Meeting

Lessons From Abroad on Electronic Cigarettes

Friday, October 11, 2019
A saleswoman holds an e-cigarette.
Speakers
Joanna Cohen

Bloomberg Professor of Disease Prevention, Johns Hopkins University Bloomberg School of Public Health

Matthew Myers

President, Campaign for Tobacco-Free Kids

Presider

Director of the Global Health Program and Senior Fellow for Global Health, Economics, and Development, Council on Foreign Relations

Global Health, Economics, and Development Roundtable Series

Over three million U.S. teens reported e-cigarette use in 2018, nearly double the prior year. A mysterious lung disease associated with vaping killed has nineteen people and injured hundreds. Congress and the president promise regulatory action, but some health advocates argue the backlash threatens the potential for e-cigarettes to make traditional cigarettes obsolete and improve the health of millions.  This roundtable, part of the Global Health, Economics, and Development Roundtable Series, is a discussion on e-cigarette regulation internationally and its lessons for U.S. policymakers, and a corrected transcript is below.

 

BOLLYKY: Terrific. Good afternoon. My name is Tom Bollyky. I’m the director of the Global Health Program here at the Council on Foreign Relations. It is my great privilege to welcome you here today for this roundtable on “Lessons From Abroad on E-Cigarettes.”

I’m sorry to report that today’s session is especially timely. The U.S. Centers for Disease Control and Prevention reported just yesterday that the outbreak of lung illnesses associated with vaping, or the inhaling of vaporized liquid that may contain nicotine, is now—there have now been nearly thirteen hundred injuries with two hundred new cases just this week. There are twenty-nine deaths including a seventeen-year-old boy in the Bronx.

The exact cause of these lung illnesses still has not been confirmed, but the people involved have inhaled a variety of compounds. Some have vaped THC, the main psychoactive compound in marijuana. Some have used a mixture of THC and nicotine. Some have vaped only nicotine.

This issue is causing particular concern because there has been an explosion in the use of e-cigarettes among U.S. adolescents. The CDC reports that 3.6 million U.S. middle and high school students used e-cigarettes in 2018, which—

MYERS: It’s up to five million now.

BOLLYKY: Is that true?

MYERS: Over five million, yeah.

BOLLYKY: —which at least in the jump from 2017 to 2018 was nearly double. Matt, your number sounds like we are on a similar pace for this last year.

This increase in youth use of e-cigarettes and this latest outbreak of lung-related illnesses has sharply increased the attention on the way e-cigarettes are regulated, which has varied significantly internationally. The World Health Organization has long pushed for strict regulations of e-cigarettes. India has recently banned the production, sale, and advertisement of e-cigarettes. England, on the other hand, has a pathway for e-cigarettes to be marketed as medicines for tobacco use cessation—so there is quite a range of regulatory approaches internationally.

Some U.S. states and cities have, at least temporarily or partially, banned e-cigarettes, and Congress and the president have promised regulatory action.

Some public health advocates, though, fear that the backlash against e-cigarettes may undermine their potential utility to make traditional cigarettes obsolete, and the potential to improve the health of millions.

To think through these issues today we’re enormously fortunate to have Joanna Cohen and Matt Myers. To save time, I’m going to grossly truncate their very impressive biographies—(laughter)—which you have in your materials.

Matt Myers is the president of the Campaign for Tobacco-Free Kids from where he has participated in nearly every major U.S. tobacco-related legislative initiative in the last twenty-five years. Joanna Cohen is the Bloomberg professor of disease prevention at the Johns Hopkins University Bloomberg School of Public Health where she also serves as the director of the Institute of Global Tobacco Control. She, too, has decades of experience on tobacco policy.

We’re going to start with ten minutes of opening remarks from Matt, who will discuss the current state of affairs in the United States on e-cigarette use and what we are seeing as the potential for regulatory action at the federal level. Joanna will then spend ten minutes of her opening remarks on the international comparative perspective, global trends on e-cigarette use, the different regulatory approaches taken by nations, and what lessons the U.S. might draw from those experiences. After that, I will ask a few questions to get us started and then turn it over to you, and we will end promptly at 1:30.

Before we start just several warnings. Please—as a reminder, today’s presentation, the discussion, the question and answer period will all be on the record. Please turn off your electronic devices and refrain from leaving early. And with that I will turn it over to Matt.

MYERS: Thank you. And it’s—since it’s a roundtable and a small enough crowd, we’ll try to keep it as informal.

I want to start with a couple of, I think, underlying premises that I think are really important because the core question is, you know, how should the government respond, and what is the role of government with the introduction of new products like these. And I think—you know, there’s a couple things that I think are important to put this current debate in perspective.

This isn’t the first time we’ve had the tobacco industry or related industries announce with great fanfare that they have a product that will dramatically reduce the risk of harm or assist smokers to quit. Frankly, it has been the tobacco industry’s playbook from the very first day that our surgeon general announced that there was a public health problem. You know, it started with simple things like filters—micronite filters and on—and on technical issues.

And, you know, historically when these have been announced in the past, we didn’t really have any regulatory structures whatsoever in place to deal with them. And the lessons we’ve learned are two-fold: one is that in the absence of government review of those basic, simple health claims, don’t assume they’re true. And even if they sound good, don’t assume they’re true over the long term. And second, in the absence of government oversight, even if they were true, and looking at public health population-based impact, you have to have great caution. I mean, as we learned later on from tobacco industry documents that the whole purpose of introducing many of these products originally was actually not to help smokers quit; it was to dissuade smokers from quitting altogether and to enlist a new generation of individuals thinking there really is a safe way to do this with regard to that.

The second important item, I think, as we look at this issue and think about how government should respond is to recognize that very few countries have significant regulatory capacity able to address these issues in a sophisticated, nuanced way. And that has broad implications because one of the important lessons to be learned is that it isn’t enough just to look at the product. Whether the product will actually produce a public health gain or harm over the long run is a result of multiple different factors, and those factors can vary from country to country, so that in deciding what’s the role of government, what should government do, what’s the right policy, the answer may well be that it’s not the same policy in every single country. What a country like the United Kingdom does may look very different when these products are introduced than if they are introduced in Uganda, or based on India’s recent calculations of what the plus and minus would be in those countries. So I think all of those are really important premises to think about as you think about this issue.

The ultimate goal from a public health standpoint is to reduce the number of people who die from tobacco use and to ask yourself the question, where do these products fit in to that core scheme? And the key answer for me is you’ve got to look in a sophisticated manner at your country’s capacity, the state of the epidemic, the rules governing that would impact abuse and use, rules governing the product itself, and other factors like that. And that will vary from country to country.

Then sadly, the U.S. is the example of what happens when government doesn’t do its job, and that I think is a really important thing to understand. And there’s an irony in it. Congress, in 2009, passed an act giving the Food and Drug Administration extensive authority over tobacco products, including authority to deal with new products, claims related to new products, population-based impacts of new products, whatsoever.

We will never know what would have happened had FDA actually exercised that authority because if FDA had exercised that authority, the products that are now on the market—whether the concern is appeal to youth or the unknown current diseases—would have had to undergo FDA review and would have had to meet a standard that says are these products—as they are manufactured, as they propose to be sold, and with any restrictions appropriate for the protection of public health—taking into account their health effect on smokers, their potential abuse among young people, potential abuse on former smokers with regard to those issues—we may have a very different setting today.

There is also a very specific provision, interestingly, that was designed to facilitate the responsible concept of harm reduction; one that says if a manufacturer wants to claim that his product—her or her product will actually reduce your risk of disease, here’s a set of standards, criteria designed to do it. It even has a set of provisions that says what decisions do we make as the science is growing and emerging so that we can deal in real time with regard to that.

FDA failed to exercise any of those authorities in real time, and the net result in the United States has been multiple. One is we do have a crisis of e-cigarette use among our youth, and some components of it are really important to understand. E-cigarettes were introduced at a time where cigarette smoking among our kids was dropping at unprecedented rates before they were introduced. If you look at what’s happened since particularly Juul came on the market, that progress has slowed significantly until this year. Juul’s impact on cigarette smoking, just from an association standpoint, has been negative.

Two, we now have the highest number of young people using nicotine in the United States since we’ve had—since 2001. I mean, that is literally two decades of potential progress.

Three, because there is no control over the product itself, Juul in particular has three times as much nicotine as would be allowed to be sold in the United Kingdom. So we shouldn’t be surprised that the data is showing not only are a large number of kids using it, but an astronomical percentage of them, by historic standards, are using them almost daily.

Point of comparison: the most recent study showed that 11.6 percent of the high-school kids using e-cigarettes are doing them more than twenty days a month. If you compare that to cigarette smoking, it’s three to five times the number of kids who are using them with great frequency.

The second part of it is, as a result of the design, particularly of Juul, and the social media marketing they use to make them popular, the kids who are using them we now know are not the kids who are most at risk of smoking. So what we’re doing is we’re not getting kids who would have smoked cigarettes and moving them over to this other product; what we’re doing is we’re getting literally millions of kids who would have used none of these products who are using these products and now are suffering from addiction.

Three, the failure to regulate the content means that, because the people who designed Juul were, in fact, brilliant—they didn’t care about health but were brilliant—it delivers nicotine more effectively than a cigarette because it has figured out how to do so without the harshness of a cigarette; that you don’t have the normal barrier to overuse, and because they figured out how to do so in a way so that it leaves no tell-tale sign on your clothes, on your smell, or on your breath. The kids in particular are able to use it without any risk of exposure, and so if any of you have kids in middle school or high school, or you know anybody who does, you know, there isn’t a high school in the world that—in the United States that isn’t facing what they call a Juul crisis where kids are using them in the bathrooms. Some of them are using them in the classrooms with regard to those issues.

You sit next to that, and you ask yourself the question, what do we know about whether these products fulfill the promise that they actually will help smokers quit, and I think that’s important. The failure of government regulation hasn’t promoted the right kind of innovation. What it has done is promote innovation designed to make the product the most attractive to the most people for the most rapid sales possible without regard to purpose. It means that we are almost a decade after the introduction of these products in the United States, and we don’t have any good studies demonstrating that these products are effective at actually helping smokers quit.

You know, we have a couple of isolated studies with a couple of individual products, which turned out not to be the products most Americans are using on this issue. So the failure of the government to regulate means the manufacturer wasn’t required to produce science to show that a particular product that delivered a particular level of nicotine in a particular way actually produced a positive benefit.

The other thing that I think is important to understand about what happens in the absence of regulation—in a way, the leadership of Juul has become quite honest, which was they say their goal was never to promote tobacco cessation, and some of their internal documents say we were—our goal wasn’t to promote tobacco cessation; that was why we never worried about health-related concerns.

They designed a product to be the Marlboro of the twenty-first century. That was the goal. And when you look at the product, it’s brilliant in doing that. Is it brilliant for protecting public health, in doing that? The answer is no, it isn’t, because it actually promotes addiction, facilitates an addiction, and makes it very hard for someone who uses the product to quit using it.

And there is an intellectual debate that says, if in fact it was only smokers who were using it, whether that long-term use is something that we would be comfortable with or uncomfortable. But since they made the same decision that Marlboro made—and they are a third owned by the same people who make Marlboro—we now know that a very significant percentage of the users will not be smokers who are actually trying to quit with regard to the product, so health impact.

All of that sends a pretty frightening message, but an important message that the global community is beginning to grapple with, which is what happens in the absence of controls over the product, controls over marketing, controls over entry into the product with regard to its impact on your other tobacco control measures.

And the U.S. is very different from the U.K. Often you hear comments about the U.K. I think—just make two quick points and then I’ll end. One is some of what you hear about the U.K. simply is not accurate. But two, the U.K. does have a different set of rules than we do. They have very strong rules governing, restricting tobacco marketing so that the kind of marketing that took place here would not be allowed there, and when one company tried it there, they clamped down on them very, very quickly.

Two, in the U.K. they have strict limits on nicotine levels so that the product that’s marketed in the U.K. by Juul, in particular, bears no resemblance to the product that we see in the United States at all with regard to that. Having said that, one shouldn’t think that the U.K.’s experience is entirely different than ours because when you actually look at the data, the increase in the number of people who use e-cigarettes to quit in the U.K. occurs at the exact time where there is an equal decrease in the number of people who are using nicotine replacement therapy to quit in the U.K.

And if you look at the charts in the U.K., the introduction of e-cigarettes—we have a very positive atmosphere—actually hasn’t led to an increase in the percentage of smokers trying to quit and the percentage of smokers who are successful in quitting there. So it’s true that in the U.K. so far they don’t have our crisis of youth, but they also don’t have the maximum impact of potential to determine are these products really helpful in getting your population to quit smoking.

The declines in adult use rates in the U.S. and the U.K. during this period of time are virtually identical, and they should be better in the U.K. because during this period of time the U.K. has introduced very strong graphic warning labels and plain packaging of cigarettes, and no longer allows the display of those products.

So it’s too early to say whether or not the different approaches in the two countries produce dramatically different results, but it’s not too early to say that, in the absence of meaningful regulation, what you see is you see the worst of the unintended consequences. And if you are a smoker who cares about—who is wanting to quit, you are not being provided either the products or the information that would maximize your effort for doing so.

So when we talk about free market innovation in this field, I think we need to learn from our experience.

BOLLYKY: Great. Joanna.

COHEN: Wonderful. So Tom asked me to talk about global trends in e-cigarette use, what other countries are doing in terms of regulating these products that Matt has touched on bit, and then any potential lessons for the U.S. So I’ll sort of go through those.

Regarding trends in e-cigarette use around the world, so the data are relatively scant so far. You know, these are new products. It takes time to get surveys onto national—or questions onto national health surveys, and then to get the data reported.

We have data from Euromonitor that sort of breaks down prevalence across the World Health Organization regions—the six regions of the world, and overall finding about 1.2 percent of people—sort of averaged across all those regions—are currently using e-cigarettes, and it does vary by region and by country. But again, it’s sort of early days to get a good handle on the data. You know, you get the early information on people’s awareness of the products, and then you get questions about ever using, and finally getting more detail on the frequency of use, you know, how much they are using, and addiction, and the types of products that they are using as well, which is important, too.

There has been a recent study published this year in the British Medical Journal that looked at youth use in the U.S., Canada, and England, so that was—the kids were sixteen to nineteen years old, and the data for 2018 was that the use—prevalence of use in the past thirty days was highest in the U.S. According to their study it was just over 16 percent. Next, in Canada, not too far behind at about 14 ½ percent. And in England 9 percent, which is still really high—one in ten kids. It’s lower, but it’s still significant, right—one out of ten kids using. And in the U.S. and Canada there had been a significant increase in use among kids sixteen to nineteen years old from 2017 to 2018. Just over the course of a year we saw big increases which, you know, we are seeing with other data in the U.S. In England there wasn’t much of a change. We’ll have to see what happens.

MYERS: England didn’t really have Juul.

COHEN: Not at that point, yeah. Again, Juul is different, though, in England—

MYERS: Yeah. Yeah, right.

COHEN: —at this—you know, so it’s hard to know what’s going to happen.

And there is some other data from the international tobacco control study that looks at fourteen countries that was published this year on addiction. And again, so these were—this was use among smokers, which is the group we would sort of—if anyone is going to use these products, that’s the group that should be using them—and they found that overall use was highest in high-income countries. That’s probably where the marketing has happened the most, then in upper and less and lower middle-income countries. So, you know, there are a lot of contextual factors that influence what products are brought to market in a country, promoted, and then what the population can actually pay for and what they’re interested in.

So that’s just a little bit of a flavor of global trends. It’s, you know, definitely to be continued, and we’re expecting, of course, rates to increase over time.

So what are countries doing with respect to this problem? And I want to acknowledge my colleague, Dr. Ryan Kennedy, who has been leading national e-cigarette policy scan for the past three or four years started with funding from the Robert Wood Johnson Foundation. And we’ve been looking at countries’ policies with regard to eight different domains, so with regard to do they ban the sale or restrict the sale of the products, minimum age of sale or purchase, warnings and packaging of the products, promotion of the products, the regulation of the products like nicotine content, whether they are allowed in—used in public places, taxation, and reporting to government. So there are lot of domains. It’s not just, oh, does a country regulate? There are lots of areas where a country can exert their powers to control use of these products.

So maybe I’ll just go through, very quickly, sort of an overview of what the world is looking like in those domains. So in terms of sale, as far as we can determine, there are at least twenty-eight countries that ban the sale of all types of e-cigarettes. OK, so those countries include countries like Brazil, Uruguay, Argentina, Singapore, Thailand, Turkey. The latest one we heard about was India.

Seven countries ban the—or at least seven countries ban the sale of nicotine-containing e-cigarettes, so Australia, Japan, Mexico are some key countries. So they are allowed to have vaping pods that don’t have nicotine, but not the ones with nicotine. So that’s just a couple things, sort of key numbers with regard to what countries are doing in terms of sales restrictions.

Many countries do state a minimum age for sale or purchase of these products, and in all these cases they default to their minimum age for buying other tobacco products like cigarettes. So here in the U.S. at a national level it’s eighteen. We know that states are going to twenty-one, but we’re not there yet here across the board in the country.

There are some countries that prohibit the advertising, promotion, and sponsorship related to e-cigarettes: Argentina, Brazil, Denmark, Finland, Australia—for the nicotine-containing products—are just some of those countries. And again, I can pass along the website and you can find all that on our website, too. No countries seem to directly address social media and Internet advertising because it’s very hard for countries to do that and enforce it, and we saw that that was really an issue here and a problem here in this country.

Thirty-one countries require child safety packaging so, you know, like pharmaceutical products, so it’s hard for kids to open the pack. It’s happening here in the U.S., in England, France, Germany, and other countries. Thirty-eight countries require health warning labels on the nicotine products; again, in this country, England, Canada, France, Germany are some of the countries that require that.

Regarding nicotine concentration that Matt mentioned, there are at least thirty-two countries that regulate either the concentration or the volume of the e-liquid and the nicotine in it, including twenty-eight member countries of the European Union. So it’s part of the European Union tobacco products directive and associated regulations. And if we have time, we can talk more about that later because it’s not so simple. I know that there is talk about that in this country, and we have to be careful about—anyway, we can talk about nicotine concentration. There are challenges with that, so we have to be careful. It’s very easy to get around those limits. And then there are countries that require premarketing notification and annual reporting of sales to the government, so that’s happening.

Regarding clean air, there are seven countries that actually prohibit e-cigarette use in private vehicles containing kids, so we know there are some states that require that around cigarettes—countries as well, but seven countries. A couple of them are Austria, Finland, Cyprus, so you can’t use e-cigarettes in your car if kids are in them. And I think there was one country, too, that if there was a pregnant person in the car, that’s also not allowed.

And then there are forty-five countries that restrict use in public places, so for example, in France you can’t use it on public—you can’t use these products on public transit. And again, I’ll just point out these are policies at the country level so there can definitely be subnational—like either state, province, city, county—policies as well, but I’m focusing on the country level. And at least thirteen countries tax—have a special tax on e-cigarettes, and they do that in slightly different ways.

So in terms of what the U.S. can take away from what countries are doing, I think it’s become clearer and clearer that there is a global consensus among the medical and health communities that no one should be using e-cigarettes except for possibly tobacco users and specifically cigarette smokers. So, you know, I think it took a while to be able to, like, say that clearly, but what we’re seeing now—it’s a clear consensus across the board. In the early days you saw a lot of controversy in the media about these products, but there is consensus. No one should be using these products except smokers trying to quit smoking.

And then we’re seeing that a lot of—there’s a lot of variation in how countries are trying to achieve this policy goal, and as Matt said, it really depends on, you know, the context of the country. England is different than the U.S. They have a National Health Service, national health care, right, and a pretty, you know—in terms of what we see in the world, they have the most sophisticated and comprehensive smoking cessation system. So e-cigarettes fit very nicely into a very planned—you know, a planned system of how health-care providers talk to smokers, so they might just be replacing NRT—nicotine replacement therapy—with e-cigarettes when they are coming in for their consults for smoking cessation.

And then, again, you know, we’re seeing a lot of middle-income, lower-income countries just banning the product because they know it’s going to be too hard to try and regulate around the edges. Their enforcement isn’t going to be strong enough—you know, the companies are just too difficult to deal with, and it’s just easier to do a blanket ban instead of trying to tinker at the edges.

So we’re seeing a really broad range of approaches to regulating these products. So far in the U.S. a laissez faire approach even though we have powers to do more. It’s been sort of—haven’t been able to do much just yet. And then countries banning the product outright—or the products or class of products outright, and then in the middle, some other countries trying to regulate, control the marketing, the promotion, where you can use it, who you can sell it to, et cetera.

So I think I’ll end there, and I’m really interested in the discussion.

BOLLYKY: Great. I’m going to ask a few questions, but you should start thinking of your questions now. I will call on people in the order I see your placards, so that gives you a chance to try to jump the queue.

So let me start with Matt on the U.S. context. You mentioned that the FDA has this authority and has had it since 2009, but did not exercise it, but you didn’t say why, or what they did try to do. And I raise that because I want to be forward-looking in this conversation and really focus on what we should do now, but, to do that, we need to know what lessons to draw from what happened between 2009. The L.A. Times recently put out a lengthy story about the attempt to get a deeming rule through the OMB process and the White House. Apparently, the draft deeming rule initially included pretty strong measures on flavors based on a couple years’ worth of CDC evidence, but that did not survive the OMB process. What can you tell us about—again, using it for what we should expect in the future and how this process might go—why they didn’t they act?

MYERS: You know, I think there are a number of conflicting reasons. One is I think some of the senior leadership at FDA itself struggled with what was the right role of government in how much benefit did these products have. As Joanna said, it took a while for certain consensuses to develop.

But the real reason that FDA didn’t act, from my perspective, is that those behind the e-cigarette industry, from day one, set out to manipulate the system in Washington to avoid regulation any way conceivable. So, you know, FDA first tried to regulate these products as drugs, and e-cigarette companies who were saying they can’t be treated as drugs—when the courts said, OK, therefore they’ve got to be treated as tobacco products, the FDA lobbied—the e-cigarette industry lobbied Congress to exempt them from the Tobacco Control Act. They failed, but they spent the next seven years lobbying the White House, OMB, and officials within FDA, trying to avoid any meaningful form of regulation.

You know, as we all know, it takes a really determined set of government officials to overcome that, and if you are ambivalent about what the role of these products are going to be, and you are uncertain about it, and the crisis hasn’t yet hit, it is sadly way too easy for a determined industry to forestall action on it. And, you know, the story in the L.A. Times—which I commend because I think it’s really well done—you know, is a classic example of that; that a recommendation went from FDA, to the secretary of Health and Human Services, to OMB that said the concern about the impact of flavors on young people is so great that we should ban all of the flavors except for tobacco flavors. That was the recommendation of the agency with expertise, the Department of Health and Human Services, and it fell into the bowels of the Office of Management and Budget where it got killed—killed without public scrutiny, public debate, and now public analysis of the data.

So, you know, the short answer is while this industry historically has tried to present itself as different from the tobacco industry, it’s engaged in all of the same behaviors to obstruct government from doing its job. We’d be a lot further ahead if the industry had gone to FDA from day one and said, how do we do a balance here—you know, regulations that protect the public but that don’t stifle innovation, and they did the opposite.

BOLLYKY: Joanna, let me ask you a question on the international side. Let me play a bit of a role of the skeptic just to draw you out a bit on what’s the difference with e-cigarettes.

So countries have limited regulatory capacity are banning them because they have limited regulatory capacity oversee the tobacco industry and cigarettes. But those same countries with limited regulatory capacity oversee the advertising, sale of tobacco products. They oversee the pharmaceutical industry—pretty complicated industry. What is different about e-cigarettes than the complicated products we ask low and middle-income countries to regulate as a matter of course?

COHEN: Well, in this case, I mean, they are concerned about the health of their kids, right? And they are actually taking a stronger stand than we can, and see that there are—you know, I think they’ve learned from the whole tobacco debacle of how, you know, when you don’t take a strong stand, you know, we have a pandemic. We haven’t talked about cigarettes when there are many more deaths each and every day—thirteen hundred in this country each and every day. And so they’ve learned. They know it’s hard to regulate those products. Once the horse is out of the barn, you can’t do—it’s very hard to, you know, pull back the hands of time. So I think they’ve learned, and they know they want to protect their kids and not have—you know, repeat the mistakes that this country has done, and so they are saying, we’re going to—we’re going to take action.

So I don’t think it’s that they can’t do anything. They are just seeing these new products and, you know, why do we need another tobacco product here; there’s no reason—no reason to have just one more of these harmful products on the market.

MYERS: You know, India may be a good example for you on that one, too. First of all with regard to drug regulation, countries with low levels of capacity are able to depend on the wealthy world for doing a lot of the work so that what they need to do is much less. In this case, in India, India debated about treating it like a tobacco product. They debated about treating it like a drug. Juul, in particular, came in and violently opposed them on both counts with regard to that and created an atmosphere in the equivalent of the ministry of health and equivalent of our FDA that they weren’t going to be able to get a handle on this.

The other thing that happened in India is—if you understand the Indian context a little bit—more than 25 percent of Indians use tobacco products, but only 4 percent of Indians smoke traditional cigarettes. So the actual market for Juul of smokers by Indian standards is really very, very small. And you looked at the kind of effort that was being made—again, particularly by Juul—in which you realized, if you looked at the Indian market and the American market, they weren’t going to make money off of cigarette smokers switching because, you know, despite the numbers there weren’t that many who were interested in quitting.

But India has over a hundred million kids whose families have moved into the middle class over the last twenty years who are really interested in cool, high-tech, smooth-looking stuff. And you wanted to look—and the Indian government looked at the growth market there and said, it isn’t smokers; it is our young people—I mean, the fact they’ve chosen here—and said, what we’re going to do is we’re going to step in, and we’re going to try to stop that before it moves forward.

The other thing that’s important in India to understand is it’s described as a ban, and it is, except if a company comes in and makes an application to the equivalent of our Food and Drug Administration for approval as a tobacco cessation product. That is permitted under Indian law if any company is actually interested in doing it. I think experience will tell us it’s not because it’s the same way it is in Australia, and nobody has done it.

BOLLYKY: Great. I’m going to ask one last question —I have lots of question, but I’m going to keep to a last one and then turn it over to the group.

But one thing I didn’t hear is what US policymakers should take from the experience of regulating e-cigarettes abroad. I got the sense there is a lot of diversity in approaches and it’s really early days. But based on what we do know, what can we learn? U.S. policy makers, both on the Hill and in the executive branch are in the midst of grappling with what they should do. Is there another country they should look toward? Is there anything from the international experience that they should consider given that there is a diversity other nations have done?

COHEN: It’s challenging because we haven’t—we don’t really have the U.S. experience in other countries to see how it would apply. So we’re talking about flavor bans, for example—banning of flavors in e-cigarettes. And so countries have not implemented that yet, so we don’t—we can’t really learn from, you know—and part of what’s important in a comparison country is that you do have a significant proportion of cigarette smokers who you are trying—thinking that they might—this might be a pathway for them to quit smoking, and then to see, you know, if you—how you tax the product, whether you allow flavors or not, where people can purchase the product, all those things to see how they influence that process and of cigarette smokers using.

I don’t think there are any strong lessons at this point. I think we have a lot of lessons from tobacco control policies of what works and how people are influenced by changing the environment, changing the availability and accessibility of products. And that’s sort of what we can probably draw on more.

MYERS: That’s interesting because a couple of us have said to folks—people point to positive things from the U.K.—let’s adopt some of their rules, and what we face is pretty stringent opposition from the industry to the adoption of those rules. So it’s—even when you look at the U.K. and say what can we learn, it’s a challenge to then adopt them.

You know, in the U.K. you can’t make any health claims whatsoever, so none—you know, so you’re not facing that kind of thing that we’re facing here. The industry here wants to be able to do those sorts of things, so they oppose those kinds of efforts to do so.

We are in the early stages of countries trying things, and so I think everybody is looking at each other and saying, what is working, and we’re at the early stages of people trying to do it. So you have the U.S., the U.K. models. Australia—everybody is looking at what’s happening when you don’t have them allowed to be sold. New Zealand is the one country that is talking about following the U.K. model, and we’ll be able to see what happens there with regard to it.

We’ve done a lot of work in a number of African countries and, you know, they’re a good example of the government looks and says, we don’t have any mechanism whatsoever with regard to it. And in many of the Sub-Saharan African countries outside of South Africa, they have fairly low smoking rates among young people, unfortunately because of poverty. It’s hard to envision these things playing a positive role so, you know, our advice in those countries is there may come a time where these things are helpful to smokers to quit, and there may become a time where you as a country could benefit from that. But in the short term, maybe the best thing you can do is, A, strengthen your tobacco control laws and, when you do that, prevent these from undermining your efforts.

COHEN: And if I may, I just want to add on to that very quickly.

In your introduction, Tom, you mentioned that England does regulate e-cigarettes as medicines or drugs, so that is a pathway.

BOLLYKY: Right.

COHEN: But I think there’s only one or two brands that have actually followed that pathway, so they have a choice, and so the vast majority choose not to go that pathway and just be a regular consumer product. So it just reemphasizes what Matt has been saying about the real intent of these companies; that this isn’t—you know, if this was a product that was really there to help smokers, and we treated it that way, it might be different situation. But it has just been clear over and over and over again that that’s not the intent, as we see even in England—that companies don’t want to go through that pathway.

BOLLYKY: Great. You’ve all been very patient. People who have questions, let me see your placards, and I will call on you. I see Paul, then Jessica, then Vivek.

Q: Thanks—

BOLLYKY: Oh—and I’m sorry—just state your name and affiliation.

Q: I’m Paul Isenman. I’m an independent consultant. Very good presentation. Thank you.

Look, you know, I’ve worked a lot on tobacco taxes, and we now have pretty close to a consensus about what you should do, and when you should do it, and differences among countries, and all that sort of thing. We clearly do not have that in the case of e-cigarettes. There’s a great, great need for evidence. So we need evidence on regulation. We need evidence on taxation.

There’s a good new blog at the Center for Global Development (CGD) by Bill Savedoff on the effect of the tobacco industry, cigarette companies owning Juul, and others. So how do we get that evidence? And I think there is just a crying need for the major funders here, of which there have been essentially two—Bloomberg and Gates—to step in in a major way without gainsaying anything that has been said about what we need to do. They need to put a fairly big sum of money in. We need to really move fast on serious research to get the evidence that we need for improvements in policies across the board, and we ought to try to have some of that so that we’re ready in the event there happens to be a more sympathetic OMB that Matt has mentioned and whoever OMB works with.

MYERS: You know, I think everybody agrees with you, Paul, and the question is how you go about it. You know, FDA is funding a good deal of research in a pretty wide variety of areas in there. It’s the one governmental agency anywhere in the world that is doing that effectively.

Bloomberg has recently funded a project in the United States on this issue, and it has a component of funding, mostly through the Centers for Disease Control Foundation, in order to collect real-time data so that, as policies are adopted, that we can relatively rapidly evaluate what their impact has been across the board. It will produce more rapid data—more rapid, more accurate data than we would otherwise be able to collect in that area.

But there needs to be a great deal more and, you know—and on your favorite topic of taxation— because these products vary so dramatically. Even figuring out the right way to—you have to figure out what your goal is in taxing them, and then you have to figure out the right way to do it and with such a wide variety of products. That’s a discussion that is going on, and a number of different approaches are being used. A couple people are studying what those different approaches are, but there are so many variables. It’s an area that needs to be a high priority. I think everybody agrees.

Q: Internationally.

MYER: Both, yeah.

BOLLYKY: Jessica?

Q: If we were—realizing we don’t have—

BOLLYKY: Sorry, but just your name and affiliation again.

Q: Oh, sorry, yeah. Jessica Herzstein. I’m a consultant in occupational and environmental health.

BOLLYKY: Great.

Q: If we were somehow to decide and be able to ban production of e-cigarettes in this country, with what we know now, do you think that we would see an increase in tobacco smoking? Do you think we might see an increase in population risk from black market production of e-cigarettes or, you know, e-tobacco of some kind? Or do you think we might see potentially a leveling off or decrease in tobacco use because of all the, you know, fears that have risen about the use and the—just the frightening data that’s out there and, you know, gradual pulling back from use of e-anything.

MYERS: A multi-pronged question. My quick answer to it is a couple-fold. First of all, you know, while Massachusetts’ governor did put in place a short-term ban on the sale of all e-cigarettes, most of the approaches are not bans on all e-cigarettes. What they are is an effort to restrict the sale of the products that are fueling the youth epidemic—mostly flavors—and B, efforts to get FDA to actually begin to review these products and begin to set some standards.

No one is talking about banning all of them. What they are talking about doing is getting a handle on them so that we don’t see that.

The second question you raised is an interesting one, and that is if we take strong action right now, you know, what’s the likely consequence in terms of—on people using these products with regard to it?

I think a couple of things are important to understand with that. First is if we don’t take strong action now, and we continue to see the youth trends going up—a million-and-a-half kids new to these each year. The long-term consequences of that are really substantial with regard to that, and we have to factor that in.

Second, if I had a chart here, I would show you an interesting chart. Over the last four years, while youth rates of these products have skyrocketed, the percentage of adults who use them has been dead flat, right around 3 percent—so low that when I’ve gone to epidemiologists, they’ve said to me, even if these products were fabulously effective, the percentage of people using them isn’t large enough to have actually significantly impacted the rate of decline. So that if we interrupt that, it’s really highly unlikely that we would see a reversal of those trends out there with regard to it, and I think that’s important to understand.

I mean, it goes to Joanna’s point—is it’s intriguing. With all the marketing and everything else that’s going on, the only impact it has had is on kids. And I don’t believe these people who are spending hundreds of millions of dollars market are that stupid. I think they know what they are doing on that score.

But, you know, the third point is that the entire discussion should take place within the context of what do we need to be doing while we’re dealing with e-cigarettes to continue to drive down usage of these products, and that includes partially a discussion of we now have five million kids, a large percentage of them addicted; what do we do to deliver better cessation services, more effective cessation services both to adults and the kids so that the default—when you are hooked and the product you are using goes away—isn’t to go to a cigarette. It is to be given help about breaking the addiction. I mean, that would be the way I would describe it.

COHEN: I think the fourth point, though, is that we have been seeing cigarette numbers—they have been going down before e-cigarettes came on board, so there’s still a lot of work to do. We’re waiting for our health warning labels on cigarette packs to come out, and talking about banning menthol cigarettes and, you know, there’s a lot more we can do for sure. We still don’t have, across the country, smoke-free public places, you know, across the board.

So I think, you know, the trends were going down. I don’t think it’s going to have—would have a major impact.

MYERS: You know, an interesting statistic not many people realize—it’s now a year out of date so I’m hoping the data is better than this even—and that is in 2018, in eight states in the United States, high-school smoking rates were under 5 percent. Think about that. It means that we were at a point where, if we could do that dosage around the country, the concept of talking about a tobacco-free generation isn’t just rhetoric.

You were down there. In California, high-school smoking rates in 2018 were 2 percent—of cigarettes. I mean, just think about that. So we sometimes act as if our only solution is this one that sits over here as opposed to—we have learned an enormous amount about how to make a difference. Let’s put the energy into doing that. And if these products have a role for people who can’t or won’t quit, let’s figure out how to maximize it.

BOLLYKY: OK. Vivek.

Q: Thank you. My name is Vivek Murthy. Thank you, Joanna and Matt, for the wonderful remarks that you made.

I had actually a two-part question. One is I was curious if there were any countries that you have encountered that are taking a solely prescription-based approach to e-cigarettes—or are trying to. Obviously it’s something that has been discussed a lot here. It seems far from reality here although I think it makes a lot of sense.

But the second thing I’m wondering about is around public sentiment. Given especially the news recently with vaping-related illnesses, I’m curious if you are sensing that there is a shift taking place in public perception around e-cigarettes, particularly among parents and among youth, and if you think that that is translating to lawmakers—especially federal law makers—being more open perhaps to sensible regulation around e-cigarettes.

MYERS: Want to do the first one?

COHEN: So no, I haven’t seen anything with prescription only, and again, that fits into the model that this is a smoking cessation aid for cigarette smokers who want to quit, and the companies have refused to—you know, have fought against being regulated in that way. So no, we haven’t seen that yet. I think it is really an interesting approach.

MYERS: In terms of the public sentiment, yes, we’ve been doing a fair amount of polling recently, and no one should be surprised. You know, after the White House announced on September 11 that it was proposing to do a ban on flavors, we polled. And interestingly, as divided as our nation is, whether you were talking to a Democrat or a Republican, a conservative or a liberal, support for the policy ranged between 73 and 77 percent. I mean, it cut across enormous barriers with regard to that.

And anecdotally, you know, the U.S. House of Representatives Oversight Committee held a hearing in July, and there were a number of very conservative libertarian Republicans, members of Congress, who participated. And they almost were apologetic. One of them began by saying, every time I go home, I’m bombarded by mothers and fathers talking about the problem of Juul use in their school. He then went on to parrot the Juul language, but without any passion with regard to it.

So my sense is, yes, the answer is yes, but what I think the challenge for everybody is how do you capitalize on it, how do you make sure that we—that that doesn’t fade, that you create a smart and strategic public policy discussion and try to get things done while people feel this way.

BOLLYKY: One last question.

Q: So you kind of started to touch on my question. My name is—

BOLLYKY: Apologies, but we just have two minutes so please be quick.

Q: It will be. My name is Tishina Okegbe. I’m with FHI 360.

So not to be very cynical, but it seems like there is a lot of money in lobbying efforts coming from the e-Juul—or e-cigarette companies, and so I was just curious as to what you think will actually work to push the needle on this. And you started to mention some of it but, I mean, when there is money in the room, money talks often.

MYERS: Well, money talks almost always. You know, as public advocates, I think it’s our job to make that money poisonous. And that’s why Vivek’s question is the right one.

The public debate has changed. It changed rapidly with regard to the youth explosion, and when you layer on to it the concerns that—now every parent whose kid is using an e-cigarette is terrified about what the implication is, and this is no longer a long-term problem; this is an immediate problem with regard to that.

So I think there is an opportunity, despite the money, to get government officials to do—to act responsibly. We’re seeing it pretty clearly. We’re engaged in campaigns in half a dozen cities and about half a dozen states on this issue, and the response we’re getting is strong. Sometimes I feel like the conservative in the room actually. (Laughter.)

But, you know, it’s a nice problem to have with regard to it. Will we get Congress to do it? I don’t know. The fact that the White House proposed taking strong action under this administration took a lot of people by surprise. We’ll see if they follow up on it. That’s still uncertain with regard to it.

But I think the public debate has moved forward very quickly, and the behavior of particularly one e-cigarette company has so concerned so many parents across so many domains that I think the challenge is how do we seize it.

You know, there was an event at the White House the day before yesterday hosted by the First Lady on this very issue, and Kellyanne Conway participated and began by saying, I have four children. You know, it cuts across political belief. We have to figure out how to maximize the benefit of that.

BOLLYKY: Great. We’re out of time, but Joanna, I wanted to give you one minute if you wanted to say anything in closing.

COHEN: Well, only just to add to that. I think where the country is definitely together is everyone wants to protect their kids, and so this is a great moment to finally address this issue in the way that we should have.

BOLLYKY: Great. Well, this was a really useful discussion. Thank you for everybody for coming out at the last minute, and thank you to the speakers for their great remarks. (Applause.)

(END)

This is a corrected transcript.

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