Juul Labs is seeking to get Food and Drug Administration approval for U.S. authorization of its new age-restricted menthol-flavored pods for its next-generation vapor platform. The company announced Dec. 19 that it has submitted a premarket tobacco product application (PMTA) with the FDA.
The submission includes comprehensive science and evidence for new menthol-flavored pods at 18-milligrams nicotine concentration. Juul Labs submitted a premarket tobacco product application (PMTA) for the e-cigarette with tobacco-flavored pods with the FDA in July, the Washington, D.C.-based company said.
The product has been available in the United Kingdom since 2021 as the Juul 2 System.
“This latest submission advances our commitment to addressing two public health problems: improving adult smoker switching from combustible cigarettes and restricting underage access to vapor products,” the company said.
Looking to mitigate the risks of social sourcing, Juul Labs said not only would the number of devices be limited for purchase but features of the next-generation platform include other features as well including age-verification technology as well as device-locking.
Juul Labs said it is looking to bring its new technology to the more than 28 million adult smokers here in the United States who continue to smoke combustible cigarettes, the leading cause of preventable death.
Initial behavioral research of real-world purchasers of the Juul2 System in the United Kingdom reveals "compelling adoption and switching among adult smokers, with over 25.3% of users in a study reporting switching completely away from combustible cigarettes six months after purchasing the product,” the company said.
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