On July 19, JUUL announced on its official website that it had submitted a "Pre-Sale Tobacco Product Application" (PMTA) for a new generation of e-cigarettes to the US Food and Drug Administration (FDA). 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 on innovative data-driven technologies used to limit underage use.

Kirk Phelps, chief product officer at JUUL, said:

"Our next-generation platform provides a technological solution to two public health problems: improving adult smokers' switching from combustible tobacco, and limiting underage use of vaping products. This is just the beginning of new technologies we are developing and refining to eliminate combustible tobacco and combat underage use."

It is reported that this latest e-cigarette platform was first launched in the UK in 2021, called JUUL2 System, which provides adult smokers with a better experience, adopts unique authentication technology to solve the problem of illegal products, and has age verification technology functions.

JUUL has submitted an application for a new generation of e-cigarette products to the FDA and will continue to appeal to the FDA

JUUL2 product image｜Image source: JUUL

Based on feedback from adult smokers, features of the next-generation platform include:

A more consistent smoke experience that better competes with combustible tobacco;

Bluetooth-enabled devices with larger and longer-lasting batteries, and "smart light systems" that show users battery life and e-liquid levels;

Newly designed tamper-resistant pods to improve aerosol release;

Innovative heating elements to improve product performance and temperature control accuracy;

Unique authentication chip, among other technical features, prevents the use of illegal counterfeit pods that are not compatible with next-generation devices;

Mobile and web-based apps enable age verification technology, including device lock, and provide age-verified consumers with real-time product information and usage insights, with industry-leading data privacy protections.

According to JUUL, preliminary behavioral research on the new platform in the UK has shown convincing switching and use among adult smokers. Six months after purchasing the product, more than 32% of JUUL2 System users had completely given up combustible tobacco.

While the currently sold JUUL System has successfully converted more than 2 million U.S. adult smokers, the company hopes to bring this new technology to the more than 28 million U.S. adults who continue to use combustible tobacco, the leading cause of preventable death.

JUUL Chief Regulatory Officer Joe Murillo said:

"Our next-generation e-liquid platform, PMTA, builds on novel technology, advances public health goals, and demonstrates clear public health benefits that are required for marketing authorization. We look forward to working with FDA during the review process while pursuing this important harm mitigation opportunity."

This PMTA application is the basis for the Company to pursue additional applications aimed at expanding viable, science-based alternatives for adult smokers to switch from combustible tobacco and quit altogether, while continuing to combat underage use with novel and proven technological solutions.

In addition, the company is continuing its administrative appeal of the FDA's approval decision on the JUUL System and believes that the product will also receive marketing authorization under the decision on science and evidence, free from political interference.

Finally, JUUL attached its submitted PMTA, but no product has yet passed the review application.

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