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Juul Labs has focused our resources on the development of technologies aimed at transitioning even more adult smokers away from combustible cigarettes while combating underage use of our products.
Launched initially in the United Kingdom as the JUUL2 System, the next-generation platform delivers an improved vapor experience for adult smokers, utilizes unique PodID authentication to address illicit products, and incorporates age-verification technology capabilities.
Features of the next-generation platform, informed by insights from adult smokers, include:
Pod ID Chip: Enabling New Tech Capabilities and Preventing the Use of Illicit Products
JUUL App: Engaging Adult Smokers While Restricting Access
The next-generation device has built-in Bluetooth connectivity that enables users to pair the product with the JUUL App — a mobile and web application — that currently has limited and tailored features for age-verified adult consumers, including:
Privacy is embedded into every stage of the development of our products and services, including the JUUL App. For users who choose to use the JUUL App, any location data is not sent to Juul Labs, and puff usage data stays local on the user’s device by default
The next-generation device contains a single rechargeable lithium-ion battery with precise heating-control technology. While a combustible cigarette burns more than 900°C when smoked, the platform heats a nicotine-containing e-liquid to a preset target temperature of less than 300ºC to produce aerosol that the user inhales. As a result, the aerosol contains significantly lower levels of HPHCs compared to combustible cigarettes and even lower levels, on a nicotine normalized basis, relative to other vapor products.
As a part of the FDA’s Premarket Tobacco Product Application (PMTA) process, Juul Labs has conducted multiple nonclinical studies, including targeted and non-targeted chemistry analyses and in vitro and in vivo toxicology studies, as well as clinical studies and a computational modeling study on the next-generation vapor platform. For the initial application, Juul Labs has submitted for the new device and new pods with Virginia Tobacco flavor at 18 mg/mL nicotine concentration.
The scientific evidence included in our PMTA demonstrates that use of the new platform with Virginia Tobacco pods is likely to present significantly less health risk than smoking cigarettes and is within the range of non-JUUL comparator vapor products.
Our nonclinical research examines JUUL2 System aerosol through analytical chemistry, in vitro studies, and toxicological assessments. This includes:
Testing for Harmful and Potentially Harmful Constituents (HPHCs): Chemical analyses of JUUL2 System aerosol are conducted to quantitatively assess the presence of HPHCs identified by public health bodies such as the World Health Organization (WHO) and the U.S. Food and Drug Administration as key toxicants of concern. We measure the levels of specific constituents in the aerosol and compare them to those found in combustible cigarette smoke.
Chemical analyses demonstrate that aerosols from the new platform contain fewer and substantially lower levels of harmful and potentially harmful constituents (HPHCs) than cigarette smoke.
Additionally, the results from in vitro studies show that the new pod aerosol condensate is not cytotoxic, mutagenic, or genotoxic under the conditions of the studies, and is, overall, comparable to or lower in toxicity than comparator vapor products and less toxic than cigarette smoke.
Our clinical research program examines the impact of the JUUL2 System on adult smokers including the rate and level of nicotine absorption in the body, such as:
Pharmacokinetic Studies: Pharmacokinetic studies assess the rate and level of nicotine absorption in the body as well as subjective effects of use of various products. During testing, we analyze regular blood nicotine measurements before, during, and after use of each product to assess nicotine delivery and to help us understand nicotine absorption rates compared to cigarettes and other nicotine-containing products.
Pharmacokinetic studies of a prototype of the new vapor platform demonstrate a nicotine delivery that is competitive with, but lower than combustible cigarettes, and within the range of other vapor products.
Our behavioral research program was designed to evaluate the use of the new vapor platform among adult smokers as well as to assess mitigation efforts among non-target populations such as those who are underage.
A study of JUUL2 purchasers in the UK found increasing rates of switching over one year among purchasers — suggesting that the marketing of a new platform will result in meaningful switch rates among adult smokers.
JLI employs a stepwise health-risk evaluation approach when assessing its products. This process begins with product characterization, progresses to the evaluation of information generated from the product and identification of potential hazards, and then integrates actual-use data into a whole product risk assessment.
The chemical, toxicological and clinical data integrated in the whole product risk assessment support that the individual health risks of the new platform are expected to be lower than cigarettes and within the range of currently marketed vapor products.
We will update our publication library with research on the new platform as we continue to report results from our studies.