On July 19, 2023, Juul Labs, the pioneering e-cigarette company, announced the submission of its first Premarket Tobacco Product Application (PMTA) for their next-generation vapor platform to the U.S. Food and Drug Administration (FDA). In an innovative move that combines health considerations and advanced tech, the company’s application features a new device along with new tobacco-flavored pods at an 18 mg/mL nicotine concentration. The platform also introduces data-driven technologies focused on restricting access for underage users.

 

Kirk Phelps, Chief Product Officer, stressed that innovation is embedded in the company’s DNA. “Our next-generation platform is a technological solution to two public-health challenges – transitioning adult smokers from combustible cigarettes and limiting underage access to vapor products. This is only the beginning of our plan to refine and develop new tech for the U.S. market and beyond. Our goal is to eliminate combustible cigarettes and curb underage use,” Phelps stated.

 

Originally launched in the U.K. in 2021 as the JUUL2 System, this cutting-edge vapor platform offers an enhanced vapor experience for adult smokers. Its unique features include Pod ID authentication to tackle the problem of counterfeit products, and age-verification technology to reduce underage use.

 

The features of this upgraded platform, which have been informed by adult smoker insights, include:

 

• A more reliable vapor experience that rivals combustible cigarettes.
• A Bluetooth-enabled device fitted with a large, long-lasting battery and a “smart light system” that informs users of the battery life and e-liquid level.
• Newly-designed, tamper-resistant pods that boost aerosol delivery.
• An innovative heating element that enhances product performance and temperature-control precision.
• A unique Pod ID chip that prevents the use of illicit counterfeit and compatible pods with the next-generation device.
• A mobile and web-based app that enables age-verification technology, including device-locking, and provides real-time product information and usage insights for age-verified consumers, with industry-leading data-privacy protections.

 

Preliminary behavioral research on the JUUL2 System in the U.K. indicates significant adoption and switching among adult smokers, with over 32% of users having fully transitioned from combustible cigarettes six months after purchasing the product. Despite the success of the currently-marketed JUUL System, which has helped over 2 million U.S. adult smokers make the switch, Juul Labs is eager to introduce their innovative technology to the estimated 28 million adult smokers in the country who still use combustible cigarettes, the leading cause of preventable death.

 

“Our next-generation vapor platform PMTA is built on innovative technology that advances public health goals. The compelling science behind it demonstrates a clear public-health benefit, a requirement for securing marketing authorization,” said Joe Murillo, Chief Regulatory Officer. “We look forward to engaging with the FDA throughout the review process while we strive to bring this crucial harm-reduction opportunity to fruition.”

JUUL’s PMTA Journey

This PMTA submission forms a crucial part of Juul Lab’s broader strategy to provide viable, science-backed alternatives for adult smokers to transition away from combustible cigarettes. The company is also continuing its efforts to curb underage use by introducing and improving technological solutions.

Juul Labs is currently appealing the FDA’s decision to stay the authorization for the JUUL System. The company maintains that it will receive marketing authorization once the decision is based on scientific evidence, free from political interference.

 

The company’s mission to improve public health is evident in their dedication to product innovation and generation of scientific evidence. They pledge to continue leading the sector with innovative solutions, striving to eradicate combustible cigarettes for the betterment of public health.

 

Below is a summary of Juul Labs’ PMTA submissions to date(JUUL’s PMTA journey):

 

• PMTAs for the Currently-Marketed JUUL System – Submitted in July 2020; currently, the administrative appeal is pending and JUUL products remain available for adult smokers.
• PMTAs for a New Tobacco Flavor as part of Currently-Marketed JUUL System – Submitted in December 2022; currently under review.
• PMTAs for the Next-Generation Vapor Platform – Submitted in July 2023; currently pending acceptance review.

 

Link: https://www.juullabs.com/next-generation-platform-pmta/