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

No. 23-1038

In the

Supreme Court of the United States

FOOD AND DRUG ADMINISTRATION,

Petitioner,

v.

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

TRITON DISTRIBUTION, ET AL.,

Respondents.

On Petition for Writ of Certiorari to the

United States Court of Appeals

for the Fifth Circuit

BRIEF IN OPPOSITION

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

May 17, 2024

Counsel for Respondents

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

i

QUESTION PRESENTED

Respondents make bottled “e-liquids”—a liquid

that contains nicotine used in electronic nicotine

delivery systems (“ENDS”). Respondents flavor their

e-liquids to taste like fruit or sweets; and they began

selling their e-liquids years before FDA adopted a rule

giving itself regulatory authority over ENDS products.

By a court-ordered deadline, Respondents (and

hundreds of other companies) filed applications with

FDA so they could keep their products on the market.

But while those applications were pending, and with

no notice to applicants, FDA decided it (1) would not

grant marketing authorization for a flavored ENDS

product unless the application established via a

product-specific longitudinal comparative efficacy

study that the product was more effective than

tobacco-flavored ENDS products in helping adult

smokers quit smoking; and (2) would not bother to

review applicants’ proposed plans to keep their

products out of kids’ hands even though FDA had told

applicants those plans were “critical” to the

applications. Based on those decisions, FDA later

denied Respondents’ applications. But the en banc

Fifth Circuit found FDA’s denials arbitrary and

capricious because FDA (1) changed its position on the

authorization requirements without fair notice to

Respondents and without considering Respondents’

reliance interests, and (2) committed prejudicial error

by refusing to consider Respondents’ plans to prevent

underage access and use.

The question presented is:

Whether FDA’s denial of Respondents’

marketing applications was arbitrary and capricious

ii

where FDA changed its position on the authorization

requirements without fair notice to Respondents and

without considering Respondents’ reliance interests

and where FDA ignored other aspects of the

applications the agency previously described as

“critical.”

iii

CORPORATE DISCLOSURE STATEMENT

Pursuant to Supreme Court Rule 29.6, the

undersigned counsel of record certifies that neither

Respondents Wages and White Lion Investments,

L.L.C. (d/b/a Triton Distribution) nor Vapetasia,

L.L.C. has a parent corporation and no publicly held

company owns 10 percent or more of the stock of either

Respondent. 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 (respondent below) is the Food and

Drug Administration. Respondents (petitioners below)

are Wages and White Lion Investments, L.L.C. (d/b/a

Triton Distribution), and Vapetasia, L.L.C.

RELATED PROCEEDINGS

United States Court of Appeals (5th Cir.):

Wages & White Lion Investments, L.L.C. v. FDA,

No. 21-60766 (Jan. 3, 2024)

Wages & White Lion Investments, L.L.C. v. FDA,

No. 21-60800 (Jan. 3, 2024)

iv

TABLE OF CONTENTS

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

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

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

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

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

STATEMENT ..............................................................1

A.

Statutory Background............................1

B.

Electronic Nicotine Delivery Systems

(“ENDS”) .................................................2

1. Cartridge-Based ENDS ......................4

2. Disposable ENDS ...............................5

3. Open System ENDS ...........................5

C.

The Shifting Deadline for Submitting

ENDS Premarket Applications .............7

D.

FDA’s 2019 Proposed PMTA Rule .......11

E.

FDA’s 2020 Enforcement Guidance ....12

F.

FDA’s Receipt of Applications for

Millions of Flavored ENDS ..................14

G.

FDA’s August 17, 2021 Internal

Decision Regarding Requirements

for PMTAs for Flavored ENDS ............15

H.

FDA’s Denial of Respondents’

PMTAs ..................................................18

I.

Proceedings Below ...............................20

REASONS FOR DENYING THE PETITION ..........22

v

A.

The Decision Below is Correct .............22

1. FDA changed its position on the

authorization requirements for

ENDS

without

giving

Respondents fair notice and

without considering Respondents’

reliance interests ............................22

2. FDA committed prejudicial error

when it ignored Respondents’

marketing and sales access

restriction plans ..............................26

B.

This Court Has Other Vehicles to

Resolve the Circuit Splits on These

Issues ....................................................29

CONCLUSION ..........................................................30

vi

TABLE OF AUTHORITIES

Cases

American Academy of Pediatrics v. FDA,

399 F. Supp. 3d 479 (D. Md. 2019) ........................ 10

Bidi Vapor LLC v. FDA,

47 F.4th 1191 (11th Cir. 2022)..................... 3, 27, 29

Christopher v. SmithKline Beecham Corp.,

567 U.S. 142 (2012) ................................................ 22

Ewing v. Mytinger & Casselberry,

339 U.S. 594 (1950) ................................................ 11

FCC v. Fox TV Stations, Inc.,

556 U.S. 502 (2000) ................................................ 22

Gripum, LLC v. FDA,

47 F.4th 553 (7th Cir. 2022)................................... 30

Heckler v. Chaney,

470 U.S. 821 (1985) ................................................ 11

Liquid Labs LLC v. FDA,

52 F.4th 533 (3d Cir. 2002) .................................... 30

Lotus Vaping Techs., LLC v. FDA, petition for cert.

pending, No. 23-871 (filed Feb. 9, 2024) ................ 30

Magellan Tech., Inc. v. FDA, petition for cert.

pending, No. 23-799 (filed Jan. 22, 2024) .............. 30

Nat’l Ass’n of Home Builders v. U.S. Army Corp of

Eng’rs, 417 F.3d 1272 (D.C. Cir. 2005) .................. 24

Pereira v. Sessions,

585 U.S. 198 (2018) ................................................ 29

Prohibition Juice Co. v. FDA,

45 F.4th 8 (D.C. Cir. 2022) ..................................... 30

vii

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

65 F.4th 182 (5th Cir. 2023)................................... 20

Safari Club Int’l v. Zinke,

878 F.3d 316 (D.C. Cir. 2017) ................................ 24

St. Vincent Randolph Hosp., Inc. v. Price,

869 F.3d 510 (7th Cir. 2017) .................................. 27

Statutes

5 U.S.C. § 551(4) .................................................. 18, 23

5 U.S.C. § 553 ............................................................ 22

5 U.S.C. § 553(b)(4)(A) ............................................... 24

21 U.S.C. § 321(rr)(1) (2010) ....................................... 2

21 U.S.C. § 321(rr)(1) (2022) ....................................... 2

21 U.S.C. § 331(a) ........................................................ 8

21 U.S.C. § 331(a)(1) .................................................... 8

21 U.S.C. § 333(f)(9)(A) ............................................... 8

21 U.S.C. § 355(d) ........................................................ 9

21 U.S.C. § 371(h)(1)(C) ............................................ 24

21 U.S.C. § 387a(b) .................................................. 1, 2

21 U.S.C. § 387b(6)(A) ................................................. 7

21 U.S.C. § 387e(j) ....................................................... 2

21 U.S.C. § 387g(d)(3)(A) ............................................. 1

21 U.S.C. § 387j ....................................................... 2, 7

21 U.S.C. § 387j(a)(2)................................................... 2

21 U.S.C. § 387j(c)(1)(B) ............................................ 20

21 U.S.C. § 387j(c)(2)(A) .............................................. 8

viii

21 U.S.C. § 387j(c)(4) ................................................... 9

Family Smoking Prevention and Tobacco Control Act

of 2009, 123 Stat. 1776 ............................................. 1

Regulations

1 C.F.R. § 18.12.......................................................... 23

21 C.F.R. Ch. I, Subch. D., Pt. 314 ............................. 9

21 C.F.R. § 10.115, et seq. .......................................... 24

21 C.F.R. § 10.115(d)(1) ............................................... 9

21 C.F.R. § 17.2............................................................ 8

21 C.F.R. § 1100.1........................................................ 2

21 C.F.R. § 1114.31.................................................... 20

45 C.F.R. § 102.3.......................................................... 8

Deeming Tobacco Products To Be Subject to the

Federal Food, Drug, and Cosmetic Act, as

Amended by the Family Smoking Prevention and

Tobacco Control Act; Restrictions on the Sale

and Distribution of Tobacco Products and

Required Warning Statements for Tobacco

Products, 81 Fed. Reg. 28,974 (May 10, 2016) .... 2, 8

Premarket Tobacco Product Applications and

Recordkeeping Requirements, 84 Fed. Reg.

50,566 (Sept. 25, 2019). .......................................... 11

Other Authorities

C. Berg, et al., Vape Shop Owners/Managers’

Opinions About FDA Regulation of E-Cigarettes,

23 Nicotine and Tobacco Research 535 (2021) .... 6, 7

ix

CDC Visual Dictionary for E-Cigarettes and

Vaping Products,

https://www.cdc.gov/tobacco/basic_information/

e-cigarettes/pdfs/ecigarette-or-vaping-productsvisual-dictionary-508.pdf ......................................... 4

K. Cullen, et al., E-Cigarette Use Among Youth in

the United States, 2019, 322 JAMA 2095 (2019) .. 13

FDA Draft Guidance, Premarket Tobacco Product

Applications for Electronic Nicotine Delivery

Systems (May 2016).................................................. 9

FDA Guidance, Enforcement Priorities for

Electronic Nicotine Delivery Systems (ENDS)

and Other Deemed Products on the Market

Without Premarket Authorization

(Jan. 2020) ...................................... 12, 13, 14, 15, 28

FDA Guidance, Extension of Certain Tobacco

Product Compliance Deadlines Related to the

Final Deeming Rule (August 2017) ....................... 10

FDA Guidance, Premarket Tobacco Product

Applications for Electronic Nicotine Delivery

Systems (June 2019) ................................... 10, 17, 24

FDA Press 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) ....................... 14

FDA Searchable Products Database,

https://www.accessdata.fda.gov/scripts/searchto

bacco/......................................................................... 2

FDA, Technical Project Lead (TPL) Review of

PMTAs (May 12, 2022) ............................................. 3

x

A. Gentzke et al., Tobacco Product Use Among

Middle and High School Students – United

States, 2020, 69 Morbidity and Mortality Weekly

Report 1881 (Dec. 18, 2020) ................................... 28

FDA, E-Cigarettes, Vapes, and Other Electronic

Nicotine

Delivery

Systems,

https://www.fda.gov/tobacco-products/productsingredients-components/e-cigarettes-vapes-andother-electronic-nicotine-delivery-systems-ends..... 5

FDA Press Release, FDA Denies Marketing

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

Evidence They Appropriately Protect Public

Health (August 26, 2021) ....................................... 18

Park-Lee, et al., E-Cigarette Use Among Middle

and High School Students—National Youth

Tobacco Survey, United States, 2021, 70

Morbidity and Mortality Weekly Report 1387

(Oct. 1, 2021) .......................................................... 28

1

STATEMENT

A. Statutory Background

The Family Smoking Prevention and Tobacco

Control Act of 2009 (“Act”) gave FDA regulatory

authority over “cigarettes, cigarette tobacco, roll-yourown tobacco, and smokeless tobacco.” 21 U.S.C.

§ 387a(b). Congress granted this authority to FDA

because those products “cause cancer, heart disease,

and other serious adverse health effects.” § 2(2), 123

Stat. 1776, 1777.

Indeed, Congress found that the use of such

products “is the foremost preventable cause of

premature death in America,” that it “causes over

400,000 deaths in the United States each year,” and

that “approximately 8,600,000 Americans have

chronic illness relating to smoking.” § 2(13), 123 Stat.

1776, 1777. Congress also found that a 50 precent

“reduction in youth smoking” would save “over

3,000,000” minors “from premature death due to

tobacco-related disease” and “would result in

approximately

$75,000,000,000

in

savings

attributable to reduced health care costs.” Ibid. And

Congress found that “[b]ecause the only known safe

alternative to smoking is cessation, interventions

should target all smokers to help them quit

completely.” § 2(34), 123 Stat. 1776, 1779.

All that said, the Act prohibits FDA from

“banning all cigarettes.” 21 U.S.C. § 387g(d)(3)(A). In

fact, cigarette manufacturers can market “new”

cigarettes—defined as cigarettes that were not

commercially marketed in the United States as of

February 15, 2007—if the manufacturer can

2

demonstrate to FDA that the new cigarette is

“substantially equivalent to” one marketed in the

United States before that date. 21 U.S.C. § 387j(a)(2);

21 U.S.C. § 387e(j). FDA has authorized the marketing

of hundreds of new cigarettes through the issuance of

“substantially equivalent” orders. 1

B. Electronic Nicotine Delivery Systems

(“ENDS”)

The Act also authorizes FDA to issue rules that

“deem” other “tobacco products” to “be subject to [the

Act].” 21 U.S.C. § 387a(b). 2 In 2016, FDA finalized a

rule that deemed electronic nicotine delivery systems

(“ENDS”)—also referred to as “electronic cigarettes”—

to be subject to the Act. 3

Unlike combustible cigarettes (i.e., traditional

cigarettes), ENDS do not contain tobacco leaf that is

burned to create smoke that the user inhales. Instead,

See FDA Searchable Products Database, available at

https://www.accessdata.fda.gov/scripts/searchtobacco/

(last

accessed on May 11, 2024).

1

2 The Act defined a “tobacco product” as “any product made or

derived from tobacco that is intended for human consumption,

including any component, part, or accessory of a tobacco product.”

21 U.S.C. § 321(rr)(1) (2010). Nicotine is derived from tobacco.

Congress later expanded the definition to include products

“containing nicotine derived from any source.” 21 U.S.C.

§ 321(rr)(1) (2022).

See Deeming Tobacco Products To Be Subject to the Federal

Food, Drug, and Cosmetic Act, as Amended by the Family

Smoking Prevention and Tobacco Control Act; Restrictions on the

Sale and Distribution of Tobacco Products and Required Warning

Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10,

2016); see also 21 C.F.R. § 1100.1.

3

3

ENDS use an “e-liquid” that usually contains nicotine

and other ingredients. The liquid is heated to create

an aerosol that the user inhales.

According to FDA, “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.” Pet. App. 251a-252a. And according to FDA,

“the currently available evidence indicates that

smokers who switch completely to ENDS will have

reduced toxic exposures and this likely leads to less

risk of tobacco-related diseases.” FDA, Technical

Project Lead (TPL) Review of PMTAs at 6 (May 12,

2022). 4

As a general matter, there are three categories

of ENDS: (1) cartridge-based ENDS, (2) disposable

ENDS, and (3) “open system” ENDS. Cartridge-based

and disposable ENDS are referred to as “closed”

systems and “tend to be smaller” and easier to use

than open system ENDS. See Bidi Vapor LLC v. FDA,

47 F.4th 1191, 1196 (11th Cir. 2022).

This case deals with Respondents’ bottled eliquids, which are sold for use in open system ENDS.

Although this case does not deal with cartridge-based

or disposable ENDS, the differences between the three

categories of ENDS are important when determining

4 FDA cites this document at page 5 of its Petition.

The document

is available at

https://www.fda.gov/media/165236/download?attachment (last

accessed May 11, 2024).

4

whether FDA’s denials of Respondents’ product

applications were arbitrary and capricious.

1. Cartridge-Based ENDS

Cartridge-based ENDS use a replaceable

cartridge (also called a “pod”) filled with e-liquid. Once

all the e-liquid in a cartridge is used, the user can

replace the empty cartridge with a new, pre-filled

cartridge. JUUL is perhaps the most well-known

cartridge-based ENDS.

The photo below, which is taken from the CDC’s

Visual Dictionary for E-Cigarettes and Vaping

Products, shows a cartridge-based ENDS on the left,

four cartridges, and a USB charger for the product on

the right. 5

FDA says that cartridge-based products have

“design features” that make them “popular with young

people,” such as “pre-filled cartridges or pods,” and “a

relatively small size that allows for easy

concealability” in “the palm of one’s hand or in a

pocket.” C.A. App. A199. According to FDA, this

The

CDC

Visual

Dictionary

is

available

at

https://www.cdc.gov/tobacco/basic_information/ecigarettes/pdfs/ecigarette-or-vaping-products-visual-dictionary508.pdf (last accessed May 5, 2024).

5

5

concealability “may allow youth to use” cartridgebased ENDS “in circumstances where use of tobacco

products is prohibited, such as at school.” Ibid. 6

2. Disposable ENDS

Disposable ENDS come pre-filled with e-liquid

and are intended to be thrown away once that e-liquid

is used up. In other words, the user does not replenish

the e-liquid once the disposable ENDS is empty.

Disposable ENDS are generally similar in size to

cartridge-based ENDS. The photo below, which is

taken from FDA’s website, shows two examples of

disposable ENDS. 7

3. Open System ENDS

Open system ENDS do not come pre-filled with

e-liquid and do not use pre-filled cartridges or pods of

6 Starting in or around 2019, several public school districts sued

JUUL on the theory that JUUL products created a “youth ecigarette crisis” in their schools. See In re JUUL Labs, Inc.,

Mktg., Sales Practices, & Prods. Liab. Litig., 497 F. Supp. 3d 552,

577-78 (N.D. Cal. 2020).

7 The relevant FDA website page is https://www.fda.gov/tobacco-

products/products-ingredients-components/e-cigarettes-vapesand-other-electronic-nicotine-delivery-systems-ends

(last

accessed May 5, 2024).

6

e-liquid. Instead, the products have an open tank.

Users of open system ENDS purchase bottles of eliquid, typically manufactured by a different company

than the one who manufactured the open system

ENDS, and then fill the tank with that e-liquid. The

photo on the left below, which is taken from the CDC’s

Visual Dictionary, shows two examples of open system

ENDS; the photo on the right shows an example of one

of the bottled e-liquids at issue in this case.

Unlike cartridge-based and disposable ENDS—

which are sold in convenience stores—open system

ENDS and bottled e-liquids are sold primarily in “vape

shops.”

See C. Berg, et al., Vape Shop

Owners/Managers’ Opinions About FDA Regulation

of E-Cigarettes, 23 Nicotine and Tobacco Research

7

535, 536 (2021). 8 Vape shops “are tobacco specialty

stores that predominately sell vaping devices and

nicotine e-liquids but not conventional tobacco

products.” Id. at 536.

A “substantial proportion of vape shops are

small businesses or single-store owners.” Id. at 53637. And “many people working in the vape shop

industry are former smokers who used vaping to quit

smoking traditional cigarettes or reduce harm, believe

that their products are effective for these purposes and

are largely safe, and want to help their consumers.”

Id. at 537.

C. The Shifting Deadline for Submitting

ENDS Premarket Applications

When FDA “deemed” ENDS to be tobacco

products in 2016, there were already millions of ENDS

on the market in the United States (including

Respondents’ products). Those products immediately

became subject to the Act’s premarket authorization

requirement. See 21 U.S.C. § 387j. And because those

products did not have premarket authorization, they

were immediately “deemed to be adulterated” under

the Act. 21 U.S.C. § 387b(6)(A).

Persons who sell adulterated tobacco products

in interstate commerce are subject to civil money

penalties of up to $20,678 for each violation, not to

exceed $1,378,541 for all violations adjudicated in a

8 Available at

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885784/

(last

accessed May 5, 2023). The Berg article is based on research

conducted in 2018 and funded by, among other organizations, the

National Cancer Institute. See Berg at 537, 541.

8

single proceeding (such proceedings are conducted by

an ALJ, not an Article III judge). 9 They are also

subject to criminal prosecution that can result in up to

one year in prison and/or a fine of up to $1,000. See 21

U.S.C. §§ 331(a), 333(a)(1).

When FDA finalized its “deeming” rule in 2016,

it also announced a “compliance policy” under which

the agency would not initiate enforcement actions

against ENDS products that were on the market as of

August 8, 2016, so long as the manufacturer

submitted a premarket tobacco product application

(“PMTA”) by August 8, 2018. See 81 Fed. Reg. 28,974,

29,011. The compliance policy also provided that if a

manufacturer submitted a timely PMTA for an ENDS,

the agency would not initiate an enforcement action

against the product for one year after the PMTA was

submitted. Ibid. In short, under FDA’s compliance

policy, manufacturers marketing an ENDS product by

August 2016 could expect to be able to keep that

ENDS on the market without FDA authorization for

up to three years (up until August 2019) so long as

they submitted a timely PMTA.

A lengthy compliance policy period made sense.

After all, even though Congress established a

statutory standard for premarket authorization of

tobacco products, see 21 U.S.C. § 387j(c)(2)(A) (the

“appropriate for the protection of the public health”

standard), 10 FDA had not even proposed, let alone

9 See 21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3.

10 The statutory standard requires a PMTA applicant to show,

among other things, “that permitting such tobacco product to be

marketed would be appropriate for the protection of the public

health” (“APPH”). 21 U.S.C. § 387j(c)(2)(A). The APPH

9

finalized,

regulations

11

applications.

for

tobacco

product

Rather than immediately issue proposed

regulations for PMTAs for ENDS, FDA issued a draft

guidance document. See FDA Draft Guidance,

Premarket Tobacco Product Applications for

Electronic Nicotine Delivery Systems (May 2016). But

even finalized FDA guidance documents do not have

the force of law. See 21 C.F.R. § 10.115(d)(1)

(“Guidance documents do not establish legally

enforceable rights or responsibilities. They do not

legally bind the public or FDA.”). And in any event, the

draft guidance nowhere suggested that PMTAs for

flavored ENDS products would have to include

evidence that the product is better than a comparator

tobacco-flavored ENDS product in helping smokers

reduce or quit smoking, much less that such evidence

would have to take the form of a product-specific

longitudinal study.

In January 2017, a new presidential

administration took over. A few months later, FDA

determination is 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 APPH

determinations, 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(c)(4)(A)-(B).

FDA always adopts corresponding product application

regulations when Congress sets forth a statutory standard for a

product approval. See, e.g., 21 U.S.C. § 355(d) (approval standard

for new drugs); 21 C.F.R. Ch. I, Subch. D., Pt. 314 (regulations

regarding applications to market new drugs).

11

10

extended the compliance policy deadline for

submission of PMTAs for ENDS until August 2022,

and stated that ENDS with timely filed PMTAs could

remain on the market unless and until FDA took a

negative action on the PMTA. See FDA Guidance,

Extension of Certain Tobacco Product Compliance

Deadlines Related to the Final Deeming Rule (August

2017).

In June 2019, FDA finalized its guidance

document on PMTAs for ENDS (the “2019 PMTA

Guidance”). C.A. App. A284. 12 Like the 2016 draft

version, the 2019 PMTA Guidance did not suggest that

PMTAs for flavored ENDS would have to include

evidence that the product is better than a comparator

tobacco-flavored ENDS in helping smokers reduce or

quit smoking over time. But the 2019 PMTA Guidance

did say “FDA does not expect that applicants will need

to conduct long-term studies to support an

application.” C.A. App. A317.

One month after FDA issued the 2019 PMTA

Guidance, a district court ordered FDA to accelerate

the PMTA deadline from August 2022 to May 2020,

and the court ordered that products with timely-filed

PMTAs could remain on the market without being

subject to an FDA enforcement action for a period not

to exceed one year after the PMTA deadline while the

agency considered the applications. See American

Academy of Pediatrics v. FDA, 399 F. Supp. 3d 479,

487 (D. Md. 2019). The court later extended the PMTA

12 FDA Guidance, Premarket Tobacco Product Applications for

Electronic Nicotine Delivery Systems (June 2019).

11

deadline to September 2020 due to the Covid-19

pandemic. 13

D. FDA’s 2019 Proposed PMTA Rule

In September 2019, FDA proposed a rule for

PMTAs. See Premarket Tobacco Product Applications

and Recordkeeping Requirements, 84 Fed. Reg. 50,566

(Sept. 25, 2019). The proposed rule gave no hint that

applicants for flavored ENDS would have to establish

that their products have an added benefit relative to

tobacco-flavored ENDS in helping smokers completely

switch away from or significantly reduce their

smoking. But the proposed rule said that the agency

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.” Id. at

50,619. And the proposed rule said that applicants’

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

13 The district court did not explain what it would have done had

FDA not enforced the court’s PMTA deadline or had FDA

extended its enforcement discretion policy beyond one year after

the deadline. It is doubtful that the district court could have done

anything if either of those situations occurred. FDA does not have

the authority to unilaterally bring an enforcement action against

someone who is violating the Federal Food, Drug, and Cosmetic

Act (by, for example, selling an unauthorized tobacco product).

Like most federal agencies, FDA can only request that the

Attorney General initiate an enforcement action. See Ewing v.

Mytinger & Casselberry, 339 U.S. 594, 599 (1950). And this Court

has never held that the Judicial Branch can order the Executive

Branch to bring an enforcement action. See Heckler v. Chaney,

470 U.S. 821 (1985).

12

to, and youth exposure to, the labeling, advertising,

marketing, or promotion of, a new product.” Id. at

50,581.

E. FDA’s 2020 Enforcement Guidance

In January 2020, less than 10 months before

the September 2020 deadline for Respondents and

others to submit their PMTAs for bottled e-liquids,

FDA published a guidance document describing how

the agency “intend[ed] to prioritize [its] enforcement

resources with regard to the marketing of certain

[ENDS] that do not have premarket authorization.”

See FDA Guidance, Enforcement Priorities for

Electronic Nicotine Delivery Systems (ENDS) and

Other Deemed Products on the Market Without

Premarket Authorization at 2 (Jan. 2020) (“2020

Enforcement Guidance”). 14 According to the 2020

Enforcement Guidance, FDA’s top enforcement

priority was “[f]lavored, cartridge-based ENDS

products (other than tobacco- or menthol-flavored

ENDS products).” C.A. App. A193.

FDA’s decision to prioritize enforcement

against flavored, cartridge-based ENDS was likely

driven by the popularity of JUUL products among

underage consumers. A paper published two months

before the 2020 Enforcement Guidance was released,

co-authored by officials from FDA and CDC, and cited

in the 2020 Enforcement Guidance, noted:

14 See C.A. App. A183, A185. The document at C.A. App. 183 is

the April 2020 revised version of the guidance document issued

in January 2020. The April 2020 revisions are not relevant to this

case. See C.A. App. A214 (explaining differences between the

January 2020 and April 2020 versions of the guidance document).

13

Most youth who were current e-cigarette

users reported JUUL as their usual ecigarette brand in 2019; the next most

frequent response was “no usual brand.”

This mirrors trends in retail sales data

showing that JUUL has held the

majority of the market share of U.S. ecigarette sales since December 2017. 15

The 2020 Enforcement Guidance further

explained that FDA was prioritizing enforcement

against flavored, cartridge-based ENDS because such

products had “design features” that make the

“products so popular with young people” (e.g., small

size, easy concealability, ability to use immediately

after purchase, and “prefilled cartridges, which are

convenient because they do not require filling prior to

use and are easy to dispose of”). C.A. App. A199. The

2020 Enforcement Guidance also noted that

“particularly easy-to-use products, such as cartridgebased products, may have lower barriers to entry.”

C.A. App. A200.

The 2020 Enforcement Guidance stated that

FDA’s other enforcement priorities were all “other

ENDS products for which the manufacturer has failed

to take (or is failing to take) adequate measures to

prevent minors’ access,” and any “ENDS product that

is targeted to minors or whose marketing is likely to

promote use of ENDS by minors.” C.A. App. A201.

15 K. Cullen, et al., E-Cigarette Use Among Youth in the United

States, 2019, 322 JAMA 2095 (2019) (cited in 2020 Enforcement

Guidance at 12, n.31, C.A. App. A195); see also id. at 16, C.A. App.

A199 (stating “the leading brand is a cartridge-based product

that commands approximately 70 percent of the market”).

14

Importantly, the 2020 Enforcement Guidance stated

that these enforcement priorities “should have

minimal impact on small manufacturers (e.g., vape

shops) that primarily sell non-cartridge-based ENDS

products, unless they market to youth or fail to take

adequate measures to prevent youth access.” Ibid.; see

also C.A. App. A207 (stating FDA’s enforcement

priorities “should have minimal impact on those vape

shops that primarily sell non-cartridge-based ENDS

products and that ensure purchasers are of requisite

age and not purchasing for resale (e.g., are not

purchasing in large quantities)”).

The 2020 Enforcement Guidance also

recommended a number of marketing and sales access

restrictions that manufacturers of open system ENDS

and bottled e-liquids could adopt to prevent minors’

access to and interest in their products. See C.A. App.

A209-210 (marketing restrictions); C.A. App. A205

(sales access restrictions).

F. FDA’s Receipt of Applications

Millions of Flavored ENDS

for

By September 9, 2020—the court-ordered

deadline for PMTAs—FDA received 6.5 million

applications for newly “deemed” tobacco products, the

majority of which were for ENDS products, including

e-cigarettes and e-liquids. 16 FDA later described the

task of reviewing these applications by September 10,

2021—the court-ordered end of the enforcement

16 See FDA Press 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).

15

discretion period

“unprecedented.” 17

for

unauthorized

ENDS—as

Among the 6.5 million applications were those

for Respondents’ bottled e-liquids. 18 Due to the courtordered accelerated deadline for submitting PMTAs,

Respondents joined with other similarly situated

applicants to jointly fund development of non-productspecific data, including a comprehensive review of the

scientific literature on ENDS. See, e.g., C.A. App.

A369, A374. Respondents also submitted productspecific data, such as assessments of the levels of

harmful or potentially harmful constituents

(“HPHCs”) in their e-liquids. C.A. App. A382, A452.

Respondents also submitted proposed plans for

marketing and sales access restrictions that tracked

the recommendations in the 2020 Enforcement

Guidance. Compare C.A. App. A377-378, A392-400,

A430-433, A445-452 with C.A. App. A205, A209-210.

G. FDA’s August 17, 2021 Internal Decision

Regarding Requirements for PMTAs

for Flavored ENDS

In January 2021, another new presidential

administration took over. In July 2021, the new

administration’s Acting FDA Commissioner directed

the agency to “develop a new plan” to “take final action

on as many applications as possible by September 10,

2021,” the day on which the district court said FDA’s

enforcement discretion for unauthorized products

must end. C.A. App. A155.

17 Ibid.

18 C.A. App. A3, A109.

16

A few weeks later, FDA made the internal

decision that applicants for flavored ENDS would

have to meet “a high burden” to show that the

marketing of their products would be appropriate for

the protection of the public health. C.A. App. A167.

Specifically, applicants would have to provide

evidence that their “flavored products have an added

benefit relative to tobacco-flavored ENDS in

facilitating smokers completely switching away from

or significantly reducing their smoking.” C.A. App.

A168. Based on its “completion of numerous scientific

reviews over the last 10 months,” C.A. App. A175,

FDA concluded that such evidence would “most likely”

need to be in the form of a “randomized controlled

trial” or a “longitudinal cohort study,” C.A. App. A168.

Such studies would need to track participants over

time and provide 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.

C.A. App. A175-176.

FDA set forth its rationale for this internal

decision in an 11-page, single spaced “Memorandum

to File,” dated August 17, 2021. See C.A. App. A167181. FDA did not release the Memorandum to the

public. At bottom, FDA reasoned that because

underage users of ENDS preferred flavored ENDS

over tobacco-flavored ENDS, an applicant for a

flavored product would have to show that the benefit

of the flavored product to adults outweighs the risk

that youth will be attracted to and use the product. See

C.A. App. A177.

17

FDA stated that assessing the risk that youth

will be attracted to and use a specific ENDS product

“includes evaluating the appropriateness of the

proposed marketing plan.” C.A. App. A175. But in a

footnote, FDA said that “for the sake of efficiency, the

evaluation of the marketing plans in applications will

not take place at this time.” C.A. App. A175 n.xxii.

According to FDA, none of the marketing plans

included in the PMTAs that it had already reviewed

“would decrease appeal to youth to a degree significant

enough to address and counter-balance the

substantial concerns” about “youth use,” and that the

agency was “not aware of access restrictions that, to

date, have been successful in sufficiently decreasing

the ability of youth to obtain and use ENDS.” Ibid.

However, FDA did not identify the marketing plans

that it had already reviewed or the products for which

access restrictions had been unsuccessful. Nor did it

say whether the plans it had reviewed were for open

system ENDS or bottled e-liquids, or that it had found

access restrictions for open system ENDS or bottled eliquids to be unsuccessful.

Although the August 17, 2021 Memorandum

made a few brief references to the 2019 PMTA

Guidance, 19 the Memorandum did not focus on that

Guidance. To the contrary, the Memorandum cited 65

publications other than the 2019 PMTA Guidance. See

C.A. App. A178-181 (listing the Memorandum’s

“References”).

On August 25, 2021—the day before FDA began

rolling out its en masse denials of applications for

19 See C.A. App. A174, A175, A176.

18

flavored ENDS products 20—FDA “rescinded” the

August 17 Memorandum in a three-sentence

“Memorandum to File.” C.A. App. A182. FDA said it

had “reconsidered the process for [its] PMTA ENDS

reviews and [had] determined that it will not consider

or rely on the August 17, 2021, memo as a supporting

document in that process,” and therefore, “the August

17, 2021, memo is no longer needed.” Ibid.

FDA did not say what, if any, “process” replaced

the one set forth in the August 17, 2021 Memorandum.

Nor did FDA say (at least in writing, anyway) that the

Memorandum was problematic in that it meets the

Administrative Procedure Act’s definition of a “rule.”

See 5 U.S.C. § 551(4) (defining “rule” as “the whole or

part of an agency statement of general or particular

applicability and future effect designed to implement,

interpret, or prescribe law or policy”).

H. FDA’s Denial of Respondents’ PMTAs

In September 2021, FDA denied Respondents’

PMTAs for their bottled flavored e-liquids because

Respondents had not presented evidence sufficient to

show that their products “will provide a benefit to

adult users that would be adequate to outweigh the

risks to youth.” See, e.g., Pet. App. 167a. FDA

explained that this “evidence could have been

provided using a randomized controlled trial and/or

longitudinal cohort study that demonstrated the

benefit of your flavored ends [sic] over an appropriate

20 See 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

(August 26, 2021).

19

comparator tobacco-flavored ends [sic],” or “other

evidence” that “reliably and robustly evaluated the

impact of the new flavored vs. Tobacco-flavored [sic]

products on adult smokers’ switching or cigarette

reduction over time.” Pet. App. 167a-168a. FDA also

explained that because this “key evidence” was

“absent,” the agency did not review other aspects of

the PMTAs (e.g., the proposed marketing and sales

access restriction plans). Pet. App. 168a.

Each of the PMTA denial orders was based on a

document titled “Technical Project Lead (“TPL”)

Review.” See, e.g., Pet. App. 177a. Although the TPLs

were not word-for-word copies of FDA’s August 17,

2021 Memorandum, the TPLs were substantively the

same as the Memorandum. For example, The TPLs

included a footnote that repeated the footnote in the

August 17, 2021 Memorandum about declining to

review the applicants’ proposed marketing and sales

access restriction plans “for the sake of efficiency.”

Compare, e.g., Pet. App. 200a-201a n.xix with C.A.

App. A175 n.xxii. As another example, with one

exception, the 66 publications listed in the

“References” section of the TPLs were the same 66

publications listed in the “References” section of the

20

Memorandum. Compare, e.g., Pet. App. 216a-225a

with C.A. App. A178-181. 21, 22

Respondents were not the only applicants to

have their PMTAs denied. “FDA admits that it ‘has yet

to grant’ a single application to market non-tobaccoflavored [ENDS]. This means it has denied over

355,000 such applications, which amount to 99% of all

timely-filed PMTAs.” R.J. Reynolds Vapor Co. v. FDA,

65 F.4th 182, 192 (5th Cir. 2023) (quoting FDA press

release).

I. Proceedings Below

Respondents timely filed separate petitions for

review of FDA’s denial orders at the Fifth Circuit. A

unanimous motions panel granted Respondent Triton

Distribution’s motion to stay pending disposition of its

petition. Pet. App. 144a. The motions panel found,

among other things, that Triton was likely to succeed

on the merits because FDA changed the requirements

for authorization of flavored ENDS after Triton

21 Reference number 20 in the TPLs was a 2019 article by A.M.

Leventhal in the journal Pediatrics; reference number 20 in the

August 17 Memorandum was a 2019 article by A.M. Leventhal in

the Journal of the American Medical Association. Both articles

address youth usage of flavored ENDS. See Pet. App. 219a; C.A.

App. A179.

22 Neither the denial orders nor the TPLs said FDA’s decisions

were based on the names of Respondents’ bottled e-liquids. FDA’s

reference to some of those names in its Petition (Pet. at 6) is a

distraction from the relevant issues in this case. If FDA believes

that a name change is necessary, it can require such a change in

a marketing granted order, so long as the required change

complies with the First Amendment. See 21 U.S.C.

§ 387j(c)(1)(B); 21 C.F.R. § 1114.31.

21

submitted its PMTAs but without giving Triton notice

of the changed requirements and because FDA

ignored Triton’s proposed marketing and sales access

restriction plans. Id. at 148a-161a.

The circuit court subsequently consolidated the

Triton and Vapetasia petitions. In a 2-1 decision, the

merits panel denied the petitions. In her dissenting

opinion, Judge Jones observed that “FDA (1) changed

the rules for private entities in the middle of their

marketing application process, (2) failed to notify the

public of the changes in time for compliance, and

(3) then rubber-stamped the denial of their

applications because of the hitherto unknown

requirements.” Pet App. 126a.

The full Fifth Circuit vacated the merits panel

decision and reheard the case en banc. The court

granted the petitions for review because FDA

(1) changed its position on the authorization

requirements without fair notice to Respondents and

without considering Respondents’ reliance interests,

and (2) committed prejudicial error by refusing to

consider Respondents’ plans to prevent underage

access and use. Pet. App. 1a et seq.

FDA timely filed a Petition for Writ of

Certiorari.

22

REASONS FOR DENYING THE PETITION

A. The Decision Below is Correct

1. FDA changed its position on the

authorization

requirements

for

ENDS without giving Respondents

fair notice and without considering

Respondents’ reliance interests.

A federal agency must give regulated parties

fair notice when it changes the requirements the

agency places on those parties. See, e.g., Christopher

v. SmithKline Beecham Corp., 567 U.S. 142, 156

(2012). And an agency must take parties’ reliance

interests into account when changing those

requirements. See, e.g., FCC v. Fox TV Stations, Inc.,

556 U.S. 502, 515 (2000). For example, when an

agency intends to adopt those new requirements

through a rule, the agency must, at a minimum,

publish the proposed rule and the bases for the rule in

the Federal Register and give interested persons the

opportunity to submit comments on the rule. 5 U.S.C.

§ 553.

Here, FDA adopted certain requirements for

PMTAs for flavored ENDS in August 2021—nearly a

year after Respondents had submitted their PMTAs

pursuant to the court-imposed deadline. As reflected

in FDA’s internal August 17, 2021 Memorandum,

FDA

decided

that

manufacturers

seeking

authorization for flavored ENDS would have to meet

the “high burden” of establishing that their “flavored

products have an added benefit relative to tobaccoflavored ENDS in facilitating smokers completely

switching away from or significantly reducing their

23

smoking.” C.A. App. A167-168. Applicants would need

to show this added benefit through a product-specific

longitudinal comparative efficacy study that

compared their product to a tobacco-flavored ENDS

product in terms of smoking reduction or cessation

over time. C.A. App. A175-176.

The requirement adopted in the August 17,

2021 Memorandum was a “rule” because it was “an

agency statement of general or particular applicability

and future effect designed to implement, interpret, or

prescribe law or policy.” 5 U.S.C. § 551(4). Indeed, the

Memorandum had many of the features of a preamble

in a notice of proposed rulemaking. See 1 C.F.R.

§ 18.12 (stating proposed rules “shall” include “a

preamble which will inform the reader . . . of the basis

and purpose for the rule”).

Specifically, the

Memorandum included nearly 11 single-spaced pages

of analysis in support of FDA’s new requirement, and

it included 24 footnotes and 66 endnotes in a

“References” section listing 66 publications, nearly all

of which were articles from medical or scientific

journals. C.A. App. A180-181.

FDA did not make the August 17, 2021

Memorandum public, let alone publish a notice of

proposed rulemaking for its new longitudinal

comparative efficacy study requirement for flavored

ENDS. Although FDA purportedly “rescinded” the

August 17, 2021 Memorandum on August 25, 2021—

the day before it released its first massive wave of

denial orders for flavored ENDS— the TPLs for each

24

denial were substantively

Memorandum. 23

the

same

as

the

As for the timing of the purported rescission,

“FDA’s very able [agency] counsel presumably

recognized that [the August 17, 2021 Memorandum]

spelled trouble for the agency,” Pet. App. 24-a, in that

the requirement adopted in the Memorandum was

arguably a “rule,” but that the agency could hopefully

alleviate that trouble if the requirement were adopted

in an “adjudication,” such as a TPL. However, an

agency “may not escape [the notice-and-comment]

requirements of § 553 by labeling its rule an

‘adjudication.’” Safari Club Int’l v. Zinke, 878 F.3d

316, 332 (D.C. Cir. 2017); see also Nat’l Ass’n of Home

Builders v. U.S. Army Corp of Eng’rs, 417 F.3d 1272,

1285 (D.C. Cir. 2005) (“It is of course the [agency’s]

decision whether to proceed by rule or adjudication,

but ‘rules is rules,’ no matter their gloss.”) (cleaned

up).

In its Petition for Certiorari, FDA argues that

its 2019 PMTA Guidance, when read in conjunction

with the text of the TCA itself, put applicants for

flavored ENDS on notice that they would need to

establish that their products have an added benefit

relative to tobacco-flavored ENDS in facilitating

smokers completely switching away from or

23 The Administrative Procedure Act does not require notice and

comment for “interpretive rules.” 5 U.S.C. § 553(b)(4)(A). But

even if the requirement FDA adopted in the August 17, 2021

Memorandum could be called an “interpretative rule,” the

Federal Food, Drug, and Cosmetic Act and FDA regulations

required FDA to give the public advance notice of such a rule. See

21 U.S.C. § 371(h)(1)(C); 21 C.F.R. §§ 10.115, et seq.

25

significantly reducing their smoking. Pet. at 15-17.

But that begs the question: If the 2019 Guidance and

the text of the TCA put applicants on notice of that

requirement, why did FDA feel the need to write an

11-page, single-spaced memorandum, complete with

24 footnotes and 66 endnotes, setting forth the

requirement and the bases for that requirement?

Moreover, FDA does not cite to any language in

the 2019 Guidance, or any other public statement from

the agency prior to the first wave of its en masse

denials of PMTAs, in which FDA said something along

the lines of: “applicants will have to demonstrate that

their flavored products have an added benefit relative

to tobacco-flavored ENDS in facilitating smokers

completely switching away from or significantly

reducing their smoking through a product-specific

comparative cessation study conducted over time.”

FDA cherry-picks a handful of snippets from the 2019

Guidance, but FDA takes those snippets out of

context, and none of them show the agency put the

public on notice of the requirement FDA adopted in

August 2021.

For example, FDA says: “The 2019 Guidance

stated that applications ‘should include’ an

assessment of ‘the trends by which users consume the

product over time.’” Pet. at 17 (quoting C.A. App.

A310). But that language is in the section of the

Guidance where FDA recommends that applications

include a summary of all published and unpublished

research on the product. C.A. App. A309-301. In that

section of the Guidance, FDA says the summary is “not

required,” but that the summary can address

published and unpublished research on various issues,

26

including “user topography (how individual users

consume the product, e.g., the number of puffs, puff

duration, puff intensity, duration of use), and the

trends by which users consume the product over time.”

C.A. App. A310 (emphasis added); see also C.A. App.

A324-325 (similar). That language cannot be read as

putting applicants for flavored ENDS on notice that

they should submit evidence of “the impact of the new

flavored vs. Tobacco-flavored [sic] products on adult

smokers’ switching or cigarette reduction over time.”

C.A. App. A167a-168a.

As another example, FDA says that the 2019

Guidance says applicants should submit “scientific

reviews of flavors.” Pet. at 17 (quoting C.A. App.

A327). But the full passage does not say that such

scientific reviews must include a review of “the impact

of the new flavored vs. Tobacco-flavored [sic] products

on adult smokers’ switching or cigarette reduction

over time.” The full passage does not even say that

such reviews must be in the form of randomized

controlled trials, longitudinal cohort studies, or other

studies conducted “over time.” It says, “scientific

reviews” could include “toxicological analyses of flavor

additives, chemistry analysis, clinical studies, [and]

literature reviews.” C.A. App. A327.

2. FDA committed prejudicial error

when it ignored Respondents’

marketing

and

sales

access

restriction plans.

FDA concedes that it erred in ignoring

Respondents’ marketing and sales access restriction

plans. Pet. at 17-18. That concession makes sense.

Instead of reviewing proposed marketing and sales

27

access restriction plans for bottled e-liquids, including

those of Respondents, FDA just assumed that such

plans would be ineffective because FDA had concluded

that certain marketing and sales access restriction

practices for another category of ENDS products

(cartridge-based products) were ineffective. Bidi

Vapor, 47 F.4th at 1205. But that is not reasoned

decision making. See St. Vincent Randolph Hosp., Inc.

v. Price, 869 F.3d 510, 513 (7th Cir. 2017)

(Easterbrook, J.) (“When the agency just asserts an

ipse dixit, then the decision falls for the lack of

reason.”).

Rather than defend its decision to ignore those

plans, FDA says any error was harmless because

Respondents “have failed to show the measures they

proposed differ from those the agency has already

deemed inadequate. Pet. at 18 (emphasis in original).

But as Chief Judge Pryor recognized when writing for

the Eleventh Circuit in Bidi Vapor, there is no

evidence that FDA ever reviewed any proposed

marketing and sales access restriction plans for

bottled e-liquids, let alone evidence that FDA found

proposed plans for bottled e-liquids to be ineffective.

See Bidi Vapor, 47 F.4th at 1203 (stating it is “unclear

from the record before this Court what marketing

plans or sales access restrictions [FDA] considered

before making the decision to ignore the plans

proposed by these six [applicants]”). (Bidi Vapor

involved applications for, among other products,

bottled e-liquids. See id. at 1200).

FDA notes that when it “prioritized

enforcement against cartridge-based flavored ecigarettes that were popular with youth in 2020, youth

28

migrated to disposable flavored e-cigarettes.” Pet. at

9. But FDA omits the fact that its enforcement against

cartridge-based products resulted in “a meaningful

reduction in” overall “youth use prevalence.” C.A. App.

A169. 24 In any event, the fact that taking cartridgebased ENDS off the market resulted in some youth

moving to disposable ENDS—another “closed” system

ENDS with many of the same features as cartridgebased products—does not excuse the agency’s failure

to review Respondents’ plans for bottled e-liquids—

products used in “open” systems, which are much less

user-friendly than “closed” systems. See photos supra

at 4-6.

Moreover, FDA never told Respondents (or the

public) that the agency now considered the

recommendations for marketing and sales access

restrictions for bottled e-liquids in the 2020

Enforcement Guidance 25 to be inoperative. And as

In the Department of Health and Human Services’ Annual

National Youth Tobacco Survey (“NYTS”) conducted from

January 16 – March 16, 2020, 13.1% of middle and high school

students reported using an ENDS during the previous 30 days.

See A. Gentzke et al., Tobacco Product Use Among Middle and

High School Students – United States, 2020, 69 Morbidity and

Mortality Weekly Report 1881, 1884 (Dec. 18, 2020). When that

same survey was conducted from January 18 to May 21, 2021,

only 7.6% of middle and high school students reported using an

ENDS during the previous 30-days. Park-Lee, et al., E-Cigarette

Use Among Middle and High School Students—National Youth

Tobacco Survey, United States, 2021, 70 Morbidity and Mortality

Weekly Report 1387, 1388 (Oct. 1, 2021).

24

See C.A. App. A209-210 (FDA recommended marketing

restrictions); C.A. App. A205 (FDA recommended sales access

restrictions).

25

29

Judge Jones noted in her dissenting opinion in the

now vacated merits panel decision in this case: “To the

extent FDA means to say that youth will migrate to

any flavored ENDS products if other avenues are

closed off, it provided no evidence of that migration

toward petitioners’ [bottled e-liquid] products during

the periods in question.” Pet. App. 137a n.6.

FDA says Bidi Vapor is distinguishable because

in that case the court’s finding of prejudicial error

hinged on the fact that the applicants proposed “novel”

sales-access-restriction plans. Pet. at 19. FDA is

wrong. Only two of the six applicants in Bidi Vapor

proposed plans described as “novel,” and the court

found prejudicial error in FDA’s refusal to review all

six plans, including e-liquid manufacturers’ plans that

were not “novel.” Bidi Vapor, 47 F.4th at 1205; see also

id. at 1216 (Rosenbaum, J., dissenting) (noting that

“only two” of the applicants submitted “novel accessrestriction plans”).

B. This Court Has Other Vehicles to

Resolve the Circuit Splits on These

Issues

As FDA highlights in its Petition, circuits other

than the Fifth and Eleventh Circuits have denied

petitions for review of FDA denials of PMTAs for

flavored ENDS. Respondents will not attempt to point

out the flaws in those circuits’ opinions here. But

Respondents will note it’s no secret that “reflexive

deference” to agency decisions is common in the lower

courts, Pereira v. Sessions, 585 U.S. 198, 221 (2018)

(Kennedy, J., concurring), especially when another

lower court has already ruled for the agency on the

same issue. So, it is unsurprising that the (now

30

vacated) merits panel decision in this case started a

domino effect in some other circuits that benefited

FDA. 26

In any event, Respondents respectfully submit

that this Court has other appropriate cases through

which it can resolve the circuit splits on the issues

raised in petitions for review of FDA marketing denial

orders for flavored ENDS products. See Lotus Vaping

Techs., LLC v. FDA, petition for cert. pending, No. 23871 (filed Feb. 9, 2024); Magellan Tech, Inc. v. FDA,

petition for cert. pending, No. 23-799 (filed Jan. 22,

2024). And unlike the present case, those cases do not

involve small business applicants who have had to

undertake the time and expense of both a merits panel

hearing and an en banc rehearing.

CONCLUSION

For the reasons discussed above, Respondents

request that the Court deny the Petition for Certiorari.

26 About one week after the merits panel released its decision in

this case, the D.C. Circuit released its decision in Prohibition

Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). And about one

month after that, the Seventh Circuit released its decision in

Gripum, LLC v. FDA, 47 F.4th 553 (7th Cir. 2022). And two

months after that, the Third Circuit released its opinion in

Liquid Labs LLC v. FDA, 52 F.4th 533 (3d Cir. 2002). Perhaps

this deference train would have never left the station had the

Fifth Circuit merits panel reached the decision that the full Fifth

Circuit eventually reached.

31

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

Phone: 202.331.8800

Eric.Heyer@ThompsonHine.com

Counsel for Respondents