On 10, December 2019, the United States Court of Appeals for the D.C. Circuit ruled in support of actions by the Food and Drug Administration (“FDA”) on the regulation and classification of electronic nicotine delivery system (“ENDS”) products like electronic cigarettes and vaping devices.
The case originally began in 2016 after FDA re-classified a number of products containing nicotine as tobacco products in the agency’s “Deeming Rule.” Finalized in May of 2016, the action extended FDA jurisdiction to all tobacco products, including electronic cigarettes, cigars, pipes, and hookahs (waterpipes). In response, e-cigarette manufacturer Nicopure Labs LLC filed a lawsuit, asking that the United States District Court for the District of Columbia reject FDA’s directive. In mid-June, 11 e-cigarette trade groups joined Nicopure’s action, each of whom had requested in an additional suit that the court enjoin FDA from enforcing the rule.
Claiming that the designation would restrict ENDS devices to more arduous constraints than traditional combustible cigarettes, the plaintiffs also alleged that the action surpassed the agency’s legal authority and even defied the First and Fifth Amendments.1 Primarily focusing on potential violations to the Administrative Procedure Act (“APA”), the complaint further asserts that FDA failed to account for adult consumers hoping for an alternative to conventional cigarettes.2
Despite the claims against FDA in Nicopure Labs LLC v. U.S. Food & Drug Administration, the D.C. Circuit’s decision found the arguments unsubstantial. Clearing FDA of any situational wrongdoing, the court unanimously stated that ENDS products were “indisputably highly addictive and pose health risks, especially to youth, that are not well understood.”3
Detailing the court’s judgment over forty-eight pages, the opinion written by Judge Cornelia Pillard addressed the alleged First Amendment violations, highlighting a lack of sound evidence on the safety of ENDS products by stating: “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.”4
The December decision marks one of the first e-cigarette or vaping product cases to be handled at the federal level, but will certainly not be the last. Over the last few months, countless state officials and major retailers like Walmart and Walgreens have made attempts to limit the sale of ENDS devices, focusing heavily on the role of flavored e-cigarettes and the trend’s popularity with youth and adolescents.5 Such products have found their way into the national spotlight amidst reports of vaporizer-related illnesses.6
With the increase in public scrutiny regarding the safety of e-cigarette and vaping devices, pressure has mounted on FDA to promulgate much-needed guidelines for the industry. Earlier this year, the agency was embroiled in a separate lawsuit regarding the controversial decision to delay e-cigarette filing regulations. In 2017, after taking office as head of the FDA, former Commissioner Scott Gottlieb delayed the Obama administration’s deadline for companies to file e-cigarette product applications with the FDA until 2021 – or 2022 in some instances.7 A subsequent court order issued last summer forced the agency to restrict filings to a 10-month deadline.8
We can only hope that the government and the citizens of this country wake up and recognize that the vaping industry is simply Big Tobacco in modern form with fresh optics. More importantly, we hope that the industry is employing the delaying and obfuscation tactics that were perfected by tobacco companies prior to the class actions of the 1990s.
- Public Health Law Center. “NicoPure Labs LLC v. U.S. Food & Drug Administration.” Public Health Law Center. Mitchell Hamline School of Law, 2019. https://www.publichealthlawcenter.org/content/nicopure-labs-llc-v-us-food-drug-administration
- Marimow, Ann. “FDA Can Regulate e-Cigarettes Just like Conventional Cigarettes, Appeals Court Says.” The Washington Post. WP Company, December 10, 2019. https://www.washingtonpost.com/local/legal-issues/fda-can-regulate-e-cigarettes-just-like-conventional-cigarettes-appeals-court-says/2019/12/10/e4c28836-cffc-11e9-b29b-a528dc82154a_story.html
- Marimow, Ann. “FDA Can Regulate e-Cigarettes Just like Conventional Cigarettes, Appeals Court Says.”
- Harris, Andrew, and Gerald Porter. “E-Cigarette Regulations Survive Industry’s Legal Challenge.” Yahoo! News. Bloomberg, December 10, 2019. https://news.yahoo.com/e-cigarette-regulations-survive-industry-154323411.html
- Satel, Sally. “The Vaping Overreaction.” The Atlantic. The Atlantic Monthly Group, October 23, 2019. https://www.theatlantic.com/ideas/archive/2019/10/danger-vaping-bans/600451/
- LaVito, Angelica. “CDC Says No Single Brand Is Likely Responsible for the Outbreak of Vaping Lung Disease.” CNBC. CNBC LLC, December 6, 2019. https://www.cnbc.com/2019/12/06/vaping-lung-disease-outbreak-likely-caused-by-multiple-brands-cdc-says.html
- Kirkham, Chris. “FDA under Fire for Years of Delays on e-Cigarette Regulation.” Reuters. Thomson Reuters, December 18, 2019. https://www.reuters.com/article/us-juul-ecigarettes-fda-sidebar/fda-under-fire-for-years-of-delays-on-e-cigarette-regulation-idUSKBN1YM1D2
- Reuters. “U.S. Federal Judge Orders FDA to Implement 10-Month Deadline for e-Cig Applications.” Reuters. Thomson Reuters, July 12, 2019. https://www.reuters.com/article/us-usa-vaping/u-s-federal-judge-orders-fda-to-implement-10-month-deadline-for-e-cig-applications-idUSKCN1U72GR