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Of the factors that drove us to the front of the policy debate this year. When waone was the yearoveryer increases in the number of teens reporting use and thats been increasing for several years between 19 we saw another significant increase over the last year. Another was this interrelated that sort of distinct issue of the smalthatwe saw starting over with the related illnesses that were getting to emerge that we have now seen thousands, dozens dead from this. Thats related to a but the urgency prompted policymakers to want to respond more broadly. And the Administration Starts the new year with an announcement. You are covering the story. What did they say . Guest the Administration Says early february, products like juul that are the most Popular Among Young People use nicotine cartridges are only able to be sold in flavors like tobacco or menthol. Previously it had been available in flavors like mint, mango and the Companies Already have taken a softer market because of public pressure and anticipation of the flavor restrictions, but the products like this that are similar to have to take their flavors of the market. The other Product Available is those which the users can refill with liquid nicotine itself that tend to be more popular among adults. They will continue to operate as long as they have the age verification procedures in place anand as long as they are not selling flavors that are obviously marketing to children so they wouldnt be able to be some cereals or Something Like that. They previewed the announcement speaking with reporters. Lets take a listen. We are going to be announcing very shortly some people already know about what we are doing. We have to protect our families at the same time we want to protect the industry taking officers in flavors they are going to protect our families, our children into the industry. The hopefully everything will be back very, very shortly. It can be good from the standpoint if you look at. Ive not heard of the House Oversight subcommittee hearing from july. We will hear from High School Students and their pairing. Two of the High School Students say that a representative of the company juul gave a presentation to the ninth grade classroom and said that they are totally safe. Im Meredith Berkman in the present prevents against the cigarette it group founded by three concerned moms. We already have groups of activated parents across the country from california to new york and places in between. We have people today from texas, georgia, virginia, new york, new jersey, etc. My cofounders are behind me with members of the families. We have nine kids between the ages of seven to 19. Along with our friend also here, in response to the juul epidemic that is as it seemed to come out of nowhere yet experts consider one of the most serious adolescent publichealth crisis the country has faced for decades. Our goal today is to give a voice to the 3. 6 million teens better juul. The most recent figure is already outdated and as you said between 2017 and 2018 that is 2s 78 rise in the use of the products by High School Students and 48 rise of use by middle School Students and experts believe that the new figures will likely be much higher because nothing has happened to have them go down. We hear from desperate parents every day that contact us seeking resources, information and help for their nicotine addicted kid but there is not yet any treatment for this kind of nicotine addiction. I will share very briefly just one of the stories because they are heartbreaking and come from every state represented here on the panel. From massachusetts to describe how they developed the cost and complaineofcomplaint he wasnt o breathe while he became distant, irritable and have extreme bouts of anger. It turned out that he has restrictive lung disease and needs inhalers and oral steroids and had been smoking pot date, the equivalent of more than a pack of cigarettes a day for years, for three years. It was the extreme anger and it turned out our 14 year old had a Substance Abuse problem and now i want to share a personal story how it went after our kids and their friends without the knowledge of the school were us concerned parents, they sent a representative to talk to our kids about a product under the guise of education. April 32017 caleb told us there had been a talk at the school for the ninth grade they left the room and the man named allie gave a talk about jewel telling them that it wasnt for kids but for adults. They would approve it. They took out and showed them how it worked and called it the iphone of vaping and that is when we decided to fight back. We discovered a few months before our kids were doing this at home right under our noses. It is solved by design. We knew it is harmful to our kids brains. We knew that the Deceptive Behavior seemed to be a part of this marketing strategy. In california, the retired School Superintendent was offering schools in his state into massachusetts money that they would implement the curriculum that they were offering. They get involved disclaimer that we immediately realized was a veteran to taking information that it shouldnt have. Juul says its no longer restocks the orders of the save. The flavors if juul really wants to slow the epidemic and keep kids from starting they will immediately remove all of the flavors from the market including a run ball and it meant and stop spending millions on lobbyists to oppose sensible regulation that these parents and our Many Coalition partners are fighting for all over the country to restrict access and other products. We hope todays hearing motivates members of congress on both sides. We all care about kids to hold them accountable not only for the epidemic, but for the predatory practices for causing harm to so many kids in the country. Its not a political issue, but moral individuals take action now, we face an entire generation of kids addicted to nicotine who are human for the experiment overall. After you discovered a present for representing juul gave a closed assembly youve researched the issue and formed a group to inform about the dangers of adolescent use of i was shocked to hear they had access to children without the presence of teachers or administrators and without parental permission. They continue to partner with organizations across the country so its important to understand what outreach looks like on their part. Id like to ask a couple of questions of your sons if thats okay. Good you please come to the table for a couple of minutes id like to first address caleb speak directly into the microphone. What the students told the presentation before it began . I think many kids were already and had their doubts did they say that it was safe . Yes. Did the presenter call it totally safe more than once . Yes. What impact did those totally safe comments have on your classmates, some of whom may have already started . For my classmates that already were coming up with a sigh of relief because now they were able to without any concern. Fo for their kid kids but neverd that were more likely to try after hearing they were totally safe . I remember that after the meeting, kids were more inclined to because now they thought it was just a flavor device that didnt have any harmful substance is. You approached the presenter when the assembly concluded. What motivated you to even approach them in the first place . I believe they were sending mixed messages by saying the juul is totally safe and following up every totally safe statement with but we dont want to lose customers and the polemics message being sent and i believe the presenter was playing under the rebellious side when team were told not to do something they are more likely to do it. Let me ask you a couple of questions. What was your experience in speaking to the present her . The went up and talked to him and asked a question about what can you do if your friend is addicted to nicotine. Were you addicted at the time of the presentation . I was. And when you ask what to do if you have a friend addicted to nicotine, was he referring to you . He was. How do they answer the question of how he could help his nicotine addicted friend . Since he wasnt specific on what kind of nicotine he was at it to some of the speake speaker thought that he was talking about cigarettes instead of 50 should mention juul because it is a safer alternative. Said he wanted you to switch from a combustible cigarette . The presenter demonstrate the product to you . He did take it out and show it to us. This is very disturbing behavior to say the least. A person connected to juul pulled out the device demonstrated safety to the teenagers at a time wide about the product being totally safe. Did he say anything else about whether the government had approved of . He mentioned that the fda was about to come out and say that it was 99 safer than cigarettes and he said that would happen very soon and it wa that was ine fda approval while that was going on. Think you. Let me ask your mother to see a couple of words here. Thank you for coming today. Your son philip stated he was addicted to juul. How did his addiction impact your family . It was difficult i difficultt we didnt understand what was going on as a young 14 year old hes interested in so many things from cooking to his little sister and i started to find flash drives, these green plastic caps in his pockets and i didnt know what it was at first. So he kept saying they belonged to a friend and we had fights about it and i figured out what it was because i looked at the name on the side and it was difficult. Kind of overnight he started a e time it would work if he became moody. Let me recognize the Ranking Member for questioning. I assume that you approached the school board, the principal what was the reaction . They had no idea that the outside group had brought a juul representative. We believe the outside group was naive definitely but in good faith because when i called to ask about the presentation, the staffer that answered the phone said he found the right person. I was researching antijuul Education Online and came across the name of a woman named Julie Henderson who was listed then and no longer on the website as the youth prevention coordinat coordinator. She called and this woman said tihave the perfect person and sd alley. Thank you. Could you explain the difference from the Health Perspective i guess between a traditional cigarette and juul cigarette . There are many differences. Traditional cigarette consist of from thisdebate preparation of o leaves that when burned creates smoke and contain roughly 7,000 different chemicals most of which are not good for the human body. E. Cigarettes contained far fewer ingredients in addition to nicotine usually Something Like piglets alter commonly found ingredients for example and some flavorings. This in general in terms of the number of compounds makes them in general safer. A lot of it depends on temperature control so if they have adequate temperature control they can be less toxic. We have known for her while they cause cancer, talking about prevention i remember in third grade seeing bombs sitting in a jar that somebody had passed away from cigarette use. I guess what im trying to get down to is that of the aspects of the combustible side and the nicotine side. Well, thats actually an important point to raise. If we look at nicotine in and of itself i isnt riskfree, but is probably a lot less toxic than compared to the other chemicals that come out of cigarette smoke. Nicotine probably doesnt cause cancer. It may have some small effects on existing cardiovascular disease and so forth. The brain might have to adapt to having a drug number based on the narrow advantage is that for for any drug. But the nicotine itself is in the culprit when it comes to things like cancer at least as far as we know. We seem to have kind of a competing set of effects, we have data that shows cigarette use has gone up about it and then you mentioned that a lot of that is transitional or is it not come i guess if you can kind of clarify that a little bit for us to have a better understanding of the transitional use. Thats an important question as i dont think we have a good handle on it yet because a lot of the surveys that we look at our bar called Cross Sectional slice in time and we see kids with report to us that they are using one or two a day or every day or so put in what we need are studies that track kids over time actually to see whether the ones who are starting out one or two days go on to use more but once again, we dont know what the implications are of these different patterns of use and i want to emphasize i share the concern that kids shouldnt be trying these products. They shouldnt be using them certainly on a frequent basis. The cdc data shows that huge use over 2 million american High School Students and many hundreds of thousands of middle School Students. The fraction of them of course experiment and others become regular users. I do want to touch on this as a physician on the helpfulness that they think. If you start smoking today it is 20, 30, 40 years before you see lung cancer. Nobody knows what it does to the human lungs to breathe in and out Propylene Glycol over and over. Its an experiment frankly. We will find out years from now the results. The flavor and industry knows that the compounds we put into our food when you breathe them in for example, the classic example of this buttered microwave popcorn, the compounds in the industrial setting caused severe restrictive lung disease on the part of the industrial workers. We are taking a wide variety of this industry has taken flavor chemicals, thousands of different fonts, cotton candy and cookie flavors asked with providing glycol and then they are exposed over and over to the lungs. We dont know yet the longterm result. There is no doubt in my mind that they deem it safer than conventional smoking but that doesnt mean that it is safe. Thank you. I now recognize congresswoman for five minutes of questioning. Thank you so much mr. Chairman. I want to thank all of the witnesses for being here and as a mother i can sense your frustration i just want you to know being here a short seven months in hearing i dont call it, some people call it rhetoric, kind of discredit. A lot of things we are pushing for i want you to know you have the truth on your side and just be stronger for that because we dont need more studies. We already know the truth here. In a few years after it was founded in 2015, it dominated the market for the targeting Advertising Campaign and it seems to be a strategy as juul accounts for 76 of the usb cigarettu. S. Thecigarette marke. Simply staggering. What i find troubling is that in the same timeframe, the rate of teen nicotine addiction skyrocketed. The cdc found 75 increase in the cigarette use from 2017 to 2018. So, it is no coincidence to me that teen to use e. Cigarettes almost exclusively refer to the activity is julling. You have studied the marketing practice since the Company Started in 2015. Based on your expertise, should they have been aware of the Marketing Campaign would appeal to the youth 1 . It doesnt happen by accident. Accident. The goals and beanie babies were products of very clever promotional activities, and so is a juul. They are professionals in and ad agencies understand the difference between marketing to baby boomers, like newspapers, radio broadcast tv and the generation zero that sit all day on the phone looking at social media. And said they were very half one helpful as they designed the advertising that we left the two hour meeting with the very first thing we talked about how surprising it was that that juul was grounded in traditional advertising. We know very well having studied tobacco advertising that juul capitulates the methods used by the Tobacco Industry to target young people that includes marlborough, american spirit, newport because of that advertising. So juul Mission Statement it aims to improve the lives of the world 1 billion adult smokers. Due to those practices which you have studied for years does that align. Not the first three and half years on the fourth here at that point when the youth fad was already raging they became more calibrated to the adult audience now they have switch campaigns depicting middleaged and older adults its imprinted television no longer on social media. But this only happened long after there was a youth epidemic because of that unwanted intense attention by regulators and interestingly with the point about when we visited with them particularly National Companies Like Fidelity that certainly didnt want to be associated with products that were widely seen. No. It all leads to profit. Juul deleted instagram and facebook. So how do we continue to see an additional Marketing Campaigns with kids on and social media . Juul taking off its own marketing did not stop all the hashtags juul alone the first five years three months through november 2181 quarter of a million mostly by young people. Since last november it has now doubled to half a million. I really do appreciate that but it is important to know they deleted facebook and instagram but the twitter followers half of them are under 18. Just because you delete them doesnt mean it never happened. Thank you so much. We heard from a medical School Professor who testified juul advertising based on the advertising of the cigarette industry. The next day juul executive denied that. After we founded juul labs the chief product officer i am grateful for the opportunity to be here today to address you all from the moment we began the journey we work here in our goal to help improve the lives of adult smokers. We are proud of the progress we have made towards that goal. We never wanted nobody under age to ever use juul products. The data clearly shows a significant number of underage americans are doing so. This is a serious problem. Our company has no higher priority than to fight it. Understand the stance that is helpful to understand how the company came about in the first place. Adam and i smoked and we tried to quit and we failed. We were on her way to become nearly one of the 500,000 americans who die each year from smokingrelated disease. For us giving up smoking required an alternative that did not exist at the time to found juul labs. To do it no Previous Technology has done to help adult smokers stop smoking combustible cigarettes on a widespread and consistent basis. Recent behavioral studies find more than half of adult smokers who purchase and use juul products which completely from smoking cigarettes within six months of fact we could not be more proud of that study opens realworld experience in 2018 cigarette sales fell at the fastest rate of decline in a decade. Put simply juul labs is not big tobacco we are here to eliminate the product of the cigarette. The difference from tobacco manufacturers is first our product does not involve tobacco that unleashes 7000 chemicals at least 250 are known to be harmful. Those that do contain nicotine that is addictive and not directly responsible for the diseases associated with Smoking Public Health authorities have concluded that vaping is a fraction of the risk of smoking that we see less harmful and of negligible risk to bystanders. Second the incentives are totally different traditional Cigarette Companies have a saturated Global Market juul labs on the other hand has zero. 3 percent of the Global Market of 1 billion smokers 70 percent of whom want to quit our incentive is to help them achieve their goal with transitioning from cigarettes it is an astonishing Business Opportunity no doubt that it is a historic opportunity for Public Health. Under age use of our product imperils that goal. Third unlike cigarette manufacturers to quickly act upon Public Health data. We have voluntarily restrict our own practices with the Public Health goals. To unilaterally giving product to Retail Stores and investing our own fund to drive compliance to proactively raising the legal age to buy our own products. We believe the steps we have already taken became the category wide standard would go a long way to drive down access of the vapor products. We are prepared to do more mister chairman. We have met with our sharpest critics with suggestions on how we can improve. We remain open. We are committed to cooperating with this committee the state attorneys general and other officials who wish to examine our practices and we are dedicated to learning from our mistakes and not repeating them. In doing so we hope to earn from the public we are grateful to discuss these topics and look forward to answering your questions. Professor from Standford University testified under oath before the subcommittee that you confirm to him you reviewed standford Online Library to find it very helpful to design juul advertising. You did in fact meet with doctor didnt you quick. I did that i did not make that statement. You are under oath and you are denying you made that statement quick. I think unfortunately he may have misheard my commentary because the resource he compiled is useful when we were at stanford we were very interested in understanding more about the historical actions of Tobacco Companies and at that point we were very interested in using the research to understand exactly what action Tobacco Company has taken to familiarize ourselves how not to run a business. You deny his statement under oath. So put it into context please show advertisement number one. Sir, these images that you see on advertisement one contain a few different images. Here is a picture of marlboro and in the middle is the original juul than on the far right is the most recent juul design. Early on in your advertising you entered into a settlement with Philip Morris and the board minutes that you produce to us it says due to requirements outlined in the settlement we have removed all juul branding of triangles. You want they said that you copied their trademark. Thats what they said. How much did you pay quick. There is no exchange of money that you abandoned the diamonds which are very similar to marlboro. We never designed the product to look anything. You deny they look similar quick. I do with all due respect mister chairman you are comparing a piece of packaging to a piece of product hardware. The last thing we wanted was to be confused with any major Tobacco Companies. The board minutes a due to the pmi settlement we removed everything that uses triangles and diamond shapes do you deny that is what was said we request you provide the subcommittee with the Settlement Agreement within two weeks. Ill have to get back to you on that i dont know why that would be a problem. We will subpoena if that is required. The doctor testified marlboro is the leading youth initiation cigarette. So juul chose marlboro to emulate. Lets look at the flavors highlighted as you can see on the right what is depicted in the advertisement and on the left is the juul products the colors are very similar between the two companies products in one interesting thing i like to point out is the flavors. Is talk about the flavors you have meant and may go and virginia tobacco. So what is currently the topselling product quick. Currently after we pulled all of the flavored products off the market now the top selling is meant i believe. Thats right. Meant accounts for about 74 percent of your Company Sales it is a menthol based product intending to appeal to consumers using menthol based cigarettes it is a menthol based flavor. Correct. Recently you took add a fullpage ad in the Washington Post and said taking flavored products out of stores. But the problem here that i see is that you left the menthol based flavors in the stores such as mitt. So mint is Still Available overthecounter in the store and over the 2015 and 2017 population assessment, 96. 1 percent they start with a flavored product that 97 percent of current users use a flavored in the past month such as meant mint thats the flavor that you left. With all due respect mister chairman these were unprecedented actions that we took. We heard these concerns and i agree we should be concerned and ever since we first heard that we look to ourselves without new regulation coming or being imposed upon us in and of ourselves. The products we pulled from market the flavored products represented more than 50 percent of our business at the time. I cannot imagine a more proactive step we could take to exactly the point you are making. But when you pull the other flavors off the market it took the place of all other flavors. Do you disagree with that quick. I do unfortunately it was the illegal products. Is meant in the store or not quick. Yes. It is a flavored product and it is still in the store with that i will now recognize the Ranking Member for five minutes of questioning. Its great to have you here do you feel juul has purposely used deceptive Marketing Tactics to convey their products are not harmful quick. Never. What was the purpose of creating the flavored pods quick. The purpose of flavors was to create a more efficacious solution so the purpose of the company is to improve the lives of 1 billion adult smokers around the world and we know 70 percent of those want to quit there are a number of tools we used as we were designing the juul platform in the first place with that empathetic research with smokers to see opportunities to make a product that could be superior to cigarettes it would make them obsolete but what we see in plenty of studies is that flavored products over index switching efficacy and with my Opening Statement i said 54 percent of adult smokers who pick up juul and use it quit smoking entirely after a sixmonth period and even more importantly that number continues to go up as we look longitudinally the number is much higher by as much as 30 percent when they have access to flavored products that is our intent. You created the company to decide on disrupt the cigarette industry. Smoking cigarettes is a lazy leading cause to kill almost 500,000 americans every year. So are you concerned about the teenagers vaping or using juul quick. I could not be more concerned about that. Was your product ever intended for underage use quick. Absolutely not. 100 percent not. You never intended on that product having the rights of others. The long history of tobacco is Tobacco Products as long as they have been available underage consumers can access those products and use them almost always illegal i about those products illegally and i use them. There hasnt been a lot of advancements in the way that we control access to those products. Now in building these products not only are they not designed for use but what we really need to do is work with this committee hopefully and every tobacco researcher and everyone we can get our hands on that can help us to create industry wide practices we are trying to prove what they should be or what they can be. So preventing under age usage is a priority. No higher priority. What steps are you taking to prevent this quick. As we mentioned earlier , last year november 2018, going back even further than that we have taken escalating steps as we learn about the problems that most of the criticism we receive doesnt come directly to the company although we welcome that would love to work more directly with people who have critiques with the company when we hear the criticism we take it seriously through the escalating steps and one that i really want to highlight november 2018 we pulled over 50 percent of revenue proactively nothing required us to do that but we were hearing critique about flavored products what was left on the market was tobacco based in menthol based products the same way cigarettes exist on the market. Have you been working with the fda to institute changes to prevent use of your product quick. There have been some conversations with the fda to provide some guidance in particular to understand what we want to better understand the usage issue its very difficult for us to study use directly so one of the ways the most valuable positive relationship was just getting guidance from them. My time is expired. You are taking this you seriously but unfortunately there is so much evidence to the contrary hoping you can offer her some answers when your product enter the market they contain between ten and 20 milligrams of nicotine removes the bad taste and then tripled the nicotine content with the most potent ecigarette on the market. They have capped nicotine levels in the uk which is one third of the us product. Is real also captain at 20 milligrams and they call that a grave danger to Public Health 59 milligrams is already on the market there. You recall the 59 milligrams and enter that with a 20milligram product. So obviously juul has determined it can make money so yes or no do you think it can accomplish the mission through conventional cigarettes. Let me provide some context. Not that much context. The first concentration and you talk about right now was designed to mimic bed not excee exceed. I want a clear answer can you achieve the stated mission using a 20milligram per milliliter quick. We would love to try. You are already trying in every country except this one. The uk study proposition that could help them quit smoking but you fail to do it with the below 20milligram per milliliter number nowhere near the 59 level. Late last year it was reported juul had applied to comply with a 20milliliter cap but would increase the voltage and the temperature to deliver more nicotine to the blood. Is that accurate quick. Im not sure what you are referring to with voltage and temperature. The actual delivery device you increase the voltage and the temperature instead of having 59milligram you go down to 20 but you deliver a more potent Delivery System of nicotine into the bloodstream. Is an accurate quicks. Im not sure. I am not aware. Answer that record one question for the record. Are you aware this could make the pod even more addictive if that were the case quicks. To increase the voltage quick. And the temperature at which the liquid is delivered. Our products that is temperature controlled he would never increase the temperature. If you say thats not accurate i would like to get more specific and very condition for mission for the record developing a product while manipulating nicotine delivery to the fullest intent of the law you are book marketing yourself a Smoking Cessation but you are not fda approved for that purpose nicotine delivery highlight why thats the case fda include instruction to step down intake does your product come with these instructions does not not we would not market as cessation jewel is not a cessation product. You dont market . That is news to me that juul does not market yourself as a nicotine or Smoking Cessation product so thats every other product except yours . Would you have any problem keeping them as a customer for life . You dont want to use it as Smoking Cessation just people to be addicted to nicotine their entire life. 70 percent of the world 20 billion smokers want to stop smoking immediately the most important thing they could do to improve their Life Expectancy is move away from cigarettes. That is the stage we are at right now juul does a great job. Do you consider yourself a part of big tobacco quick. I consider big traditional tobacco a big investor in our company. I appreciate your indulgence. We heard from congresswoman Wasserman Schultz about her legislation on vaping. So what are the major issues congress is considering and what are the prospects for any legislation quick. There is a lot of bills in congress right now a significant a number of notable republicans assigned on as well. It is doing more to limit access to flavors and really require any company that wants to sell a flavored product to prove the flavor is essential to help an adult switch from a traditional cigarette and also show it isnt a risk to start nicotine in the first place. Because that such a tough standard to meet with that legislation to think it will effectively banned flavors from the market. Now we hear from the cofounder. You have aikens a product consumers like. You and your friend sitting around at college and say we will develop a product we would like to try to develop a product that is much less harmful than traditional cigarettes, can get people away from smoking traditional cigarettes and you did that. Thats correct. Did you follow the law quick. We did absolutely. Did you break any laws . 70 percent growth of market share . And the tremendous market share to follow the law the entire time you had that growth. I believe so to take a more harmful traditional cigarette that can phase off nicotine altogether and somehow you are a terrible guy. Consumee products. We need to Work Together to make sure that no underage consumers use these products. Its terrible for the business and Public Health and for the reputation. None of this is good stuff. We want to get on to the business of eliminating and saving lives. The things that can be sold at retail outlets is that right . Thats correct. You dont have to make those changes. For the reputational concerns coming yeacoming u. S. The compae decision to do those two things. Not just for that reason alone. And the actions were taking we are trying to lead by example and show we are willing to take independent action is needed to protect the. On the industrywide basis to stop these counterfeit products from entering the market if other companies that were not willing to do the thing these ta collective basis are held accountable to the same standards. As a way to help people move off of traditional cigarette and stop smoking altogether. There is a 76 growth and market share and 3,000 people. You made some decisions you decided to change they dont get access to the product starting marketing on social media platforms and limiting the quantity that could be sold at retail outlets you dont think anyone should be using any Tobacco Products including your own until they are 21 and yet you get out in front of products. Code congress and yelled out. I never met a more Mission Oriented group of folks that come here because we know that there is a lot of stigma and its easier to assume we are tobacco 2. 0. We heard the cofounder take credit for voluntarily removing flavored cigarettes other than mental from store shelves but the head of the american gaping Association Says that they should remain on the market. They are the most used products by adultproductby adults despitc saying flavors just exist to target u. S. And they were in these products because of consumers back in 2009, 2010. They demanded flavors and started creating their own to the industry responded and users of tobacco flavors are more likely to still be smoking a and thacandidate actually leads peoe to continue to smoke a. But i for the most popular among those that have fully switched. In september President Trump appeared in the office would hophelp from the secretary and e food and Drug Administration to announce plans to ban flavored cigarettes. We have a problem in our country. It is a new problem, it is a problem nobody really thought about it too much a few years ago, and its called vaping. Especially as it pertains to innocent children coming home saying i want to vaping and the parents dont know much about it and nobody knows too much about it but they do know that its causing a lot of problems and we are going to have to do something about it. One of the words one of the reasons we are meeting today is to let you know that its out there and we want to have parents understand we are starting studying it very carefully. Its a new and potentially very bad. There have been deaths there have been a lot of other problems. People think it is an easy solution but it turns out it has its own difficulties. So, i am going to ask the secretary to say a few words and then it occurred youve been doing a fantastic job and i want to thank you. We want to discuss the situation because not only is it a problem overall but with respect to children. We are getting some stories that we dont want to hear and we may have to do something very strong about it so if i could ask you to say a few words. Thank you mr. President. We have briefed the president and first lady today on the data that we have from the Youth Tobacco survey. This information shows surging in adolescent usage. It also shows they are drawn to flavored cigarettes including mint and mental. This is exceptionally harmful to our children. An entire generation of children risk becoming addicted to nicotine because of the attractiveness of the appeal and availability so with the president s support for the food and Drug Administration contends to finalize a guidance document that would come and enforcement to require that all flavors would be removed from the market. This would include men, mental, ca,candy, bubblegum, fruit, alcohol, you get the drift. Once the fda would finalize the guidance we would begin Enforcement Actions to remove all products from the marketplace. We would allow tobacco flavoring to remain subject to their filing. The manufacturing filing for a approval with the food and Drug Administration to assure the availability of the product is consistent with Public Health and standards set by the Tobacco Control act. They would have to meet that standard to want to caution with thwant to caution thatthe presie would allow the tobacco to remain on the market to be available for those that are seeking to stop the use of combustible tobacco, if we find children are being attracted and increasing manufacturers are marketing the tobacco flavored cigarettes to children or placing them in settings where they get them we will take in person actions also. What we turn over to the food and Drug Administration for any details and comments that he would have. It shows a very concerning an alarming trend. The president is directing the fda to take Decisive Action against this problem and to finalize the plans we have been working on. This would have the effect that we believe drive child abuse and would help get a handle on this trend hes going to double and triple up and we are looking at very strong rules and regulations and we already have laws as we need them but we want to get to the bottom of a very unusual situation. Its so new and its become so big and so fast that it could be a potential severe problems you know what to do and its something that should have been looked into years ago in a much more advanced way. We have something that will be very interesting to see what turns up but he will be able to report back and we will see what happens. Thank you very much. President trump said his administration would report back on rules for flavored cigarettes. We talked about the announcement for the administration. What has happened since the september announcement by President Trump in addition to that announcement in early january. Have they come out with additional rules and will they come out with additional rules . Theres been an evolution in the Administration Since the initial september announcement. Announcement. At the time but they said they would clear the market entirely of flavors with no exceptions and doing india and was making exceptions for the shops selling more adult oriented products. They said they did this because as they got more data back from the 2019 natural surveys, it showed that among youth, the most popular products or juul anwere juuland other cartridged devices that are the main target of the flavor policy and those like mint, mango and other fruit flavors while a very small percentage of High Schoolers were reporting tobacco or menthol flavors there is some fear that young people will continue to use it with the tobacco or menthol flavors they want the option for those that use products like this because Menthol Cigarettes are Still Available and they would still rather do your adult stores using the Paper Products rather than combustible cigarettes in the first place. Heres some of that now. If you dont get it to them it is going to come in here illegally. But the companies now instead of having a flavor they will have a flavor thats poison that is a big problem. Small mom and pop shops, businesses from the ground up and so you need a sophisticated plan. They are demanding these flavors. Somebodys going to open up a shop in china and uganda with standard youryou dont knowwhag isnt that a problem . What they are focused on his enforcement they are not producing around the market today. Separate, a million kids today are using these products with addiction. Yowe have seen no increase whatsoever. The number o number one flavorls tobacco flavor. We are not talking about removing all. What youre talking abou we areg is removing the flavors that fuel the epidemic among our kids. Wont they just be made illegally . But you will see is last year we saw 1. 5 million more kids become addicted. You said correctly in september the former commissioner said the same thing. We can close the ramp as long as they are people need to flavs in order to do it to go back to using the flavor of the product 70 get their funding from people 18 years or older. 8. 4 . Kids are overwhelmingly able to get these. Separate and apart where kids typically frequent theres a big shop. Nine to 17yearolds get it from a gaping shop. The same study also shows a [inaudible] we sell a lot of products like i said earlier it is likely is lit to the members of the reasons its much better with flavor and without. We take it very seriously. The audience here firmly believes the strong evidence that they held at old cigarette smokers have reduced the risk. There are also cases of huge concern about being attracted to vapor because of the flavors. We have to double down a serious problem we need to act quickly. We thought the response of a thing to do as a leader in the industry was to remove the u. S. From getting access to flavors. We demonstrate to our Business Model that we can build without creating a new audience of use users. They conducted 14,603,729 violations. By way of comparison tools it is more violations of the 60 times. Violations, 60 times. They told three times more than 60 times more violation. Its because of the way we have implemented the policies that limit use. What were focused on doing we separate the posers and they demonstrated playing an Important Role to make an important choice to put they cant quit and switch to a product with less risk. Its very important and that is what were focused on the 6 million kids addicted to nicotine 66 of the kids addicted are saying they didnt even know it had nicotine and it basically are taking these products off the market because thewe care about our kids. The adults have access to mental products putting of cotton candy flavor and what is it that, unicorn fruit flavor. Advertising to the kind complaining about everybody has criticized the industry for their marketing but nobody is talking about actually putting the marketing we thin we thit its the wrong approach. A better approach would be to raise the age of 21. To put restrictions on how to market a product and on top of that you have to increase penalties from retailers because our retailers are fine because they do know they are keeping them out of the hands of kids, some three strikes and youre out before you were told to stop selling Tobacco Products. That is unacceptable and its okay from our perspective. On top of that we are in the age of technology and its helping people quit smoking. I take care of children every day and this is a crisis and these parents and children i had one in my office telling me he couldnt get off of it. It is a crisis. They keep them unde under their pillow in the middle of the night so they can take a vape. We need to take the flavors off the market they are worried if we take one off of the market the children to go to that because they will want something [inaudible] its going to be shifted from mexico [inaudible] this is where it goes back we have addiction that w but we dot another 5 million addicted [inaudible] we ask kids what would you do if the flavors were taken off the market and 60 the number one answer is quite. Weve introduced an app on the phone and with no promotion, 60,000 kids signed up for it. They are angry. They didnt sign up for this. They thought i that it was all n and flavors [inaudible] i think you had an opportunity here to save a generation from addiction. They are attracted to these flavors and to those they havent found evidence that the products they had evidence and that they should take it where we can evaluate and make decisions based on science and that. Would you say that its a lesser problem . [inaudible] how does that compare to normal smoking and cigarettes . Neither one are good. [inaudible] the physician who want to get their own commissioners they say [inaudible] the products are not just kids and kids that wouldnt become smokers, so that the risk for these kids [inaudible] and all th the government studi, these are our figures. Ththere just is not accurate. Less than 1 . Most of the kids that try to this product have already tried cigarettes or some other Tobacco Products. These are kids that have atrisk behaviors and that is why. [inaudible] [inaudible] the American Cancer Society as an organization like all Public Health. What is your stance on this . The problem that five years ago, i mean when did this really begin . Two years ago. Our stance is aligned with what you suggested on september 11. We believe and support that positioto protectposition to tad cigarettes off of the market. With over 21. It isnt a virtue, it is an epidemic. What in the uswouldnt they use . Then we get back to the counterfeits. If the flavor just disappear in 2000 [inaudible] because they are playing a longterm example, the longterm play is to sit out, file, with the small and mediumsized businesses go the way of the dinosaurs and then they can come back and have 90 of the market. You have 10000 shops. Is 40000 employees so there are going to go on and not to go to business because they have a lot of products. They will not all go out of business. Some may. That would be unfortunate. But there are 50000 employees with five and a half million kids that essentially minimum wage i put the kids first. These are the threat sector of the industry. It is competing for the first time to get them off of that cigarette. There is no reason why we cant do both in this country. But if you eliminate flavors according to this report because it makes it between 85 and 90 percent they will go out of business. Theres no question. No Small Business owner can ever take that hit. You say you are going out of business clicks quick. They can wait it out they can go back to having the market share they have today. It is science based evidence of this is for adult smokers who dont have the option. We were a part of it we had to address it as a leader and we took the tough steps. So it is dangerous. It plays a role for the role adults have a transition but the problem is kids get access to the flavor. But then who takes their place clicks then you have counterfeiters in every state. We have not seen a growth of the adults with the introduction of flavors. What you will have is that have tobacco flavor it may be among adults. But what we are talking about here for the companies that have a product with her without a flavor and does not appeal to kids can go to the fda for the review. We are not talking about a permanent band but to develop the science for those that have the authority to review it then have a science based decision about what is in the publics interest. That is what we are talking about. And now wake up and another million and a half kids and then you cant quit. So the concept of letting the states make their own decision we talked about that the other day. What about that clicks we put a limit on 21 to be agree on that clicks the age limit what about the concept of every state decides quick. I think nationwide it should be in an area that does not address this issue that your children are at risk. Thats why fda has this authority we have a Governmental Agency that has the authority to address complicated questions that exist to put in place rules to make these decisions. Every company in the country has to do that by may of this year anyway under statutory obligation to provide an answer. So what we really way is the nearterm solution. I have children i wouldnt want them using these products so it is a six through ten month decision the fda has to make a decision by december of next year anyway will affect 100,000 jobs. This is an important conversation about jobs but i am here because our perspective is millions of families of moms all across the country and dads and grandparents, you can go to any stay in this country and this is what people are worried about those that have children. I will tell you this is the generation of children that otherwise would not have been initiated into tobacco. We know that because the figures were at the lowest they had ever been before teethree came on the market there was huge amounts of nicotine thats when they get the head rush this addiction is severe enormous amounts of nicotine. And parents are terrified. We hear this every day from people all around the country and they feel they have lost their kids. Star athletes cannot run 1 mile. And what i hear over and over all the time is i dont recognize my child. Because of the anger parents are in pain. What is your solution . To get it to end quick. No. My solution is what you said in the beginning take the flavor away from the kids. The original suggestion we are not prohibitionist. Leavitt for the adults. In the end if science ultimately proves that this is going to help them quit, then they should have that right. We have no interest. I dont think the sciences they are yet to. Just to clarify theres a lot of statements about ecigarettes and the devices. There has been no evidence presented to the fda to that fact so to make that claim they will be enforced against. See you may think there is but that is the process and that would be part of the process. Its hard to take those virtues. Icon from bluecollar. My brother is a smoker. I understand it is very addictive behavior. Was exciting in the beginning to think there is an opportunity to get off tobacco. At that point the people who bought the product were aging out they didnt have a generation behind them but the truth is they talk to kids that were on social media that you were cool. So many of these same people are in cahoots with the Tobacco Industry. We get money from nobody. I like the original solution. Ban all flavors and go to 21 and van advertising. Your point earlier was correct theres always something about blackmarket. We could make drugs or opioids i dont know if that works. The American Lung association i want to echo our Public Health partners. On a daytoday basis the number one concern. So all of us are looking to your leadership role to create the next generation. My recommended solution is to ban all flavors. Including mint and menthol . Id is certainly an important step, mister president. 150 million reasons Michael Bloomberg did not compromise. We are parent advocate volunteers. I sat with people on 13 families from the state of massachusetts every story was individual to them but also the same that their kids were no longer recognizable. They could not focus in school. Having trouble reading. They are angry. This is not a new thing. Introducing nicotine at these levels parents across this country, all parents care and we know that you care. They want to ban all flavors. If you get rid of mint it will go to menthol. Only now they understand they are not in control and with that predatory behavior the reason we have our group is because our son came home said there was a message presentation that in their School Coming from the anti Addiction Group and it turned out to be a juul representative saying that it is not for kids and its totally safe and would receive fda approval any moment and that remains untrue and thats why mom started to do their own research to understand this is an epidemic of enormous proportions and the kids were targeted. This is all families. Means there are millions of families that are in pain and i need you to save our generation. So now how many children if you reduce flavors . They are using flavored vaping. But if the kids have access to flavors. Can they put their own flavors in . Can they inject their own flavors . [inaudible conversations] the president went through an evolution with his thinking particularly under age. How did that you evolve . The president after announcing what sounded like a widespread, he seemed moved by concerns raised by conservative groups and Small Businesses of the vaping industry about economic and political impact. A lot of the vaping industry is a Large Corporation but there is a segment of Small Businesses that sell nicotine liquids and there are thousands of jobs that potentially could have been at stake if they banned the flavor and put that into effect. But the groups are saying the number of adults that vapor that trump one in michigan, wisconsin and pennsylvania that exceeds the margin of his victory and they were making the argument that if he bands flavors he could essentially lose those voters. And indeed the days leading up to the january policy announcement when trump was at his florida results maralago there were protesters with shirts and signs that say weve eighth and we vote wind up along his motorcade. We did hear some talk about banning the use vaping with ecigarettes 21 and above the administration talked about tha that. The purchasing age for Tobacco Products is now 21 nationwide. When President Trumps one sign the spending bill into law that was the law of the land. The fda probably will take a few months before it is fully enforced around the country in the meantime a lot of states already have the age 21 in plac place. States that dont may be a little slower. But for now, it is illegal for retailers to sell to anyone under 21. They need to be checking the ids of anybody that looks under 30. Not long after that meeting ahead of the fda center to testify before congress he asked if the fda plans to ban flavored cigarettes. You are aware september 11th hhs secretary a czar said the fda will issue guidance claiming the market nontobacco favored ecigarettes including mint and menthol products. Yes. Are you aware the ban was announced because the numbers show a continued rise in the disturbing rates of youth ecigarette use especially through non tobacco flavors that appeal to kids. Correct. The secretary further stated that more than one quarter of High School Students were current users and the overwhelming majority majority users and 75 percent of High Schoolers the overwhelming majority sided popular fruit and menthol flavors. The purpose of banning or clearing the market decreases vaping. And there is urgency that said the president said the guidance would come in a couple of weeks. Thats what was said. There was the urgency that was felt at that time. At october 25th you say the fdas work the issue was a very very high priority we are trying to complete work on it as quickly as possible. So this has not yet been published for flavored guidance. A letter sent to me yesterday it drafted guidance and sent it as we talked about before on october 25th. Just to be clear the guidance document follow through on secretary a czar september 11 announcement the fda would acquire the market of all nontobacco flavors. I dont want to get into the substance of the document that was submitted. And on the basis quick. Because there has been no final decision made on his policy their ongoing discussions taking place i cannot get into the substance of that document instructed you quick. Discussions internally there a Standard Practice with ongoing policymaking we dont talk publicly what is under consideration. In my remarks is that im happy to come back to review with your staff with a final decision but this remains an ongoing set of discussion. According to the fda letter sent yesterday the review was concluded on november 4th. Was there any changes to the initial guidance submitted quick. I cannot go into the details of what remains ongoing discussions. You are familiar with executive order 81266. The fda cannot publish and tell that has completed its review. And this is one of them its policy because of the significance we sent it to omb for review. And to talk about the types of policies submitted and then sent back to fda. Correct that has been marked completed that meads is back with the fda. They completed their review november 4th and sent the document back to us but we still have ongoing policy related discussions in parallel but oira did complete it and send it back to us. When they are policy discussions ongoing between who quick. Parallel policy discussions going on between the two agencies. The fda is not allowed to publish intel oira completes the review but now they can release the guidance. Effectively executive branch review of the policy was done but as i said in parallel there are other policy related discussions going on. In addition to the oira review. These parallel discussions it sounds like the irregular channel independent of the standard submission of the guidance from fda to oira and back . So that review that is happening right now that has nothing to do with oira or fda. There are ongoing policy related discussions about what the policy should be. Did oira really complete its review if they are still discussing the document . Oira completed its review but there are levels within the department and the white house and agency, they are happening in parallel. Who is part of these with the fda . Perlman one dash proliferate really and at the white house . The various offices to omb i have not been directly involved in discussions. You were to agree with me the White House Domestic Policy Council do you agree the fda should be regulating Tobacco Products quick. That is our job. Is not a waste of time quick. And this is what i devoted the last 25 years of my life. I am so concerned of your prior answer the white house domestic counsel is part of these discussions when they said its a huge waste of time for fda to regulate tobacco. Last week the state of massachusetts had a permanent ban on ecigarette products. If we banned flavors we ban all flavors including menthol and mint to not do so would be discriminatory because menthol has a unique and deadly burden. We must have cracked down and not the possession of it. Because there are intergenerational consequences of broken windows policing for black and brown communities. B must be at 22 Public Safety to ensure there are no more eric garners. Big Tobacco Companies and that theres no menthol ads in black neighborhoods sometimes ten times as many to report nine out of ten black smokers have Menthol Cigarettes i would say that targeting was as effective. I agree. If Menthol Cigarettes were banned they would quit smoking. The fda announced plans to ban them that it was necessary. And then with those underserved communities and four years past with the fda followthrough why is that quick. As you said we went through advanced rulemaking on a variety of issues including the presence of a menthol in cigarettes. And those Public Health concerns mentholated cigarettes that the disproportionate use of africanamericans those of any color to experiment. And we continue to review the comments and the regulatory options and policy should be and we share your concern. Just to be clear does the fda plan to follow through with this band . Because all related to flavors of all Tobacco Products to follow that regulatory science to come up with the right policy. What about omb quick. You need to be more specific. I dont know what specific instance you are referring to. That point i am reiterating the 47000 black people die every year this is the largest preventable even more than gun violence or car accidents. We dont have more time. People are dying. I went to go to a different line. R ecigarettes recognized as a secession aid quick. They are not approved fda as such. If not then menthol is not the offramp for adult smokers they are the on ramp to hook a new generation. We can go past the 20 seconds that you have left there is a Public Health balancing act would ever policy emerges on flavors. And was of those off of completely and its part of the balancing we need to do. And those that attract to experiment and that those are Harmless Products but it is a balancing act those to transition completely away from cigarettes. The official could not say a flavored ecigarettes would be banned the administration has since made the decision. So what has been banned and what is not quick. You can no longer buy fruit flavored cartridges or pods for the ecigarette brands the only flavors are tobacco and menthol. If you use a product that has a refillable tank that you can buy liquid for, you can continue to buy flavors as long as the flavors they are selling are not explicitly targeted toward children. We heard the announcement on ecigarettes with the Energy Commerce committee what else might be here from congress in 2020 quick. To see how strongly this enforces a may deadline for ecigarette manufacturers this is something that was required under the 2009 Tobacco Control act and a decade later the cigarette manufacturers have to fit these applications to the fda with safety and data if it helps adults quit and how risky it is to establish new nicotine users. Maybe the fda will consider those applications how much will the trunk administration and lay the risks or weigh the risks for helping adult smokers. And and to have any flavors on the market will mean that young people will have been attracted to ecigarettes and while getting anything enacted into law beyond the tobacco 21 law seems unlikely in this session but it will take up bills to pass to put more restrictions on how the fda considers the risk for a flavor to be on sale. Some people already know what to do brick we have to protect one protector families and as you know we are taking the flavors for a certain time we will protect our families and children and industry. So the flavors will come off we dont want anybody dying from this but we are doing an exhaustive examination and what could be good from the standpoint is to stop smoking if you can stop smoking is the biggest advantage. That we have to protect the children and we have to protect the families we will also take care of the industry

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