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. 

Joe’s address pinpointed critical areas where the industry and stakeholders can find common ground in the pursuit of progress, including educating society on the benefits of tobacco harm reduction and using risk-proportionate regulation to elevate alternatives that can ultimately end the death and disease caused by smoking combustible cigarettes. It is imperative that alternatives can compete with combustible cigarettes and that adult smokers have clear information on a product’s relative risk compared to smoking. As Joe noted, “smokers are most successful in complete switching when they understand differences in risk.”

As Juul Labs works to earn trust and establish a license to operate in society, this year’s GTNF provided an invaluable opportunity for a diverse set of stakeholders to come together and speak about using innovation and regulation to create sustainable change in the tobacco and nicotine market. Through open engagement and collaboration, we can responsibly accelerate switching for adult smokers while continuing our aggressive efforts to combat underage use.

Read the Full Remarks Below as Prepared For Delivery:

First, let me begin with a tremendous thank you to all our keynote speakers, panelists, and, of course, our audience for their participation this week.  

In these times of social distancing and separation, it has been a great pleasure to connect over the GTNF platform for the last few days – whether through lively Q&A sessions or in private conversation in our engagement spaces. Thank you for making the first virtual GTNF a success. 

We have covered substantial ground this week on a wide range of topics. Every discussion brought out this year’s theme of “Sustainable Change Through Innovation and Regulation”.  

As we heard from all speakers, this space is in the midst of a massive change, driven by innovation. Progress in innovation for lower risk products can best succeed where regulatory and policy frameworks are truly risk-proportionate, and flexible enough to accommodate this changing landscape.  

This progress must be sustainable. Abrupt or forced change can have significant unintended consequences, impacting consumers and their communities through illicit trade, economic disruptions, and retrenchment back to more harmful products. 

We’ve managed to accomplish a lot, even without the magic of time travel.

At the outset of the conference I asked you to please consider four main questions. I’d like to turn again to them as we look back on learnings and, hopefully, actions, leaving the GTNF. 

First, how can we find common ground and move forward to eliminate the death and disease caused by smoking?

For starters, we can’t ignore the hard questions. One guiding principle as we put together this week’s content was to keep those tough questions at the forefront, difficult as they may be

A panel hosted by Clive Bates and some of the preeminent public health and industry experts tackled some of these hard topics head on, asking us to clearly articulate our goals as stakeholders.Setting goals is incredibly important. We need to state our goals publicly and hold ourselves — and others — to them. Our goals must not be so rigid as to not change when the evidence does — changing your mind with new data is a key tenet of science. And this category must be driven by science.

I want to lead by example here and lay out Juul Labs’ goal. We are working towards ending the age of the combustible cigarette. Ending the death and disease caused by smoking. For good.

A meaningful first step in accomplishing this goal is to think about how policies and regulations can be designed to accelerate switching away from cigarettes. And we will not succeed unless we combat the problem of youth use of tobacco and nicotine products. 

Public health organizations have a critical role to play. And multiple speakers urged us to think about the WHO FCTC as “a living document in a changing world” — one which has the flexibility to evolve as the evidence does.

Second, in order to find common ground and a path forward, we need to learn from what is working. 

As you’ve heard, there are global barriers to harm reduction around the world. But we are seeing glimmers of hope, too. Japan is one such country. Dr. Kumamaru discussed with us the country’s marked decline in cigarette sales in just a few short years after the introduction of heat not burn. I’m hopeful that vapor products will become available in Japan as well, to drive down smoking even more.

New Zealand is another country where we’ve seen progress in creating pathways to market for noncombustibles. And I’d be remiss not to mention the US. We heard updates about the FDA’s progress in reviewing and approving sound, science-based modified risk claims for noncombustible products. With the PMTA submission deadline a few weeks ago, we will continue to see changes in this marketplace as FDA considers these applications.

Many speakers discussed the importance of educating consumers. But we need to go further than that to help society understand the differences in risk between products that burn and products that don’t. Rosemary Leonard and others reminded us that misunderstandings about nicotine extend to healthcare providers, too. A large majority of physicians still believe that nicotine directly contributes to cancer, COPD, and other diseases. Correcting these misperceptions is common ground on which we can build. Confusion about nicotine and its role in smoking-related diseases can stop people from switching away from cigarettes.  

This is a daunting task, but we heard from many speakers that they are optimistic about the future. We heard about models of harm reduction around the world, and hope that progress can be made elsewhere. We need to ensure global and equitable access to harm reduction products. 

We cannot forget the consumers — the 1 billion smokers who still smoke cigarettes. As Cliff Douglas pointed out, we cannot forget those smokers who are unable or unwilling to quit.

I share our speakers’ optimism. We have the technology to end smoking, and are seeing how different geographies are able to make it work for their population.  

For my second question, I asked you to consider how industry can leverage innovation toward a sustainable future for the category.
Before we address that though, Mike Cummings posed an important, foundational question: Can capitalism, and by extension, industry, advance harm reduction? His answer is yes, and many others agree. Public health and business incentives can align to drive down smoking rates.

But to achieve this alignment, we must be responsible stewards of this technology. This includes a commitment to global underage use prevention.From innovative product design to marketing, we must make sure our decisions are rooted in science and informed by the evolving evidence.

I was excited to hear more about oral nicotine products, and I’m keen to see what the future holds for product development in this category. We also heard from top company scientists about how they are adapting their science programs to comply with regulations and inform the broader scientific and public health community. 

And as the saying goes, “change is the only constant in life.” We must accept change and rise up to this opportunity.

Many speakers in the Americas spoke about the possibility to accelerate the end of cigarettes through changes in both the combustible and noncombustible markets, most notably through the FDA’s Comprehensive Plan to limit the nicotine in cigarettes to minimally or non-addictive levels. This would present a fundamental change to the nicotine market as we know it — focused on driving down combustible tobacco use in this country and shifting demand to potentially lower risk alternatives. 

Of course, any such proposal would require an ample market of authorized lower risk alternatives and come with a concerted effort to avoid the creation of illicit markets. In addition, we need to consider other policies to increase the value proposition of noncombustibles in the US and around the world.

My third question was: Industry has a role and responsibility in this marketplace evolution, but we certainly aren’t alone. How can all stakeholders, especially consumers, participate in the dialogue on the future of nicotine in our society?

The question might be better put: How can we ensure that we, and others, are listening to and supporting consumers? As we saw clearly this week, they are participating already – actively. It’s our job to listen and act upon what they say.

Alex Clark, head of CASAA, explained, consumers can’t and won’t surrender their voice in this debate. They are standing on their own two feet to make their experiences heard. Their stories and journeys away from smoking help us understand how noncombustible products have changed their lives, and their families’ lives.  As Tikki Pang eloquently put it, the right to better health is a fundamental individual right. 

And on that note, consumers teach us the importance of having a range of noncombustible options available. On the consumer panel, we heard a variety of switching stories. We know that no one product will work for every smoker because consumers tell us so.

Another learning from this week is that consumers’ voices are amplified when they have the support and partnership of other stakeholders – particularly the public health community. As a physician and head of the Australian Tobacco Harm Reduction Association, Colin Mendelsohn exemplifies the power of this partnership in action. Colin is dedicating his medical knowledge to educating and empowering consumers so that they may amplify the call to legalize nicotine vaping in Australia. 

Roberto Sussman is doing the same in Mexico and the broader Latin America region, as both a consumer and a scientist. He passionately described the challenges facing harm reduction advocates in his region, including the lack of transparency.  And on this point, Roberto also gave his perspective on what he has coined “philanthro-colonialism” — the role of private philanthropists in setting public health directives without meaningful input from those on the ground, including the smokers themselves. 

And, my last question: How do we ensure all consumers are served? That all smokers have equitable and global access to harm reduction?

Here, we have a long way to go. First, as multiple participants shared, we must meet people who smoke where they are. What are they looking for in their journey away from smoking?

We need to offer those who currently use the most harmful tobacco products a landing place down the risk continuum. Especially in countries where the concept of harm reduction has not yet taken hold. This landing place must be well populated with a range of noncombustible products that can compete with the tobacco products they know and use. This requires access to these products through pathways to market anchored in risk-proportionate regulations. 

And here in the United States, we’re seeing state and local laws that ban menthol-flavored vapor products while leaving menthol cigarettes on the market. This makes me deeply uneasy.

And of course we, as companies, need to turn the lens inward. As Rene just said, great minds don’t all think alike. A lack of diversity is hindering our ability to grow and innovate. 

So, how can we make progress? Here, too, we need to embrace change. Allison Carlson shared conclusions from Women as Levers of Change. It’s clear that employees are moving with their feet and look to their companies to innovate, transform, and become more sustainable. We need to do better – to create safe, equitable, and inclusive workplaces.

Kim Reed just put the challenge out – do we have the leadership courage to ensure people have a seat at the table? Encourage your employees to point out your blind spots, and be comfortable with discomfort.

Finally, accurate risk perceptions and communications are important. As discussed in many panels, smokers are most successful in complete switching when they understand differences in risk. This requires all stakeholders to begin in earnest the discussion that Mitch Zeller has urged. What is the role of nicotine in our society? 

The message from speakers this week was clear: We can sustainably accelerate the market away from combustible products, and do so responsibly.  

Rosemary Leonard gave us a three-part framework for thinking about the next steps in this journey. First, establish a fact base grounded in science.  Second, use that knowledge to act responsibly.  And third, make sure actions and policies promote switching — among all who smoke. 

Dr. Leonard pointed out that older smokers have been left behind so far. We know stopping smoking at every age has benefits. But older smokers, who are at the highest risk, face the greatest challenges in quitting, and have even worse misperceptions than younger smokers. Hope should not be lost if a person finds themself aging into smoking. They matter.

It’s now our responsibility to convert this week’s learnings into action. 

Thank you again for your participation and thank you to the wonderful GTNF team, particularly Elise and my fellow advisory board members, for the incredible work that went into making this event a reality. 

I wish we could have a nightcap together to close out GTNF. But I appreciated the opportunity to have these virtual conversations. Thank you for bringing the GTNF into your homes. 

I take comfort in these wise words from Cicero: “Friendship improves happiness and abates misery, by the doubling of our joy and the dividing of our grief.”

See you next year.