTS

15 U.S.C. § 1331 ......................................................... 31

21 U.S.C. § 321(rr)(1) ................................................. 32

123 STAT. 1776……………………………………………..1

-vSTATUTES AND CONGRESSIONAL ACTS - CONTINUED:

Family Smoking Prevention and Tobacco Control Act

(2009), 21 U.S.C. § 387 et seq. ........................ passim

§ 387 notes ................................................................. 4

§ 387a(b) .......................................................... passim

§ 387g .................................................................. 8, 23

§ 387g(a)…………………………………………………5

§ 387g(a)(4)(B) ........................................................... 7

§ 387g(a)(4)(B)(i) ..................................................... 10

§ 387g(c)(2)…………………………………………….…7

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

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

§ 387(l) ................................................................. 7, 10

H.R. 2248, 89th Congress (1966) ............................... 31

Regulatory Flexibility Act, 5 U.S.C. §§ 601, et seq .... 33

155 CONG. REC. No. 50 ............................................... 32

155 CONG. REC. No. 82 ............................................... 32

REGULATIONS

21 C.F.R. §1114.7 ....................................................... 14

61 FED. REG. 44,619 (Aug. 29, 1996)………………...…31

81 FED. REG. 28,974 (May 10, 2016) .......................... 33

82 FED. REG. 37,459 (Aug. 10, 2017).......................... 27

84 FED. REG. 50,566 (Sept. 25, 2019)……………..……22

86 FED. REG. 55,300 (Oct. 5. 2021) ............................ 14

- vi RULES

S. CT. R. 37.2 ................................................................. 1

S. CT. R. 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) ................................................ 27, 28

Ambrose BK, et al. Flavored Tobacco Product Use

Among US Youth Aged 12-17 Years, 2013-2014. J.

AM. MED. ASSOC. 2015 ............................................ 16

American Vapor Manufacturers Ass’n, The Future of

Vaping in the US: A Conversation with FDA’s Dr.

Brian King, Feb. 24, 2023 ........................................ 3

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

Univ. of Chicago L. Rev. 56:4 1175 (Fall 1989) ..... 10

C-SPAN, FDA Commissioner on E-Cigarettes and

Public Health Concerns (Sept. 25, 2018) ................. 4

Donald F. McGahn, Federalist Society National

Lawyers Convention, Barbara K. Olson Memorial

Lecture (Nov. 17, 2017) .......................................... 10

Du P, et al., Changes in Flavor Preference in a Cohort

of Long-Term Electronic Cigarette Users, ANN. AM.

THORAC. SOC. 2020 May;17(5):573-581 .................. 18

- vii OTHER AUTHORITIES - CONTINUED:

FDA Announces Comprehensive Regulatory Plan to

Shift Trajectory of Tobacco-Related Disease, Death

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

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) .............................................................. 26

FDA, Final Regulatory Impact Analysis Final

Regulatory Flexibility Analysis Unfunded Mandates

Reform Act Analysis, Table 9 (May 2016) ................ 2

FDA News Release, Youth E-Cigarette Use Drops to

Lowest Level in a Decade (Sept. 5, 2024) ............... 16

FDA, Perspective: FDA’s Preparations for the

September 9 Submission Deadline (Aug. 31, 2020)...2

FDA, Premarket Tobacco Product Applications and

Recordkeeping Requirements, (Sept. 25,

2019)...…………………………………………...…14, 22

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

14, 2018) .................................................................. 27

FDA, Statement of Mitchell Zeller, “Progress and

Challenges: The State of Tobacco Use and Regulation

in the U.S.” (May 14, 2014) ...................................... 3

Friedman, A., et al., E-cigarette Flavor Restrictions’

Effects on Tobacco Product Sales (Sept. 26,

2023)...…………………………………………...…19, 20

- viii -

OTHER AUTHORITIES - CONTINUED:

Gades, Mari S., BA, et al., The Role of Nicotine and

Flavor in the Abuse Potential and Appeal of

Electronic Cigarettes for Adult Current and Former

Cigarette and Electronic Cigarette Users: A

Systematic Review, NICOTINE AND TOBACCO

RESEARCH 2022:1332-1343, at 1332, 1339 ............. 18

Glasser, A., et. al., Patterns of E-cigarette Use and

Subsequent Cigarette Smoking Cessation Over 2

Years (2013/2014–2015/2016) in the Population

Assessment of Tobacco and Health Study, NICOTINE

& TOBACCO RESEARCH, 23:4, 669-677, Apr. 2021….17

Kharrati, K., Global E-Cigarette and Vape Market Size

Likely to Surpass at a CAGR of 4.5% By 2033,

Custom Market Insights (Mar. 4, 2024) ................ 29

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)……..………………………………….31

Lin Li, Ph.D., et al., How Does the Use of Flavored

Nicotine Vaping Products Relate to Progression

Toward Quitting Smoking? Findings From the 2016

and 2018 ITC 4CV Surveys, NICOTINE AND TOBACCO

RESEARCH 2021:1490-1497 ..................................... 19

Perrone, M., Insider Q&A: FDA official on vaping’s

“promise or peril,” The Associated Press, (Sept. 26,

2022) .......................................................................... 4

- ix OTHER AUTHORITIES - CONTINUED:

Reagan-Udall Foundation, Operational Evaluation of

Certain Components of FDA’s Tobacco Programs, 11

(Dec. 19, 2022)......................................................... 23

Robyn L. Landry, et al., The role of flavors in vaping

initiation and satisfaction among U.S. adults,

ADDICT. BEHAV. 2019 Dec;99:106077 ..................... 19

Shiffman S., et al., PATH Data: Harm Reduction is

Teens' Top Reason for Using e-cigarettes. Poster

SRNT 2017, Pinney Associates .............................. 16

Wellman RJ, et al. Predictors of the Onset of Cigarette

Smoking: A Systematic Review of Longitudinal

Population-Based Studies in Youth. AM. J. PREV.

MED. 2016 ............................................................... 16

William Shakespeare, Romeo and Juliet, act 2,

sc. 4 .......................................................................... 28

-1INTERESTS OF AMICI CURIAE

Amici are small businesses and trade associations

representing a diverse cross-section of the nation’s

flavored vaping product manufacturers, distributors,

and retailers. 1 Millions of smokers have used flavored

vaping products to quit smoking. Many of them had

enough faith in the technology to start thousands of

businesses to serve smokers. Amici thus share a

common

mission:

advocating

for

reasonable

regulations which maximize consumer access to less

harmful flavored vaping products.

Amici have an interest here because the outcome

will determine the future viability of flavored vaping

products. The ruling will either force the U.S. Food and

Drug Administration’s (FDA) to recalibrate its policies

concerning flavored products or decimate the vaping

industry despite it having driven a significant

reduction in smoking. The latter would ultimately

harm public health.

INTRODUCTION

The Court could plausibly believe this case arises

because FDA either grossly miscalculated its expected

receipt of vaping product Pre-Market Tobacco Product

Applications (PMTA) or it consciously calculated the

mass denial of millions of PMTAs.

FDA promulgated a rule in May 2016 to deem

vaping products as subject to the Family Smoking

Prevention and Tobacco Control Act (TCA), 123 STAT.

1776 (2009), codified as 21 U.S.C. § 387 et seq. FDA’s

1 No counsel for any party authored this brief in whole

or in part or made any monetary contribution, S. CT. R. 37.6,

and notice of intent to file was provided to counsel for all

parties more than 10 days in advance of the filing deadline,

S. CT. R. 37.2. Amici are listed in the attached appendix.

-2fiscal analysis stated an expectation of receiving no

more than 2,500 PMTAs, 2 later increased to 6,800

PMTAs. 3 Two months after the increase, however,

FDA acknowledged receiving over 400 million vaping

product registrations and predicted it would be

unlikely to complete a timely review (within one year)

if only a portion of those products filed PMTAs. 4

More ominous, FDA represented the Deeming

Rule would result in “significant product exit and

reduced reentry,” 5 particularly for flavored products

(predicting a 180-day market exit). 6 FDA could not

have known this more than four years before receiving

or reviewing any PMTAs absent a preordained plan to

impose ban all flavored vaping products.

At the core of this case is FDA’s erroneous

presumption that all flavored vaping products carry

the same youth risks. FDA applied this presumption

despite knowing a stark distinction exists between the

respective youth risks posed by “open-system” and

“closed-system” vaping products: distinctions which

concern the size of manufacturers; physical product

characteristics; and their retail channels.

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

2

3 Decl. of Mitchell Zeller, Am. Acad. I., (D. Md., No. 18cv-883) filed Jun. 12, 2019, ECF#120-1.

FDA, Perspective: FDA’s Preparations for

September 9 Submission Deadline (Aug. 31, 2020).

4

5 FDA, Final Regulatory Impact Analysis, at p. 20.

6 Id., at 152.

the

-3These distinctions also divine a difference in

youths’ product preferences. FDA knows youths

overwhelmingly

prefer

flavored

closed-system

products and rarely choose their flavored open-system

counterparts. This distinction is logical: closed-system

products are smaller and more easily obtained and

concealed than open-system products. FDA refused to

tailor its PMTA standards to account for these risk

distinctions vis-a-vis open-system flavored vapor

products. FDA’s miscalculations and refusal to

regulate based upon its knowledge lie at the heart of

this case. 7

SUMMARY OF THE ARGUMENT

The Court may scratch its head and wonder why a

controversy exists about vaping products based upon

the prior public statements of FDA’s former

leadership. In 2014, Mitch Zeller, the former Director

of FDA’s Center for Tobacco Products (CTP), opined in

congressional testimony that it “would be good for

public health” if adult smokers “completely switch all

of their cigarettes” to vaping products. 8 In 2018, FDA’s

7 The magnitude of FDA’s failure is further accentuated

by the fact that practically every trope uttered by antivaping advocates begins with the focus group-tested word

“epidemic.” Although FDA disclaims the propriety of such

word, see American Vapor Manufacturers Ass’n, The Future

of Vaping in the US: A Conversation with FDA’s Dr. Brian

King, Feb. 24, 2023 at 22:10 to 23:00, any issues of youth

vaping substantially relates to the same closed-system

products which its policies have allowed to proliferate the

market.

https://www.youtube.com/watch?v=zfQ8u59z8Ac

8 FDA, Statement of Mitchell Zeller, “Progress and

Challenges: The State of Tobacco Use and Regulation in the

U.S.” at 1:59:00, (May 14, 2014).

-4then-Commissioner concurred, 9 as does CTP’s current

Director. 10 They rooted their opinions in the TCA’s

preamble which evidences a clear congressional intent

that FDA ensure adult smokers have access to lower

risk products to help move them away from cigarettes.

21 U.S.C. § 387 notes.

The TCA requires that manufacturers file a PMTA

to obtain FDA authorization for each vaping product.

FDA must decide whether a product is “appropriate for

the protection of the public health” (APPH) by

evaluating all information and data included in each

PMTA. 21 U.S.C. § 387j(c). This is not a one-size-fitsall process because the evidence warranting the

authorization of one product may not justify the

authorization of another.

For example, the APPH analysis requires FDA to

consider how manufacturers propose to restrict youth

marketing and access to their vaping products. The

APPH analysis also requires that FDA balance any

youth access concerns against all other evidence in the

PMTA which warrants authorization. This was a clear

congressional policy choice: the first ever populationlevel health standard which requires consideration of

both a products’ benefits and risks across the

population as a whole. 21 U.S.C. § 387j(c)(4). This

required that FDA account for all stakeholder interests

by conducting a complete review of each PMTA.

FDA ignored the TCA’s plain language when

reviewing the Appellees’ PMTAs and those of

thousands of other vaping product manufacturers.

C-SPAN, FDA Commissioner on E-Cigarettes and

Public Health Concerns, at 10:25, (Sept. 25, 2018).

9

10 Perrone, M., Insider Q&A: FDA official on vaping’s

“promise or peril,” The Associated Press, (Sept. 26, 2022).

-5FDA, instead, applied an ultra vires 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

non-tobacco flavored (e.g., mint and fruit) vaping

products. Wages & White Lion Inv. LLC v. FDA, 90

F.4th 357, 384 n.5 (5th Cir. 2024) (en banc). FDA

disproportionately skewed the APPH benefit/risk

analysis by focusing on youth access at the expense of

the benefits to adult smokers.

The above facts set the context for amici’s following

arguments.

First, FDA ignored Congress’s clearly mandated

process for adopting a tobacco product standard when

implementing its de facto ban on flavored vaping

products. The TCA prescribes how to adopt product

standards (i.e. standards concerning a product’s

ingredients and constituents) by requiring that FDA

engage in public notice-and-comment rulemaking. 21

U.S.C. § 387g(a). FDA, instead, imposed a de facto

product standard through its PMTA adjudication

process, relying upon SEC v. Chenery Corp., 332 U.S.

194 (1947) (Chenery II), a case which countenanced

agencies making ad hoc regulatory adjudications. The

Court should overrule Chenery II as being

incompatible with its current jurisprudence.

Second, the amici demonstrate why this case is

perfectly suited for analysis under Loper Bright

Enterprises vs. Raimondo, 603 U.S. ___, 144 S.Ct. 2244

(2024). Amici address elements of the APPH standard

and how FDA arbitrarily ignored its requirements

when considering the relevant factors as to the

population as a whole by selectively focusing on

distinct aspects of two particular “subpopulations.”

FDA erroneously and arbitrarily anchored its position

as to the risks to one subpopulation by presuming that

-6all flavored vaping products are equally attractive to

youths; ignoring that its presumption does not apply to

open-system flavored products.

Third, FDA acted arbitrarily by: (1) articulating

post hoc justifications; (2) failing to provide fair notice

of its comparative efficacy standard; (3) changing a

substantive position without displaying an awareness

of, and explaining, the change; and (4) ignoring the

Appellees’ reliance interests. Amici discuss these

elements in showing the en banc panel accurately

concluded that FDA arbitrarily denied the Appellees’

PMTAs.

Finally, the amici argue the TCA’s deeming

provision, 21 U.S.C. § 387a(b), is unconstitutional

under the major question doctrine. FDA v. Brown &

Williamson Tobacco Corp., 529 U.S. 120 (2000) held

the regulation of tobacco products was a “major

question” and FDA lacked regulatory authority absent

specific enabling legislation. Congress identified four

tobacco product subsets in the TCA for which it

granted FDA immediate regulatory authority, 21

U.S.C. § 387a(b), but impermissibly delegated FDA

with legislative authority to determine which

additional tobacco products would be regulated. This

was a determination which only Congress could make

given Brown & Williamson. The Court should strike

down 21 U.S.C. § 387a(b) as an unconstitutional

legislative delegation.

─────────♦─────────

-7ARGUMENT

I.

FDA’S IMPOSITION OF A DE FACTO

PRODUCT STANDARD THROUGH ITS PMTA

ADJUDICATION PROCESS IMPERMISSIBLY

IGNORED THE TCA’S RULEMAKING

PROCESS.

This Court’s ruling in Loper, supra. altered how

courts review agency interpretations of ambiguous

statutes. Congress requires that FDA base marketing

decisions upon an ambiguous APPH standard for

which it failed to articulate definitive metrics. FDA

now argues that it does not have to articulate the

APPH metrics. See FDA Brief 26, 27.

The TCA authorizes FDA to craft tobacco product

standards which concern:

“the construction, components, ingredients,

additives, constituents, including smoke

constituents, and properties of the tobacco

product.”

21 U.S.C. §§ 387g(a)(4)(B), 387(l) defines flavorings as

being an “additive.” The TCA, however, cabins FDA’s

authority: mandating that it engages in notice-andcomment rulemaking for any proposed tobacco product

standard. 21 U.S.C. § 387g(c)(2).

FDA ignored the TCA’s clear and straightforward

requirement; hastily creating an unannounced review

standard for flavored products after the PMTA

deadline, without an opportunity for manufacturers to

supplement their PMTAs. FDA did so by requiring that

manufacturers demonstrate their flavored products

were more effective than a comparator tobaccoflavored product in causing smoking cessation. FDA,

however, never identified either a comparator tobaccoflavored product or how many smokers must be

-8converted to achieve efficacy. FDA relies upon Chenery

II to justify its application of a de facto tobacco product

standard for flavored vaping products during the

PMTA adjudication process in lieu of the notice-andcomment rulemaking process required by 21 U.S.C. §

387g.

FDA’s pre-PMTA written guidance repeatedly

stated its clear and unambiguous expectations. 90

F.4th at 363-68. Never did FDA ever mention before

the PMTA deadline any intention to apply a

comparative efficacy standard for flavored vaping

products or the need for long-term studies to satisfy

that standard. To the contrary, FDA specifically

disclaimed the need for any specific type of studies,

including long-term studies, let alone a comparative

efficacy study. Id., at 363, citing FDA’s October 2018

stakeholder presentation.

FDA then flipped the script after the PMTA

deadline when adjudicating flavored open-system

product PMTAs by adopting an ad hoc policy of

requiring a showing they have a “magnitude of the

potential benefit to adult smokers” which is “adequate

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

was the “surprise switcheroo” characterized by the

Fifth Circuit’s stay panel in Wages & White Lion, 16

F.4th 1130, 1138 (5th Cir. 2021), and the “wild goose

chase” later characterized by the en banc panel, 90

F.4th at 362.

FDA believes this Court should countenance its

PMTA review process, citing Chenery II, in arguing it

owed no fair notice obligation to inform vaping product

manufacturers of the “scientific goal line.” FDA Brief

27. FDA justifies this position by arguing that

Appellees and other industry stakeholders are “private

part[ies]” who approach the government “to secure a

-9benefit to which

entitlement.” 11 Id.

[they]

lack[]

an

established

Chenery II concerned the propriety of an agency

retroactively applying a new substantive legal

standard during a regulatory adjudication process.

The Court countenanced ad hoc agency regulatory

adjudications by rationalizing that formal rulemaking

is preferred 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. This Court expressed in Chenery II

that agencies should be able to informally adjust their

rulemaking processes as needed “to meet particular,

unforeseeable situations” and “must be equipped to act

either by general rule or by individual order.” Id. This

was meant to allow agencies the ability to respond

quickly and efficiently to emergent situations, not

adopt blanket policies which impact entire industries

and are better left for formal rulemaking.

The continued adherence to Chenery II is

inconsistent with basic notions of due process and fair

notice; “empower[ing] agencies to issue retroactive

regulations through adjudication” and “announce new

rules during enforcement actions without any fair

11 FDA’s argument is absolutely tone deaf since citizens

routinely apply to the government to obtain some kind of

benefit: like Social Security/Medicare benefits or veterans’

benefits. They apply to agencies like EPA for a myriad of

permits, or for more mundane things like drivers’ licenses,

business licenses and building permits. Does FDA seriously

argue the government owes no obligation to be transparent

about the rules for obtaining these benefits?

- 10 notice to the parties being regulated.” 12 The late

Justice Scalia observed that:

“[r]udimentary justice requires that those

subject to the law must have the means of

knowing what it prescribes.” 13

FDA’s serial application of its post-PMTA comparative

efficacy standard is an illegitimate “subregulatory

action.” 14 Chenery II is also inconsistent with Brown &

Williamson’s holding in that an agency:

“[r]egardless of how serious the problem

[it] seeks to address,” 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). Congress set forth

processes in the TCA which FDA must follow

regarding the implementation of tobacco product

standards.

FDA justified its actions by pointing to the “known

risks to youth of marketing flavored [vaping

products].” 15 Pet. App. 167a. Congress, however,

12 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

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

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

14 McGahn at 24:14 - 24:22.

15 FDA articulated the same justification vis-à-vis

thousands of other flavored vaping product manufacturers.

- 11 specifically told FDA how to address this risk: adoption

of a tobacco product standard through notice-andcomment rulemaking to regulate flavors as an

“additive,” 21 U.S.C. §§ 387g(a)(4)(B)(i) and 387(1).

FDA recently moved the goalposts again when

adjudicating the PMTA for the NJOY® Ace menthol

vaping product. It did so by announcing “the most

stringent mitigation measures—specifically device

access restrictions”—have the potential to mitigate

against youth access to flavored vaping products. 16

FDA, however, has never adopted this position

through the TCA’s rulemaking process, instead

applying Chenery II to make an end run around the

TCA’s statutory requirements.

FDA’s view that it can adjust the PMTA review

standard in real time as its experiences and

understanding evolve is inconsistent with this Court’s

recent jurisprudence. Certainly, FDA can adjust its

standards but only within the framework established

by Congress. 17 FDA assumes its view is correct because

other circuits have countenanced its ad hoc review

process; seeking a continued adherence to Chenery II.

FDA’s position, however, is contrary to this Court’s

jurisprudence in ETSI Pipeline, Christopher v.

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

v. Fox Television, 556 U.S. 120 (2000) and Brown &

Williamson.

Time has proven accurate Justice Jackson’s

dissent in Chenery II that ignoring the rulemaking

16 Id., at 7.

17 The Court should strictly construe FDA’s adherence

to the TCA’s requirements given its pronouncement in

Brown & Williamson, supra., that the regulation of tobacco

was constitutionally a major question.

- 12 process “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). The Court should overrule Chenery II as

being inconsistent with its current administrative law

jurisprudence.

II.

THIS CASE WAS TAILOR-MADE FOR REVIEW

UNDER THE NEW LOPER STANDARD.

Loper, supra., articulated a new standard for

reviewing agency interpretations of ambiguous

statutes. The TCA’s APPH standard is requires that

FDA’s analysis had to consider “the risks and benefits

to the population as a whole, including users and

nonusers of the tobacco product” upon:

“(A) the increased or decreased

likelihood that existing users of tobacco

products will stop using such products;

and

(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). Congress did not express

definitive baseline metrics for evaluating these two

increased or decreased likelihoods when determining

if a vaping product is APPH, but instead mandated

that FDA balance the respective risks. Id.

FDA’s application of the APPH standard evidences

why this case is suited for review under Loper. FDA’s

Marketing Denial Order evidences its reliance upon

- 13 agency expertise; 18 something not conclusive but one

of the factors having the “power to persuade,” 144

S.Ct. at 2248, citing Skidmore v. Swift & Co., 323 U.S.

134, 140 (1944), “depend[ing] upon the thoroughness

evident in [the agency’s] consideration” and “the

validity of its reasoning,” id., at 140. FDA, however,

disregarded the panoply of relevant APPH factors by

focusing upon two subfactors: the proven benefit in

transitioning adult smokers away from cigarettes

versus the risk of underage access and use. See Pet.

App. 237a, footnote vii in which FDA acknowledged its

failure to consider the respective benefits and risks of

the Appellees’ vaping products with respect to the

population as a whole in lieu of the two identified

subfactors.

FDA rationalized this approach by stating the

“subpopulations” raised the “most significant public

health concerns” which were “the most relevant in

evaluating the impact on the population as a whole.”

Id. FDA thus concluded that Appellees’ flavored

vaping products failed to satisfy the APPH standard

because the supporting evidence was “insufficient” to

demonstrate they “would provide an added benefit

that is adequate to outweigh the risks to youth.” Pet.

App. 228a. FDA’s analysis was incomplete, however,

because its APPH determination failed to account for

the benefits or risks as to other population subsets visà-vis the adult smoker and youth subsets.

FDA further skewed its APPH analysis was

further skewed because it by anchoring its youth risk

determination upon a generalized finding that:

“the availability of a broad range of

flavors is one of the primary reasons for

18 See e.g. Pet. App. 180a, 201a, 234a and 255a.

- 14 the popularity of [vaping products]

among youth.”

Pet. App. 241a. FDA’s assumption disregarded the fact

that youths predominantly use flavored closed-system

(pod or disposable) products and rarely use flavored

open-system products like the Appellees manufacture.

This explains why FDA failed to articulate that youths

have historically used the Appellees’ products. FDA’s

failure to accord these facts when crafting its review

process vis-à-vis open system products ignored both

reality and its own acknowledgment that PMTAs

require individualized determinations. 19 FDA’s

fixation with youth risks led it to ignore two critical

points: its prior representation about the importance of

marketing plans and that science does not support its

presumptions about flavored vaping products.

As to the former point, FDA’s pre-PMTA

representations stressed to Appellees the importance

of manufacturers’ marketing plans—they were

intended to inform FDA how they proposed to keep

their products away from youths. The fact that

flavored open-system products are sold in agerestricted stores mitigates FDA’s concern given its

acknowledgment that youths typically neither use

such products nor obtain them in that retail channel.

FDA, however, never reviewed the Appellee’

marketing plans “for the sake of efficiency” and

justified that failure because the types of restrictions

seen in previous PMTAs were insufficient to “decrease

youth appeal to a degree significant enough to address

FDA, Premarket Tobacco Product Applications for

Electronic Nicotine Delivery Systems: Guidance for Industry

(June 2019), 86 FED. REG. 55,300, 55,414-32 (Oct. 5, 2021),

codified as 21 C.F.R. § 1114.7 (listing of extensive

information and data required for PMTAs).

19

- 15 and counter-balance the substantial concerns” about

youth use. 20 Pet. App. 200a – 201a.

As to the latter point, the FDA stresses the role of

flavored vaping products in youth initiation; pointing

to data showing youths widely use non-tobacco

flavored vaping products; and concluding the flavor of

the products were the “primary reason” for use. Pet.

App. 187a – 191a. FDA, however, articulated this

presumption in the face of key scientific studies like a

2016 published systematic review which found 98

“conceptually different” potential onset risk predictors,

including:

• age;

• lower socioeconomic status;

• poor academic performance;

• sensation-seeking or rebelliousness;

• future smoking intentions;

• receptivity to tobacco promotion;

• smoking susceptibility;

• smoking by family members and friends;

and

• exposure to films,

whereas factors like higher self-esteem and high

parental monitoring/supervision of the child appeared

20 FDA noted the elements of NJOY’s marketing as a

basis for its marketing authorization but curiously told

Petitioners those same elements were insufficient.

See https://www.fda.gov/media/179499/download at 29.

- 16 to protect against smoking onset. 21 These risk factors,

not a products’ flavor, are drivers for tobacco initiation.

FDA also ignored the re-analyzed data 22 from a

key study upon which it premised denying Appellees’

products. 23 This re-analyzed data showed youth

motivations for consuming flavored vaping products

included various forms of harm reduction recognition:

• they might be less harmful to me than

cigarettes (79.1%);

• they might be less harmful to people around

me than cigarettes (78.1%);

• they help people to quit smoking cigarettes

(59.5%).

The TCA mandates that FDA consider this data as a

benefit to youths in its APPH analysis: a benefit which

must fully or partially be viewed as offsetting its youth

risk findings. 24

21 Wellman RJ, et al. Predictors of the Onset of Cigarette

Smoking: A Systematic Review of Longitudinal PopulationBased Studies in Youth. AM. J. PREV. MED. 2016.

22 Shiffman S., et al., PATH Data: Harm Reduction is

Teens' Top Reason for Using e-cigarettes. Poster SRNT

2017, Pinney Associates.

Ambrose BK, et al. Flavored Tobacco Product Use

Among US Youth Aged 12-17 Years, 2013-2014. J. AM. MED.

ASSOC. 2015.

23

FDA’s position is further undermined by the 2024

National Youth Tobacco Survey which revealed that 5.9% of

youths vape at least once in a 30-day period and 1.55%

vaped daily, the former representing a 70% reduction since

2019. See FDA News Release, Youth E-Cigarette Use Drops

to Lowest Level in a Decade (Sept. 5, 2024).

24

- 17 FDA justifies its position by suggesting the names

of the Appellees’ products are youth appealing. 25 See

FDA Brief 16. This position accentuates why carefully

considering marketing plans was critical—it is far less

significant that a particular flavored product is

characterized as “child appealing” if they are only sold

in age-restricted retail channels. The fact Appellees’

flavored products, like other open-system products, are

sold in such age-restricted stores is a relevant APPH

factor which FDA ignored.

FDA also ignored a 2019 study on which it

collaborated; a study finding that flavored products

predominately help adult smokers. This study

analyzed data from the 2013 through 2016 Population

Assessment of Tobacco Health study, also collaborated

on by FDA, in concluding that consistent and frequent

product use over time, particularly with flavored ELiquids, is associated with higher adult smoking

cessation rates. 26 2012-2014 and 2017-2019 population

studies, again underwritten by FDA, further showed a

decrease in adults’ preference for tobacco-, menthol- or

mint-flavored vaping products over time; a stable

preference for fruit-flavored products, but a

significantly increased preference for chocolate/candy

or other sweet-flavored products, and a slightly

FDA has never promulgated labeling/branding

standards which restrict the use of product names or

descriptors which could be youth-enticing.

25

Glasser, A., et. al., Patterns of E-cigarette Use and

Subsequent Cigarette Smoking Cessation Over 2 Years

(2013/2014–2015/2016) in the Population Assessment of

Tobacco and Health Study, NICOTINE & TOBACCO

RESEARCH, 23:4, 669-677, Apr. 2021.

26

- 18 increased preference for other flavors. 27 The science

reflected in these studies do not cease to exist simply

because FDA fails to recognize them when crafting its

APPH standards.

Peer reviewed scientific evidence of the adult

preferences for flavored vaping products has only

become more robust (to borrow from FDA’s lexicon)

since it denied marketing to the Appellees. For

example, Gades, et al., an extensive literature review

of 104 studies including clinical studies from 2007 to

2020, suggested that consumer access to a variety of

non-tobacco flavors is likely to be associated with

higher use levels and appeal for cigarette smokers, and

that flavor variety “might facilitate complete

substitution for cigarettes.” 28

The Gades study, however, warns policymakers

that any:

“[r]egulation of…flavors aimed at decreasing

naïve uptake may inadvertently decrease

uptake and complete switching among

smokers, reducing the harm reduction

potential of e-cigarettes.” 29

The Gades study frames the arguments here:

“[e]vidence-based effects of regulating … flavors must

be considered for the population as a whole, including

27 Du P, et al., Changes in Flavor Preference in a Cohort

of Long-Term Electronic Cigarette Users, ANN. AM. THORAC.

SOC. 2020 May;17(5):573-581.

28 Gades, Mari S., BA, et al., The Role of Nicotine and

Flavor in the Abuse Potential and Appeal of Electronic

Cigarettes for Adult Current and Former Cigarette and

Electronic Cigarette Users: A Systematic Review, NICOTINE

AND TOBACCO RESEARCH 2022:1332-1343, at 1332, 1339.

29 Id. at 1332.

- 19 smokers.” 30 FDA’s de facto ban on flavored open

system products is anything but “evidence-based.”

Instead, FDA fixed its sights vis-à-vis flavored

products and refused to budge despite science

contradicting its position. FDA’s fixed position with

youth access to flavored vaping products has an

unintended consequence which bears squarely upon

the APPH standard. A 2023 Yale University School of

Public Health study, funded in part by FDA,

analyzed 5 years of cigarette sales data from 7 states

and 375 localities that banned flavored vaping

products in finding an increased use of 15 cigarettes

(3/4 of a pack) for every banned 0.7ml flavored pod. 31

This conclusion should have shaken FDA to its

core and resulted in an immediate re-evaluation of how

it viewed flavored vaping products, particularly open

system products. FDA’s concern with youths accessing

30 Id.; see also, e.g., Robyn L. Landry, et al., The role of

flavors in vaping initiation and satisfaction among U.S.

adults, ADDICT. BEHAV. 2019 Dec;99:106077, at 14 (survey

of over 1,000 adult vapors showing “[t]hose who used

flavors, particularly mint/menthol and flavors other than

tobacco flavor, had higher odds of reporting high

satisfaction with vaping…than respondents who did not use

flavored e-cigarettes.”); Lin Li, Ph.D., et al., How Does the

Use of Flavored Nicotine Vaping Products Relate to

Progression Toward Quitting Smoking? Findings From the

2016 and 2018 ITC 4CV Surveys, NICOTINE AND TOBACCO

RESEARCH 2021:1490-1497, at 1490-91, 1494 (survey of

concurrent (or dual) users of cigarettes and vaping products

finding that the greatest success in quitting occurred among

adult smokers using sweet-flavored vaping products

(13.8%) relative to tobacco-flavored ENDS (9.6%)).

31 Friedman, A., et al., E-cigarette Flavor Restrictions’

Effects on Tobacco Product Sales (Sept. 26, 2023). See

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=45867

01

- 20 tobacco products was the entire basis for its de facto

ban on flavored vaping products. Yet, the Yale study

suggests the occurrence of an unintended opposite

effect—increasing cigarette sales among brands

disproportionately used by youths.

FDA not only refused to recalibrate its focus in the

face of the Yale study, it also authorized closed system

vaping products sold in the retail channels it knows

youths predominately prefer. The Yale study

crystalized the ultimate issue here: “any public health

benefits of reducing [vaping product] use via flavor

restrictions may be offset by public health costs from

increased cigarette sales.” 32

It was illogical for FDA to predicate its PMTA

decisions upon youth access to flavored vaping

products and then mass deny the products sold in the

retail channels which do not admit youths while

knowingly authorizing products sold in the channels

that youths prefer. It is equally illogical for FDA to not

consider as a mitigating factor that banning flavored

vaping products carries an inherent risks of youths

initiating or migrating to cigarettes.

Loper was critical to the review of agency

determinations because it allows courts to look behind

the curtain instead of reflexively acting as a rubberstamp. FDA failed to stay true to the TCA’s mandate

to base marketing decisions upon the “population as a

whole.” Instead, FDA ignored critical differences

between the two vaping product classes vis-à-vis risks

to youths and then attempted to justify its desired

policy goal by cherry-picking a select group of scientific

studies. This is a prime example of an arbitrary agency

action which Loper was meant to expose.

32 Id.

- 21 This Court noted in Loper that a “statute’s

meaning may well be that the agency is authorized to

exercise a degree of discretion.” 144 S.Ct. at 2262.

Whatever discretion Congress granted FDA under the

TCA did not include the authority to apply it in the way

it has here. This case is tailor-made for review under

Loper because FDA must now justify its many

deviations from permissible regulatory practices and

not expect automatic deference.

III. THE EN BANC PANEL ACCURATELY FOUND

THAT FDA’S PMTA REVIEW PROCESS FOR

FLAVORED

ENDS

PRODUCTS

WAS

FRAUGHT WITH LEGAL DEFECTS.

FDA’s PMTA review process for flavored vaping

products suffers from four fatal defects: (1) a reliance

upon post hoc justifications to justify the rejection of

Appellees’ PMTAs; (2) a failure to provide the

Appellees fair notice when adopting its comparative

efficacy standard; (3) a change of a substantive policy

position without displaying an awareness of, or

explaining, the change; and (4) a disregard of

Appellees’ reliance interests. Any of these flaws is

alone sufficient to affirm the en banc panel.

A. FDA’S POST HOC RATIONALIZATIONS;

AN ATTEMPT TO JUSTIFY ITS FLAWED

PMTA PROCESS.

The Appellees’ arguments below fleshed out the

significant legal flaws with FDA’s standard for

flavored vaping products. FDA responded with post hoc

rationalizations which the en banc Fifth Circuit

rejected 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.”

- 22 90 F.4th at 371, citing SEC v. Chenery Corp., 318 U.S.

80, 87 (1943). FDA’s arguments below did not match

the rationale underlying its marketing denial.

Over several years, FDA had many pre-PMTA

interactions with manufacturers which affirmatively

represented that PMTAs would not need the support of

long-term studies, and certainly never informed them

of the need for studies which compared the efficacy of

their flavored vaping products to an unknown tobaccoflavored product. 90 F.4th at 372. Instead, FDA

focused on the importance of the details of

manufacturers’ marketing plans, id., but its

representations and assurances did not frame the

scope of reviewing the Appellees’ PMTAs.

The en banc panel noted that FDA predicated its

marketing denial here 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. 200a – 201a n. xix.

FDA’s guidance, however, clearly articulated the

critical importance of marketing plans in remediating

against any youth-attractiveness of flavored vaping

products. 33 Shockingly, FDA admitted “not even

read[ing] the marketing plans.” 90 F.4th at 372, citing

Pet. App. 201a n. xix (acknowledging FDA’s failure to

review marketing plans).

33 FDA, Premarket Tobacco Product Applications and

Recordkeeping Requirements, supra., 84 FED. REG. 50,566,

50,581 (Sept. 25, 2019).

- 23 FDA defended this failure by pointing to an

evolved mindset based on what it “learned” from

“review[ing] PMTAs for flavored [products].” 34 Pet.

App. 181a, n. vi. May an agency recalibrate policies as

its knowledge and experience evolves? Sure, but not

without limits. FDA could adopt a changed mindset as

its experiences evolved. The law, however, required

that FDA both acknowledge such evolution and

articulate a “detailed justification” for it before

abandoning existing expectations. Encino Motorcars,

LLC v. Navarro, 579 U.S. ___, 136 S. Ct. 2117, 2125

(2016) (quotation omitted). Congress also added a

public notice-and-comment rulemaking requirement.

See 21 U.S.C. § 387g.

FDA tried to regulate on-the-fly because its

erroneous PMTA expectations led to unrealistic

compliance deadlines. FDA responded by extending

the PMTA deadline outside the required rulemaking

process, resulting in a federal court artificially setting

an earlier PMTA date. 35 FDA realized the impossibility

of complying with this artificial deadline, 36 and simply

made up a new, after-the-fact evidentiary rule as a

matter of expediency in order to dispatch with the

deluge of PMTAs instead of seeking judicial relief from

the artificial PMTA review deadline.

34 FDA employed this same explanation in its marketing

decisions for all other flavored open-system vaping products

adjudicated to date.

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.

35

36

See Reagan-Udall Foundation, Operational

Evaluation of Certain Components of FDA’s Tobacco

Programs, 11 (Dec. 19, 2022).

- 24 FDA’s hasty post-PMTA change of position was

indeed the “surprise switcheroo” found by the Fifth

Circuit stay panel, 16 F.4th at 1138, and embodied in

the en banc panel’s ruling. The latter panel did not err

in refusing to defer to FDA arbitrarily springing a new

and unexpected evidentiary requirement on Appellees

after it was too late to comply.

A legitimate regulatory process should be able to

stand the crucible of scrutiny without resort to post hoc

rationalizations. FDA’s post hoc rationalizations speak

for themselves given its decision to double down before

the en banc panel. See 90 F.4th at 373, 388. Those

rationalizations are alone a sufficient basis to affirm

the en banc Fifth Circuit.

B. FDA’S ACTIONS VIOLATE

NOTICE STANDARD.

THE

FAIR

The proposition that regulatory processes must be

fair, open and transparent is a linchpin of this Court’s

jurisprudence. Christopher, supra., at 156 (agencies

must “provide regulated parties fair warning” of what

it “prohibits or requires” before punishing

noncompliance); Fox Television, supra., at 515

(agencies cannot “depart from a prior policy sub

silentio or simply disregard[ ] rules that are still on the

books”).

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, including regulation

by informal guidance, Morton v. Ruiz, 415 U.S. 199,

235 (1974). The en banc Fifth Circuit laid bare that

FDA’s PMTA review process was anything but fair,

open, and transparent.

- 25 FDA’s August 2017 extension of the PMTA

deadline commenced its interactions with vaping

product stakeholders. 90 F.4th at 363. FDA undertook

this step to buy time to clarify the APPH standard’s

mechanics and allow itself time to “promulgate

[PMTA] instructions.” Id. Next, FDA provided

instructions on five occasions: October 2018

(stakeholder presentation); June 2019 (guidance

document); September 2019 (proposed PMTA rule);

October 2019 (public stakeholder meeting); and

January 2020 (guidance document which prioritized

its enforcement against non-tobacco and non-menthol

flavored closed-system products). 90 F.4th at 363 –

366.

The en banc panel described its analysis of these

FDA interactions with industry stakeholders as

“dizzying” in observing 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. FDA never gave “fair notice that flavored

vaping product manufacturers had to submit robust

scientific studies on flavored” open-system products.

Id. at 368-9 (emphasis added). 37

Instead, FDA honed its pre-PMTA focus on

flavored closed-system products based upon specific

characteristics which enhanced their youth appeal. 90

37 In fact, FDA did not reflect its evolution of thought by

contemporaneously rescinding its pre-PMTA guidance; a

step which would have at least given stakeholders a hint of

its changed expectations.

- 26 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) 5, 16, 17. FDA’s Guidance

positively contrasted open-system products because

their characteristics lessened any youth appeal. 90

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

FDA’s Guidance and pre-PMTA industry dealings

represented the fixing of an APPH standard to treat

flavored open-system products less strictly than their

closed-system counterparts. FDA did an about face

regarding open-system flavored vaping products after

the PMTA deadline without either notice to

manufacturers or an opportunity to amend their

PMTAs. The Fifth Circuit’s characterizations of a

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

accurate and warranted.

The en banc panel’s “dizzying” analysis evidences

that FDA made a mockery of the fair notice principles.

FDA took this mockery further by imposing its

comparative efficacy standard without identifying a

comparator tobacco-flavored product or defining how

many smokers must quit for a flavored product to be

“effective.” It begs the question how manufacturers

could conduct a reliable comparative efficacy analysis

without knowing the above baseline metrics.

FDA saying one thing before the PMTA deadline

but doing the opposite after the deadline is the

hallmark of an arbitrary regulatory regime which

lacks basic elements of fairness, openness, and

transparency. FDA’s failure to adhere to the fair notice

standard is alone a sufficient basis to affirm the en

banc Fifth Circuit.

- 27 C. FDA FAILED TO EXPLAIN ITS POLICY

SWITCH REGARDING FLAVORED ELIQUIDS.

Another linchpin of this Court’s jurisprudence is

the proposition that agencies cannot “depart from a

prior policy sub silentio” or simply disregard existing

rules and must “display awareness” of any policy

change and support it with a “detailed justification”

when the new policy alters “engendered serious

reliance interests.” Fox Television, supra., at 515. It

was unreasonable for FDA to embark on a departure

from its pre-PMTA guidance and assurances without

sufficiently explaining the change and giving accord to

the Appellees’ reliance interests.

FDA’s numerous pre-PMTA actions evidence it

was never prepared to receive and review PMTAs. For

example, FDA announced plans in mid-2017 to issue

“regulations outlining what information” it expected in

PMTAs, 38 part of a larger policy shift which included a

4-year PMTA deadline extension. 39 FDA acknowledged

in early 2018 that it had not “delineate[d] key

requirements” of the PMTA process, 40 and by early

2019, still had not determined the PMTA “rules of the

road.” 41 FDA saw no urgency given the 2017 deadline

FDA Announces Comprehensive Regulatory Plan to

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

2017), https://tinyurl.com/4e4xutd5.

38

39

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.

40

Agriculture, Rural Development, Food and Drug

Administration, and Related Agencies Appropriations for

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

41

- 28 extension as it still expected receiving relatively few

PMTAs.

FDA’s numerous pre-PMTA representations

disclaimed the need for manufacturers to submit

specific studies, including long-term studies, only to

pivot 180 degrees to a new position after the PMTA

deadline. 90 F.4th at 363. FDA justified this pivot by

saying its pre-PMTA guidance was merely “nonbinding recommendations” and “never promised or

committed itself” to doing any particular thing: a “wild

goose chase.” 42 90 F.4th at 383.

Indeed, FDA’s pre-PMTA assurances lulled the

Appellees and thousands of other flavored open-system

manufacturers to spend millions of dollars to timely

file PMTAs. They did everything FDA asked in its prePMTA guidance, and remarkably did so in the face of

both an arbitrarily shortened PMTA deadline and the

many 2020 Covid business restrictions. FDA attempts

to justify its radical position change by shrugging its

shoulders and saying it was not bound by anything

contained in its pre-PMTA industry dealings, a tact

wholly inconsistent with Fox Television, supra. FDA’s

failure to sufficiently explain its policy shift regarding

flavored open-system vaping products is alone a

sufficient basis to affirm the en banc panel.

D. FDA FAILED TO GIVE ACCORD

APPELLEES’ RELIANCE INTERESTS.

TO

A final linchpin of this Court’s jurisprudence is

that agencies must accord reliance interests when

considering a policy change. See Christopher, supra., at

156-57 (agencies cannot penalize a party for a “good

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

Comm’r Gottlieb).

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

- 29 faith reliance” upon a prior position) and Fox

Television, supra., at 515 (agencies must take “serious

reliance interests” into account). An agency must do so

even when reversing a regulatory policy not enacted

according to law. Department of Homeland Security v.

Regents of the University of California, 591 U.S. 1

(2020).

FDA failed to accord the Appellees’ reliance

interests in its pre-PMTA assurances. 90 F4th at 384.

FDA’s policy change vis-a-vis open-system flavored

vaping products was a significant policy shift given

their substantial market space. 43 Aside from FDA’s

policy shift contradicting the TCA, it also failed to

sufficiently accord the reliance interests of the

Appellees and other flavored open-system product

manufacturers. FDA’s post-PMTA regulatory flip-flop

was wholly inconsistent with this Court’s reliance

interests jurisprudence.

Here, FDA’s pre-PMTA guidance could be

interpreted to say that flavored vaping products

needed to perform long-term scientific studies, but

could also be reasonably interpreted to say that a

manufacturer’s flavored vaping product PMTAs did

not need “specific studies,” “[y]outh behavioral data,”

or “long-term studies.” 90 F.4th at 385, citing FDA’s

October 2018 Guidance 18, 26. The former

interpretation is weakened because “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

Kharrati, K., Global E-Cigarette and Vape Market

Size Likely to Surpass at a CAGR of 4.5% By 2033, Custom

Market Insights (Mar. 4, 2024).

https://www.custommarketinsights.com/press-releases/ecigarette-and-vape-market-size/

43

- 30 e-cigarette products and other nonflavored e-cigarette

products.” 90 F.4th at 385. Implicit in the en banc

panel’s ruling is the basic interpretative principle that

any ambiguities in FDA’s guidance documents were to

be held against it. It correctly held that FDA could not

send the Appellees ambiguous instructions and then

penalize them for obeying the wrong one. Id.

The Appellees are in the same shoes as thousands

of other open-system flavored product manufacturers

who relied upon a reasonable interpretation of FDA’s

pre-PMTA assurances and representations. It would

be one thing if the Appellees’ interpretation and

reasonable reliance occurred in isolation. It is a

completely different thing when thousands of flavored

vaping product manufacturers from all corners of the

nation reached the same understanding. It is

statistically improbable these manufacturers all

reached the same conclusion by accident. The Court

should hold FDA to its pre-PMTA representations.

IV. THE TCA’S DEEMING PROVISION VIOLATES

THE MAJOR QUESTIONS DOCTRINE.

The Court’s recent jurisprudence evidences a

significant reliance upon the separation of powers

subset principle: the “major questions doctrine.” It is

implicated when an agency adopts a policy having a

broad national effect without specific congressional

authorization. See e.g., West Virginia v. EPA, 597 U.S.

697 (2022) (EPA lacked congressional authorization to

regulate emissions from existing plants based on

generation shifting mechanisms); Ala. Ass’n of

Realtors v. HHS, 594 U.S. 758 (2021) (Centers for

Disease Control’s Covid-era eviction moratorium

intruded into an area of vast economic and political

significance

without

express

Congressional

authorization); and Biden v. Nebraska, 600 U.S. 477

- 31 (2023) (Department of Education’s student loan debt

cancellation plan lacked congressional authority).

Brown & Williamson is the foundation of this

Court’s recent major question doctrine jurisprudence.

Brown & Williamson addressed the constitutionality of

FDA invoking the Federal Food Drug and Cosmetic Act

(FFDCA) to regulate tobacco products by classifying

nicotine as a drug, and cigarettes as a drug delivery

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

Congress had never authorized FDA’s regulation of

tobacco, instead constraining its regulatory efforts to

labeling and advertising restrictions in response to the

1964 Surgeon General’s report. 529 U.S. at 137-38.

Congress considered 75 smoking-related bills between

1965 and 1978, 44 even proposing to amend the FFDCA

to grant FDA regulatory authority. 45 Congress instead

took a far lesser step by enacting the first federal

cigarette labeling act. 46

The foundation of the Court’s major question

holding in Brown & Williamson rested upon the

proposition that tobacco products concerned a

“significant portion of the American economy,” and had

a “unique place in American history and society” thus

requiring congressional imprimatur. 529 U.S. at 15960. Congress confirmed its understanding of this

significance through its policy choice embodied in 15

U.S.C. § 1331 that the:

“commerce and the national economy

may be . . . protected to the maximum

44 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).

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

46 Klebe, supra.

- 32 extent consistent with” the principle of

consumers “being adequately informed

about any adverse health effects.”

Id. at 138-39.

Brown & Williamson’s major question holding

bound Congress and FDA concerning any future

regulation of tobacco products. Congress, however,

ignored this by using the TCA to impermissibly

delegate seminal legislative authority to FDA. This is

evident from Congress predicating the TCA’s operative

provisions upon the FFDCA’s extant “tobacco product”

definition which included:

“any product made or derived from tobacco

that is intended for human consumption,

including any component, part, or

accessory....” 47

21 U.S.C. § 321(rr)(1), but did not immediately subject

all tobacco products to the TCA’s requirements. 21

U.S.C. § 387a(b). Instead, Congress constrained FDA’s

authority to merely four specific product subsets

(cigarettes, cigarette tobacco, roll-your-own tobacco,

and smokeless tobacco), and specifically left all other

tobacco products, including vaping products, outside

the TCA’s immediate scope. Id.

Congress’ exclusion of vaping products is

significant because it knew they existed. 48 Yet,

Congress has never amended the TCA to expand the

list of regulated products. Instead, it delegated plenary

47 The same definition applied at the PMTA deadline.

48 See e.g. 155 CONG. REC. No. 50 at H3802 - H3805

(daily ed. Mar. 24, 2009) (statement by Rep. Buyer); 155

CONG. REC. No. 82 at S6009 - S6012 (daily ed. Jun. 3, 2009)

(statement by Sen. Burr).

- 33 authority to the Health and Human Services Secretary

to deem all other tobacco products through a

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

Congress disregarded Brown & Williamson by

delegating to FDA the responsibility to identify any

additional tobacco products to be regulated.

Congress

compounded

its

impermissible

delegation by not “provid[ing] standards for when and

how [FDA] was to exercise its discretion to deem[.]”

Nicopure Labs, LLC v. FDA, 266 F. Supp.3d 360, 392

(D. D.C. 2017). FDA admitted the lack of congressional

standards (“Congress’s choice of the deferential word

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

requirement that the product meet the ‘tobacco

product’ definition—demonstrate that Congress

committed the exercise of this authority to the agency’s

broad discretion”). 49 Id.

FDA exercised its deeming authority in May 2016

as to all other tobacco products, including vaping

products, by way of is “Deeming Rule.” 81 FED. REG.

28,974 (May 10, 2016). 50 FDA’s claim of broad

regulatory discretion begs the question given

Congress’s violation of Brown & Williamson’s

constraints. Therein, this Court dictated that

Congress, and only Congress, could authorize FDA to

regulate tobacco products. Brown & Williamson

implicitly required that Congress specifically construct

The lack of guiding standards also presents a nondelegation 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).

49

50 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.).

- 34 the blueprint of the regulatory framework for tobacco

products. This also implicitly required that Congress

identify the specific tobacco products to be regulated as

an integral part of crafting any regulatory framework.

Congress’s delegation of authority to FDA to make that

identification of any additional products for purposes

of 21 U.S.C. § 387a(b) violated the separation of powers

doctrine. Independent of the en banc Fifth Circuit’s

analysis, the Court should rule the deeming provision

in 21 U.S.C. §387a(b) is unconstitutional.

CONCLUSION

Based on the foregoing, this Court should affirm

the en banc Fifth Circuit’s Opinion in its entirety.

October 8, 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)

LIQUID LABS LLC (NJ)

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.

A-2

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

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)