Juul Labs seeks FDA approval for a new product with age-verification features

JUUL Labs Inc. is planning to launch a new menthol product in the U.S. market.<\/p>

The company has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for a new generation platform device and menthol-flavored pods that require user age verification—reportedly one of the first electronic nicotine delivery systems (ENDS) products to fully implement age restrictions submitted for FDA review.<\/p>

This application includes comprehensive scientific evidence for the new menthol-flavored pods (with a nicotine concentration of 18 mg per milliliter), which will 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.
This next-generation ENDS platform was initially launched in the UK in 2021 as “JUUL2,” providing an improved vaping experience for adult smokers, utilizing unique Pod ID authentication to address the issue of illicit products, and incorporating age verification technology capabilities.<\/p>

The company stated in a release: “This latest submission advances our commitment to addressing two public health issues: improving the transition of adult smokers from traditional cigarettes to e-cigarettes and limiting minors' access to vaping products.”<\/p>

As explained by Juul Labs, each menthol pod compatible with the NGP contains a secure microchip that communicates age verification requirements to the NGP device before use. The NGP device itself can also be locked by the user at any time to prevent unauthorized use.<\/p>

To further mitigate the risk of social procurement, Juul Labs will also limit the number of new devices that each unique age-verified user can activate and use with menthol-flavored pods.<\/p>

The company added that the NGP aligns with the FDA's goal of seeing non-tobacco-flavored ENDS products equipped with age restriction technology.<\/p>

The company stated: “The technological advancements enabling device-level age verification complement the procedural efforts Juul Labs has undertaken since the company's reset in 2019 to address the issue of underage use of its products. While more work should and can be done to broadly address the issue of underage use of vaping products, we are encouraged by the data from the 2023 National Youth Tobacco Survey, which shows a continued decline in the percentage of middle and high school students using ENDS products in the past 30 days.”<\/p>