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.

With its PMTA submission, Juul Labs has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole. The application includes detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.

As part of the PMTA process, Juul Labs has built a comprehensive research program focused on examining the public health impact of the JUUL System. This includes research addressing the harm reduction potential of the product. This research is supplemented with information on the controlled design and repeatable manufacturing processes associated with the JUUL System, as well as data-driven measures to limit unintended consequences to the overall population, including initiation among nonusers.

“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.

“Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” said Joe Murillo, Chief Regulatory Officer at Juul Labs. “We respect the PMTA process and believe it is the right forum to

determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.”

Late last year, the company, under Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.

Juul Labs has built up its science and evidence-based capabilities and will use its research and data to explore additional pathways in other countries. The company will continue to share its research with regulators and the public health community globally through peer-reviewed journals, conferences, and one-on-one meetings.