Review Juul2 - Juul Labs Submits PMTA for 2G JUUL Device.

Review Juul2 - Juul Labs Submits PMTA for 2G JUUL Device.

Posted by ART / ITM on Jul 21st 2023

Review Juul 2 device
Juul Labs is seeking approval from the FDA to market a second-generation vaping device in the United States, nearly two years post its initial launch in the United Kingdom as the JUUL2. The company unveiled today that they've initiated a premarket tobacco application (PMTA) for this upgraded gadget and its associated tobacco-flavoured refill pods.

Without an approved marketing granted order (MGO) from the FDA, Juul will not be eligible to sell the novel device within U.S. borders. The FDA Deeming Rule dictates that products containing tobacco-derived nicotine, which weren't available as of August 8, 2018, must be endorsed by the FDA before hitting the market. The original JUUL device's PMTA remains in the scrutiny phase by the FDA, three years subsequent to its submission.

According to the FDA's history of inspecting and making determinations on PMTA submissions, Juul should brace for a minimum of a two-year pause before the authority renders a preliminary judgment on whether the innovative device is "suitable for public health protection." There may be a period of legal disputes following this process.

There's a potential the new device won't bear the JUUL brand. It features Bluetooth functionality and an app for both mobile and web, facilitating age verification, device locking, and blocking the usage of third-party Juul pods termed as "compatible." Juul indicated this as "the dawn of upcoming tech creation" for the U.S. marketplace, yet didn't elucidate the reason for the company's delay of two years post the JUUL2's UK debut to file an FDA application for the gadget. The JUUL2 is also marketed in Canada.

The JUUL2 boasts "enhanced airflow proficiency," outperforming the existing JUUL device. This improvement is critical as the new device will only be accessible with 18 mg/mL nicotine-strength pods. The present-day JUUL pods offered in the U.S. range from 5 percent (59 mg/mL) to 3 percent (36 mg/mL) strengths. The JUUL2, according to Juul's research, emits more vapor per puff, facilitating delivery of higher nicotine levels to the consumer despite using lower-strength e-liquid.

Research by Juul Labs in the UK demonstrated over 32 percent of JUUL2 users had fully transitioned from traditional cigarettes after a six-month usage period.

The Wall Street Journal reported today that Juul remains undecided whether the next-generation JUUL device will be marketed under the Juul brand.

While the original JUUL still awaits an FDA "re-review", Juul persists in anticipation of the FDA's conclusive decision on the PMTA it presented in July 2020 for its flagship JUUL device. In June 2022, the FDA discarded the PMTA, issuing Juul a marketing denial order (MDO) stating the company's application "lacked ample evidence regarding the toxicological profile of the products to illustrate that marketing of the products would be suitable for the protection of public health."

Subsequently, a federal court granted Juul a temporary stay of the MDO, but this appeal was suspended when the FDA promptly retreated and awarded an administrative stay of its own denial order. The FDA then pledged "further review" of Juul's PMTA, a process that has been ongoing for more than a year now.

Today, Juul Labs also unveiled that in December 2022, they filed a PMTA for a fresh tobacco-flavoured pod designed for the original JUUL device.