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:
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 |
October 2, 2024
On September 26th, Juul Labs’ Chairman & Chief Executive Officer, K.C. Crosthwaite, delivered the keynote address at the 2024 Global Tobacco & Nicotine Forum,…
July 29, 2024
Juul Labs announced today the settlement with a group of noteholders that confirms the conversion of the convertible notes to equity, and provides an…
June 6, 2024
Today, the FDA rescinded its June 2022 Marketing Denial Orders (MDOs) for the JUUL System and placed our applications back into scientific review. We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.