Juul Labs Submits PMTA for JUUL2 Menthol Pods

Juul Labs announced on Tuesday that it is seeking FDA approval for its new menthol-flavored pods. The JUUL2 pods require age verification and are designed to be used with Juul’s e-cigarette device, which is currently under regulatory review.

The new menthol-flavored pods have a nicotine concentration of 18 mg/mL and are Juul’s latest premarket tobacco product application (PMTA) submission to the FDA, according to media reports.

This follows a submission Juul Labs 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 before 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, which is appealing those decisions.

Juul Labs 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.