Juul Labs is hoping to launch its next-generation vapor platform in the United States. The company announced Wednesday it has submitted a premarket tobacco product application (PMTA) for the e-cigarette with the Food and Drug Administration.
The submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18-milligrams nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access, the Washington, D.C.-based company said.
The product already launched in 2021 in the United Kingdom as the Juul2 System.
“Our company DNA is product innovation,” said Kirk Phelps, chief product officer with Juul. “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. 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.”
Features of the next-generation platform include, according to Juul:
- 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.
- Tamper-resistant pods that enable improved aerosol delivery.
- An innovative heating element that improves product performance and temperature-control precision.
- A unique pod ID chip that, among other tech capabilities, 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 real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections.
Initial research of the new platform in the U.K. demonstrated that 32% of Juul2 System users switched completely from combustible cigarettes six months after purchasing the vapor device, Juul said. The company said it aims to bring its new technology to the more than 28 million adult smokers in the United States who continue to smoke combustible cigarettes, the leading cause of preventable death.
“Our next-generation vapor 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 Joe Murillo, chief regulatory officer. “We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.”
The FDA has already issued a marketing denial order for Juul’s earlier variation in tobacco and menthol flavors; however, the denial was stayed pending further review. Juul said it intends to continue its appeal of the FDA’s MDO.
If authorized by the FDA, Juul’s next-generation vapor product could take years to hit the market. Its PMTAs for the currently marketed Juul System, for example, were submitted in July 2020, and the decision on whether they can remain on the market is still pending.
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