Nicopure Labs, LLC v. FDA

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued September 11, 2018 Decided December 10, 2019

No. 17-5196

NICOPURE LABS, LLC AND RIGHT TO BE SMOKE-FREE

COALITION,

APPELLANTS

AMERICAN E-LIQUID MANUFACTURING STANDARDS

ASSOCIATION, ET AL.,

APPELLEES

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

APPELLEES

Appeal from the United States District Court

for the District of Columbia

(No. 1:16-cv-00878)

Miguel A. Estrada argued the cause for appellant Nicopure

Labs, LLC. With him on the brief for amicus curiae NJOY

LLC were Theodore B. Olson, Amir C. Tayani, and Jacob T.

Spencer in support of plaintiffs-appellants.

Eric P. Gotting argued the cause and filed the briefs for

appellants Nicopure Labs, LLC and Right to Be Smoke-Free

Coalition. Douglas J. Behr entered an appearance.

2

Thomas J. Miller, Attorney General, and Jacob Larson,

Assistant Attorney General, Office of the Attorney General for

the State of Iowa, were on the brief for amicus curiae State of

Iowa in support plaintiffs-appellants.

James W. Bryan was on the brief for amicus curiae

Consumer Advocates for Smoke-Free Alternatives Association

in support of plaintiffs-appellants.

Cory L. Andrews and Richard A. Samp were on the brief

for amicus curiae Washington Legal Foundation in support of

plaintiffs-appellants.

Christopher G. Browning, Jr. and Bryan Michael Haynes

were on the brief for amici curiae Clive Bates and Additional

Public Health/Tobacco Policy Authorities in support of

plaintiffs-appellants.

Lindsey Powell, Attorney, U.S. Department of Justice,

argued the cause for appellees. With her on the brief were Brett

A. Shumate, Deputy Assistant Attorney General, Jessie K. Liu,

U.S. Attorney, and Mark B. Stern, Alisa B. Klein, and Tyce R.

Walters, Attorneys.

Scott L. Nelson, Allison M. Zieve, and Julie M. Murray

were on the brief for amicus curiae Public Citizen, Inc. in

support of defendants-appellees.

Charles Sims was on the brief for amici curiae First

Amendment Scholars in support of defendants-appellees.

Mark Greenwold, Carlos T. Angulo, and Andrew N.

Goldfarb were on the brief for amici curiae Public Health

Groups in support of defendants-appellees.

3

Thomas Bennigson was on the brief for amicus curiae

Public Health Law Center in support of defendants-appellees.

Before: ROGERS and PILLARD, Circuit Judges, and

SENTELLE, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge PILLARD.

PILLARD, Circuit Judge: Nicotine is among the most

addictive substances used by humans. An e-cigarette delivers

nicotine by vaporizing a liquid that includes other chemicals

and flavorings. The device heats the liquid until it generates an

aerosol—or “vapor”—that can be inhaled. The chemicals in

the liquid vary, but any e-cigarette that contains nicotine is

subject to federal regulation. The Family Smoking Prevention

and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776

(2009) (Tobacco Control Act, TCA, or Act), addresses the

American public’s continuing addiction to tobacco products

containing nicotine by empowering the Food and Drug

Administration (FDA) to regulate their sale and marketing.

The legislation grew out of Congress’ recognition that more

limited efforts to regulate tobacco products had “failed

adequately to curb tobacco use by adolescents.” Id. § 2(6), 123

Stat. at 1777. Based on extensive evidence of tobacco’s

widespread use and nicotine’s addictive character and harmful

effects, Congress found that the “use of tobacco products by

the Nation’s children is a pediatric disease of considerable

proportions that results in new generations of tobacco-

dependent children and adults.” Id. § 2(1), 123 Stat. at 1777.

In enacting the Tobacco Control Act, Congress decided an

immediate ban on a product to which millions of Americans

were addicted would foster a black market and harm existing

tobacco users and the broader public. See H.R. Rep. No. 111-

4

58, pt. 1, at 38 (Mar. 27, 2009). Congress instead took the then-

current tobacco product market as a baseline from which to

ratchet down tobacco products’ harms to public health. See id.

The Act does not authorize the FDA to ban nicotine in tobacco

products or completely prohibit tobacco product sales. 21

U.S.C. § 387g(d)(3). It calls for regulation that is

“substantially related to accomplishing the public health goals”

of the Act, TCA § 2(30), 123 Stat. at 1778, and that “ensure[s]”

tobacco products will not be “sold or accessible to underage

purchasers,” id. § 3(7), 123 Stat. at 1782.

To those ends, the Act bans the distribution of free samples

of tobacco products. It also requires FDA premarket review of

all new tobacco products, including e-cigarettes. The Act

contains three approval pathways depending on the type of

tobacco product: those that are purely recreational, those

marketed as safer than existing tobacco products (“modified

risk” tobacco products), and those marketed as smoking

cessation products. The Act grandfathers tobacco products

already on the market and, relative to that baseline, requires

manufacturers of any new tobacco product to show that their

product’s public health harms do not exceed its benefits. See

21 U.S.C. § 387j. Modified risk products must meet more

stringent public-health standards. See id. § 387k. And

smoking cessation products must meet the FDA’s even more

exacting standards for a drug or device. See id. § 387k(c). No

e-cigarette has yet sought and received clearance from the FDA

under any of the three pathways.

Nicopure, an e-cigarette manufacturer and distributor, and

an e-cigarette industry group, Right To Be Smoke-Free

Coalition (jointly, Appellants or the Industry) raise three

challenges. First, they argue that the FDA violated the Tobacco

Control Act and the Administrative Procedure Act (APA) by

not providing an easier premarket authorization pathway for e-

5

cigarettes. Then they claim that two provisions of the Tobacco

Control Act violate the First Amendment. They challenge the

premarket review standards applicable to modified risk tobacco

products, contending that the standards impermissibly burden

what they say are truthful, nonmisleading statements about e-

cigarettes. They also challenge the ban on distribution of free

samples of tobacco products, including e-cigarettes, as

suppression of constitutionally protected expressive conduct.

We are unpersuaded by these challenges. E-cigarettes are

indisputably highly addictive and pose health risks, especially

to youth, that are not well understood. It is entirely rational and

nonarbitrary to apply to e-cigarettes the Act’s baseline

requirement that, before any new tobacco product may be

marketed, its manufacturer show the FDA that selling it is

consistent with the public health. What is more, the First

Amendment does not bar the FDA from preventing the sale of

e-cigarettes as safer than existing tobacco products until their

manufacturers have shown that they actually are safer as

claimed. That conclusion is amply supported by nicotine’s

addictiveness, the complex health risks tobacco products pose,

and a history of the public being misled by claims that certain

tobacco products are safer, despite disclaimers and disclosures.

Finally, nothing about the Act’s ban on distributing free e-

cigarette samples runs afoul of the First Amendment. Free

samples are not expressive conduct and, in any event, the

government’s interest in preventing their distribution is

unrelated to the suppression of expression. We accordingly

affirm the district court’s judgment sustaining the Tobacco

Control Act and its application to e-cigarettes.

6

I. Background

A. Tobacco Control Act

In 1996, the FDA concluded an extensive factual

investigation and rulemaking process during which it found

that most smokers begin smoking as adolescents, become

addicted to nicotine, and struggle with that addiction

throughout their lives. Regulations Restricting the Sale and

Distribution of Cigarettes and Smokeless Tobacco to Protect

Children and Adolescents, 61 Fed. Reg. 44,396, 44,398-99

(Aug. 28, 1996). At the time of the study, approximately three

million American adolescents smoked, and 82% of adults who

had ever smoked had their first cigarette before the age of 18.

Id. at 44,398. The FDA determined that one-third of

adolescents who become smokers “will die prematurely as a

result.” Id. at 44,399. Propelled by its findings about health

risks, addiction, and the need for accurate information about

and effective controls on the uses of tobacco products, the FDA

concluded that nicotine was a “drug” that it should regulate

under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

§§ 301 et seq. (FDCA), to protect the public health, see 61 Fed.

Reg. at 44,397.

In response to the Supreme Court’s holding that the FDA

lacked authority under the FDCA to regulate tobacco as a drug,

see FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120

(2000), Congress enacted the Tobacco Control Act to empower

the agency to regulate tobacco products. Congress found that

“nicotine is an addictive drug” and that “[v]irtually all new

users of tobacco products are under the minimum legal age to

purchase such products.” TCA §§ 2(3), (4), 123 Stat. at 1777.

Based on decades of research, Congress made extensive

findings about the public health risks of tobacco use: “A

consensus exists within the scientific and medical communities

7

that tobacco products are inherently dangerous and cause

cancer, heart disease, and other serious adverse health effects.”

Id. § 2(2), 123 Stat. at 1777.

Because more limited approaches had failed to curb

tobacco use, including by adolescents, Congress insisted on

“comprehensive restrictions on the sale, promotion, and

distribution” of tobacco products. Id. § 2(6), 123 Stat. at 1777.

Congress 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 (except for raw materials other than tobacco used in

manufacturing a component, part, or accessory of a tobacco

product).” 21 U.S.C. § 321(rr)(1); see also Sottera Inc. v. FDA,

627 F.3d 891, 897 (D.C. Cir. 2010). The Tobacco Control Act

expressly empowers the FDA to deem new tobacco products

that enter the market to be “tobacco products” subject to the

Act’s requirements. 21 U.S.C. § 387a(b).

In addition to a default premarket authorization pathway,

Congress created a more rigorous pathway for modified risk

tobacco products. The Act defines “modified risk tobacco

products” as those a manufacturer intends to market “for use to

reduce harm or the risk of tobacco-related disease associated

with commercially marketed tobacco products.” 21 U.S.C.

§ 387k(b)(1). The Act established this pathway based on

findings that modified risk tobacco products may encourage

new users to take up tobacco products, rather than simply

reduce risk to those who already use them. TCA § 2(37), 123

Stat. at 1780. Citing a Federal Trade Commission study,

Congress noted that advertisements that claim one tobacco

product is less harmful than another mislead consumers, even

when the putatively less risky products contain “disclosures

and advisories intended to provide clarification.” Id. §§ 2(41),

(42), 123 Stat. at 1780. Congress found that disclaimers and

8

other “[l]ess restrictive and less comprehensive approaches

have not and will not be effective” in communicating risks

associated with tobacco products sold as safer. Id. § 2(31), 123

Stat. at 1779. Congress therefore concluded that “the only way

to effectively protect the public health from the dangers of

unsubstantiated modified risk tobacco products is to empower

the Food and Drug Administration to require that products that

tobacco manufacturers s[ell] or distribute[] for risk reduction

be reviewed in advance of marketing, and to require that the

evidence relied on to support claims be fully verified.” Id.

§ 2(43), 123 Stat. at 1780.

B. Deeming Rule

In April 2014, the FDA issued its proposed rule to deem e-

cigarettes and several other new items “tobacco products”

under the Act. 1 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:

Proposed Rule, 79 Fed. Reg. 23,142 (Apr. 25, 2014). After

accepting and reviewing comments, the FDA in May 2016

issued a final rule, effective August 2016, deeming the new

items tobacco products. 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: Final Rule, 81 Fed. Reg. 28,974 (May 10, 2016)

(Deeming Rule). The FDA concluded that treating e-cigarettes

1

We use the term “e-cigarettes” to refer to the full range of products

that the Industry calls “vapor products” and the FDA calls Electronic

Nicotine Delivery Systems, or ENDS. They go by many other names

as well, including e-cigs, cigalikes, e-hookahs, mods, vape pens,

vapes, and tank systems. In physical form, these devices include

“cigalikes,” designed to look like traditional cigarettes, and

electronic devices that look like other everyday objects, such as flash

drives.

9

(as well as the other new items) as tobacco products—therefore

subject to the Act’s ban on distribution of free samples of

tobacco products and its preclearance pathways for new,

modified risk, and smoking-cessation products—would enable

it to protect consumers from “initiat[ing] tobacco product use

or continu[ing to] us[e] tobacco when they would otherwise

quit.” Id. at 28,976.

The FDA’s Deeming Rule cited to a robust body of

scientific evidence about the uses and risks of e-cigarettes and

explained in detail how the evidence informed the agency’s

decision to subject them to the Act’s requirements. We

summarize some of the FDA’s relevant findings here.

1. Nicotine is highly addictive and harmful, especially to

youth. “Nicotine is one of the most addictive substances used

by humans.” Id. at 28,988 (internal quotation marks and

citation omitted). “[N]icotine is the primary pharmacologic

agent of tobacco that can be absorbed into the bloodstream and

cause addiction.” Id. at 29,047. “[A]ddiction to nicotine is the

fundamental reason that individuals persist in using tobacco

products, and this persistent use contributes to many diseases.”

Id. (internal quotation marks and citation omitted). Even

without the combustion of tobacco solids that is responsible for

so many of the carcinogens associated with conventional

cigarettes, most e-cigarettes contain nicotine at levels that can

be hard to determine, and in some instances deliver more

nicotine than conventional cigarettes. Id. at 29,030-32.

Nicotine has acute toxicity at high doses, id. at 28,981, and

nicotine poisoning is on the rise, id. at 29,035. The Deeming

Rule noted the first death of a toddler from accidental

poisoning from e-liquid. Id. at 29,036. Nicotine acts on both

the brain and the body and can have “detrimental effects on the

cardiovascular system and potentially disrupt the central

10

nervous system,” id. at 29,033; see also id. at 29,047—effects

to which adolescents are “particularly vulnerable,” id. at

29,029. Evidence of nicotine’s effect on animals suggests that

exposure to nicotine before maturity can also disrupt brain

development, decrease attention performance, and increase

impulsivity, with effects lasting long into adulthood. See id. at

28,981, 29,047.

Because of “their developmental stage, and the fact that

brain maturation continues into the mid-twenties, adolescents

and young adults are more uniquely susceptible to biological,

social, and environmental influences to use and become

addicted to tobacco products.” Id. at 29,047. Young people

generally “underestimate the tenacity of nicotine addiction and

overestimate their” ability to stop using it. Id. at 28,981

(internal quotation marks and citation omitted). Most people

addicted to nicotine develop physical dependence before

adulthood, and the addiction becomes lifelong. Id. People who

become addicted to nicotine as adolescents may be at increased

risk of developing substance abuse disorders and various

mental health problems as an adult. See id. at 29,047.

2. E-cigarette liquids and vapor contain chemicals in

addition to nicotine that pose known risks. The aerosol emitted

from e-cigarettes is not simply water vapor; rather, e-cigarette

aerosols have been found to contain at least carbonyls, tobacco

specific nitrosamines, heavy metals, and volatile organic

compounds. Id. at 29,029. E-liquids may contain

formaldehyde, diacetyl, acetyl propionyl and various

aldehydes. Id. at 29,029-31. Aldehydes, “a class of chemicals

that can cause respiratory irritation” and “airway constriction,”

appear in many flavored e-cigarettes, including cotton candy

and bubble gum. Id. at 29,029. One study found that the

flavors “dark chocolate” and “wild cherry” exposed e-cigarette

users to more than twice the recommended workplace safety

11

limit for two different aldehydes. Id. Like secondary smoke

inhalation from conventional cigarettes, exhaled aerosol from

e-cigarettes may include nicotine and other toxicants that can

pose risks for non-users. See id. at 29,031-32.

3. Young customers are especially important for the

tobacco industry, given that eighty percent of adult smokers

start before age 18. See 79 Fed. Reg. at 23,153. A person who

reaches age twenty-six without starting to use cigarettes is

unlikely ever to smoke, Deeming Rule at 29,047, whereas

youth users are likely to become permanently addicted, id. In

developing e-cigarettes, the tobacco industry introduced many

sweet flavors particularly appealing to children, including

“gummy bear” and “bubblegum.” See 79 Fed. Reg. at 23,157.

E-cigarette use is rampant and climbing sharply among

middle and high school students. For example, e-cigarette use

among high school students rose “nearly 800 percent from 1.5

percent in 2011 to 13.4 percent in 2014.” Deeming Rule at

28,984; see also id. at 29,028-29. 2 Middle schoolers and high

schoolers use e-cigarettes more than any other tobacco product.

Id. at 28,984. People addicted to nicotine from using e-

cigarettes may gravitate to conventional cigarettes; in

particular, studies show that youth who use e-cigarettes are

more likely to smoke conventional cigarettes. See id. at 28,985,

29,040-41.

2

Youth e-cigarette use has risen even more since then. The FDA

and Centers for Disease Control and Prevention’s 2019 survey found

that over 5 million young people are currently using e-cigarettes,

with almost 1 million using them daily. Overall, 27.5% of high

schoolers and 10.5% of middle schoolers used e-cigarettes. See

Karen A. Cullen, et al., e-Cigarette Use Among Youth in the United

States, 2019, Journal of the American Medical Association, at E3,

E6 (Nov. 5, 2019).

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4. E-cigarettes have not been shown to reduce the

incidence of conventional smoking. There is “insufficient data

to draw a conclusion about the efficacy of e-cigarettes as a

cessation device,” id. at 29,041; see also 79 Fed. Reg. at

23,152; id. at 23,147, and the Industry is not seeking approval

of e-cigarettes as smoking cessation products, nor is it

instructing users in cessation, see Deeming Rule at 29,037-38.

But e-cigarette manufacturers nonetheless have actively

marketed their products as if they were a safer, healthier

substitute for conventional cigarettes. See id. at 29,039-40.

People addicted to nicotine thus may be misled into turning to

e-cigarettes over evidence-based nicotine reduction therapies.

See id. at 29,039. And people who would avoid combustible

cigarettes as unhealthy may be led to believe that e-cigarettes

are safer. See id. The effect of e-cigarettes is not just to lead

some people away from combustible cigarettes. They also

provide a trendy on-ramp to tobacco use for people who

otherwise might never have used it. See id. at 29,036-37.

Accordingly, while e-cigarettes have been touted as less risky

than combustible cigarettes, those claims remain unproved.

Meanwhile, e-cigarettes clearly have the potential to increase

tobacco use and net health costs for the public as a whole. Id.

at 29,038.

5. There has been very little rigorous or sustained

scientific research on the effects of e-cigarettes. Although

some of their immediate effects have been established, it is too

soon to know their long-term impact. Id. at 28,984; see also id.

at 29,028 (discussing gaps in existing data). Long-term,

population-level research is underway, but has yet to be

completed. Id. at 29,029. Some reports suggest that e-

cigarettes may be safer than regular cigarettes. For instance,

the Industry stresses a study by Public Health England that

concluded e-cigarettes are only five percent as harmful to an

individual user as conventional cigarettes. See Appellants’ Br.

13

6; J.A. 245-357. Because the Public Health England study

relied on data that did not consider the population effects of e-

cigarettes—among several other problems—the FDA, unlike

the Industry, did not find that study “sufficiently conclusive on

the relative risks of using different tobacco products.”

Deeming Rule at 29,029-30.

C. Statutory Scheme

There is no amount of tobacco use that is health-protective

for any individual. Congress in the Act nevertheless decided

to take existing tobacco use in the United States as a baseline

against which to evaluate “risks and benefits to the population

as a whole,” 21 U.S.C. § 387j(c)(4), when assessing the effect

on public health. The FDCA, as amended by the Tobacco

Control Act, uses a range of measures to reduce death and

disease from tobacco use while weaning the public from

widespread nicotine dependence.

Premarket Authorization. In general, all new tobacco

products must be cleared by the FDA before they can be

marketed and sold in the United States. See id. § 387j. 3 The

3

An alternative route for premarket authorization of a new tobacco

product, not directly relevant here, is to show that the new product is

“substantially equivalent” to a product that was already on the market

as of February 15, 2007. See 21 U.S.C. § 387e(j). The Industry

contends that there were no e-cigarettes on the market as of February

15, 2007, so the only relevant approval pathways are those for new

tobacco products not substantially equivalent to a preexisting

product. For its part, the FDA identifies an e-cigarette “that may

have been on the market on February 15, 2007.” Deeming Rule at

28,978. In view of the Industry’s position, we accept its conclusion

that the substantial-equivalence pathway is unavailable to it. By the

same token, an even more streamlined process is also inapplicable

here. Under that process, a product that the FDA concludes has been

14

Act defines a tobacco product as “new” if it was not

commercially marketed in the United States as of February 15,

2007. Id. § 387j(a)(1). The Act thus effectively grandfathers

permission to market tobacco products then already on sale

without premarket review of their public health implications or

their suitability for the purposes for which they are sold. 4 For

new products, the Act requires the FDA to assess their health

effects on the population as a whole (a “population-effects”

standard) in view of both the “likelihood that existing users of

tobacco products will stop using such products,” and the

“likelihood that those who do not use tobacco products will

start[.]” Id. § 387j(c)(4).

Every application for premarket authorization to market a

new tobacco product must contain all extant reports of

investigations of its health risks, a list of ingredients, and

information to show it meets relevant tobacco product

modified in only a minor respect from a product that was already

permissibly marketed under the Act does not require even a

substantial-equivalence report and may sidestep the application

process altogether. 21 U.S.C. §§ 387j(a)(2)(A)(ii), 387e(j)(3).

4

The proposed Deeming Rule included a two-year period (until

November 2018) for manufacturers of any newly-deemed tobacco

product to prepare and file their premarket authorization

applications. 79 Fed. Reg. at 23,174. In August 2017, the FDA

extended those deadlines by four years. See Ctr. for Tobacco

Products, Food & Drug Admin., U.S. Dep’t of Health & Human

Servs., Extension of Certain Tobacco Product Compliance

Deadlines Related to the Final Deeming Rule: Guidance for Industry

(Aug. 2017). As a result, the deadline for new-product premarket

authorization applications for e-cigarettes that were on the market on

August 8, 2016, became August 8, 2022. On July 12, 2019, a federal

district court ordered a new deadline of May 12, 2020. See Am. Acad.

of Pediatrics v. FDA, 399 F. Supp. 3d 479, 487 (D. Md. 2019),

appeal filed No. 19-2130 (4th Cir. Oct. 30, 2019).

15

production standards. See id. § 387j(b)(1). As relevant here,

the FDA “shall deny” the application if, based on the

application and “any other information” in the agency’s

possession, the Secretary finds that:

(A) there is a lack of a showing that permitting such

tobacco product to be marketed would be

appropriate for the protection of the public

health;

...

(C) based on a fair evaluation of all material facts,

the proposed labeling is false or misleading in

any particular; or

(D) such tobacco product is not shown to conform

in all respects to a tobacco product standard in

effect . . . , and there is a lack of adequate

information to justify the deviation from such

standard.

Id. § 387j(c)(2). In brief, a new product must be “appropriate”

for the public health, not make false or misleading claims, and

conform to existing tobacco product standards.

Modified Risk Products. The Act separately regulates

tobacco products sold as safer than other tobacco products. See

21 U.S.C. § 387k. “No person may introduce or deliver for

introduction into interstate commerce any modified risk

tobacco product” that has not been cleared as such by the FDA.

Id. § 387k(a). A modified risk tobacco product is “any tobacco

product that is sold or distributed for use to reduce harm or the

risk of tobacco-related disease associated with commercially

marketed tobacco products.” Id. § 387k(b)(1). The Act further

16

specifies the definition of “a modified risk tobacco product” as

a product—

(i) the label, labeling, or advertising of which

represents explicitly or implicitly that—

(I) the tobacco product presents a lower

risk of tobacco-related disease or is less

harmful than one or more other

commercially marketed tobacco

products;

(II) the tobacco product or its smoke

contains a reduced level of a substance

or presents a reduced exposure to a

substance; or

(III) the tobacco product or its smoke does

not contain or is free of a substance;

(ii) the label, labeling, or advertising of which uses

the descriptors “light,” “mild,” or “low” or

similar descriptors; or

(iii) the tobacco product manufacturer of which has

taken any action directed to consumers through

the media or otherwise, other than by means of

the tobacco product’s label, labeling, or

advertising . . . respecting the product that

would be reasonably expected to result in

consumers believing that the tobacco product

or its smoke may present a lower risk of disease

or is less harmful than one or more

commercially marketed tobacco products, or

17

presents a reduced exposure to, or does not

contain or is free of, a substance or substances.

Id. § 387k(b)(2)(A). A statutory exemption to section

387k(b)(2)(A)(i)(III)’s definition of a modified risk tobacco

product—regarding sale of products as “free of” an identified

substance—was designed for chewing tobacco. The exemption

states that use of the phrases “smokeless tobacco,” “smoke-

free,” and similar defined terms in advertising or labeling a

tobacco product will not alone require that it be reviewed as a

modified risk product under section 387k(b)(2)(A)(i). Id.

§ 387k(b)(2)(C).

The marketing of a modified risk product must “enable the

public to comprehend the information concerning modified

risk and to understand the relative significance of such

information in the context of total health and in relation to all

of the diseases and health-related conditions associated with

the use of tobacco products.” Id. § 387k(h)(1). In granting

premarket approval to a modified risk tobacco product, the

Secretary must take into account the benefit to the health of

individuals and to the population as a whole by reference to the

following information:

(A) the relative health risks to individuals of the

tobacco product that is the subject of the

application;

(B) the increased or decreased likelihood that

existing users of tobacco products who would

otherwise stop using such products will switch

to the tobacco product that is the subject of the

application;

18

(C) the increased or decreased likelihood that

persons who do not use tobacco products will

start using the tobacco product that is the

subject of the application;

(D) the risks and benefits to persons from the use of

the tobacco product that is the subject of the

application as compared to the use of products

[approved] for smoking cessation . . . ; and

(E) comments, data, and information submitted by

interested persons.

Id. § 387k(g)(4).

A product may be marketed as presenting a lower risk of

disease or harm than other tobacco products on the market

(e.g., “safer than combustible cigarettes”) only if “the applicant

has demonstrated that such product, as it is actually used by

consumers,” will—

(A) significantly reduce harm and the risk of

tobacco-related disease to individual tobacco

users; and

(B) benefit the health of the population as a whole

taking into account both users of tobacco

products and persons who do not currently use

tobacco products.

Id. § 387k(g)(1). An applicant for approval to sell a modified

risk tobacco product is therefore held to a more robust public

health standard than a manufacturer of an ordinary new tobacco

product. In particular, the applicant must show that the product

“significantly” reduces harm and the risk of harm from

19

tobacco-related disease to individual users below the risk from

tobacco products they might otherwise use. Id.

§ 387k(g)(1)(A). And rather than meet the ordinary tobacco

product standard that it merely be “appropriate for the

protection of the public health,” id. § 387j(c)(2)(A), the

manufacturer of a modified risk tobacco product must show it

will be a net public health “benefit,” id. § 387k(g)(1)(B).

The Act also establishes a “Special Rule for Certain

Products” with a less demanding and more targeted standard

for the subset of modified risk products that purport to contain

a reduced level or none of an identified substance (e.g., “no

diacetyl”). See id. § 387k(b)(2)(A)(i)(II) & (III). Modified risk

products subject to the Special Rule need not show a prospect

of “significantly” reduced harm or risk to the individual user

and must be only “expected” to benefit the health of the

population as a whole. Id. § 387k(g)(2)(B). A product under

the Special Rule must show only that—

(i) [an authorizing] order would be appropriate to

promote the public health;

...

(iii) scientific evidence is not available and, using

the best available scientific methods, cannot be

made available without conducting long-term

epidemiological studies for an application to

meet the [general standard for modified risk

products]; and

(iv) the scientific evidence that is available without

conducting long-term epidemiological studies

demonstrates that a measurable and substantial

reduction in morbidity or mortality among

20

individual tobacco users is reasonably likely in

subsequent studies.

Id. § 387k(g)(2)(A). The substance identified as reduced or

absent must actually be harmful, the reduction must be

substantial and accurate as labeled, the product must not expose

the consumer to increased levels of other harmful substances,

and consumer perception testing must show that consumers

will not misinterpret a specific claim as an assurance of relative

overall safety. Id. § 387k(g)(2)(B). An applicant under this

Special Rule must also “conduct postmarket surveillance and

studies” and submit the results to the Secretary annually to

allow her to “determine the impact of the order on consumer

perception, behavior, and health and to enable the Secretary to

review the accuracy of the determinations on which the order

was based[.]” Id. § 387k(g)(2)(C)(ii).

Smoking Cessation Products. Products that the FDA

recognizes as “smoking cessation products,” marketed to help

people quit smoking by treating tobacco dependence, are not

considered ordinary or modified risk products, id. § 387k(c),

but are subject to approval as medical drugs or devices under

the FDCA, see id. § 355.

An applicant seeking FDA approval of a new drug or

device must submit “full reports of investigations” showing

that the drug is safe and effective in use. Id. § 355(b)(1). The

FDA and the applicant may meet to discuss the design and size

of clinical trials that will form the basis for the effectiveness

claim. Id. § 355(b)(5)(B). The Secretary may deny an

application if it does “not include adequate tests by all methods

reasonably applicable,” if there is “a lack of substantial

evidence that the drug will have the effect it purports or is

represented to have under the conditions of use prescribed,

recommended, or suggested in the proposed labeling thereof,”

21

or if the proposed labeling is “false or misleading in any

particular.” Id. § 355(d). “[S]ubstantial evidence” under this

standard means “evidence consisting of adequate and well-

controlled investigations, including clinical investigations, by

experts qualified by scientific training and experience to

evaluate the effectiveness of the drug involved[.]” Id. The

FDA has approved as smoking cessation products some

nicotine replacement therapies, such as patches, chewing gums,

and nasal sprays. See Deeming Rule at 28,976, 29,037. New

products proposed for smoking cessation may be treated as

“breakthrough therapies” and fast-tracked through the approval

process. Id. § 387r(a)(1).

Free Sample Ban. Finally, the Act bans the distribution

of free samples of tobacco products. Id. § 387a-1(d)(1); see

also 21 C.F.R. § 1140.16(d)(1). The only exception is for

smokeless tobacco (i.e., chewing tobacco), which may be

distributed for free in “qualified, adult-only” facilities. Id.

§ 387a-1(d)(2).

D. Proceedings in the District Court

In May 2016, the Industry challenged the FDA’s Deeming

Rule and selected provisions of the Tobacco Control Act as

contrary to the APA and the First Amendment. On the parties’

cross-motions for summary judgment, the court sustained the

Act and the Deeming Rule in full. See Nicopure Labs, LLC v.

FDA, 266 F. Supp. 3d 360 (D.D.C. 2017). The district court’s

thorough opinion spans more than 60 pages in the official

reporter.

At the outset, the district court stressed that it “wishes to

reassure the many worried vapers who followed these

proceedings closely that this case is not about banning the

22

manufacture or sale of the devices.” Id. at 367. As the district

court explained,

[a ban] is not what the Deeming Rule does or what it

was intended to accomplish. In the Deeming Rule, the

FDA simply announced that electronic cigarettes, or

electronic nicotine delivery systems (“ENDS”) would

be subject to the same set of rules and regulations that

Congress had already put in place for conventional

cigarettes.

The Rule requires manufacturers to subject their

products to review before marketing them, to tell the

truth when making any claims about their health

benefits, and to warn consumers about the dangers of

nicotine when offering a means to deliver the

substance to consumers. In short, the manufacturers of

e-cigarettes are now required to tell the 30 million

people who use the devices what is actually in the

liquid being vaporized and inhaled.

This case does not pose the question—which is better

left to the scientific community in any event—of

whether e-cigarettes are more or less safe than

traditional cigarettes. The Rule did not purport to take

the choice to use e-cigarettes away from former

smokers or other adult consumers; the issue is whether

the FDA has the authority to require that the choice be

an informed one.

Id. The Industry has not pursued on appeal its broadside

challenge to the FDA’s decision to deem e-cigarettes “tobacco

products” under the Act, including its challenges to relevant

deadlines for e-cigarette compliance. Only the following three

of the district court’s holdings are at issue here.

23

First, the district court held that the FDA’s decision to

subject e-cigarettes to premarket authorization was non-

arbitrary and supported by substantial evidence of nicotine’s

harmful and addictive character, adolescents’ unique

vulnerability to this harm and addiction, and the significant

variability in labeled and actual content of several chemicals

found in e-cigarettes. Id. at 393-95. It held that the FDA

rationally rejected alternatives urged by the Industry in favor

of “premarket review [that] is a creature of statute.” Id. at 397.

Second, the district court held that the modified risk

pathway did not violate the First Amendment. Id. at 419-21.

Although the court thought the pathway imposed a restriction

on speech, it held that it survived the scrutiny applicable to

commercial speech under Central Hudson Gas and Electric

Corporation v. Public Service Commission, 447 U.S. 557

(1980). Applying Central Hudson, the court recognized the

substantial governmental interest in protecting the public

health and preventing unsubstantiated and misleading claims

about relative health benefits, especially where youth are

concerned. Nicopure Labs, 266 F. Supp. 3d at 419-20. The

modified risk pathway “directly and materially” advances

those governmental interests in a reasonably fitting manner, the

court held, because it “does not ban truthful statements about

health benefits or reduced risks; it simply requires that they be

substantiated.” Id. at 421.

Third, the district court held that the ban on free samples

of e-cigarettes was not constitutionally protected speech under

the First Amendment, but a permissible conduct regulation. Id.

at 412-15. It further held that, even if Central Hudson were

applicable to the free sample ban, it meets that standard

because it directly and materially advances the substantial

governmental interest in preventing children and adolescents

24

from gaining access to tobacco products. Id. at 416-17. The

court sustained the FDA’s determination, based on its past

experience with tobacco product giveaways, that no alternative

to a ban on free samples would effectively prevent youth

access, and that the ban is no broader than necessary because it

permits “other, less risky marketing options” for e-cigarettes,

including “discounting sample kits sold in stores to curious

adults.” Id. at 418.

We review the district court’s grant of summary judgment

de novo. See Stand up for California! v. Dep’t of Interior, 879

F.3d 1177, 1181 (D.C. Cir. 2018); Am. Freedom Defense

Initiative v. WMATA, 901 F.3d 356, 363 (D.C. Cir. 2018).

II. Discussion

A. Application of the New-Product Premarket

Authorization Pathway to E-Cigarettes Does Not

Violate the APA

The Industry contends that the FDA arbitrarily subjects e-

cigarettes to the Tobacco Control Act’s premarket

authorization for new tobacco products because it has declined

to “tailor” that process to e-cigarettes, instead imposing a “one-

size-fits-all” regime that the Industry views as inappropriately

“onerous.” Appellants Br. 48. Under the ordinary premarket

authorization pathway, the FDA must deny permission to

market any product that, in light of its effects on the population

as a whole, is not shown to be “appropriate for the protection

of public health.” 21 U.S.C. § 387j(c)(2)(A). The Industry

objects that requiring premarket authorization—and, in

particular, long-term clinical and epidemiological studies to

satisfy the population-effects standard—imposes “enormous

time and financial burdens” that it contends could drive much

of the e-cigarette industry out of business. Appellants Br. 50-

25

54. E-cigarettes are “less risky” to the individual user than

traditional tobacco products, the Industry asserts, and thus

should be subject to less stringent authorization than the Act’s

ordinary premarket pathway. Id. at 4.

The Industry’s claim that the FDA acted arbitrarily is

miscast. The FDA has made no blanket rule excusing e-

cigarettes from the premarket authorization requirement, nor

could it. The premarket approval requirement is in the Act. It

was Congress, not the FDA, that imposed it on new tobacco

products, including e-cigarettes. There is no exemption in the

Act for certain new tobacco products speculated to be less risky

than other new tobacco products. Only tobacco products

consistent with the population-effects standard fulfill the Act’s

requirement that each new tobacco product’s risks not

outweigh its benefits to the public health. Once the FDA

deemed e-cigarettes to be “tobacco products”—a decision

Appellants no longer challenge—e-cigarettes became subject

to premarket authorization and the requirement to meet the

population-effects standard. The “FDA is not authorized to

deviate from this statutory standard.” Deeming Rule at 28,999.

The Industry’s wholesale objection is to Congress’ design, not

to any arbitrariness on the FDA’s part in carrying it out.

In requesting an easier path, the Industry impermissibly

assumes the very public health conclusion that premarket

authorization requires be substantiated before a product may be

sold: that e-cigarettes are no more risky to the population as a

whole than preexisting tobacco products, balancing the

prospect that they may lead existing users to less harmful

products or usage patterns against the risks that existing

tobacco users will postpone reductions or intensify their usage

and that non-users will start. The Industry has failed to show

that the population-effects standard as applied to e-cigarettes is

mismatched to the risks for which it is designed to screen, let

26

alone that the standard would completely prohibit e-cigarettes.

Indeed, as of their complaint in this case, Appellants had not

yet submitted to the process nor sought to work with the FDA

to explore the most efficient appropriate course to make the

requisite determinations regarding any actual e-cigarette.

Notably, although the FDA “may not modify the statutory

pre-market review procedures, the agency has stated that it will

be flexible in reviewing applications to the extent permitted by

statute.” Appellee Br. 26. The Act specifies that “whether

permitting a tobacco product to be marketed would be

appropriate for the protection of the public health shall, when

appropriate, be determined on the basis of well-controlled

investigations,” including “clinical investigations.” 21 U.S.C.

§ 387j(c)(5)(A). But it further provides that, if there is “valid

scientific evidence” other than such investigations that is

“sufficient to evaluate the tobacco product,” the Secretary may

authorize the FDA to make a determination on the basis of that

evidence. Id. § 387j(c)(5)(B). The FDA has expressed

willingness to accept scientific literature reviews instead of

commissioned studies in support of e-cigarette applications in

appropriate circumstances. Deeming Rule at 28,998. In short,

the premarket authorization pathway is a creature of Congress

not subject to challenge under the APA and, in any event,

simply is not the blunt, arbitrary instrument that the Industry

portrays.

B. The First Amendment Does Not Bar “Modified Risk

Tobacco Product” Premarket Review of E-

Cigarettes Designed For Use To Reduce Harm Or

The Risk of Disease

As we have explained, all tobacco products entering the

market after February 2007 must obtain FDA authorization

pursuant to one of three statutory paths, depending on whether

27

the product is (a) a new tobacco product, (b) a new modified

risk tobacco product, or (c) a new smoking cessation product.

The least demanding of those three paths is the standard for a

new tobacco product that is not sold or distributed either for

use to reduce the harm or risk of disease from tobacco

consumption, nor to help the customer quit, but as an ordinary

tobacco product for recreational use by adults. Again, the Act

requires the manufacturer of such a product to establish that,

viewed in the context of products currently on the market, its

new product will not be a step backward for the public health.

The most demanding of the three paths, in contrast, is for new

tobacco products intended to be used for smoking cessation.

Manufacturers of any smoking cessation product must gain

FDA approval by showing its efficacy as a “drug or device” for

curbing addiction. The Industry does not challenge either of

those paths on First Amendment grounds.

The Industry’s First Amendment challenge is focused on

the modified risk product pathway, which applies to products

not cleared for smoking cessation but that the manufacturer

nonetheless seeks to market “for use to reduce harm or the risk

of tobacco-related disease associated with commercially

marketed tobacco products.” 21 U.S.C. § 387k(b)(1). Whether

a product falls in the modified risk category turns on how the

manufacturer describes the product’s characteristics and

intended use. The Industry contends that FDA’s use of a

manufacturer’s claims about its product’s characteristics—

such as a claim that the product is “safer than cigarettes” or

produces “no tar”—to assign the product to the appropriate

review pathway burdens speech in violation of the First

Amendment.

We are unpersuaded for two reasons. First, our precedent

explicitly approves the use of a product’s marketing and

labeling to discern to which regulatory regime a product is

28

subject, and to treat it as unlawful insofar as it is marketed

under a different guise. As we held in Whitaker v. Thompson,

353 F.3d 947 (D.C. Cir. 2004), the FDA’s reliance on a seller’s

claims about a product as evidence of that product’s intended

use, in order that the FDA may correctly classify the product

and restrict it if misclassified, does not burden the seller’s

speech. Second, even if we were to scrutinize the FDA’s

reliance on new tobacco product descriptors as a burden on the

Industry’s commercial speech, the modified risk product

pathway clears First Amendment scrutiny because it is

reasonably tailored to advance the substantial governmental

interest in protecting the public health and preventing youth

addiction.

1. Speech as Evidence of Product Type. In Whitaker, we

approved the FDA’s use of claims made by a “saw palmetto

extract” manufacturer to determine whether the product was

subject to the demanding premarket approval applicable to

drugs, or could be marketed under the less demanding

standards for dietary supplements. 353 F.3d at 223-24. Once

the manufacturer made a “drug claim” regarding treatment of a

disease or its symptoms, it was required to clear the FDA’s

drug approval pathway, and its sale accompanied by a drug

claim without approval as a drug became unlawful. Id. at 953;

see also Village of Hoffman Estates v. Flipside, Hoffman

Estates, Inc., 455 U.S. 489, 502 (1982) (finding exempt from

First Amendment scrutiny a village ordinance that required a

license for sale of certain smoking devices when they were

marketed with intent to be used with marijuana or other illegal

drugs, even though no license was needed to market the same

items for other uses). The modified risk product pathway

similarly regulates only products “sold or distributed for use to

reduce harm[.]” 21 U.S.C. § 387k(b)(1). Just as the

government may consider speech that markets a copper

bracelet as an arthritis cure or a beach ball as a lifesaving

29

flotation device in order to subject the item to appropriate

regulation, so, too, the FDA may rely on e-cigarette labeling

and other marketing claims in order to subject e-cigarettes to

appropriate regulation. See Whitaker, 353 F.3d at 953; cf.

Brown & Williamson, 529 U.S. at 170 (Breyer, J., dissenting)

(“[E]ven in the absence of express claims, the FDA has

regulated products that affect the body if the manufacturer

wants, and knows, that consumers so use the product.”

(citations omitted)).

The Industry seeks to market e-cigarettes as safer than

competitor tobacco products without subjecting them to the

requirements of the corresponding premarket review pathway.

It stresses repeatedly the usefulness of manufacturers’

proposed modified risk characterizations to adult consumers of

tobacco products who might be interested in switching from

traditional cigarettes. It claims that “long-time smokers . . .

look to vapor products in attempts to move away from deadly

cigarettes,” Appellants Br. 2, “vapor products are primarily

used by adult smokers to avoid significant health hazards

associated with cigarettes,” id. at 6, and that “[c]onsumers

routinely seek information that would be helpful when

attempting to move away from cigarettes and learn more about

the features of particular vapor products,” id. at 17. Yet the

Industry seeks to sidestep public-health protections by

avoiding the modified risk product pathway. It does so even as

it fails to address the most risky potential uses: intensified use

rather than diminution by existing tobacco users, and uptake of

e-cigarettes by people, including youth, who otherwise avoid

tobacco products altogether but who are persuaded to try a

modified risk tobacco product as a putatively healthier

alternative.

The Industry would distinguish Whitaker by contending

that the FDA’s modified risk product pathway does not use

30

proffered claims that e-cigarettes are safer than combustible

cigarettes to establish the manufacturer’s intent in marketing

the product, but to regulate the message itself. Reply 5 n.7.

But the same could be said of the FDA regulation in Whitaker

where, unaccompanied by the speech that characterized it, the

extract could be lawfully sold. Deliberately selling an e-

cigarette as less risky without going through the requisite

regulatory review for reduced-risk tobacco products renders

the sale-as-labeled unlawful, just as selling saw palmetto

extract as a drug without FDA premarket approval was

unlawful. It is well established that “commercial speech

related to illegal activity” is not subject to constitutional

protection. Central Hudson, 447 U.S. at 564. “[S]peech

proposing an illegal transaction [is speech] which a

government may regulate or ban entirely.” Hoffman Estates,

455 U.S. at 496.

Under Whitaker, therefore, the FDA does not run afoul of

the First Amendment when it relies on manufacturer statements

defining modified risk products.

2. Permissible Conditions on Commercial Speech. Even

if we view the modified risk pathway as burdening speech, it

passes constitutional muster. The modified risk product

pathway—like the other pathways—applies only to products

containing nicotine, which, as all concede, is an inherently

addictive, dangerous class of products. It authorizes the FDA

to treat marketing of a tobacco product with implicit or explicit

assurances that it is safer than other tobacco products as

making a claim that is misleading until the manufacturer shows

otherwise. The Act does not ban manufacturers from making

accurate claims that their products have less risky attributes,

but requires them to substantiate such claims with evidence of

their overall public health effects in advance of marketing, and

to show that the proposed product as marketed will not mislead

31

consumers as to its safety. If a manufacturer shows its product

is in fact safer, and shows that consumer perception accurately

grasps the nature and limits of any safety claim, the product

will be marketable. Because the Act withholds from market

only those tobacco product claims that, upon review, are found

to be misleading, it bars only commercial speech that by

definition is unprotected by the First Amendment.

Under Central Hudson, a statute regulating commercial

speech that is “neither misleading nor related to unlawful

activity” must clear a three-part test: (1) it must be supported

by a “substantial” governmental interest; (2) it must “directly

advance [that] state interest”; and (3) the speech restriction

must be no “more extensive than is necessary to serve that

interest.” 447 U.S. at 564-66. Placing an obligation on a

manufacturer to demonstrate that an e-cigarette is in fact safer

before it may market it as such easily satisfies this test.

First, the government has a substantial interest in ensuring

that any modified risk statements are accurate and non-

misleading in order to protect consumers from buying a highly

addictive product with a false sense of the risks it presents. To

that end, the modified risk pathway is designed to identify

marketing that would spread specious or unsubstantiated

information and to intervene before those products go on sale.

Congress found that the “dangers of products sold or

distributed as modified risk tobacco products that do not in fact

reduce risk are so high that there is a compelling governmental

interest in ensuring that statements about modified risk tobacco

products are complete, accurate, and relate to the overall

disease risk of the product.” TCA § 2(40), 123 Stat. at 1780.

That interest is especially powerful given that younger

customers are consistently the principal market for new

tobacco products. The Supreme Court has acknowledged that

“tobacco use, particularly among children and adolescents,

32

poses perhaps the single most significant threat to public health

in the United States.” Brown & Williamson, 529 U.S. at 161;

see also Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 528

(2001) (“The governmental interest in preventing underage

tobacco use is substantial, and even compelling[.]”). The

Industry itself concedes, as it must, that Congress “articulated

. . . a compelling interest in protecting the public from

unsubstantiated claims that one tobacco product is safer than

another.” Appellants Br. at 20. Given the addictive nature of

nicotine and the unexamined health effects of e-cigarettes, that

substantial interest amply supports protecting the public health

from the dangers of e-cigarette use encouraged by

unsubstantiated, misleading claims of relative safety.

Second, the modified risk product pathway directly

advances this substantial interest. Regulating lawful but

addictive and harmful products in a manner protective of the

public health presents distinct challenges: Products that may

help addicted consumers to transition to less harmful ones may

promote the public health, whereas products that appeal to new

users are virtually certain to harm it. These products call for

rigorous and balanced assessment, especially when a single

product may hold both kinds of potential. The modified risk

product pathway codifies that balanced scientific review.

The modified risk product pathway regulates only those

products marketed as safer than those already on the market.

A manufacturer may not introduce any new tobacco product,

even under the ordinary premarket authorization pathway, until

the FDA considers its population-wide impact and is satisfied

that, considering both individual and population effects, it is in

fact “appropriate” for the protection of the public health. 21

U.S.C. §§ 387j(c)(2)(A), (4). Under the modified risk product

pathway, a manufacturer seeking to sell its product as less risky

must likewise take into account “both users of tobacco products

33

and persons who do not currently use tobacco products,” id. at

§ 387k(g)(1)(B), but must meet a standard higher than is

required of ordinary tobacco products. Such a product must be

more than “appropriate” for the public health; a modified risk

product requires a demonstration that it will “significantly”

reduce harms and risks of tobacco-related disease to individual

users, id. at § 387k(g)(1)(A), and will “benefit” the health of

the population as a whole, id. at § 387k(g)(1)(B).

Requiring those showings directly advances the

government’s interest in accuracy and public health. Given

that no tobacco product has ever been shown to be safe,

Congress ensured that the FDA will not lightly authorize the

sale of tobacco products as carrying reduced health risk. The

modified risk standard requires a showing of significant harm

reduction and clear net benefit in order to ensure that any claim

that describes a tobacco product as safer is justified. To offset

risks of intensified use of products perceived as safer, the

manufacturer must show benefits to the individual and the

public as a whole. A new product sold as less risky because it

reduces harm to an individual who already smokes may

misrepresent its public health benefits if it “raises the aggregate

number of people (especially juveniles) who use tobacco

because it leads them to believe that an unsafe product is

relatively safe[.]” Discount Tobacco City & Lottery Inc. v.

United States, 674 F.3d 509, 536 (6th Cir. 2012).

The Act’s “Special Rule” for certain products in the

modified risk category also directly advances the government’s

interest by preventing misleading marketing of products sold

as free of or containing a reduced level of a substance. 21

U.S.C. § 387k(g)(2)(A)(ii). It sets out for those products a less

stringent standard; they need not meet the “significant”

reduction of harm standard, and also need only be “expected to

benefit the health of the population as a whole.” Id.

34

§ 387k(g)(2)(B)(iv). That standard applies where the

manufacturer is able to establish that (1) the reduction claim is

accurate and the overall reduction in exposure to the substance

at issue is substantial, (2) the product does not expose

consumers to higher levels of other harmful substances, and

(3) consumer testing shows that consumers will not be misled

by the claim. Id. § 387k(g)(2)(B)(i)-(iii). Each element of the

inquiry is targeted towards ensuring that any specific-substance

claim that consumers may understand as a relative safety claim

is accurate and not misleading.

The modified risk product pathway therefore passes

Central Hudson’s second requirement that it directly advance

Congress’ substantial interest in promoting the public health by

preventing misleading information about a highly addictive

product.

Finally, the modified risk product pathway meets Central

Hudson’s third requirement that the regulation be “not more

extensive than necessary” to serve the government’s interest.

Central Hudson, 447 U.S. at 566. This is the heart of the

Industry’s challenge. In making this “fit” determination, “the

least restrictive means is not the standard; instead, the case law

requires a reasonable fit between the legislature’s ends and the

means chosen to accomplish those ends[.]” Lorillard Tobacco,

533 U.S. at 556 (internal quotation marks and citations

omitted).

The modified risk pathway is reasonably tailored to

prevent the sale of highly addictive, risky products on terms

that are likely to mislead consumers. Congress found that “the

only way to effectively protect the public health from the

dangers of unsubstantiated modified risk tobacco products is to

empower the Food and Drug Administration to require that

products that tobacco manufacturers s[ell] or distribute[] for

35

risk reduction be reviewed in advance of marketing, and to

require that the evidence relied on to support claims be fully

verified.” TCA § 2(43), 123 Stat. at 1780. As applied to the

proposed marketing of e-cigarettes as less risky than other

products—whether generally or by specifying that they contain

less or none of a particular substance—the modified risk

pathway appropriately requires that manufacturers substantiate

their safety claims in advance. The modified risk product

pathway’s Special Rule accommodates the more concrete

nature of claims that a tobacco product is free of or contains a

reduced level of a particular substance by accepting a more

focused and conditional showing.

The Industry primarily highlights its desire to promote

products as involving reduced levels of harmful substances.

The Special Rule for such products is tailored to allow the

manufacturer to argue that scientific evidence establishing its

appropriateness for the public health is unavailable and not

easily attainable, 21 U.S.C. § 387k(g)(2)(A)(iii), and to instead

submit a lesser showing followed by post-market monitoring

of the product’s impact on consumers, id. § 387k(g)(2)(C)(ii).

The pathway thus reasonably tailors the requisite substantiation

to the type of product. For products marketed as generally less

harmful, scientific studies must show that a “substantial

reduction in morbidity or mortality among individual tobacco

users occurs” with their use, whereas for those marketed under

the Special Rule only as less harmful because they contain a

reduced level of a substance, the manufacturer must show only

that reduced morbidity and mortality is “reasonably likely.” Id.

§ 387k(l)(1)(A) (emphasis added). The FDA is entitled to

impose these reasonable requirements on manufacturers of

products containing nicotine—like makers of dangerous or

potentially dangerous pharmaceuticals—to show at the

threshold that their marketing claims are accurate and not

misleading.

36

The Industry objects that its claims cannot constitutionally

be subject to premarket approval because, in its view, they are

accurate. But modified risk claims that might be technically

accurate if viewed in isolation are in fact often misunderstood

by consumers. In particular, consumers have been misled

about the health consequences of claims that a tobacco product

did not contain or contained reduced level of a harmful

substance: “[M]any smokers mistakenly believe that ‘low tar’

and ‘light’ cigarettes cause fewer health problems than other

cigarettes,” which “can reduce their motivation to quit smoking

entirely and thereby lead to disease and death.” TCA § 2(38),

123 Stat. at 1780. By the same token, product labeling or

advertising that touts an e-cigarette as free of a specified

ingredient may mislead consumers to view the product as

generally safer, even if other chemicals it contains, such as

formaldehyde, are equally or more harmful than the disclaimed

ingredient. The Industry’s claims of accuracy are

unsubstantiated, and it has yet to submit an application with

appropriate consumer-perception evidence.

The First Amendment test of regulation of potentially

misleading commercial speech allows for contextual

determination of accuracy based on consumers’ understanding.

In evaluating regulation of commercial speech to prevent

misleading claims, we look to whether “consumers acting

reasonably under the circumstances” would understand a

product claim to contain a false message. POM Wonderful,

LLC v. FTC., 777 F.3d 478, 499-500 (D.C. Cir. 2015). In

appropriate circumstances, even “innuendo” or an “overall net

impression” received by a “significant minority of reasonable

consumers” can mean that a statement is misleading to

consumers. Id. at 490. Because the rationale supporting First

Amendment protection of commercial speech is “the

informational function of advertising,” “[t]he government may

37

ban forms of communication more likely to deceive the public

than to inform it.” Central Hudson, 447 U.S. at 563. And

“misleading commercial speech is not only subject to restraint;

‘[it] may be prohibited entirely.’” Ass’n of Private Sector

Colleges & Univs. v. Duncan, 681 F.3d 427, 457 (D.C. Cir.

2012) (quoting In re R.M.J., 455 U.S. 191, 203 (1982)). That

is because “elimination of false and deceptive [advertising]

claims serves to promote the one facet of commercial price and

product advertising that warrants First Amendment

protection—its contribution to the flow of accurate and reliable

information relevant to public and private decisionmaking.”

Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer

Council, Inc., 425 U.S. 748, 781 (1976) (Stewart, J.,

concurring).

Moreover, when the speech in question addresses matters

on which the “public lacks sophistication,” then

“misstatements that might be overlooked or deemed

unimportant in other advertising may be found quite

inappropriate[.]” In re R.M.J., 455 U.S. at 200. The

importance and complexity of assessing the effectiveness of

one lawyer versus another, for example, supports the

constitutionality of regulating attorney advertising to “correct

omissions that have the effect of presenting an inaccurate

picture[.]” Id. at 201. So too here. The modified risk pathway

seeks to enable “the public to comprehend the information

concerning modified risk and to understand the relative

significance of such information in the context of total health

and in relation to all of the diseases and health-related

conditions associated with the use of tobacco products.” 21

U.S.C. § 387k(h)(1). Tobacco products are by definition

harmful and addictive, and choosing among them based on

comparative safety is inherently risky and complex, making the

public especially susceptible to being misled and harmed.

38

Congress’ knowledge of the history of tobacco marketing

strongly supports its decision to require premarket approval to

prevent misleading marketing of some tobacco products as less

risky than others. The record is clear that tobacco

manufacturers used unsubstantiated or false modified risk

claims about tobacco products to entice consumers to use and

become addicted to them. See Discount Tobacco, 674 F.3d at

534-45. Those statements proved especially consequential in

the marketing of addictive, dangerous products. Many people

“who would not otherwise consume tobacco products, or

would consume such products less,” were induced to use

hazardous products marketed as safer and healthier, and

millions struggled with a lifetime of addiction as a result. Id.

§ 2(37), 123 Stat. at 1780.

In the e-cigarette context, the FDA found that marketing

of e-cigarettes as less risky had already led consumers

(especially young adults) to “often mistakenly think non-

cigarette tobacco products are safe alternatives to cigarettes.”

79 Fed. Reg. at 23,146. Consumers have frequently and

erroneously read narrow safety statements about an identified

substance as materially complete claims that the product is safe

overall. Accordingly, for claims that e-cigarettes contain a

reduced level or are free of a dangerous substance, the modified

risk pathway fittingly requires the “testing of actual consumer

perception” to show that “consumers will not be misled into

believing that the product . . . is or has been demonstrated to be

less harmful” more broadly, or “to present less of a risk of

disease” overall than other commercially marketed tobacco

products. 21 U.S.C. § 387k(g)(2)(B).

In attempts to show that the regulation is more extensive

than necessary, the Industry presents alternative approaches

that it asserts the government was required to have taken

39

instead of the modified risk product pathway. None is

convincing.

First, the Industry contends that Congress could have

required disclaimers on modified risk products in order to

clarify any misleading statements. But Congress considered

and rejected that option, finding that disclaimers had been

ineffective to prevent deceptive tobacco marketing in the past.

TCA § 2(41), 123 Stat. at 1780. As Congress noted, tobacco

advertisements “in which one product is claimed to be less

harmful than a comparable product, even in the presence of

disclosures and advisories intended to provide clarification, are

misinterpreted by consumers.” Id. The risk of

misinterpretation regarding a highly addictive product supports

the FDA’s choice of preclearance over a disclaimer

requirement.

Second, the Industry argues that post-market enforcement

would address the FDA’s concerns, and that the FDA did not

adequately consider requiring manufacturers to maintain

records substantiating their product characterizations that

could subsequently be inspected by the FDA. Each of those

suggestions seeks to place the onus on the government, rather

than on manufacturers. Each would require the FDA to

investigate the harms of an open-ended litany of substances

that might appear in e-cigarettes, and to continually test

products for their presence. Restricting the government’s

regulatory options in that way is inappropriate for products

containing harmful and addictive substances about which the

public is known to be easily misled and about which the

manufacturer has superior information. The FDA has already

noted inaccuracies in claims made by various e-cigarettes about

their nicotine content, see, e.g., Deeming Rule at 29,034, and

significant variability between labeled and actual content of

various chemicals, id. at 28,984. Once inaccurate or

40

misleading information influences people to start using a

powerfully addictive substance, damage has been done.

This is not, therefore, a case in which the government has

not “offered any reason why” alternative, less restrictive

regulations would fall short in protecting the public interest.

Thompson v. Western States Med. Ctr., 535 U.S. 357, 373

(2002). Instead, taking into account a highly addictive product

with known and unknown health risks, and a history of claims

likely to mislead many people down a path of lifelong

addiction, the modified risk product pathway is a fitting means

to protect the accuracy of information and the public health.

The Industry’s reliance on Sorrell v. IMS Health Inc., 564

U.S. 552 (2011), is also misplaced. The Court in Sorrell held

that barring pharmaceutical companies from accessing doctors’

records of prescriber information unconstitutionally restricted

“sophisticated and experienced consumers,” namely

prescribing physicians, from accessing “truthful,

nonmisleading advertisements” that would have aided them in

making more informed prescription decisions. Id. at 577-78

(internal quotation marks and citation omitted). In contrast,

here, the consumers most likely to be targeted and misled by

the two types of modified risk products are not sophisticated

professional physicians, but ordinary laypeople, including

adolescents. They are not choosing from a range of potentially

beneficial health options in line with their professional

obligations; they are considering whether to take up use of an

indisputedly unhealthy, addictive tobacco product.

And, unlike the statute in Sorrell, the modified risk product

pathway does not create a blanket ban on information going to

one speaker while placing no restrictions on its dissemination

to others. The Court in Sorrell faulted the regulation for

keeping objective information—lists of prescribers—from

41

pharmaceutical marketers while private and academic

researchers were free to buy and use the same information. Id.

at 563. But here, there is no analogous information that others

may use that the Industry may not. First, the modified risk

product pathway does not impose an absolute bar, but allows

e-cigarette manufacturers to make marketing claims that they

have shown are accurate and nonmisleading. Products

accompanied by descriptive claims are therefore not excluded

from the marketplace of information, only evaluated first to

prevent them from misleading consumers. Second, the

Industry has identified no actor other than the FDA that it

contends may—without premarket approval—make the claims

it seeks to make in connection with a commercial transaction.

Sorrell’s concerns about suppression of advertising messages

in the marketplace of ideas are inapposite here, where the

products are acknowledged to be risky and addictive, are

subject to premarket approval, not a ban, and no comparable

speech by others is permitted.

Finally, the Industry points out that the Act permits

smokeless tobacco—also known as chewing tobacco—to be

marketed as “smokeless” or “smoke free” without being

cleared as a modified risk product, while the same terms cannot

be used to describe e-cigarettes. 21 U.S.C. § 387k(b)(2)(C). It

contends this is an “arbitrary distinction[]” not “permitted

under the First Amendment.” Appellants’ Br. 28. The

regulatory treatment of chewing tobacco calls into question the

government’s interest in regulating e-cigarettes, they claim,

just as the exemption of tribal casinos from a broadcast-

advertising ban on casino gambling in Greater New Orleans

Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 193

(1999), undermined the government’s asserted interest in

curbing gambling’s social costs. See also Rubin v. Coors

Brewing Co., 514 U.S. 476, 488-89 (1995) (invalidating

alcohol-content labeling restriction applicable to beer, but not

42

wine and spirits). But the exemption for smokeless tobacco

products is not arbitrary.

Congress concluded that chewing tobacco could be

identified as “smokeless” without pre-approval for two

reasons. First, chewing tobacco has for decades been identified

as “smokeless” to distinguish its intended use from smoking

tobacco sold loose for roll-your-own cigarettes or pipes. See

21 U.S.C. § 387(18) (“[A]ny tobacco product that consists of

cut, ground, powdered, or leaf tobacco and that is intended to

be placed in the oral or nasal cavity.”). This rationale is

inapplicable to e-cigarettes. Second, unlike e-cigarettes, which

involve heating of e-liquid and inhalation of the resulting vapor

into the lungs, chewing tobacco is not inhaled. Deeming Rule

at 28,987; see Competitive Inst. v. U.S. Dep’t of Transp., 863

F.3d 911, 919 (D.C. Cir. 2017) (sustaining a rule that prohibits

e-cigarette use on airplanes, in part because “e-cigarette vapor

in confined aircrafts could harm non-users”). To the extent that

consumers may view “smokeless” as a claim about relative

pulmonary risk, decades of experience supports the FDA’s

allowance of that claim for chewing tobacco whereas the FDA

lacks any similar track record regarding e-cigarettes. This

narrow and justified exception is not the kind of fatal

inconsistency that might call into question the government’s

interest in promoting public health through preventing the

commercial dissemination of misleading speech about new

tobacco products.

In sum, even if the modified risk product pathway is

treated as a speech restriction that implicates the First

Amendment, it meets the Central Hudson standard, as well as

any further scrutiny under Sorrell.

43

C. The Free Sample Ban Does Not Violate the

First Amendment.

Finally, Appellants challenge the Act’s ban on free

samples of tobacco products as applied to e-cigarettes. 21

U.S.C. § 387a-1(a)(2)(G); 21 C.F.R. § 1140.16(d)(1).

Distribution of free samples as a marketing technique seeks to

entice people who otherwise would not try a product to use it

and, based on their experience, to continue doing so. But

products given out for free are often not consumed by their

immediate recipients, who may have little or no interest in the

giveaways so set them aside where curious children can find

them. The purpose of the e-cigarette sample ban is to eliminate

an easily accessible source for youth that are especially

vulnerable to the risks of tobacco use and addiction. See

Deeming Rule at 28,986.

The Industry argues that the free sample ban is a violation

of e-cigarette manufacturers’ First Amendment right to

freedom of expression. But the ban targets conduct, not

speech, and it is far from clear how that conduct is expressive.

As the district court noted, the Industry has not identified the

“entirely unstated” message it believes is silenced by the free

sample ban. Nicopure Labs, 266 F. Supp. 3d at 413. The

Industry says that free samples are “expressive” because they

“convey[] important information to smokers who want to

switch to vapor products, including key consumer information

about different e-liquid flavors and device performance

characteristics.” Appellants’ Br. 11-12. Free samples are, in

the Industry’s view, “the quintessential example of what the

First Amendment protects in the commercial context” because

they are “the most effective and efficient means of obtaining

product-specific information when trying to switch away from

deadly cigarettes.” Id. at 35. The Industry thus appears to be

urging us to afford constitutional protection to the

44

informational value of customers’ experience trying out

vaping, including the experience of sampling the available

flavors and sensations.

This extraordinary argument, if accepted, would extend

First Amendment protection to every commercial transaction

on the ground that it “communicates” to the customer

“information” about a product or service. Even if we could

bridge the gap between the opportunity to use a product and the

expression of an “idea,” the Supreme Court has long rejected

the “view that an apparently limitless variety of conduct can be

labeled ‘speech’ whenever the person engaging in the conduct

intends thereby to express an idea.” United States v. O’Brien,

391 U.S. 367, 376 (1968); see also Barnes v. Glen Theatre,

Inc., 501 U.S. 560, 570 (1991). Indeed, “[i]t is possible to find

some kernel of expression in almost every activity a person

undertakes—for example, walking down the street or meeting

one’s friends at a shopping mall—but such a kernel is not

sufficient to bring the activity within the protection of the First

Amendment.” City of Dallas v. Stanglin, 490 U.S. 19, 25

(1989). The services offered at a particular hotel may in part

be intended to encourage a guest to return there the next time

she travels, and eating a certain brand of fast food or breakfast

cereal may inform a family about whether it is a type of food

that suits them. But the seller’s intention that those experiences

leave consumers with helpful information that encourages

future purchases does not convert all regulation that affects

access to products or services into speech restrictions subject

to First Amendment scrutiny.

Even if the e-cigarette free sample ban somehow imposed

an incidental speech burden, the restriction itself applies to

conduct and is imposed “for reasons unrelated to the

communication of ideas,” so would not implicate the First

Amendment. Lorillard Tobacco, 533 U.S. at 569. The free

45

sample ban is not directed at the communication of

information, but at the danger that children—to whom e-

cigarettes cannot legally be sold—will obtain and use them. It

is well documented that free samples of tobacco products “give

young people a risk-free and cost-free way to satisfy their

curiosity about tobacco products,” and can be an introduction

into lifelong addiction. Deeming Rule at 28,986 (internal

quotation marks and citations omitted). Young people tend to

be more price sensitive than adult consumers, so are

particularly susceptible to becoming exposed through free

samples. TCA § 2(24), 123 Stat. at 1778; see also Deeming

Rule at 28,986. The ban does not seek to restrict the

manufacturer’s ability to communicate, but only to distribute

its product free of charge. It leaves open many ways to help

customers make product choices. It permits manufacturers to

sell sample kits and retail facilities to “allow customers to

touch, hold, and smell their products without violating the free

sample ban.” Deeming Rule at 29,055. The prohibition against

distributing e-cigarettes for free is a conduct regulation that

readily clears the rational-basis review applicable to ordinary

market regulation.

The free sample ban’s character as a conduct restriction is

underscored by its bearing only on product price: Under

section 1140.16(d)(1), manufacturers may not offer e-

cigarettes at zero dollars. 21 C.F.R. § 1140.16(d)(1). The

Supreme Court in Expressions Hair Design v. Schneiderman,

137 S. Ct. 1144 (2017), recently reaffirmed that ordinary price

regulation does not implicate constitutionally protected speech.

The surcharge ban at issue in Expressions Hair Design was

“not like a typical price regulation,” the Court observed,

because—unlike the bar here against charging $0 for e-

cigarettes—it did not actually restrict price; it prohibited sellers

from quoting a credit card “surcharge” above the cash price,

and directed that they instead offer a “discount” for paying

46

cash. Id. at 1150. That regulation, limited to the retailer’s

characterization of the incremental price difference, was

designed to send a particular message about the charge. That

is why, the Court held, it implicated speech in a way that an

ordinary price restriction would not. Id. at 1150 (citing 44

Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 507 (1996)

(plurality opinion) (minimum prices or taxes would not restrict

speech); id. at 524 (Thomas, J., concurring in part and

concurring in the judgment); id. at 530 (O’Connor, J.,

concurring in the judgment)). The Court emphasized that a

typical price restriction is constitutionally valid—even though

it incidentally regulates the content of speech through requiring

the seller to communicate only the lawful price. Expressions

Hair Design, 137 S. Ct. at 1150-51. But such a law’s “effect

on speech would be only incidental to its primary effect on

conduct, and ‘it has never been deemed an abridgment of

freedom of speech or press to make a course of conduct illegal

merely because the conduct was in part initiated, evidenced, or

carried out by means of language, either spoken, written, or

printed.’” Id. at 1151 (quoting Rumsfeld v. Forum for Acad. &

Inst. Rights, Inc., 547 U.S. 47, 62 (2006)) (further citations

omitted). The ban on free tobacco product samples is no

different from a typical price restriction; it simply prevents

purveyors from offering their e-cigarettes for free, and the

Industry identifies no speech component like the price-related

commentary in Expressions Hair Design that would implicate

the First Amendment.

The constitutionality of the prohibition against free e-

cigarettes samples is unaffected by the Act’s allowance for

distribution of free samples of chewing tobacco at “qualified,

adult-only” facilities. See 21 U.S.C. § 387a-1(a)(2)(G); 21

C.F.R. § 1140.16(d)(2). To the Industry, that exception shows

the ban “guards against youth access for one product” but

“irrationally risks access to another.” Appellants’ Br. 42.

47

Because the sample ban does not regulate expression, the

exception for chewing tobacco is permissible so long as it is

not “so arbitrary as to fail the rational basis test.” Glickman v.

Wileman Bros. & Elliott, Inc., 521 U.S. 457, 496 (1997).

Anyone with even basic awareness of e-cigarettes and chewing

tobacco, and their differential health consequences for and

uptake by youth, will readily discern rational reasons to treat

free samples of chewing tobacco differently from free samples

of e-cigarettes. E-cigarettes are discreet and trendy in a way

that chewing tobacco is not. Additionally, Congress’ limited

exemption for free samples of chewing tobacco in specified,

controlled circumstances reflects Congress’ knowledge of

youth access and usage derived from years of experience. As

the Industry concedes, no comparable information exists for e-

cigarettes. Additionally, users of e-cigarettes inhale into their

lungs myriad potentially hazardous substances not limited to

those derived from tobacco. Congress’ decision to exempt

chewing tobacco but not e-cigarettes from the free sample ban

readily survives rational basis review.

The Industry points to Discount Tobacco as support for its

characterization of the free sample ban as “an attempt to

regulate the ‘communicative impact’ of the activity, not the

activity itself.” 674 F.3d at 539. The Sixth Circuit addressed

a regulation covering a range of clearly communicative

promotional activities—including the distribution of tobacco-

branded merchandise (t-shirts, baseball caps, bobblehead dolls)

and event sponsorships—together with a prohibition on free

product samples, and its First Amendment analysis grouped

them together as “marketing bans.” Id. We do not agree that

banning the free distribution of a tobacco product itself is

properly equated for First Amendment purposes with a ban on

giving away logoed merchandise or sponsoring events in order

to promote a brand. Even treating the sample ban as a

“marketing ban,” however, the Discount Tobacco court

48

concluded that any burden on the expressive element of free e-

cigarette samples was easily justified by the FDA’s

“overwhelming evidence” of the danger that free samples fall

into the hands of young people. Id. at 541. The court held that,

although “an opportunity for an underage nonsmoker to

actually try a tobacco product, at no cost, may serve as the best

advertisement of all for a product that is physiologically

addictive, and socially attractive to youth, . . . placing cigarettes

and other tobacco products into the hands of minors clearly

undermines the purposes and interests undergirding the Act.”

Id. The court thus concluded that “[b]anning such practices

embodies a narrow fit between the harm articulated and the

restriction employed.” Id.

The same rationale provides added support for application

of the free sample ban to e-cigarettes. The Industry urges us to

distinguish Discount Tobacco on the ground that

“consideration of costs and benefits for vapor products is much

different than for the cigarettes at issue” in that case, because

where e-cigarettes are concerned, “consumers are searching for

truthful information regarding a novel and potentially life-

saving product category.” Appellants’ Br. at 46-47. Given the

relatively unknown and potentially grave risks of e-cigarettes

to all users, and their extraordinary allure to middle and high

school students, we cannot agree.

* * *

For the reasons discussed above, we hold that the Tobacco

Control Act’s premarket authorization pathway for new

products does not violate the APA, and that both the

preclearance pathway for modified risk products and the free

sample ban are constitutional. Accordingly, we affirm the

district court’s judgment.

So ordered.