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I’m Charles Burt allow me the Dean of the NYU College of Dentistry and we are one of the co-hosts of this event along with the College of Nursing and the College of global Public Health increasingly I’ve seen that the field of Public Health is a really tough field and the reason is I think because it never seems to present us with the choice of good versus bad it always seems to present us with the choice of bad versus worse and that’s a really difficult situation to be in I have a grand nephew who went to his first junior high school dance he said he’s not going back he didn’t dance when I asked him why he said because all the boys were in the bathroom using e-cigarettes for vaping now is that a good thing or a bad thing I don’t know would it have been any better if they had all been in the bathroom smoking and would have been all the boys what would as many have been attracted to the stench of burning tobacco and paper as they were to the aroma of bubblegum and creme brulee I just don’t know I do know that this is a common problem and not just on the subject of today’s symposium but in my own field we do everything we can to discourage people from using sugar containing soft drinks but we try to do it without at the same time encouraging the use artificial sweeteners because we just don’t know the effect of all of those chemicals on health over the long term and then there’s the marketing when the choice is between bad and worse the bad can come across as good or at least you can be marketed that way I think you some of you might remember the Seinfeld episode where a fat free yogurt shop moves into the neighborhood and all the characters gorge themselves on fat-free yogurt thinking that it’s better for them but then as they start gaining weight and begin to ask for the first time what did they replace the fat with and then they come to learn that maybe that wasn’t so good for them either so I think we’re all hoping for or your guidance distinguished assemblers like this I’m hoping can provide some science that will help resolve what to me right now sounds like a moral argument on both sides rather than a scientific one and in my case I need the outcome before next spring because that’s when the eighth grade dance takes place so thank you for being here and now I’m very pleased to welcome to the podium the representative of the NYU College of Nursing after Emerson yeah good morning everyone it is a pleasure to be here I’ve been greetings from Dean Eileen Sullivan Marx and a College of Nursing who welcomes all of you and really thank you for participating in this interdisciplinary conference a very important conference to really tackle a public health issue that’s really impacting local and global health the title of this conference the tectonic shift in nicotine and tobacco consumption opportunity or threat to saving lives has actually captured the public’s fascination about this rapidly growing industry that has generated many questions controversies and concerns about its health effects and regulation and Dean Bartolome has alluded to some of them as members of the health care team and as health advocates nurses are concerned about the short and long term effects of e-cigarettes on health we are also very interested in learning and who are paying close attention to the evidence about how a cigarette influenced initiation and cessation of combustible tobacco cigarette use and its effect on oral health and the adoption of e-cigarettes allow our youth thank you your esteemed guests and experts on tobacco and health researchers from NYU and around the world policymakers and healthcare professionals who are here today as they will help us better understand the health effects of e-cigarettes and its implications to research clinical practice and policy as a school whose mission is to generate knowledge through nursing and interdisciplinary research educate and develop nursing and healthcare leaders and provide innovative and evidence-based health care Myers College of Nursing is pleased to support and co-host this important dialogue with a college of dentistry and a college of local public health we look forward to a robust discussion and the ideas that will surely be generated in this conference it is now my pleasure to introduce the doctor Cheryl Hilton was a Dean of the NYU college at Lowell public health good morning and thank you Charles and Emerson it is an honor to join with the college’s of dentistry and nursing for this important forum to delve deeply into the promise or peril of electronic cigarettes for those of us who have been fighting the war on tobacco which remains the number one preventable cause of death globally our first keynote speaker is a tenacious and respected lawyer warrior in this battle I worked for nearly 20 years with Mitch Zeller including when we both led the American Legacy Foundation and launched the award-winning National Truth campaign Mitch trained at Dartmouth and American University where he earned his law degree he first cut his teeth as a public health interest lawyer with the Center for Science in the Public Interest and in 1993 signed on to what was to have been a two-week stint with dr.
David Kessler who was then commissioner of the US Food and Drug Administration I think it’s safe to say that those two weeks changed the course of Mitch’s career when he became associate commissioner and director of FDA’s first office on tobacco and health and helped to organize and set its 1996 tobacco strategy which made history and it still is making history though it got to its ultimate end in a different path than what was intended in 1996 this ultimately led him to his current role as director of the center for tobacco products his work is grist for the mill of books and films and as he worked to examine the practices of the tobacco industry we learned what an evil empire we were up against today Mitch leads the FDA Center for tobacco products with a dedication to reducing harm from all tobacco products across our entire population with a focus on how and why people begin smoking why and how they quit and why and how they relapse please join me in a warm and weiu welcome for Mitch Zeller Thank You Cheryl for that very touching introduction in just a personal note about my coming to the then Legacy Foundation in 2000 what Cheryl I think might have been alluding to was the work that FDA did under dr.
Kessler in the 1990s ultimately led to the demise of the office of tobacco programs at FDA when after years of litigation filed by the tobacco industry that went all the way to the Supreme Court the Supreme Court ruled in 2000 that only Congress could decide whether FDA should be in the business of regulating tobacco products and so everything that Kessler and the the merry band of us had had built at FDA had to be shut down and on a personal professional note I could have stayed at FDA but if I stayed at the agency I couldn’t have worked on tobacco and I wanted to keep on working on tobacco and Cheryl gave me the opportunity to come to legacy just a few months after the foundation had formally opened its doors and it was a a great two years of work there prior to my leaving and going into the private sector before coming back to the agency now more than five and a half years ago so I was asked to set the stage for what looks like a wonderful series of presentations and panel discussions today and congratulations to the organizers of this meeting for figuring out maybe not knowing when you first came up with idea just how timely convening on this would be unfortunately I have to give remarks in DC this afternoon so I’m going to be leaving right after the this this first session but I look forward to hearing how the rest of the day went but I’m gonna use my time to lay out the FDA framework for the regulation of tobacco and nicotine what it looks like a very hefty agenda for me to walk through in the next 30 minutes or so and it is I want to start by just level setting with some basic background information and an explanation of our regulatory authorities some basic background information on e-cigarettes or the the broader term of electronic nicotine delivery systems and how that fits into the population level public health standard that FDA is responsible for implementing and enforcing before diving into the agency’s comprehensive plan for the regulation of tobacco and nicotine and then an even deeper dive into the major components of the plan regulatory policies what we’re doing to protect kids and the science-based review of potential so called modified risk tobacco products I’ll end with some concluding thoughts and I very much look forward to general Miller’s remarks and then Dave Abrams will moderate a question-and-answer session so first just the level set Congress passed the Family Smoking Prevention and Tobacco Control Act again in the aftermath of the the Supreme Court case that shut the PERT of the original program down it took Congress nine years to put FDA back in the business of regulating tobacco products it became law on June 22nd 2009 the original statutory grant of authority was for cigarettes cigarette tobacco roll-your-own tobacco and smokeless tobacco but there was this odd word that we ordinarily don’t use in conversation deem the first time I gave a talk as a center director this is an aside I was referring to the deeming rule and there was a reporter in the room who thought I was saying the demon rule and it almost got reported that I was talking about some demon rule it’s not a word that that we weren’t nearly used but what Congress said is beyond those original categories of products if there are other products that meet the statutory definition of a tobacco product which is basically anything that’s made or derived from tobacco and intended for human consumption then the agency could go through a rulemaking process to extend its authority and that’s what we did between 2014 and 2016 and as many people in the room know the final deeming rule began to go into effect August 8th of 2016 as we began to regulate all of the categories of products that you see listed on this slide we do this using a different kind of statutory standard for those of you that work in the areas of anything related to treatment and if you work in tobacco cessation the historical standard for medical products has been safety and efficacy well the standard in the Family Smoking Prevention and Tobacco Control Act is different it’s a basically a population level of Public Health standard and I’ll have more to say about that in a couple of minutes the law requires us to take into account of some mandatory considerations it’s it’s it’s written in different ways in different places its impact on users and non-users or another way to think about it is the positive and the negative impacts when it comes to initiation and cessation and the bottom line for us is and this is not in the law but this is our interpretation of it following the regulatory science our job is to assess what are the net and population-level public health impacts policy cannot be made on the basis of anecdote policy cannot be made on the basis of individual reports because we are making policy at a population level so e cigarettes under that broad public health standard the all of the products get lumped into this notion of electronic nicotine delivery systems a cigarettes a hookah vape products a cigars but generally what we’re talking about is a product that that heats an e liquid to a point where an aerosol can be generated and inhaled by the user ordinarily these products contain nicotine but there are products out there that do not contain nicotine they can contain a variety of flavorings and other carriers vegetable glycerin propylene glycol and other ingredients as best we can tell they started to be introduced in the United States roughly in 2007 and the the icons here are just a representation of the different sizes and shapes and types of products that they can come in and roughly we break them down into what are called open tank systems which have a larger diameter and the closed systems which have a smaller diameter well a lot of this is a function of the diameter of the product which is the rate limiting factor on how large they the battery can be for now many of these products are on the market based upon a compliance policy that we altered July of last year to allow currently marketed products that were lawfully on the market as of August 8th 2016 to remain on the market as long as they got a pre market application in by August of 2022 obviously I will have more to say about that in a bit but what do we know about e-cigarettes Congress commanded that FDA commissioned a report of what used to be the Institute of Medicine what is now the National Academies of Sciences engineering and medicine Nason and their report which came out January of this year was supposed to evaluate all of the available scientific literature on the short and long term health effects of the use of ends electronic nicotine delivery systems it’s a very lengthy report so hard to summarize in just a couple of sub-bullets but here are three key findings from the Nason report this expert panel that was convened concluded that there was substantial evidence that if you completely switch from regular cigarettes to e-cigarettes that this would result in reduced short term adverse health outcomes this requires complete substitutions is not about dual use if you can completely substitute the panel concluded that there would be reduced short term adverse health outcomes and that there would be a reduction in an individual’s exposure so the toxins and the carcinogens that are found in smoke I think the other key finding at a thirty-five thousand foot level was the conclusion that there were substantial evidence to suggest that youth and young adults who use e-cigarettes are more likely to transition or experiment with a combustible cigarette we all spend a lot of time thinking about the the most recently available survey data and the National Youth tobacco survey which is the only nationally representative survey of kids in middle school in high school that focuses exclusively on tobacco use has for a number of years reported as you see in the the bubbles to the right that e-cigarettes are by far the most popular category of products with combined middle school and high school age kids these are the 2017 results more than two million middle and high school students being current users in 2017 and we’re all trying to figure out why and and what has happened between 2017 and 2018 I’ll I’ll touch on that also and the the theory is that it’s the explosive popularity of Joule which has now become an autonomous verb to jewel or Julie in high school bathrooms all of this needs to be factored into that population level public health standard that I refer to and that’s what I want to talk about just for the next couple of minutes and this is a somewhat crude representation of what does it mean to assess net impacts at a population level so this doesn’t encompass every single possible consideration but for the sake of the animation and this slide for the next couple minutes make believe you are the regulator and you’re following the regulatory science and you’re trying to figure all of this out and somehow at the end of the day put your put your finger on what is the net of all this and so crudely net impacts are a combination of what do we know about patterns of use what do we know about the products the harmful constituents and the products following specific users what’s going on with former smokers are are they remaining former smokers or not and what’s going on with kids and so the challenge for us as regulators is this is not going to be black and white in fact before I show you the color on this slide I think the color that’s up there is the is the most instructive color and that is gray it’s not going to be black and white it’s not going to be all positive population level public health impacts and it’s not going to be all negative and that’s the point of this animation so for that subset of smokers unable or unwilling to quit are they completely switching to whatever the non combustible product of the day is that we happen to be convening to to talk about and discuss or instead of making that complete switch or quitting they have become dual users so that it’s not just some transitional phase but it’s if what we can call it the new normal and we color this red because if if there are users out there for which dual use is the new normal is there a diminished interest in quitting the more harmful product along the way for product toxicity is the new product less toxic or harmful to the user or more and the reality is as we look at these new products it’s some combination of well some harmful or potentially harmful constituents go down and for whatever reason others go up so it’s going to be some combination of that what’s going on with former smokers are they are they initiating and relapsing to any of these tobacco products or they remaining abstinent and the thing that’s getting most of the attention currently what’s going on with at-risk teens are they starting to use any of these products or are they remaining abstinent and not initiating and the reality is it’s some combination of all of the above so we put together a comprehensive plan for the regulation of tobacco and nicotine that Commissioner Gottlieb first announced July of last year he became commissioner about 17 months ago may of May of last year and he had done a previous tour of duty at the agency at a time in the aftermath of that supreme decision where there was no regulation of tobacco products nationally and he reached out to me he and I did not know each other before he became commissioner he reached out to me before becoming commissioner to say that he intended to spend a lot of time with me and my a my senior team when he became commissioner so that he could get up to speed he said I know the medical product centers I know the safety and efficacy standard I want to spend time with you and your folks getting up to speed programmatically on everything that you’re doing and the statute in and through those conversations in the first couple of months that he was on board he kept on coming back to this this fundamental question how can we use the tools of product regulation these powerful tools that Congress has given the food and drug administration to have the greatest impact on public health and when the comprehensive plan was initially announced July of last year he he made this comment about crossroads that we and he wasn’t just talking about FDA he was talking about all of us that work in tobacco control in public health being at a crossroads when it comes to efforts to reduce tobacco use and let me just give you a couple of thoughts about what when I think about the Crossroads notion what comes to mind first is the you can call it the the epidemiological irony that if we look back to the first Surgeon General’s report in 1964 to the 50th anniversary report those of us that that made any contribution at any level to reduce consumption and prevalence of tobacco products primarily cigarettes can take pride in going from an adult smoking rate in the mid 1960s of 43 or 44 percent to about 15 or 16 percent in 2014 at the 50th anniversary report and even lower today the the reality the irony is with that two-thirds reduction in prevalence and an even greater reduction in per capita consumption it’s still the leading cause of preventable disease and death in this country and the other irony with the 50th anniversary report is with all of that progress the annual death toll from two using the 50th anniversary report went up and it went up because the Surgeon General was able to add diseases to the list of tobacco-related diseases and so now the conservative estimate I would say this is extremely conservative is four hundred and eighty thousand completely avoidable preventable deaths every year from tobacco use primarily from firsthand and secondhand exposure to cigarette smoke and those of you who have heard me make the following remark before you just do the simple math and you take that out from the 50th anniversary report through mid-century and I’m not talking rest of world this is the United States that is seventeen million six hundred thousand avoidable deaths in the United States with all the progress that has been made in the first half century plus from the first Surgeon General’s report the other crossroads notion is as a field we have reached stalemate in the harm reduction debate I’m talking domestically now there are pitched camps and they are well represented in this room today and there’s virtually no common ground not even an ability to articulate principles that that might bring us together in some kind of collaborative and cooperative way to take on these issues and this is almost a humorous manifestation of the tension and the conflict because as we deal with the stalemate inside our field what is the public to think what is the public hearing well each day we get an electronic set of daily clips newspaper stories links to TV stories and editorials and I was looking at the daily clips just a little over a week ago and then the following two headlines were basically right next to each other on the clips so first there was an editorial the headline of which was east cigarette restrictions not happening fast enough and then like two entries later US FDA should relax its response to vaping I’m not making this up and what is a consumer to think what is the health concern smoker to think what is the friend or loved one of a health concern smoker to think if we can’t collectively get our act together so in all these discussions with the commissioner we felt that all roads led back to what’s the primary cause of all that continuing disease and death and it’s cigarettes and it’s cigarettes because they are so powerfully addictive they’re deliberately designed to create and sustain addiction so what can we do about it and in a speech that he gave literally a year ago to this day he talked about this and he talked about in the context of the continuum of risk saying that while nicotine can be highly addictive it’s delivered through products on that continuum and that it’s the combustible cigarette that leads to incredible amounts of disease and death so is this an opportunity to reframe anything related to the ongoing harm reduction debate around nicotine ask some tough questions about nicotine and see if there’s some kind of common ground to move forward this is the vision that the Commission Commissioner articulated last year and despite everything that’s going on today with kids and e-cigarettes this remains our vision and it’s a world where through regulatory policy cigarettes will still be out there they’ll still be incredibly dangerous and toxic but imagine a world where they could no longer create or sustain addiction 90% of adult smokers start smoking when they’re kids half of them become regular smokers before they turn 18 kids are going to experiment and engage in risky behavior so this is a generational effect and what a future generations of kids who will experiment with cigarettes can’t then go down the trajectory of regular use in addiction and in that same world where adults and here we’re talking about adults whose brains have been rewired by the nicotine in cigarettes if they’re still seeking nicotine that they can get it from alternative and less harmful sources if we do this right this can decrease the likelihood that those future generations of kids will ever be become addicted will help more did smokers quit will encourage innovation in the right way for the less harmful products for adults who need them and will also do better when it comes to medicinal nicotine products and other therapeutic cessation aids we got to look at nicotine differently we have to acknowledge that the continuum exists we can agree to disagree aware to place certain categories between the anchor points where do we put smokeless where do we put a cigarette where would we put heat heated tobacco products but I think that we can agree that the anchor points at one end is combustible cigarettes and at the other end is NRT or nicotine replacement therapy the continuum is real and as Michael Russell said many decades ago when it comes to cigarette smoking people smoke for the nicotine but they died from the tar the nicotine in cigarettes does not directly cause all the tobacco related lung cancer other cancers heart disease and lung disease nicotine obviously plays a role in creating and sustaining addiction so that the decades of continued smoking and the exposure to the compounds in tobacco and smoke that are associated with those diseases wind up with 480,000 avoidable deaths each year but but therein lies this this public health opportunity if you will to move people down that continuum whether it’s health concern smokers interested in quitting or smokers unable or unwilling to quit there’s an opportunity to recognize that the continuum is real and most people down it so our plan falls into three broad categories and I’m going to walk through in detail each one of them for you regulatory policies protecting kids and the review of potential modified risk tobacco products and I’ll start with regulatory policies and the first is nicotine reduction in cigarettes a NPRM stands for advanced notice of proposed rulemaking a lot of people in the room are familiar with with each of the actions that we took in March but just to review the bidding we issued an advance notice of proposed rulemaking in March on the issue of taking nicotine levels down in cigarettes to minimally or non-addictive levels and in this a NPRM we shared all the science that we had we framed the issues and we asked a bunch of questions around what we saw as some of the most critical issues related to the possibility that we would do a rulemaking a proposed rule and a final rule that would then become legally enforceable but we wanted to know more about what is the right level how do you measure it how should it be implemented do you take the nicotine down gradually or all at once what should the scope of such a product standard be should it just be combustible cigarettes should it be other combustible products should it include non combustible products and then what if we get it wrong what are the unintended consequences and we called out to for comment one was if we don’t get the nicotine level right are we simply facilitating what’s called compensatory smoking behavior that there would still be enough nicotine in the in the cigarette for the smoker to alter the way he or she smokes to extract the nicotine that they are seeking which is what happened with the the fraud of the light cigarette and the other unintended consequence would be illicit trade the concern being not so much someone making illegal higher nicotine cigarettes and selling them out of the back of a garage the back of a car or a garage but massive national criminal enterprise selling illegal hiring at 13 cigarettes at the same time that the ANPRM came out in March we published a dynamic population level model in the New England Journal Medicine we took one of the nicotine reduction scenarios and projected it out through the end of the century and the reason why we had to go out through the end of the century is because it that Public Health return on investment for this is generational it’s what happens to future generations of would-be smokers and what the model told us is that in this in this one scenario that there would be more than 33 million people who would otherwise have gone on to become regular smokers who won’t that this would produce an adult smoking rate below percent and that would result in more than 8 million deaths that would otherwise have occurred from the use of these products from not a current so this is a potential game-changing policy were we to do it regulation alone regulatory policy alone is insufficient gatherings like this and other conferences that many of us in the room have participated in our start on what needs to be a sustained national dialogue not on e-cigarettes good or bad harm reduction good or bad I think there needs to be a sustained national dialogue that includes smokers the friends and loved ones of smokers and the general public on some critical issues related to nicotine starting with dispelling and correcting these profound misperceptions that a certain percentage of the public and even health care professionals have about nicotine safety talk to smokers and focus groups talk to smokers anywhere and and just talk about nicotine gum nicotine patch nicotine lozenge and some of them will say well why would I want to switch to that just traded one form of cancer for another so there are some profound misperceptions about nicotine safety that needs to be debunked the public doesn’t understand the continuum of risk I showed you those two completely conflicting headlines what is the public to think about this as as we go about a a public dialogue on these kinds of issues and the continuum of risk in my mind is completely irrelevant to kids no kid should be initiating on any nicotine containing product whether tobacco is present whether combustion is present but the public needs to understand that there is a relevance to the principle of the continuum and that if there are addicted adults who for whatever reason can’t quit they need to have the opportunity to seek alternative products and then there’s also the issue of how do we handle vulnerable populations the remaining smoker today the second ANPRM was on everyone’s favorite issue flavors and here we asked for comment and information and evidence on all sides of the flavored debate the degree to which and the role to which flavors are having an adverse impact in attracting kids but also the beneficial role that flavors may be playing in helping addicted cigarette smokers switch something happened to the docket of this and PRM and we wind up with over 500,000 comments hundreds of thousands of those comments were bought generated and we are trying to what we have successfully sorted through bot generated comments but whoever was responsible for that understand that as a regulator while this is a democracy and anybody can file any comment that they want in any way that they want but the comments that are the most meaningful to us when it comes to policy making are comments that have an an individual or organizational point of view that are responsive to the issues and the questions that we have asked and that contain information especially information that we may not have been aware of Youth tobacco prevention earlier this year the Commissioner announced the agency’s youth tobacco prevention plan calling out the great progress that’s been made in reducing kids use of cigarettes but sending a warning signal that we can’t allow new generations of kids to become hooked to these newer products the plan has three elements preventing access curbing marketing and education and the concern in part being driven by the popularity of products like jewel but jewel is not the only one that resemble USB flash drives that have incredibly high levels of nicotine flavors that are attractive to kids and designed in such a way that they can be used very discreetly even in school walk you through the initial actions that we took in the spring but um what I’m going to tell you in just a couple minutes is it wasn’t enough we conducted a nationwide blitz we have an enforcement program where with contracts that we have with 55 56 states and territories trained in commissioned adults accompany a minor into a store and since August of 2016 this has include going into vape shops and and brick-and-mortar stores and even online where the kid tries to buy a tobacco product including nowI cigarettes and cigars the first blitz was what’s going on with the sale of Joule to minors and in the spring we announced that we had to issue 56 warning letters and six CMPs which stand for civil money penalties those are fines that we collect from retailers who have had at least a second violation first violation you get a warning letter civil money penalties start with the second violation we also announced that we’ve worked with eBay to take down a whole bunch of jewell products that were listed there and eBay deserves a lot of credit for the work that they did bit of whack-a-mole there as things kept on popping up but eBay has remained on the case and we sent the series of what are called 904 B letters to Joule and other companies demanding information you’re going to see some animation on the slide hopefully which is the e-liquid and which is the kid appealing food product which is the juice box which is the e-liquid which is the candy which is the e-liquid which which is the ready-whip which is the e-liquid these products were being sold in flagrant violation of the law and we issued warning letters 13 of which were done jointly with the Federal Trade Commission a total of 17 to the manufacturers distributors of these products the good news is they got the message and all 17 companies completely reformulated the marketing of their products now half of these companies also were told that they had to illegally sold these products to minors online so they’ve got some work to do there but that was a significant enforcement action this past spring it wasn’t enough this is the headline of an op-ed that the Commissioner and HHS secretary Alex SR co-authored last week in The Washington Post we cannot let E’s cigarettes become an on-ramp for teenage addiction you’re hearing leaders and federal governments talk about ramps in ways that ramps have never been talked about before but the idea is this shouldn’t be an on-ramp for kids but what about e-cigarettes being an off-ramp for addicted adults cigarette smokers and to the degree that we take action to to restrict the on-ramp for kids what would the impact be on the off-ramp for adults that’s the rough analogy or metaphor this OP Edie for the first time on the record shared data from a preliminary look at the 2018 National Youth tobacco survey results something had been leaked to The Washington Post last month but in this op-ed the Commissioner the secretary went on the record with a couple of the key data points with more to come when the article publishes now remember the earlier results from 2017 where east cigarettes were already the most popular category of tobacco products with kids so we’re starting from a baseline of it’s already the most popular with kids yet from 2017 to 2018 what the NY TS results show is that for high school-age kids e cigarette use rose by more than 75 percent within one year and for middle school kids by almost 50% so in mid-september we announced some additional actions I can tell you that that when we got the first preliminary look at this data long before it was even cleaned up in and ready for publication we knew that we had to have some serious internal discussions and take a hard look at everything that we had announced and those discussions have been taking place now for over a month so here are the steps that we’ve taken since mid-september first we announced the largest coordinated enforcement action in the history of FDA it wasn’t just an enforcement blitz for one brand or one product it was an enforcement blitz to see if any e-cigarettes would be illegally sold to minors at retail and unfortunately we had an issue over 1100 warning letters and 131 civil money penalty actions for the illegal sale of e-cigarettes to minors those products where the manufacturers cleaned up their app what we found 12 online retailers that haven’t gotten the message and we’re still selling those products so we sent warning letters to those 12 online manufacturers and last week we had to issue a warning letter to this company hello cig they were putting powerful prescription drugs into their illiquid one for erectile disfunction the other for weight loss and we also announced that we were sending letters to 21 different companies covering over 40 products where complaints have been filed with the agency over time from the public health and tobacco control community but also from industry asking us to look into our particular products lawfully or unlawfully on the market that magical cutoff data is August 8th 2016 for product was commercially marketed as of that date than they are subject to what we call this enforcement discretion policy and at least for now can remain on the market until 2022 unless we changed that policy so we had done our due diligence and the next step was to send these letters to companies to prove to us that their products were lawfully on the market as of that cutoff date and we are indefinitely stepping up this this blitz approach to try to tamp down on the illegal sale of e-cigarettes at retail and this also includes online earlier we had sent letters to the manufacturers of the five market leaders for cartridge-based East cigarette products these were also products that made up the vast majority of those more than 1,100 warning letters and the Commissioner has made clear that everything is on the table for reconsideration every single policy that we’ve announced we’re gonna look at a number of factors and considerations cartridge-based versus open tank the presence of characterizing flavors etc and we released just about a month ago our first branded National Youth East cigarette prevention public education campaign using the brand name of the real cost that we have had in the field now for over four years these are ads that are going to run online and that our location targeted these communicate both the risks of nicotine and addiction as well as health consequences the research that we did into these at-risk kids when it comes to e-cigarettes is that they have a completely cost free mentality they believe that e-cigarettes are not only less harmful there are some kids who think there’s just no harm attached to them and it’s like we’re starting all over again they understand the risks of smoking cigarettes there is this what we call cost-free mentality when it comes to each cigarettes there is a concern about what we call adult spill adults should not be seeing these at so there is not a single TV ad not a single radio ad as part of this campaign this is laser targeted digital and geographically based on school grounds and if this all works I’ll show you the digital ad 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 it’s vaping that’s how you get through to kids when we tested these ads with kids and we’ve been running dozens and dozens of ads for cigarettes and smokeless tobacco over the last four years the the measure that means the most to us before we start running ads is something called perceived effectiveness and it’s on a five-point scale and while all our ads have done very well on the so called PE score that ad tested the highest of any ad that we ever ran through perceived effectiveness adults are not supposed to see that ad it is aimed at at-risk vulnerable 12 to 17 year olds and wherever kids are consuming media they’re going to see these kinds of messages including in high school bathrooms and yes your food and drug administration is putting posters in high school bathrooms that say strangely enough some students come in here to put crap into their bodies the the first of these posters are in place now in more than 10,000 high school bathrooms around the country we’re working with students against destructive decisions where they’re going to be taking posters through their own local chapters and putting them up in additional schools and we’re also working with scholastic in the weeks and months to come to get information to about 750,000 school administrators and teachers just quickly on the sciencebase review of potential modified risk products the Philip Morris International I cost product was the subject of one of our advisory committee meetings in January of this year Mr T P stands for modified risk tobacco product bylaw when we accept one of these applications where a company is seeking authorization to make a claim to either reduce exposure or reduce risk we have to make the application publicly available and take it to our tips act tobacco product scientific advisory committee that meeting was held in January we continue to review the marketing authorization and the claims request just last month we had a tip sac meeting on six Camel snus smokeless tobacco products that comment period remains open last month we announced that we’d accepted for filing and review under the mrt P process an application for Copenhagen snuff fine cut and just last week or within the last two weeks we announced that Swedish match had returned to the agency with an amendment to their original application for general snus that we had ruled on in late 2016 outright rejecting one of their requests and deferring and basically encouraging them to go back to the drawing board and come back to us with an amendment which they have some closing thoughts and then I very much look forward to Tom’s remarks and the discussion to follow it comes back to that notion of how and we’re not the only ones doing this assessment how should we all assess net impacts at a population level it’s complicated it’s hard but it needs to be done knowing that every step along the way kids should not be initiating on any of these products the Commissioner and the team at the agency and with the support of HHS is absolutely committed to the pensive plan that was announced last year we’re reconsidering policies but we were remain committed to the plan and we believe that that vision that I articulated earlier is absolutely achievable a world where we’re future generations of kids won’t become addicted to cigarettes and where the adult had smoke where the addicted adults who are looking for less harmful forms of nicotine can get it but that can only take place in a properly regulated marketplace where a combination of the right public health considerations and the relevant regulatory science as close to being available to all of us in real time as possible is the guide so two less thoughts I said after walking you through the advanced notice of proposed rulemaking on nicotine reduction that we need a a sustained dialogue on all this with all sectors including Joe Sixpack smokers friends and loved ones of smokers etc and we need to ask some tough questions about nicotine what if there’s a subset of smokers who not only have completely switched to any of these alternative products but in order to avoid the lapse and the relapse knowing that nicotine is not a completely benign and safe compound what if there are some people who need to stay on those alternative products for a very long term period of time or forever how do we feel about permanent use of alternative forms of nicotine delivery for people who need them to avoid the lapse and relapse to cigarettes to do something about that conservative half a million annual death toll primarily from cigarette use some tough questions about nicotine and then as we all sort through the maze and the mess of e-cigarettes and kids and figure out how that all fits in how much weight should we be putting on this adverse population level impact regarding kids uptake of any of these products today it’s ecig arrest who knows what it’s going to be five years from now we have to account for it but if we’re trying to do this net assessment how much weight should be attributed to this one critical factor thank you all very much and I look forward to Tom’s remarks on the discussion Thank You Mitch that was terrific it is now my distinct pleasure to introduce General Tom Miller who was first elected to serve the state of Iowa as their Attorney General in 1978 a graduate of Harvard Law School general Miller has been a tireless advocate for the public consumers and farmers I know him best for his long-term efforts to safeguard youth from the enormous haul of tobacco addiction and disease he was one of the leaders and advisors of the 1998 master settlement agreement on tobacco and he worked to save lives from the deadly toll by serving on the board of the Legacy Foundation now known as the truth initiative this foundation was created in part and probably substantially due to General Miller’s efforts to insist that something in the master settlement agreement address the youth epidemic in the United States so please welcome my good friend and colleague General Tom Miller the longest-serving AG in the United States I Thank You Cheryl and Cheryl thanks for your great work in tobacco control and for bringing us together this this is this is a wonderful crowd and I think a really interesting agenda that you’ve put together and thank you for that and Mitch thanks thanks for your your your remarks but more importantly thanks for all your work over the years in tobacco control and particularly now where you have immense responsibility immense authority and we we look to you to exercise that authority and as you said it’s it’s not a lot it’s not totally clear there’s a lot of there’s a lot of gray out there I want to try and put this discussion in in the context that I believe that it should be in and the context that it should be in is is a harm reduction concept a concept that’s it’s quite common in public health but not as common perhaps in tobacco control as other parts of Public Health and what what happens in harm reduction of course is that you analyze the the benefit carefully and thoroughly and then you take a good look at the harm and in any other unintended consequences so I think that’s the that’s the paradigm so look at let’s look at the benefit which is the the natural starting point in harm reduction analysis or debate in public health and I believe the the benefit of e-cigarettes is absolutely enormous keep in mind I’m sort of an optimist I’m a bit on the optimistic side but here I mean I continue to be totally excited about what these cigarettes and other non combustibles can do to deal with the death the awesome deaths that Mitch talked about and the starting point is what England England England public health did with enormous sort of enormous discussions of all the the really top people in England and they came to the conclusion that I think is right and that I don’t think it’s been successfully challenged in the last three or four years and that is that e-cigarettes are at least 95 percent less harmful than combustibles for the reasons that meant that that Mitch talked about doesn’t have the smoke doesn’t have the carbon monoxide and all the chemicals that kill people so we have something that’s at least 95 percent less harmful and just think think about the potential here we have 36 38 million smokers in in America today 18 to 19 million will die from tobacco-related disease if everybody switched to e-cigarettes we could save 10 12 15 million lives that’s that’s that’s that’s the potential that we’re dealing with and the good news is that it’s starting to happen that last year smoking in America dropped to thirteen point nine percent of the adult population that’s by far the lowest in our lifetime in fact it’s the first time it’s been under 15 it’s the first time it’s been under 14 pretty amazing and over the last three years the adult smoking rate dropped seventeen percent again the greatest drop in any of our lifetimes so it’s starting to happen these cigarette as cigarettes are are having this having this effect and another way to sort of understand it and to see it at a macro level is that the three years ago three or four years ago when you compare the smoking rates in Australia United Kingdom in the United States Australia had the lowest smoking rate they were the best and they have enormous restrictions on e-cigarettes what has happened during the last three years they’ve gone from the best to the worst they now have the highest smoking rates of the of the three countries other examples is a jewel some of the things that are going on with jewel jewel has their studies and they’re trying to refine them more to to ensure the accuracy but I think there’s at least three studies that show the quit rate for combustible users when they get when they get to jewel is in the fifty to sixty percent range which is an enormous quit rate another sort of smaller fact is it in Portland Oregon now if you take the combined combustible an e-cigarette market a jewel now has 12 percent what has happened there’s 10% less combustibles smokers in Portland so as I say it’s it’s it’s starting to happen another example of a different and a non combustible was in Japan with I close and Japan tobacco’s he’d not burn product over over two years they’ve captured enough of enough of the market that there are 27 percent less combustible sold in Japan not all of that is because of the heat not burn but most of it a substantial amount so it’s starting it’s starting to happen and I’ve done a little paper and I can share it with you I’ve got a few copies with me and it’s on our website that I believe that if we do the right things which is basically use e-cigarettes use heat not burn and reduce the nicotine rate in combustibles and three years by 2011 we can move from 39 to under ten and once we gain that momentum I think over three years to 2024 six years from now we can go under 5% in combustible smoking rates in America which would be one of the greatest public health achievements and accomplishments in the history of the country all of that I think is possible now a lot of people rightly so are concerned about kids use of e-cigarettes I am too we all are enormous ly sensitive to the interest of kids and we should be I just spent last weekend with my one-year-old grandson my first grandson for his birthday and you know the value of him and kids is just a mess so let’s look at let’s look at what’s happened with cigarettes in kids two things are really important to keep in mind in addition to to the obvious concern that e-cigarette use is gone up to about 20% of kids and that’s one in thirty days and that’s important to real it does focus on kids using e-cigarettes one in the last 30 days that’s troublesome and Mitch is troubled and he should be but one of the important ingredients there is this that it’s overwhelmingly casual it’s overwhelmingly experimental the if we extrapolate from previous uses for the figures we have it would be probably about 2 percent would be daily use of e-cigarettes and obviously that’s what I’m most concerned about and I think we all should be most concerned about that is where the addiction takes place so when we when we talk about an epidemic of e-cigarette use among kids I think it’s very important to be more precise it’s an epidemic of casual use it’s an epidemic of experimental use it’s not an epidemic of daily use 2% it’s not an epidemic and also another thing that comes up is that we say and rightly so we’re concerned about addicting a new generation of nicotine well happily that’s not happening 2% of your daily use to addictions is not an epidemic not a jannat gent not a new generation addicted ninety-eight percent are not addicted so I think that those are those when you hear that we should be concerned about each cigarettes addicting a generation unless things change dramatically and Nicola and Mitchell Keep Watch on that that is not is not happening the other thing to put in perspective about kids use of of e-cigarette is the harm addiction is is is certainly a significant harm to be concerned about but keep in mind that that the overall harm is one in 20 in terms of an e-cigarette versus a combustible the harm is one twentieth of a combustible according to public health England so it’s it’s it’s it’s it’s important to sort of keep that in context to the amount of harm and the amount of abuse that’s casual or there or experimental you know one way to look at it is that based roughly based on our numbers I think that a daily use of combustibles by kids would be two-thirds of what now is is these cigarettes if the factor is twenty that would mean that under the current situation under the current use of combustibles and e-cigarettes combustibles are 13 times more dangerous and more harmful when you consider harm and end use also when you look at at drinking which is a great great concern for me about kids had a real struggle that I didn’t win with my son on on drinking I think that’s more harmful I think it’s at least as equally harmful as a combustible therefore 20 times more harmful than any cigarette while in drinking once in 30 day once in 30 day use of drinking among kids is higher than these cigarettes the binge drinking is higher than the daily use so in a lot of ways combined out of ways drinking is much more of a threat maybe 30 40 times the threat of e-cigarettes but we don’t have this enormous campaign this enormous concern about those other two things right now that are so many more model bolts more harmful and I think the I think the other things too a couple of other things to think about is as Mitch goes through this analysis and I think the public health analysis the public health benefit and harm analysis is absolutely crucial when you have millions of lives at stake you’ve got to do it right according to the science it can’t be on emotion it can’t be on politics it has to be on the numbers and the science a couple of other things to keep in mind when when when the analysis is done is that this current um big use of e-cigarettes by kids may be a spike we had a spike in 2015 it went up to 16 or 17 percent at a much greater percentage increase than the current one and then receded down into the 10 and 10 or 11 11 percent range also on you know we we recognize that jewel is a very popular item with adults and kids part of the attraction of jewel is that it’s too high it’s the new thing it’s the hot thing the end thing well you don’t stay the hot end thing very long in kid’s life or our lives it becomes sort of the establishment thing the and so there’s certainly the possibility of that so as you go through as Mitch as you go through I think you have to consider whether we’re dealing with with a spike right now – other – other considerations I think that are important in your in your scientific analysis is that surveys show a surprising number of kids saying that in their e-cigarettes they’re using flavors and not Nick and at first we sort of attended to dismiss it because it just didn’t seem right but there’s there’s enough out there that indicates there are a group of kids that use flavors and not nicotine and you I think our niche are in the position to really make the the best and most credible analysis of that and the other thing is that and and this isn’t talked about instant some people think we shouldn’t talk about this but I disagree another important part of the analysis that needs to be done is the benefit to kids of e-cigarettes that sounds surprising it sounds wrong and that’s how I took it initially but it’s not and the benefit to kids are kids that are using e-cigarettes that otherwise would be using combustibles you know that’s a 20 time benefit according to England and there’s a there’s a very good study that’s professionally and mathematically correctly done by Abbey Friedman at Yale that shows that there’s a statistical meaningful difference between situations where the e cigarettes are were available and where they weren’t in terms of the reduction of kids with combustibles so that that has to be factored in and you know I think as as Mitch and mr.
Godley even goes through this and others analyze this I think that when we deal with this issue of this explosion epidemic if you want to call it of casual use of e-cigarettes by kids the measures that we want to take there are really two different sets they’re the sets of things that we can do to restrict kids and e-cigarettes that don’t have an impact on adults and I think we need to be aggressive and we need to be quick at dealing with those and among those are the two fundamental ones of these cigarette manufacturers not selling to kids themselves and e-cigarettes the manufacturers not marketing to kids when you get into other issues when you’re dealing with consequences to adults then you need really the define analysis that that mitches has alluded to so often this morning a scientific analysis that judges the harm and the benefit in the right way and I would just add in that context we know that we know the overall answer and that’s been provided by ken Werner and others and been agreed to ratified by the National Academy of Sciences and that is that in any plausible scenarios at the matha at the macro-level e cigarettes are a public health benefit benefit in every plausible assumption and that’s primarily because you’re dealing with death on the benefit side and addiction on the harm side and you’re dealing with a huge potential huge number of adults on the one side you’re dealing with a very small number of kids who have been become addicted to percent at the highest level so that is what I think this is all about I think this is all about harm reduction I think it’s all about this exciting possibility of doing incombustible smoking as we’ve known it in six years well before we ever even thought about it or dreamed about it and it’s also doing the best we can to protect kids because they are so important but it’s based on science and policy not on emotion not on political pressure it’s based on what we really think we should be making decisions on the the mission of the FDA and more importantly the opportunity the opportunity to save all these lives change smoking as we know it it’s an opportunity that we should just shouldn’t blow thank you Thank You directors Ella and general Miller I’m David Abrams a professor of Social and Behavioral Sciences here at NYU’s global Public Health and I lead the college’s tobacco research lab I’d like to begin this morning by posing a couple of questions to our speakers and then I will open it up for audience questions please come to the microphones and identify yourselves give your affiliation and please keep your questions short and to the point so let me just get the ball rolling with one question to both Mitch Zeller and general Miller in July 2017 as Mitch alluded to the FDA announced an ambitious comprehensive roadmap to shift the trajectory of tobacco-related disease and death that plans goal to summarize it was to make certain the FDA is striking an appropriate balance between regulation and encouraging the development of innovative nicotine products that are substantially less dangerous than cigarettes both of you general Miller and and director Zeller have supported the FDA’s July 2017 comprehensive plan in various ways but what do you see are the most encouraging developments to thread this needle in support of realizing the plan to reduce the death and diseases from combustible smoking and what do you see is the biggest threats obviously youth vaping has been a recent focus but what else is important because smokers lives matter and they don’t matter less than non-smokers lives a couple years ago my my kids gave me a t-shirt for Father’s Day and it just said half-full there was just a little drawing of a glass that was half-full because despite the challenges that we face in our field in what remains an elusive search for common ground I’m gonna remain at least somewhat optimistic that we can get there so that the vision that we articulated last year is as I said in my concluding remarks achievable I think I think we can get to a world where the cigarette as we know it will not addictions of kids and that for addicted smokers who have been unable to quit that the alternatives will be available to them that are less harmful in a properly regulated marketplace the challenge obviously and this is this was my final point the challenge is we’re talking about policy at a population level so we’re we’re talking about not looking at the toxicological or chemistry profile of products in the abstract the challenge is we need the answers to two fundamental questions and until we have those answers this remains all of us together regardless of the sector including industry people who are here all of us trying to figure this all out in real time and the two questions for whatever the product of the day is that that we’re convening on today it’s e-cigarettes and tomorrow it’ll be something else put aside the product analysis chemistry tox what-have-you and look in the real world and answer two questions who is using the product and how is it being used and and where is the regulatory science to guide getting those answers as close to in real time as possible a product that is demonstrably less harmful when one is looking at it in the abstract because it delivers substantially lower levels of harmful or potentially harmful constituents in a chemistry analysis or a toxicological analysis can be an agent of harm increasing in the real world depending upon the answers to those two fundamental questions and to me that’s where the greatest challenge lies well first of all I want to thank micchon and commissioner a godly for what you did in January June and July of last year that was an incredible step and move that they took and embracing harm reduction setting the reduction of nicotine and combustibles starting that process that well that was that was really incredible in in my view largely because it came from them and they they uttered what I view is the magic words that the England does and as well and that is that for adults smokers if you’re unable or unwilling to quit combustibles to switch to e-cigarettes that’s the message that that is so important and it’s so crucial to saving lives and for them to to embrace that was was absolutely incredible in terms of the in terms of the positive side you know what’s happening 13.9% smoking rate in America is is pretty incredible at this point and as a real indicator of what they said was right and what they said is is happening one of the things I’ve observed in the tobacco control community is for some reason a reluctance to celebrate good news and to acknowledge good news and I’m not sure why that’s the case but I but I’ve seen it over the years and I think we should all be celebrating 13.9% that is an enormous drop with enormous potential if I get one thing and I guess not to be a debbie downer from Saturday Night Live wah-wah-wah but everybody has heard that that when we when we had preliminary access to the 2018 data internal discussions that FDA started immediately and in that op-ed last week the first two of the data points was released obviously there’s more to come Tom made some important points along the lines of frequency of use passed 30-day use had always been the gold standard regardless of whatever the frequency was it’s increasingly been called into and all I’ll say is when the 2018 data comes out pay close attention to what’s going on with frequency of use and and if and if if there are changes in the wrong direction we’re talking about kids use now what does that mean for us what does it mean for the debate what does it mean for what the right set of of policies are and I I think the the problem with the the once in thirty days and that being the standard when it’s announced each year it’s clearly said it’s once in 30 days and but then it’s always this kids smoking rate it’s not mentioned the one in thirty days and people assume it reasonably assume that it’s regular or semi semi regular use rather than once in thirty days and once we once we talk about concerns and crisis people are more and more I think it’s it’s it’s a daily use number so I think it’s I think it’s important to use both numbers to give the perspective and when you’re talking about addiction an epidemic it’s even more important to use the daily use because that’s much more relevant to those two concepts thank you I’m not seeing anybody coming up for questions so please come up to the microphone and I’ll just ask a second question while you guys getting ready so Mitch you have said nicotine is not benign but is not directly responsible for tobacco cause cancer lung disease or heart disease that kill the hundreds of thousands of Americans you refer to I would also like to add that you know nicotine addiction decoupled from smoke while of concern because of the addiction is not the same in terms of the death and disease and that has to be considered for both youth and adults there’s also research that’s been suppressed I think or ignored that actually nicotine can help the brain function far better in terms of increasing alertness concentration memory and those studies are fairly solid so this may be a recreational drug not unlike alcohol that is okay for adult use and I you raise the question just recently that the fundamental question for society is can society accept the use of nicotine and in certain forms especially if it’s not as harmful as in the combusted cigarette as we do alcohol are we really going for nicotine prohibition because of the addiction being equated with the harm when the harm is really in the smoke so that leads to all these massive public misperceptions about the harms of nicotine not just in terms of cancer but also in terms of its benefits and harms to the brain and so what kinds of things do you think about implementing policies and regulations to encourage the use of substantially less harmful products instead of smoke tobacco by society and speeding the obsolescence of the cigarette I think it starts though with dispelling the misperception what what to the degree that there is a greater recognition that the continuum is out there and that and that the reality of the continuum needs to drive our thinking on regulatory policy communications research whatever whatever our day jobs are we will we will never achieve what could be achieved without doing earnest work to have this dialogue with the public and start with dispelling those those safety misperceptions there are safety issues related to nicotine there are some cardiovascular effects there are some fetal affects it’s but there are some tough questions that need to be asked about compared to what and to what magnitude and to what degree and and I don’t think that that’s a dialogue just for the more highly educated people in this room here I think it’s a dialogue for society I think that civil society has a responsibility to lead that discussion I think the research community has a role to play industry needs to participate there needs to be a sustained dialogue on this and the other reason why I’m so passionate about the need for the dialogue is perhaps perhaps it’s a way to get us out from the rut that we’re in in our field over the harm reduction debate and the continuum if we can start reframing the questions that are related to all of that in along the lines of your question to me about nicotine is I think there are some profound questions about nicotine and some tough questions that really society needs to play on long-term permanent use for those who need it that’s not going to be a slam-dunk with people especially if they’re walking around with any misperceptions and Mitch you know I’m sort of a broken record as well as an optimist and Mitch knows that a number of times I’ve asked him begged him to have the the FDA do a public service campaign on TV ads essentially saying what they said on July 7th of 2017 for adults smokers if you’re unable or unwilling to quit combustibles to switch to e-cigarettes that would be an enormous myth public health message it also would stir the debate maybe that you’re talking about it as as well and also again I’m the optimist there is some data that that smokers get it right about the harm of combustibles and e-cigarettes better than the general population so that the that and and that’s part of the reason that it’s working so far so I’m happy to see we have quite a few questions I’ll ask you to identify yourself and state your affiliation and give as brief and focused question as you can so we can try to get through as many as possible I’ll start on the side and then I’ll alternate hi my name is Blake Dodge and I’m with Bloomberg News this morning commissioner Gottlieb said the FDA was thinking of confining flavored e-cigarettes to vape shops prohibiting them from convenient stores earlier you said you were committed to the plan as a whole but we’re also reconsidering policies I was wondering if you guys are taking a step back from harsh regulations on e-cigarettes and if the banning from convenience stores as opposed to a full ban as an example of that the Commissioner is obviously free to say anything he wants publicly all I can tell you was the all policy options are on the table and are under consideration and internal deliberations and can’t add anything to that thank you and I would just say that that flavors are probably the the the issue that that’s probably them gonna be the most controversial and and and and and the most important and I just think and hope that Commissioner Gottlieb n and Mitch teller do not take any action on flavors unless it’s totally supported by the data in terms of public health benefit versus public health harm that is the in the area where the public health harm could be the greatest in terms of adult smoking lives that would be lost and they have to be considered I think very seriously on the other hand you know Canada really has come up with I think a very good idea they’ve asked the basically van all flavors except tobacco menthol mint and fruit flavors I think that is a balanced reasonable way to go at least at this point the other option could be held for later but to go beyond that I suspect would cost a lot of lives thank you okay go ahead hi i’m jennifer DiPiazza from Hunter Bellevue School of Nursing hi David thank you and thank you director Zeller in general Miller from what I understand is that there’s been a decrease in combustible tobacco use by youth dramatic decrease and also a dramatic increase in a cigarette use from what I also understand is that there’s only a mere 2% that are of youth that we think are sustaining their use of e-cigarettes and that mostly it’s contained to experimentation but we might find out more in the 2018 data so I’m looking forward to seeing that my questions relate to the real cost campaign I enjoyed watching the video clearly it’s to deter youth from using e-cigarettes general director Zeller is there a concern in that a campaign such like that might draw youth back to using combust tobacco and are there the same campaigns when you say these are not campaigns for adults to see but yet we’re gonna see them in or we are seeing them in the schools or the bathrooms are there similar campaigns right now where the youth are seeing videos such as the one with the e-cigarette for also combustible tobacco so I’m just wondering at the message that we’re sending these I know the message that it’s sending the youth about the e-cigarettes because of the concern and the rise but are they getting a message about combustible tobacco as well being as we as we know for certain incredibly harmful I’m just worried about the kickback effect and I’m wondering if that’s if what your thoughts are about that thank you and just to clarify I think what you’re asking is making sure youth know that e-cigarettes are not harmful competin nothing they are harmful and they shouldn’t use them but relative to tobacco they’re still much less harmful than combusted tobacco and I also worry about it but I think that’s what you’re saying thank you David that is what I’m saying but but I’m also saying is while they’re seeing these ads on the e-cigarette are we also giving them ads on the combustion yeah so you only are the only walking in and seeing East cigarettes the the fear of the e-cigarette are they seeing an ad about the fear of the combustible tobacco so when when I got to that part of my talk you saw that we’re doing it under our brand called the real cost the real cost has been a major national youth tobacco prevention campaign now for over four and a half years we started with and we have put hundreds of millions of dollars into a cigarette only campaign under the real cost and the longitudinal evaluation results that came out of that just from the first two years of the real cost cigarette campaign and we are still pumping a lot of money into those cigarette ads to reinforce the message about the harms of cigarette use but two pieces of evaluation from the real cost cigarette campaign first from 2014 to 2016 the evaluation found that exposure to the real cost cigarette ads resulted in about 350,000 kids who would have gone on to try smoking who won’t and that’s independently just because of repeated exposure the kind of awareness that we build in with with unbelievable reach and frequency with our ads then more recently we published a cost-effectiveness analysis from that same time frame and the the cost of net the cost-effectiveness analysis concluded that again just from those first two years in terms of the healthcare costs direct and indirect down the road that would be avoided because a percentage of those 350,000 roughly half would not go on to become regular smokers will save society 31 billion dollars or for every $1 that we invested in that cigarette campaign the return on investment was a hundred and twenty eight health care cost dollars saved so yes we are absolutely on the case when it comes to sending a message to at-risk kids for cigarette use the real cost cigarette campaign remains out there and will be out there my concern is is part of those main conclusions from the National Academy report if you take the universe of never users amongst kids kids who have never used any product of any kind a kid who experiments on an e-cigarette is more likely to try a cigarette that’s that that’s the concern is it definitive does it prove Gateway does it prove that that experimentation will lead to regular smoking we don’t have those answers yet but there was enough evidence in the literature with the National Academies setting the bar pretty high for what studies even counted to be included that they were able to draw that conclusion that should be of concern to us thanks again England England is ahead of us public health England has concluded and I think they’re right based on certainly what I’ve seen but they know a lot more than I do that each cigarettes are not a gateway to regular use of combustibles they can lead to experimental use but in terms of a gateway to combine to regular use to addiction they’re not the case and you know we had the search in general’s report in 1964 that changed everything that was was dramatic well England was three years ahead of us on that they’ve been ahead of us on on the the 95% and the switching they’re ahead of us also on on the Gateway question thank you and we have about five minutes left so let’s try to keep this very short and try to get to everybody so really quickly if you can hi my name is Kevin Shrove from Rutgers University and until recently from New York City Department of Health Director Zeller mentioned the the the issue that we have where there’s a divide and there’s a credibility issue where there’s people on two different sides of this issue and Attorney General Miller and I know you you appear to be an Anglophile on this you you mentioned the you mentioned the public health England report and the 95 percent number I think a lot of people in this room would probably agree that that study in particular has been critiqued very credibly and is not really a role of reliable number the National Academies report on the other hand is more reliable in many ways and and has information that can be useful in supporting a harm reduction argument by specifically identifying how the toxicant profile of e-cigarettes has more in common with NRT than it does with cigarettes combustible cigarettes I think it’s important for the people in this room to try to come together and find common ground where it exists and where it’s directly related to science so so I guess my comment than a question but I’d like to know what people think about trying to find the real science and I know it’s a complicated topic and and messaging something that’s complicated to the public is difficult and important but there is evidence out there that can support this theory but I don’t think it’s the public health England 95% number thank you well I obviously disagree I think that was well thought out when when it came out and I got involved in these sets of issues I would read something that would contradict it for instance the formaldehyde scare the popcorn lungs scare and I’d begin I’d get concerned so I’d look into it and it would be false the questions the harm that’s that’s that’s alleged just just wouldn’t pan out scientifically in formaldehyde and popcorn law are two examples I think I think I think the public health England study has held up very very well and you know I think what I think everybody should be able to agree to is that e-cigarettes are substantially less harmful than combustibles I don’t think there’s any doubt about that any reasonable doubt about that thank you well I understand I think a few thoughts I mean it’s appropriate that that question was asked in the context of who sponsored this this conference and and the role of research in driving policy debate communications etc the challenge for us as regulators is more often than not though that this needs to change in the world of research more often than not the study that gets published in 2018 was the result of being in the field five years earlier stopping the clock and not analyzing the data going through peer review and then getting it published years later that’s that that should be a challenge for all of us if we’re looking at at at publications in peer-reviewed journals where the data was gathered three four or five years earlier and what can be done to speed up the process so that as we’re struggling with all of these issues in real time which we are as we’re trying to get answers to what I still think are the fundamental questions that with all respect I don’t think Tom is paying attention to the real world of who’s using the product how they’re being used those are all study Abul and those should be more study of Alif that’s even a word in real time papers are getting published based upon reviews of databases where the clock stopped in 2013 or 2014 ask yourselves how helpful is that going to be as we’re having these kinds of discussions on the cusp of 2019 thank you know I would I would just underline in in an in a situation of uncertainty all the more reasons that we don’t take dramatic action that are going to cause the loss of hundreds of thousands of adult lives that that there should be caution in terms of things on flavors and issues that affect adults significantly their lives I’m afraid we’re running out of time maybe one last question I’m sorry for not being able to do it but there will be other Q&A periods that you can bring back to some of these issues in general thank you hi I’m Jennifer Pomerance I’m at the college of global Public Health I guess I kind of want to push back on your two questions director thank you both for talking today because the video you showed was about toxins and you said that you think that there’s smoke smoking vapor so that’s we’re actually talking about ingredients and toxins and something I was under the impression that FDA could regulate so my question is is the FDA regulating ingredients if not why not if your answer is Congress didn’t give you the authority please let us know because then this is something we could rally around to get Congress to give the authority to actually regulate the ingredients because who’s smoking and where and how doesn’t really matter if it actually was vapor the answer is yes we have the authority to regulate ingredients and we have the authority to regulate the products under something called the product standard Authority which requires us gathering the data and going through the rulemaking process it I can’t tell if implied in your question is that should proceed public education efforts like this or not I think it’s critical given the explosive use of e-cigarettes by kids and the insights that we gain from the qualitative and quantitative another formative research that we did before we came up with that campaign that to the agree that kids perceive east cigarettes as being less harmful than cigarettes that they’ve adopted what I’m calling this cost-free mentality that they don’t think that there’s any arrests make them less harmful through the ingredient regulations and simultaneous with your education campaign we can use the product standard Authority to to deal with product safety issues we can look at the the role of flavors and should flavors be permitted or not that’s policymaking there there was an imperative to get the word out to kids to dispel the misperceptions that they’re walking around because kids get it about cigarettes but they don’t seem to get it about about e-cigarettes it’s not either/or these things all need to be done in in parallel or at least sequentially given that rulemaking takes a lot longer than that does okay I’m gonna try to steal one minute cuz it looks like you have a pressing question all are you stepping down the mandate was to step down but I do have a very quick very quick given the potency in the history of the tobacco industry and the current climate that’s anti-regulatory and anti-scientific and the recent beheading of the head of the office of children’s environmental health how is it that you can continue the FDA to have such a strenuous and science-based approach to this and are there reasons to be concerned that this will be prohibited obviously I can’t make any political comments on the state of affairs in Washington what I can say is FDA is a public health agency with a public health mission and in this administration with the leadership that we have both in the Commissioner’s Office and as you saw from I think a pretty powerful op-ed being co-authored with the Secretary of the Department of Health and Human Services a cabinet-level office a cabinet-level official in this administration that there is and has been support for what we are doing and what we are trying to do and I’ll leave the political commentary to others ii-i’ll make the political commentary well no not-not-not really I would just say that one of my reactions when when Mitch and Commissioner Zeller Commissioner Gottlieb did what they did in in July of last year was that they were geniuses and we hope the genius continues Mitch thank you so much