JUUL LABS SUBMITS PMTA FOR NEXT-GENERATION MENTHOL-FLAVORED PODS WITH DEVICE-LEVEL LOCKING

Company News

December 19, 2023

Juul Labs has taken another important step in its path forward to introduce novel technologies that provide adult smokers an alternative to combustible cigarettes while also leading the industry in efforts to combat underage use. 

The company today announced the submission of a Premarket Tobacco Product Application (PMTA) to FDA for our next-generation platform (NGP) device and menthol-flavored pods requiring user age verification — among the first fully age-gated electronic nicotine delivery system (ENDS) products to be submitted to FDA for review. This submission to FDA includes comprehensive science and evidence for new menthol-flavored pods at 18 mg/mL nicotine concentration to be used with our next-generation device, for which the company submitted a PMTA to FDA in July 2023 along with tobacco-flavored pods. 

Our next-generation ENDS platform, launched initially in the U.K. in 2021 as “JUUL2,” delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products, and incorporates age verification technology capabilities. This latest submission advances our commitment to addressing two public health problems: improving adult smoker switching from combustible cigarettes and restricting underage access to vapor products.

Device-Level Age Verification

Consistent with FDA’s objective to see non-tobacco flavored ENDS products equipped with age-gated technology to mitigate the risk of underage use, each NGP-compatible menthol pod contains a secure microchip that communicates to the NGP device a requirement for age verification prior to use. The NGP device itself can further be locked by the user at any time to prevent unauthorized use. In addition to limiting the number of devices that can be purchased, Juul Labs will also limit the number of new devices that each unique age-verified user can activate and use with menthol-flavored pods to further mitigate the risks of social sourcing. 

The technological advancements that enable device-level age verification complement the programmatic efforts Juul Labs has taken since the company’s 2019 reset to address underage use of its products. While more can and should be done to continue to combat underage use of vapor products broadly, we are encouraged by data from the 2023 National Youth Tobacco Survey showing that past 30-day use of ENDS products continues to decline among middle and high school students. 

Overall vapor product use among middle and high school students declined in 2023 to 7.7%, down from 9.4% last year and 20% in its peak in 2019. Among middle and high school students who reported ENDS use over the past 30 days, use of JUUL as “any brand” used fell to 16.5% in 2023 from 50.1% in 2020. (“Any brand” use is a measurement where students can report any and all brands used among many.) Among all middle and high school students (not just the cohort of youth using ENDS products), JUUL use fell to 0.3% in 2023 from 11.6% in 2019, representing a 97% decrease from its peak. 

Meanwhile, more than half (60.7%) of past 30-day underage vapor product users reported using disposable products most often, while 16.1% reported using pods or cartridge devices most often. Among all middle and high school students (not just the cohort of youth using ENDS products), use of disposables increased from 0.5% in 2019 to 4.7% in 2023, representing an 840% increase.

Adult Switching

Juul Labs looks forward to bringing its next-generation technology to the over 28 million adults in the country who continue to smoke combustible cigarettes – the leading cause of preventable death. Initial behavioral research of real-world purchasers of our NGP products in the U.K. demonstrates compelling adoption and switching among adult smokers, with over 25.3% of users in a study reporting switching completely away from combustible cigarettes six months after purchasing the product. This study is ongoing and will continue to be updated over the months ahead.  

FDA has indicated that manufacturers of non-tobacco flavored ENDS must demonstrate an incremental benefit in terms of rates of adult smoker switching compared to tobacco-flavored ENDS in order to outweigh the risk of underage use. Juul Labs has submitted multiple streams of scientific evidence to FDA demonstrating that menthol-flavored ENDS, like the menthol NGP pods, facilitate higher rates of complete switching away from cigarettes among adult smokers than tobacco-flavored ENDS, particularly among adults who use menthol cigarettes.

Data Privacy

Juul Labs carefully considers the customer experience and customer privacy with all of our products and services. The next-generation platform can be used with a mobile or web-based app that enables age verification technology, including device-locking, and real-time product information and insights for age-verified consumers. 

As our apps are currently available in other markets, we already adhere to industry-leading data-privacy protections that are compliant with the EU’s General Data Protection Regulation (GDPR), generally viewed as one of the most comprehensive data privacy protection laws in existence. Some examples of our consumer data privacy policies and practices are as follows:

• The NGP-compatible JUUL Mobile App and Web App do not transmit any customer location data to Juul Labs; the location data necessary to provide app features is stored locally on the customer’s smart phone or computer. 
• Similarly, we do not have access to a consumer’s device usage (i.e., puff) information.
• Device usage information necessary to provide app features is stored either (a) locally on the customer’s smart phone or computer, or (b) in customer opt-in, end-to-end encrypted backups. As those backups are end-to-end encrypted, Juul Labs has no access to any underlying information. 

U.S. Submissions Roadmap

The FDA has suggested that PMTAs for ENDS with device access controls such as the ones included in our growing NGP portfolio will be prioritized in the application review process, and we are optimistic that our technology will be a game-changer for access restrictions in vapor products in the United States. With this new submission to the FDA, Juul Labs plans to demonstrate that our NGP device and menthol-flavored pods with device-level locking are appropriate for the protection of public health. 

We are committed more than ever to our mission, and will continue to pursue a robust product roadmap by introducing technological innovations to help transition even more adult smokers away from cigarettes while combating underage use. 

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 with Tobacco-Flavored Pods	July 2023	Submitted and pending acceptance review
PMTAs for the Next-Generation Vapor Platform with Menthol-Flavor Pods	December 2023	Submitted and pending acceptance review