Trial News

The D.C. Circuit has affirmed that the Family Smoking Prevention and Tobacco Control Act (TCA) empowers the FDA to regulate e-cigarettes. The decision, in which the court rejected industry challenges to the FDA’s authority, came weeks before the Trump administration announced a ban on the sale of most flavored e-cigarette cartridges to try to curb teen usage. (Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019).)

In response to a U.S. Supreme Court decision that the FDA could not regulate tobacco as a drug (FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000)), Congress passed the TCA, which set a new standard requiring FDA premarket approval of tobacco products entering the market after Feb. 15, 2007. It also created three different approval pathways for recreational products, products marketed as “safer” or having a “modified risk,” and products marketed as tools to quit smoking. With a limited exception for smokeless tobacco, the TCA also banned the distribution of free samples of tobacco products.

In April 2014, as authorized by the TCA, the FDA issued a proposed rule to deem e-cigarettes “tobacco products” and therefore subject to the act’s requirements. The FDA referenced a wealth of data about the risks of nicotine use and e-cigarettes—including their appeal to youth—and argued that treating these products like tobacco would help the agency protect public health.  

In May 2016, Nicopure Labs, LLC, and the Right To Be Smoke-Free Coalition, an e-cigarette manufacturer and industry group, sued the FDA, challenging the rule and several provisions of the TCA. Both parties moved for summary judgment, and the district court “sustained the Act and the [rule] in full.” On appeal, the manufacturer challenged three of the district court’s findings—but notably dropped its earlier claim that the FDA acted improperly when it deemed e-cigarettes to be tobacco products.

First, the manufacturer argued that the FDA’s decision to require e-cigarettes to undergo the same premarket approval processes as other tobacco products was unlawfully arbitrary under the Administrative Procedure Act. But the D.C. Circuit found that this claim mischaracterized the FDA’s obligations under the TCA, which requires the agency to follow set premarket authorization procedures for any tobacco product. Therefore, the manufacturer’s “wholesale objection is to Congress’ design, not to any arbitrariness on the FDA’s part in carrying it out.”

Second, the manufacturer claimed that the pathway for “modified risk” products violates the First Amendment. Due to findings that these tobacco products may actually encourage consumers to start smoking—not simply reduce the risk to existing users—the TCA empowers the FDA to mandate that they “be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully verified.” To determine whether a product should be subject to the modified risk pathway, the FDA relies on the manufacturer’s description of the product—for example, a claim that a tobacco product contains less tar. The e-cigarette manufacturer argued that this unconstitutionally burdened its ability to speak about its products.

Citing Whitaker v. Thompson (353 F.3d 947 (D.C. Cir. 2004)), the D.C. Circuit agreed with the district court that the FDA may rely on a seller’s statements to classify a product and that even if this reliance burdens commercial speech, that burden is not unconstitutional. The court wrote that “[p]lacing an obligation on a manufacturer to demonstrate that an e-cigarette is in fact safer before it may market it as such easily satisfies” the test established in Central Hudson Gas and Electric Corp. v. Public Service Commission (447 U.S. 557 (1980)), which requires that statutes limiting commercial speech support a substantial government interest, directly advance that interest, and limit speech only to the extent necessary to further that interest. The court quoted the district court’s conclusion that the modified risk pathway advances the government’s interest in protecting public health, “particularly where youth are concerned,” and that the modified risk pathway is properly balanced because “it does not ban truthful statements about health benefits or reduced risks; it simply requires that they be substantiated.”

Finally, the e-cigarette manufacturer claimed that the TCA’s ban on free samples of e-cigarettes violates its First Amendment right to freedom of expression, in part because it argues that free samples “are the most effective and efficient means of obtaining product-specific information when trying to switch away from deadly cigarettes.” The court rejected this position, noting that the ban “targets conduct, not speech,” and that the manufacturer’s “extraordinary” argument would effectively make all commercial transactions protected speech. Given the unknown risks of e-cigarettes and “their extraordinary allure to middle and high school students,” the court found that the TCA’s prohibition is constitutional and appropriately tailored to prevent a harm.

Scott Nelson of Public Citizen, which filed an amicus brief in support of the FDA, described the D.C. Circuit’s opinion as “one of the best analyses given by any recent appellate court of why First Amendment challenges to regulations requiring health warnings and regulations of claims that products may be used for health reasons are fundamentally misguided. It explains that limiting the marketing of a product for a particular use only if it has been shown to be safe for that use is not a regulation of speech but one that addresses commercial conduct. And addressing the alternative view that the First Amendment is implicated, the court explains that requiring a company that markets a potentially dangerous product to demonstrate the accuracy of its claims about health impacts easily satisfies the applicable standards for regulation of commercial speech.”

“The court’s opinion makes practical as well as doctrinal sense,” Nelson continued. “The court was not fooled by the vaping industry’s claim that it only seeks to advance public health goals by marketing products aimed at helping cigarette smokers shift to a safer alternative. It is becoming ever more apparent that the vaping industry is pushing products with harmful ingredients and substantial risks, the extent of which the industry itself doesn’t even know, all to hook as many of our nation’s young people as possible on nicotine. The need for the sensible regulation that the D.C. Circuit’s decision makes possible is urgent.”