The longitudinal study found that after accounting for key factors such as demographics and smoking history, rates of switching away from combustible cigarettes among adult smokers in the United States and Canada, where JUUL products are available in 59 mg/mL, were higher than in the United Kingdom, where the highest concentration available is 18 mg/mL. Researchers posited that heavier and more dependent smokers in particular may require the greater nicotine delivery of the higher nicotine concentration JUULpods (59 mg/mL) in order to successfully transition away from cigarettes.

Providing a satisfying nicotine effect and experience compared to combustible cigarettes is critical to facilitate an adult smoker’s transition from cigarettes to a potentially less harmful alternative nicotine-delivery product. Under the Tobacco Products Directive (TPD) regulatory framework in the European Union, the current maximum allowable concentration of nicotine in e-cigarettes is 20 mg/mL. Existing research suggests that these nicotine limits on e-cigarettes may reduce the ability of such products to switch adult smokers off of combustible cigarettes in the EU.

Notably, in both the US/Canada and the United Kingdom, more than 82% of participants reported using the highest JUUL nicotine concentration available (18 mg/mL in the United Kingdom and 59 mg/mL in the US/Canada).

The results from this study suggest that the availability of JUUL products (and other e-cigarettes) in a variety of nicotine concentrations — some greater than 20 mg/mL — may be associated with increased switching among adult smokers.

“When considering laws and regulations governing nicotine concentration in ENDS, policymakers should bear in mind that the availability of a variety of alternative nicotine products may facilitate even more smokers transitioning away from cigarettes,” said Mark Rubinstein, Vice President of Global Scientific Affairs at Juul Labs.

To be clear, JUUL products are not intended to be used for smoking cessation or other therapeutic purposes.

The study, entitled “Differences in Switching Away from Smoking among Adult Smokers using JUUL Products in Regions with Different Maximum Nicotine Concentrations: North America and the United Kingdom” was published in the journal Nicotine & Tobacco Research.

Juul Labs is fully committed to the Premarket Tobacco Product Application (PMTA) process in the United States, and to that end has built a robust scientific research program to help assess the harm-reduction potential of JUUL products, including their impact on the individual user, their ability to move adult smokers away from combustible cigarettes, and the net-population impact on public health.

We are committed to working cooperatively with regulators, public health officials, and other stakeholders to preserve the historic opportunity to transition adult smokers away from combustible cigarettes, while combating underage use.

Juul Labs will continue to share results from its science and research program transparently with the public health community as it works to support the scientific basis for the category, as well as future regulatory filings.

About the Study

A total of 10,082 adult established smokers in the United Kingdom, the United States and Canada who newly purchased JUUL products were recruited into a longitudinal study (UK: N=1,247; US/Canada: N=8,835). Complete switching (defined as no smoking, not even a puff, for more than 30 days) was assessed 1, 3, and 6 months after purchase. Propensity score matching and logistic regression compared switching after adjusting for baseline characteristics.

In both the United States/Canada and the United Kingdom, ≥82% of participants reported using the highest JUUL nicotine concentration available in that region. Rates were significantly higher in the United States/Canada (compared to the United Kingdom) at 3 and 6 months. After adjusting for factors such as demographics and smoking history, rates were significantly higher in the United States and Canada (compared to the United Kingdom) at 3 months and 6 months.

About Juul Labs

Juul Labs’ mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We believe that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco. Nicotine is addictive and can potentially be harmful. It would be best if no one used any nicotine product. Anyone who smokes should quit. Adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products. Juul Labs does not want any non-nicotine users, especially those underage, to try our products, as they exist only to transition adult smokers away from combustible cigarettes. JUUL products are not intended to be used for smoking cessation or other therapeutic purposes.

For the general public and policymakers looking for more information about the company, please visit www.juullabs.com.

For scientists, members of the public health community, regulators and policymakers looking to learn more about Juul Labs’ scientific research, please visit www.juullabsscience.com.

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.