The Food and Drug Administration (FDA) has ordered JUUL Labs Inc to stop selling and distributing its electronic nicotine delivery system (ENDS) in the US.
The banned products include the JUUL device and 4 types of JUUL pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
Individual consumers are not restricted from having or using JUUL products; however, the Agency will ensure compliance by retailers, noting that retailers are subject to enforcement action if the products are marketed unlawfully.
The Agency stated that JUUL’s premarket tobacco product applications (PMTAs) lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. The FDA has authorized 23 ENDS products under the PMTA pathway.
“As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards, said Michele Mital, acting director of the FDA’s Center for Tobacco Products, “However, the company did not provide that evidence and instead left us with significant questions.” Specifically, the Agency had concerns about insufficient data related to genotoxicity and potentially harmful chemical leaching from the e-liquid pods.
JUUL’s chief regulatory officer, Joe Murillo, responded in a statement indicating that the company had provided sufficient information to address the issues raised by the FDA. “In our applications, which we submitted over 2 years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health’. We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator.”
Others, such the American Medical Association, applauded the decision saying, “Today’s action is a significant step toward keeping harmful tobacco products out of the hands of young people. AMA policy supports banning the sale and distribution of all e-cigarette and vaping products, with the exception of those approved by the FDA for tobacco cessation purposes.”
US Food and Drug Administration. FDA Denies Authorization to Market JUUL Products. News Release. Accessed June 23, 2022. https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products