JUUL: Federal court suspends FDA ban

On June 23, the U.S. Food and Drug Administration issued marketing cease orders (MDOs) to manufacturer JUUL Labs Inc. for all of its products currently marketed in the United States. As a result, the company would have had to stop selling and distributing these products and remove those currently on the U.S. market, or face enforcement action.[1]Two days later, however, the federal court in Washington temporarily suspended the agency's order.

The products targeted by the ban include the JUUL device and four types of pods: Virginia tobacco-flavored pods with nicotine concentrations of 5% and 3% and menthol-flavored pods with nicotine concentrations of 5% and 3%. The ban comes as part of a broader review of vaping products by the FDA following a years-long fight by policymakers and public health groups. Vaping products in the United States are classified as tobacco products. At issue is the regulation of these products as strictly as other tobacco products at a time when vaping use has exploded among U.S. teens.

Washington federal court stays FDA enforcement

The federal court in Washington said the ban should be “administratively stayed” while lawyers for JUUL Labs Inc. prepare a full appeal of the FDA’s decision. In its initial appeal, JUUL said the FDA acted under political pressure from Congress, which holds the company responsible for the youth vaping epidemic. The company has until July 12 to prepare its appeal.

Insufficient data on the toxicological profile of JUUL products

After reviewing the Company's premarket applications, the FDA determined that the evidence regarding the toxicological profile of the submitted products was insufficient to protect public health. In particular, some of the data results submitted by the Company raised concerns due to the insufficiency and inconsistency of the data. This was particularly the case with respect to genotoxicity and potentially hazardous chemicals leaching from the Company's e-liquid pods. Because these dimensions were not adequately addressed, the FDA was unable to conduct a comprehensive toxicological risk assessment of the products listed for which the Company is seeking approval.

A protective ban on the youngest

For public health actors, and in particular the Campaign for Tobacco-Free Kids (CTFK)[2], the FDA's decision to ban all JUUL products currently marketed in the United States, represents the most significant action yet to reverse the high use of this product among adolescents.

E-cigarette use among U.S. high school students more than doubled between 2017 and 2019 (from 11.7 % to 27.5 %), and more than 5.3 million adolescents used e-cigarettes in 2019, an increase of more than 3 million youth in just two years. A growing number of these youth used these products frequently or daily. This regular use is a criterion for addiction caused by high-nicotine products such as the JUUL e-cigarette. Although the prevalence has since declined due in part to government restrictions on flavored products and the impact of the COVID-19 pandemic, youth use of these products remains a serious public health problem, with more than 2 million users in 2021, according to the 2021 National Youth Tobacco Survey. JUUL remains one of the most popular brands among youth.

The CTFK organization is calling on the FDA to go further and ban the marketing and sale of disposable puff-type e-cigarettes, which are also very popular among young adolescents.

Keywords: FDA, JUUL, vaping, ban, youth

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[1] Press release, FDA Denies Authorization to Market JUUL Products, FDA website, published June 23, 2022, accessed June 27, 2022

[2] Press release, FDA Acts to Protect Kids by Denying Marketing Applications for Juul E-Cigarettes, Acting to Remove Product that Drove Youth E-Cigarette Epidemic, Campaign for Tobacco-Free Kids, published June 23, 2022, accessed June 27, 2022