Petition for Writ of Certiorari — Magellan Technology, Inc., Petitioner v. Food and Drug Administration

Supreme Court briefJan 22, 2024

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No. ______

In the

Supreme Court of the United States

MAGELLAN TECHNOLOGY, INC.,

Petitioner,

UNITED STATES FOOD AND DRUG ADMINISTRATION,

Respondent.

On Petition for Writ of Certiorari

to the United States Court of Appeals

for the Second Circuit

PETITION FOR WRIT OF CERTIORARI

ERIC N. HEYER

Counsel of Record

JOSEPH A. SMITH

JAMES C. FRASER

THOMPSON HINE LLP

1919 M Street, NW, Suite 700

Washington, DC 20036

Phone: 202.331.8800

Eric.Heyer@ThompsonHine.com

January 22, 2024

Counsel for Petitioner

Becker Gallagher · Cincinnati, OH · Washington, D.C. · 800.890.5001

QUESTION PRESENTED

This case presents a circuit split on an

important matter—whether FDA’s denial of hundreds

of thousands of marketing applications for electronic

nicotine delivery systems (also known as “ENDS” and

“e-cigarettes”), including Petitioner’s applications,

was

arbitrary

and

capricious

under

the

Administrative Procedure Act. FDA denied the

applications, all of which were for “flavored” ENDS

(i.e., ENDS flavored to taste like something other than

tobacco) solely because the applications did not

include certain types of studies showing that the

flavored ENDS are more effective than tobaccoflavored ENDS in helping cigarette smokers quit or

reduce smoking. But FDA had not previously informed

Petitioner (or the public) that such studies would be

required for marketing authorization. Moreover, for

the “sake of efficiency,” FDA ignored other evidence in

all applications for flavored ENDS—detailed plans to

limit youth exposure and access to the products—that

the agency had previously said would be “critical” for

marketing authorization. While the court below (and

some other circuits) found FDA’s actions were not

arbitrary and capricious, the Fifth Circuit (sitting en

banc) and the Eleventh Circuit have found FDA’s

actions were arbitrary and capricious.

The question presented is:

Whether FDA’s denial of Petitioner’s marketing

applications for flavored ENDS was arbitrary and

capricious where FDA based the denial solely on a

previously unannounced requirement for certain types

of studies and where FDA ignored other evidence in

the applications that FDA previously said was

“critical” for marketing authorization.

iii

CORPORATE DISCLOSURE STATEMENT

Pursuant to Supreme Court Rule 29.6, the

undersigned counsel of record certifies that Petitioner

Magellan Technology, Inc. has no parent corporation

and that no publicly held company owns 10 percent or

more of the stock of the Petitioner. There is no other

publicly held corporation or other publicly held entity

that has a direct financial interest in the outcome of

this case.

PARTIES TO THE PROCEEDINGS

Petitioner Magellan Technology, Inc. was the

sole petitioner in the court of appeals.

Respondent United States Food and Drug

Administration was the sole respondent in the court of

appeals.

RELATED PROCEEDINGS

United States Court of Appeals (2d Cir.),

Magellan Technology, Inc. v. United States Food and

Drug Administration, No. 21-2426 (judgment entered

June 16, 2023; petition for panel rehearing, or, in the

alternative, rehearing en banc, denied on August 25,

2023).

TABLE OF CONTENTS

QUESTION PRESENTED .......................................... i

CORPORATE DISCLOSURE STATEMENT ........... iii

PARTIES TO THE PROCEEDINGS ........................ iii

RELATED PROCEEDINGS ..................................... iii

TABLE OF APPENDICES ........................................ vi

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

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

OPINION BELOW ......................................................3

JURISDICTION ..........................................................3

STATUTORY PROVISIONS INVOLVED..................4

STATEMENT OF THE CASE ....................................4

FDA’s Regulatory Authority Over ENDS ........4

II.

FDA’s Instructions for PMTAs .........................6

A. FDA’s Public Meetings ................................6

B. FDA’s PMTA Guidance ...............................9

C. FDA’s Proposed PMTA Rule .....................11

III.

Magellan’s PMTAs ..........................................11

IV.

FDA’s Sub Silentio Changes to its

Requirements for Flavored ENDS Products..12

Magellan’s Marketing Denial Orders and

Technical Project Lead Report .......................15

VI.

Proceeding Below ............................................16

REASONS FOR GRANTING THE PETITION........17

The Decision Below Conflicts with

Decisions by the Fifth Circuit (Sitting En

Banc) and the Eleventh Circuit .....................17

II.

The Decision Below Conflicts with this

Court’s APA Principles Regarding Fair

Warning,

Reliance

Interests,

and

Consideration of Important Aspects of the

Relevant Problem............................................20

A. With no warning to Petitioner, FDA

adopted

comparative

efficacy

requirement for flavored ENDS ................20

B. FDA failed to consider Petitioner’s

reliance interests when it changed its

policy on the types of studies that would

be required in a PMTA ..............................23

C. FDA ignored key aspects of Petitioner’s

PMTAs, including Petitioner’s plans for

limiting youth access to its products ........25

III.

This Case Presents a Question of Great

Importance to the ENDS Industry, Former

and Transitioning Smokers Who Use

Flavored ENDS Products, and Cigarette

Smokers Who Want to Quit Smoking ............27

CONCLUSION ..........................................................29

TABLE OF APPENDICES

Appendix A

Opinion in the United States

Court of Appeals for the Second

Circuit

(June 16, 2023)......................... App. 1

Appendix B

Judgment in the United States

Court of Appeals for the Second

Circuit

(June 16, 2023)....................... App. 21

Appendix C

Order Denying Petition for

Rehearing in the United States

Court of Appeals for the Second

Circuit

(August 25, 2023) ................... App. 23

Appendix D

Mandate Judgment in the United

States Court of Appeals for the

Second Circuit

(June 16, 2023)....................... App. 25

Appendix E

Letter of Denial from the U.S.

Food and Drug Administration

(September 8, 2021) ............... App. 27

Appendix F

Technical Project Lead (TPL)

Review of PMTAs from the U.S.

Food and Drug Administration

(September 8, 2021) ............... App. 34

Appendix G

Relevant Statutory Provisions ..App. 82

5 U.S.C. § 706(2) .................... App. 82

21 U.S.C. § 387j...................... App. 82

21 U.S.C. § 387l(b) ................. App. 84

vii

TABLE OF AUTHORITIES

CASES

Bidi Vapor LLC v. FDA,

47 F.4th 1191 (11th Cir. 2022)............ 17, 18, 19, 26

Breeze Smoke, LLC v. FDA,

18 F.4th 499 (6th Cir. 2021)............................ 27, 28

Calcutt v. FDIC,

143 S. Ct. 1317 (2023) ........................................... 26

Christopher v. SmithKline Beecham Corp.,

567 U.S. 142 (2012) ......................................... 20, 21

DHS v. Regents of the Univ. of Cal.,

140 S. Ct. 1891 (2020) ..................................... 24, 25

Encino Motorcars, LLC v. Navarro,

579 U.S. 221 (2016) ............................................... 23

FCC v. Fox Television Stations, Inc.,

556 U.S. 502 (2009) ............................................... 20

Gen. Elec. Co. v. EPA,

53 F.3d 1324 (D.C. Cir. 1995) ............................... 21

Gripum, LLC v. FDA,

47 F.4th 533 (7th Cir. 2022).................................. 19

Liquid Labs LLC v. FDA,

52 F.4th 533 (3d Cir. 2022) ................................... 19

Logic Tech. Dev. LLC v. FDA,

84 F.4th 537 (3d Cir. 2023) ................................... 19

Lotus Vaping Techs., LLC v. FDA,

73 F.4th 657 (9th Cir. 2023).................................. 19

viii

Motor Vehicle Mfrs. Assn. of United States, Inc. v.

State Farm Mut. Auto. Ins. Co.,

469 U.S. 29 (1983) ................................................. 25

Prohibition Juice Co. v. FDA,

45 F.4th 8 (D.C. Cir. 2022) .................................... 19

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

65 F.4th 182 (5th Cir. 2023).................................. 23

Safari Club Int’l v. Zinke,

878 F.3d 316 (D.C. Cir. 2017) ............................... 23

Vapor Technology Ass’n v. FDA,

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

Wages & White Lion Investments, LLC v. FDA,

No. 21-60776, __ F.4th __, 2024 U.S. App.

LEXIS 133 (5th Cir. Jan. 3, 2024)

(en banc) .................... 1, 6, 17, 18, 19, 20, 24, 26, 27

STATUTES

5 U.S.C. § 551(4)-(5) .................................................. 22

5 U.S.C. § 551(6)-(7) .................................................. 22

5 U.S.C. § 553 ............................................................ 23

5 U.S.C. § 706(2) .......................................................... 3

21 U.S.C. § 387a(b) ...................................................... 5

21 U.S.C. § 387j ........................................................... 4

21 U.S.C. § 387j(b)(4)(A)-(B) ....................................... 4

21 U.S.C. § 387j(b)(5)................................................... 4

21 U.S.C. § 387j(c)(2)(A) .............................................. 4

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

21 U.S.C. § 387l(a)(1)(B) ........................................... 16

21 U.S.C. § 387l(b) ................................................. 4, 16

28 U.S.C. § 1254(1) ...................................................... 3

REGULATIONS

21 C.F.R. § 10.115(e) ................................................. 23

21 C.F.R. § 1114.7(f) .................................................. 26

81 Fed. Reg. 28973 (May 10, 2016) ......................... 5, 6

FDA, Premarket Tobacco Product Applications and

Recordkeeping Requirements, Proposed Rule, 84

Fed. Reg. 50566 (Sept. 25, 2019) .................... 11, 26

OTHER AUTHORITIES

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 ...............................28

Committee on Oversight and Accountability

Democrats Press Release, Subcommittee

Hearing Offers Insight into Future of ECigarette Regulation (June 23, 2021),

https://perma.cc/74XV-8DR7.................................12

Early Release of Selected Estimates Based on Data

from the 2022 National Health Interview Survey

(Apr. 23, 2023), https://perma.cc/D25X-2ASE ......28

FDA, Deemed Product Review: A Conversation

with the Office of Science (June 11, 2021),

https://perma.cc/Z65M-ZWMT ..............................13

FDA, Press Release, FDA Denies Marketing

Applications for About 55,000 Flavored ECigarette Products for Failing to Provide

Evidence They Appropriately Protect Public

Health (Aug. 26, 2021), https://perma.cc/8ZH8SQ7F ......................................................................15

FDA, Press Release, FDA Makes Significant

Progress in Science-Based Public Health

Application for Review, Taking Action on Over

90% of More than 6.5 Million ‘Deemed’ New

Tobacco Products Submitted (Sept. 9, 2021),

https://perma.cc/L9ZM-GFBW ..............................15

Federal Judicial Center, Reference Manual on

Scientific Evidence (3d ed. 2011) ............................9

Quida Holmes & Priscilla Callahan-Lyon,

Premarket Tobacco Product Applications

Content

Overview

(Oct.

28,

2019),

https://perma.cc/B4CF-WLXH ................................9

Iilun Murphy, Premarket Tobacco Product

Application Content Overview (Oct. 23, 2018),

https://perma.cc/2JF4-J3ZR ............................7, 8, 9

Operational Evaluation of Certain Components of

FDA’s

Tobacco

Program

(Dec.

2022),

https://perma.cc/SVP9-DMJ4................................22

INTRODUCTION

As the Fifth Circuit recently recognized in an en

banc opinion, “[o]ver several years, the Food and Drug

Administration (“FDA”) sent manufacturers of ecigarette products on a wild goose chase.” 1

Before a court-ordered deadline for applicants

to submit premarket tobacco product applications

(“PMTAs”) to keep their ENDS products on the

market, FDA set forth its expectations for PMTAs at

public meetings, in guidance documents, and in a

proposed rule. Starting approximately one year after

that deadline, FDA denied hundreds of thousands of

PMTAs for flavored ENDS, including Magellan’s

PMTAs. Moreover, “FDA has not approved a single

PMTA for a single one of the more than 1,000,000

flavored e-cigarette products submitted to the

agency.” 2

How is it that not a single applicant for a

flavored ENDS got it right? Well, after Magellan and

the other applicants submitted their PMTAs, and with

no notice to the public, FDA decided that it would

authorize the marketing of a flavored ENDS only if the

flavored ENDS is more effective than a tobaccoflavored ENDS in helping combustible cigarette

smokers quit or reduce smoking. And FDA decided

that this new standard would have to be met through

a randomized clinical trial, longitudinal cohort study,

1 Wages & White Lion Investments, LLC v. FDA, No. 21-60776, __

F.4th __, 2024 U.S. App. LEXIS 133, *1 (5th Cir. Jan. 3, 2024) (en

banc).

2 Id. at *22-23.

or some other study similarly conducted “over time,”

even though FDA had previously stated that it did

“not expect that applicants will need to conduct longterm studies to support an application.” To make

matters worse, FDA decided that it would not review

applicants’ plans to limit youth exposure and access to

their products, even though FDA had previously

stated that such plans would be “critical” for making

marketing authorization determinations.

Relying on decisions from other circuits, the

court below found that FDA did not act in an arbitrary

or capricious manner by denying Magellan’s

application based on a lack of the above-mentioned

comparative efficacy studies, and that any error in

FDA’s failure to review Magellan’s plans to limit youth

access was harmless. But the decision below conflicts

with decisions from the Fifth Circuit (sitting en banc)

and the Eleventh Circuit.

The Fifth Circuit has correctly found that

FDA’s denial of PMTAs for flavored ENDS was

arbitrary and capricious because the agency did not

give the ENDS industry fair warning that PMTAs for

flavored ENDS would need to include studies

comparing those products to tobacco-flavored ENDS,

let alone randomized controlled trials, longitudinal

cohort studies, or other similar studies conducted

“over time.” The Fifth Circuit has also correctly found

that FDA’s denial of the PMTAs was arbitrary and

capricious because the agency failed to take into

account that the industry had reasonably relied on

FDA’s previous public statements that the abovementioned studies would not be required, and that

other types of studies could adequately support

PMTAs. Both the Fifth Circuit and the Eleventh

Circuit have correctly found that FDA’s denial of

PMTAs for flavored ENDS was arbitrary and

capricious because the agency did not bother to review

the applicants’ plans for limiting youth exposure and

access, and that FDA’s failure to review the plans was

not harmless.

This Court should grant the instant petition to

resolve the circuit split on whether FDA’s denial of

PMTAs for flavored ENDS was arbitrary and

capricious under the APA.

OPINION BELOW

The Second Circuit’s opinion (App. 1) is

reported at 70 F.4th 622. The opinion upheld a

marketing denial order that FDA issued to Magellan

on September 8, 2021 (App. 27).

JURISDICTION

The judgment of the court of appeals was

entered on June 16, 2023. The court of appeals denied

Magellan’s petition for panel rehearing, or, in the

alternative, rehearing en banc, on August 25, 2023.

Justice Sotomayor extended the deadline for

petitioning for writ of certiorari to January 22, 2024.

The jurisdiction of this Court is invoked under 28

U.S.C. § 1254(1).

STATUTORY PROVISIONS INVOLVED

Pertinent statutory provisions are reproduced

in the appendix as follows:

5 U.S.C. § 706(2). App. 82.

21 U.S.C. § 387j. App. 82.

21 U.S.C. § 387l(b). App. 84.

STATEMENT OF THE CASE

FDA’s Regulatory Authority Over ENDS

Under the Federal Food, Drug, and Cosmetic

Act (“FDCA”), as amended by the Family Smoking

Prevention and Tobacco Control Act of 2009 (“TCA”),

anyone wishing to market a “new tobacco product” in

interstate commerce must file a Premarket Tobacco

Product Application with FDA establishing that the

marketing of the product “would be appropriate for the

protection of the public health.” 21 U.S.C.

§ 387j(c)(2)(A).

The FDCA requires FDA’s determination on

whether a new tobacco product is appropriate for the

protection of the public health (“APPH”) to be based on

“the risks and benefits to the population as a whole,

including users and nonusers of the tobacco product.”

21 U.S.C. § 387j(c)(4). When making that

determination, FDA must consider “the increased or

decreased likelihood that existing users of tobacco

products will stop using such products,” and “the

increased or decreased likelihood that those who do

not use tobacco products will start using such

products.” 21 U.S.C. § 387j(b)(4)(A)-(B). FDA’s APPH

determination may be based on “well-controlled

investigations,” including “clinical investigations,” as

well as “other valid scientific evidence.” 21 U.S.C.

§ 387j(b)(5).

The FDCA’s tobacco provisions originally

applied only to some traditional tobacco products (e.g.,

cigarettes). 21 U.S.C. § 387a(b). In 2016, FDA adopted

a rule extending those provisions to all tobacco

products, including electronic nicotine delivery

systems. 81 Fed. Reg. 28973 (May 10, 2016).

Unlike traditional (combustible) cigarettes,

ENDS do not contain tobacco leaf that is burned to

create smoke that the user inhales. Instead, ENDS

use an “e-liquid” containing nicotine which is heated

to create an aerosol that the user inhales. According to

FDA, “[c]urrent scientific literature demonstrates that

ENDS are generally likely to have fewer and lower

concentrations of harmful and potentially harmful

constituents (HPHCs) than combustible cigarettes,

and biomarker studies demonstrate significantly

lower exposure to HPHCs among current exclusive

ENDS users than current smokers.” App. 55-56.

Some ENDS are “flavored,” meaning that they

have a flavor other than tobacco (such as fruit), while

other ENDS are tobacco flavored. App. 45. According

to FDA, tobacco-flavored ENDS are far less popular

than flavored ENDS, not only among youth, but

among adult ENDS users as well. See id. at 45-46

(noting that only 22.3% of adult ENDS users and

13.3% of youth ENDS users use tobacco-flavored

ENDS and that the remainder of both groups use

flavored ENDS).

By the time FDA extended the FDCA’s tobacco

provisions to ENDS in 2016, millions of ENDS

products were already on the market. Rather than

immediately remove those products from the market

for lack of FDA authorization, FDA implemented an

“enforcement discretion” policy under which it would

not take action against unauthorized products that

were on the market by August 8, 2016, so long as the

manufacturer submitted a corresponding PMTA by a

certain deadline (later set at September 8, 2020) and

so long as that PMTA remained under FDA review.

See 81 Fed. Reg. at 29009-15; Vapor Technology Ass’n

v. FDA, 977 F.3d 496, 497-502 (6th Cir. 2020).

II.

FDA’s Instructions for PMTAs

Over a two-year period leading up to the

September 2020 deadline for PMTAs, FDA provided

the public with detailed instructions for the

preparation and submission of PMTAs. Those

instructions, which are discussed in more detail below,

“are important to understand why every single

[ENDS] manufacturer in the entire Nation behaved

just as [Magellan] did.” Wages, 2024 U.S. App. LEXIS

133, *7. And those instructions “are important to

explain why FDA cannot now pretend that it gave the

regulated community fair notice of the PMTA

requirements.” Id.

A. FDA’s Public Meetings

At an October 2018 public meeting, FDA stated:

“No specific studies are required for a PMTA; it may

be possible to support a marketing order for an ENDS

product without conducting new nonclinical or clinical

studies given other data sources can support the

PMTA.” Iilun Murphy, Premarket Tobacco Product

Application Content Overview, at 26 (Oct. 23, 2018),

https://perma.cc/2JF4-J3ZR.

FDA recommended that applicants “compare

the new tobacco product to a representative sample of

tobacco products on the market (i.e., either

grandfathered or with authorization)” and “[i]nclude

justification for why using evidence or data from other

products is appropriate.” Id. at 11. In the area of

human subject studies, FDA recommended including

evidence from single-point-in-time studies on

consumer perceptions and appeal of the subject

product and noted that such studies were “widely

accepted” as predictors for initiation and cessation. Id.

at 13, 16. The presentation specified that “[p]roduct

perceptions/intentions, including how consumers

(especially youth) perceive, use, or intend to use the

products is useful information to FDA.” Id. at 16.

Nowhere in the presentation did FDA suggest

that manufacturers of flavored ENDS products should

conduct a switching study comparing the rates of

reduction in use of combustible cigarettes by users of

flavored ENDS products against those of users of

tobacco-flavored ENDS products over time. 3

The only reference to switching studies stated: “Switching

studies: Participants could be directed to substitute an ecigarette with similar nicotine delivery for usual brand

cigarette.” Id. at 20. Far from prescribing a required comparator

product, FDA suggested instead that applicants provide a

“[r]ationale for selection of comparator products (e.g., e-liquid

nicotine concentrations, flavors, etc.).” Id.

In a slide titled “What is Appropriate for

Protection of Public Health?”, FDA described the

evidence it required to find that a tobacco product

meets the statutory standard for marketing

authorization as follows:

These are considerations that

FDA has used in deciding whether a

product is appropriate for the protection

of public health:

Are the levels of [harmful and

potentially harmful constituents]

and other constituents of toxic

concern in the new tobacco product

similar or lower than levels of

similar [tobacco products] or other

appropriate comparator products

currently on the US market?

Does the scientific evidence

provided in the application

support that the use of the

[tobacco product] has a lower risk

of disease for the individual than

the use of other similar or

appropriate comparator [tobacco

products] on the market?

Will the marketing of the new

[tobacco product] affect the

likelihood of nonuser uptake,

cessation

rates,

other

significant

shifts

user

demographics in a manner to

decrease morbidity and mortality

from tobacco product use?

Id. at 32.

At a similar public meeting a year later, FDA

repeated many of these points, including its

statements on switching studies and the three

“considerations” for determining whether a tobacco

product satisfies the statutory standard. Quida

Holmes & Priscilla Callahan-Lyon, Premarket

Tobacco Product Applications Content Overview, at 15,

18, 34 (Oct. 28, 2019), https://perma.cc/B4CF-WLXH.

B. FDA’s PMTA Guidance

In June 2019, FDA published a guidance on

PMTAs for ENDS products. See CA.A197 (“PMTA

Guidance”). 4 In the Guidance, FDA stated: “Given the

relatively new entrance of ENDS on the U.S.

market . . . limited data may exist from scientific

studies and analysis. Nonetheless, in general, FDA

does not expect that applicants will need to conduct

long-term studies to support an application.”

CA.A212. FDA stated that “[a]lthough randomized

clinical trials could address cessation behavior of

users of tobacco products, FDA believes this would

also be true for observational studies (perception,

actual use, or both) examining cessation behaviors.”

CA.A237. A “cross-sectional” study is one type of

observational study. See Federal Judicial Center,

Reference Manual on Scientific Evidence 560 (3d ed.

2011).

4 “CA.A” refers to the Joint Appendix filed with the court below.

The PMTA Guidance nowhere suggested that

applicants should compare flavored ENDS against

tobacco-flavored ENDS to determine whether more

smokers reduced or eliminated their combustible

cigarette use with the flavored ENDS product over

time. The section of the Guidance that speaks to

comparison studies focused on physiological health

risks associated with the compared products and

again emphasized that applicants could choose what

they believed to be appropriate comparators and

should justify their selections. CA.A211. FDA also

specifically recommended that ENDS product

manufacturers evaluate the risks of ENDS products in

relation to the risks of combustible cigarettes.

CA.A213. Similarly, the section that addressed

cessation studies did not mention comparative

cessation studies and specifically suggested that it

would be appropriate to include information from

peer-reviewed scientific journals on the likelihood of

product use by nonusers, including youth. CA.A237.

The PMTA Guidance suggested that applicants

“may propose specific restrictions on sale and

distribution that can help support a showing that

permitting the marketing of the product would be

APPH.” CA.A211. The Guidance recommended

including a detailed marketing plan “to enable FDA to

better

understand

the

potential

consumer

demographic” and “better estimate the potential

impact on public health.” CA.A238. FDA promised to

“weigh[] all of the potential benefits and risks from the

information contained in the PMTA to make an overall

determination of whether the product should be

authorized for marketing.” CA.A211.

C. FDA’s Proposed PMTA Rule

In September 2019, FDA issued a proposed rule

governing PMTAs that reiterated that FDA did “not

expect that long-term clinical studies (i.e., those

lasting approximately 6 months or longer) [would]

need to be conducted for each PMTA.” FDA, Premarket

Tobacco Product Applications and Recordkeeping

Requirements, Proposed Rule, 84 Fed. Reg. 50566,

50619 (Sept. 25, 2019). FDA confirmed that marketing

plans would be “critical to FDA’s determination of the

likelihood of changes in tobacco product use behavior”

and that the agency “will review the marketing plan

to evaluate potential youth access to, and youth

exposure to, the labeling, advertising, marketing, or

promotion of, a new tobacco product.” Id. at 50581.

Nowhere in the proposed PMTA rule did FDA

require or even recommend that applicants seeking

marketing authorization for flavored ENDS products

conduct switching studies comparing the flavored

ENDS products against tobacco-flavored ENDS

products.

III.

Magellan’s PMTAs

Magellan submitted its PMTAs to FDA by the

September 2020 deadline. In accordance with FDA’s

representations and 2019 Guidance, Magellan’s

PMTAs included, among many other things, consumer

perception and cross-sectional studies, CA.A338-340,

419-20, a systematic literature review, CA.A346, and

a detailed marketing and sales-access restriction plan

for limiting youth exposure and access to the products,

CA.A267-300.

IV.

FDA’s Sub Silentio Changes

Requirements

for

Flavored

Products

to its

ENDS

Ten months after Magellan submitted its

PMTAs, and without notice to anyone outside the

agency, in July 2021, FDA issued an internal

memorandum stating that, at the Acting

Commissioner’s urging, FDA would apply a new

“standard for evidence” for PMTAs for flavored ENDS

products. See CA.A46. This change deviated from

FDA’s original PMTA review plan and came just two

weeks after the Acting Commissioner’s testimony

before Congress, during which she encountered

substantial political pressure to deny all PMTAs for

flavored ENDS products. 5

Under the July 2021 memorandum, the Office

of Science in FDA’s Center for Tobacco Products

(“CTP”) was “tasked with developing a new plan to

effectively manage the remaining non-tobacco

flavored ENDS PMTAs” not already in substantive

scientific review to enable FDA to take “final action on

as many applications as possible by September 10,

2021.” CA.A46. Under this new “standard for

evidence,” rather than review an entire PMTA and its

contents in context, given the “large number of

applications that remain[ed] to be reviewed by

5 See Committee on Oversight and Accountability Democrats

Press Release, Subcommittee Hearing Offers Insight into Future

of E-Cigarette Regulation (June 23, 2021), https://perma.cc/74XV8DR7.

September 9, 2021,” 6 FDA would “conduct a Fatal

Flaw review . . . a simple review in which the reviewer

examines the submission to identify whether or not it

contains the necessary type of studies.” Id. FDA

decided the “fatal flaw” would be the absence of

randomized controlled trials or longitudinal cohort

studies demonstrating that an applicant’s nontobacco-flavored ENDS products provide a greater

benefit to adult smokers in terms of promoting

smoking cessation relative to tobacco-flavored ENDS

products. Id. Any application lacking this evidence

would “likely” be denied. Id.

Although FDA claims that this memorandum

was later superseded, the “fatal flaw” analysis is

substantially reflected in FDA’s internal “scientific

review” forms. In these forms, FDA described the

scope of its review as follows:

This review determines whether the subject

PMTAs contain evidence from a randomized

controlled trial, longitudinal cohort study,

and/or other evidence regarding the impact

of the new ENDS on switching or cigarette

reduction

that

could

potentially

demonstrate the benefit of their flavored

ENDS over an appropriate comparator

tobacco-flavored ENDS.

CA.A16.

6 FDA expected 6,800 product applications but received 6.5

million, exceeding its anticipated volume “by orders of

magnitude.” FDA, Deemed Product Review: A Conversation with

the Office of Science (June 11, 2021), https://perma.cc/Z65MZWMT.

On August 17, 2021, FDA issued another

internal memorandum with a subject of “PMTA

Review: Evidence to Demonstrate Benefit of Flavored

ENDS to Adult Smokers.” CA.A58. The August 17,

2021 memorandum purports to describe FDA’s

“findings with respect to the type of evidence that may

support a finding that the marketing of a flavored

ENDS is appropriate for the protection of public

health.” Id. The memorandum instructs that, based on

FDA’s “completion of numerous scientific reviews over

the last 10 months,” CA.A66, product-specific evidence

enabling a comparison between the applicant’s new

flavored ENDS product and an “appropriate

comparator” tobacco-flavored ENDS product in terms

of their impact on tobacco use behavior among adult

smokers would be required. CA.A66-67. This evidence

could be generated through either a randomized

controlled trial or a longitudinal cohort study. CA.A67.

On August 25, 2021, the day before FDA issued

its first marketing denial orders for flavored ENDS

products, two FDA officials signed a three-sentence

internal memorandum purportedly rescinding the

August 17, 2021 memorandum. CA.A73. However, as

discussed below, FDA incorporated substantial

sections of the memorandum into its subsequent

Technical Project Lead report on Magellan’s

applications and the reports for other applicants that

also received denial orders for their flavored ENDS

products.

As with the July 9, 2021 internal memorandum

before it, FDA failed to contemporaneously disclose to

applicants the conclusions it reached in its August 17,

2021 memorandum.

Magellan’s Marketing Denial Orders and

Technical Project Lead Report

On August 26, 2021, FDA revealed via a press

release that marketing of flavored ENDS products

would be authorized only if PMTAs included studies,

such as a randomized controlled trial or longitudinal

cohort study, showing that an applicant’s flavored

ENDS product was more effective at promoting

switching or cessation of combustible cigarette use

than a comparable tobacco-flavored ENDS product

over time. 7 Only two weeks later, FDA announced that

it had issued marketing denial orders for more than

946,000 flavored ENDS products. 8

On September 8, 2021, FDA issued a marketing

denial order (“MDO”) on Magellan’s PMTAs on the

ground that they did not satisfy the standard

announced in the August 26 press release. App. 27.

The MDO also noted that FDA did “not proceed to

assess other aspects of these applications,” such as

Magellan’s proposed marketing plan to limit youth

exposure and access to the products. App. 30.

In its Technical Project Lead (“TPL”) report

supporting the MDO, FDA incorporated word-for7 FDA,

Press 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://perma.cc/8ZH8-SQ7F.

FDA, Press Release, FDA Makes Significant Progress in

Science-Based Public Health Application for Review, Taking

Action on Over 90% of More than 6.5 Million ‘Deemed’ New

Tobacco

Products

Submitted

(Sept.

2021),

https://perma.cc/L9ZM-GFBW.

word much of its “rescinded” August 17, 2021

memorandum. Compare App. 34-81 with CA.A58-72.

Thus, the TPL report disclaimed any notion that crosssectional or consumer perception studies could

adequately address smoking cessation. App. 62-63. In

further contrast to its earlier representations, FDA

also concluded that “the general scientific literature,

though informative for evaluation of some types of

products, is not adequate to address this assessment

because it does not provide product-specific

information.” App. 63.

VI.

Proceeding Below

On September 24, 2021, Magellan timely

petitioned the court below for review of the MDO

pursuant to 21 U.S.C. § 387l(a)(1)(B). Circuit courts

review such petitions under the APA’s “arbitrary and

capricious” standard of review. See 21 U.S.C. § 387l(b).

Magellan argued that FDA’s denial of its

PMTAs was arbitrary and capricious because (1) FDA

never told Magellan (or the public) that the agency

would authorize a flavored ENDS product only if a

randomized controlled trial, longitudinal cohort study,

or some other study conducted “over time” showed the

product was more effective than tobacco-flavored

ENDS at getting smokers to reduce or quit smoking;

(2) FDA had failed to take into account Magellan’s

reliance interests when the agency changed its policy

on the types of studies that would be necessary to

support a PMTA; and (3) FDA failed to consider

Magellan’s detailed plans to limit youth exposure and

access to the products. The court below rejected the

first two arguments; as to the third argument, the

court found that any error in FDA’s failure to consider

Magellan’s marketing and sales-access restriction

plans was harmless. App. 1-20.

REASONS FOR GRANTING THE PETITION

The Decision Below Conflicts with

Decisions by the Fifth Circuit (Sitting En

Banc) and the Eleventh Circuit.

The Court should grant certiorari in this case

because the decision below conflicts with the decisions

of two other circuit courts: Wages & White Lion

Investments, LLC v. FDA, No. 21-60776, __ F.4th __,

2024 U.S. App. LEXIS 133 (5th Cir. Jan. 3, 2024) (en

banc) and Bidi Vapor LLC v. FDA, 47 F.4th 1191 (11th

Cir. 2022). In both cases, the circuit courts found that

FDA’s denials of PMTAs for flavored ENDS were

arbitrary and capricious.

In Wages, the Fifth Circuit found that FDA’s

denial of the PMTAs was arbitrary and capricious

because the agency had not given the ENDS industry

fair warning that PMTAs for flavored ENDS would

need to include studies comparing those products to

tobacco-flavored ENDS, let alone randomized

controlled trials, longitudinal cohort studies, or other

studies conducted “over time.” See, e.g., Wages, 2024

U.S. App. LEXIS 133, *59 (“There is not a single

sentence anywhere in the voluminous record before us

that says: ‘manufacturers should submit long-term

scientific studies on the differences between their new

flavored e-cigarette products and other [tobaccoflavored] e-cigarette products.”); id. at *47 (“The

problem of course is that FDA never gave petitioners

fair notice that they needed to conduct long-term

studies on their specific flavored products.”). 9

The Fifth Circuit also found that FDA’s denial

of the PMTAs was arbitrary and capricious because

the agency failed to take into account that the industry

had reasonably relied on FDA’s previous public

statements that the above-mentioned studies would

not be required, and that other types of studies, such

as cross-sectional studies, could support PMTAs. See

Wages, 2024 U.S. App. LEXIS 133, *60 (“[W]hen the

agency says: ‘you need not submit long-term studies’

and ‘this is general guidance,’ the regulated entity

cannot have its application denied because it did not

submit long-term studies.”); id. at *61 (stating the law

“prohibits administrative agencies from saying one

thing, pulling a surprise switcheroo, and ignoring the

reasonable reliance interests engendered by its

previous statements”); id. at *39 (“FDA ignored as

irrelevant petitioners’ cross-section studies without

any acknowledgment that the agency previously

invited them.”).

Both the Fifth Circuit and the Eleventh Circuit

found that FDA’s denials of PMTAs for flavored ENDS

were arbitrary and capricious because the agency did

not bother to review the applicants’ plans for limiting

youth exposure and access to the products. See Bidi,

47 F.4th at 1203 (“Because the marketing and salesaccess-restriction plans were relevant factors and

addressed an important aspect of the problem, it was

arbitrary and capricious for [FDA] not to consider

9 The Fifth Circuit referred to tobacco flavored ENDS as

“unflavored” ENDS.

them.”) (cleaned up); Wages, 2024 U.S. App. LEXIS

133, *67 (stating that because FDA “repeatedly

represented that the marketing plans were ‘critical’

and ‘necessary’ to a successful application,” FDA

“cannot now claim they were in fact always

meaningless”) (cleaned up). And both those courts

rejected FDA’s argument that any error in failing to

review the plans was harmless. Bidi, 47 F.4th at 1205

(“Finally, ignoring the marketing and sales access

restriction plans was not harmless error.”); Wages,

2024 U.S. App. LEXIS 133, *72 (“[W]e agree with the

entirety of the Eleventh Circuit’s analysis and its

application of [the harmless error rule].”). 10

10 In addition to the court below, four other circuits have denied

petitions for review of FDA denials of PMTAs for flavored ENDS.

See Liquid Labs LLC v. FDA, 52 F.4th 533 (3d Cir. 2022);

Gripum, LLC v. FDA, 47 F.4th 533 (7th Cir. 2022); Lotus Vaping

Techs., LLC v. FDA, 73 F.4th 657 (9th Cir. 2023); Prohibition

Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). But as the Fifth

Circuit explained, “law is not a nose-counting exercise,” and those

other circuits misread FDA’s 2019 Guidance. Wages, 2024 U.S.

App. LEXIS 133, *61; see also id. at *64 (“Neither the D.C. Circuit

nor any other court of appeals that has sided with FDA can point

to a single word in the June 2019 Guidance (or any other

guidance) that says existing data on [tobacco-flavored] ecigarette use is categorically irrelevant to the public health

benefits of flavored e-cigarettes.”). Petitioner anticipates that, in

addition to the instant petition, the Court will soon receive

additional petitions for certiorari requesting review of the Ninth

Circuit’s decision in Lotus Vaping Technologies, 73 F.4th 657, and

of a decision by the Third Circuit addressing a marketing denial

order for menthol-flavored ENDS, see Logic Tech. Dev. LLC v.

FDA, 84 F.4th 537 (3d Cir. 2023), mandate stayed pending

petition for certiorari (Jan 4, 2024). FDA’s deadline to file a

petition for certiorari in Wages has also not yet expired.

II.

The Decision Below Conflicts with this

Court’s APA Principles Regarding Fair

Warning,

Reliance

Interests,

and

Consideration of Important Aspects of the

Relevant Problem.

The Court should also grant certiorari in this

case because the decision below conflicts with this

Court’s well-settled principles regarding the fair

warning agencies must provide to regulated entities—

particularly those with reliance interests in the

agency’s previous pronouncements—and an agency’s

obligation to consider all important aspects of the

relevant problem.

With no warning to Petitioner, FDA

adopted a comparative efficacy

requirement for flavored ENDS.

An agency cannot pull the rug out from under a

regulated party by imposing new requirements

without notice after the party relied on the agency’s

prior representations. See FCC v. Fox Television

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

agency must give regulated entities “fair warning” of

what the agency expects of them. Christopher v.

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

Anything less “would result in precisely the kind of

‘unfair surprise’ against which [this Court’s] cases

have long warned.” Id. (collecting cases). Indeed, FDA

concedes that it was required to give ENDS applicants

fair warning of the agency’s expectations for PMTAs.

See Wages, 2024 U.S. App. LEXIS 133, *30-31 (“It is

common ground between the parties that the fair

notice doctrine applies.”).

FDA violated the fair warning requirement by

denying Magellan’s PMTAs on the ground that

Magellan did not satisfy FDA’s comparative efficacy

requirement for flavored ENDS—i.e., because

Magellan did not establish that its flavored ENDS had

an added benefit relative to that of tobacco-flavored

ENDS in facilitating smokers completely switching

away from or significantly reducing their smoking.

But FDA did not publicize this new comparative

efficacy requirement until after the agency began its

en masse denial of PMTAs for flavored ENDS.

The court below found that FDA acted within

its authority to adopt a comparative efficacy

requirement because the FDCA requires the agency to

evaluate whether a new tobacco product “presents less

risk than other tobacco products.” App. 19. In other

words, the lower court found that FDA reasonably

interpreted the FDCA as allowing the agency to

impose the comparative efficacy requirement.

But even if FDA’s new interpretation of the

FDCA were a reasonable one, the APA still required

FDA to give applicants “fair warning” of that

interpretation. SmithKline Beecham, 567 U.S. at 156;

see also Gen. Elec. Co. v. EPA, 53 F.3d 1324, 1329 (D.C.

Cir. 1995) (holding that fair notice requires that

regulated entities be able to identify with

“ascertainable certainty” the standards with which an

agency expects them to conform). The court below

ignored this requirement, and did not, because it could

not, point to any document or communication in which

FDA timely advised the public about the agency’s new

interpretation of the FDCA. 11 For that reason alone,

the decision below was incorrect.

FDA will argue that its actions were not

arbitrary and capricious because agencies may

interpret statutes through “adjudication.” FDA’s

argument lacks merit. FDA formulated its new

interpretation of the FDCA before it adjudicated any

PMTAs for flavored ENDS and the agency did not

apply that interpretation until it later adjudicated

PMTAs en masse by issuing marketing denial orders

for flavored products. Therefore, under the APA,

FDA’s interpretation of the FDCA was a “rule

making,” not an “adjudication.” Compare 5 U.S.C.

§ 551(4)-(5) (providing that a “rule” includes “the

whole or a part of an agency statement of general or

particular applicability and future effect designed to

implement, interpret, or prescribe law or policy” and a

“rule making” includes an “agency process for

formulating . . . a rule”) with 5 U.S.C. § 551(6)-(7)

(stating that an “order” is “the whole or part of a final

disposition . . . of an agency matter other than

11 Notably, in December 2022, an expert panel convened at the

invitation of the FDA Commissioner to evaluate the Center for

Tobacco Products criticized CTP for a lack of “adequate guidance

and transparency regarding CTP’s expectations” and a “lack of

clarity regarding review standards,” concluding that applicants

“will struggle to address the issues necessary to meet the APPH

standard unless FDA clearly articulates its expectations.” See

Operational Evaluation of Certain Components of FDA’s Tobacco

Program (Dec. 2022), https://perma.cc/SVP9-DMJ4, at 11, 18, 20.

The report found that “[a]s FDA’s plans and approaches to

tobacco regulation changed, such changes were not always

announced and communicated clearly to external stakeholders or

even to staff.” Id. at 13 (emphasis added).

rulemaking” and an “adjudication” is “the agency

process for the formulation of an order”). 12 And FDA

must give the public advanced notice of new rules –

either through notice and comment rule making (for

substantive rules) or through guidance documents (for

interpretive rules). See 5 U.S.C. § 553; 21 C.F.R.

§ 10.115(e); see also R.J. Reynolds Vapor Co. v. FDA,

65 F.4th 182, 193 (5th Cir. 2023) (concluding that

FDA’s comparative efficacy standard for flavored

ENDS “bears all the hallmarks of a substantive rule”)

(cleaned up). FDA did neither here.

B. FDA failed to consider Petitioner’s

reliance interests when it changed its

policy on the types of studies that

would be required in a PMTA.

When an agency makes a “policy change,” it

must take into account “industry reliance on the

[agency’s] prior policy,” Encino Motorcars, LLC v.

Navarro, 579 U.S. 221, 222 (2016), and it “must

consider the alternatives that are within the ambit of

FDA purported to rescind its August 17, 2021 internal

memorandum, but applied its new interpretation of the FDCA set

forth therein when it adjudicated Magellan’s PMTAs, as the

nearly identical content of the TPL report illustrates. Compare

App. 34-81 with CA.A58-72. Because FDA applied the same

interpretation to deny Magellan’s PMTA, the “rescission” of the

memorandum does not change the fact that the agency’s new

interpretation set forth in that memorandum was a “rule.” See

Safari Club Int’l v. Zinke, 878 F.3d 316, 332 (D.C. Cir. 2017) (“An

agency cannot escape the requirements of § 553 by labeling its

rule an ‘adjudication.’”).

existing policy,” DHS v. Regents of the Univ. of Cal.,

140 S. Ct. 1891, 1913 (2020) (cleaned up).

Here, FDA not only adopted a comparative

efficacy requirement for flavored ENDS, the agency

also “flip-flopped” on the types of studies that it

required for PMTAs. Wages, 2024 U.S. App. LEXIS

133, *38. Prior to the submission deadline, FDA

repeatedly said that applicants would not need to

conduct long-term studies to support an application.

See, e.g., CA.A212. And, prior to the submission

deadline, FDA stated that single-point-in-time

studies, such as observational studies (which include

cross-sectional surveys) and consumer perception

studies, could provide relevant data on initiation and

cessation of tobacco product use. CA.A237.

But after the submission deadline, without

notice to applicants, FDA decided that PMTAs for

flavored ENDS would need a randomized controlled

trial, longitudinal cohort study, or “other” study

showing use of the product “over time.” App. 61-62.

And after the submission deadline—and also without

notice—FDA decided that cross-sectional surveys and

consumer perception studies would be insufficient to

support marketing authorization. App. 62-63.

Relying on FDA’s pre-submission deadline

statements, Magellan did not conduct any long-term

studies, and instead submitted, among other things,

cross-sectional survey data and consumer perception

data regarding its products. Even though FDA should

have been aware that applicants like Magellan relied

on FDA’s previous representations regarding study

requirements, FDA did not consider such reliance, let

alone potential alternatives to simply denying PMTAs

for lacking the newly required studies, such as

announcing the new study requirements and allowing

applicants a reasonable time to conduct new studies

and amend their applications accordingly. FDA’s

failures render its denial of Magellan’s PMTAs

arbitrary and capricious. Regents, 140 S. Ct. at 1913. 13

C. FDA ignored key aspects of Petitioner’s

PMTAs, including Petitioner’s plans for

limiting youth access to its products.

Agency action is arbitrary and capricious if the

agency fails to “examine the relevant data and

articulate a satisfactory explanation for its action,”

including when the agency “entirely fails to consider

an important aspect of the problem.” Motor Vehicle

Mfrs. Assn. of United States, Inc. v. State Farm Mut.

Auto. Ins. Co., 469 U.S. 29, 43 (1983). Here, FDA failed

to examine the relevant information in Magellan’s

applications, including Magellan’s detailed plans to

limit youth exposure and access to its products.

FDA concedes that it did not bother to evaluate

Magellan’s marketing and sales-access restriction

plans for the “sake of efficiency.” App. 59 n.xix.

13 In denying Magellan’s petition for review, the lower court noted

that FDA did review Magellan’s cross-sectional and consumer

perception studies and found them “insufficient.” App. 15-16.

Because FDA reviewed the studies, the court below reasoned that

FDA did not really impose a new requirement. Id. But the court

failed to recognize that FDA had already decided that all crosssectional and consumer perception studies, not just Magellan’s

studies, are inadequate to support a PMTA for a flavored ENDS

product. App. 62-63.

Magellan’s plans were designed to ensure that the

company’s products are attractive and available only

to adults and not to youth. That FDA did not bother to

evaluate those plans is striking because FDA requires

applicants to include such plans in their PMTAs, see

21 C.F.R. § 1114.7(f), and the agency has repeatedly

described the plans as “critical” and said that it will

review such plans when evaluating PMTAs, see, e.g.,

84 Fed. Reg. at 50581.

The court below found that any error in failing

to consider the plans was harmless because Magellan

did not prove that those plans would have convinced

FDA to authorize marketing of Magellan’s products.

But the lower court’s finding of harmless error

conflicts with this Court’s opinion in Calcutt v. FDIC,

143 S. Ct. 1317 (2023) (per curiam). As this Court

recognized in Calcutt, it is “well established” that “if

the agency has not considered all of the relevant

factors, the proper course, except in rare

circumstances, is to remand to the agency for

additional explanation or investigation.” Id. at 1320

(cleaned up). Such “rare circumstances” do not include

cases, such as this one, where an agency applies its

discretion

“highly

fact-specific”

product

applications. Wages, 2024 U.S. App. LEXIS 133, *71

(rejecting FDA’s harmless error argument because

“[t]his case is controlled by Calcutt”); see also Bidi, 47

F.4th at 1205 (rejecting FDA’s harmless error

argument).

III.

This Case Presents a Question of Great

Importance to the ENDS Industry, Former

and Transitioning Smokers Who Use

Flavored ENDS Products, and Cigarette

Smokers Who Want to Quit Smoking.

It is not every day that FDA seeks to remove an

entire class of products from the market. But that is

exactly what FDA is attempting to do with respect to

flavored ENDS. FDA has denied PMTAs for hundreds

of thousands of flavored ENDS, and it has not

authorized the marketing of a single flavored ENDS

product. Wages, 2024 U.S. App. LEXIS 133, *21. In

other words, FDA has implemented a “de facto ban on

flavored e-cigarettes.” Id. at *56 n.5. This de facto ban

is not only devastating to the ENDS industry; it also

poses a real risk to former and transitioning cigarette

smokers who use flavored ENDS products, as well as

current cigarette smokers who want to quit smoking.

For at least four reasons, removing all flavored

ENDS products from the market harms the interests

of former cigarette smokers who have successfully

used flavored ENDS products to quit, transitioning

cigarette smokers who use those products now, and

current cigarette smokers who want to quit smoking.

First, FDA has stated that, because they do not

involve combustion, “ENDS are generally likely to

have fewer and lower concentrations of harmful and

potentially harmful constituents (HPHCs) than

combustible cigarettes, and biomarker studies

demonstrate significantly lower exposure to HPHCs

among current exclusive ENDS users than current

smokers.” App. 55-56; see also Breeze Smoke, LLC v.

FDA, 18 F.4th 499, 505 (6th Cir. 2021) (noting FDA’s

acknowledgment “that ENDS products may provide a

beneficial alternative to combustible cigarettes

because they deliver nicotine without also bombarding

the user’s lungs with the toxins found in cigarettes”).

Second, nearly six percent of adults in the

United States currently use ENDS products, whereas

over eleven percent of adults in the United States

currently smoke cigarettes. See Early Release of

Selected Estimates Based on Data from the 2022

National Health Interview Survey (Apr. 23, 2023). 14

Third, an overwhelming majority of adult

ENDS users use flavored ENDS. App. 45-46 (FDA

stating that approximately 77% of adult ENDS users

use flavored ENDS); CA.A98 (FDA stating that “the

majority of adult [ENDS] users use [flavored ENDS]”).

Fourth,

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 adverse

health

impacts

from

smoking

combustible

cigarettes. 15

In short, even though millions of adults who use

ENDS as a less harmful alternative to cigarettes

strongly prefer flavored ENDS, FDA is taking that

14 https://perma.cc/D25X-2ASE.

15 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.

option away from them. That fact alone warrants this

Court’s review.

CONCLUSION

For the forgoing reasons, this Court should

grant the petition for certiorari.

Respectfully submitted,

ERIC N. HEYER

Counsel of Record

JOSEPH A. SMITH

JAMES C. FRASER

THOMPSON HINE LLP

1919 M Street, NW, Suite 700

Washington, DC 20036

202.331.8800

Eric.Heyer@ThompsonHine.com

Counsel for Petitioner

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.