Company News

July 19, 2023

Juul Labs today announced the submission of the first Premarket Tobacco Product Application (PMTA) for the company’s next-generation vapor platform to the U.S. Food and Drug Administration (FDA). The company’s submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 mg/mL nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access. 

“Our company DNA is product innovation. 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.” – Kirk Phelps, Chief Product Officer.

Launched initially in the U.K. in 2021 as the JUUL2 System, this new vapor platform delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products, and incorporates age-verification technology capabilities.

Features of the next-generation platform, informed by insights from adult smokers, include:

  • 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
  • Newly-designed, 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 behavioral research of the new platform in the U.K. has demonstrated compelling adoption and switching among adult smokers. Over 32% of JUUL2 System users have switched completely from combustible cigarettes 6 months after purchasing the product. While the currently-marketed JUUL System has switched over 2 million adult smokers in the U.S., the company looks forward to bringing this new technology to over 28 million adult smokers in the country 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. We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.” – Joe Murillo, Chief Regulatory Officer.

This PMTA submission is a foundational application through which the company will pursue additional filings to expand viable, science-based alternatives for adult smokers to transition and completely switch them from combustible cigarettes, while continuing to combat underage use with novel and tested technological solutions. 

Additionally, the company continues to pursue its administrative appeal of the FDA’s stayed decision for the JUUL System and believes that it too will receive marketing authorization once a decision is made on science and evidence, without political interference.

Juul Labs has focused its resources on product innovation and science generation to advance and accelerate its mission and harm-reduction opportunity. We have dedicated our product roadmap to accomplish just that and will continue to lead the category in innovation to realize an endgame for combustible cigarettes for the benefit of public health.

JLI’s PMTA Submissions To Date

Submission Date Submitted Status
PMTAs for the Currently-Marketed JUUL System July 2020 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 December 2022 Submitted and pending filing review
PMTAs for the Next-Generation Vapor Platform July 2023 Submitted and pending acceptance review