By Donielle Tigay Stutland, J.D.
The FDA may regulate e-cigarettes, and the Tobacco Control Act’s Deeming Rule is constitutional.
On December 10, 2019, the U.S. Court of Appeals for the District of Columbia rejected a First Amendment challenge by vaping companies, including Nicopure Labs, LLC (Nicopure), concerning the 2016 "Deeming Rule," which subjects e-cigarettes to Food and Drug Administration (FDA) review under the federal Family Smoking Prevention and Tobacco Control Act (TCA) (P.L. 111-31). According to the court, the First Amendment does not bar the FDA from preventing e-cigarette manufacturers from marketing them as "safer" than existing products until the manufacturers can show that they actually are safer. The circuit court judges unanimously agreed with the FDA’s argument that the public health standard for e-cigarette pre-marketing approval is "entirely rational and nonarbitrary." The appellate court found that the Deeming Rule is constitutional, and that the "FDA is not authorized to deviate from this statutory standard." The appeals court reiterated the lower court’s finding that any e-cigarette that contains nicotine is subject to federal regulation (Nicopure Labs, LLC v. FDA, December 10, 2019, Pillard, C.).
Background. The TCA empowers the FDA to regulate the sale and marketing of tobacco products. In general, all new tobacco products must be cleared by the FDA before they can be marketed and sold in the United States. Additionally, the TCA bans the distribution of free samples of tobacco products. The only exception is for smokeless tobacco (i.e., chewing tobacco), which may be distributed for free in "qualified, adult-only" facilities. No e-cigarette product has yet sought to receive clearance from the FDA.
On May 5, 2016, the FDA issued a final rulem to extend its regulatory authority to other products meeting the definition of a tobacco product, including e-cigarettes. Nicopure, as well as other vaping industry groups, filed suit on May 10, 2016 to challenge the FDA’s Deeming Rule and selected provisions of the Tobacco Control Act as contrary to the Administrative Procedures Act (APA) and the First Amendment. On the parties’ cross-motions for summary judgment, the district court sustained the TCA and the Deeming Rule in full.
Nicopure’s challenge. Nicopure and the other appellants raised three challenges to the TCA. First, they argued that the FDA violated the TCA and the APA by not providing an easier premarket authorization pathway for e-cigarettes. Second, they claimed that two provisions of the TCA violate the First Amendment. They challenged the premarket review standards applicable to modified risk tobacco products, contending that the standards impermissibly burden what they say are truthful, non-misleading statements about e-cigarettes. Finally, they challenged the ban on distribution of free samples of tobacco products, including e-cigarettes, as suppression of constitutionally protected expressive conduct.
Appellate court decision. The D.C. Circuit rejected the arguments presented by the vaping companies and vaping advocates. Noting that e-cigarettes are highly addictive and pose health risks, especially to youth, the court of appeals concluded, "It is entirely rational and non-arbitrary to apply to e-cigarettes the Act’s base line requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health."
With respect to the vaping industry’s contention that because e-cigarettes are safer and, therefore, they should be subject to an easier pre-market authorization process, the appellate court indicated that until the industry actually shows that e-cigarettes are in fact safer than cigarettes, the First Amendment does not bar the FDA from regulating the industry. The court further noted that this conclusion was "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, the court rejected the vaping industry’s arguments pertaining to the First Amendment. The decision made clear that giving out free samples is not expressive conduct and that the government’s interest in preventing their distribution is unrelated to the suppression of expression.
The case is No. 17-5196.
Companies: Nicopure Labs, LLC, Right to be Smoke-Free Coalition, American E-Liquid Attorneys: Douglas James Behr (Keller and Heckman LLP) and Miguel A. Estrada (Gibson, Dunn & Crutcher LLP) for Nicopure Labs, LLC and American E-Liquid Manufacturing Standards Association. Alisa B. Klein, U.S. Department of Justice, for the FDA
Companies: Nicopure Labs, LLC; American E-Liquid Manufacturing Standards Association
MainStory: TopStory TobaccoProductsNews DistrictofColumbiaNews
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