Nicopure Labs, LLC v. FDA ( 2019 )

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).
12
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.