Juul seeks approval for vape with age-verification in U.S.
The device launched in the U.K. in 2021.
Juul Labs Inc. submitted its first premarket tobacco application (PMTA) for its next-generation vapor platform to the U.S. Food and Drug Administration. The updated device reportedly uses technology to restrict both underage use and counterfeit pods.
"Our company DNA is product innovation. With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products," said Kirk Phelps, chief product officer at Juul. "This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use."
The PMTA submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 milligram/milliliter nicotine concentration, along with information on novel, data-driven technologies to restrict underage access, the company said.
The next-gen product initially launched in the United Kingdom in 2021 as the JUUL2 System. According to Juul, its features include:
A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections;
A unique Pod ID chip that, among other technology capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device;
A more consistent vapor experience that better competes with combustible cigarettes;
A Bluetooth-enabled device with a larger, long-lasting battery and a "smart light system" that communicates battery life and e-liquid level to the user;
Newly-designed, tamper-resistant pods that enable improved aerosol delivery; and
An innovative heating element that improves product performance and temperature-control precision.
Juul claimed that behavioural research in the U.K. showed that more than 32 percent of JUUL2 System users have switched completely away from combustible cigarettes six months after purchasing the product.
"Our next-generation vapour platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization," said Chief Regulatory Officer Joe Murillo. "We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity."
Juul noted that the company is also continuing to pursue its administrative appeal of the FDA's stayed decision regarding the JUUL System and believes it will also receive marketing authorization once a decision is made on science and evidence.