JUUL has submitted a next-generation vape to the FDA product application appeal

On July 19, JUUL released a statement on its website that it has submitted a Pre-Market Tobacco Product Application (PMTA) to the U.S. 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 cartridges, which have a nicotine concentration of 18mg/mL, as well as information on innovative data-driven technologies used to limit underage use.

Kirk Phelps, Chief Product Officer at JUUL, said:

“Our next-generation platform provides technological solutions to two public health problems: effectively improving adult smokers’ conversion from combustible tobacco and restricting underage use of e-cigarette products. This is just the beginning of new technologies we are developing and refining to eliminate combustible tobacco and combat underage use.”

This latest e-cigarette platform, which is known to launch as early as 2021 in the UK under the name JUUL2System, offers a better experience for adult smokers, uses unique authentication technology to address illicit products and features age verification technology.
As per feedback from adult smokers, the next generation platform features among others:

A more consistent smoke experience that better competes 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 oil levels;
Newly designed tamper-resistant cartridges that improve aerosol release;
Innovative heating element to improve product performance and temperature control precision;
A unique authentication chip that, between other technological features, prevents the use of illegal counterfeit vape cartridges that are incompatible with next-generation devices;
Mobile and web-based apps that enable age-verification technology, which includes device locking and provides age-verified consumers with real-time product information and usage insights, while offering industry-leading data privacy protection.
JUUL describes that initial behavioral research with the new platform in the U.K. has shown compelling switching and usage among adult smokers. Six months after consumers purchased the product, more than 32% of JUUL2System users had completely given up combustible tobacco.

And while JUULSystem, as currently sold, has successfully converted more than 2 million adult U.S. smokers, the company hopes to bring this new technology to the more than 28 million adults in the U.S. who continue to use combustible tobacco, a leading cause of preventable death.

Joe Murillo, JUUL’s Chief Regulatory Officer, said:

“Our next-generation e-cigarette oil platform, PMTA, builds on new technology, advances public health goals, and demonstrates clear public health benefits that are necessary to obtain marketing authorization. Very much looking forward to working with the FDA during the review process while pursuing this important harm reduction opportunity.”

This PMTA application is the basis for the company’s pursuit of additional applications dedicated to expanding viable, science-based alternatives for adult smokers to motivate them to switch from combustible tobacco and eschew it altogether, while at the same time continuing to combat underage use with novel and proven technological solutions.

In addition to this, the company is continuing its administrative appeal of the FDA’s decision to approve JUULSystem and believes that there will be no political interference with the decision on science and evidence, and that this product will be granted marketing authorization.

At the end, JUUL attached the PMTA it has submitted, but none of the products have yet passed the review application.