On July 19, JUUL announced on its official website that it has submitted a “Pre-sale Tobacco Product Application” (PMTA) to the US Food and Drug Administration (FDA) for a new generation of e-cigarettes. The company’s submission includes comprehensive science and evidence for the new device and the new tobacco-flavored cartridge, which has a nicotine concentration of 18mg/mL, and includes information about the innovative data-driven technology used to limit underage use.
Kirk Phelps, JUUL’s chief product officer, said:
“Our next-generation platform provides technological solutions to two public health problems: improving the conversion of adult smokers from combustible tobacco and limiting the use of e-cigarette products by minors.” This is just the beginning of new technologies that we are developing and perfecting to eliminate combustible tobacco and combat underage use.”
It is reported that the latest e-cigarette platform launched in the UK as early as 2021, called JUUL2 System, provides a better experience for adult smokers, uses unique identity verification technology to address illegal products, and has age verification technology features.
Based on feedback from adult smokers, features of the next generation platform include:
A more consistent smoke experience to better compete with combustible tobacco;
Bluetooth-enabled devices with larger and longer-lasting batteries, as well as a “smart light system” that shows users battery life and e-cigarette fluid levels;
The newly designed tamper-proof smoke bomb can improve aerosol release;
Innovative heating elements to improve product performance and temperature control accuracy;
A unique authentication chip that, among other technical features, prevents the use of illegal counterfeit cartridges incompatible with next-generation devices;
Mobile and web-based applications enable age verification technologies, including device locking, and provide age-verified consumers with real-time product information and usage insights and industry-leading data privacy protections.
According to JUUL, preliminary behavioral studies of the new platform in the UK have shown convincing conversion and use among adult smokers. Six months after purchasing the product, more than 32 percent of JUUL2 System users have completely given up combustible tobacco.
While the current JUUL System has successfully converted more than 2 million adult smokers in the United States, the company hopes to bring the new technology to the more than 28 million adults in the United States who consistently use combustible tobacco, the leading cause of preventable death.
Joe Murillo, JUUL’s chief regulatory officer, said:
“Our new generation of e-cigarette vaping platform, PMTA, is built on new technologies that advance public health goals and demonstrate the clear public health benefits necessary to obtain marketing authorization.” We look forward to working with the FDA during the review process while pursuing this important harm mitigation opportunity.”
This PMTA application is the basis for the company’s pursuit of additional applications aimed at expanding viable, science-based alternatives for adult smokers to convert from combustible tobacco and abandon it entirely, while continuing to combat underage use with novel and proven technological solutions.
In addition, the company is continuing to pursue an administrative appeal of the FDA’s approval decision regarding the JUUL System and is confident that under the decision on science and evidence, there will be no political interference and the product will also receive marketing authorization.
Finally, JUUL attached the PMTA it had submitted, but none of its products had yet passed the application for review.
 A TECHNOLOGICAL SOLUTION FOR PUBLIC-HEALTH PROBLEMS: JUUL LABS SUBMITS THE FIRST PMTA FOR ITS NEXT-GENERATION PLATFORM TO IMPROVE ADULT-SMOKER SWITCHING AND RESTRICT UNDERAGE ACCESS