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

Supreme Court briefOct 15, 2024

Ask Donna

What actually matters in this document.

Text

No. 23-1038

IN THE

Supreme Court of the United States

————

FOOD AND DRUG ADMINISTRATION,

Petitioner,

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

DBA TRITON DISTRIBUTION, ET AL.,

————

Respondents.

On Writ of Certiorari to the

United States Court of Appeals

for the Fifth Circuit

————

BRIEF OF ELECTRONIC NICOTINE

DELIVERY SYSTEM TRADE ASSOCIATIONS

AND SMALL BUSINESSES AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

————

ERIC P. GOTTING

Counsel of Record

AZIM CHOWDHURY

KELLER AND HECKMAN LLP

1001 G Street, N.W.

Suite 500 West

Washington, D.C. 20001

(202) 434-4100

gotting@khlaw.com

chowdhury@khlaw.com

Counsel for Amici Curiae

October 15, 2024

WILSON-EPES PRINTING CO., INC. – (202) 789-0096 – WASHINGTON, D.C. 20002

TABLE OF CONTENTS

Page

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

iii

GLOSSARY ..........................................................

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

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

ARGUMENT ........................................................

Non-Tobacco Flavored ENDS Present

Less Risk Than Cigarettes And Are

Effective In Helping Transition Adult

Smokers .....................................................

FDA Received PMTAs Covering Millions

Of Flavored ENDS Products, But

Adopted An Across-The-Board Strategy

Of Denying Marketing Authority For

Virtually All Non-Tobacco Flavored

ENDS.........................................................

III. The TCA’s Clear Text, Context, And

Structure Require FDA To Conduct A

Full Scientific Review Of Each PMTA;

FDA Cannot Shortcut That Process.........

IV. FDA Consistently Interpreted The TCA

As Requiring A Full Scientific Review Of

All Information Contained In A PMTA ...

II.

(i)

TABLE OF CONTENTS—Continued

Page

FDA Did A Sudden About-Face, Interpreted The TCA As Allowing It To Forgo

Full Scientific Reviews And, Instead,

Uniformly Denied Marketing Authorization For Virtually All Non-Tobacco

Flavored ENDS Based On The Mere

Absence Of One Type Of Specific

Evidence ....................................................

VI. TCA Section 910(c)(5)(B) Governing The

Use Of “Valid Scientific Evidence” Does

Not Authorize FDA To Deny A PMTA

Solely Because It Does Not Contain A

Comparative Efficacy Study ......................

CONCLUSION ....................................................

APPENDIX

iii

TABLE OF AUTHORITIES

CASES

Page(s)

Bidi Vapor LLC v. FDA,

47 F.4th 1191 (11th Cir. 2022) ................

Loper Bright Enters. v. Raimondo,

144 S. Ct. 2244 (2024) ................ 1, 4, 13, 17, 24

Michigan v. EPA,

576 U.S. 743 (2015) ................................... 24, 25

R.J. Reynolds Vapor Co. v. FDA,

65 F.4th 182 (5th Cir. 2023) ....................

Skidmore v. Swift & Co.,

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

Sossamon v. Texas,

563 U.S. 277 (2011) ...................................

Vapor Tech. Ass’n v. FDA,

977 F.3d 496 (6th Cir. 2020) ....................

STATUTES

Consolidated Appropriations Act of 2022,

Pub. L. No. 117-103, 136 Stat. 49 (Mar.

15, 2022) ...................................................

Family Smoking Prevention and Tobacco

Control Act of 2009, 21 U.S.C. § 387,

et seq. .............. 1-3, 5, 9-11, 13-17, 21, 24, 25, 26

21 U.S.C. § 387 note (2) ............................

21 U.S.C. § 387 note (4) ............................

21 U.S.C. § 387 note (7) ............................

§ 901(b), 21 U.S.C. § 387a(b).....................

§ 906(d), 21 U.S.C. § 387f(d) .....................

TABLE OF AUTHORITIES—Continued

Page(s)

§ 907, 21 U.S.C. § 387g .............................

§ 907(a)(3), 21 U.S.C. § 387g(a)(3) ............

§ 907(a)(3)(B)(i), 21 U.S.C. §

387g(a)(3)(B)(i) ..........................................

§ 907(a)(4), 21 U.S.C. § 387g(a)(4) ............ 14, 15

§ 910, 21 U.S.C. § 387j .......................... 3, 10, 27

§ 910(a), 21 U.S.C. § 387j(a) .....................

§ 910(b), 21 U.S.C. § 387j(b) ..................... 10, 13

§ 910(b)(1), 21 U.S.C. § 387j(b)(1) .............

§ 910(c), 21 U.S.C. § 387j(c) .... 10, 13, 14, 17, 25

§ 910(c)(1)(B), 21 U.S.C. § 387j(c)(1)(B) ....

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

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

§ 910(c)(4), 21 U.S.C. § 387j(c)(4).......... 2, 13, 14

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

§ 910(c)(5)(B), 21 U.S.C. § 387j(c)(5)(B)..... 4, 24-26

COURT FILINGS

Certified admin. record index, Bidi Vapor

LLC v. FDA, No. 21-13340 (11th Cir.)

(Dkt. 16) ...................................................

Decl. of Mitch Zeller, Am. Academy of

Pediatrics v. FDA, 8:18-cv-00883-PWG

(D. Md.) (Dkt. 120) ...................................

TABLE OF AUTHORITIES—Continued

Page(s)

Mem. Op. and Order, Am. Academy of

Pediatrics v. FDA, 8:18-cv-00883-PWG

(D. Md.) (Dkt. 127) ...................................

Order, Am. Academy of Pediatrics v. FDA,

8:18-cv-00883-PWG (D. Md.) (Dkt. 182) ..

Public Statement of Mitch Zeller, Bidi

Vapor LLC v. FDA, No. 21-13340 (11th

Cir.) (Dkt. 40) ............................................

OTHER AUTHORITIES

81 Fed. Reg. 28974 (May 10, 2016) .... 5, 10, 11, 17

86 Fed. Reg. 55300 (Oct. 5, 2021) ................ 20, 21

A. Arrazola, et al., Tobacco product use

among middle and high school students –

United States, 2011 and 2012, 62 MMWR

893-897

(Nov.

15,

2013),

https://www.ncbi.nlm.nih.gov/pmc/articl

es/PMC4585347/ ......................................

CDC, QuickStats: Percentage Distribution

of Cigarette Smoking Status Among

Current Adult E-Cigarette Users, by Age

Group—National Health Interview Survey

(Mar. 10, 2023), https://perma.cc/TYR89KUV .........................................................

TABLE OF AUTHORITIES—Continued

Page(s)

Eunice Park-Lee, et al., Notes from the

Field: E-Cigarette and Nicotine Pouch

Use Among Middle and High School

Students – United States, 2024, 73

MMWR 774-78 (Sept. 5, 2024), https://

www.cdc.gov/mmwr/volumes/73/wr/mm7

335a3.htm?_cid=mm7335a3_w ................

FDA, Deemed Tobacco Product Applications:

A Public Meeting (Oct. 28, 2019), https://

tinyurl.com/2vmbtxv3 ...............................

FDA, FDA Makes Determinations On More

Than 99% of the 26 Million Tobacco

Products For Which Applications Were

Submitted (March 15, 2023), https://tiny

url.com/3spczmy5...................................... 11, 12

FDA, Modifications to Compliance Policy for

Certain Deemed Tobacco Products (March

2019), https://tinyurl.com/vr6ph8.............

FDA, News Release: FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

(July 27, 2017), https://tinyurl.com/vrub

w8tz ...........................................................

FDA, News Release: FDA Authorizes

Marketing of Four Menthol-Flavored

E-Cigarette Products After Extensive

Scientific Review (June 21, 2024), https://

tinyurl.com/yzy38 mnm ............................

vii

TABLE OF AUTHORITIES—Continued

Page(s)

FDA, News Release: FDA Denies Marketing

Applications for About 55,000 Flavored

E-Cigarette Products for Failing to

Provide Evidence They Appropriately

Protect Public Health (Aug. 26, 2021),

https://tinyurl.com/ n9c9rwu8 ..................

FDA, News Release: FDA Makes Significant Progress in Science-Based Public

Health Application Review, Taking Action

on Over 90% of More Than 6.5 Million

‘Deemed’ New Tobacco Products Submitted

(Sept. 9, 2021), https://tinyurl.com/24km

kdnb ...................................................... 12-13, 23

FDA, Premarket Tobacco Product Applications and Recordkeeping Requirements,

84 Fed. Reg. 50566 (Sept. 25, 2019),

https://tinyurl.com/4ajzm434.............. 18, 19, 21

FDA, Premarket Tobacco Product Applications for Electronic Nicotine Delivery

Systems: Guidance for Industry (Draft

Guidance) (May 2016), https://tinyurl.

com/mp3d462 ............................................ 17, 18

FDA, Premarket Tobacco Product Applications for Electronic Nicotine Delivery

Systems: Guidance for Industry (Draft

Guidance) (June 2019), https://tinyurl.

com/2s33cz3h ............................................

FDA, Premarket Tobacco Product Marketing

Granted Orders, https://tinyurl.com/4dm

xe4v3 .........................................................

viii

TABLE OF AUTHORITIES—Continued

Page(s)

FDA, Tobacco Product Application Review

Public Meeting (Oct. 22, 2018), https://

tinyurl.com/yc6hm88c...............................

FDA, Tobacco Products Marketing Orders:

FDA Sample Decision Summary Document

(Sept. 17, 2021), https://tinyurl.com/npn2

x4ec ............................................................ 21, 23

J. Birdsey, et al., Tobacco Product Use

Among U.S. Middle and High School

Students – National Youth Tobacco Survey,

2023, 72 MMWR 1173-1182 (Nov. 3, 2023),

http://dx.doi.org/10.15585/mmwr.mm724

4a1 ............................................................. 16-17

Karin A. Kasza, et al., Associations between

nicotine vaping uptake and cigarette

smoking cessation vary by smokers’ plans

to quit: longitudinal findings from the

International Tobacco Control Four

Country Smoking and Vaping Surveys,

ADDICTION 2022;1-13.................................

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........

TABLE OF AUTHORITIES—Continued

Page(s)

Mari S. Gades 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........

8, 9

Matthew J. Carpenter, et. al., Effect of

unguided e-cigarette provision on uptake,

use, and smoking cessation among adults

who smoke in the USA: A naturalistic,

randomised, controlled clinical trial, Lancet

eClinical Medicine, 2023;63:102142, DOI:

10.1016/jeclinm.2023.102142; PMCID:

10518503, https://tinyurl.com/2ee6ttyc ....

7, 8

National Academies of Sciences, Public

Health Consequences of E-Cigarettes, NAT’L

ACADEMIES PRESS (2018), https://tinyurl.

com/bde9fyw2 ............................................

5, 7

Nicola Lindson, et al., Electronic cigarettes

for smoking cessation, Cochrane Database

of Systematic Reviews 2024, Issue 1. Art.

No.: CD010216, DOI: 10.1002/14651858.

CD010 216.pub8, https://tinyurl.com/s4jz

w8wv..........................................................

6, 7

Ping Due, MD, Ph.D, et al., Changes in ECigarette Use Behaviors and Dependance

in Long-term E-Cigarette Users, AM. J.

PREV. MED. 2019:57(3):374-383 ................

TABLE OF AUTHORITIES—Continued

Page(s)

public health, American Heritage Dictionary,

https://tinyurl.com/ywxdthby ......................

public health, Merriam-Webster Dictionary,

https://tinyurl.com/55p876pn ......................

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

in vaping initiation and satisfaction

among U.S. adults, ADDICT. BEHAV. 2019

Dec;99:106077, https://tinyurl.com/24j47

x8c..............................................................

Teresa W. Wang, et al., Tobacco Product

Use and Associated Factors Among Middle

and High School Students – United

States, 2019, 68 MMWR 1-22 (Dec. 6,

2019), https://www.cdc.gov/mmwr/volum

es/68/ss/ss6812a1.htm ..............................

Yoonseo Mok, MPH, et al., Associations

between e-cigarette use and e-cigarette

flavors with cigarette smoking quit attempts

and quit success: Evidence from a US

large, nationally representative 20182019 survey, NICOTINE AND TOBACCO

RESEARCH (2022) ......................................

6, 7

GLOSSARY

APPH

Appropriate for the Protection of the Public

Health

CDC

Centers for Disease Control

ENDS

Electronic Nicotine Delivery Systems

FDA

U.S. Food and Drug Administration

MDO

Marketing Denial Order

MGO

Marketing Granted Order

NAS

National Academies of Sciences

PMTA Premarket Tobacco Product Application

TCA

Family Smoking Prevention and Tobacco

Control Act

TPL

Technical Project Lead

INTERESTS OF AMICI CURIAE

Amici are national and state trade associations, as

well as small businesses, who represent manufacturers,

distributors, and retailers of Electronic Nicotine Delivery

Systems (“ENDS”) (commonly known as “e-cigarettes”).1

Millions of addicted smokers in the U.S. have used

ENDS to transition away from more dangerous traditional cigarettes. Indeed, many of these companies were

started by individuals who themselves relied on ENDS

to successfully move on from their own smoking habits.

Amici therefore share a common goal in advocating for

a reasonably regulated marketplace that gives consumers

access to less risky tobacco products.

Amici also have a substantial interest in this litigation.

Over the past several years, they have watched with

great alarm as the U.S. Food and Drug Administration

(“FDA”) has reached far beyond any reasonable interpretation of the Family Smoking Prevention and Tobacco

Control Act (“TCA”) and rejected premarket applications

for virtually all non-tobacco flavored ENDS. What is

worse, the majority of circuit courts considering challenges

to FDA’s denials have afforded FDA extreme deference

in rubber-stamping a wholly unlawful regulatory scheme.

In this brief, Amici thus reflect on the adverse impact

that FDA’s approach has had on this industry and the

addicted adult smokers it serves, and demonstrate

that FDA’s overall approach to reviewing premarket

applications for non-tobacco flavored ENDS products,

particularly in light of Loper Bright Enters. v. Raimondo,

144 S.Ct. 2244 (2024), has no basis in the TCA itself.

This brief was not authored in whole or in part by counsel for

any of the parties; no party or party’s counsel contributed money

for preparing or submitting this brief; and no one other than

amici and their counsel have contributed money for preparing or

submitting this brief. Amici are listed in the attached appendix.

SUMMARY OF ARGUMENT

Congress granted FDA authority in the TCA to

ensure addicted, adult cigarette smokers in this country

have access to lower risk tobacco products to help them

move away from more dangerous, combustible cigarettes.

ENDS are now firmly recognized by the scientific

community as a risk reduction tool for cigarette smokers.

Under the statute, ENDS manufacturers must submit

to FDA premarket tobacco product applications

(“PMTAs”) to obtain marketing authorization for their

products. FDA is required by the TCA’s plain language

to then evaluate all information and data submitted

by a manufacturer when determining whether a given

product is “appropriate for the protection of the public

health” (“APPH”). Significantly, this is not a one-sizefits-all process; rather, it obligates FDA to weigh all

evidence in each PMTA on a case-by-case basis.

By way of example, part of the APPH process

involves ensuring ENDS do not appeal to minors. But

any concerns about youth (under 21 years-old) use

must be balanced against all other evidence contained

in the PMTA warranting a grant of marketing

authorization, such as underage marketing and access

restrictions implemented by the manufacturer. Before

FDA ever received a PMTA, Congress had already

made a policy choice, in creating its first ever

population-level health standard, that only through a

complete review of a PMTA would FDA be able to

fairly balance all of the evidence and account for all

stakeholder interests involved. Congress did so by

mandating that FDA consider, inter alia, both the

“risks and benefits” of a tobacco product across the

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

Unfortunately, FDA has applied a generic, acrossthe-board scheme resulting in the denial of virtually

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

products, and in the process focusing its attention

largely on underage use at the expense of adult

smokers. FDA had initially read the TCA correctly –

and consistently put forth that interpretation over

the span of five years in guidance and other public

statements – obligating the agency to conduct a full

scientific review of an entire PMTA before making a

marketing authorization decision. However, in an

about-face, FDA adopted a new strategy following a

deluge of PMTAs filed prior to a court-imposed

deadline – what FDA described in an internal memo

as the “fatal flaw” approach – expressly designed to

quickly deny marketing authorization for as many

non-tobacco flavored ENDS as possible. Agency staff

were suddenly ordered to engage in a simple boxchecking exercise and issue a marketing denial if the

PMTA merely failed to contain a single study comparing

the cessation benefits of the manufacturer’s tobacco

and non-tobacco flavored ENDS (what is referred to in

this amici brief as the “comparative efficacy” study or

test requirement).

Needless to say, FDA’s interpretation – concluding it

could base a marketing denial solely on the absence of

one piece of evidence – does not accurately reflect

Congressional intent. FDA’s cookie-cutter approach to

PMTA reviews clearly violates the plain language of

the TCA. In Section 910, the statute lists numerous

factors that are relevant to an APPH finding. Indeed,

the population-level health standard itself incorporates

the term “appropriate,” which this Court has held is a

broad and all-encompassing term requiring consideration

of all relevant factors. And this reading is consistent

with the statute’s command that the “risks and

benefits” of a product be considered across the

“population as a whole.”

FDA argues in its merits brief that Section

910(c)(5)(B) authorizes it to reject a PMTA simply

because it does not include a comparative efficacy

study. FDA seriously misreads that provision. Rather,

the “best” reading of Section 910(c)(5)(B), pursuant to

this Court’s recent decision in Loper Bright Enters. v.

Raimondo, 144 S. Ct. 2244 (2024), is that the absence

of such a study must still be weighed and balanced

against all other information and data contained in a

given PMTA, including those that favor a marketing

granted order. That much is required by the statute’s

plain text, context, and structure.

The Questions Presented in the instant case do not

directly implicate FDA’s claimed authority to review

PMTAs under the abbreviated comparative efficacy

approach. Rather, this Court has been asked to

resolve more discrete issues of fair notice and whether

FDA arbitrarily and capriciously failed to consider

Respondents’ underage marketing and access restrictions.

However, the fact that FDA never had, in the first

instance, authority to rely solely on the absence of a

comparative efficacy study to deny ENDS marketing

authorization may generally inform this appeal.

Amici therefore request this Court decide in favor of

Respondents and affirm the judgment below.

ARGUMENT

I. Non-Tobacco Flavored ENDS Present Less

Risk Than Cigarettes And Are Effective In

Helping Transition Adult Smokers

It is now well-established ENDS pose far less health

risk than traditional cigarettes. For instance, in 2018,

the National Academies of Sciences (“NAS”) completed

a comprehensive review of over 800 research and

scientific papers examining ENDS and their health

impacts. 2 NAS found “substantial evidence that

except for nicotine, under typical conditions of use,

exposure to potentially toxic substances from e-cigarettes

is significantly lower compared with combustible

cigarettes.” 3 This is because ENDS do not burn tobacco

leaf or even contain tobacco, and there is no combustion or

smoke. Rather, the aerosol produced by an ENDS is

created by heating and vaporizing an e-liquid solution.

Not surprisingly, NAS concluded the “evidence about

harm reduction suggests that across a range of studies

and outcomes, e-cigarettes pose less risk to an

individual than combustible tobacco cigarettes.” 4

Most adult ENDS users in this country are also

either current or former smokers, with many of these

National Academies of Sciences, Public Health Consequences

of E-Cigarettes (“NAS”), NAT’L ACADEMIES PRESS, at Preface

(2018), https://tinyurl.com/bde9fyw2.

Id. at 18 (emphasis in original).

Id. at 11. FDA agrees. 81 Fed. Reg. 28974, 29030 (May 10,

2016) (FDA concluding in rule applying the TCA to ENDS

products that “completely switching from combusted cigarettes to

[e-cigarettes] may reduce the risk of tobacco-related disease for

individuals currently using combusted tobacco products, given

the products’ comparative placements on the continuum of

nicotine-delivering products.”).

individuals turning to ENDS to reduce or completely

quit their smoking habits. 5 Recent studies validate

these efforts, with a Cochrane Systematic Review being

particularly instructive. A group of university researchers

from the United States and around the world reviewed

88 completed studies, including randomized controlled

trials and cross-over trials, which investigated whether

ENDS help adults stop smoking. 6 Those studies

represented 27,235 participants, of which 47 were

randomized controlled trials (“RCTs”). The review

concluded that “[p]eople are more likely to stop smoking

for at least six months using nicotine e-cigarettes than

using nicotine replacement therapy (7 studies, 2544

people), or e-cigarettes without nicotine (6 studies,

1613 people).” In addition, studies comparing nicotine

e-cigarettes with behavioral or no support also showed

Ping Due, MD, Ph.D, et al., Changes in E-Cigarette Use

Behaviors and Dependance in Long-term E-Cigarette Users, AM.

J. PREV. MED. 2019:57(3):374-383, at 375; Yoonseo Mok, MPH, et

al., Associations between e-cigarette use and e-cigarette flavors

with cigarette smoking quit attempts and quit success: Evidence

from a US large, nationally representative 2018-2019 survey,

NICOTINE AND TOBACCO RESEARCH, at 5 (2022) (“Mok, et al.”).

According to the Centers for Disease Control (“CDC”), among

adult ENDS users, approximately 69.7% are former or current

cigarette smokers, including 92.8% of users over 45 years old –

the age group most susceptible to near-term health impacts from

smoking combustible cigarettes. CDC, QuickStats: Percentage

Distribution of Cigarette Smoking Status Among Current Adult

E-Cigarette Users, by Age Group—National Health Interview

Survey (Mar. 10, 2023), https://perma.cc/TYR8-9KUV. FDA has

calculated that approximately 77% of adult ENDS users use nontobacco flavored (i.e., flavored) ENDS. Pet. App. 188a.

Nicola Lindson, et al., Electronic cigarettes for smoking

cessation, Cochrane Database of Systematic Reviews 2024, Issue

1. Art. No.: CD010216, DOI: 10.1002/14651858.CD010216.pub8,

https://tinyurl.com/s4jzw8wv.

higher quit rates in people using nicotine e-cigarettes

(9 studies, 5024 people). 7

The largest ENDS clinical trial in the U.S. to date

also confirmed the role of these products in smoking

cessation. 8 The 2023 study demonstrates that ENDS

can be a viable means of quitting or reducing more

harmful combustible cigarette use for adult smokers

(21+). This study, significant because it supports the

role that ENDS play in combustible cigarette reduction or

quitting in the real-world setting (i.e., without detailed

instructions or additional cessation support), was conducted using 638 adult smokers across 11 U.S. cities

over a span of four years. Previous studies showing

ENDS can lead to cessation have been far more

structured and included smokers wanting to quit. But

Id.; see also, e.g., NAS, supra note 2, at 19 (finding “moderate

evidence from randomized controlled trials that e-cigarettes with

nicotine are more effective than e-cigarettes without nicotine for

smoking cessation”); Mok, et al., supra note 5, at 14 (data from

nationally representative survey “clearly indicat[ing] that those

who use e-cigarettes more intensely (at least 20 of the past 30days)…have…a higher odds of making a quit attempt and of

succeeding in quitting cigarette smoking”); Karin A. Kasza, et al.,

Associations between nicotine vaping uptake and cigarette

smoking cessation vary by smokers’ plans to quit: longitudinal

findings from the International Tobacco Control Four Country

Smoking and Vaping Surveys, ADDICTION 2022;1-13, at 1-2, 7

(finding smokers “not planning to quit in the next 6 months

who started vaping daily experienced a 32% cigarette quit rate

compared with a 7% quit rate among their counterparts who did

not take up vaping”).

Matthew J. Carpenter, et. al., Effect of unguided e-cigarette

provision on uptake, use, and smoking cessation among adults

who smoke in the USA: A naturalistic, randomised, controlled

clinical trial, Lancet eClinical Medicine, 2023;63:102142, doi:

10.1016/j.eclinm.2023.102142; PMCID: 10518503, https://tinyurl.

com/2ee6ttyc.

in this clinical trial, cessation and smoking reduction

outcomes favored the ENDS group, even among

smokers who expressed little interest in quitting at

study outset. Smokers in the ENDS group showed

declines in combustible cigarette dependence and

increased motivation and confidence to quit smoking.

Key to the study’s findings is the fact that smokers

spontaneously ceased smoking even when they had no

intention of quitting. Importantly, these participants

received no encouragement, motivation, or rewards for

their smoking cessation efforts during the trial. 9

The latest research also places into serious question

the wisdom of preventing adult access to non-tobacco

flavored ENDS which are increasingly recognized as

a key factor in enhancing adult smokers’ ability to

quit combustible cigarettes for good. For example, the

greater efficacy of flavored ENDS in supporting adult

smokers quitting combustible cigarettes was explored

in depth by Gades, et al. Experts at the University

of Minnesota conducted an extensive literature review

of research, including clinical studies, from 2007 to

2020. 10 Results from 104 of those studies suggested

that 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.” 11

Accordingly, the researchers warned “[r]egulation

of…flavors aimed at decreasing naïve uptake may

Id.

Mari S. Gades 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.

Id. at 1332, 1339.

inadvertently decrease uptake and complete switching

among smokers, reducing the harm reduction potential

of e-cigarettes. Evidence-based effects of regulating…

flavors must be considered for the population as a

whole, including smokers.” 12

II. FDA Received PMTAs Covering Millions

Of Flavored ENDS Products, But Adopted

An Across-The-Board Strategy Of Denying

Marketing Authority For Virtually All

Non-Tobacco Flavored ENDS

Congress enacted the TCA in 2009. 13 While the

statute initially applied to only four listed tobacco

products (i.e., cigarettes, smokeless tobacco, roll-yourown tobacco, and cigarette tobacco), Congress authorized

FDA to “deem” additional tobacco products as subject

to the TCA via rulemaking. 14 In August 2016, FDA’s

Id. at 1332; 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, https://tinyurl.com/

24j47x8c (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 ENDS finding

that the greatest success in quitting occurred among adult

smokers using sweet flavored ENDS (13.8%) relative to tobacco

flavored ENDS (9.6%)).

21 U.S.C. § 387, et seq.

21 U.S.C. § 387a(b).

“Deeming Rule” went into effect, which applied the

TCA to ENDS. 15

At the time, tens of thousands of ENDS products

were already on the market. 16 Under the Deeming

Rule, these ENDS, and those introduced into the

marketplace in the future, were immediately subject

to numerous TCA provisions, including a requirement

that manufacturers obtain premarket authorization

from FDA before continuing to market and sell their

products. 17 A manufacturer must submit a PMTA

which entails a time-consuming and costly process

(often totaling millions of dollars per product) of

compiling extensive scientific, technical, and marketing

data that FDA must review before granting or denying

market authorization. 18

To avoid a sudden, mass market exit of ENDS

products, FDA adopted an enforcement policy which

permitted existing ENDS to remain on the market for

up to a year after a timely filed PMTA. Initially, the

Deeming Rule set an August 8, 2018 PMTA filing

deadline. 19 FDA said this balanced concerns regarding

underage use and providing access to products adult

smokers may be using to move away from more

81 Fed. Reg. 28974 (May 10, 2016).

Vapor Tech. Ass’n v. FDA, 977 F.3d 496, 498 (6th Cir. 2020).

21 U.S.C. § 387j. Under the TCA, ENDS are subject to the

PMTA requirement because they are “new” tobacco products – i.e.,

they were introduced into the marketplace after February 15,

2007 and therefore were not grandfathered from the PMTA

process, as were more dangerous cigarettes that had been

commercialized prior to that date. 21 U.S.C. § 387j(a).

21 U.S.C. § 387j(b)-(c).

81 Fed. Reg. at 28978.

dangerous cigarettes. Over the ensuing years, FDA

extended the PMTA deadline, finally landing on

August 8, 2021. 21 But in response to a lawsuit filed

by anti-vaping groups, a federal judge in Maryland

eventually moved the due date back to September 9,

2020 and allowed products with timely filed applications to remain on the market for an additional year

(or until September 2021) without the threat of

enforcement. 22

Although FDA anticipated it would receive less than

6,800 PMTAs,23 applications covering 26 million products

were eventually submitted.24 Mitch Zeller, then-Director

of FDA’s Center for Tobacco Products, admitted in

February 2021 that these unexpectedly large numbers

would present review “challenges” for FDA due to the

Id. at 28977-78.

FDA, News Release: FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death (July

27, 2017), https://tinyurl.com/vrubw8tz; FDA, Modifications to

Compliance Policy for Certain Deemed Tobacco Products (March

2019), https://tinyurl.com/vr6ph8.

Mem. Op. and Order, Am. Academy of Pediatrics v. FDA

(“AAP”), 8:18-cv-00883-PWG (D. Md.) (Dkt. 127 & 182).

AAP, Dkt. 120-1 at 15 (Declaration of Mitch Zeller, Director,

FDA Center for Tobacco Products).

FDA, FDA Makes Determinations On More Than 99% of

the 26 Million Tobacco Products For Which Applications Were

Submitted (March 15, 2023), https://tinyurl.com/3spczmy5. This

figure includes PMTAs for 6.7 million products filed by September

9, 2020, applications for more than 18 million products received

after that deadline, and PMTAs for another 1 million products

covering e-liquids made with non-tobacco derived nicotine (or

synthetic nicotine) that were filed by a May 14, 2022 PMTA

deadline established by a new federal law (Consolidated Appropriations Act of 2022) passed in March 2022, which added such

products to coverage under the TCA. Id.

“size, complexity and diversity” of the PMTAs. 25 Since

mid-2021, while FDA has made determinations on 99%

of these PMTAs,26 it has issued Marketing Granted

Orders (“MGOs”) for only 34 ENDS products, only four

of which were for non-tobacco flavored ENDS. 27 In

contrast, FDA has issued Marketing Denial Orders

(“MDOs”) for over 1.2 million products, almost all of

which were for non-tobacco flavored ENDS. 28 Just in

its initial release of MDOs in August 2021, FDA denied

applications en masse for about 55,000 non-tobacco

flavored ENDS products. 29 And a few weeks later, FDA

announced it had resolved applications for 6.5 million

products subject to timely filed PMTAs, including

MDOs issued for 946,000 non-tobacco flavored ENDS

based on the “fatal flaw” approach. 30

Bidi Vapor LLC v. FDA (“Bidi”), No. 21-13340 (11th Cir.)

(Public Statement of Mitch Zeller) (Dkt. 40 at FDA-BIDIVAPOR005261-62).

Supra note 24.

FDA, Premarket Tobacco Product Marketing Granted

Orders, https://tinyurl.com/4dmxe4v3. On June 21, 2024, FDA

granted marketing authorization for four menthol-flavored ENDS

manufactured by NJOY. FDA, News Release: FDA Authorizes

Marketing of Four Menthol-Flavored E-Cigarette Products

After Extensive Scientific Review (June 21, 2024), https://tinyurl.

com/yzy38mnm.

Supra note 24. The remaining 25 million determinations

constituted refusals to accept or file incomplete or otherwise noncompliant PMTAs based on an initial screening process. Id.

FDA, News Release: FDA Denies Marketing Applications for

About 55,000 Flavored E-Cigarette Products for Failing to Provide

Evidence They Appropriately Protect Public Health (Aug. 26,

2021), https://tinyurl.com/n9c9rwu8.

FDA, News Release: FDA Makes Significant Progress in

Science-Based Public Health Application Review, Taking Action

on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco

III. The TCA’s Clear Text, Context, And

Structure Require FDA To Conduct A Full

Scientific Review Of Each PMTA; FDA

Cannot Shortcut That Process

Under this Court’s decision in Loper Bright, the

pertinent question is “Does the statute authorize the

challenged agency action?” 31 And here, the answer is

an emphatic “no.” The “best” interpretation of the

APPH standard is that FDA must consider, weigh, and

balance all evidence contained in a PMTA before it

determines whether to grant an ENDS product marketing

authorization. 32 It cannot shortcut that process by

limiting its review solely to a comparative efficacy

study. Once FDA receives a complete PMTA, it must

do more than a cursory evaluation; it must assess and

balance the application’s contents in its entirety.

The plain language of the TCA makes this clear.

Section 910(c)(2) of the TCA explicitly provides that

a PMTA shall only be denied if “upon the basis of

the information submitted to [FDA]…and any other

information before [FDA]” the product is not APPH. 33

Section 910(c) of the statute describes APPH in broad

terms with respect to “the risks and benefits to the

population as a whole,” including “users and nonusers

of the tobacco product.” 34 In this context, Section

910(b) enumerates numerous forms of evidence that

must be in any PMTA, including data on health risks,

Products Submitted (Sept. 9, 2021), https://tinyurl.com/24kmkd

nb.

144 S. Ct. at 2269.

Id. at 2266 (holding that it is a court’s independent duty to

discern the “best” interpretation of statutory language).

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

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

ingredient and additive information, product design,

manufacturing practices, product samples, labeling

specimens, and any other information required by FDA.35

Section 910(c) then obligates FDA to also evaluate

whether an ENDS product will help people quit other

tobacco products (i.e., cessation) or compel them to start

(i.e., initiation).36

More specifically, when the TCA says FDA must

consider the whole population, this necessarily includes

not only adult smokers and underage non-smokers, as

is the focus of FDA’s comparative efficacy test, but also

any other demographics that might be impacted by a

particular ENDS product (e.g., adult non-smokers,

underage cigarette smokers, etc.). Indeed, the very

notion of “public health” is broad and contemplates

protecting the “community” as a whole, not just certain

sub-populations. 37 And FDA must also gauge all other

risks and benefits of a given product, including health

factors, like the extent to which a product results in

relatively less or more exposure to harmful constituents. 38

The statute also explicitly makes relevant the impact

21 U.S.C. § 387j(b)(1).

21 U.S.C. § 387j(c)(4). As part of the APPH analysis, FDA

must account for “(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.”

Merriam-Webster Dictionary, https://tinyurl.com/55p876pn

(“the art and science dealing with the protection and improvement of

community health”); American Heritage Dictionary, https://tiny

url.com/ywxdthby (“The science and practice of protecting and

improving the health of a community”).

See, e.g., 21 U.S.C. § 387g(a)(4) (defining APPH in context of

tobacco control standards as including reduction or elimination of

harmful constituents).

that restrictions on the sale or distribution of a product

could have on the APPH determination. 39 These

include constraints on access to a given product, as

well as advertising and marketing limitations, aimed

at reducing underage use (e.g., only allowing face-toface transactions in adult-only facilities). 40

The all-inclusive nature of the APPH standard is

further confirmed by other references to “APPH” in the

TCA. This is evident, for example, in Section 907 where

FDA is authorized to promulgate “tobacco product

standards.” 41 Such standards may govern everything

from nicotine yields, the reduction or elimination

of harmful constituents, characterizing flavors, and

product design, to product testing protocols and sales

restrictions. 42 In adopting a tobacco product standard,

FDA must find that it is APPH. 43 But that finding is

not limited to issues of comparative efficacy. Like the

TCA’s PMTA provision, Section 907(a)(3)(B)(i) separately

provides that FDA must also consider “the risks and

benefits to the population as a whole.” 44

Finally, all of these provisions comport with one of

the underlying purposes of the statute – to boost harm

reduction efforts. To be sure, Congress set out in the

21 U.S.C. § 387j(c)(1)(B).

Id. (referencing examples of restrictions identified in 21

U.S.C. § 387f(d)).

21 U.S.C. § 387g.

21 U.S.C. § 387g(a)(4).

21 U.S.C. § 387g(a)(3).

21 U.S.C. § 387g(a)(3)(B)(i); see also 21 U.S.C. § 387f(d)

authorizing FDA to impose sales and distribution restrictions on

a tobacco product if it would be APPH, taking into account, in

addition to initiation and cessation, the “risks and benefits to the

population as a whole.”

TCA, in part, to protect underage consumers. 45 But it

also requires FDA to “provide new and flexible enforcement authority to ensure that there is effective

oversight of the tobacco industry’s efforts to develop,

introduce, and promote less harmful tobacco products.” 46

FDA also must “continue to permit the sale of tobacco

products to adults in conjunction with measures to

ensure that they are not sold or accessible to underage

purchasers.” 47 In the TCA, Congress decided that these

goals would be best achieved by broadly defining the

APPH standard to include a weighing and balancing

of numerous factors. 48

21 U.S.C. § 387 note (2) (Sec. 3. Purpose).

Id. at note (4).

Id. at note (7).

We note that youth ENDS usage peaked in 2019, when 27.5%

of high school students reported using ENDS within the last 30

days. Teresa W. Wang, et al., Tobacco Product Use and Associated

Factors Among Middle and High School Students – United States,

2019, 68 MMWR 1-22 (Dec. 6, 2019), https://www.cdc.gov/

mmwr/volumes/68/ss/ss6812a1.htm. At the time, the federal

minimum age for the purchase of ENDS products was only 18,

meaning many high school seniors could legally purchase the

products. The federal minimum age was increased to 21 in late

2019, and use of ENDS products by youth has steadily declined

since, with only 7.8% of high school students reporting use in

2024. Eunice Park-Lee, et al., Notes from the Field: E-Cigarette

and Nicotine Pouch Use Among Middle and High School Students

– United States, 2024, 73 MMWR 774-78 (Sept. 5, 2024),

https://www.cdc.gov/mmwr/volumes/73/wr/mm7335a3.htm?_cid=

mm7335a3_w. While 15.8% of high school students reported past

30-day use of combustible cigarettes in 2011, when ENDS were

still novel, by 2023, that figure had declined to 1.9%. See A.

Arrazola, Tobacco product use among middle and high school

students – United States, 2011 and 2012, 62 MMWR (Nov. 15, 2023);

62(45): 893-897, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC

4585347/; J. Birdsey, et al., Tobacco Product Use Among U.S.

IV. FDA Consistently Interpreted The TCA As

Requiring A Full Scientific Review Of All

Information Contained In A PMTA

In Loper Bright, this Court also recognized that due

respect to an agency’s reading of a statute may be

“especially warranted when [the agency] interpretation

was issued roughly contemporaneously with enactment of

the statute and remained consistent over time.” 49

This has particular relevance here. Beginning in 2016

when the Deeming Rule was promulgated, FDA also

interpreted the TCA as obligating FDA to consider all

information and data contained in a PMTA before

deciding whether to grant marketing authorization.

Along with the Deeming Rule, FDA published draft

guidance to assist ENDS manufacturers in preparing

PMTAs, which included identifying information that

must be submitted in an application and would be

relevant to the APPH review. 50 Significantly, FDA

stated it “will weigh all of the potential benefits and

risks from the information contained in the PMTA to

make an overall determination of whether the product

Middle and High School Students – National Youth Tobacco

Survey, 2023, 72 MMWR 1173-1182 (Nov. 3, 2023), http://dx.doi.

org/10.15585/mmwr.mm7244a1.

Loper Bright, 144 S. Ct. at 2258; see also id. at 2259 (citing

Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944) (whether an

agency’s statutory interpretation deserves respect would “depend

on the thoroughness evident in its consideration, the validity of

its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if

lacking power to control”) (emphasis added).

FDA, Premarket Tobacco Product Applications for Electronic

Nicotine Delivery Systems: Guidance for Industry (Draft Guidance)

(May 2016), at 1, https://tinyurl.com/mp3d462.

should be marketed.” FDA then confirmed this view

three years later when it finalized the guidance. Again,

FDA said it will “weigh[] all of the potential benefits

and risks from information contained in the PMTA to

make an overall” APPH determination. 52

FDA consistently took this view over time. In a 2019

proposed PMTA rule, FDA described its comprehensive

analysis under the APPH standard as involving the

weighing and balancing of multiple factors:

Finding that there is a showing that permitting the marketing of a new tobacco product

would be APPH is a complex determination

that must be made with respect to risks and

benefits to the population as a whole….When

determining whether the marketing of a

particular new tobacco product would be

APPH, FDA will evaluate the factors in light

of available information regarding the existing

tobacco product market, tobacco use behaviors,

and the associated health risks at the time of

review….Section 910(c) of the [TCA] requires

FDA to consider an array of potential risks

and benefits of the new tobacco product with

respect to the population as a whole when

determining whether permitting the marketing

of a new product would be APPH….Because

the APPH standard requires a balancing of

product-specific potential risks and benefits,

the factors that could help demonstrate that

Id. at 13 (emphasis added).

FDA, Premarket Tobacco Product Applications for Electronic

Nicotine Delivery Systems: Guidance for Industry (Draft

Guidance) (June 2019), at 12 (emphasis added), https://tinyurl.

com/2s33cz3h.

the marketing of a particular new tobacco

product would be APPH might not support the

marketing of a different new tobacco product. 53

Indeed, in the 2016 and 2019 versions of the PMTA

guidance, FDA detailed, over the course of 50-plus

pages each, numerous types of information and data it

deemed relevant to APPH. Just a sampling includes

information related to an ENDS product’s aerosol

constituents (e.g., harmful and potentially harmful

substances or “HPHCs”); toxicology (e.g., cytotoxicity,

genotoxicity, carcinogenicity, respiratory, reproductive,

developmental); user topography (e.g., puff duration,

puff intensity, duration of use); abuse liability (i.e.,

addictiveness potential); health risks compared to

other tobacco products (e.g., HPHC exposures); underage

marketing and access restrictions; sales data; ingredients; design features; performance specifications; and

manufacturing processes. FDA sought much of this

information through, inter alia, extensive public literature reviews, in vitro and in vivo studies, consumer

intention and perception surveys, observational studies,

and marketing plans. 54 FDA did not overstate matters

when, during 2018 and 2019 public informational

meetings directed at ENDS manufacturers, it described

the APPH analysis as being “multi-disciplinary.” 55

FDA, Premarket Tobacco Product Applications and

Recordkeeping Requirements (Proposed Rule), 84 Fed. Reg. 50566,

50618 (Sept. 25, 2019) (emphasis added), https://tinyurl.com/

4ajzm434.

See, e.g., supra note 50 at 10-46; supra note 52 at 19-50.

FDA, Tobacco Product Application Review Public Meeting

(Oct. 22, 2018), at 116, 119, https://tinyurl.com/yc6hm88c; FDA,

Deemed Tobacco Product Applications: A Public Meeting (Oct. 28,

2019), at 114, 117-18, https://tinyurl.com/2vmbtxv3.

Even when adopting the final PMTA rule in October

2021, just after issuing the first MDOs, FDA continued

to maintain that the APPH standard involves a

“complex determination,” 86 Fed. Reg. 55300, 55335

(Oct. 5, 2021), that FDA “considers many factors,”

id. at 55314, and that FDA does not make a

“determination on one static set of requirements,” id.

at 55385. FDA further declined “to assign weight to

different types of evidence,” id., emphasizing APPH

“requires a balancing” of risks and benefits. Id. at

55384. FDA also refused “to create a series of criteria”

that all products must meet for APPH, stated that an

APPH “determination would involve consideration of

many factors,” and noted it “will be made with respect

to…the population as a whole, rather than whether a

product meets each item in a series of specific criteria.”

Id. at 55386. FDA committed to determining APPH

on an “individualized” basis, the “risks and benefits

of a specific tobacco product” and “based on all of

the contents of the application.” Id. at 55320, 55390

(emphasis added).

Tellingly, during the rulemaking, FDA also rejected

a comment demanding that an APPH evaluation focus

on population segments most likely to be affected by

ENDS and “require applications to show a public health

benefit for those specific groups.” FDA concluded that

APPH does not require applicants to show a public

health benefit for specific population segments. Id at

55385. Further, in response to comments asking FDA

to impose specific requirements on flavored tobacco

products before issuing a marketing order, FDA again

“declin[ed] to create a series of criteria that either all

products or a specific subset of products must meet…to

be considered APPH.” Id. at 55386.

And all of this makes sense. FDA “has interpret[ed]

the APPH standard in 910(c)(2)(A) to require a showing that permitting the marketing of a new tobacco

product would likely have at least a net benefit to

public health based upon the risks and benefits to the

population as a whole.” 56 In other words, the APPH

standard is a relative concept and thus will always

entail a weighing and balancing of all evidence in an

individual PMTA – both for and against marketing

authorization. Restricting PMTA review to just a comparative efficacy study is the very antithesis of FDA’s

longstanding views.

V. FDA Did A Sudden About-Face, Interpreted The TCA As Allowing It To Forgo

Full Scientific Reviews And, Instead,

Uniformly Denied Marketing Authorization For Virtually All Non-Tobacco Flavored

ENDS Based On The Mere Absence Of One

Type Of Specific Evidence

Unfortunately, FDA ultimately did not adhere to

either the TCA nor its own interpretation of the APPH

standard. Despite the statute’s clear language, FDA

proceeded to issue cookie-cutter MDOs for over one

million non-tobacco flavored ENDS products without

conducting a full scientific review of each PMTA. FDA

has denied marketing authorization for virtually every

non-tobacco flavored ENDS product for the same

reason – because the PMTAs did not contain a single,

Supra note 53 at 50618 (emphasis added) (proposed PMTA

rule); see also 86 Fed. Reg. at 55386 (final PMTA rule) (same);

infra note 65 at 4 (sample Technical Project Lead (TPL) review)

(requiring applicant to “show a net population health benefit

necessary to determine that permitting the marketing of the new

tobacco product is APPH.”) (emphasis added).

highly-specific study designed to elicit a discrete datapoint in which the cessation benefits of the applicant’s

non-tobacco flavored ENDS were compared to the

applicant’s tobacco-flavored products. 57

Without warning, FDA informed applicants that

absent this distinct evidence manufacturers could

not demonstrate there would be an added benefit to

smokers of using non-tobacco flavored ENDS sufficient

to outweigh risks of such products to underage users,

and thus the products were not APPH. 58 Significantly,

the MDOs stated FDA did not proceed to assess any

other part of the applications once it noted the absence

of a comparative efficacy study – i.e., FDA did not

conduct a scientific review. 59

In fact, FDA’s assessment of the PMTAs consisted

of nothing more than a literal box-checking exercise.

For each application, FDA staff completed a check-list

indicating the PMTA did not include a randomized

controlled trial, longitudinal cohort study, or other

similarly robust evidence evaluating the impact of the

manufacturer’s non-tobacco flavored ENDS on adult

switching or cigarette reduction over time compared to

a tobacco flavored ENDS. 60 As with the MDOs, these

checklists indicated FDA would only move to a “full

scientific review” if such evidence was present. 61

And that is not all. The MDOs and checklists

tracked an approach outlined by FDA in an internal

See, e.g., Bidi Dkt. 40 at FDA-BIDIVAPOR-000031-33 (MDO

example).

Id.

Id. at FDA-BIDIVAPOR-000032.

See, e.g., id. at FDA-BIDIVAPOR-000057-60 (checklist example).

Id. at FDA-BIDIVAPOR-000059.

document distributed just a month before the first

MDOs were issued. In a July 9, 2021 memo, FDA set

forth what it called a “fatal flaw” review in which

PMTAs for non-tobacco flavored products that did not

contain a comparative efficacy study would likely be

denied. 62 This “simple” review would be implemented

in lieu of a full scientific review. 63 Importantly, the

stated goal of the fatal flaw memo placed expediency

over substance by allowing FDA to “manage” the large

number of PMTAs and to “take final action on as many

applications as possible by September 10, 2021,” when

the year-long grace period for timely filed PMTAs

ended. 64 FDA kicked this process off by issuing MDOs

for 55,000 products in one fell swoop. 65 So much for the

APPH standard.

Id. at FDA-BIDIVAPOR-005226-27.

Id. at FDA-BIDIVAPOR-005227.

Id. at FDA-BIDIVAPOR-005226.

Supra note 29. In ensuing litigation over the MDOs, FDA has

argued the “fatal flaw” memo was “Superseded.” See, e.g., Bidi

Dkt. 16 at 8 (certified administrative record index). Whether true

or not, FDA clearly implemented an across-the-board, fatal flaw

approach for non-tobacco flavored products in which an MDO

would issue if a PMTA did not contain any study or other evidence

going to a comparative efficacy test. See R.J. Reynolds Vapor Co.

v. FDA, 65 F.4th 182, 193 n.9 (5th Cir. 2023) (noting the checklists

followed the fatal flaw memorandum). Along with each MDO,

FDA also issued a document titled “Technical Project Lead (TPL)

Review of PMTAs” that sought to justify the fatal flaw and

comparative efficacy approach. See FDA, Tobacco Products

Marketing Orders: FDA Sample Decision Summary Document

(Sept. 17, 2021), https://tinyurl.com/npn2x4ec. The TPLs, however,

at no point reviewed all the evidence contained in a given PMTA

aside from confirming whether a comparative efficacy analysis

was conducted. Id. at 11, 13 (stating the scope of review was

limited to confirming the absence of a comparative efficacy study).

For example, despite conceding that the efficacy of a manufac65

VI. TCA Section 910(c)(5)(B) Governing The

Use Of “Valid Scientific Evidence” Does

Not Authorize FDA To Deny A PMTA Solely

Because It Does Not Contain A Comparative

Efficacy Study

In its merits brief, FDA argues that Section 910(c)(5)(B)

authorizes it to make an APPH determination based

solely on “valid scientific evidence” that is submitted

in lieu of “well-controlled investigations” (i.e., clinical

trials). 66 FDA no doubt leans heavily on this alternative as it had repeatedly told applicants that long-term

clinical trials would likely not be necessary. 67 In doing

so, however, FDA places more weight on that provision

than it can bear. Section 910(c)(5)(B) does not authorize

FDA to reject a PMTA – and applications for over one

million products – merely because they did not contain

a single comparative efficacy study. FDA has it wrong.

First, FDA demands deferential review and, for

support, cites to Loper Bright for the proposition

that the term “appropriate” gives FDA significant

“flexibility.” 68 Yet FDA leaves out Loper Bright’s further admonition that any discretion is constrained by

“limits imposed by [the] term or phrase.” Importantly,

Loper Bright relies on Michigan v. EPA, 576 U.S. 743,

turer’s access and marketing restrictions aimed at reducing

underage use could be “critical” to an APPH determination, FDA

admitted that “for the sake of efficiency” it had “not evaluated any

marketing plans submitted with these applications.” Id. at 11

n.xix. See Bidi Vapor LLC v. FDA, 47 F.4th 1191, 1195 (11th Cir.

2022) (holding failure to consider marketing plans was arbitrary

and capricious).

FDA Br. 13, 18; see 21 U.S.C. § 387j(c)(5).

Wages Br. at 13, 41.

FDA Br. 16 (citing Loper Bright, 144 S. Ct. at 2263).

752 (2015), where the Court considered EPA’s authority

under the Clean Air Act (“CAA”) to regulate power

plants if “appropriate and necessary.” In interpreting

the meaning of “appropriate,” the Court viewed the

term in its “present context.” 69 Stated differently, a

term like “appropriate” must be read in light of any

surrounding provisions and cannot be employed by an

agency to claim implicitly delegated authority Congress

did not give.

As discussed above, Section 910(c) of the TCA makes

clear that the APPH standard is broad and that it

encompasses a range of considerations well beyond a

comparative efficacy test. In fact, this Court in Michigan

described “appropriate” in the CAA as “the classic

broad and all-encompassing term that naturally and

traditionally includes consideration of all the relevant

factors.” 70 As such, Section 910(c)(5)(B) cannot be read

as permitting FDA to automatically issue an MDO

simply because a single study on one of many relevant

factors was missing. While FDA is correct that it has

discretion (or flexibility) in weighing and balancing all

of those factors, it does not have authority to rely on

only one factor to the complete exclusion of all others.

Second, this is the “best” reading of Section 910(c)(5)(B).

That provision states “for purposes of [making a

determination under] paragraph (2)(A)” that FDA

“may authorize” that it be made based on “valid scientific

evidence” (hardly a surprising notion given the subject

Loper Bright, 144 U.S. at 2263; Michigan, 576 U.S. at 752-53

(also stating that “[s]tatutory context reinforces” a court’s

interpretation); see also Sossamon v. Texas, 563 U.S. 277, 287

(2011) (holding the “word ‘appropriate’ is inherently context

dependent”).

Id. at 752 (also noting the “capaciousness” of the term in

holding that it would include “cost” considerations).

matter). But that does not mean, as FDA argues, the

absence of a single study may, without more, also

result in an across-the-board denial of marketing

authorizations. Rather, paragraph (2)(A) provides, in

turn, that a marketing decision be based on the APPH

standard which, as we have already demonstrated,

Congress intended to encapsulate all relevant

information and data in a PMTA. In that context,

Section 910(c)(5)(B) can only mean that if a PMTA is

missing “valid scientific information” that FDA deems

relevant to evaluating an ENDS product, such absence

must still be weighed and balanced against other data

favoring a marketing granted order (e.g., evidence

showing that minors are not using a product subject to

a PMTA). Indeed, FDA’s approach would completely

read out of paragraph (2)(A) the all-encompassing

term “appropriate,” as well as the statute’s command

that a marketing decision be based on “the risks and

benefits to the population as a whole.” 71

Third, FDA never explains how Section 910(c)(5)(B)

can be better read as authorizing the agency to

completely ignore all other relevant evidence in a

PMTA. For instance, what if there is no evidence minors

are using a manufacturer’s product and the circumstances

indicate that any future underage use is unlikely (e.g.,

a PMTA submitted by a single vape shop located in a

sparsely populated area that employs strict marketing

and access restrictions, and only makes e-liquids

“to order” for known, adult customers)? Surely, under

Section 910(c)(5)(B) is also limited to “scientific” evidence. As

such, that provision cannot be interpreted to mean that Congress

somehow relied on that provision alone to implicitly give FDA

authority to completely ignore all of the non-scientific information that

Congress otherwise considered relevant to APPH, like marketing

and access restrictions.

those circumstances, the scales would tip heavily in

favor of granting market authorization, provided other

evidence showed those e-liquids are being used by the

adult customers to reduce or quit their smoking habits

and such products are less risky than combustible

cigarettes. But under the FDA’s interpretation of the

TCA, those factors would have never been considered

and, in fact, would have been rendered totally irrelevant.

FDA would have completely failed to ascertain whether

there was a “net benefit.” Accordingly, FDA’s acrossthe-board MDOs simply cannot be reconciled with

Section 910’s APPH standard.

CONCLUSION

Based on the foregoing, amici ask that this Court

affirm the judgment below.

Respectfully submitted,

ERIC P. GOTTING

Counsel of Record

AZIM CHOWDHURY

KELLER AND HECKMAN LLP

1001 G Street, N.W.

Suite 500 West

Washington, D.C. 20001

(202) 434-4100

gotting@khlaw.com

chowdhury@khlaw.com

Counsel for Amici Curiae

October 15, 2024

APPENDIX

APPENDIX TABLE OF CONTENTS

Page

APPENDIX: List of Amici Curiae .......................

APPENDIX

List of Amici Curiae

American Vape Company, LLC d/b/a Ludicrous Distro

(TX)

American Vapor Manufacturers Association (AZ)

American Vapor Group d/b/a Red Star Vapor (AZ)

Bidi Vapor, LLC (FL)

Breeze Smoke, LLC (MI)

ECIG Charleston (SC)

Flavour Art North American (Canada)

FLV USA d/b/a Flavorah (WA)

Lead by Sales, LLC d/b/a White Cloud Cigarettes (FL)

Lotus Vaping Technologies, LLC (ID)

Magellan Technology, Inc. (NY)

Matrix Minds, LLC (TX)

NicQuid, LLC (OH)

Ohio Vapor Trade Association, Inc. (OH)

Pastel Cartel, LLC (TX)

Smoke-Free Alternatives Trade Association (DC)

SS Vape Brands (FL)

Streamline Vape/MH Global (CA)

SV3, LLC (CA)

Vape Element LLC d/b/a BLVK E-Liquid (CA)

Vertigo Vapor, Inc. d/b/a Baton Vapor (WA)

White Horse Vapor (RI)

YLSN Distribution LLC d/b/a Happy Distro (AZ)

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.