In April 2021, we announced a significant milestone in our efforts to contribute to this dialogue with the publication of 11 peer-reviewed studies in a monograph edition of the American Journal of Health Behavior (AJHB). The articles published in the AJHB represent a significant portion of our research portfolio and our Premarket Tobacco Product Application (PMTA), including our core behavioral data.

Coinciding with the monograph publication, Juul Labs’ Chief Regulatory Officer, Joe Murillo, published a piece entitled “Juul Labs: Advancing the Scientific Dialogue About Tobacco Harm Reduction” in the Food & Drug Law Institute (FDLI) newsletter. In addition to discussing key findings from the monograph publication, the piece details the importance of FDA’s oversight role of the category and the science and evidence-based PMTA process. He also discusses the company’s commitment to fostering much-needed scientific dialogue about the harm reduction potential of ENDS products by engaging with the public health community on the science and facts underlying our products.

Excerpts from the FDLI Newsletter

• Determining the public health impact of alternative noncombustible tobacco products, and providing a process for their marketing authorization, is a key tenet of the agency’s 2017 Comprehensive Plan for Tobacco and Nicotine Regulation. Under the Comprehensive Plan, FDA seeks to implement science-based regulations that will help smokers who would not otherwise quit move down the continuum of risk to less harmful noncombustible nicotine alternatives. The Comprehensive Plan is firmly rooted in the concept of tobacco harm reduction—and nicotine is its centerpiece.
• We are beginning to see trends moving in the right direction as the 2020 National Youth Tobacco Survey data found an approximately 30% decline in all past-30 day underage vaping, and a 70% decrease in the number of youth who self-reported JUUL as a primary brand. We are encouraged that underage use has declined significantly, which shows the importance of evidence-based interventions, but realize more must be done. We remain committed to working with regulators and stakeholders to combat underage use.
• As a company, we are committed to working collaboratively with regulators, policymakers, public health leaders, and other stakeholders as we strive to earn a license to operate in society. We understand that in order to foster this much-needed scientific dialogue about the harm reduction potential of ENDS products, including JUUL, we must engage with the public health community on the science and facts underlying our products. In furtherance of this goal, we have published five articles and presented over 45 posters at various scientific and policy conferences around the world.
• This month we celebrate a significant milestone in those efforts with the publication of 11 articles in a monograph edition of the American Journal of Health Behavior (AJHB). The monograph focuses on the centerpiece of our behavioral research program: the Adult Juul User Switching and Smoking Trajectories (ADJUSST) study. The ADJUSST study sought to understand patterns of tobacco product use among adult JUUL product purchasers, and collected data on over 55,000 current, former, and never smokers over the course of a year. The ADJUSST study found high switching rates—defined as no past-30 day smoking, not even a puff—of over 50% across established smokers.
• The research also examined patterns of tobacco use across populations of special interest, including smokers of different ethnic groups, income levels, and mental health comorbidities. Encouragingly, results from the ADJUSST study demonstrate very similar high switching patterns among these cohorts compared to the general population.
• In addition to adult behavioral data, the monograph also includes an article assessing the potential effectiveness of enhanced access controls implemented at retail stores selling JUUL products. Juul Labs firmly believes the harm reduction potential of ENDS for adult smokers is at risk with high levels of underage use.
• Finally, the monograph closes with an article detailing the population health model submitted to FDA, taking into account both intended and unintended use of our products. Relying on data from ADJUSST and other sources (PATH, NYTS, Royal College of Physicians, etc.), the model projects that continued availability of ENDS like JUUL could prevent up to 2.5 million premature deaths by the year 2100.

We are proud to have submitted a Premarket Tobacco Product Application (PMTA) to the US FDA in 2020 for the JUUL System, which contains over 110 original scientific studies and 125,000+ pages of data, including information about our products’ impact on the individual user, their ability to help adult smokers transition away from combustible cigarettes, and the net-population impact on public health.

Following the PMTA filing last summer, our Regulatory team turned their attention to publishing some of the key research underlying our application through peer-reviewed manuscripts. While FDA is ultimately responsible for analyzing the scientific evidence about our products and making a determination regarding their public health impact, we also appreciate that the scientific and public health community have an interest in better understanding the harm reduction potential of vapor products, including JUUL products.

This month we celebrate a significant milestone in those efforts with the publication of 11 peer-reviewed studies in a monograph edition of the American Journal of Health Behavior (AJHB). The monograph focuses on the centerpiece of our behavioral research program: the Adult JUUL User Switching and Smoking Trajectories (ADJUSST) study, which sought to understand patterns of tobacco product use among adult JUUL Product purchasers. The ADJUSST study collected data on over 55,000 current, former, and never smokers who bought a JUUL Starter Kit for the first time, and followed them over the course of a year.

These articles, and the data they reflect, represent a significant portion of our research portfolio and address many of the key topics of public health concern and interest. Our hope is that the AJHB monograph published this month helps to further the necessary scientific dialogue about the harm reduction potential of our products, and the role they may play in reducing the smoking-related death and disease which kills almost half a million Americans each year.

We look forward to continuing to share results from our science and research program as we work to support the scientific basis for the category and help advance the Agency’s Comprehensive Plan.

Below is a full list of articles in the monograph publication:

• Prevalence of ENDS and JUUL Use, by Smoking Status, in National Samples of Young Adults and Older Adults in the U.S.
• The Adult JUUL Switching and Smoking Trajectories (ADJUSST) Study: Methods and Analysis of Loss-to-Follow-Up
• Switching away from Cigarettes across 12 Months among Adult Smokers Purchasing the JUUL System
• Dual Use of Cigarettes and JUUL: Trajectory and Cigarette Consumption
• Switching away from Cigarette Smoking with JUUL: Populations of Special Interest
• Cigarette Smoking Trajectories in Adult Former Smokers Using the JUUL System
• Smoking Trajectories of Adult Never Smokers 12 Months after First Purchase of a JUUL Starter Kit
• Transitions in Smoking among Adults Newly Purchasing the JUUL System
• Changes in Dependence as Smokers Switch from Cigarettes to JUUL in Two Nicotine Concentrations
• Improving Retailer Compliance for Tobacco Purchases: Pilot Study Findings Modeling the Population Health Impact of ENDS in the U.S.