Juul Labs Seeks FDA Approval for Age-Verified Menthol Vapor Product
SAN FRANCISCO — Juul Labs Inc. is looking to bring a new menthol product to the U.S. market.
The company submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) for a next-generation platform device and menthol-flavored pods that require user age verification — among the first fully age-gated electronic nicotine delivery system (ENDS) products to be submitted to FDA for review, according to the company.
The submission includes comprehensive science and evidence for new menthol-flavored pods at 18 milligrams per milliliter nicotine concentration to be used with Juul's next-generation device, for which the company submitted a PMTA to the agency in July 2023 along with tobacco-flavored pods.
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The next-generation ENDS platform, launched initially in the United Kingdom in 2021 as "JUUL2," delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products and incorporates age verification technology capabilities.
"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 in a release.
As Juul Labs explained, each NGP-compatible menthol pod contains a secure microchip that communicates to the NGP device a requirement for age verification prior to use. The NGP device itself can also be locked by the user at any time to prevent unauthorized use.
In addition to limiting the number of devices that can be purchased, Juul Labs will also limit the number of new devices that each unique age-verified user can activate and use with menthol-flavored pods to further mitigate the risks of social sourcing.
The NGP is consistent with FDA's objective to see nontobacco flavored ENDS products equipped with age-gated technology to mitigate the risk of underage use, it added.
"The technological advancements that enable device-level age verification complement the programmatic efforts Juul Labs has taken since the company's 2019 reset to address underage use of its products. While more can and should be done to continue to combat underage use of vapor products broadly, we are encouraged by data from the 2023 National Youth Tobacco Survey showing that past 30-day use of ENDS products continues to decline among middle and high school students," the company stated.