United States Court of Appeals, District of Columbia Circuit
Nicopure Labs, LLC and Right To Be Smoke-Free Coalition, Appellants American E-Liquid Manufacturing Standards Association, et al., Appellees
Food & Drug Administration, et al., Appellees
September 11, 2018
from the United States District Court for the District of
Columbia (No. 1:16-cv-00878)
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.
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.
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.
W. Bryan was on the brief for amicus curiae Consumer
Advocates for Smoke-Free Alternatives Association in support
L. Andrews and Richard A. Samp were on the brief for amicus
curiae Washington Legal Foundation in support of
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
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.
L. Nelson, Allison M. Zieve, and Julie M. Murray were on the
brief for amicus curiae Public Citizen, Inc. in support of
Charles Sims was on the brief for amici curiae First
Amendment Scholars in support of defendants-appellees.
Greenwold, Carlos T. Angulo, and Andrew N. Goldfarb were on
the brief for amici curiae Public Health Groups in support of
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.
Pillard Circuit Judge.
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.
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- 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.
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.
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-
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.
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.
Tobacco Control Act
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.
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 that tobacco products are inherently dangerous
and cause cancer, heart disease, and other serious adverse
health effects." Id. § 2(2), 123 Stat. at
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).
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 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.
April 2014, the FDA issued its proposed rule to deem
e-cigarettes and several other new items "tobacco
products" under the Act. 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 (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.
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
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.
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 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.
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.
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 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.
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.
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. 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.
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.
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. 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.
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.
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. The 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. 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).
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
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 ...