Juul Labs has officially submitted a premarket tobacco product application (PMTA) to the FDA for a menthol-flavored refill pod designed exclusively for use in Juul’s “next-generation” device. This follows Juul’s earlier PMTA submission in July, which covered the device itself and a tobacco-flavored pod.
The menthol refill pod is engineered to function solely with the 2G device, incorporating age verification requirements for operation and featuring a user-controlled lock. Juul is implementing restrictions on the purchase of 2G devices and activation limits for each age-verified user, aiming to prevent legal-age buyers from activating the device and subsequently selling it to minors.
It’s noteworthy that the FDA has not yet granted marketing authorization for any menthol-flavored vaping product, rejecting numerous PMTAs for menthol and other non-tobacco-flavored vapes, including menthol refills for authorized devices like the Vuse Vibe. Several manufacturers, including R.J. Reynolds, the maker of Vuse, have challenged the menthol denial orders in court.
The next-generation Juul device, known as the JUUL2, has been available in the United Kingdom since September 2021 and is also accessible in Canada. Offering improved airflow capability compared to the original JUUL device, the JUUL2 delivers more vapor per puff and increased nicotine levels, despite using e-liquid with reduced 18 mg/mL nicotine strength.
While a PMTA for Juul’s original device has been under FDA review since 2020, the agency rejected the application in June 2022. Following a temporary stay of the denial granted by a federal court, the FDA has agreed to re-review Juul’s PMTA.
