Company News, Policy

November 6, 2020

Juul Labs Chief Regulatory Officer Joe Murillo participated in a panel discussion at the 2020 Food & Drug Law Institute (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference, where he discussed the role of nicotine in tobacco harm reduction.

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.