Juul Submits PMTA for Next Generation Menthol Pod

[Θðηα mάkαя]

Juul Labs has submitted a marketing application to the FDA for a menthol-flavored refill pod designed to be used in Juul’s “next generation” device. In July, Juul submitted a premarket tobacco product application (PMTA) for the device and a tobacco-flavored pod.

The menthol refill pod will only work in the 2G device, which requires age verification to operate, and has a user-controlled lock. The company will limit the number of 2G devices that can be purchased, according to a press release. Juul says it will also limit the number that can be activated by each age-verified user, which will help prevent legal-age buyers from activating the vape and then selling them to minors.

The FDA has not yet granted marketing permission for any menthol-flavored vaping product. The agency has rejected millions of PMTAs for menthol and other non-tobacco-flavored vapes—even rejecting menthol refills for devices it has authorized, like the Vuse Vibe. Several manufacturers have challenged the menthol denial orders in court, including Vuse manufacturer R.J. Reynolds.

The next generation Juul device has been sold in the United Kingdom since September 2021, where it is called the JUUL2. It is also available in Canada. The JUUL2 has “improved airflow capability” compared to the original JUUL device, and Juul’s research shows it delivers more vapor per puff, and more nicotine, despite using e-liquid with reduced 18 mg/mL nicotine strength.

A PMTA for Juul’s original device has been under review since 2020. The FDA rejected the application in June 2022, but after Juul received a temporary stay of the denial from a federal court, the agency backed down and agreed to re-review Juul’s PMTA.

Просмотр полной статьи