The E-Cigarette Dilemma: A Public Health Perspective

welcome to the forum live streamed worldwide from the leadership studio at the Harvard th Chan School of Public Health I'm Dean Michelle Williams the forum is a collaboration between the Harvard Chan School and independent news media each program features a panel of experts addressing some of today's most pressing public health issues the forum is one way the school advances the frontiers of Public Health and makes scientific insights accessible to policymakers and the public I hope you find this program engaging and informative thank you for joining us welcome my name is Chris Kirkham I'm an enterprise reporter with Reuters focusing on tobacco issues I'm also today's moderator our panelists starting for my immediate right are Howard Koh professor of the practice of Public Health leadership at the Harvard th Chan School of Public Health we have Robin Koval CEO and president of the truth initiative Vaughn Reiss director of the Center for Global tobacco control at the Harvard th Chan School of Public Health and Mitch Zeller director of the Center for tobacco products at the US Food and Drug Administration this event is being presented jointly with Reuters and as part of the dr. Lawrence H and Roberta Kohn forum series we're pleased to welcome the Kohn family and friends today we're streaming live on the websites of the forum and Reuters and on Reuters TV we are also streaming live on Facebook and YouTube this program will include a brief Q&A and you can email questions to the forum at HHS pH you can also participate in a live chat that's happening on the forum site right now so ten years ago east cigarettes were just entering the US market and we're largely popular among hobbyists and small businesses ordering parts from China now it's a multi-billion dollar industry jewel labs Inc now has a thirty eight billion dollar valuation and popularity is soaring one particular question about this popularity is youth usage it's of especially grave concern to policymakers right now following a huge uptick in high school and middle school use especially over the last year so policymakers and regulators are wrestling with a vexing question who and what our cigarettes for are they a tool to help smokers quit or at least minimize the harm of traditional cigarettes or are they a new Avenue towards addiction particularly with youth and with little yet known about the health consequences over the long term one recent study from researchers here at the Harvard Chan School found that some e-cigarettes were contaminated with toxins linked to asthma and other lung problems how do each cigarette intersected with other tobacco related technologies such as the I Coast tobacco device that was just cleared for sale in the u.s. last week today our panelists will take on these questions and more but first let's look at a clip from Reuters about a major east cigarette maker jewel which decided last fall to pull sweet flavored products from stores following a regulatory crackdown working to reduce a surge of teenage vaping East cigarette maker Jewell said it will pull popular fruity flavors such as mango and cucumber from retail stores on Tuesday the company said it will temporarily stop selling flavors except for tobacco mint and menthol in all retail outlets that's until technology has put in place to scan buyers IDs and ensure they're over the age of 21 the move by jewel coming amid heightened scrutiny from the FDA in September the FDA threatened to ban jewel and four other East cigarette products unless the companies took steps to prevent underage use that compliance period has now ended Jewell said Tuesday it is shutting down its social media channels on Facebook and Instagram and is working to remove unauthorized youth oriented content on their platforms despite pulling the plug on retail stores Jewell said it's sweet fruit flavored pods can still be purchased on their website which uses an age verification system to screen customers all right so Howard Jewell pulled those products in November after a threatened FDA banned due to concerns about underage use and this clip demonstrates some of the market and regulatory forces at play here particularly when it comes to youth use can you bring us up to date a bit on what has happened since then and also give us kind of a bigger picture on how cigarettes in public health intersects what parallels are there between a cigarette and traditional tobacco control efforts well thank you Chris and it's very important to take this new and very troubling youth epidemic within the broader context of the Global tobacco pandemic that's engulfed the world for the better part of a century and more so just to remind everybody tobacco use independence remains the largest preventable cause of death and suffering worldwide we know that in our country nearly half a million people die each year from tobacco dependence and related disorders globally it's projected by the whu-oh that we'll have a billion deaths from tobacco misuse this century unless we do something dramatically different and when we talk about the biggest public health challenges of our time this is it there's no other condition that causes this level of suffering now about 98 percent of those deaths are due to what's called combustible tobacco products for example cigarettes that are burned to release nicotine and other toxins which can cause so much disease and suffering the only good news here is that we have a very robust tobacco control program in this country and worldwide that's trying to address all this and in the u.s. adult and youth cigarette smoking rates are declining but as you mentioned Kris over the last decade we now have non combustible tobacco products that heat and vaporize liquids to release nicotine but but much lower levels of toxins and this has raised the discussion about possibly using e-cigarettes as a form of harm reduction a very fascinating and very controversial topic right now the hope is that the use of e-cigarettes could help adult smokers to switch and they're therefore reduce a risk but a challenge is the uptake for kids and what we're seeing now with the entrance of jewell into the e-cigarette market is this skyrocketing rate of use among young kids and in fact just several months ago the highly respected monitoring the Future survey which has been tracking the substances that kids use and misuse dozens of them reported that the rate of rise of yiii cigarette use fueled by joule was the highest ever recorded in the 44 years they've been tracking these outcomes so these are very ironic and troubling the discussions to have particularly in a day and age where the whole country is talking about substance use and opioids in general this is another substance use issue that we need to tackle head-on and that's that's the setting for this forum today so Robin Howard you know mentioned the youth use question tell us a little bit about what makes East cigarettes so appealing to young people well they are kind of the perfect storm in in many ways so you've got a piece of technology which is very appealing to young people it's easy to conceal it comes in flavors and it feels cool and compounding that is the way jewel in particular but other products as well have gone to market so not necessarily as products targeted to a 40-year old smoker who needs to quit but in ways that are very peeling to young people so we have a slide that shows some examples of Jewel's early marketing attempts which I don't have to explain a lot this clearly shows young attractive people looking you know like they're having a lot of fun I think we even have a couple of image there from a jewel competitor called candy pens which uses hip-hop stars and young very sexy women in their advertising which you know has made these products very appealing to young people and even more than the investment that's been made by the individual companies is you know the best marketing in the world is when you can get other people to do it for you and so there's was an explosion and there still is an explosion on social media of young people basically advertising to one another so even when jewel says they've taken down their Facebook page and Instagram pages the all of this lives on in the social media sphere that young people share with one another the other thing that I think is a huge fan to here beyond the tech enos and the easy to conceal it's the very very appealing flavors that these come with young people often don't know that these products contain nicotine they don't think there are any risks they think well it's just mango which of course it isn't in our own studies we know that two-thirds of the young people we spoke to this is about a year ago so maybe it's changed but at that time two-thirds didn't know that a jewel always contains nicotine and again when you take a look I have another slide at the way these flavours have been presented these are products that in fact FDA sent letters in crackdown on because they're so egregious but it's hard to tell here what's the e-cigarette and what's the cookie or apple juice product or one that particularly bothers me this is a very recent one of a codeine cough syrup that's abused in in in by a lot of people an e-cigarette flavour that's been made to look just like it so this is what's going on out there so the the opportunity to realize the benefit of e-cigarettes is being compromised but while it's happening actually out in the marketplace with young people very interesting Vaughn can you tell us a bit about where we are now globally in the fight against harmful tobacco and how do you see a cigarette s– fitting into this picture that's that's the fascinating question and and dr. Koh's explained to us that tobacco is the the four most preventable cause of death and disease globally and and and it is in that context I think that we need to think about strategies to regulate e-cigarettes of course we are concerned about the you know the rising tide of e-cigarette use particularly among young people too many kids have used a nicotine product in recent years who otherwise may never have smoked or used any such product and we're concerned because this is driven largely by a predatory industry who target young people with products that are highly addictive and and the potential to cause long-term harm through addiction and and the potential to use more deadly products is very real I think though we need to examine the bigger picture and I think we need to think strategically about how we can regulate vaping products in a way that that reduces the harm associated with adult smoking while ensuring that we have very rigorous strategies to prevent youth or young people from initiating use of e-cigarettes we don't want to see another generation of young people addicted to nicotine and so the question is how might we approach this how can we regulate vaping products in a way that that the protects youth while providing opportunities to adults to reduce the harm associated with combusted tobacco use and reduces their exposure to the harmful constituents in cigarettes and there's been something of a I think a split or a divide in the both the tobacco control community and the public health community that I think we need to attempt to try to resolve by developing a something of a more unified vision around around our strategy here and I think what we need to do is go back to thinking about what works and we've seen over the past five decades some very effective evidence-based strategies that have had enormous impact in reducing rates of smoking not just among adult smokers but but certainly also among youth we've seen some of the fastest decreases in youth smoking that we've seen historically in the past few years so I think we understand what what these strategies look like in FDA I know are pursuing these strategies quite vigorously but we need to regulate across product types in a way that that is synergistic that that applies similar approaches to to both vaping products and combusted products that that both protect youth and and encourage adult switching so for example we can impose rigorous restrictions on access to vaping products among young people we can look at the way young people through marketing and communications to ensure that that that manufacturers don't make the product more appealing we can reduce or eliminate flavors particularly flavors that are appealing to youth or young people we can introduce product standards particularly around the addictiveness of products to ensure that that adults no longer turn to combusted tobacco products for nicotine but look for safer alternatives I think if we take this approach that is that is evidence based that that seeks to both protect youth and and reduce harm among adult smokers it certainly is like threading the needle and and it is something of a public health balancing act but I think with with a unified vision among those working in the field it will help to define a regulatory agenda and a research agenda to support that mission we talked about a balancing acts and Mitch has the pleasure of navigating that balancing act to the FDA so Mitch what should regulators be thinking about as we craft rules around east cigarettes but also in a sort of changing landscape where we're getting new data about youth usage and tell us just a little bit about the status of where we are on the regulations of regulation of this industry today well Vaughn talked about the need for a vision and we have a vision and we think it's achievable from a regulatory policy perspective the the challenge is what's going on with kids uptake of e-cigarettes but the the vision is fairly easy to articulate 90% of all adult smokers started smoking when they were kids in old industry documents the tobacco industry had identified young people as the replacement smokers for addicted adult smokers who died or quit so part of our vision is a world where cigarettes as we know them are no longer capable of creating or sustaining addiction the cigarette would still be out there and it would still be very dangerous and toxic but through regulation it could no longer create or sustain addiction while adults who are still seeking nicotine because we still have thirty four million addicted adult smokers whose brains have been real I earned by the nicotine in cigarettes and for those people who are still seeking nicotine in a properly regulated marketplace they could get them from alternative and less harmful sources today it's e-cigarettes tomorrow it might be some different technology it's all possible we think that that vision is achievable the challenge is and this goes to something else that once said as regulators we're responsible for a population level public health standard and and and by law we have to take into account all of the impacts good bad or otherwise and the law makes it clear that that includes studying impacts on initiation any initiation on any of these products by kids goes on to the negative side of the ledger but also the impact on cessation and with these cigarettes there is at least anecdotal reports that e-cigarettes and the presence of flavors in e-cigarettes is helping some addicted adult cigarette smokers smokers transition away from cigarettes so it's very much this this public health balancing act with within this larger larger vision that we see and that we see is achievable that the challenge is how much weight do you put on these different considerations from our survey the National Youth tobacco survey that's an that's an annual survey from 2017 to 2018 there was a 78 percent increase in current a cigarette used by kids in high school in one year and that's starting from a baseline where it was already the most popular category of products with kids and for middle school kids the increase was almost 50% in one year and just as disturbing the increase in the frequent use of e-cigarettes went up almost 40% in one year frequent use being defined as you didn't just use it during the past 30 days you used it on 20 or more of the past 30 days it's not just for us as the regulators to factor all of this and this is this is a discussion that we all need to have how much weight should we put on the negative impacts how much weight should we put on the positive impacts there's imperfect science we don't have answers to all of the the key questions yet yet we as the regulators are responsible for the policy governing the marketplace and that's what we are navigating our way through with with with imperfect science but that that vision that I articulated even with what's going on with kid any cigarettes I still believe is achievable so one other question for you Mitch could you tell us a little bit about just sort of the the regulations where they stand right now on e-cigarettes because this was a little bit of a gray area sort of for for a number of years before before a certain rule was put into place in 2016 Craig sure so let's go let's go back in time and and and in the historically unregulated e-cigarette marketplace we were calling it the wild wild west because the products were out there there was no premarket review of any products coming to market claims were being made all manner of marketing was taking place we first had regulatory authority over east cigarettes in the starting in the summer of 2016 and it sounds somewhat counterintuitive that we're regulating e-cigarettes as tobacco products since there's no tobacco in e-cigarettes but that comes down to the statutory definition of a tobacco product which is anything that's made or derived from tobacco and intended for human consumption and at least as of now the nicotine in e-cigarettes is derived from tobacco so that's how we got the statutory and regulatory authority over these products from the day that that rule began to go into effect in the summer of 2016 we immediately began enforcing the youth access restrictions that were referred to earlier so we have a program where we do contracts at the state and local level and we've conducted now over a million of these unannounced inspections at retail and up until 2016 we would see if retailers were illegally selling cigarettes or smokeless tobacco to kids and ever since August of 2016 we've expanded that program to include illegal sales of e-cigarettes and cigars so enforcing the youth access restrictions went into effect immediately but what about the marketing of the products in the first place but people don't understand that technically east cigarettes are on the market without a waffle marketing authorization we have only enabled these products to remain on the market through an exercise of what FDA calls enforcement discretion and in light of the explosion in the kids use of e-cigarettes we've been reconsidering that exercise of enforcement discretion so in March we put out a proposed guidance that looks at ecig arete along a continuum of flavors what we see from the data is mint and menthol flavored east cigarettes they're popular with kids but they are incredibly popular with adults so we proposed and we're reviewing the comments that have come in so we have we're just beginning the process of a final guidance we propose to draw a line between mint and menthol and tobacco flavored cigarettes on one side and all other flavors on the other side grape bubble gum cotton candy there's even a flavor called unicorn puke and if a retailer wants to sell one of those products they can but if it's a brick-and-mortar establishment it has to be in an age-restricted location inside the store and if it's an online retailer they have to be heightened age verification restrictions in place at least that's what we proposed in the draft guidance and this goes back to the earlier notion of this public health balancing act the last thing that we would want to see is someone who used to be a menthol cigarette smoker walk into their gas station and convenience store and they had successfully transitioned to a mint or menthol East cigarette but that the only product that would be available for them to purchase is a menthol cigarette so it's a it's very much this balancing act and the 2019 National Youth tobacco survey is in the field through the end of of this month and a lot of people are trying to predict what the results will be if the numbers go up and go up again in 2019 then we will have to reconsider policy later this year but but but for now we've proposed it along this line of flavors recognizing that actually none of these products have a lawful marketing authorization to enable them to lawfully be on the market Thanks that overview so shift the conversation and take a deeper look now at these issues but first let's watch a series of clips that specifically take on the issue of youth vaping and we're going to begin with one from the real cost campaign of the FDA one from the truth initiative and one from the CDC there's an epidemic spreading scientists say it can change your brain it can release dangerous chemicals like formaldehyde into your bloodstream it can expose your lungs to a Kirlian which can cause irreversible damage it's not a parasite not a virus not an infection it's vaping I've been vaping but it's safer than smoke oh you know one jewel pod contains as much nicotine as twenty cigarettes vaping is like safer than vaping is safe safer safer than all right so Robin let's start with you as we sort of delve a little more into detail on this so you already mentioned sort of the powerful marketing forces at play and even even marketing forces that don't necessarily come from companies that are sort of ground up from just the popularity of the product and the ability to reach friends and strangers through social media so what can be done from a messaging perspective to combat this like you know how how serious is sort of the the marketing and the you know just kind of the popularity you know what do we need to do to sort of counterbalance that well you know I I compare it to you know with all the counter marketing that's been done on tobacco and that we still do we do that with the wind at our back right young people have been well-educated on the risks of tobacco they still experiment but we're working from a base of knowledge on e-cigarettes it's very different I think you see in the truth campaign work and the work from the FDA we have to educate young people because there's so little knowledge they think they're just vaping flavors and water vapor which of course is not true as I said earlier two-thirds of them don't even know that there's nicotine in the product and so one of the things that we've seen is that giving facts and that's always been a basis of the truth campaign is you know kind of where you have to start so that these products do potentially make you four times more likely to smoke cigarettes which most young people think is disgusting I would never smoke is what they say that there are brain effects from nicotine one of the things that we know has always been very compelling and something we're considering is is their industry manipulation going on here right young people don't like the idea of thinking industries making decisions for them and now that Altria owns 35% of jewell make no mistake about a joule is a big tobacco company so when we say safer doesn't equal safe we're really trying to put something out there for young people to to grab on to and the real cost is doing the same thing the other thing that we've seen is that young people are really interested in this messaging so we've had higher engagement with for instance the we call it puppets the work that you just saw from truth in the last six months so engagements on social media and places like that then we've had in some of our more recent tobacco campaigns which has also been very high so young people want to know and then I think the other thing we shouldn't forget is that we now have twenty percent of young people using these products a great number of them are really addicted and they're shocked they say this isn't what I signed up for I thought it was just mango and water vapor and then they can't study they can't sleep at night they don't know what's wrong with them so one of the things we're also doing is we've got a program called this is quitting that is the first vaping cessation program for young people I never thought we'd need something like that we introduced it in January we've got 40,000 young people who have already signed up which i think is a good measure of starting to understand in that population that oh well maybe this isn't what I thought it was and you know I mean I think one thing that this is sort of a question going back to your point about how successful the sort of campaign against combustible cigarettes just traditional cigarettes has been but you know III think there is sort of always this question I feel like with young people where you know it's just you know adult figures telling them not to do something is is a recipe for what doing it twice as much right so so how do you what was successful maybe about sort of the historical tobacco efforts it seemed like a lot of that was about really making cigarette smoking no longer fashionable and no longer cool is there a way to maybe get at that with with vaping as well I mean ultimately you hope to de norm the behavior one of the ways that has been very successful for the truth campaign is you know will always say give young people the facts don't talk down to them don't fing or web you know one of the reasons why the truth campaign often uses humor so the puppets are funny so it's trying to entertain as we educate but also one of the things that's been very important in the truth campaign is helping young people to understand that when you're addicted you're not making decisions for yourself in fact the industry is making those decisions for you and so the truth campaign has always tried to be as aggressive as we can be on industry manipulation which is taking place and continues to take place and I always kind of call it sort of the the double-edged sword on Altria making a major stake in in jool you know that allows us to say that well now they are a big tobacco company – and how do you feel about that I mean the best in the best business model in the world is addiction exactly so Mitch let's let's delve a little bit more into sort of the regulatory tools that that the FDA has and I guess first you know I kind of want to you touched on the flavor question and and that there's really kind of at least right now you're you're attempting kind of a balancing act even within the flavors but as I'm sure you know there are a lot of calls you know particularly from you know concerned parents and educators around the country to just just ban flavors entirely and and I'm sure that's something that you know I know that's something the FDA is has looked at you know it is an option and and something that former FDA Commissioner Scott Gottlieb who was very vocal on this issue he also talked about the potential for possibly banning these pod based devices which are which are the you know if you sort of have seen a jewel it's essentially this cartridge that you that you put into the device and it's it's different than the earlier versions of e-cigarettes where you know you had a larger tank and often you were having to buy liquid to refill it the pods are essentially a kind of easier kind of more commoditized version of this but but dr. Gottlieb had some had some issues sort of about that and you know raise the specter that this could be banned if you know the data on youth usage don't increase tell us a little bit about sort of the the tools including what you're working on with flavors and and how you're sort of assessing the data as it comes in as or what what other options may there be if this youth uptake issue doesn't improve so I don't want to prejudge any any any possible policy options down the road but sort of at a high level remember I said earlier for e-cigarettes unlike other newly regulated products such as cigars which because they've been around so long can be lawfully on the market there's no marketing authorization for any e-cigarette on the market they remain on the market because we were exercising this thing called enforcement discretion so one tool that we have and that was the the basis for this draft guidance that we issued in March the comment period closed less than a week ago not going to prejudge where we're gonna go on a final guidance because we only begun the process of reviewing the thousands and thousands of comments that we that we received in response to the draft guidance but one regulatory tool is to revisit this principle of enforcement discretion and ask ourselves through a population level public health lens how should the exercise of enforcement discretion be used going forward we came up with an approach in the guidance based upon certain types of flavors without proposing to ban any flavors just saying look you want to sell unicorn puke that's okay but if you're going to sell it in an in a brick-and-mortar store there has to be an age-restricted location somewhere inside the store depending upon whatever changes in the in the evidence base we can revisit our exercise of enforcement discretion the tool to ban flavors is called the product standard Authority and for e-cigarettes we see that there are two sides to the flavor debate that flavors could be playing a positive role in helping addicted cigarette smokers successfully transition by contrast we don't see the public health benefit to the presence of characterizing flavors in cigars and so while we have grandfathered a lot of flavored cigars because they meet the statutory definition for being on the market as a lawfully marketed product because they were on the market as of a magical cutoff date of February 15th 2007 we could use that product standard Authority and we have proposed to do this to ban characterizing flavors in cigars and that is our intent because we don't see the public health benefits of the presence of characterizing flavors in cigars the the e-cigarette debate is obviously more complicated than that and as I said earlier we're responsible for a population level public health standard and so we have to account for the positive and the negative impacts of things like flavors in a cigarette so let's take one step back from this and remind ourselves that tobacco use is the leading cause of completely preventable disease and death in the country the the conservative annual death toll mostly because of cigarettes is 480,000 premature deaths every year that was from the 2014 50th anniversary surgeon general's report so you just do the math from that point through mid century and that's more than 17 million deaths in the United States just from tobacco use primarily from firsthand exposure to cigarette smoke that 480,000 figure doesn't even include deaths from secondhand exposure what can be done to to to make a dent in in this remarkable vector for disease and death and I'll just leave you with where I started with the vision that we have which is a world where the cigarette as we know it is no longer capable of creating or sustaining addiction and for those who are still seeking nicotine being able to get it from alternative and less harmful sources that's what we're working on I want to move on to Howard but really quick one other just newsy topic that i wanted to get you to touch on briefly mitch was so last week the FDA make sure I get this term right for sale a device called the IKOS the FDA did not approve this device but tell us a little bit about this because I coast is a it's a device called a reduced risk product by Philip Morris that it's different from an e-cigarette and then an e-cigarette vaporizes a liquid that has nicotine now this this product is essentially used as sort of a plug of tobacco that is then heated and then creates sort of an aerosol nicotine so it has a bit of the same effect in the it's largely satisfying this need for nicotine but tell us what the FDA's thinking in allowing this market to be sold in sure so let's start with the concept of how this product got to market in the first place one of the bedrock consumer protection principles that the public has come to rely on FDA for whether it's for new drugs or even food additives is companies don't get to decide whether new products can be brought to market companies file applications with FDA on a pre market basis and FDA examines the science behind a new drug application or a food additive petition and it's the scientists at FDA who decide whether this new product should come to market same principle applies to certain new tobacco products and this Philip Morris International product known as I costs had to go through that pre market evaluation process they filed their application they filed an application both to be authorized to sell and they separately filed applications seeking authorization to make health-related claims to either reduce exposure or to reduce risk last week we authorized marketing authorization we have not yet made a decision on whether any claims along a health line should be authorized for this product but under that population-level public health standard in looking at the science and and the heated tobacco product is quite different from an e-cigarette we've said earlier there's no tobacco in e-cigarettes even though we are regulating the mists tobacco products there is tobacco and this heated tobacco product then and Chris described it as a plug of something called reconstituted tobacco and the way it works is it gets heated to a sufficient point short of burning and that releases or volatilizes nicotine and other flavors and things and we've analyzed the chemistry and the toxicology of this product and the levels of harmful and potentially harmful constituents not across the board but for many of them is lower than combustible cigarettes so primarily on that basis but very concerned about unintended consequences once a product like this is in the marketplace in addition to saying yes you can start selling this product in the United States there was a lengthy document on post marketing requirements obligations and restrictions to make sure that there are no unintended consequences primarily uptake of this product in disturbing numbers by kids where this product has been available for sale in other countries around the world where there's no premarket review the youth uptake has been low we're obviously concerned about what's going on with kids in e-cigarettes in the United States but this is a different kind of product it has tobacco in it the initial purchase is an expensive purchase so we will be doing monitoring and surveillance in the marketplace and we will revisit the marketing authorization decision if we if we have to and and very importantly we have not yet made a decision on whether any kind of health related claim should be authorized for this product thanks for that overview um so Howard one of the questions I think I get asked the most about e-cigarettes is how dangerous are they you know how like is it seems like it might be better than a cigarette but do we know and and I think that that seems to be one of the major questions right now is that we're we're kind of operating in this space where we're deciding you know how should these be regulated what are the limitations on their sale but we're kind of operating from a lack of long-term data and research on this right sure and so once again it's very important to contrast that what we know and the status of research in combustible tobacco products and tobacco control from that point of view and then contrasting that to what we know or don't know about non combustible products like a cigarette so in terms of tobacco control with respect to cigarettes and combustible products the research is robust many people in this room have contributed to that research we we know what works with prevention education cessation counter advertising smoke-free in public places taxation and that evidence-based that strong evidence base has led to a a really scientifically based tobacco control public health effort that is global now it underpinned the so-called Framework Convention on tobacco control was which was the first international public health treaty that's went into forest in 2005 so if you talk about control of combustible tobacco products the public health community is united around those scientific principles then shift over to the non combustible tobacco products like cigarettes there is little research it's embryonic it's imperfect in Mitch's term that there are hopes for moving the science up so we can talk about informed harm reduction but because the data and research is so Umbreon 'ok we can't say with scientific precision how best to apply a potential tool like a cigarettes for a harm reduction and so we have issues that that all converge with respect to looking at this broadly and that is when you stop and think about it how did a cigarette industry and tobacco industry gain so much business popularity for a product that leads to the death of half of its long-term users well they normalized and glamorized this deadly product and Robin was referring to that with respect to conventional cigarettes because of all the work of so many we can say that the public health community has helped to D normalize and D glamorize conventional combustible tobacco products and now we need more research about e-cigarettes there was a widely quoted study that came out the United Kingdom a couple months ago comparing cigarettes to standard nicotine replacement therapy and in a randomized trial and showed increased benefits for those randomized to the e-cigarette arm so that was very important science that contributed to this debate that's in the United Kingdom with a past generation the e-cigarette device and but very importantly about 80% of those who are abstinent who were in the East are gonna arm stayed on e-cigarettes for over a year after after that study was completed and in short the long-term health effects of e-cigarettes are simply unknown so the concern now especially with the youth rates going up is that we've gone from normalization D normalization and now concern that we are reading normal izing all this all over it's some would say this is deja vu all over again so that that's the concern and that's the balancing act that we're facing here and as all my colleagues have said if we try to do our best to investigate how this could help adult smokers but keep this keep this away from kids that's where we're trying to get to and Vaughn I'd like to turn to you on this question of I guess maybe looking at kind of the the long view on you know tobacco use and how do we how do we cut down on it but also how do we who kind of deal with the fact that this is an extremely addictive product and it's very hard for people to quit and throughout time there have been other solutions put out there they've been patches other sort of drugs from the pharmaceutical industry they've kind of not had great success how do these cigarettes in your mind sort of fit into this really kind of central question of how to if we can't get people to just quit cold what what are other options well I think a cigarettes you know are a disruptive technology but we may be able to use that disruptive technology in a way that that benefits the public the public health particularly of adult smokers by providing a relatively safe or a relatively more safe alternative to smoking e-cigarettes have the advantage that they deliver nicotine in a pulmonary manner they delivered nicotine through inhalation to the lung and and make nicotine rapidly available which is reinforcing to smokers and it is exactly that's sort of nicotine here that smokers are looking for as they they seek to satiate nicotine urges or cravings patches and gums provide a valuable resource for smokers but they don't provide that that very powerful nicotine hit and so therefore smokers not always successful in quitting in fact often not successful in quitting using those mechanisms so cigarettes if properly regulated if made as safe as possible and and there are access to young people is restricted may may be a useful alternative but I think that you know the question is how do we think about that the questions that that are the points that Howard and Robin both separately raises questions around the Met is around demand for tobacco products and what is it about these products that increases demand particularly among young people it's some it's not just the way in which they are communicated or marketed to young people people to make them socially acceptable and cool but it is the way these products are designed to promote addiction and we need we need to put in place the FDA certainly is looking at reducing the potential to reduce nicotine levels in combusted tobacco products below the threshold at which they can be addictive and I think that's a very sensible strategy we may also need to think beyond nicotine and other product characteristics that promote appeal among young people and think carefully about how we might regulate those flavor of course is one piece of that but there may be other factors that we might want to look at closely for example the way in which some products are presented to consumers to look like for example USB flash drives and in thinking about how products have formulated apresenta to consumers that promote appeal and an increased demand should all be you know legitimate targets of regulation so if we can design products to to have lower appeal lower demand among young people while providing a safe effective form of administering nicotine to adult smokers who are looking to reduce their risk I think we will be getting closer to what to reducing the burden of death and disease that dr. Koh has described right so just like how do we how do we do that that seems to be the main question is how do we design something that isn't appealing to youth and only falls into the hands of the current smoke cigarette smokers who who can't stop smoking well I think now we're going to turn to some QA and we've got some questions from online and from the audience and I want to start with a question from Meredith which is why not at least temporarily suspend the sale of these flavors either until they have completed premarket review or until the youth use figures begin to crest and subside that might be a question for anyone would who would like to take it I know Howard or Mitch like might be one for Mitch not to prejudge where we might be going with policy but this comes back to this balancing notion were were flavors to be banned what would the potential I would say from a public health perspective unintended consequences of that be if flavors are playing a beneficial role in helping transition some smokers completely away from cigarettes to e-cigarettes so we're not talking about continuing to smoke and vaping at the same time but complete transition away from combustible forms of nicotine delivery to pulmonary delivery of nicotine without the burning of tobacco leaves and I think we need to be cognizant of the trade-offs and it is an open question about how much weight should be put on the the negative impacts of flavors compared to the potentially positive impacts of flavors it's a question for society it's a question for policy makers and thought leaders that we'd be very interested in a dialogue on going forward anybody else want to quickly jump in on that one well I'll jump in and say I agree because I think you know one of the things that has become part of the narrative is that these Flay are very important for smokers who are trying to quit or at least 100 percent switch there is not a lot of evidence that is out there supporting that in the same time we know from talking to young people and from some fairly robust robust survey they survey data that that is why young people are using them so there's a lot of evidence on the youth uptake side and from our study of it not that level of compelling evidence on the adult hopefully quitting at least 100 percent switching side sure I can add that the regulatory approaches are of course a matter of great debate but last year San Francisco passed a ban on flavored tobacco products and so following how that is implemented evaluating that closely could provide some of the evidence that we've been discussing it needs to be generated here and you know that the argument has been put and I agree with Robin that there is limited data I that I've seen that that's that suggested smokers need a large number of flavors to support their their switching to a less risky product some flavors may be helpful to adult smokers but the you know the range of hundreds of exotic and candy and fruit flavors that are clearly developed to be – to appeal to youth increased demand among youth should be looked at very carefully and eliminated if possible alright so let's go to another one um see if governments could require Joule and all other device makers to build in a feature that would enable use only in proximity to a cellphone carrying the users certified age preferably 21 plus would that solve this problem if so why not impose this requirement as soon as possible very interesting idea who would like to go first on out other panelists well I think the question I would ask is you know in the age of where anything can be hacked and we've all seen many many stories about that I think that you know from a sort of an ideal situation is it would definitely be a step in the right direction I think the question is is how well could that really be you know policed I think that issue should be explored especially since there's a broader discussion with respect to control of Tabac combustible tobacco products of this tobacco 21 standard that's going across the country we now have over a dozen states that raise the age of sale for cigarettes to to 21 from 18 and many of us are hoping that doctor will be a nationwide standard sooner rather than later so one of the benefits of this conversation is how does this impact not just the a cigarette world but the broader combustible tobacco world and that tobacco age of sale at 21 is an issue that we should be also following very very carefully I would just say that the restricting access at the point of use makes sense some vaping product manufacturers have said that they that their target market is is adult smokers so if that's the case then this would you know to some technological mechanism to restrict youth access would make very good sense this would help them to achieve the desired or stated objective and and help to place these products only in the hands of adults and preferably adult smokers so it would be an enormous advantage but technologically how we achieve that and and legally how we regulate it questions that remain to be answered I'm sure the companies would have no interest in gathering other information about us from those devices and so let's move on I think we got it we got time for a few more it's a question from Heather I work in su D treatment about 75% of our clients use tobacco many see e-cigs and vaping as a much better alternative to tobacco use suggested strategies for placing this issue on the radar cost of use health hazards etc and that's an interesting question because you know I I do get the sense that you know in the UK there is a little bit of a different approach on this from the medical community in which you know I think there is more kind of outright recommendation of you know use of e-cigarettes to you know as a smoking cessation tool what do you think are the you know do you think there are some ways that that this could be you know suggested that people who are really struggling by health professionals this could be the tool that we're looking for we've certainly see vast disparities in in combusted tobacco use among those kinds of populations in other words those who use or who have problems with other substance use people with mental illness problems people from very poor or low-income backgrounds have vastly higher or greater rates of combusted tobacco use and worse harms associated with that with combusted tobacco use than the general population and we we haven't seen much change in the rates of use among those marginalised or vulnerable populations for several decades which suggests that we need to rethink policy about how we can serve to better protect the interests of vulnerable populations and if we think very carefully around regulation of e-cigarettes or vaping products that might provide an alternative to were to vulnerable people who who have not been able to work to quit or to switch successfully to it to a less harmful product so it may be a valuable resource just a couple points from the from the FDA perspective regulating e-cigarettes as tobacco products is not the only regulatory pathway available to e-cigarette companies if they want to get an authorization as a cessation aid under a different standard the safety and efficacy standard they can file new drug applications with our Center for drugs so that's a non public process so I'm not going to talk about whether such applications have been submitted or not but it is a pathway and the Center for drugs has put out guidance documents and the door is open for companies to come in and and and have a dialogue with drug reviewers at FDA in terms of what advice to give any sub popular about e-cigarettes the Preventive Services Task Force is has not been able to conclude that that e-cigarettes are on the list as proven and effective cessation aids having said that we have anecdotal Evans can't make policy on the basis of anecdotal evidence we have anecdotal evidence that that smokers who had tried everything beforehand gum patch lozenge hypnosis what-have-you it was only when e-cigarettes with flavors came along that they were able to successfully get off of combustible cigarettes somewhere between that anecdotal evidence and there being a robust enough evidence base to show that at a population level this is an effective cessation aid is where we need to go and it can start with these companies seeking FDA authorization not as a tobacco product but as either a drug or a device under the safety and efficacy standard if they could demonstrate that this works to help smokers quit and if I can say if the question is putting it on the radar I think this is a very appropriate place to raise the possibility and start the conversation because in the broader world of substance use disorders and opioid dependence which we hear about every day we talked about harm reduction we're focusing mostly on methadone and syringe exchange programs no one talks about smoking cessation or tobacco control so if that's a way to bring this conversation into the broader public health world and they the aim to protect people who are using substances in general that's I think that's a useful conversation well I think unfortunately we may have to wrap up so I guess I'm just going to throw it back to each of you if you have any kind of closing points or just you know Universal solutions to this entire problem you like to throw it out feel free well maybe say just one thing that you know I think this dialogue on these cigarettes and nicotine is going to continue and it's an important one but I would hope that it doesn't distract from all the other tools we have and things we need to be doing I think one of the the things that has happened is there's a narrative that I think some people are buying into a lot of us get distracted by that if we can only figure out e-cigarettes will solve this problem when in fact we have an industry now that is opposing every tax increase that is being put out there when we know they're raising the price of tobacco is probably the most effective thing we have to help smokers quit and prevent initiation and that's just an example so I think it's an important conversation but I hope it doesn't prevent us from focusing on all the other things we have this is a additive to the toolbox it's not the tool I think I think what I would say in closing is as divisive as the e-cigarette debate has been within the public health and tobacco control sectors it the the ongoing attention that this category is receiving is an opportunity to raise to society to everyone who could possibly be interested in this because we all have a friend or a loved one who's been affected by tobacco and that is to start asking some really tough questions about nicotine and nicotine policy nicotine does not directly cause the cancer lung disease and heart disease 90% of all smokers started smoking when they were kids half of them became regular smokers before they turned the age of 18 and it's because of the presence of nicotine delivered in an extraordinarily efficient way from the cigarette to receptors in the brain in less than 10 seconds with pulmonary delivery of nicotine in the absence of combustion we now have some tough questions to ask ourselves as a society about nicotine and and the so called continuum of risk and unintended consequences and intended consequences tough questions like if somebody needs to stay on one of these alternative nicotine delivery products for a long period of time or possibly forever how do we feel about that especially if it's if it's a technology like ease cigarettes because there's pulmonary delivery raises what's called the abuse liability profile of this product meaning it's more addictive or can be more addictive but what if that's what it takes for that smoker to avoid the lapse and the relapse to the most harmful form of nicotine delivery which is the cigarette Howard said cigarettes kill half of on all long-term users cigarettes are the only consumer product that are designed in a way that will kill half of all long-term users later in life and that's why tobacco use remains the leading cause of preventable disease and death in the country and the world so my closing thought is this puts some really tough questions about nicotine policy on the table not just for people in the field and policy makers but for everybody other of you have closing Temecula very quickly I realize we're out of time I think you know we've got to keep our eye on the big picture and that is that is combusted tobacco use with you know with the advent of the 21st century and technological innovation we've seen the introduction of new products that have enormous appeal for young people that offer the promise of lower risk we need to what we need to capitalize on our capacity to to innovate and to regulate these technological innovations in a way that that protects or supports reduction of harm among adult smokers while while ensuring that we we make these products less call less appealing and less addictive to protect young people from ever beginning and so I think I'm quote very simply we have to keep our kids substance free we have to reverse this vaping epidemic as soon as possible and then we have to help smokers find the best ways to quit or protect them as they look at possible ways to reduce harm and then all those conversations have got a support is all my colleagues have said that's broader conversations of how best we reduce a level of suffering from tobacco dependence worldwide alright well think thank you all thank you to panelists for sharing their thoughts and thank you all for coming and I'll wrap it up [Applause]

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