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

Supreme Court briefSep 3, 2024

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Text

No. 23-1038

In the Supreme Court of the United States

___________

FOOD AND DRUG ADMINISTRATION, PETITIONER

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

DBA TRITON DISTRIBUTION, ET AL.

___________

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

___________

BRIEF OF GLOBAL ACTION

TO END SMOKING, INC.

AS AMICUS CURIAE

IN SUPPORT OF NEITHER PARTY

___________

Carter G. Phillips

Counsel of Record

Sean C. Griffin

Torrey Cope

Peter A. Bruland

SIDLEY AUSTIN LLP

1501 K Street, N.W.

Washington, D.C. 20005

(202) 736-8000

cphillips@sidley.com

Counsel for Amicus Curiae

TABLE OF CONTENTS

Page

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

iii

INTEREST OF AMICUS CURIAE ......................

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

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

I. The Tobacco Control Act reflects a historic

consensus around the public-health

benefits of a harm-reduction strategy. .........

A. Brown & Williamson rejected FDA’s bid

to ban tobacco products. ..........................

B. Public consensus developed around a

harm-reduction model. ............................

C. Congress enacted legislation embodying

that consensus. ........................................

II. Flavored e-cigarettes are an important

harm-reduction tool. ......................................

A. E-cigarettes reduce harm by helping

adult smokers move down the

continuum of risk. ...................................

1. E-cigarettes are less dangerous than

traditional cigarettes. .......................

2. E-cigarettes are likely better than

FDA-approved cessation aids at helping adult smokers reduce harm. .......

B. Flavor options boost e-cigarettes’ harmreducing potential. ..................................

III. FDA’s de facto flavor ban strays from the

agency’s harm-reduction mission. ................

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

iii

TABLE OF AUTHORITIES

Page

CASES

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) ...................... 3, 6, 7, 11, 12

Logic Tech. Dev. LLC v. FDA,

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

Nat’l Fed’n of Indep. Bus. v. Dep’t of Lab.,

595 U.S. 109 (2022) ...................................

United States v. Philip Morris USA, Inc.,

449 F. Supp. 2d 1 (D.D.C. 2006) ...............

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

90 F.4th 357 (5th Cir. 2024) ......... 22, 24, 25, 26

West Virginia v. EPA,

597 U.S. 697 (2022) ...................................

STATUTES

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

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

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

21 U.S.C. § 387j(a)–(b) ..................................

21 U.S.C. § 387j(a)(1) ....................................

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

21 U.S.C. § 387j(c)(2)(A)............................ 5, 12, 22

21 U.S.C. § 387j(c)(4)..................... 5, 12, 21, 22, 26

Pub. L. No. 111-31,

123 Stat. 1776 (2009) ........................... 3, 11, 25

TABLE OF AUTHORITIES – Continued

LEGISLATIVE MATERIALS

The Family Smoking Prevention and

Tobacco Control Act: Hearing on H.R.

1108 Before the Subcomm. on Health of

the H. Comm. on Energy and Com., 110th

Cong. 37 (2007)..........................................

Page

OTHER AUTHORITIES

Bloomberg Philanthropies, Bloomberg

Philanthropies Launches New $160 Million Program to End the Youth ECigarette Epidemic (Sept. 10, 2019) .........

John Buckell, Should Flavours Be Banned

in Cigarettes and E-Cigarettes? Evidence

on Adult Smokers and Recent Quitters

from a Discrete Choice Experiment,

28 J. Tobacco Control 168 (2019)..............

Anne Buu et al., The Association Between

E-Cigarette Use Characteristics and

Combustible Cigarette Consumption and

Dependence Symptoms: Results from a

National Longitudinal Study,

84 Addictive Behavs. 69 (2018) ................

Ralph S. Caraballo et al., Quit Methods

Used by US Adult Cigarette Smokers,

2014–2016, 14 Preventing Chronic

Disease (2017) ...........................................

Campaign for Tobacco-Free Kids,

Tobacco-Free Kids Strongly Endorses Dr.

Robert Califf for FDA Commissioner

(Nov. 12, 2021) ..........................................

CDC, Current Cigarette Smoking Among

Adults in the United States (2023) ...........

TABLE OF AUTHORITIES – Continued

Page

Julia Cen Chen, Flavored E-Cigarette Use

and Cigarette Smoking Reduction and

Cessation—A Large National Study

Among Young Adult Smokers,

53 Substance Use & Misuse 2017 (2018) ...

Clifford E. Douglas, et al. The American

Cancer Society Public Health Statement

on Eliminating Combustible Tobacco Use

in the United States, American Cancer

Society Public, 68 CA: Cancer J. Clin.

240 (2018) ..................................................

Clifford E. Douglas, It is Time to Act with

Integrity and End the Internecine Warfare over E-Cigarettes (Mar. 2021) ...........

Jeffrey Drope et al., Who’s Still Smoking?

Disparities in Adult Cigarette Smoking

Prevalence in the United States,

68 CA: Cancer J. Clin. 106 (2018) ............

Olufemi Erinoso, Choice of Smoking Cessation Products Among People with Substance Use Problems in the US,

158 Addictive Behaviors (2024) ................

Konstantinos E. Farsalinos et al., Impact

of Flavour Variability on Electronic

Cigarette Use Experience: An Internet

Survey, 10 Int’l J. of Env’t Res. &

Pub. H. 7272 (2013)................................... 20, 21

FDA, FDA Authorizes Marketing of Four

Menthol-Flavored E-Cigarette Products

after Extensive Scientific Review

(June 21, 2024) ..........................................

FDA, Protecting American Families:

Comprehensive Approach to Nicotine and

Tobacco (June 28, 2017) ....................... 13, 22, 23

TABLE OF AUTHORITIES – Continued

Page

FDA, Statement from FDA Commissioner

Scott Gottlieb, M.D., on New Steps to

Address Epidemic of Youth E-Cigarette

Use (Sept. 11, 2018) ..................................

FDA, “Want to Quit Smoking? FDAApproved and FDA-Cleared Cessation

Products Can Help (July 21, 2022) ...........

Abigail S. Friedman et al., Associations

of Flavored e-Cigarette Uptake with

Subsequent Smoking Initiation and

Cessation, 3 JAMA Network Open

(2020) .........................................................

Inst. of Med., Clearing the Smoke: Assessing

the Science Base for Tobacco Harm

Reduction (2001), .............................. 8, 9, 14, 15

Inst. of Med., Ending the Tobacco Problem:

A Blueprint for the Nation (2007) ............. 10, 11

Inst. of Med., Public Health Consequences

of E-Cigarettes (2018) ......................... 15, 16, 17

N. Lindson et al., Electronic Cigarettes for

Smoking Cessation (Review), Cochrane

Database of Systematic

Revs. 2023 ............................................ 16, 17, 18

Nicola Lindson et al., An Exploration

of Flavours in Studies of E-Cigarettes

for Smoking Cessation,

118 Addiction 634 (2023) ..........................

Michael F. Pesko et al., United States Public Health Officials Need to Correct ECigarette Health Misinformation,

118 Addiction 785 (2023) .......................... 23, 24

vii

TABLE OF AUTHORITIES – Continued

Page

Nyah Phengsitthy, FDA to Launch Updated

Portal for Tobacco Product Applications,

Bloomberg Law (July 15, 2024), ...............

Christopher Russell, Changing Patterns of

First E-Cigarette Flavor Used and Current Flavors Used by 20,836 Adult Frequent E-Cigarette Users in the USA,

15 Harm Reduction J. (2018).................... 20, 21

Alayna P. Tackett et al., Biochemically Verified Smoking Cessation and Vaping Beliefs among Vape Store Customers,

110 Addiction 868 (2015) .......................... 20, 21

T. Thuy et al., New Estimates of SmokingAttributable Mortality in the U.S. from

2020 through 2035, 66 Am. J.

Preventative Med. 877 (2024).................. 13, 15

U.S. Dep’t of Health & Hum. Servs.,

The Health Consequences of Smoking—

50 Years of Progress (2014) ........... 12, 13, 14, 15

Kenneth E. Warner et al., A Proposed Policy Agenda for Electronic Cigarettes in the

US: Product, Price, Place, and Promotion, 41 Health Affs. 1299 (2022)..............

Jeffrey Weiss, The Regulatory Capture of

FDA’s Tobacco Policy—and How to Reverse It, 79 Food & Drug L.J. (2024) ........ 24, 25

viii

TABLE OF AUTHORITIES – Continued

Page

Mitchell Zeller, The Strategic Dialogue on

Tobacco Harm Reduction: A Vision and

Blueprint for Action in the US,

18 Tobacco Control 324 (2009)....... 9, 10, 13, 16

Shu-Hong Zhu et al., E-Cigarette Use and

Associated Changes in Population Smoking Cessation: Evidence from US Current

Population Surveys,

358 BMJ 3262 (2017) ................................

INTEREST OF AMICUS CURIAE *

Global Action to End Smoking, Inc. is an independent nonprofit dedicated to ending the smoking epidemic. In furtherance of its charitable mission, Global

Action funds research around the world to advance

public-health knowledge, empower smokers to quit,

and help tobacco farmers in the developing world to

identify new livelihoods. Through September 2023,

Global Action received charitable gifts from PMI

Global Services, Inc. In October 2023, the organization received a final grant from PMI and adopted a

policy not to seek or accept funding from companies

that produce tobacco or nonmedicinal nicotine products.

This case matters to Global Action because tobaccocontrol thought leadership is at a crossroads. All responsible stakeholders in this arena share the goal of

ending the needless suffering and premature death

caused by cigarette smoking. And all agree that children and youth must not fall prey to nicotine addiction in any form, particularly to the uniquely deadly

harms of smoking. But neither can we ignore the tens

of millions of existing adult smokers in the United

States who continue to suffer from cigarette addiction. To balance those public-health concerns, tobacco-control efforts should involve harm reduction: minimizing to the greatest extent possible the morbidity

and mortality resulting from the widespread use of

conventional, combustible cigarettes. Instead of

fighting an all-or-nothing crusade, we must help

those adults who are unable or unwilling to cease

No counsel for any party authored this brief in whole or in

part, and no person or entity aside from amicus and its counsel

funded the brief’s preparation or submission.

nicotine use by (i) substantially reducing their exposure to harmful chemicals and (ii) supporting alternatives that would allow them to switch away from

smoking and toward lower-risk, less-harmful products. To date, science has shown electronic cigarettes

to be the best-positioned alternative to allow adults to

make that potentially life-saving change.

Global Action offers this brief to explain how ecigarettes fit within the harm-reduction framework

that Congress adopted in the Family Smoking Prevention and Tobacco Control Act. That statute tasked

the Food and Drug Administration with fostering the

development of less-harmful tobacco products, with

the goal of reducing harms from combustible tobacco

use. The Fifth Circuit’s decision vacating FDA’s current regulatory approach to e-cigarettes provides an

opportunity to refocus on that mandate.

SUMMARY OF ARGUMENT

Every year, smoking cigarettes and similar combustible tobacco products kills nearly half a million adult

Americans. Tens of millions more are currently addicted to cigarettes. If these adult smokers cannot or

will not stop using nicotine, they need effective tools

to substantially reduce the harms caused by smoking.

The Family Smoking Prevention and Tobacco Control

Act lays out a pragmatic strategy for tackling that

problem. But the Food and Drug Administration

strayed from that sensible, science-based harmreduction approach, adopting an all-or-nothing stance

that exalts outright cessation and all but ignores the

harm-reduction strategy that Congress mandated.

Beyond departing from Congress’s intent, FDA’s position ignores overwhelming scientific evidence that ecigarettes containing flavor additives have an im-

portant role to play in moving adult smokers down

the continuum of risk. The Court should take this opportunity to ensure that FDA’s scorched-earth regulatory approach does not deprive adult smokers of

that important tool.

I. The Tobacco Control Act grew out of a robust debate over the best way to regulate the use of tobacco.

In FDA v. Brown & Williamson Tobacco Corp., 529

U.S. 120 (2000), this Court held that Congress had

not authorized FDA to regulate and ban tobacco under its power to regulate drugs and devices. That decision sparked a national conversation about the

principles that should govern tobacco policy. Eventually a consensus developed in the public-health community around a strategy of harm reduction. The Tobacco Control Act embodies that consensus—calling

on FDA to “reduce the risk of harm,” Pub. L. No. 11131, sec. 2(44), 123 Stat. 1776, 1780 (2009), and oversee the development of “less harmful tobacco products,” id. sec. 3(4), 123 Stat. at 1782.

II. E-cigarettes have proven to be a powerful harmreduction tool. When a traditional cigarette burns, it

releases nicotine, the primary reason that many people continue smoking in the face of great risk. Although nicotine is addictive, it does not itself cause the

diseases and death resulting from combustible tobacco use. Instead, those harms come from the over

7,000 other chemicals—including at least 70 known

carcinogens—that are released when tobacco burns.

These compounds lodge in the lungs, increasing the

risk of cancer, heart disease, and respiratory illnesses

not only for the smoker but also for those nearby.

E-cigarettes use a fundamentally different means of

delivering nicotine to smokers. Instead of burning tobacco, e-cigarettes use a heating coil and a liquid res-

ervoir, and they emit aerosolized water vapor, not

deadly particulate matter known as “tar.” That

makes them far less dangerous than cigarettes. It also makes them a powerful, lower-risk alternative for

adult smokers who are not ready to quit nicotine outright. Indeed, dozens of peer-reviewed studies show

that e-cigarettes may be better than patches, gums,

and other cessation therapies at reducing the longterm risks and harms of smoking tobacco.

E-cigarettes with flavors not associated with traditional cigarettes (that is, flavors other than tobacco or

menthol) can boost that potential even further. A

growing body of evidence demonstrates convincingly

that such flavors play an important role in adults’ decisions about stopping cigarette use. On the one

hand, studies suggest that adult smokers who have

flavor options are more likely to move from cigarettes

to e-cigarettes. Conversely, restricting flavor options

for adults makes adult smokers less likely to switch—

and more likely to relapse if they do. In short: extensive experience, combined with mounting scientific

evidence, shows that flavored e-cigarettes are exactly

the sort of tool that Congress envisioned when it told

FDA to identify and encourage the use of lessharmful alternatives.

III. FDA’s approach in recent years has given short

shrift to that evidence—and to the adult smokers who

need effective harm-reduction tools. The Tobacco

Control Act does not narrowly task FDA with deciding whether the benefits of a new tobacco product

outweigh its risks. A positive benefit-risk ratio is how

FDA has always defined “safety,” and Brown & Williamson rightly observed that non-medicinal tobacco

products could never be “safe” in that sense. Instead,

the Act created an entirely new standard, which asks

whether the introduction of a new tobacco product

will be “appropriate for the protection of the public

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

that answering this question requires balancing

(i) the odds that the new tobacco product would help

current tobacco users against (ii) the risk that it

might lead individuals to newly take up or return to

tobacco products. See id. § 387j(c)(4)(A)–(B).

Unfortunately, FDA has not faithfully balanced

those factors. It has generally ignored the first prong,

brushing past the benefits that e-cigarettes—and especially flavored e-cigarettes—offer adult smokers.

Instead, it has focused single-mindedly on the risk

that youth might begin using these products. At the

same time, FDA has also refused to consider creative

proposals to address the risk of youth uptake (e.g.,

technological advances in device design that allow for

e-cigarettes to be “locked,” novel age-verification

techniques at the point of sale, and marketing restrictions), without depriving adult smokers of access

to an important harm-reduction tool. The result is a

de facto ban on flavored e-cigarettes.

That approach strays from FDA’s harm-reduction

mandate, and it disserves the millions of Americans

who face extremely high risks from smoking. Smoking prematurely kills one in two long-term smokers,

and its harms fall hardest on Americans with lower

education and income levels, those living in rural areas, Native Americans, members of the LGBTQIA+

community, military servicemembers, and people

with mental-health conditions and substance-use disorders. While these Americans urgently need support

from our Nation’s public-health authorities, a very

real consequence of FDA’s ban on flavored ecigarettes is that more people are likely to die from

smoking cigarettes and other combustible tobacco

products. That is not what Congress intended when it

told FDA to authorize the sale and distribution of

new tobacco products that are appropriate for the

protection of the public health.

ARGUMENT

I. The Tobacco Control Act reflects a historic

consensus around the public-health benefits of a harm-reduction strategy.

A. Brown & Williamson rejected FDA’s bid

to ban tobacco products.

The story of the Tobacco Control Act begins with

this Court’s decision in Brown & Williamson. For

most of its history, FDA “repeatedly informed Congress that cigarettes [we]re beyond” its jurisdiction.

529 U.S. at 146. But that changed in the late 1990s,

when the agency declared that its “authority over

‘drugs’ and ‘devices’ included the power to regulate,

and even ban, tobacco product[s],” West Virginia v.

EPA, 597 U.S. 697, 721 (2022) (citation omitted). FDA

then used its new power to issue regulations “concerning tobacco products’ promotion, labeling, and accessibility to children and adolescents”—with the

promise of more regulatory efforts to come. Brown &

Williamson, 529 U.S. at 128, 136. Industry groups

challenged the regulations, arguing that Congress

had not authorized the agency to regulate tobacco.

See id. at 129.

This Court agreed. In its zeal to regulate tobacco,

the agency had created a “dilemma.” Id. at 139. The

Food, Drug, and Cosmetic Act “generally requires the

FDA to prevent the marketing” of drugs or devices

whose “potential for inflicting death or physical injury is not offset by the possibility of therapeutic bene-

fit.” Id. at 134 (quoting United States v. Rutherford,

442 U.S. 544 , 556 (1979)). Here, the challenged regulation “quite exhaustively documented that ‘tobacco

products are unsafe,’ ‘dangerous,’ and ‘cause great

pain and suffering from illness.’” Id. (quoting 61 Fed.

Reg. 44,412 (1996)). So if cigarettes fell within FDA’s

jurisdiction, the statute by its plain terms “would require the agency to ban them.” Id. at 137. Yet Congress had “foreclosed the removal of tobacco products

from the market”—creating a “regulatory scheme”

that was “incompatible with FDA jurisdiction.” Id. at

137, 156.

The Court also doubted that Congress would have

“delegate[d] a decision of such economic and political

significance” in “so cryptic a fashion.” Id. at 160.

While an agency’s “power to regulate in the public interest must always be grounded in a valid grant of

authority from Congress,” id. at 161, that is especially true in “extraordinary cases.” Id. at 159, 161. And

this was “hardly an ordinary case.” Id. at 159. Given

tobacco’s “unique place in American history and society,” the Court found it “highly unlikely” that Congress would “implicit[ly] delegat[e]” a decision of such

“magnitude.” Id. at 121, 159.

The Court thus sent the question of tobacco regulation back “where Article I of the Constitution says it

belongs—with the people’s elected representatives.”

Nat’l Fed’n of Indep. Bus. v. Dep’t of Lab., 595 U.S.

109, 124 (2022) (Gorsuch, J., concurring). Eight years

of robust debate followed—culminating in the Tobacco Control Act.

B. Public consensus developed around a

harm-reduction model.

1. In the early 2000s, two important developments

in the public-health sphere marked a growing consensus over the best way to regulate tobacco use.

a. The first came just a year after Brown & Williamson. In 2001, the National Academy of Sciences

published a landmark report proposing a new strategy for regulating tobacco. The heart of that strategy

was harm reduction: minimizing the “adverse consequences” of tobacco products. Inst. of Med., Clearing

the Smoke: Assessing the Science Base for Tobacco

Harm Reduction 38–39 (2001) (Clearing the Smoke).

Recognizing that “a significant proportion of individuals will continue to use tobacco for the foreseeable

future,” the report “focuse[d] on substituting conventional tobacco use” with “less harmful tobacco products or with pharmaceutical preparations.” Id. at 25.

These included nicotine-replacement products like

gums, patches, and inhalers, as well as smokelesstobacco products. Id. at 92–93, 96. The report also

predicted “an explosion” of new “cigarette-like products,” id. at 28—the precursors to today’s e-cigarettes.

See id. at 93–94 (describing a “prototype” device consisting of “flavor beads,” a “heat source” to “vaporize”

liquid, and a “system that condenses the vapor into

an aerosol”).

At the same time, the report also called for careful

guardrails. Since the 1960s and 1970s, tobacco companies had falsely touted “low tar” cigarettes as “less

harmful than conventional cigarettes.” United States

v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 430

(D.D.C. 2006). These claims “impl[ied] a benefit when

none ha[d] been proven to exist”—misleading con-

sumers and yielding “no reduction in harm.” Clearing

the Smoke at 121, 218. To avoid similar pitfalls, the

report recommended “federal regulation” that “encouraged [manufacturers] to develop and introduce

new products that will reduce the burden of tobaccorelated disease.” Id. at 8.

b. The second development came four years later,

when a group of researchers, public-health leaders,

and tobacco-control advocates launched a “forum for

discussion, debate and strategic planning” about “tobacco harm reduction.” Mitchell Zeller, The Strategic

Dialogue on Tobacco Harm Reduction: A Vision and

Blueprint for Action in the US, 18 Tobacco Control

324, 325 (2009) (Strategic Dialogue) (cleaned up).

Mirroring the “fractured and sometimes divisive debate” playing out in public, those experts approached

the question of tobacco regulation from “diverse perspectives.” Id. at 325–26. Over the course of two

years, participants in this “Strategic Dialogue”

“reach[ed] a consensus on one long-term vision.” Id.

at 326. The group declined to “embrace a policy of

prohibition” that would “ban cigarettes” outright. Id.

Instead, it echoed the National Academy’s call for

“harm reduction”—reducing “morbidity and mortality

from tobacco” by reducing “the number of people who

use cigarettes.” Id. That, in turn, led the experts to

propose two specific “policy objectives.” Id.

First, all agreed that Congress should pass “effective legislation for tobacco product regulation.” Id. at

331. Absent “public health-based regulation,” the

group explained, “there is no way to know” whether

“new or existing products will actually reduce exposure and risk.” Id. at 325. The solution: an “infrastructure and network for product testing and scientific inquiry.” Id. at 331. Regulators could then “re-

duce the harmfulness of tobacco products” through

“evidence-based policy”—from monitoring “access,

marketing and promotion,” to vetting “risk reduction

claims.” Id. at 324, 329.

Second, the group believed that public policy should

focus on a “continuum of risk.” Id. at 327. Cigarettes

are “undoubtedly … more hazardous” than “noncombustible tobacco products,” which in turn are

“more hazardous than pharmaceutical nicotine products,” which are not themselves “absolutely safe.” Id.

at 325, 328. Because outright “cessation” (the safest

outcome) is often not a realistic goal, public-health

efforts should focus on reducing harm by moving current smokers down the continuum of risk from cigarettes to less-dangerous options. Id. at 326, 328. Even

then, e-cigarettes were known to be among the most

promising options for such harm reduction. While

these products were still new, studies had already

found that early e-cigarettes produced “significantly

lower levels” of “carcinogen-related toxicants” than

“conventional combustible” tobacco. Id. at 327. As a

result, shifting to “the long term and exclusive use” of

such products could “create less harm” for “current

tobacco users” who were “unable or unwilling” to quit.

Id. at 326, 328. Cf. CDC, Current Cigarette Smoking

Among Adults in the United States (2023) bit.ly/CDC_

Statistics (estimating 28.3 million adult smokers).

2. Meanwhile, ordinary Americans and their representatives were reaching the same conclusion. A bill

“giving the FDA the authority to regulate tobacco”

passed the Senate in 2004, but stalled in the House.

Inst. of Med., Ending the Tobacco Problem: A Blueprint for the Nation 126 (2007). Three years later,

“[c]omprehensive” legislation was introduced in both

Houses of Congress. Id. Spurred by “widespread pop-

ular consensus in favor of aggressive policy initiatives,” these bills found “support across most of the

political spectrum.” Id. at 8. Hearings began in late

2007, guided in large part by ideas laid out in the National Academy’s report and the Strategic Dialogue.

E.g., The Family Smoking Prevention and Tobacco

Control Act: Hearing on H.R. 1108 Before the

Subcomm. on Health of the H. Comm. on Energy and

Com., 110th Cong. 37 (2007) (citing National Academy report).

C. Congress enacted legislation embodying

that consensus.

In 2009, Congress passed the landmark Family

Smoking Prevention and Tobacco Control Act. The

Act authorizes FDA to regulate “tobacco products”

that the agency “by regulation deems” subject to the

statute. 21 U.S.C. § 387a(b). Echoing the National

Academy and Strategic Dialogue, Congress found

that FDA has the “scientific expertise” to “reduce the

risk of harm” by “evaluat[ing] scientific studies supporting claims about the safety of products.” Pub. L.

No. 111-31, sec. 2(44), 123 Stat. at 1780. It then

called on FDA to ensure “effective oversight of the tobacco industry’s efforts to develop, introduce, and

promote less harmful tobacco products.” Id. sec. 3(4),

123 Stat. at 1782.

Congress gave FDA detailed instructions on how to

implement its harm-reduction mandate. Unlike the

rule this Court reviewed in Brown & Williamson, the

Act did not leave FDA with “the authority to ban cigarettes … entirely.” 529 U.S. at 159. Instead, products already on the market could generally stay on

the market. See 21 U.S.C. § 387g(d)(3)(A) (forbidding

FDA to “ba[n] all cigarettes”). At the same time, Congress ordered FDA to reissue a modified version of its

previous rule, see id. § 387a-1(a)(2), with additional

restrictions on the sales and marketing of existing

tobacco products, see id. § 387a-1(a)(2)(G).

Congress applied a different framework to “new tobacco products.” Id. § 387j(a)(1). As relevant here,

products that were not “commercially marketed in

the United States as of February 15, 2007” must go

through “[p]remarket review” before they can be sold.

Id. § 387j(a)(2)(A) (cleaned up). Much like new drugs

or medical devices, new tobacco products require

premarket review from FDA through a premarket tobacco application or “PMTA.” But unlike applications

for therapeutic products, a PMTA is not intended to

show that the tobacco product will be safe or effective,

which makes sense given that it would be impossible

for a nonmedicinal tobacco product to provide benefits

that outweigh its risks. Cf. Brown & Williamson, 529

U.S. at 134–35. Instead, a PMTA must show that

marketing the new tobacco product “would be appropriate for the protection of the public health,”

21 U.S.C. § 387j(c)(2)(A), considering the “risks and

benefits to the population as a whole,” id. § 387j(c)(4).

And that inquiry turns on an assessment of the “increased or decreased likelihood” that (i) “existing users of tobacco will stop using such products” and

(ii) “those who do not use tobacco products will start”

doing so. Id. § 387j(c)(4)(A)–(B).

II. Flavored e-cigarettes are an important

harm-reduction tool.

Smoking kills. It “remains the leading preventable

cause of premature death in the United States,” U.S.

Dep’t of Health & Hum. Servs., The Health Consequences of Smoking—50 Years of Progress 11 (2014)

(Health Consequences of Smoking), and it has claimed

more than 24 million lives in the last 60 years, com-

pare id., with T. Thuy et al., New Estimates of Smoking-Attributable Mortality in the U.S. from 2020

through 2035, 66 Am. J. Preventative Med. 877, 879

(2024). E-cigarettes are a powerful tool for reducing

that harm. As dozens of peer-reviewed studies have

now shown, e-cigarettes are not only less dangerous

than traditional cigarettes but also clearly help adult

smokers switch to lower-risk alternative sources of

nicotine. And appropriately regulated flavor options

boost their potential health benefits, by making

smokers more likely to step down the “continuum of

risk” and stay there. FDA, Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017), bit.ly/Comprehensive_Approach

(Comprehensive Approach).

A. E-cigarettes reduce harm by helping

adult smokers move down the continuum of risk.

By the early 2000s, public-health researchers recognized that e-cigarettes held significant promise as a

harm-reduction tool. The idea is simple. If ecigarettes are less dangerous than traditional cigarettes, and if “individuals who would otherwise be using conventional cigarettes” would be willing to

switch, then e-cigarettes would have “value in reducing exposure and disease.” Strategic Dialogue at 327–

28. While there may not have been “sufficient studies” at that time to be confident in that conclusion, id.

at 327, the science is now in. E-cigarettes are less

harmful than traditional cigarettes, and they are effective at helping smokers move to lower-risk alternatives.

1. E-cigarettes are less dangerous than

traditional cigarettes.

a. Traditional cigarettes are made from shredded

tobacco wrapped in paper. When a smoker lights up,

the tobacco catches fire and smolders at around 1,100

degrees Fahrenheit. Clearing the Smoke at 284. That

fire produces smoke, which contains nicotine. See id.

at 288. With each puff, the smoke passes through a

filter at the back of the cigarette, enters the smoker’s

airways, and is drawn into the lungs. From there, a

dose of nicotine is absorbed through the alveoli and

enters the bloodstream, reaching the brain ten to fifteen seconds later. See id. at 248, 285–87. The nicotine then binds to specialized receptors, “culminating

in release of a number of different neurotransmitters.” Id. at 244. Those chemicals account for nicotine’s “pleasurable” and “rewarding” effects. See id. at

29, 244. (In other words: the smoker’s “high.”)

But cigarette smoke contains a lot more than just

nicotine. See id. at 288. Burning tobacco releases a

“complex chemical mixture of more than 7,000 compounds that cause a wide range of diseases.” Health

Consequences of Smoking at 1. In addition, tiny particulates known as “tar” travel easily through the

cigarette’s filter and into the lungs. See id. at 87.

Some are exhaled. But the lion’s share—“from 50 to

95%”—lodge in the respiratory tract, causing a host

of health problems. Id. at 285. Cancer is one risk:

“there are many carcinogens in tobacco smoke,” id. at

164, and “20% of all cancers worldwide are attributable to smoking,” id. at 367. As U.S. data reflect, heart

disease is another: “Each year, about 150,000 cardiovascular deaths are attributable to cigarette smoke.”

Id. at 470. And then there are smoking-related respiratory diseases, which cause around 90,000 deaths

in the U.S. annually. See id. at 500. All told, cigarettes killed nearly 450,000 Americans smokers last

year (to say nothing of the tens of thousands of others

harmed or even killed by secondhand smoke). See

Thuy, supra, at 879 (accounting for current and former smokers).

b. E-cigarettes are different. They provide nicotine

for those who cannot or will not stop using it—

without the tar and with many fewer harmful compounds. The simplest e-cigarettes consist of a batterypowered heating coil and a liquid-nicotine reservoir,

all packaged together in a cigarette-like tube. See

Inst. of Med., Public Health Consequences of ECigarettes 55 (2018) (Public Health Consequences).

When the user inhales through the mouthpiece, the

heating coil engages, turning the liquid into a vapor.

See id. Like the smoke from a cigarette, the vapor

from an e-cigarette is drawn into the lungs, where

nicotine is absorbed into the bloodstream and then

delivered to the brain. But unlike cigarettes, ecigarettes don’t involve burning tobacco or the byproducts of combustion.

That difference makes e-cigarettes inherently and

significantly less dangerous than combusted products. Cigarette smoke contains “toxic combustion

products associated with cancers.” Id. at 32. By contrast, e-cigarette vapor is mostly aerosolized water

and “carrier liquid,” id. at 75, 155—making ecigarettes “likely to be far less harmful than combustible tobacco cigarettes,” id. at 1 (cleaned up). As for

nicotine, its health risks are “far fewer and less serious than those of other tobacco constituents.” Clearing the Smoke at 28–29. In fact, FDA itself has approved numerous nicotine-based products as safe and

effective drugs and has approved or cleared others as

medical devices. See FDA, Want to Quit Smoking?

FDA-Approved and FDA-Cleared Cessation Products

Can Help (July 21, 2022), bit.ly/FDA_Nicotine.

c. None of that is to say that e-cigarettes are riskfree. While e-cigarettes are significantly safer than

traditional cigarettes, they do “emit potentially toxic

substances,” including “fine particulate matter” and

metals. Public Health Consequences at 32. “These

substances are known to cause adverse health consequences such as cardiovascular and respiratory illnesses.” Id. For that reason, “[t]he safest nicotinebased products are likely to be therapeutic nicotine

products such as the gum, patch and lozenge.” Strategic Dialogue at 328. Still, after reviewing “more

than 800 peer-reviewed scientific studies,” the National Academy of Sciences found “conclusive evidence that completely substituting e-cigarettes for

combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens”—a

meaningful step down the continuum of health risks.

Public Health Consequences at 604 (cleaned up). And

(as we explain next) e-cigarettes may even offer significant benefits over the cessation products that

FDA regulates as drugs or devices.

2. E-cigarettes are likely better than

FDA-approved cessation aids at helping adult smokers reduce harm.

Recent science suggests that e-cigarettes containing

nicotine are not just far less dangerous than traditional cigarettes: “Evidence shows they work better

than nicotine replacement therapy” to help smokers

switch away from cigarettes. N. Lindson et al., Electronic Cigarettes for Smoking Cessation (Review),

Cochrane Database of Systematic Revs. 2023, at 4.

a. Smokers who are trying to stop consuming combustible tobacco products turn to e-cigarettes more

often than other tools. After following 15,000 smokers

over a two-year period, researchers affiliated with the

Centers for Disease Control and Prevention found

that more smokers turned to e-cigarettes than to “the

nicotine patch, nicotine gum, or other … cessation

aids.” Ralph S. Caraballo et al., Quit Methods Used by

US Adult Cigarette Smokers, 2014–2016, 14 Preventing Chronic Disease, at 1–2 (2017). Another group of

scientists found the same result among smokers with

substance-use disorders. See Olufemi Erinoso et al.,

Choice of Smoking Cessation Products Among People

with Substance Use Problems in the US, 158 Addictive Behaviors, at *5 (2024). This all makes perfect

sense. Unlike patches and gums, e-cigarettes offer an

immediate nicotine dose like that provided by cigarettes. At the same time, e-cigarettes evoke the “combination of pleasant stimuli associated with the

[smoking] ritual”—from the “sensations of inhaling

and exhaling” to the familiar “hand-to-mouth movements” of smoking a cigarette. Public Health Consequences at 257.

b. Perhaps more importantly, dozens of studies

have shown that e-cigarettes can help smokers stop

using cigarettes more effectively than patches, gums,

and other nicotine-replacement options. In a recent

meta-analysis, researchers reviewed 88 smokingcessation studies, involving more than 27,000 participants. See Lindson, supra, at *17. Over half of the

studies were randomized controlled trials. Id. at *18.

After analyzing for “risk of bias”—and using “sensitivity analyses” to “remov[e] studies with tobacco or

vaping industry funding”—the researchers found

“high-certainty evidence” that e-cigarettes “increas[e]

quit rates” compared to nicotine-replacement thera-

pies. Id. at *37–38. Specifically, “[f]or every 100 people using nicotine e-cigarettes to stop smoking, 8 to

10 might successfully stop, compared with only 6 of

100 people using nicotine-replacement therapy.” Id.

at *3. Meanwhile, “[n]one” of the studies “detected

serious adverse events” from e-cigarette use. Id. at

*39. In fact, there was “no clear difference” on that

score among participants using e-cigarettes, nicotinereplacement therapy, or no treatment. Id. at *36.

The big-picture results are just as striking. Every

year, public-health researchers track the “smoking

cessation rate”—the percentage of survey respondents who (i) smoked a year ago but (ii) have not

smoked for the last three months. Shu-Hong Zhu et

al., E-Cigarette Use and Associated Changes in Population Smoking Cessation: Evidence from US Current

Population Surveys, 358 BMJ 3262, at *2 (2017). For

decades, “one of the most vexing results in the smoking cessation literature” was that the cessation rate

“show[ed] no discernible trend,” even as more and

more smokers tried FDA-approved quitting aids. Id.

at *6. But the 2014–15 survey—which “coincided with

… [a] dramatic increase in e-cigarette use”—brought

a surprise: “the first statistically significant increase

in the population cessation rate.” Id. at *5–6. What

changed? “The cessation rate for those who did not

use e-cigarettes in 2014–15” was “statistically indistinguishable from those of the previous years.” Id. at

*6. But e-cigarette users “succeeded in quitting at

higher rates,” and their “increased smoking cessation

rate … translated into a higher overall population

cessation rate.” Id. at *5–6. In other words: ecigarette users appeared to pull the laboring oar.

B. Flavor options boost e-cigarettes’ harmreducing potential.

“There are many reasons to think” that adult

smokers benefit from a range of e-cigarette flavor options. Nicola Lindson et al., An Exploration of Flavours in Studies of E-Cigarettes for Smoking Cessation, 118 Addiction 634, 635 (2023). For some smokers, “[s]imply having a choice” among flavors could

make e-cigarettes a “more desirable quitting aid.” Id.

At the same time, those who find flavors they enjoy

might “continue to use” e-cigarettes, “reduc[ing] the

risk of relapse to smoking combustible cigarettes.” Id.

Unsurprisingly, studies confirmed the importance of

flavor options in helping adults switch—and stay—

away from cigarettes.

1. A growing body of evidence suggests that flavor

options increase smokers’ odds of switching away

from cigarettes.

One longitudinal study compared adult smokers

who used tobacco-flavored e-cigarettes with those

who used other flavors. See Abigail S. Friedman et

al., Associations of Flavored e-Cigarette Uptake with

Subsequent Smoking Initiation and Cessation, 3 JAMA Network Open (2020). The researchers found

that smokers in the second group were 2.3 times

more likely to give up cigarettes—a statistically significant difference. Id. at *1, *8. Other longitudinal

studies show a similar relationship between flavor

options and reduced cigarette use. See Anne Buu et

al., The Association Between E-Cigarette Use Characteristics and Combustible Cigarette Consumption and

Dependence Symptoms: Results from a National Longitudinal Study, 84 Addictive Behaviors 69 (2018)

(flavor linked to reduced smoking); Julia Cen Chen,

Flavored E-Cigarette Use and Cigarette Smoking Re-

duction and Cessation—A Large National Study

Among Young Adult Smokers, 53 Substance Use &

Misuse 2017 (2018) (similar).

Surveys show comparable results. In one study, researchers asked adult e-cigarette users about their

flavor preferences and history of smoking. See Alayna

P. Tackett et al., Biochemically Verified Smoking

Cessation and Vaping Beliefs among Vape Store Customers, 110 Addiction 868 (2015). Those who used

“fruity, candy or bakery flavors” were 2.5 times more

likely to have stopped smoking cigarettes than those

who used “traditional” tobacco or menthol flavors. Id.

at 873. The upshot: “access to a variety” of flavor options is “important for encouraging and assisting”

adult smokers to “use e-cigarettes in place of conventional cigarettes.” Christopher Russell, Changing

Patterns of First E-Cigarette Flavor Used and Current

Flavors Used by 20,836 Adult Frequent E-Cigarette

Users in the USA, 15 Harm Reduction J., at *13

(2018).

2. Conversely, when flavor options are limited,

adult smokers are less likely to switch away from cigarettes and, if they do make the switch, are more

likely to relapse and return to smoking cigarettes—

greatly increasing the risk of harm.

Smokers with fewer flavor options show “reduc[ed]

… interest in switching to e-cigarettes.” Id. Asked

how flavor restrictions would have impacted their decision to stop smoking cigarettes, 39.7% of e-cigarette

users told researchers that they would have been

“[l]ess likely to reduce or quit.” See Konstantinos E.

Farsalinos et al., Impact of Flavour Variability on

Electronic Cigarette Use Experience: An Internet Survey, 10 Int’l J. of Env’t Res. & Pub. H. 7272, 7277

(2013).

Flavor restrictions also make it easier to “rationalize a return to cigarette smoking.” Russell, supra, at

*13. According to a survey, 48.5% of e-cigarette users

would experience “increase[d] … cravings for [tobacco] cigarettes” if flavor options were restricted. Farsalinos, supra, at 7277. And experimenters found

similar results when they simulated the effects of a

flavor ban. See John Buckell, Should Flavours Be

Banned in Cigarettes and E-Cigarettes? Evidence on

Adult Smokers and Recent Quitters from a Discrete

Choice Experiment, 28 J. Tobacco Control 168 (2019).

When researchers “banned” all but tobacco-flavored

e-cigarettes, current and former smokers participating in the study were more likely to prefer cigarettes

and less likely to choose e-cigarettes. Id. at 172.

All of that evidence boils down to this: Flavor options “increas[e]” the “likelihood that existing users”

of cigarettes “will stop using such products.” 21

U.S.C. § 387j(c)(4)(A). At the same time, flavor restrictions will “decreas[e]” the “likelihood that existing” smokers “will stop,” id.—and “increas[e]” the

“likelihood that those who do not use” cigarettes anymore will relapse, id. § 387j(c)(4)(B). In other words:

“by banning flavors … regulators may be doing more

harm than good.” Tackett at 873. Thus, at a minimum in any balancing test of the best way to “reduce

the harm of tobacco use,” FDA must consider these

data in deciding on a strategy for regulating smokingrelated activities.

III. FDA’s de facto flavor ban strays from the

agency’s harm-reduction mission.

FDA has given all of these considerations short

shrift. To determine whether flavored products are

“appropriate for the protection of the public health,”

21 U.S.C. § 387j(c)(2)(A), FDA must forthrightly assess the odds that they will help current tobacco users and the risk that they might lead youth or others

to start using tobacco products. See id.

§ 387j(c)(4)(A)–(B). Unfortunately, FDA has ignored

the first prong of that analysis. Here, the agency

failed to consider both the available research about

flavored products discussed above, as well as the “inferences” that could be drawn from “robust, reliable,

and peer-reviewed scientific studies involving unflavored products.” Wages & White Lion Invs., L.L.C. v.

FDA, 90 F.4th 357, 369 (5th Cir. 2024). At the same

time, FDA also overlooked the ways that removing

flavor options can deter current smokers from switching away from cigarettes and lead former smokers to

relapse. See 21 U.S.C. § 387j(a)–(b). Finally, after ignoring both bodies of evidence, the agency claimed

that “the risks to youth” were controlling across the

board. Wages & White Lion, 90 F.4th at 370. It has

used this same logic to reject over a million flavoredproduct applications. See id.

Such a wholesale rejection is not true to FDA’s

statutory mission. When Congress passed the Tobacco Control Act, it envisioned the introduction of new,

less-harmful tobacco products, and it tasked FDA

with considering the risks and benefits that those

products could bring to both users and nonusers. But

instead of carrying out that mandate, FDA has all

but outlawed products that could save lives by helping adults who smoke move down the “continuum of

risk,” Comprehensive Approach—even as cigarettes

remain widely available. Congress has already

weighed in and rejected that all-or-nothing approach.

Straying from Congress’s harm-reduction mandate

disserves the millions of adult Americans who need

more effective and more easily accessible tools to stop

smoking. See Clifford E. Douglas et al. The American

Cancer Society Public Health Statement on Eliminating Combustible Tobacco Use in the United States,

American Cancer Society Public, 68 CA: Cancer J.

Clin. 240, 240–41 (2018).

A. Things were not always this way. Just seven

years ago, FDA promised to “recognize the potential

for innovation to lead to less harmful products,

which, under FDA’s oversight, could be part of a solution.” Comprehensive Approach. That, in turn, required the agency to “foste[r] innovation when it

comes to potentially less harmful forms of nicotine

delivery.” Id. This was especially true of the “extraordinary opportunity” offered by new “technolog[y] to

deliver nicotine, for those who need it, that doesn’t

bring with it the deadly consequences of burning tobacco and inhaling the resulting smoke.” Id.

But FDA soon changed course. In 2018, publichealth experts announced that youth had begun using e-cigarettes at alarming levels, leading to an “epidemic of e-cigarette use among teenagers.” FDA,

Statement from FDA Commissioner Scott Gottlieb,

M.D., on New Steps to Address Epidemic of Youth ECigarette Use (Sept. 11, 2018), bit.ly/FDA-Statement.

Then, a year later, news broke that some users

were being hospitalized with a serious, sometimes fatal, lung disease—later traced to illicit “THC vapes”

laced with Vitamin E acetate. Michael F. Pesko et al.,

United States Public Health Officials Need to Correct

E-Cigarette Health Misinformation, 118 Addiction

785, 785 (2023). While “no research has identified any

chemicals found in nicotine e-cigarettes” as the culprit, the outbreak led to “an immediate increase in

the perceived risks of e-cigarettes.” Id. Soon afterward, influential advocacy groups began to exploit

this public alarm by calling for the “banning [of] all

flavored e-cigarettes”—never mind that the incidents

of lung disease had nothing to do with those products.

Bloomberg Philanthropies, Bloomberg Philanthropies

Launches New $160 Million Program to End the

Youth E-Cigarette Epidemic (Sept. 10, 2019),

bloombg.org/3YRYftS.

Rather than responding to this misinformation in a

measured or scientific fashion, FDA allowed itself to

be a captive of these advocacy efforts. See Jeffrey

Weiss, The Regulatory Capture of FDA’s Tobacco Policy—and How to Reverse It, 79 Food & Drug L.J., at

*31–32 (2024). Within months, the agency vowed to

“prioritize enforcement resources” against flavored ecigarettes and issued a guidance document outlining

its plans. Wages & White Lion, 90 F.4th at 366. Then,

in 2021, it “announce[d] the en masse denial of 55,000

flavored e-cigarette applications.” Id. at 370. Another

946,000 denials followed a month later. Id.; see also

Nyah Phengsitthy, FDA to Launch Updated Portal

for Tobacco Product Applications, Bloomberg Law

(July 15, 2024), bit.ly/FDA_Applications (noting that

FDA has received 27 million applications for ecigarette products and granted only 27). Advocacy

groups praised these efforts—and urged the agency to

go further. In a statement supporting the President’s

choice for FDA Commissioner, one group “urge[d]”

the nominee to “eliminate all flavored tobacco products, including flavored e-cigarettes.” Campaign for

Tobacco-Free Kids, Tobacco-Free Kids Strongly Endorses Dr. Robert Califf for FDA Commissioner (Nov.

12, 2021), bit.ly/Califf_Endorsement.

All the while, agency staff were clashing behind the

scenes over how to handle menthol-flavored products.

See Logic Tech. Dev. LLC v. FDA, 84 F.4th 537, 545–

46 (3d Cir. 2023). FDA’s latest guidance document

“excluded menthol-flavored e-cigarettes from its definition of ‘flavored’ products,” reasoning that menthol

is “less popular with youth” than other flavors. Wages

& White Lion, 90 F.4th at 373. Applying that guidance, FDA’s Office of Science recommended granting

an application for menthol-flavored e-cigarettes. See

Logic Tech., 84 F.4th at 545. But the Center for Tobacco Products director disagreed and decided that

the same rules should apply to menthol e-cigarettes.

See id. at 546. So FDA denied that application too. Id.

To date, FDA has “consistently denied all applications” for e-cigarettes in nontraditional flavors.

Weiss, supra, at *38. And while it recently granted a

handful of applications for menthol-flavored products,

it shows no sign of budging on other flavors. See

FDA, FDA Authorizes Marketing of Four MentholFlavored E-Cigarette Products after Extensive Scientific Review (June 21, 2024), bit.ly/FDA_Menthol.

Amicus does not doubt that some applications should

be denied, lest children be exposed to harm. But we

cannot reconcile FDA’s much wider categorical ban—

and its failure to account for the needs of existing

adult smokers—with the balanced approach that

Congress mandated.

B. The result is that FDA has imposed a “de facto

ban on flavored e-cigarettes.” Wages & White Lion, 90

F.4th at 384 n.5. But that flies in the face of FDA’s

harm-reduction mission. Congress tasked FDA with

“effective[ly] overs[eeing]” the development, introduction, and promotion of “less harmful tobacco products.” Pub. L. No. 111-31, sec. 3(4), 123 Stat. at 1782.

In its zeal to restrict flavors, however, FDA is missing

opportunities to reduce harm—and letting the perfect

become the enemy of the good. While “quitting all

nicotine and tobacco use is the surest way to reduce

risk,” smokers who are unable or unwilling to do so

outright, which includes millions of people, can still

“significantly reduce their risk” by “switching to a

noncombustible” nicotine source. Clifford E. Douglas,

It is Time to Act with Integrity and End the Internecine Warfare over E-Cigarettes (Mar. 2021), at 3,

bit.ly/Douglas_Integrity.

That is not to diminish the very real risk of youth

tobacco use. “[T]here is widespread agreement that

adolescents should not use nicotine in any form, including e-cigarettes.” Kenneth E. Warner et al., A

Proposed Policy Agenda for Electronic Cigarettes in

the US: Product, Price, Place, and Promotion, 41

Health Affs. 1299, 1299 (2022). That weighty interest

calls for creative policymaking—like restricting flavors “favored by youth” while allowing “other flavors

with clearly adult-oriented marketing.” Id. at 1302.

By the same token, e-cigarettes should be restricted

to “adult-only establishments,” id. at 1303, and promotion limited to “encourag[ing] smokers who are

unable to quit by other means to try using ecigarettes instead of combustible cigarettes,” id. at

1304; see also Wages & White Lion, 90 F.4th at 369

(noting “marketing and sales-access restriction[s]” to

“limit youth access”). Had FDA not “refused even to

read” the marketing plans included in Respondent’s

applications, id. at 371, a productive dialogue about

these (and other) ideas could have followed.

Instead, FDA swung so far in one direction that it

lost sight of Congress’s command to consider both

“users and nonusers.” 21 U.S.C. § 387j(c)(4) (emphasis

added). Just as FDA must protect youth from beginning to smoke in the first place, it must also consider

the harms that existing American smokers are facing

here and now. Those harms are not spread evenly

throughout society. Smoking disproportionately affects Americans with lower education and income

levels, people in rural areas, Native Americans,

members of the LGBTQIA+ community, military servicemembers, and people with mental-health conditions and substance-use disorders. See Jeffrey Drope

et al., Who’s Still Smoking? Disparities in Adult Cigarette Smoking Prevalence in the United States, 68

CA: Cancer J. Clin. 106, 113 (2018). The Tobacco

Control Act protects these Americans as well—and

millions of other adult smokers. FDA must heed Congress’s mandate to account for the harms they face

too. Banning flavored e-cigarettes is not the answer

Congress mandated.

By rejecting FDA’s categorical approach to dealing

with flavored e-cigarettes on procedural grounds, the

Fifth Circuit has given the agency a fresh opportunity

to implement Congress’s intent. In place of the current ban on flavored products, which perpetuates

grave risks to American smokers, FDA now can evaluate each application on its merits and determine

which products will reduce harm and help adult

smokers switch away from cigarettes without encouraging our youth to begin using tobacco products.

CONCLUSION

The Court should make clear that the Tobacco Control Act requires FDA to take a more balanced and

nuanced approach to evaluating applications for flavored e-cigarettes.

Respectfully submitted,

Carter G. Phillips

Counsel of Record

Sean C. Griffin

Torrey Cope

Peter A. Bruland

SIDLEY AUSTIN LLP

1501 K Street, N.W.

Washington, D.C. 20005

(202) 736-8000

cphillips@sidley.com

September 3, 2024

Counsel for Amicus Curiae

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.