(Reuters) - Juul Labs said on Tuesday it was seeking U.S. authorization for its new menthol-flavored pods, which require user age verification, to be used with its e-cigarette device that is under review by regulators.
Juul's e-cigarettes were briefly banned in the U.S. in June 2022 after the U.S. Food and Drug Administration (FDA) concluded the company had failed to show that the sale of its products would be appropriate for public health. Following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul's marketing application.
The company's new menthol-flavored pods have a nicotine concentration of 18 mg/mL and are Juul's latest premarket tobacco product application to the FDA.
This follows an application it made in July for a vaporizer with a unique Pod ID chip to prevent the use of counterfeit cartridges and restrict underage access. The July application included a proposal for tobacco-flavored pods.
The vaporizer is already on sale in the UK after its launch in 2021 as the JUUL2 System.
The menthol pod contains a secure microchip that communicates a requirement for age verification to the device prior to use. The device can be locked by users at any time to prevent unauthorized usage.
To mitigate the risk of social sourcing, Juul said it would limit not only the number of devices that can be purchased, but also the number of new devices each unique age-verified user can activate and use with menthol-flavored pods.
So far the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including British American Tobacco (NYSE:BTI), which is appealing those decisions.
Juul said in a statement it has submitted evidence showing its new menthol pods can help more cigarette smokers transition from smoking than tobacco-flavored e-cigarettes.