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.

Joe used the opportunity to address several key topics, including the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation and the importance of the “continuum of risk” for nicotine and tobacco products that the agency has established. He also touched on how pervasive misperceptions regarding nicotine may be impacting adult smokers’ willingness to try alternative noncombustible products, pointing out that it is vital that trusted sources, such as regulators and public health organizations, work to correct these misperceptions and empower smokers with the facts about nicotine and tobacco harm reduction.

Joe stressed in his remarks that harm reduction for adult smokers cannot come at the cost of high levels of underage use. Juul Labs realizes that we will never be able to achieve our goal of eliminating smoking once and for all unless we can mitigate underage use. Rather, we urge policymakers to strike the right balance between preventing underage access to vapor products while avoiding policies that push adult smokers back to more harmful combustible products.

Some of the highlights of Joe Murillo’s remarks included:

• The best thing to do with respect to any nicotine-containing product is not to use it. Those who don’t use nicotine should never start. Anyone who smokes should quit. Adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products. For those smokers, switching completely to noncombustible products may be a way to reduce their risk of smoking-related disease. This is the basic concept of the comprehensive framework that was adopted by the FDA in 2017. As Commissioner Gottlieb and Director Zeller stated in 2017, “Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kills hundreds of thousands of Americans each year.” The basic concept of this comprehensive plan is the idea that nicotine is delivered on a continuum of risk.
• If we’re going to make progress on this concept of a nicotine framework, we’re going to have to deal with the misperceptions about nicotine. A previous PATH study from 2016 (and it is still true today) showed that 80% of those interviewed in PATH incorrectly believed that nicotine in cigarettes to be the chemical that causes most of the cancer caused by smoking. As stated by former FDA Commissioner Scott Gottlieb and CTP Director, Mitch Zeller, “Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.” And yet there remain these persistent misperceptions.
• We are at the cusp of potentially ending the age of cigarettes. No single product will work for every smoker, and a comprehensive plan that encourages people to move down the continuum of risk seems like a very opportune and thoughtful thing to do. But, the capability of products in this marketplace is not enough. We have to address the misperceptions.
• We know that misperceptions negatively impact switching. Dr. Alexander Persoskie and his colleagues recently discussed the fact that smokers who were considering switching to a potentially less risky product — in this case a vapor product — were three times more likely to switch if they properly placed the product on the risk perception scale.
  
• We can estimate that around 2 million smokers in the United States have switched completely — meaning not even a puff — from smoking cigarettes to JUUL products. We have been able to achieve this across a number of cohorts of types of smokers, from infrequent smokers to those who smoked cigarettes daily for more than five years. You also see that switching improves over time.
  
• But we don’t want to lay this just on the hands or at the feet of our regulator. Everybody needs to work within our parameters to understand that tobacco smoke, not nicotine, is the cause of smoking-related mortality and morbidity. And when we have a situation where even 80% of our doctors believe that nicotine in cigarettes causes disease, we’ll have trouble making a lot of progress on the FDA’s comprehensive framework.

Click here to read Joe’s full remarks. 

Click here to view Joe’s presentation.