The subcommittee on oversight and investigations hearing will now come to order. Today the committee is holding a hearing entitled sounding the alarm the Public Health crisis of cigarettes. The purpose is to examine the Public Health impacts the regulatory authorities related to key cigarette manufacturing sales and use. The chair now recognizes for purposes of an opening statement. Our country is facing a serious Public Health epidemic one that is causing severe harm. It will examine the cost of the epidemic and the uncontrolled rising use of e. Cigarettes lifethreatening illnesses and the use of products we must work to protect the American People from the misunderstanding about these products. The data is clear over the past several years, we have seen an unacceptably high proportion of people facing nicotine addiction. This year alone more than 27 of High Schoolers report they are using ecigarettes or vaping as it is also known. 2011 to 2015, there was a 900 increase, 900 increase in vaping and from 2017 to today, the rate of High School Use of double. The vaping epidemic are personal to me. My home state of colorado has the unfortunate distinction of leading the country in teen vaping. A major factor contributed to the dramatic rise of ecigarettes use among teens is that of the flavor products. Recent data from the center for Disease Control prevention indicates 60 of students within the last month cited using popular fruit, and all on mint flavors. People turning to ecigarettes also have a false assumption that these products are safe or relatively harmless. But contrary to the manufacturers claims, they pose risks to young people and can lead to addiction, brain development, affect respiratory health and lead to heart disease. Additionally, the cigarette use increases the risk of youth turning to conventional cigarettes. As much as we do know that troubling survey could be how much we dont know about the product. For example in some cases we dont even know what chemicals and toxins are being inhaled. The cigarette industry has launched a massive publichealth experiment on the country of which its outcomes and consequences remain unknown. The recent state epitomizes how much we are in the dark about these products. Number 530 so far increasing daily has led to hospitalizations come , longtem Health Complications in several deaths. Cdc and fda are here today and they will provide more information about the status of the investigation and what products may be the culprit. No specific classes of the illness have been determined that these agencies engage in a collaboration and i have confidence that the cost of the outbreak eventually will be identified. But even if it is isolated to the products sold on the streets or the use of thc we must keep in mind that they are not harmless and this brings me to my next concern given the potential risk associated it would be reasonable t reasonable that they have been reviewed and approved by the fda that they havent. The products are only on the market today because the fda is tempered only giving them a pass by exercising its enforcement discretion. With me be clear no ecigarette on the market today has been fully reviewed by fda for its impact on Public Health. They need to do their job, examined the products cant tell the public what the risks are and how or if they can even be solved. In other words, the fda must go forward with conducting the reviews for all ecigarette products and determine if the sale of the product is close, appropriate with the protection of Public Health. After years of delay around the regulation of the cigarettes, the administration recently announced the fda would prioritize enforcement in small to back off the flavored product review. I am encouraged by this action but the fda needs to provide Additional Details and a timeline for action. We have to ensure that there will be implemented and enforced in a reasonable way. If in the meantime nothing is stopping manufacturers from submitting their applications to the fda today, the burden is on the Cigarette Companies to demonstrate that these products meet the Health Standards coming up regardless of the administrations recent announcement, legislative action is not on the table. I and others have introduced bills to tackle the publichealth priority including the chairman who has been a steadfast leader on these issues. Based on the frontline of the epidemic, ive also been taking action on ecigarettes we are going to hear the plans today. The industry has been swift to rail against efforts to restrict products claiming and that evidence however its far more conclusive than fda has not approved. Any benefit to the adult smokers has to be weighed against the generation of young people for which vaping represents an on ramp for use. I want to thank the witnesses for being here today for the service and i look forward to how we can Work Together to address this very serious Public Health issue and i would yield back. For whatever reason the committee is scheduled, we have drug pricing upstairs and i think everybody supported the issue for the country and this is important to the country as well. Well. A lot of members share that so i apologize we are going to be in and out, but thats where we are. I am deeply concerned about the outbreak associated with vaping and ecigarette use. The marketing to kids, we need to understand the causes of this illness and ensure that they are not marketed to kids. Its also important that we understand the Health Implications more broadly whether an adult is vaping thc from marijuana, nicotine or other substances. So far, the evidence of the 553 reported cases and eight deaths do not point to the conclusive cost. But the involvement of illicit devices according to th the cenr for Disease Control most patients have experienced these illnesses and have reported a history of using ecigarettes products containing marijuana or thc. However some have reported using products that contain marijuana, thc with nicotine while others reported using products only with nicotine. Separate from the outbreak of illness according to the u. S. Food and druG Administration, the United States has a youth epidemic. The most recent data from the Tobacco Survey shows 27. 5 reported using them compared with 28. 8 in 2018. It was only 11. 3 just three years ago and the trends are unacceptable. It must be stopped and access must be blocked more effectively. The epidemic is already driving legislation and regulatory responses. Last september the fda issued more than 1300 warning letters to the brick and mortar retailers originally sold them to minors and the letters to the manufacturers about the access of their products. 18 states have increased the legal aid purchase Tobacco Products to 21. Michigan, new york and columbia issued a proposed legislation to ban flavored ecigarettes. 2019, the Trump Administration announced the fda would finalize the compliance policy and prioritize enforcement against the marketing of unauthorized long tobacco cigarettes including menthol. With these responses they are aimed at reducing the attraction of ecigarettes to use and its like a black market. In that and we also need a response to the increased demand from flavor to address the growing trade in illicit cannabis marijuana gaping products. The New York Times article reported that the recent operation was constant and revealed a very advanced market for marijuana, cartridge cartridges. Im told these observations are using a tactic in other observations cutting the product with other substances including some that could be dangerous. Advocates for examples of a particular agent that could cause breathing problems and long inflammation is not healed fully. Using smaller amounts of the extension and diluting it with oil costs much less one could increase by selling the product. Medium grade of thc can cost 4,000 a kilogram. Additives may cost pennies on the dollar. These operations rely on factories that by empty cartridges and counterfeit product packaging and fill them with thc liquidity purchased from the United States market. The packaging are also available for purchase on the internet. While federal and state authorities were gone for a response against this, we must ensure they are educated on the danger of using ecigarettes. When governor bakers administration lost the campaign in april 2019 at the department of Public Health to highlight the dangers in july 2018 of these actions are commendable and i look forward to seeing the results of the campaigns with regards to adult trying to quit smoking some are more than traditional cigarettes. According to the cdc and they have a potential benefit from combustible cigarettes with the cdc cautions that they are not safe for youth, young adults, pregnant women or adult that are not currently using Tobacco Products. Additional research is to look at the effectiveness. I want to thank the witnesses for being here on both panels today, and i look forward to this important discussion so i will be back and forth between hearings. Thats where we are and i will yield back. The chair recognizes the chairman of the full committee for five minutes for purposes. I want to thank the chairwoman for having this important hearing today. We are examining the publicHealth Crisis involving ecigarettes and the proliferation of the products among the kids and teens and im deeply concerned about the recent outbreak of the lung illnesses that have killed eight people and sickened more than 530. Im also very frustrated by the fact that the usage has reached epidemic proportions in recent years among kids if you talk to any parent of a high school student, you know that the nations ecigarettes problem is getting worse and its long past time for agencies to address the usage in a meaningful way. I look forward to hearing about what the fda and cdc can tell us about how they are addressing these tragic mystery illnesses and the recent actions to combat the use but make no mistake i believe many aspects could have been addressed if they moved forward reviewing all of them on the market when they had the chance to years ago but instead in july, 2017 the announced that it would delay implementation of the provisions of the agencies final rule to ensure all products on the market. The same day i issued a statement explaining deep concerns that it would mean the products would continue to lack oversight for several years and was continued exposure to a new generation. Here we are over two years later and my concerns have come to fruition. The usage skyrocketed more than one in four High School Students say theyve used them in the last 30 days into the products have been marketed and targeted without knowledge of the consequences and as a result we could lose an entire generation to a lifetime of nicotine addiction. At the same time people have developed illnesses following the usage of a product many instances they are manipulated beyond the year used it still rs unclear what the products contain and how exactly they were manipulated. Lack of certainty speaks to a larger problem. We do not know the full spectrum of the consequences associated with the use of the cigarettes. Years ago, the prevention act was signed into law after coming to the committee and gave the tools they needed to effectively regulate all Tobacco Products but unfortunately that isnt happening there for it is critical that fda and cdc actions are taken and what more we can be doing to protect consumers. I look forward to hearing from states that forged their own responses at the federal level and the availability of the products clearly designed putting the interest above. Im pleased by the administrations announcement that it plans to hold all products from the market until the review and that should occur immediately. We must get to the bottom of disclosing these and ensure that they are kept out of the hands of our kids and at the same time its become clear to me we must enact new comprehensive legislation to address this and prohibit online sales and make it easier for kids to buy the cigarettes and ensure that the products are not being marketed to anyone under age. This critical legislation moving forward i hope that there will received strong bipartisan support that it deserves to address the publichealth risk with ecigarette use we have to use every tool available to find out whats happening and what is actually causing the epidemics think we need to have this hearing and to move forward as a legislation we need to have this. Thank you again. I will yield back. The Ranking Member of the full committee mr. Waldron for five minutes. Recent weeks and as yet unidentified killed seven people sickened more than 500 across 38th state as we will hear the investigation of the cause or causes of the illness is his ongoing but it appears to be vaping related. Many of the individuals seem to use black marke blackmarket prt contain thc. They announced the person who died in july of severe respiratory illness used a cigarettes containing Marijuana Oil purchased from a licensed suspensory meaning that products sold and should have gone through a Testing Process regulated by the state. Much is unknown including which dispenser they sold the product and whether it was contaminated or something was added into the liquid after the purchase. July and 18yearold young man went to a hospital complaining of breathing problems. 48 hours of the intensive care unit. He was connected to a breathing tube in a medical coma for a week. To be a counterfeit of the companys product North Carolina, five individuals bought the oil that made them sick on the street for unlicensed and likely illegal dealers in all five hospitalized intensive care take a battery of tests all five had acute exogenous lipid pneumonia caused by breathing the wheel. Luckily the individuals survived, but not all have been so lucky including the individuals that died. The cases are young and seemingly healthy adults getting sick after vaping are piling up too quickly. Compared to 20. 8 for this 11. 3 in just three years. Given these trends, the Trump Administration states in this committee the right for solutions to curtail access to ecigarettes. The pursuit of the solution to the problem of access as well as the part worship and the administration states investigate these outbreaks of bonuses. Theres anothethere is another f blessed are the problem and thats counterfeit including counterfeit thc products. Cartridges are becoming too common on the market with members advertising the bootleg products and social media platforms on snap chat and according to press reports, the states that appear to be the most inundated with counterfeit products are states where Recreational Marijuana is legal. According to California Department of Public Health, there are a 28 cases among those that recently taped a cannabis products anthe cannabisproductse department of Public Health report of a cluster of seven healthy kids in king county california all admitted to hospitals with symptoms of lung disease in all seven were linked and purchased from the black market. Lab tests conducted by the Testing Company showed a contaminant including pesticides and when vaporized converged to a substance is a chemical weapon during the first war, world war i. In addition the ongoing work we need a full investigation into the counterfeit cartridges as well as the markets that need to be part of the investigation. A full set of facts to make sure we get it right Going Forward on the policy solutions. I appreciate the witnesses are going to testify today and others that have weighed in and echo the comments of the Top Republican on the subcommittee and we have two subcommittees the majority decided to schedule one on top of the other one on perception drugs that begins in about eight minutes upstairs and a very partisan so sorry that we will be going back and forth as we work on both of these issues and i yield back. The gentleman yields back into the chair asks unanimous consent the return statements he made a part of the record. Without objection, so ordered. I would like to now introduce the first panel of witnesses for todays hearing acting commissioner of thcommissioner G Administration and the principle director. I want to thank both of you for appearing before the subcommittee today. I know you both appear before the committee and its great to see you. This committee holds an investigative hearing and when it does so because the practice of taking testimony under oath. The witnesses have responded no under the rules of the house ane into the Kennedy Committee were entitled to be accompanied. Let the record reflect the witnesses have responded no. If you wer you would please rair right hand so that you may be sworn in. Do you swear the testimony you are about to give is the truth, the whole truth and nothing but the truth . You may be seated. Let the record reflect the witnesses responded affirmatively if you are now under oath in the penalty set forth i section 1001 and the United States code. The chair will now recognize the witnesses for fiveminute summary of the written statement. In front of each of you is a microphone and a series of flights that will turn yellow when you have a minute left and red to indicate your time has come to an end. Doctor, you are recognized. Members of the subcommittee, thank you for the opportunity to be here today to discuss the regulation of Electronic Systems and the agencys role in the Ongoing Investigation. Prior to coming to the fbi a lonlongtime cancer doctor my experience informed all of my work including these issues. We are here to discuss two top Priority Issues first the investigation into the cause of the injury associated and second, the ongoing efforts to address the epidemic and use of the product is including the recent announcements about our intention to issue a policy that would address ongoing marketing flavoring of products. Start by discussing the outbreak working with partners cbc most cases have been reported recent the cases seem similar isnt clear if they have a common clause or different pathogens for the presentation. Investigations do not identify any specific substance that is linked to all cases. Let me outline the main components of the investigation. The office activated in the Management Group across the agency and worked alongside the Management System the regulatory sources play a role in fact gathering analysis and we are collecting samples and analysis. The fcc is using stateoftheart methods with a broad range of chemicals like nicotine and other cannabinoids and additionally we are working with customs Patrol International facilities. The office of criminal investigations is focused on identifying products making people ill following the supply chain to the source. They are not pursuing actions associated with personal use. In manufacturing and distributing they cause illness or death and personal profit we would consider that to be a criminal act. Many of the products contain thc orioles. They received preliminary data in 2019 for the Tobacco Survey. The strong compliance education strategy 2019 data it aggressive and issues warning letters and we collaborated to remove the products on the market in the pursuit of the manufacturing on the coast by the social media influencers. A week earlier this month its a warning letter to the inc. Marketing of authorized modified risk Tobacco Products including a presentation of children. We also expanded efforts to the Prevention Campaign and Cost Campaign and efforts targeting 10. 7 million. Despite the efforts of the preliminary data and another study supported continued to rise through the use of the non tobacco flavors. More than a quarter of the students were current ecigarette users in 2019 and scientific leaders being the most popular. In short come of the data indicate they must do more. Thats why the president announced his support for the intention to finalize a policy related and it would prioritize the enforcement of the premarket authorized nation for the non tobacco flavors. They are not banning flavors that have been described in some news outlets. Rather they intended to force the existing law. The policy wouldnt mean they could never be marketed. The specific product keeps it set forth in congress the fda would authorize the product for sale. Two prioritized the actions the markets are appropriate protection and i want to ensure the subcommittee that i am committed to a point all and we will not rest until we get answers to questions for the investigation and we dramatically reduce the access. Thank you, doctor sharpless. Thank you chairwoman and Ranking Member guthrie and members of the subcommittee. Ive had the chance to update you about the Ongoing Investigation of the lung injury as well as what they are doing. I want to talk you what we know and what we dont know and what we are doing about the lack of knowledge and also what we are doing about the use of the ecigarette problem. First, the first time we learned of these cases, the cdc had been working 20 accident with the state and local Public Health as well as getting to the bottom of it. The ability to do this type of investigation relies on a critical underlying Public Health infrastructure including data systems the need of modernization a trained Public Health workforce including the data savvy workforce. The cdc has made important recommendations to the public already including the comment that while it is ongoing, people that are concerned about health risks consider refraining from using products or vaping. People should not acquire products off the street. You shouldnt modify it further beyond what is intended by the manufacturers. A bold step ecigarettes or vaping products because theyve quit cigarette smoking should return to smoking cigarettes. Fourthly, this outbreak reinforces the need to address the broader academic of cigarette usage. Its a striking young people. Half the cases are under 25. About three out of four are male, but the numbers are changing as we get more data. We are getting new cases reported every day, and i expect this weeks numbers to be hundreds higher than the reported last week. What we dont know unfortunately is the cost. We know that most of the reported cases with Information Available so far described the use of containing thc or thc and nicotine usage. But no single product brand the substance or attitude has been identified with all the uses at this point. If need be that there is one cause or there are many independent may be complex. They are working vigorously together with states to respond. Weve dispatched the disease detectives to assist some of the state and local Public Health and we have been coordinating the definition Data Collection and analysis. Weve issued clinical guidance and we are working with the committee to update that new information as it becomes available. We activated the Emergency Operation center as we do for various Public Health emergencies, and we are coordinating the Public Health and Clinical Community as well as doing frequent media to keep the public informed us all. We are working closely with the fda on the trace back of the products equal halves years and while our laboratories are not testing the patience product collected that is, the tobacco lab is working to develop the aerosol reduced and some of the products. There are challenges in the response. The investigation includes trying to gather information about exposure if so some responses may not be totally forthcoming. State law varies regarding the thc cannabis use the public hate the collections. Ecigarettes or vaping are part of a marketplace that is very wide and diverse. You heard a multitude of product varieties and different subs consists of ten used. They are often the issue with counterfeiting. Public health Data Collection response is relying on fragmented numbers the need of modernization. The disease unfortunately is moving faster than the data at this point and that is a barrier to us getting quick answers. Let me turn briefly to what we are doing about the use of this issue. We know that they are much but likely than adults. The cdc has been messaging about the concerns since 2013 when we got the initial data about the alarming increase from 2011 to 2012 with the use of cigarettes. So, we have been at this and we continue to be at this in terms of our concern. Finally, the cdc is dedicated working aroundtheclock with fda and state and local Health Officials to identify the cause or causes of the outbreak and we will continue to keep the congress updated. Thank you. Its now time for the members of the committee to ask questions and share will recognize herself for five minutes. In 2015, the cdc stated, young adults, pregnant women, as well as adults who currently do not use Tobacco Products should not use ecigarettes. I think that was also echoed by you, doctor sharpless. So, my question come about or schuchat, does the cbc really think that these ecigarette products are safe . We are concerned about the use of ecigarette use among young people, pregnant women, young adults and people with innocuous products even someone that isnt smoking or using them now its not like they are safe for people to use, is that right . For the aerosol produced can have a lot of potentially harmful substances. We have a lot to learn about longterm and shortterm effects. So your answer is no it isnt safe, but if it . Dr o are not saved in those categories. Are they safe for other people . We are focused on those categories because there is the most data about them and particularly we dont know if they are safe for the other people. Right. We are concerned about people going back and smoking cigarettes. Is it true that the youth are more likely than adults to use these products . That is correct. The 2009 Tobacco Control act gave the fda the authority to cigarettes under the Regulatory Authority which the fda did is that correct . And the administration extended the deadline by four years for companies to submit materials to the fda for the review of the Public Health is that right . Is it accurate to say that they are on the market because the fda exercised its discretion and not because the products have been reviewed by the fda . You also agree with the cbc but the products are not safe is that right . Heres my concern the fda and cdc we are seeing an explosion of people using the product and now we are seeing serious illnesses around the country, but the fda still allows products to stay on the market even though they havent undergone the review i think time is of the essence. The science driven organization would have been the same epidemic and now weve accelerated the enforcement but what is your timeline the finalizing which would have the effect of the long tobacco flavors in the market we expect that to be weeks. And what are you going to do after that . It has 30 days to go into effect and then we applied the enforcement strategy. Is the flavor strategy the only thing the fda intends to . I cant speak to the guidance in the process, but it certainly may target the effort. And why is that . Do you think that will solve the youth vaping academic . We do not think that any single policy is going to. We have enforcement, education and multiple policies. Are you continuing to review the products disease they are inherently safe or unsafe . All products will have to sub an application by may, 2020. How far are they prepared to go to protect the health and wellbeing of young people if it determines that these are safe . They are science driven organizations i now recognize the Ranking Member for five minutes. The testimony is informative. You said in all of the cases that you have data for there is no consistent. This is the cause, these are the bottom of things that we found. Is there a trend line developing that you are seeing . The data are coming in. We believe that most people that have exposure history that we gathered described using the thc or nicotine ecigarettes. I think its important to say what people said they used may not be fully descriptive of what the problem is. Maybe as you heard a cutting agent or something related to the device and how it changed over product they used and we may not know what was in the product they go. Its been reported over 80 of the cases the person report reported. That was in a report from illinois and wisconsin about the first cases and those numbers are from about 40 people but the trend is continuing as we get additional data. Its also important to recognize there may be a particular problematic source in the midwest and a different one in california. And i think we really need to be on top of this investigation to make sure that we understand all of the causes. They are not combining. One individual might have many different products that are being tested so it is a very complex investigation and understanding exposure versus the cause of the something we are trying to get out. We have specific lung injuries we are looking at and i know a lot of people are talking about the flavor and general ecigarettes we need to address, but also the thc or marijuana some states made it legal i think massachusetts that they are going to pull back a flavors but i dont know that they are going to undo a policy moving forward. In the testimony you said many suggest the need to understand the Health Effects of increasing the use in the u. S. That was in your testimony . With concerns . The brain is still developing all the way through to about age 25. Whether it is nicotine or marijuana we really want to know the effects that occur. There are data to suggest sugget conference induced behavioral data, but this is one of the reasons that there is a focus for the use. We dont know as much as we need to know about the short and longterm effects. And there are Harms Associated the adolescent brain is almost marijuana. What does the fda think about the effect of the brain on thc and vaping . There is animal data and human data to suggest the developing work brain is sensitive to these so i think we will learn more. [inaudible] the testimony states i that will be shared with the fda to assess which of the products fall into Regulatory Authority. Has the cbc shared such product information . We are sharing information continuously. One of the things we are doing is getting examples linked to the cases for the testing directly to see i know there are not many. There are about 300 samples we tested about 150. A significant fraction of the products like maybe half has no business being in the product as a cutting agent. Ten you tell us those that were tested or testaverde secor bootleg or were they actual commercially purchased . That is difficult to ascertain. The time is expired and i will yield back. Tric pulmonologist tell me what happens is it impairs the developed and if she has even seen kids whose lungs are like those of the 80yearold david is never going to resolve itself. That is going to be what happens. The chair now recognizes the gentleman from massachusetts and the subcommittee for five minutes. Thinking chair and i want to thank you for calling this important hearing. Yesterday Ccharlie Baker announced a Public Health emergency and a fourmonth ban on the sale of all of the products. To date we know nine people have died. Help me answer some of those questions how is it what do we know and how is it that we dont the first cases were in july and a relatively new entity. The product to test a lot of the products. How do we get to the point where backtracking if you are telling me that vitamin e should be an inhalant and the childrens lungs look like the point of an 80yearold we believe that would be the Illicit Activity and to regulate. You are saying with regards to those cases, you have no evidence of that as approved. It isnt approved. We dont know if its cause is anything. How do we get to the point we have a widely used Consumer Product getting people sick and understand it is a massive regulatory failure to allow this to happen, was there not . Now we are open through business to receive applications and we are going to catch up. Im extremely frustrated with the pace of the investigation. I wish we had answers already. You are frustrated with the pace of the investigation and what can we do to speed it up . We have more than 100 people working on this and making it a top priority to do the product sourcing can help, but i also think that there may be a complex set of root causes that were going to be difficult for us to address as a nation and we need to take it very seriously. There is a set of supply chains that are underground and are adulterating products in ways that are just experimental. And building on top of the population the last few years. One of them posed for the regulatory process there could be implications that we will have adverse Health Impacts. As you know, the agency containing issues are regulated at the state level and not the federal level. I would put the fda described that. Weve been raising these issues since we first saw the rise and also supports state and local Health Departments for the comprehensive approaches. Thc is a schedule one drug. To the extent those products are reviewed not all of these were linked and my concern is on the front and it should have been foreseeable that some aspect would be used or cut or otherwise. I want to understand where the process broke down. I now recognize the gentleman from west virginia. Thank you, madam chair. Your remarks earlier were missed because we have another meeting upstairs and weve been back and forth. I apologize if your testimony may explain some of this but im trying to follow the chronology because what i gathered from the internet is they were introduced in 2003, some set of 2006. When do we confirm these things came along . They began to be marketed in 2007. Back to you now. I heard the chairmans remarks, but i cant agree more with the concerns. Theres no link between the two of us. Why has the fda not finalized some kind of determination that allows these things, how do you describe the permitted use . They are not authorized to be sort of the on the market for discretion to prioritize the enforcement. The history, ecigarettes contains products is one of the byproducts get into peoples lung, weve had members of debates and the committee the last ten years, not what is happening with the cool combustion, but from what i understand, my research on this is that these ecigarettes are introducing not only 2. 5, but even smaller and getting down so if we take action that are affecting and impacting the industry across america, why are we not finalizing and saying until we know more about the carcinogens, heavy metals and other things, why arent we stopping this until the final determination . Why are these still on the market if they are causing this kind of a health risk . Twelve years after theyve been introduced. We dont consider the products safe. We think they have harm. We dont think anyone should be using them other than people in place of the tobacco. Tit has to be said to but you know that it is naive to think that is what is happening. Why arent they just off the market until you make a final determination . What is good for the Public Health in some small offramp of the transition for combustible cigarettes but we want to limit the ability of children getting access to the product because of the epidemic use. Would it be more beneficial for you if they were taken off the market . We would like to make it possible for no youth to be using these products. Why isnt Congress Working on a . If you are saying you think they should be better, why arent they out there, what is your opinion if they are causing this kind of problem introducing particular matter into the hourlong contest at the station in the industry and fossil fuels but yet we are allowing children at a higher concentration level and were putting it directly into someones mom and saying thats okay. Someones lung saying thats okay. These products will be off the market as we finalize this policy. I have run out of time. I will yield back. You can cosponsor money bill to raise the age to 21 if you havent already. We now recognize mr. Ruis. Thank you, chairwoman. There is a misleading notion when people say that its safer than tobacco cigarette, that somehow it is safe. You said, and i believe that you agree, and i wholeheartedly agree that vaping and ecigarettes is not safe. In fact, thereve been numerous scientific studies by different medical schools that have tried to elucidate whether or not vaping has any Public Health benefits. And so far, the vast majority of researchers have concluded that they believe there is more population level harm van benefits with ecigarettes. On the one hand, you both know that ecigarettes have a very narrow benefit in that it helps tobacco smokers off cigarettes to quit smoking, period. Not just to convert the market from tobacco to vaping for an industrys benefit. Those who were never smokers now smoking and babying and then they start smoking tobacco. , tobacco cigarettes. So you count those never smokers those who are stopping thats why they say there is a net Public Health harm in this industry to begin with. Then there are other study showing that the ecigarettes and vaping have those compounds that are considered carcinogenic and a young adult who has more propensity to be a deck addicted and then you can start to see they can acquire lung cancer and other types of cancer. Not to mention the concentrations have higher nicotine than tobacco when you start to see reports in the Emergency Department of teenagers coming in with cardiac arrest. I am a emergency medicine physician. Swears the benefit of this industry to our Nations Health . Except for the very small narrow area to stop get them to using tobacco and ecigarettes forgot the best Case Scenario is that new nonsmokers that the industry would love to take tobaccos market on smokers because it is safer or that it is safe. And then no longer preventing you from getting their hands on their and a mention introducing legislation that would do that to help increase the fines for first time penalties for selling these and i am also introducing legislation to do more research on the longterm effects. So what are the Secondhand Smoke effects of vaping quick. You bring back Critical Issues the aerosol includes many toxic things the direct and indirect effect are not fully understood and the issue of Additional Research to get at the longterm effects that we absolutely share nobody should be using ecigarettes. I ran out of time. Thank you i appreciate it. You said earlier theres a lot of different issues going on. One question may not lead to the next. But let me start by saying those that talk with some issues that is dea because for 20 years for Medicinal Marijuana they have not been able to do adequate studies to find out the benefits. And then you have no data. So we really dont know when you add thc into these products longterm consequences of thc as a youth like you said because the brain is developing. And then raising the age for all Tobacco Products through the age of 21. And also mentioning there is a bill at the federal level that seems to be a proper step. In reality we have two problems with serious lung disease with the flavor issues and i have written that up in particular because my wife is a District Court judge they are seeing all kinds of problems because unlike the regular cigarette the teacher can identify where it comes from they dont get that with the other cigarette they have no idea vaping is going on in the classroom. But really were talking about two different issues here today. Yes two separate critically important issues. Ecigarettes have been on the market for quite some time about 12 years at least. So does the cdc or the fda no if the current outbreak is a new phenomenon or with awareness that people started to work one for these lung disorders quick. Increasingly the data suggest there have been individual cases but nothing like we see now. In my correct the knockoffs or the ill legal imports is a relatively new development as well quick. Even the pods would be new as well. Previously we may not have had as much of the various chemicals added in or have we quick. I dont know. We really dont know. So now whether thats new or an older practice. I am aware there are a number of vapor products coming onto the market after the august 82016 deadline that means they were already sold illegally what is the fda doing right now to get those illegal products and those after the period that you alluded, we did that it can be difficult to ascertain. I mean this as a friendly question. And with that importation of illegal substances coming across the border currently do you have much hope we will have much success to keep imported possibly tainted pods coming across the border . Im trying to say how can you havent stop this. You cant stop fentanyl how do you stop pods . I agree it is a challenging issue. Our facilities to see whats going in to find out what vaping products are sent to the United States. I think we will have more hearings i appreciate your time. This is a serious issue we are all concerned and i healed back. To the chairman of the full committee. Earlier in september the president announced the fda will finalize the policy in the coming weeks with market review and i agree with the statement the doctor has made and the point that it has taken so long to get to this point it has been over three years since they were brought under Regulatory Authority and during this time the ecigarette market has become more attractive and accessible for children and teens ecigarette use in demonstrating one third of 12th graders are ecigarette users. And that minimum purchase age could also help reduce it is my strong belief that congress now has questions of guidance but first let me start with doctor sharp to outline the administrations policy of sale of nontobacco flavored products. In my opinion the lack of permanence with the issue by the agency. They will describe and how we will prioritize enforcement. And so with legal force of that statute. And by the act of congress. You will now enforce the underlying law. What kind of steps can the fda take to ensure they are complying given what you just said quick. The fda has experience with this problem we sent warning letters to the manufacturers they come into compliance usually that will have a dramatic effect. I still dont understand how you force them to comply with the guidance. The way that it works is that no longer subject to enforcement discretion. But what if they dont quick. And we have other activities that escalate like further warning letters. And you intend to impose those enforcement measures quick. Yes we would in those other enforcement measures. We would impose those of needed. Is the proposed flavor ban including mint and menthol flavor . You admit that as part plan finalized quick. I cannot describe what will come out of that guidance but for certainty i can tell you data suggest menthol was very popular with children. But you are not committed if that is part of the compliance. It sounds like you say you are not committed to it unfortunately. The only way we could realistically verify if it is flavored or not flavored, this question the only way you can verify that Tobacco Products that it dont flow to kids as direct facetoface sales lie would ban sales for online and remote sales. Can you commit to any guidance banning the sale of the eflavored cigarettes online quick. The guidance we envision what extend to all channels. Okay so three distinct ecigarette products does the fda face any capacity challenges to monitor the market that is entirely funded off of user fees with the User Fee Program and then to enforce these activities that you describe the make those that you are available to monitor from ecigarettes quick. We are using the appropriate monies. What about the user fees quick. On trying to find out if the money you are getting from user fees is available to monitor ecigarettes are you just using that money quick. That is for the use of monitoring. Sorry to go over but this is important i apologize. Thank you madame chairwoman for hosting this hearing. According to the Indiana State Department of health in a recent publication the commissioner stated the numbers are staggering. Nearly one out of five High School Students one out of 12 middle school or say they use ecigarettes in the Tobacco Survey 350 percent increase since 2012. She also writes that one ecigarette can contain in one the amount of nicotine of one cigarette there is a much it is a known and so my question for both of you is how little we knew about ecigarettes and their effects what Research Studies are currently underway to help educate everybody about ecigarettes cracks when we expect the studies to be complete in which studies are underway quick. There is a number of studies the composition of ecigarettes as that cessation device of both nih and fda but these are products and you dont have the longterm experience with them. And to launch a very vigorous Information Campaign like recent online ads. And just doing surveillance if we do test that aerosol. While in fact right after they did choose this report it indicated announcing a 2 milliondollar campaign talking about this a long injury death happen within the week of this incident and this has impacted others in our state with 400 cases. My concern is all of the research being done on marijuana still isnt conclusive. For the federal government really to come up with conclusive studies to be furnished on marijuana why do we think this is any different . Why do we think the research will be different or faster . This is a tough topic study it is a longterm effort. That the answer is it will take a while but with that regulatory framework. Whether surveillance or investigations being done is there a consistence consistent process identified so far quick. One of the reasons is it may take a while to get answers and we wanted to warn the public in the meantime. I agree the majority of projects some that are nicotine only. In the study you are doing how many report buying them versus online why are they getting counterfeit quick. Anecdotally and from where they know when they are concerned about that what the ultimate supply chain may be. Have there been questions from them whether or not they have modified the device or the product quick. I dont have yet the results because they are actually doing the interviews with their patients. Thank you. I understand you say we dont have any evidence that this could help smokers but on the website smokefree. Gov which is the part of hhs says ecigarettes are not approved by the fda and so far the Research Shows there is limited evidence that ecigarettes are effective or helping smokers quit. There are other proven and safe methods for quitting smoking so thats the quote so clearly they are not providing smokers cessation and it seems to me that if we are unable to limit cigarette use two existing smokers then we should just ban it so why should the position be to allow that to continue in any shape or form . That we should say no right now but in the meantime people are dying. How many children will be allowed to die before this is considered the emergency that it is quick. I would like to hear from both of you. I agree with what you said. They do have other approaches that are approved what is good for the public is driven by science but that argument is that there are millions who may find no other source that is gratifying or satisfying. But you said the aerosol, i understand what you are saying maybe that is true but in the meantime we have an epidemic of people ending up in the hospita hospital. Cdc doesnt have the Regulatory Authority but progressively have announced warnings for parents and teachers and state Health Departments and clinicians to know about the dangers this is associated with the recommendation say we suggest you. Vaping or ecigarettes. Thats nice. Said to ask another question so to have industry think groups that are banning to their reelection but no Public Health groups and you are not invited. Is that appropriate the Industry Groups and organizations to support that quick. Cdc is a data driven organization. I do want to ask we put into the record some articles about this potential meeting. And lets hope that all of this is datadriven. So at what point will we address this by education . Will we see implementation to take this away . What have the responses been . I dont feel a sense of urgency. I just dont feel a sense of urgency here. We do have a strong sense of urgency. We sent a letter to the manufacturer. Also this compliance guidance will have a direct effect and to be really good for kids. And it will be banned in a few weeks quick. It will be withdrawn if we stop exercising discretion. They will be banned . I heal back. The gentleman from south carolina. Use of ecigarettes is common among our youth reported death and illness associated with that are worrisome. Is it necessarily about vaping products as much as how these devices are used. We can have appropriate solutions but stop buying the pods and stop trying to get high by lacing them with thc. That seems to be the common thread. We look further into the thc counterfeit blackmarket we understand they have a short history but we need to have all the facts before we fully remedy the situation. I understand the patients with reported lung illnesses have said using ecigarettes thc in just nicotine the cdc and fda believed thc counterfeit blackmarket vapor and products pose a higher risk than unadulterated nicotine cartridges. We are concerned about both right now and it is an Ongoing Investigation about the lung injuries with the youth on the ongoing basis. I agree. No single product is linked to all cases but those that are linked we find the majority are ecigarettes but not all of the them. Are there any Enforcement Actions with cdc year fda says we should take against counterfeit manufacturers . The challenging issue with the fda that has jurisdictional challenges. I think we can certainly find through the International Mail facilities we deftly have significant enforcement authorities and the dea for their help. I really think this is a developing issue i dont have the tools that i dont know what they are but clearly there are a lot of dangers out there. Stirred studies are underway to help us understand better and to help us understand more. State and local Public Health is interviewing patients associated with long injury outbreak to find what they used and how they used it and where they got it and giving that information to the fda or dea. With those other data sets across Agency Efforts what is the cause of the outbreak . And then i mention the extensive testing from the chemistry labs to identify. And with a strong Public Service announcement the marketing effort and targeting the age groups of the households sing the cdc put out a statement with users should consider not using ecigarette products at all while the investigation is ongoing conversely the fda put out with those beeping products and abusing thc with any substance or adding in the stores but to have conflicting warnings. I would say with the warnings the two agencies are putting out i believe we want to correct that. I agree we are in lockstep except for those that are not using them as ecigarettes. Thats what we want to make it available with this information but i agree. Does it concern you at all that they are putting out conflicting statements among those that are using ecigarettes legally not the black market or adding things to it that there is confusion over those legally using these products does that concern you quick. We try to make Clear Communication and we would do better. I agree we will strive for coordinated effort. The message here today is stop the thc products illegally purchase products and stop buying black market there is a health risk coding the lungs of our children keeping the oxygen for making into the system to provide oxygen to the brain is damaging the health of our kids. Thats the message today. Stopped doing this. The gentle lady from New Hampshire. This is a critical hearing thank you to our witnesses we are here in a bipartisan way with transparency of the data to the American People and as a parent i can say this is a very scary time i personally dont think we should be holding on any of these products just because we havent had the research and we have not thoroughly tested them. But just as we were on the precipice with the nations youth the Tobacco Industry has a new wave once again to be in the crosshairs as a result ecigarettes are now most commonly used tobacco product among youth passing conventional use of cigarettes ecigarette use doubled from 2017 through 2019. Doubled demonstrating this problem is growing significantly worse dhs in New Hampshire said that at least one quarter of all High School Students use vaping products and the number is on the rise. We are still in the throes of an Opioid Epidemic that lacked regulatory open oversight. My fear we are repeating the same mistakes making way for a new generation grappling with addiction. Thats im proud to cosponsor reversing youth epidemic act which includes provisions to curb the rise of tobacco use. Based on cdc surveillance and research, what do you believe are the reasons young people are smoking ecigarettes quick. Flavors are the attractant to young people the greatest generation is also high in nicotine content and those that are a little bit more palatable because those flavors are really targeted to the youth so we think the nicotine level but the appeal of the flavors are key. Also the companies that targeted the ads. According to nih 81 percent of adolescents who have ever used Tobacco Products it was a flavored product. So what can you tell us about the contribution of flavors . Do you have anything more to add quick. Yes. We have seen a little bit of a shift in the most recent preliminary data with an increase of the menthol and mint flavors. We do think they are critical and then the nicotine provides that addictive substance to keep them going back. So the new federal policies with the flavored ecigarette products are effective quick. With the product sold on the market today. Does that include menthol would be included . We are finalizing the policy but i can say that we do some mitt that they are significant problems big last year as part of the comprehensive plan for comprehensive regulation with Youth Tobacco prevention plan can you discuss the efforts that the fda has is has a longstanding Educational Campaign we do believe it was very successful kids through age 12 through 17 but in the last year we have shifted the focus to ecigarettes with tv ads that tested off the charts with the youth markets so that they are aware that they contain nicotine so actually now juul is a verb. So manufacturers are creating a new generation of nicotine addicted consumers at a time when the youth faces unique obstacles now more than ever its important we take action to constrain refer the reverse and protect our youth. The gentle lady from florida. Thank you chairwoman this is a very important hearing. America has a growing vaping problem. I have seen firsthand my daughters are a couple of years out of high school i have noticed is the change in behavior of high school and middle school kids over the past decade and it reflects the research of the Tobacco Survey run by our department of health 2012 through 218361 percent increase of kids aged 11 through 17 that tried electronic vaping even worse 582 percent increase of those that use electronic vaping 651 percent increase only on High School Students and on top of that it also found ecigarettes are by far and away the most common form of smoking so this is clearly a very serious Public Health do term this the epidemic or emergency quick. Yes we are calling it an epidemic. As are we. On september 10th how fda is regulating ecigarette you said the rapid rise of these products has resulted from irresponsible practices of the manufacturers targeted children in particular. Give us some examples of these practices by manufacturers and juul. Those ads as unauthorized marketing claims things like saying their product is safe or 99 percent safer and giving presentations to children. So they just out right say things that are not true. There is no data to support the claims. How are these manufacturers targeting kids . What type of marketing are they using quick. We are aware of a presence on social media including social influencers or influential people like celebrities that just let cool a lot of youth are not aware there are nicotine they thought they were getting flavored water so now we see the tech needs that were used for cigarettes and so we need to take aggressive action. You said we need all the regulatory tools but you said in your Public Relations campaign that wont do it. But they are on instagram and snapchat they are using the influencers for a more modern type of Education Campaign can you get to young people quick. This is a market that requires a lot of channels. We have done this. The ftc for example took down sites that were using social media hyping the products without disclosing the dangers. So the influencers you are right they think they are cool they are not so harmful they think that happens somewhere else. Not in my friend group. But of course we have been out there with our partners and there may be kids behind me who are influential as well. Really you cannot combat this with the same old way to communicate you have to bring those most modern techniques up to bear i dont think congress has all the answers either but i encourage you to move aggressively on this otherwise others will die and others will get hooked they think its cool. I think its not harmful and all the evidence we have so far that is just not the case. So i encourage you. Thank you. The gentle man from maryland. Thank you madame chairwoman. I would like you to speak or map out for me because this is horrifying what is happening we are seeing all over again what we saw with cigarettes before the Tobacco Settlement or opioids now with a heightened scrutiny it is receiving and all the litigation and presumably some type of compensation that will come too late for many families in the Community Even dealing with those things, the aftereffects of those Public Health crisis a new one is unfolding before our eyes. You can just predict we will be having hearings ten years from now looking back and picking up the pieces of this terrible Public Health crisis with incredible impacts on communities across the country. The fact that it is starting and a breeding ground is what makes it even more horrifying. There is a lot of discussion into Better Regulation with marketing and industry practice practices, but maybe you can map out the scenario of the Public Health crisis and what it could look out look like five or ten years out if we dont take dramatic steps now to address this arguably that is on the front end of it all though we are getting deeper. Map that out because im asking you to put on the record a scenario we can come back to. I dont want to have to do that but sadly we may go find yourself coming back to and say this was all predictable. Talk about that. We have been warning about ecigarettes since 2013 when we saw the increase of the data in 2012 the industry has changed substantially this is now fourth generation that are much more risky than the earlier ones in terms of flavors and nicotine level the nicotine salts in the concealable to make a hard so if these trends continue and we dont turn the tide, we have generation addicted to nicotine with the impact on the adolescent brain that last for life such as memory, attention and the implications of that. We have the potential which we know is incredibly lethal and we have all the signs of that happening. But the issue right now with the long injury outbreak has people dying is not a question of 20 years from now but right now. And the forces that have led to that dont fully understand just what the Opioid Epidemic the prescription drugs and heroin and fentanyl. But one thing we have come to understand with the Opioid Crisis that we had the wool pulled over our eyes by industry with very Effective Marketing of how a whole industry can affirmatively encourage dependency on their products or at a minimum turned a blind eye to Alarming Trends that are happening in that we know are happening. And look for plausible deniability about their own responsibility for cry think we see that play out the same moves. We will keep focused on this thank you very much i yell back at the chair recognizes the patient gentle lady from new york. Thank you madame chair and the Ranking Members for convening this subcommittee today on the threats of ecigarettes. Also thank you to the panel for their expert testimony here today trying to protect the American People from the harmful effects but more specifically ecigarettes and vaping. As of september 19, 219530 cases associated with ecigarette use just from one territory so far people have died as a result of the overwhelming majority which the cdc has complete data under the age of 45, these are young people this is devastating it has already taken nine lives that we know of it is an obvious travesty. Also individuals currently still on life support or respirators for days on end to know about the potential longterm Health Effect of this illness associated with ecigarettes. We fear there may be longterm illness that require clinicians to follow the patients after they are discharged but its so new it is variable from those individuals but the issues of longterm effects these are young people that were pretty much fine now have a life that is quite altered. Is it possible of these cases prior to the outbreak quick. Yes there have been individual reports of serious lung injury following vaping used in the past but something new is happening to cause these cases in the states and clinicians are looking backward to look at these new cases that are occurring thats why we feel a sense of urgency to make you both said no single product has been identified but you report at least some have been traced to street products not sold by legitimate retailers. So what authority does fda have to take action against counterfeit or unregistered we have a range of authorities for counterfeit products. I mean ecigarette. When the products involve th thc. Generally speaking . Ecigarette. Using the term regulated tobacco product. So you have the ability. If it is a tobacco product yes, we have the authority. You are parsing words. We are talking specifically against about ecigarettes. I apologize for the lack of clarity. The fda has authority over Tobacco Products including nicotine and that substance those products we have authorities from the 2009 Tobacco Control act. Thc and others are jurisdictional emore challenging like a schedule one drug is thc there is a scared lawn a shared regulation thats why we work with those products. They are contributing to the illnesses could have been sold by retailers what does the fda have to get the products off the shelf quick. We can verify manufacturer source or sent warning letters we can see set tobacco sale order or retailer who was selling products. Have yorty begun that process quick. Right now the main focus is on testing finding out what they are and where they come from. But if people are losing their lives right now . Wouldnt it be prudent to do a recall until testing is done quick. But this is different. Do you know what you can do with process of elimination quick. We have products that are sold through legitimate retailers. Thank you very much madame chair i yield back. Smacked thank you to the subcommittee hearing and to the witnesses fda brought ecigarettes within the Regulatory Authority but the fda is not exercising that authority and in that discretion. And it has skyrocketed the past several years with conventional cigarette use can you explain why the fda decided to extend the compliance deadlines quick. As part of a broader comprehensive strategy. And to look at the data including ecigarette use among children that is before this explosion of youth use we have seen the last few years that to appreciate this rocket was taking off and now those policy activities. In retrospect i do believe we should have. If i understand you correctly the fda decided with the delay it was a brief decline and with those adult smokers so the question is now that we have a fuller anderson understanding of what the youth are facing have these considerations changed . As we get the data and i will argue i have done so it was very concerning. If thats true how will the fda account for them and use of these products quick. We have moved up the applications so all products on the market today if they are illegal marketed but in addition we announce the president s policy recently. We were here on the second panel michigan temporally banned flavored products while massachusetts has banned all vaping products over four dollars so that recognition of a Public Health epidemic requiring urgency of a regular agency why does it take a multistate of severe pulmonary illnesses and deaths to take action to protect Young Peoples Health quick. The major data driving the policy it is epidemic but that sense of urgency is by those long injuries of those children of top priority. When fda finally reviews these products and then to ultimately determine to have any potential benefits with that guidance of industry we have been very clear through that process and thats what we consider is the benefits you may thank you for your responses. And over the last few years with the Public Health risks is it surprising we are such in a crisis situation today . But how this administration has rejected and that is troublesome to me and how we approach this issue with all the science based evidencebased and they speak to us on the policy format. Of all people across the board. With that i yield back. We will now have a few closing questions. If this was lettuce it would be off the market tomorrow. And if this was in a Grocery Store you were trace that back to where it came from to the supply line now that if people were out there selling their vegetables in the summertime but if they are out there selling you wouldnt shut down all the supply line of the Grocery Stores. But if you could trace that. I agree. So with those cases to be totally forthcoming and the manufacturer is not here. They dont want their product to get a Bad Reputation so you can trace that. A study that would have been referenced. The fact that there is a striking epidemic is not controversial and supported by many data. One final thing i was going to ask talking about thc previously is the fda involved in any investigations or declined to be involved in any federal investigations of thc . We engaged heavily with fda, we had numerous calls with our and their enforcement people or cybercrimes people. There is a number of Ongoing Investigations into their sharing data. Our question is where are they coming from. There is good cooperation. I will finish with this, i was in your facility at jfk and your group was there and its amazing the things they are finding illicit, showing different tablets we consider brandname drugs today and how they copied the logos were offcenter and things like that. When you stand there and see the volume people are going through it is an enormous task we ask a lot of them but we appreciate the effort and all the work you guys are doing. It is a pride and thanks for the generous support of congress. I will yield back. I want to clarify how this compliance policy can work which i as i understand its the same way that it would work under the legislation and that is you send out your order and defend the companies are required to withdraw the product and then they can come and make an application with the fda to try to show if it is safe to market them. Or products from the market anyone who thought that it was good for the Public Health and could meet that standard at any time at least by may 2020 and if the products can demonstrate it would be authorized for sale. What is the criteria that would be used to allow that to happen the reason you are withdrawing it now is because there is substantial evidence to bear getting used to and hooked on nicotine. The kids like flavors and nicotine is harsh so the flavors can mask that. That i that is the evidence that would be used to counterweight. The evidence is very strong. Ive got to say i havent heard anything today to show why these products should be marketed, theres anecdotal evidence that could help some existing adult smokers not Smoke Cigarettes but other than that, i havent heard any reason why we should ban these flavors, ban kids from being able to get these imply we should aggressively pursue this from a Public Health perspective. I think that there is then confusing questioning maybe it is just illicit drugs or off market devices or whatever. You have the floor right now i would like you to tell us what is your message to the parents in america regarding whether their kids should be using any form of ecigarettes. We want parents to talk to kids. They shouldnt be using these products with nicotine or vaping products with other substances. We are very concerned. We think they are not safe for children and do not recommend their use. We dont think anyone should be using them if instead of somebody using it instead of a combustible cigarettes. I thank you both for participating today. You know the drill. Members may submit questions for the record and i would ask each of the witnesses to agree to respond promptly should you receive any end with th and wite subcommittee will dismiss panel one of the i am now delighted to introduce the second panel of witnesses for todays hearing whos the Deputy Director for chief medical executive. The state Health Director and chief medical officer of North Carolina department of health and human services. Doctor norman secretary of the Kansas Department of health and environment and monica is the commissioner of the Massachusetts Department of Public Health. I want to thank all of you for appearing before the committee today. You are aware the committee is holding an investigative heari hearing. Do you have any objections testifying today . Let the record reflect the witnesses have responded. Under the rules of the house and the committee you are entitled to be accompanied by counsel. Do any of the request to be accompanied by counsel today . Like the record reflect the witnesses have stated no. Please raise your hand so you may be sworn in. Do you swear the testimony you are about to give is the truth, the whole truth and nothing but the truth what the record reflect the witnesses have responded in the affirmative. They are already seated. Delightful turn red to indicate when your time has come to an end. Let me start with you. You are recognized for five minutes. Ranking member guthrie and members of the subcommittee, thank you for the opportunity regarding the Health Crisis of ecigarette use. As the mother of three children in a state Public Health official, theres nothing more astounding than the fact we have written entire new generations to start using Nicotine Products as a society we let these sneak up to the market without proper oversight or understanding the increased 900 between 2011 and 2016. The total number of children currently using ecigarettes was an astonishing 3. 6 million in 2018. 1. 5 million more than the previous year. In some counties in michigan, more than one third of High School Students are using ecigarettes. This epidemic can be attributed in large part to Paper Products and will be advertising and promotional activities by companies that glamorize the use of Nicotine Products nationwide. Flavors such as strawberry milk, banana split, cotton candy and gummy bear clearly targeted children and advertisements are often visually appealing to children, but pictures of candy on the packaging. Flavors are a major reason to start vaping and even scarier many young people use them without understanding the content or the fact that they have nicotine in them. I spoke with one of the parents of my childrens friends who were devastating that they found these in their childs bedroom and they are trying to find resources or support for their childs addiction. Earlier this month, under the leadership of the governor michigan became the first state to advance a ban on all flavored nicotine vaping products and also banned fraudulent or misleading advertising and marketing of products at the pointofsale. The strong leadership is necessary given the significant toll that its taken on our society and particularly the youth and im pleased other states are taking similar action. In addition to the Public Health crisis of cigarette use as of september 20, we at 530 confirmed or probable cases of associated injury across the country and nine deaths. In michigan 15 confirmed or probable cases of this illness and investigating several more. During the investigation into these illnesses, it has been heartbreaking to speak to families of young people who are otherwise healthy and are now barely clinging onto their life. There are things we must do to fight this epidemic. First, we need strong regulatory oversight. They shouldnt be allowed on the market unless they are proven to be safe and they should be able to market faqs or fraudulently marketed products as safe. More research is needed to understand the Health Effects of use. The fda hasnt approved them as a part of a program. We want to fully understand the Health Impacts before we allow them to be on the market. Finally, we need to make sure there is sustained and increased funding for tobacco prevention education as well as funding for efforts for youth and adults and prevention efforts are a critical part of putting an end to these epidemic. The data around at the epidemic is very clear and we must do more to regulate these so that no one is harmed. Thank you for allowing me to participate. I look forward to working with you. You are now recognized for five minutes. Members of the subcommittee, thank you for the opportunity to testify today for the Public Health threats posed. I serve as the state Health Director and chief medical officer for the North Carolina department of health and human services. December of 2018 the Surgeon General called ecigarette use among the youth and epidemic and as a pediatrician and physician it increased 894 in 2011. Theyve become the most commonly used tobacco product in carolina and further concerns have now risen with the investigation of the illness associated with cigarettes and vaping. Before i go on but we put a face on this epidemic. A teenager from high point North Carolina, freshman started using it as a way to fit in with upperclassmen on football friday nights. He quickly became addicted to the nicotine even to the point of selling his clothing and other items to raise 150 a week he needed to support his addiction. Once a boy scout, athlete and a student, he let his grades fall and dropped out of extracurricular activities. Usually a well behaved 15yearolds became irritable and angry throwing outbursts of. We must act to protect our children. Let me be clear they are not safe. Its a major substance found in this highly addictive. They are at risk for the longterm effects due to the exposure of nicotine on the developing brain as the outbreak of the illness associated with cigarette products 36 cases have been reported in North Carolina and almost all of the hospitalizations were half required intensive care. Thankfully weve had no deaths to date in North Carolina and hes not identified thweve note of the illness in our state. Some key factors identified the use including Marketing Strategies that appeal and other systems that are easy to conceal and used discreetly and not recognized those that attract to the products and highly addictive nicotine which keeps them coming back. Despite a 100 tobacco policy, the school staff are finding them on School Grounds to report the use is problematic contributing to disruptions and they do not think they have the resources to address this new wave of Tobacco Products. The resources do evidencebased promotion and media campaigns to compete with the messages. The quit line if they Tobacco Treatment Program is only resource to serve 18 of the members of the states tobacco users recommended best practices into the local Health Departments are not structured or resource to sustain the response to this outbreak. The epidemic among the youth and adults is a threat that will not be solved by one strategy, policy or single federal agency or state only a comprehensive approach to utilize the practices and Lessons Learned. Federal and state policies to consider include proving advertising and marketing to use limiting access and internet settings reducing access to flavored Tobacco Products by implementing the place policies and adding to the policies increased funding should be allocated to further about the extent of the recommended evidencebased state and local interventions including community interventions, Health Communications and media, evidencebased treatment and cessation interventions, Infrastructure Administration and management. Thank you for the opportunity to share some of our experience with you and im proud we have worked to address this issue. Thank you for putting a human face on this. You are now recognized for five minutes. I am the secretary of the department of Health Environment and also the health state official and Army Lieutenant colonel and army state surgeon of kansas. I want to first give a brief update as to what we are seeing in kansas. We have ten hospitalizations confirmed from vaping in ecigarette illnesses including two deaths in adults, that an increase over the numbers from last week and that was a new adults to add to the list. We have the same patterns seen around the country with illnesses from the solutions. Some have been nicotine only, some have been thc and some a combination of both including cbd oil. The final analysis is pending the test results from the fda including what he said by way of history. 16 were under the age of 353 fourths are male and over one half of all also smoke combustible cigarettes while 80 use First Contact with nicotine is through vaping. What we are doing in kansas similar to my colleagues intensive Public HealthInformation Campaign we are working closely with the department of education on School Programs for toolkits and intensive medical professional education and alerts. With the use of the military come in aggregate writedown it is at its lowest rate. Now alarmingly the users in my 2017 to 2018 deployment in the middle east, i saw injuries firsthand. This is an emerging military Health Protection issue. The hard earned gains are being quickly swept away. We need help at the state level with marketing, flavors attract the youth no question about that 96 you end up using tobacco starting with flavored products. Joe camel and the marlboro man taught us valuable lessons about the effectiveness of marketing the youth. We must together counter these efforts and regulate sales. Wwe shouldnt sell Tobacco Products to those less than 21 years of age. Regulating content is important. There is no consistent labeling of the products. There should be. We dont know what the substances are. We need to know what those are. We need time for the science to catch up with the epidemic of illnesses. We need to broaden the law to include ecigarettes and support the funding. In the summary, ecigarettes are widely efficient design. The Smoking Cessation methods are not approved for those under 18 and we must prevent addiction to nicotine. Vaping is effectively showing them the way in addiction. In the task forcand the task for professional Research Organizations they say insufficient evidence to support ecigarettes as they Tobacco Cessation and other proven methods do exist. We must apply Consumer Protection fundamentals to protect our citizens as much as we would tainted meat for malfunctioning automobile airbags. I will welcome your questions later of course. Thank you for the opportunity to provide testimony on this pressing issue today. As the commission of Public Health and is a community as a y member, i am extremely concerned about vaping especially among the youth. Thank you. I commend you for shedding light on this crisis today. Id like to take a few minutes to thank you for what we are seeing. We are proactive in our response based on evidencebased education programming. The purchased tobacco product including ecigarettes to 21. We also prohibited where it became the first state in the nation to end the sale of all Tobacco Products. Massachusetts has made significant progress curbing the youth and adult use over the last few decades. Looking back to 1996 it was 38 . Now today it is a 6. 4 6. 4 in or adult smoking rate is one of the lowest in the nation at less than 14 . The cornerstone of the work has always been prevention. We have a strong cessation infrastructure and network of Community Partners and dedicated advocates to help educate the community is on what we know. Unfortunately, this progress is now at risk. The industries are using the same old to bring new products, cheap, sweet and attractive and its working in massachusetts and across the country. We hear it time and time again Horror Stories when children talk about vaping in the bathroom after school and children 11 and 12yearsold and have ttosleep with devices undeh the pillow because they are so addicted and waking up in the middle of the night to use them. We know that from our 2017 data, thats 40 of High Schoolers have tried these products and one in five, 20 are using them regularly. Now we are confronted with the emergence of this lung disease seen across the country. Two weeks ago i exercised my authority as the Public Health commissioner to mandate that physicians immediately begin reporting any unexplained associated disease to us at the department of Public Health. We immediately started to hear about cases. We are now looking at 66 reported cases and have already reported to the cdc in two possible ones. This tells me the answer im afraid of, this is just the tip of the iceberg what we will see related to these cigarettes. We dont know what is causing these illnesses yet, but we want to act now to protect our children. Yesterday in massachusetts we took a landmark step. Our governor declared a Public Health emergency in the commonwealth and put in place an immediate ban on the sale of all vaping products, both nicotine and thc. The ban on vaping Product Sales will enable the states to take a muchneeded pause and gather more information and data to inform the next steps to protect our Public Health. We cant stand by and watch the industry hooked another generation on these products. It is up to us to confront the facts, sound the alarm and protect Public Health particularly in the youth. Our goal is simple. Thank you for your commitment to the issue and i look forward to working with you. Thank you to the entire panel. The chair will now recognize herself for questioning. The Surgeon General declared. I would guess you probably agree with the Surgeon General. Agree. You said in your written testimony to be the generation that ended to smoking. That legacy is now in jeopardy. What do you think needs to be done to reverse the tide and end the epidemic . We are focusing today mostly on the youth use of cigarettes. One thing we cannot lose sight of is that these are so addictive we have to also think about smoking in general because this is a an on ramp. You might have heard me say to the previous panel, i sponsored legislation to increase the age to 21 for all of these products. I was telling mr. Guthrie and it is a bipartisan bill we had a bipartisan sponsorship and in the senate the Senate Majority leader has the companion bill but nonetheless as ive been talking to people on both sides of the aisle and try to get cosponsorship, people are reminiscent because they say if somebody is serving in the military, they should be able to smoke and people over 18 can serve in the military. When i was listening to your testimony i thought you would be the perfect person to give the answer to that. So what is the answer to that . That is a Public Health expert talking. They have a long history as even supporting smoking to be honest, way back to today is that i thes a c. Rations and they are available at very low cost. We need to accelerate. Do you think it is a good idea that we are making them available to the military . Spinnaker is nothing to support that from the Public Health perspective. You said you think it is a good idea to raise the age to 21. Does that then include the military . Is because of the risk to Public Health is that right . Yes. What do you think they could be doing to protect children more . We need to make sure that we dont allow the fraudulent marketing to children saying that these products are safe area do we need more evidence and data that they are even effective for Smoking Cessation because that isnt scientifically proven so that is what i believe. Thats important. As i mentioned in my comments, we need to think about a comprehensive approach. Tobacco control, the same as the combination of the policy around marketing and regulation implementing access to the price policies. We need to make it less appealing and regulate the availability to an older population and i think that we need to control the labeling of products to people know what is actually in their. We passed the back of the 21 last year based on the science of developing. Its a different question than whether or not someone should be using a tobacco product. We know that there can be damage to that and that is how we support a tobacco being raised to 21 for all. I was going to add i support the other panelists sat around the restriction. I want to ask one more question. Use it after you used your authority to the reporting, the reports skyrocketed. The link that will happen in other states around the country as we get into more reporting . The reason for that is several. One is that clinicians havent been asking about vaping and team havent been disclosing the use of the products as we begin to ask and come forward. We will see those cases and there seems to be something going on in the current environment. Thats why i said i meant to put the iceberg and we will see more as well. The principle is if somebody is going to be old enough to wear the uniform are they not going to make another decision. To ban the nicotine but theres other states across the country to give more opportunities i know they are not focusing but if they give opportunities to have that debate come access to marijuana advocate into the hands and im glad to see that you have banned all forms of vaping, even thc. I have a question that yo but yd of answered this in your statement. You reported cases associated in for each of you how many have been reported in your state and can you provide a breakdown of how many involved nicotine, thc or both and did also have in michigan weve had over 44 cases that have been reported to the health department. They are confirmed or probable cases. We have seen a mix and this is family members or patients that are Self Reporting so we have questions for the actual truth h may be that it is selfreported. Its been nicotine and both are some of them so we dont know what the exact substance is. We have not michigan we dont test the products ourselves. We are in the midst of investigating the cases, so for the 27 that we have the medical record information from, 75 of them have reported the u. S. And certain teen reported cbd. 45 reported that nicotine flavors and others thc and nicotine. Of the 16 that have actual interviews, 94 have revealed the use of thc and 56 reported vaping nicotine. We have been doing testing in the state lab. We do not have the reports back what we found that 41 we have results from 71 have had evidence of thc and hal have had evidence of vitamin e. As well as we found nicotine, menthol and glycerol as well so a mixed bag of different findings. We have had 66 cases reported to us. We have been confirmed in to probably and the rest are under investigation however, we do know that so far the majority of them are under the age of 30 and we also know that it is a mix of thc from nicotine only in some of thc and nicotine. Do you know if there are other orioles . We do not deny the materials they are surveys for both clinicians and individuals, so we are doing the actual testing of the latter. All of these, how long does it take to get the results and have they told you about the information and how the results compared to the overall race will . Im not sure how long it will take to get the results back. We do have regular communications with the fda but i am not aware of how long it will take to get those results back. This is relatively new. We havent gotten specific results back that we have gotten communications from the fda talking about what they have been finding. And again one specific additive and the finding of the broad ranges, not one substance seems to be identified as we have been getting qualitative reports back but not specific qualitative reporting. The first was sent in an august and we havent received any of the results back yet. Our information at this point is qualitative as well. A picture that had the corner as a vaping device i dont know if it was an illicit side but obviously it is marketing towards children and appeared and nobody knows what they are doing it. I will yield back to my friend. August 23 of this year we learned that in illinois a resident died from the outbreak that it is tragic but the more i listen to the testimony ive ofr today so seems to be preventab preventable. If the fda hadnt deleted the Obama Administration it would have started the regulation in 2018. The people and the potential users know that it is until we too use ecigarettes so it isnt out of a lack of knowledge. I think that is where the holy grail is. The regulation could have started i dont know if anyone else wanted to. I do know that they are used in the state of michigan who dont even know what is in the products i dont think we know for sure for these related illnesses. [inaudible] and how things like the aerosol could affect the health, anybody . We have more information about what is in the solution that goes in and what comes out because it is certainly changed the process. Were you all here for the last panel . Do you feel satisfied that Going Forward we are going to make progress as best we could and as effectively as we could on what you heard both for me im pleased they are providing support to the state and local governments but i think collectively as a society we probably could have done or sooner. What i know is we are seeing an alarming increase as you mentioned earlier of these pulmonary disease diseases and n massachusetts we put a temporary ban of all the products in place in order to take a pause to prevent the further illness index and the associated disease and be able to gather more data and information. Is this something that is going to be alleviated at this point are we going to see this increase going on as we go forward . Yes or no . We need the full steam ahead approach. I think we are going to see if marked up. Nicotine is highly used in the way that its marketed with its flavors and access. Because it isnt legalized do you believe they are accurately reporting the use of thc when they become sick . People however in both our reporting thc up to 75 said sos hard to know that everybody is reporting accurately that a large percentage are reporting. I dont think people are always honest with their medical history. And they understand the analysis is there any you might use to increase the accuracy of the reporting . The evaluations are straightforward. Its what we do the public medicine and health that we need more of the analytics. We asked the same question sometimes to ask something similar to pursue a better response. We are making sure we are reporting the data. Our interviewers are pretty experienced during interviews with patients its hard to know exactly i will take that as a yes you are doing some interesting things. What are the jurisdictions doing to crack down on the illicit street products that are not from your commercial sellers . The Tobacco Sales are not licensed to target to use the licensing data to track within our license. The investigation o of already sits within the peer of investigation. If theres a complaint to figure out a signal it looks like it is coming from this Geographic Area and then they can go and investigate the complaint but right now we dont have enough localizing data to direct them. It is around the sales of a temporary ban. They pass the ball and updated and now it is an alternative nicotine product. You raised an issue earlier when you were talking about the fda and testing whats going in that you dont know if they are testing what is comin that is c. Thats what we heard last week. Im not an expert on the engineering that goes into the devices. There is many different ones. They could be either or both. Whats in it to begin with and what is coming at us as smoke or a combination of the two. Some combination thereof and we need to know all the answers. Recognize i the gentleman frm massachusetts. It is now the businesses across its clearly been a regulatory failure. What should they be doing immediately to separate the state efforts to contain the outbreak . There are several things the partners could do. They look at massachusetts and went to tobacco 21 in the labor restrictions and also decrease access as well as understanding what is the content of the products just like we do in Tobacco Products and testing the nicotine levels as well as allowing us to limit advertising and put warnings on the products. She said that no end product is on the market legally. But i do understand is there are fda nicotine replacement fda approved replacement therapies available and that is what i had edifies individuals to use the fda approved a. Part of the education has to be around what approved cessation and its part of our temporary ban in massachusetts in doing thand doing the effortd enhanced education and access at the replacement products. For the businesses that are now losing their jobs and more forced into the black market but theres no part of the solution that is good at the moment. We dont know what the substance of the device is that is causing these illnesses, so when you dont know it is kind of hard to say what you could have done to prevent it at the same time the fraudulent marketing and effective of adults and youth think that they are effective but they dont know it is in the product or that they are affected is a problem i think we could potentially have stronger regulations sooner. We have the problem with nicotine into the problem of the substances. I think weve known forever nicotine is highly addictive and the Lessons Learned and to apply the same Lessons Learned. Six years ago when i was the chief medical officer at the Kansas Health system i outlawed vaping on the healthcare campus because we had a note tobacco policy and got pushed back for the benefit of the Tobacco Cessation. It didnt be neede believe it td dont believe now. It would have benefited by much tighter regulatory controls on the products in the devices and solutions. If members would like to ask questions there upstairs at the hearing and cant get down so under the Committee Rules members do have ten additional Business Days to submit questions and i suspect many members including doctor ruis was a medical director and cares about these issues they will want to ask questions i appreciate you coming today. Your perspective around the country being on the ground and what we can do is vital to the consideration and i hope you dont mind i decided to deputize all of you as our experts assisting us a high want to thank everybody and with that, the committee is adjourned. [inaudible conversations] [inaudible conversations] thank you for joining us today thank you for welcoming the ftc chairman