Juul Labs Submits PMTA for 2G JUUL Device

Juul Labs is asking for FDA authorization to sell a second-generation device in the United States nearly two years after the product launched in the United Kingdom as the JUUL2. Juul announced today it has submitted a premarket tobacco application (PMTA) for the device and tobacco-flavored refill pods.

Juul will not be able to sell the new device in the U.S. until it receives a marketing granted order (MGO) from the FDA. Per the FDA Deeming Rule, all products made with tobacco-derived nicotine that were not on the market as of Aug. 8, 2018 must be authorized by the FDA before they can be sold. The PMTA for the company’s original JUUL device remains under FDA review three years after being submitted.

Based on the FDA’s track record reviewing and making decisions on PMTA submissions, Juul can expect at least a two-year wait before the agency makes an initial determination as to whether the new device is “appropriate for the protection of public health”—and possibly years of legal wrangling after that.

Juul Labs may not use the JUUL name on the new device

The device has Bluetooth capability and a mobile- and web-based application that allows age verification and device locking, and prevents the use of third-party “compatible” Juul pods. Juul says this is “only the beginning of new tech being developed” for the U.S. market, but didn’t explain why the company waited two years after the British launch of the JUUL2 to submit an FDA application for the device. The JUUL2 is also sold in Canada.

The JUUL2 has “improved airflow capability” compared to the current JUUL device—a necessity, since the new device will only be available with 18 mg/mL nicotine-strength pods. Current JUUL pods are available in the U.S. in 5 percent (59 mg/mL) and 3 percent (36 mg/mL) strengths. The new device puts out more vapor per puff, according to JUUL research, allowing it to deliver more nicotine to the user with lower-strength e-liquid.

According to Juul Labs, research in the UK shows over 32 percent of JUUL2 users had switched completely from combustible cigarettes after six months of use.

The Wall Street Journal reported today that Juul has not yet decided whether to market the next-generation JUUL device under the Juul brand.

The original JUUL: still waiting for FDA ``re-review``

Juul is still waiting for a final FDA decision on the PMTA it submitted in July 2020 for its flagship JUUL device. In June 2022, the FDA rejected that PMTA, issuing Juul a marketing denial order (MDO) because, said the agency, Juul’s application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

Juul immediately received a temporary stay of the MDO from a federal court, but that appeal was put on hold when the FDA quickly backed down and granted an administrative stay of its own denial order. The agency promised “additional review” of Juul’s PMTA, which has now been in progress for over a year.

Juul Labs also announced today that it submitted a PMTA in December 2022 for a new tobacco-flavored pod for the original JUUL device.