Nicopure Labs, LLC v. Food & Drug Admin.

944 F.3d 267

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

No. 17-5196

United States Court of Appeals, District of Columbia Circuit.

Argued September 11, 2018

Decided December 10, 2019

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, 120 S.Ct. 1291, 146 L.Ed.2d 121 (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....