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Nicopure Labs, LLC v. Food & Drug Administration

United States Court of Appeals, District of Columbia Circuit

December 10, 2019

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

          Argued September 11, 2018

          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.

          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.

          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.


          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- 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- 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.

         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 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 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 (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 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 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.

         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. 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 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 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 ...

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