The somebody on oversight and investigations hearing will now come to order. Today the committee is holding a hearing entitled sounding the alarm, the Public Health threats of ecigarettes. The purpose is to examine the Public Health impacts related to ecigarette manufacturing, sales and use. The chair recognizes herself for purposes of an opening statement. Our country is facing a serious Public Health epidemic, one that is causing severe harm. This hearing will examine the cause of that epidemic, the uncontrolled and rising use of ecigarettes. As lifethreatening illnesses sweep the country and the use of products by yunoung people soar we must protect the American People from these products. First the data is now clear, over the past several years, weve seen an unacceptably high proportion of young people facing nicotine addiction. This year alone, more than 27 of High Schoolers report theyre using ecigarettes or vaping as its also known. From 2011 to 2015, there was a 900 increase, a 900 increase in youth vaping and from 2017 until today, the use the rate of High School Use doubled. The vaping epidemic and its impact are personal to me. My home state of colorado has the unfortunate distinction of leading the country in teen vaping. A major factor contributing to the rise of ecigarette use among teens is that inundation of flavored products. Data from the centers for Disease Control and prevention indicate that 60 of students using ecigarette, used popular flavors. Young people may also have the false assumption that these products are safe or harmless. But contrary to many manufacturers claims, ecigarettes pose risks to young people and can lead to addiction, harm brain development, affect respiratory health and can lead to heart disease. Ecigarette use increases the risk of youth turning to conventional cigarettes. As much as we do know. The more troubling concern may be how much we dont know about these products. For example, in some cases, we dont even know what chemicals and toxins are being inhaled. The ecigarette industry has launched a massive Public Health experiment on our country of which its outcomes and consequences remain unknown. A recent spade of serious vaping illnesses epitomizes just how much were in the dark about these products. These illnesses, numbers 530 so far, and increasing daily, have led to hospitalizations, Longterm Health Complications and several deaths. While cdc and fda are here today, and i want to thank both witnesses, and theyll provide more information about the status of the investigations and what products may be the culprit no specific causes of the illnesses have been determined. With these agencies engaged and in collaboration with state partners i have confidence that the root cause of this outbreak eventually will be identified. But even if the cause is isolated to a product sold on the street or the use of thc, we must keep in mind that branded ecigarette sold in stores are not harmless. This brings me to my next concern. Given the potential risk associated with these products it would be reasonable to assume they have been approved by the fda but they havent. Ecigarette products are only on the market today because fda is temporarily giving them a pass by exercising its Enforcement Discretion. Let me be clear no ecigarette currently on the market in the United States today has been fully reviewed by fda for its impact on Public Health. Fda needs to do its job examine these products, tell the public what the risks are and how they can be legally sold. Fda must go forward with conducting its repeatedly delayed premarket reviews for all ecigarette products and determine whether the sale of the product is, quote, appropriate for the protection of Public Health. After years of delays around the regulation of ecigarette, the administration announced that the fda would prioritize enforcement and clear the shelves of nontobacco ecigarette products pending review. I am encouraged by this recent action. Fda needs to provide details and a timeline for action and ensure that this policy will be implemented and enforced in a reasonable way. In the meantime nothing is stopping manufacturers from submitting their applications to fda today. The burden is on the Cigarette Companies to demonstrate that these products meets the fdas health standards. And regardless of the administrations recent announcement legislative action is not off the table. I and others have introduced bills to tackle this Public Health priority including chairman pallone who has been a stedfast leader on these issues. States on the front lines of the youth epidemic have been taking action on ecigarettes. Were going to hear some of their plans today. The industry has been swift to rail against efforts to restrict the products claiming they assist adult smokers. That evidence, however, is far from conclusive and fda has not approved ecigarettes for cessation purposes. Any benefits to adult smokers has to be weighed against the generation of young people for which vaping represents an on ramp to use. I want to thank the witnesses for being here today for their service and look forward to hearing how we can Work Together to address this serious public issue and yield to mr. Guthrie from kentucky. Thank you for holding this hearing and i want to say i know a lot of our members will have to go back and forth for whatever reason, this committee scheduled two important subcommittee hearings at the same time and so we have drug pricing upstairs, i think everybody agrees its an important issue and a lot of member share that subcommittee. Thats where we are. I want to say im deeply concerned about the outgoing break of lung illness with vaping and ecigarette use as well as the marketing of ecigarettes to kids. We need to understand the causes and ensure that ecigarette are not marketed to kids. Its important that we understand the Health Implications of vaping in ecigarette use more broadly whether an adult is vaping thc, to derive from marijuana, nicotine or another substance. So far the Available Evidence of the 553 reported cases of lung illness and Health Deaths do not point to a conclusive cause. The test samples overwhelmingly suggest involvement of illicit ecigarette devices, the psycho active ingredient in marijuana called thc and other black market products. For example, according to the centers for Disease Control most patients have reported a history of using ecigarette products containing marijuana or thc. However, some have reported products that contain thc, marijuana with nicotine and others reported only using products with nicotine. Separate from the outbreak of lung illnesses according to the food and Drug Administration the United States has a youth ecigarette epidemic. The most recent data from the National Youth Tobacco Survey show 27. 5 of use reported using ecigarettes compared with 20. In 2018. These trends are unacceptable. The marketing of products to children must be stopped. This epidemic is driving legislation and regulatory responses. Last september the fda issued more than 1300 warning let and fines to brick and mortar retailers who illegally sold ecigarette products to minors and five warning letters to ecigarette manufacturers about their plans to address youth access of their products. 18 states have increased the legal age to purchase Tobacco Products to 21. Michigan, new york and the District Of Columbia have issued a proposed regulation to ban flavored ecigarettes. On september 11th, 2019, the Trump Administration announced that the fda would finallyize a compliance policy to prioritize enforcement against the marketing of unauthorized nontobacco flavored ecigarettes including mint and menthol ecigarettes. With these responses, while these responses are aimed at reducing the attraction of ecigarettes to youth, wide bands will create black markets. In that vain we will need a response to an increased black market demand for flavored pods to address the growing trade in illic illicit cannabis marijuana vaping products. Revealed a very advanced and mature market for marijuana, vape cart rims and distribution of contaminated marijuana based vape carts. I am told these illicit operations are using a tactic and other illegal drug operations. Theyre cutting their product with other substances including some that could be dangerous. Public Health Advocates said a particular cutting agent is an oil that could cause breathing problems and lung inflammation if not heated fully during the vaping process. Using smaller amounts of the expensive thc or marijuana and diluting it with oils that cost much less, one can increase their profit by selling the product. Medium grade thc can cost 4,000 a kilogram but additives may cost pennies on dollars. These operations rely on pin factories that buy empty vape cartridges and counterfeit packaging from chinese factories and fill them with thc liquid they purchase from the United States market. Empty cart rims and packages are available to purchase on the internet. While federal and state authorities are working on effective response, we must ensure that our youth is educated on the dangerous of using ecigarettes. In Massachusetts Governor bakers administration launched a campaign in 2019 and the Massachusetts Department of Public Health launched a campaign to highlight the dangers of vape pens of ecigarettes in july 2018. These actions are commandable and i look forward to seeing the results of these campaigns. With regard to adults trying to quit smoke something studies suggest ecigarettes are less harmful than traditional sigs. According to the cdc they have the potential benefit sensation for adult smokers but the cdc cautions ecigarettes are not safe for youth, young adults, pregnant women or adults not currently using Tobacco Products. Additional research should look at the effect of this. I want to thank our witnesses for being here on both panels today and i look forward to this important discussion and sorry well be back and forth between hearings. I yield back. I thank the gentleman. The chair recognizes the chairman of the full committee, mr. Pallone for five minutes. Thank you. I want to thank chairwoman goodette for having this important hearing today. Were coming the growing Public Health crisis involving ecigarettes and the proliferation of these products amongst kids and teens and im deeply concerned about the recent outbreak of lung ills in that have killed eight people and sickened 530 in the u. S. Im also frustrated by the fact that ecigarette usage has reached epidemic proportions of kids. You know our nations ecigarette problem is real and getting worse and its long past time for Public Health agencies to address vaping and ecigarette usage in a meaningful way. I look forward to hearing about what the fda and the cdc can tell us about how theyre addressing the tragic mystery illnesses and the recent actions to combat youth ecigarette use but make no mistake, i firmly believe many aspects of the youth vaping epidemic could have been addressed if the fda had moved forward with reviewing all skigs on the market when it first had the chance two years ago. In july of 2017 fda announced it would delay implementation of key provisions of the agencys final rule which ensured the agency would review all ecigarette products on the market. That same day i issued a statement expressing deep concerns that these delays would mean that ecigarette products would continue to lack needed Public Health oversight for several years and risk continued exposure to a new generation. Here we are over two years later and unfortunately my concerns have come to fruition. Since that decision, youth ecigarette usage has sky rocketed more than one in four High School Students say theyve used ecigarettes in the past 30 days. These products have been marketed and targeted to kids without our knowledge of the full Public Health consequences and as a result we could lose a new generation to a lifetime of nicotine addiction. At the same time hundreds of people throughout the country have developed unknown lung illnesses following the usage of Vape Products. Many instances these products were manipulated beyond the products intended use but still remains unclear what these products contain and how exactly they were manipulated. The lack of certainty on the root cause of these illness speaks to a larger problem. We do not know the full spectrum of Health Consequences associated with the use of ecigarettes. Ten years ago the family smoking prevention and Tobacco Control act was signed into law after coming out of this committee. This law gave fda the tools that it needed to effectively regulate all Tobacco Products. Unfortunately, that is not happening. Therefore, its critical that fda and cdc explain today what actions theyre taking and what more we can be doing to protect consumers. I also look forward to hearing from states that have forced their own responses in the wake of the inaction at the federal level. Flavored ecigarette products for kids consumption are putting the interests of industry above the health of our kids and im pleased by the administrations announcement it plans to pull all flavored ecigarette products from the market until the end of full review i believe the ban should occur immediately. Above all else we must get to the bottom of what is causing lung illnesses and ensure that Vape Products are kept out of the hands of our kids at the same time its become clear to me we must enact new comprehensive legislation to address this growing youth epidemic. We must eliminate flavors, prohibit online sales that make it easy for kids to buy ecigarettes and ensure the products are not being marketed to anyone underage. Legislation reversing Youth Tobacco epidemic act as each of these things raising the age to 21 to buy Tobacco Products. Its my intention to move this critical legislation forward and hope it will receive the strong bipartisan support it deserves. Its long past time to address the Public Health risks associated with ecigarette use. We have to use every tool at our disposal to solve this crisis. If i could say, madam chair, i am although its true as you mentioned that we do want to move legislation, i also think that its very important for the oversight and investigation subcommittee to find out whats happening and what the agencies are doing, whats actually causing this epidemic, so i really appreciate the fact that youre having this hearing. I think we need to have this hearing as much as i want to move forward with the legislation to get to the bottom of this. Thank you, again. I yield back. Chairman yields back. The chair recognizes the Ranking Member of the full committee, mr. Walden, for five minutes. Thank you, madam chair. Thanks for holding this hearing. Electronic cigarettes, the current outbreak of lung illnesses with the youth vaping epidemic are a front and Center Health concern in the United States and in my state of oregon. In recent weeks and as yet unidentified lung illness has killed seven people, sickened more than 500 across 38 states. As we will hear from dr. Sharpless and dr. Schuchat today, the investigation of the cause or causes of the illnesses is ongoing but appears to be vaping related. Many of the individuals who have gotten sick seem to have used black market products that contain thc. Earlier this month Public Health officials in oregon announced a person who died in july of severe respiratory illness used an ecigarette containing marijuana oiled purchased from a licensed dispensry, meaning the product sold in the store should have gone through a testing process, regulated by the state of oregon. It was the first death in the u. S. Tied to a vaping product bought in a marijuana shop. Much is still unknown, however including which dispensary sold the product and whether it was contaminated or something was added into the liquid into the device after the purchase. In july an 18yearold young man went to a hospital complaining of breathing problems. Within 48 hours he was sent to the intensive care unit diagnosed with acute respiratory syndrome associated with acute lung injury. He was connected to a breathing tube and placed in a medically induced coma. The patients mother found an ecigarette cartridge based in california that sells thc products. The cartridge was found to be a counterfeit of that companys product. In North Carolina five individuals bought marijuana oils that made them sick on the street from unlicensed and likely illegal dealers. All five hospitalized, three in intensive care. It took a battery of tests to figure out all have acute pneumonia, lung inflammation caused by breathing oil. Luckily the individuals in new york and North Carolina survived but not all have been so lucky including the individual from oregon who died. These cases, young seemingly healthy young adults getting sick after vaping are piling up quickly. These cases are shining a light on the youth vaping epidemic in the United States the most recent data from the National Youth Tobacco Survey, very troubling, about 27. 5 of youth reported using ecigarette in 2019 compared to 20. 8 in 2018. Thats an 11. 3 jump in just three years. Given these trends the administration, the Trump Administration, the states and this committee, are right to look for solutions to curtail youth access to ecigarettes. I appreciate the Trump Administrations pursuit of an effective solution to the youth access and the partnership between the administration, the states to investigate these outbreaks of lung illnesses. However, theres another overlay to the ecigarette problem and thats counterfeit products including counterfeit thc products, bootleg thc cart rims too common on the market with vendors advertising bootleg products such as snapchat and instagram and according to press reports the states that appear to be the most inundated with counterfeit thc products are states where Recreational Marijuana is legal. According to the California Department of Public Health there were 28 potential cases of acute lung disease among people who had vaped cannabis products. Seven healthy kids in king county, california, all admitted to hospitals symptoms of severe lung disease and all seven were linked to thc vapes purchased from the black market. Lab tests conducted by a Third Party Testing company showed contaminants in the counterfeit vapes including pesticides, a fungus ids that when vaporized converts into a substance used as a chemical weapon by the french during the first war. World war i. In addition to the ongoing work we need a full investigation into counterfeit thc cartridges ma madam chair and the vaping and cannabis black markets. Lets get a full set of facts to get it right when we move forward on policy solutions. I appreciate the witnesses who will testify today and echo the xhechbtsz Top Republican on the subcommittee mr. Guthrie. Unfortunately we have two very important subcommittees that the majority decided to schedule one on top of the other, one on prescription drugs that begins in about eight minutes upstairs, and a very partisan bill, and this one. So sorry, but we will be going back and forth as we work on both of these issues. I yield back. The chairman yields back. The chair asks unanimous consent members written Opening Statements be made a part of the record. Without objection so ordered. I would like to introduce our first panel of witnesses for todays hearing. Dr. Norman sharpless, m. D. , acting commissioner of the food and Drug Administration and dr. Anne schuchat, m. D. , the Principal Deputy director, centers for Disease Control and prevention. I want to thank both of you before appearing before the subcommittee today. I know youve both appeared before this committee before and its great to see you. Youre aware, i know, that this committee holds an investigative hearing and when it does so it has the practice of taking testimony under oath. Do you have any objections to testifying under oath . No. Let the record reflect the witnesses have responded no. The chair then advises that under the rules of the house and committee, youre entitled to be accompanied by counsel. Do either of you desire to be accompanied by counsel . Let the record reflect the witnesses have responded no. Please rise and raise your right hand so you may be sworn in. Do you swear that the testimony youre about to give is the truth, the whole truth and nothing but the truth . You may be seated. Let the record reflect the witnesses have responded affirmatively and youre now under oath and subject to the penalties set forth in title 18 section 1001 of the United States code. The chair now will recognize our witnesses for a fiveminute summary of their written statements. In front of each of you is a microphone and series of lights. The light will turn yellow when you have a minute left and red to indicate your time has come to ap end. Dr. Sharpless youre recognized for five minutes. Good morning, chairwoman, Ranking Member and members of the subcommittee. Thank you for the opportunity to discuss the regulation of electronic nicotine delivery systems. And the agencys role in the Ongoing Investigation into the lung injuries experienced by individuals. Im a longtime cancer doctor. My experience has informed my work at the agency including the issues before the agency today. We are here to discuss two top Priority Issues the Ongoing Investigation into the cause of the lung injury associated with the use of vaping products and second, fdas efforts to address an epidemic of youth use of ends products including the recent announcement about our intention to issue a policy that would address ongoing marketing of flavored ends products. The vaping illness outbreak. Working with state partners cdc and fda have been investigating an outbreak of lung injury associated with the use of vaping products. Most cases have been reported use of products including thc in marijuana although these cases seem similar it is not clear if they have a common cause or if they have different path they again with similar presentations. They have not identified substance or product linked to all cases. Let me outline the main components of our investigation. Fdas office of Emergency Operations has activated an Incident Management Group to coordinate across the agency and work alongside cdcs management system. Fdas Regulatory Field force playing a Critical Role in fact gathering and analysis with Health Department we are collecting samples at our forensic chemistry center. Using stateoftheart methods to assess the presence of a broad range of chemicals including nicotine, thc and others, opioids, cutting agents and additives, pesticides and toxins. Fdas office of criminal investigations is focussed on identifying the products making people ill and following the supply chain to the source. Fda is not pursuing actions associated with personal use of any vaping products. Our interest is in the suppliers. If we determine someone is manufacturing or distributing illicit vaping products that caused illness or death for personal profit, we would consider that to be a criminal act. Many of the products associated with the cases contain thc oils we engage the dea to help. Let me turn to the fdas efforts to address the rate of ends use by children. This summer working with cdc the agency received preliminary data from the 2019 National Youth Tobacco Survey or nyts. Despite strong compliance the 2019 data indicate another alarming increase in youth use of ends products. Fdas response to the 2018 nyts data was aggressive and multipronged and stepped up compliance and enforcement letters to retailers for sales of ends to minors and collaborated with the firsttime firstti federal trade commission and pursued manufacturers of unlawful online posts by influencers. Earlier this month issued a warning level to Juul Labs Incorporated for marketing unauthorized Tobacco Products including a presentation to children given at a school. We also expanded our efforts to educate youth about the dangers. Our youth ecigarette Prevention Campaign is a comprehensive targeting nearly 10. 7 million youth aged 12 to 17. Despite these significant efforts, the 2019 nyts data as well as another study supported by nyda demonstrate a continued rice in the disturbing rate of ecigarette use especially through the use of nontobacco flavors. In particular the data shows that more than a quarter of High School Students were current ecigarette users in 2019 and youth ecigarette users cited fruit and menthol mint flavors as the most popular. This data indicates the fda must do more. Thats why the president announced his support for the fdas intention to soon finalize a compliance policy related to flavored ends. This policy would prioritize fdas enforcement of premarket authorization for nontobacco flavors. Fda is not banning flavors as has been described in some news outlets, rather fda intends to force law that limits the marketing of such products. This would not mean that flavored ecigarette products could never be marketed. A company can show a specific product meets the standards set forth by congress then the fda would authorize that ends product for sale. Fda intends to prioritize enforcement action such that flavored ecigarette products will be expected to exit the market until manufacturers provide Scientific Evidence demonstrating that marketing their products is appropriate for the protection of the Public Health. I want to ensure the subcommittee i am committed to employing all the tools we will not rest until we have answers to the questions in the investigation and until we have reduced the access and appeal of ecigarettes to children. Thank you. Thank you. Dr. Schuchat, youre now recognized for five minutes. Thank you, chairwoman degette and Ranking Member guthrie and members of the subcommittee. I am happy to have the chance to update you about our Ongoing Investigation of lung injury as well as what were doing related to the youth epidemic of ecigarette use. I want to tell you what we know and what we dont know. What were doing about the lack of knowledge and also wa were doing about the youth ecigarette problem. I want to make four key points. First, since the first time we learned of these cases of lung injury, cdc has been working 24 7 hand in hand with the state and local Public Health as well as the fda to get to the bottom of it. Secondly, our ability to do this type of investigation relies on a critical underlying Public Health infrastructure including data systems that need modernization and a trained Public Health work force including a data savvy Public Health work force. Third, cdc has made important recommendations to the public already, including the comment that while this investigation is ongoing, people who are concerned about health risks should consider refraining from using ecigarette products or vaping and should not acquire products off the street and should not modify these further beyond what was intended by the manufacturers. Adults who use ecigarettes or vaping products because they have quit cigarette smoking should not return to smoking cigarettes. Fourthly, this outbreak reinforces the need to address the broader epidemic of cigarette use among youth. What we know so far is this epidemic is striking young people, half of the cases are under 25. About three in four are male, but those 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 what we reported last week. What we dont know, unfortunately, is the cause. We know that most of the reported cases with Information Available so far describe ecigarette use containing thc or thc and nicotine ecigarette use. But no single product, brand, substance, or additive has been identified with all cases at this point. It may be there is one cause or many causes and complex root causes. Cdc is working vigorously together with the states to respond. Weve dispatched our disease detectives to assist some of the state and local Public Health. Weve been coordinating Case Definition, Data Collection, and analysis. Weve issued clinical guidance and working with the Clinical Community to update that as new information becomes available. We activated our Emergency Operation center as we do, and we are coordinating and c convening the Public Health to keep the public informed as well. Were working closely with the fda on the trace back of products that people have used and while our laboratory is not testing the patient products that are collected, thats the fdas role at this point, our tobacco lab is working to develop to test the aerosols produced from some of the products. There are challenges with this response. The investigation includes trying to gather information about exposures to potentially illicit products and so some respondents may not be totally forthcoming. State laws vary regarding thc and cannabis use that can complicate the Data Collection challenges. Ecigarettes or vaping are part of a marketplace that is very wide and diverse as youve heard, a multitude of product varieties and different substances can be used with the devices and also the issue of counterfeiting or black market products. Public health Data Collection for response is relying on antiquated or fragmented systems that need modernization. The disease unfortunately is moving faster than our data systems at this point and that is a barrier to our getting to quick answers. Let me turn briefly to what were doing about the youth vaping issue or the youth ecigarette use. We know that youth are much more likely than adults to use ecigarettes. Cdc has been messaging about our concerns with youth ecigarette use since 2013 when we got the initial data about the alarming increase from 2011 to 2012 in youth use of ecigarettes. We have been at this and continue to be at this in terms of our concerns. Finally cdc is dedicated to working around the clock together with fda and state and local Health Officials to identify the cause or causes of this outbreak and we will continue to Keep Congress updated. Thank you. Thank you so much, doctor. Its now time for members of the committee to ask questions and the chair will recognizer herself for five minutes. So in 2015 the cdc stated youth, young adults, pregnant women and adults who do not currently use Tobacco Products should not use ecigarettes. I think that was also echoed by you. So, dr. Sharpless, my question is, dr. Schuchat, does the cdc believe that ecigarette products are safe . We are really concerned about the use of ecigarette products among youth, pregnant women, young adults and those who are not using tobacco product snooze even somebody who is not using not smoking or using ecigarettes now, its not like theyre safe for people to use, isnt that right . The aerosol that ecigarettes produce can have a lot of potentially harmful substances. We have a lot to learn about shortterm and longterm effects. Your answer is, no, its not safe . Yes, its safe . Right. What is it . It is they are not safe for those categories. Are they safe for other people . We are focused on those categories because theres the most data about them we dont know if theyre safe for the other people . Right. But we also are quite concerned about people going back to smoking cigarettes and dont want them to do that. Is it true that youth are more likely than adults to use these unsafe product sfz. Thats correct. Now dr. Sharpless, the 2009 Tobacco Control act gave the fda the authority to put ecigarettes under its Regulatory Authority whiches the fda did in the 2016, is that right . Thats correct. In 2017, the administration extended the compliance deadline by four years for companies to submit materials to the fda for review of the Public Health risks of ecigarette products, is that right . Thats correct. Is it accurate to say that ecigarette products are only on the market because the fda has exercised its Enforcement Discretion to allow them to remain on the market and not because the products have been reviewed by the fda . All ends products on the market are illegal, they have not been reviewed by the fda. Okay. In fact, your testimony says, quote, no ends product in the United States is on the market legally. Right . Correct. Okay. And so you also agree with the cdc that ecigarette products are not safe, that is right . Ecigarette products are not safe and not without harm. Okay. So heres my concern. Both fda and cdc says ecigarettes are not safe. Were seeing an explosion of young people usings the products and now were seeing serious illnesses around the country, but fda still allows these products to stay on the market even though they havent undergone a full market review. I think time is of the essence and i would like to ask you, dr. Sharpless, when does the fda intend to use its Regulatory Authority to assess the Health Impact of these products . I agree with you time is of the essence and i think the contention of the history is perhaps important in 2017 with the light regulatory touch was taken the data at that time showed that youth use of those products was sort of leveling off or going down and therefore i think the fda being a science driven organization, opted for that policy at the time. What happened as you described is the epidemic of youth use and now weve accelerated our time line, stepped up enforcement and education and i can tell you we are on this problem. What is your timeline . The next Major Development will be the finalizing of the compliance guidance which will have the effect of removing nontobacco flavors from the market and expect that to be weeks. Okay. What are you going to do after that . When a guidance is finalized it has 30 days to go into effect or some period along those lines and then we apply an enforcement strategy. Is the flavor strategy the only thing the fda intends to do . I cant speak to a guidance and process but it is the major target of that effort. Why is that . Do you think thats going to solve the youth vaping epidemic. We do not believe any policy or product will solve the vaping epidemic. Its a combination of enforcement and education and multiple policy things were doing. Are you continuing to review these products to see if theyre inherently safe or unsafe. All ends products will have to submit an application to the fda by may 2020. Okay. Very soon everything should be coming in. Flavors would be removed from the market sooner than that because of our concerns about the youth epidemic use. One last question. How far is the fda prepared to go to protect the health and well being of young people if it determines that these are unsafe . The fda is science driven organization. If the data support more aggressive measures we will take those. How far . We could ban all flavors, for example. Thank you. I now recognize the Ranking Member for five minutes. Thank you very much. I thank you both for being here and your testimony is informative. Dr. Schuchat, you said that in all the 530 cases or all katsz you have data for theres no consistent, this is the cause, these are the one things we found or the thing that we found. Is there a trend line thats developing in what youre seeing . The data are coming in really literally as we speak. We believe that most people who have exposure histories that weve gathered describe using either thc, ecigarettes or thc ecigarettes and nicotine ecigarettes. There are few that used only nicotine ecigarettes. But i think its important to say that what people say they used may not be fully descriptive of what the problem is. It may be as you heard a cutting agent, it may be something together, something related to the device and how the device changed whatever product they used and they may not know what was in the product they got. Its been reported over 80 of the cases, the person reported they used thc. Thats right. That was in the report from illinois and wisconsin about the first 53 cases and those numbers are from about 40 people. That trend is continuing as we get additional data. I think its 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. Absolutely. And make sure that we understand all of the causes. When you say people are doing thc and nicotine, they have nicotine and thc or not combing. Separate products. Separate products. One individual might have many different products that are being tested, so its a very complex investigation and understanding exposure versus causality is something were trying to get to. I think were looking at the lung injuries in this hearing. A lot were talking about the flavored and the general growth in ecigarettes which we need to address. But also, the thc or marijuana, some states have made it illegal. Massachusetts will pull back flavors but dont know that they announced they will undo their marijuana policies moving forward. In your written testimony you said that ecigarettes or vaping products containing thc in many patients in this outbreak suggest the need to understand the Health Effects of increasing marijuana use in the u. S. What concerns does the cdc about the affects of brains on teenagers who Vape Products containing thc. The adolescent brain is still developing. Brains develop through about age 25. So whether its nicotine or marijuana, i think we really want to know the effects that occur. Theres animal data to suggest some concerns and theres behavioral data. This is one of the reasons that theres a focus for the ecigarette issue on avoiding use in adolescence and young adults. We dont know as much as we need to know about both short and longterm effects and there are Harms Associated with nicotine in the aspleasant brain as well as marijuana. Does the fda have what does fda think of the effect of the brain on thc and vaping . As dr. Schuchat said, there is animal data and some human data to suggest that the deal brain is sensitive to these chmscals and large ongoing trials that nih is funding to address these questions. Well know more. Our current recommendation children should not be exposed to high doses of nicotine or thc for long period of time. Thats a bad thing. Dr. Sharpless, cdcs testimony states product information from the outbreak cases will be shared with the fda to help fda assess which of the products fall within fdas Regulatory Authority. Has cdc shared product information with the fda . We are sharing information continuously both with cdc and states and with the dea. I think, you know, one of the things that were doing that is important is we are getting these samples from the states that are linked to the cases and taking them to our lab and testing them directly to see what they contain. Are you seeing a trend. Weve received about 300 samples and tested about 150. The answer is about 70 are thc products, the rest Nicotine Products or something else. A significant fraction of the products half of them are contained with vitamin e which you mentioned a skin oil that hs no business being in a pulmonary product added as a cutting agent. Can you tell if the 150 tests were secondhand or bootlegged or were they actual commercially purchased . Can you tell that . Thats difficult to ascertain. Some of the products are things you can buy at a store be manufactured products. My time has expired and i will yield back. Dr. Sharpless, you said the oils dont have any place in peoples lungs. Can you explain . Can you explain why you said that . Sure. Vitamin e is a skin oil. Its used for sort of wound healing in the skin. Its an oily goo. It is we have looked, there is virtually no pulmonary literature on the use of this product as an inhaled substance. An oily thing, the lung is not going to be easily cleared and could cause a thing like pneumonia which has been seen in some of the cases. Im sorry to say this, but i had a pediatric pulmonologist in denver tell me what happens with this oil it settles in kids lungs and impairs the development of their lungs. And shes even seeing kids whose lungs are like the lungs of 80yearolds and thats never going to resolve. Thats going to be what happens. Thats why were worried. The chair recognizes the gentleman from massachusetts, the vice chair of this subcommittee for five minutes. Thank you, madam chair. Want to thank you for calling this important hearing. Thank our witnesses for being here. Yesterday massachusetts about governor baker announced Public Health emergency and four month ban on the sale of vaping products. To date we know at least nine people have died and 530 have been diagnosed nationwide. Back home in massachusetts at least 61 possible cases. Yet, we dont know concretely why. We dont know whether its a nicotine product or the thc products, additives responsible or if its parts of the tee vice causing illness, we dont know if the products can be traced back to black market sales or over the counter purchases. Building off of what the chair asked, dr. Sharpless, help me answer some of those questions, how is it, what do we know and how is it we dont know more . Regarding the vaping lung injury . Im sorry. Regarding the vaping lung injury . Yes. I think, you know, the first cases were appreciated in july so its a new entity. I think the progress in the federal cooperation has been good. We have a rigorous Case Definition weve begun to test a lot of the products both and interview the cases and started a criminal investigation for to learn more and i think we will gather more information quickly. I dont know if dr. Schuchat wants to comment. How do we get to the point where we are backtracking on this rather than putting in place the right Consumer Protections from the front end if youre telling me that vitamin e shouldnt be an inhalent and coating peoples lungs to the sense that childrens lungs look like an 80yearold where was the regulatory failure to allow that to happen . We believe that adele ter rating a thc product would be illegal and tough to regulate illicit drug dealers effectively. That is people cutting their product to sell it for greater profit. And so youre saying that with regards to those specific cases with vitamin e acetate or oil in it, you have no evidence that any of that is an approved commercial sale . No. Vitamin e acetate is not approved for inhaled use. Its only present in about half of the thc products. A lot of cases not associated with vitamin e. We dont know if it causes anything or a market for adele ter rags or a bad product. To both of you, how do we get to a point where we have now a widely used consumer series of Consumer Products that are getting 530 people sick and understanding it is somewhat new here, but there was a massive regulatory failure that allowed this to happen, was there not . I believe speaking about not to conflate the two issues the epidemic of youth use of ecigarettes, in retrospect the fda should have acted sooner and begun regulating these devices sooner. Since ive been at the agency we put out education campaigns, announced policies like the guidance to help people submit applications and open for business to receive the applications. We will catch up. Doctor . I would say im frustrated with the pace of our investigation and wish we had answers already. If youre frustrated with the pace of the investigation what can speed up the pace of the investigation . Well, i think we have more than 100 people working on this and the states are making this a top priority. The fda and dea doing product sourcing can help. But i actually think there may be a very complex set of root causes here that are going to be difficult for us to address as a nation and we need to take it very seriously like what . If theres a set of supply chains that are completely underground that are adulter rating products that in ways that are experimental, and are building on top of a population addicted to ecigarette use as young people through the past few years, that we have a vulnerable pop place and a very challenging supply chain to address. And were none of those questions posed throughout any aspect of the regulatory process before the products were approved . Nobody thought there would be a possibility of diversion or illicit use or implications that were going to have adverse Health Impacts . So as you know, the thc containing issues are really regulated at the state level, not at the federal level. I guess i would let the fda describe that. Cdc is not a Regulatory Agency but we have been raising the alarm about ecigarettes in youth when we first saw the rise and support state and local Health Departments to exert Tobacco Control comprehensive approaches. I will let you finish. I think as dr. Schuchat said, thc is a schedule one drug illegal by federal law but being tolerated in the state sovereignty issue. To the extent those products are reviewed and regulated it generally occurs at the state level now. Right. Just briefly, its not as you said, not all of these illnesses and deaths are linked squarely to thc. Theres other issues here as well and my concern is that if theres a failure on the front end it should have been easily foreseeable that some aspect would have been illicitly used or cut or otherwise and so i want to understand where that process broke down to make sure it doesnt happen again. I yield back. Thank you. The chair recognizes the gentleman from West Virginia. Thank you, madam chairman. Thank you to the panel. I missed the earlier your remarks, because we have another meeting going upstairs on prescription drugs. You can see whats happened back and forth through this. I apologize that maybe your testimony might explain some of this. Im trying to follow the chronology of this because from what i can gather on the internet, is that the cigarettes were introduced to the market around 2003, some said 2006. Can one of you confirm when these things came on . The ecigarettes began to be marketed in 2007 to my knowledge. So back to you now, doctor, if theyve been 2007, again, ill accept your 2007, ive got 2003, but 2007, why is the fda not come up with a final . I heard the chairmans remarks that i cant agree more with her concerns. I mean, theres no light between the two of us on this. Is why the fda not finalized some kind of determination that allows these things because theyre still out there on a generally approved or with whats how do you describe their permitted use . Sure. No ends products on the market are legally. Theyre all illegal. Im sorry. Theyre illegal. They are not authorized to be sold. Theyre on the market through a policy of enforcement description. The fda can prioritize the enforcement of its authorities. The history is, you know, ecigarettes became deemed products subject to the Tobacco Control in 2016. You missed my point . Im sorry. If one of the byproducts of these are fine particles, getting into peoples lungs, weve had numbers of debates in this committee over the last eight or ten years about the whats happening with the coal combustion of particular matter 2. 5 microns but from what i understand, my research on this is that these ecigarettes are introducing not only 2. 5 microns but even less, smaller and getting down in the lungs so if we take action that are affecting impacting the fossil fuel industry across america, why are we not finalizing and saying until we know more about the carcinogen, the heavy metals and other things, cutting fluids or whatever this is, why arent we stopping this until your final determination . Why are these things still on the market if theyre if theyre causing this kind of health risk . 12 years after they were introduced. Doctor . I think the we dont consider these products safe. Excuse me . We do not consider these products safe. We think they have harm. We do not think anyone should be using them other than people who are using them in place of combustent tobacco. It has to be said you know thats naive to think thats whats happening. Why arent they just off the market until you make a final determination . So the drive of the fda is to be guided by the science and whats gad for the Public Health. We think that some small off ramp to allow addicted smokers to another product is a Public Health value but want to limit the ability of youth in children to get access to these products because of the epidemic youth use. Would it be more beneficial to our youth and others if these cigarettes were taken off the market . We would like to make watch what i said. Should we take it off the market. We would like no youth to be using these products. So why hasnt Congress Worked on that . Did you sigh why isnt congress . Yeah. Why arent they off the market . If youre thinking they should be better, why are they still out there . Whats your opinion of why theyre still throughout if theyre causing this problem, introducing particulate matter in our lungs were having devastation with the coal industry and all fossil fuels yet allowing children to inhale it at a higher concentration level let alone something a thousand feet up in the air were putting it into someones lungs saying thats okay . To be clear, congressman, our plan is now to clear the market abruptly of characterizing flavors so that these kid appealing products will be off the market as we finalize the guidance and implement the new policy. Ive run ot of time and yield back. And dont worry you can cosponsor my bill to raise the smoking age to 21 if you havent already. The chair will recognize mr. Ruiz for five minutes for questioning. Thank you, chairwoman. There is a misleading notion when people say that its safer than tobacco cigarettes, that somehow it is safe. Youve said and i believe you agree and i wholeheartedly agree that vaping and ecigarettes is not safe. In fact, theres been numerous scientific studies by different medical schools that have tried to illicit whether or not vaping has any net Public Health benefit. So far the vast majority of researchers have concluded that they believe that theres more population level harm than benefit with ecigarettes. On one hand, you both know that ecigarettes has a very narrow benefit in that it helps tobacco smokers of cigarettes quit smoking, period, not just to convert the market from tobacco to vaping for an industrys benefit, but its to quit smoking and inhaling nicotine. Theres no benefit to nicotine period. That is very narrow. The harm, the biggest harm here, is that youth and young adults never smokers, nonsmokers, people who have never touched a cigarette are starting to smoke nicotine through ecigarettes. These are new users. And there is even suspicion that there are more new users than there are those who are actually using ecigarettes to stop smoking in general. So the benefit harm you can see clearly. In addition theres a study from pittsburgh that shows that those who are never smokers, who are now smoking and vaping, 47. 7 of those youth and young adult smokers start smoking tobacco. Tobacco cigarettes. So you count those with never smokers compare those to those stopping to smoke, thats why theyre saying theres a net Public Health harm with the industry to begin with. Then, there are other studies showing that vaping, those ecigarettes, still have volatile organic compounds that are still carcinogenic and cancer and if you get a young adult who are more have more propensity to be addicted, more propensity to stay smokers for a longer period of time therefore inhale benzene for a longer period of time, you can start to see they can also acquire lung cancer and other types of cancers. Thats not to mention that the concentration of these pods, cute little pods that they do in u usb cords have higher nicotine than tobacco and youre starting to see reports in the Emergency Department of teenagers coming in with cardiac arrest and cardiac arrhythmias. Im an emergency medicine physician. So where is the benefit of this industry to our Nations Health . Except for that very small, narrow, tobacco smokers to get them to stop using tobacco and stop using ecigarettes. So the best Case Scenario was that. The worst Case Scenario is that new smokers, nonsmokers and lifetime ecigarette smokers wish the ecigarette industry and vaping industry would love to take tobacco smokers, since theyre large around the world, and simply buy our products because its safer ii. E. The misnomer its safe. We need to prevent the youth from getting their hands on there and im introducing legislation that will just do that to help increase the fines for firsttime penalties for selling these to the youth and im also introducing legislation to do more research. More research on the longterm effects. I would like to ask you, dr. Schuchat, what are the Secondhand Smoke effects of vaping . You know, youve raised really Critical Issues that aerosol that ecigarettes can produce includes many toxic things and the direct and indirect effects are not fully understood so the issue of Additional Research to really get at those longterm effects makes sense and we absolutely share the concern about youth that no youth should be using ecigarettes and it can open the door for many problems. I ran out of time. The chair recognizes the gentleman from virginia for five minutes. Thank you. I appreciate it. Dr. Schuchat, you said there were a lot of different issues going on here and so im going to touch on a couple different issues and jump around so one question may not lead to the next question. Let me start by just saying that theres an agency not here that i think has some issues that we need to look at and thats the dea because for 20 years ive been for Medicinal Marijuana but not been able to do adequate studies to find out what the benefits are and if you cant find out benefits you dont have data on the harm. When you start adding thc into the Vape Products we dont know the longterm consequences of thc when you start as a youth. Its not good because the brain is developing as you said dr. Schuchat to 25. Vat Va Legislature this last year raised the age for Tobacco Products to 21. You know, obviously the states can lead on that and she mentioned she has a bill that would do that at the federal level. That seems to be a proper step for youth. In reality, dr. Schuchat, you may have mentioned this yesterday as well, really two problems, we have this mysterious lung disease and then the whole youth and flavor issues. Because my wife is a juvenile Domestic Relations District Court judge, and they are seeing all kinds of problems in the schools because iunlike a regulr cigarette where the teacher can immediately identify what part of the classroom its coming from, theyre not getting that with the vape cigarette, theyre putting it in their pockets, whipping it out real quick when the teachers back is turned and have no idea that vaping is going on in the classroom unless they actually catch them which sometimes does happen. But am i correct, were really talking about two different issues here today. Yes, theres two extremely important Critical Issues where they overlap, we dont know yet. Right. Now, one question that my colleague from West Virginia brought up, that is that ecigarettes have been on the market for quite some time. 12 years, at least. But the vaping illnesses seem to be new. So heres the question, id like a quick answer if i can get it because i got other things i want to ask about. Does the cdc or fda know if the current outbreak is a new phenomena or a new awareness and people started looking for these lung disorders from people who may have been vaping . Increasingly, the data suggests its a new outbreak. There have been individual cases in the past but nothing like what weve seen now. And am i correct that the knockoffs, the illegal imported, many times, pods, is a relative lou n new development as well . Even the mod pods are relatively new. Knockoffs of mod pods would be new as well. Okay. And so preechviously we may not have had as much of the various chemicals being added in to dilute, or have we . I dont actually know, im not i dont have that knowledge. Dr. Charles . We dont really know what the practice of adulterating these has become. Whether thats a new or older practice, we cant say. Now, dr. Sharpless, im aware there are a number of Vape Products or vapor products for sale in the u. S. That came onto the market after the fdas august 8th, 2016, deadline. That means theyre already being sold illegally. What is the fda doing right now to get those illegal products, many of womhich are compatible r use with legally sold products, off the market . We identify products that are on the market after the period that you alluded. We act to remove them from the market by sending warning letters and other notifications. Weve done that in a handful dr significant number of instances. It can be difficult to ascertain when something came on the market. That makes it a little more tedious than you would expect it. All right. Now, i mean this as a friendly question, we cant control all the importation of illegal substances coming across our borders, currently. Do you have much hope that were going to have much success with keeping imported, possibly tainted, mods, pods, whatever the right terminology would be, coming across the border . And what im trying to say is somebody else earlier said that, you know, how come yall havent stopped this . If we cant stop fentanyl, how are we going to stop pods for vaping . Conchmi agree thats a very challenging issue. We engaged the dea to help to discuss these topics and rely on their expertise. International mail facilities works with custom and border protect to find whats coming in and find what vaping products are being sent to the United States and what are the characteristics. All right. I think well probably have more hearings. I appreciate your time. This is a serious issue. Were all very concerned about it and i yield back. Chair now recognizes the chairman of the full committee, mr. Pallone, for five minutes. Thank you, madam chair. Earlier in september, the president announced that fda intends to finalize the policy in the coming weeks to clear the market of flavored ecigarettes until products undergo full premarket review and i certainly agree with the statement dr. Sharpless made that we must act swiftly against flavored ecigarette products, i am d disappointed its taken so long to get to this point. Ecigarettes have been available for purchase for over a decade and its been over three years since they were brought under the Regulatory Authority of fda and during this time the ecigarette market has dramatically expanded and become more attractive and accessible to children and teens. Ecigarette use amongst middle and High School Students has risen sharply with preliminary data released last week demonstrating a third of 12th graders are ecigarette users. I agree that the clearing the market of flavors could help reduce youth utilization of ecigarettes and raising the minimum purchase age for tobacco to 21 could also help reduce youth access. These steps in isolation arent enough. Its my strong belief that Congress Must take comprehensive action and i now have some questions about fdas guidance and our need to do more. So first, let me start with dr. Sharpless. Its my understanding that fda intends to outline the administrations policy to prohibit the sale of nontobacco flavored products through guidance, is that correct, yes or no . That is correct. Dr. Sharpless, fda guidance, in my opinion, lacks the permanence and legal force of a statute or a formal rule issued by the agency. Is that correct . To be clear, the guidance will just allow us will describe how were going to enforce existing law, so these products are illegal and were just announcing how were going to prioritize enforcement of existing law. So, but do you disagree that the guidance lacks the permanence and legal force of the statute or form er by th agency . The products are illegal by the act of congress, so so youre saying that with the guidance, you will now enforce the underlying law. Right. The guidance will describe our enforcement policies. Well, what kind of steps can the fda take to ensure that the industry is complying with this flavored tobacco prohibition given what you just said . Sure. The fda has experience with this kind of problem, generally, we send warning letters to the legitimate retailers and manufacturers. They will come into compliance, usually, and then that will have a dramatic effect of the products on the market. Well, i still dont understand how you force them to comply with the guidance. The way it works is we send a warning letter. It says that your product is no longer, you know, subject to Enforcement Discretion, and at that time, we expect it to be removed from the market. Any flavored products. And if they dont . Then we have a number of other activities that escalate. You know, further warning letters, civil money penalties, we actually, manufacturers we can seize you intend to impose those enforcement measures . Whats that, im sorry . You would impose those fines and those other enforcement measures . For manufacturers, usually an injunction, yes, but we would impose those if needed. Okay. Let me ask, the proposed flavor ban included mint and mentholflavored products. Can you commit that these flavors will remain part of the compliance guidance when its finalized . I you know, i cant describe whats going to come out in a future guidance were working on with certainty. I can tell you that the data suggests that mint, menthol, are very popular with children and if the policies i mean, youre not committed if thats going to be part of the compliance, when its finalized . T the compliance guidance will sounds like youre saying youre not committed to it, unfortunately. I think the only way we can realistically verify Tobacco Products, flavored, nonflavored, dont flow to children is through direct this question is about facetoface sales. I think the only way you can verify the Tobacco Products, whether theyre flavored, nonflavored, dont flow to kids is through direct face to face sales and my bill would ban the sale to online and other would ban online and other remote sales. Can you commit any guidance banning the sale of the flavored ecigarettes would extend to online and other remote sales . The guidance we envision would extend to all retail channels so online and inperson sales. Okay. As i understand it, there are reports of as many as 3 million distinct ecigarette products currently available for sale in the u. S. Does the fda face any resource or capacity challenges in monitoring the ecigarette market, be able to enforce the agencys existing authorities . So, as you know, the center, fda, is entirely funded off user fees. Ecigarette products do not pay a user fee in contradiction to other Tobacco Products, a User Fee Program for ecigarettes would be helpful to the fda to enforce the activities you described. Are those user fees that youre receiving now available for monitoring ecigarettes . We are using the appropriate moneys for our Tobacco Products. What about the user fees . Im sorry, sir. What im trying to find out is if the money youre getting from user fees is available for monitoring ecigarettes or just using the money from appropriated sources . The money were getting for userdes is available for the use of monitoring ecigarettes. All right. Thank you. Thank you, madam chair. Sorry to go over. Such an important issue. I apologize. Chair now recognizes the gentlelady from indiana, ms. Brooks, for five minutes. Thank you, madam chairwoman. Thanks for hosting this incredibly important hearing. According to the Indiana State Department of health in a recent publicati publication, as dr. Chris box, the commissioner stated, the numbers are staggering in indiana as well. Nearly one in five High School Students and 1 in 12 middle schoolers say they use ecigarettes. According to the 2018 indiana Youth Tobacco survey and its a 350 increase since 2012. She also writes that one ecigarette can contain the same amount of nicotine as an entire pack of cigarettes . I think there is so much that is not known about ecigarettes and so my question for both of you, given little how little we know about ecigarettes and longterm effects of ecigarettes, what research or studies are currently under way to help educate everybody about ecigarettes . Dr. Sharpless, when do we expect the studies to be complete, what studies are under way . Sure. Theres a number of studies by a variety of federal agencies looking at the composition of ecigarettes and their use as switch or sensation device type approaches. From both nih and fda and other agen agencies. But, you know, these are still relatively new products and we dont have the longterm experience with them that we would like. The fda has launched a very vigorous education campaign, particularly targeting youth, about the dangers of ecigarettes including recent online, you know, ads and tv ads. My concern, and dr. Schuchat, anything else youd like to share about studies and research . Yes, cdc is doing surveillance and monitoring. Were not doing research. We do test the aerosols and were really, really focused right now on the lung injury outbreak and studies related to that. Well, in fact, right after dr. Box issued this report and indicated that our governor holcam, one of my high schools, announced a 2 Million Campaign to curb youth vaping at fishers high school. Talked about this, announced it at fishers high school. A lung injury death happened to a Young Hoosier within the week of this incident and impacted 50 others in our state, nationwide, over 400 cases. My concern is is that all of the research, if we wait, the research being done on marijuana still isnt conclusive. Were still waiting on the federal government to really come up with conclusive studies to be finished on marijuana decades after we started it. Why do we think that this is going to be any different than that . Dr. Sharpless, why do we think the research is going to be any different . And its going to be done any faster . Because more people are dying . No, i think i agree with you that this is going to be a tough topic to study. Its going to require a longterm effort, i think some data will be more easy to glean forthcoming, but the answer to the question is we really want to know, like, whats the safety of these products over years and decades . Its going to take a while. In the interim, i think the fdas charged with using existing science to come up with a Regulatory Framework that is best for the public good. So whether its a surveillance or investigations being done, is there a consistent substance, brand, or product identified in the cases so far . Theres not yet a consistent one, and one of the reasons that we took action of making broad recommendations right now is it may take a while to get answers and we wanted to warn the public in the meantime. Dr. Sharpless, anything that youre any different statement on that . I would agree that the majority of products, as i mentioned, are tch but theres certainly some that are nicotine only and theres no particular brand or product or contaminant that we identified in all cases. And then in the studies that youre doing, how many do we know, if the individuals are reporting buying them at vaping products at stores versus online, are they getting counterfeit or blackmarket products on the street . Anecdotally we see a lot of social sources. Not retail purchachase but more from someone they know. So i think were concerned about that in terms of what the ultimate supply chain may be. And do we know have there been questions from them by those that are asking the questions whether or not theyve modified after purchasing either the device or the product . There are a set of questions and i dont have yet the results of the interviews. The states on the next panel may have more information because they are actually doing the interviews with their patients. Okay. Thank you. I yield back. Gentlelady yields back. Chair now recognizes the gentlelady from illinois, ms. Schakowsky, for five minutes. Thank you. I understand that youre saying that we dont have any evidence or that the evidence is that this might help some smokers, but on the website, smokefree. Gov, which is part of the department of health and Human Services, it says, ecigarettes are not approved by the fda as a quitsmoking aid. So far the Research Shows there is limited evidence that ecigarettes are effective for helping smokers quit. There are other proven safe and effective methods for quitting smoking. So, thats the quote. So, clearly, ecigarettes are not proving to provide smokers Smoking Cessation and it seems to me that, you know, if we are unable to limit cigarette use to existing smokers that we should just ban it. I dont understand why the default position right now should be to allow it continue in any shape or form. Dr. Schuchat, who i barely remember out of uniform, that we should be saying no right now and then if theres a way to phase in some of it, okay. But meantime, people are dying including a person in my state. How many children are we going to allow to die before this is considered the emergency it is and we just say no . So id like to hear from both of you. Sure, ill start, if you dont mind. I agree with much of what you said. These are not approved cessation devi devices. The fda has oather cessation devices that are approved. Science, whats good for the Public Health, the argument against banning all ecigarettes is that we think in that instance, there are people, millions of americans, usingcigarettes today who may find no other source of nicotine thats gratifying, satisfying to them other than moving back to okay. Dr. Schuchat, you said they have aerosols in them. In the meantime, we have an epidemic of people ending up in the hospital and eight people who are dead. Let me ask dr. Schuchat cdc doesnt have the Regulatory Authority but we have aggressively announced warnings and we want parents, teachers, state Health Departments, and clinicians, to know about the dangers that this outbreak is associated with. Our recommendations say if you have concerns about health risks, we suggest you not use vaping or ecigarettes thats nice. At this time. Thats nice, but, so, i want to ask another question. I understand, and weve heard from several Media Outlets and i want to put some articles into the record, that report that the white house is still planning to hold a listening session with several conservative think tanks and Industry Groups that are concerned that eliminating or banning any part of this would hurt the president s reelection. And so it seems that no other no Public Health groups are on the list and you were not invited as i understand. Do you think thats appropriate that Industry Groups and organizations that support the president and support vaping should be in a meeting . I cant really comment on meetings the white house plans to take. Yeah, cdc is a datadriven organization. Were gathering the data and alerting people about risks. Well, i do want to ask that we put into the record some articles about this potential meeting and lets hope that the whole without objection, so ordered. Thank you. And lets just hope that all of this is data data driven. But do you have any metrics on at what point we say were going to address this not just by education . Are we going to see an implementation of taking this away . Did you send the letter yet that you said is going out and what have the responses been . I dont feel a sense of urgency. I just dont feel a sense of urgency here. Congressman, we are very have a strong sense of urgency, the fda, on this topic. We sent a letter to the manufacturer, i mentioned juul labs, regarding marketing practice. We also this compliance guidance as we finalize it in a few weeks will have a dramatic effect on the marketing of flavored products. Whats available to the American Consumer today. I think it will be really good for kids because we know flavors are particularly attractive to the young people. They will be banned in a few weeks . They will be withdrawn from the market because we will exercise our we will stop exercising Enforcement Discretion over those products. And they will be banned. That will have the effect of removing them from the market, yes, maam. I yield back. Chair recognizes the gentleman from south carolina, mr. Duncan, for five minutes. Thank you, madam chair. The use of ecigarettes is common among our youth and the reported deaths and illnesses associated with that are incredibly worrisome. The issue, as i see it, isnt necessarily about vape or vaping products as much it is about how these devices are abused. I thiank the witnesses for bein here to help us understand the issue better so we can hopefully find appropriate solutions, but i believe the immediate answer is for our youth to stop buying blackmarket pods and stop trying to get high by lacing these pods with thc. That seems to be the common thread. I believe its crucial we look further into the thc counterfeit blackmarket products people are buying. I understand these products have a short history, but we need to have all the facts before we can fully remedy the situation. So im going to ask both witnesses here today, i understand that patients with the reported lung illnesses have admitted to using ecigarettes containing just thc, thc and nicotine and just nicotine. But does cdc and or the fda believe that thc counterfeit blackmarket vaping products pose a higher risk than legally sold unadulterated nicotine cartridges used in ecigarettes . Both witnesses. Were concerned about both right now. And its an Ongoing Investigation about the lung injury outbreak. Were very concerned about ecigarettes and youth on an ongoing basis because the trends are increasing. Okay. I agree with you. I think the no single product has been linked to all the cases. When we test cases, products that are actually linked to cases in our lab, we find the majority are thc products but not all of them. Certainly nicotineonly products as well. Thank you for that. Are there any Enforcement Actions that cdc and fda believe we should be taking against counterfeit manufacturers . Challenging issue for the fda, particularly around thc which provides jurisdictional challenges. I think we can certainly try and enforce what comes in at the borders through the International Mail facilities. When it is an fda regular tated Tobacco Products, we have significant authorities. We end gauge tgage the dea for p on products that are challenging for us jurisdictionally. I think this is a very challenging issue. I dont have the tools and not sure what the tools are but i think counterfeiting there are clearly are a lot of dangerous products out there. Given what little we know about these counterfeit products, what research or studies are currently under way to help us understand more . What are you all doing to help us understand more . Just briefly, the state and local Public Health are interviewing patients associated with the lung injury outbreak and identifying what they used, where they got it, how they yusd it and providing that product information to fda or as appropriate to dea. Were taking the data were getting from cdc and other data sets and integrating and that and have an across the Agency Effort involving all our scientists to think about whats the cause of this outbreak, what we can do to prevent further cases then i mentioned the extensive testing that were doing in our criminal lab to our Forensic Chemistry Lab to identify the components and the possible contaminants. I think there needs to be a strong Public Service announcement, marketing effort, targeting the age groups of middle school and high school that are using these, even college and even young adults. Two weeks ago the cdc put out a statement regarding whether users should consider not using ecigarette products at all while the investigations ongoing. Conversely, the fda put out a statement urging consumers to avoid buying vaping products from the street and refrain from using thc oil or modifying using any substance adding any substance to products purchased in the stores. Why have the cdc and fda been putting out conflicting warnings and recommendations to the public . You know, i would say theres no light between the recommendations that the two agencies have been putting out, and if its interpreted a differeas different, we want to protect that. I would agree. I think were in lockstep on this about the Public Health emergency here and avoi dance of these products by all parties except for those people who may be using them to not use combustible cigarettes. We look at slightly different data sets. As data emerges in real time, we want to make it available to the public as quickly as possible because of the Public Health import of this information, but i agree, were in substantially in agreement on this. Does it concern you at all that the federal Health Officials, Public Health officials, are putting out conflicting statements, and there will be confusion among those using ecigarettes illegally, not the ones buying the blackmarket, not the ones adding things to it, confusion over those that are legally using vaping products . Does that concern you at all . We strive for Clear Communication and want to do better. I agree. We have constant communication and strive for coordinated communication. I think the message here today is stop putting tch products in lisegally purchased pods and stop buying blackmarket pods. Theres a health risk and is coating the lungs of our children, keeping the oxygen from making it into the system to provide oxygen to the brain, its damaging the health of our kids. Thats the message today. Stop doing this. I yield back. Gentlemans time expired. Chair now recognizes gentlelady from new hampshire, ms. Kuster, for five minutes. Thank you, chairwoman degette for holding this incredible hearing and thank you to our witnesses for joining our committee while we seek answers from the public about this Public Health emergency. I think youre hearing in a bipartisan way the research is really important, communication and transparency of the data to the American People, i can certainly say as a parent this is a very scary time in terms of i personally dont think we should be holding out any of these products as, quote unquote, safe to the public because we havent had the research and we have not thoroughly tested them. Based on the data, just as we were on the precipice of minimizing tobaccos hold on our nations youth, the Tobacco Industry has devised a new way to place our children once again in the crosshairs. As a result, ecigarettes are now the most commonly used tobacco product among youth, surpassing the rate of youth use of conventional cigarettes five years ago in 2014. In fact, ecigarette use among youth doubled from 2017 to 2019, doubled, demonstrating this problem is only getting significantly worse. My own home state of new hampshire, the department of health and Human Services estimates that at least onequarter of all High School Students use vaping products and that number is on the rise. You may know our state is still in the throes of an Opioid Epidemic that began with misleading marketing and lack of regulatory oversight. My fear is that were repeating those same mistakes and making way for a new generation grappling with addiction. And thats why im proud to cosponsor the reversing Youth Tobacco epidemic act of 2019 which includes numerous important provisions to curb the rise of Youth Tobacco use, and with that, i want to ask a few questions. Dr. Schuchat, based on cdcs surveillance and research, what do you believe are the reasons that young people are smoking ecigarettes at such alarming rates . We know flavors are a principle attract tant to young people. The latest generation of ecigarettes are also extremely high in nicotine content. They often include nicotine salts which are a little more palatable or less bitter. The flavors are really targeted at youth. We think the addictiveness of the high nicotine level and the appeal of the flavors are key. We also think some of the companies have had youth targeting ads. And the marketing. According to the National Institute of health, 81 of adolescents who have ever used Tobacco Products began with a flavored product. Dr. Schuchat, what more can you tell us about the contribution of flavors to this dramatic rise . And youve mentioned this. Anything more to add . Yes, i think that we have seen a little bit of a shift in the most recent preliminary data with an increase in the menthol and mint flavors among what youth are using. So we do think flavors are a critical beginning to youth use and the nicotine provides that addictive substance that keeps them going back. Thank you. Dr. Sharpless, will you ensure the newly announced federal policy to clear the shelves of flavored ecigarette products will be effectiveness . We believe this policy will have a dramatic effect on the flavored products sold in the market today. Does that include menthol and mint cigarettes will be cleared from the shelves . We are finalizing the policy and i dont want to prejudge the policy under preparation, but i can say that the data support mint and menthol being significant problems, dr. Schuchat alluded to this being very popular in children. Thank you. Last year as part of the fdas comprehensive plan for tobacco and nicotine regulation, the agency launched the Youth Tobacco prevention plan. Dr. Sharpless, what are the goals of this youth focus plan, and can you discuss the status of some of the efforts like the campaign that fda has or plans to implement . Thank you for the question. The fda is a longstanding antitobacco campaign, educational campaign, initially focused around combustible cigarettes, getting use that to use that. Campaign reaches 11 million kids, users of tobacco product, open to using Tobacco Products. In the last year or so, we really shifted that focus to ecigarettes to catch up with this epidemic. Tv ads, tested off the charts with the youth markets. Discourage use of ecigarettes. Sometimes kids arent even aware some of these products contain nicotine, for example. So juuling has become a verb in high schools that is not really understood to be a dangerous product, necessarily. So theres really a lot of education effort devoted by the fda toward this well, in my vie manufacturers and retailers are creating a new generation of we face unique obstacles now more than ever. Its important we take action for further reversals and to protect our youth. With that, i yield back. Chair now recognizes the gentlelady from florida, ms. Castor, for five minutes. Thank you, chairwoman degette. This is a very important hearing. Thanks to our witnesses for being here. America has a serious and growing vaping problem. Ive seen it firsthand. My two daughters are just a couple of years out of high school, and i noticed a sea change in behavior among high school kids, middle school kids, over the past decade. And it reflects the research, the yearly florida Youth Tobacco survey that is run by our department of health found that from 2012 to 2018, there was a 361 increase of kids age 11 to 17 whod tried electronic vaping. Even worse, there has been a 582 increase in kids that currently use electronic vapes. And 651 increase when the survey focused only on High School Students and on top of that, the survey also found that ecigarettes are by far and away the most common form of youth smoking, so clearly this is a very serious Public Health problem. Do you term it an epidemic or emergency, drmplt. Schuchat . Yes, were calling it an epidemic. As are we. Dr. Sharpless, on spent 10th in a post titled how fda is regulating ecigarettes, you wrote that clearly some of the rapid rise in youth use of these produ products, meaning ecigarettes, resulted from irresponsible practices of the manufacturers who have targeted children, in particular. Give us some examples of these insidious practices by juul and other manufacturers. So, on september 9th we sent a letter to Juul Labs Incorporated detailing their use of unauthorized marketing claims. Socalled modified risk tobacco product claims. So things like saying their product is essentially safe, or much safer, 99 safer, some of these were made in presentations to children and they so theyre just outright saying things that are untrue. Theres no data to support those claims. Theres no data to support those claims. Thats untrue, dr. Schuchat . Yes. How are these manufacturers specifically targeting kids . What type of marketing are they using that really alarms you . Were aware of a lot of presence on social media and recruiting youth social influencers, you know, influential people, celebrities and so forth, to make this look cool or fun and certainly, the as dr. Sharpless mentions, a lot of youth arent aware theres even nicotine in ecigarettes. You know, flavor and water, thats what i thought i was getting. So i think were seeing the kind of tactics that were used with cigarettes being used again and we think we that were using these social Media Influencers that were hyping eliquid products without disclosing they were using nicotine. Who are the Public Health influencers you all are going to bring to bear . These products, youre right, young people, they think theyre cool, they think theyre not so harmful, they think, oh, that has happened somewhere else, its not happening in my in my friend groups. In terms of Public Health, of course, the Surgeon Generals really been out there and our partners at state and local Public Health, i think theres a lot of kids behind me who might be influential as well. Really, you got to get with the program here. This is youre not going to be able to combat this with the same old ways to communicate to young people these days. Youve got to get youve got to bring the most modern techniques to bear. I dont think the congress has all the answers in that, either, so i really encourage you and i encourage the committee to move aggressively on this, otherwise, other people are going to die and other other young people are going to get hooked that they dont even they think its cool, they think its not harmful, and now all of your the evidence we have so far, thats just not the case. So that ill yield back my time and encourage you to be more hip. Thanks. Gentlelady now lets see. Now recognizes the gentleman from maryland, mr. Sarbanes, for five minutes. Thank you, madam chairwoman. I want to thank the witnesses for being here today. Id like you to speak, both of you, but maybe dr. Schuchat to begin, on map out for me because i think this is horrifying whats happening, and its sort of were playing the same reel over again that we saw with, you know, cigarettes before the tobacco settlement, with opioids before now the heightened scrutiny that its receiving and all the litigation that has ensued and presumably some kind of compensation that will come too late for many families in many communities. But even as were dealing with those things, the aftereffects of those crises, those Public Health crises, weve got a new one unfolding before our eyes. And you can just predict that were going to be having hearings ten years from now looking back and picking up the pieces of a terrible Public Health crisis. With incredible impacts on communities across the country. The fact that its its starting, its breeding ground is among children, is what makes it even more horrifying. So theres a lot of discussion about how we need to better regulate this and addressing industry practices and marketing and all the rest of it which is important. But maybe you can map out the scenario of what the Public Health crisis could look like ten years out, five years out, ten years out, if we dont take really dramatic steps now to address this on what, arguably, is still kind of the front end of it, although were kind of getting into the thing. Map that out for me because in a way, what im asking you to do is put on the record a scenario that we can come back to. I dont want to have to do that, but that sadly we may find ourselves coming back to later and saying, this was all predictable. So talk about that. Weve been warning about ecigarettes in youth since 2013 when we first saw the increase in our data front 2011 to 2012, but the industry has changed substantially since then and the products in this fourth generation of ecigarettes are much more risky even than the earlier ones in terms of nicotine level, flavors, the nicotine salts and the conce concealable product that make it really hard to know that anybodys using in class and so forth. So if these trends continue and we dont turn this tide, we have a generation addicted to nicotine with potentially the impacts on the adolescent brain, or the developing brain, that last for life in terms of memory, attention difficulties, learning problems and the implications of that as adult workers. We have the potential to progression of cigarette smoking which we know is incredibly lethal in people who smoke and have all the signs of that happening in terms of the last few years of data. The issue right now with the lung injury outbreak has people dying. Its not a question of 20 years from now. Its a question of now. And the forces that have led to that, we dont fully understand. Just as with the Opioid Epidemic, we didnt understand prescription drugs, to heroin, to fentanyl, to analogs, to stimulants. So i think we have a lot of people getting one thing one thing we have come to understand, and we probably could have understood in the moment with the opioid crisis, if we hadnt, in effect, had the wool pulled over our eyes by an industry with very Effective Marketing techniques, is how a whole industry can either affirmatively be trying to encourage dependency on their product or at a minimum turn a blind eye to Alarming Trends that are happening, that they know are happening, and look for sort of plausible deniability about their own responsibility. And i think were seeing it all play again, same movie, so, anyway, were going to keep our focus on this. Thank you very much, madam chair, for convening the hearing. I yield back my time. Chair you recognizes the very patient gentlelady from new york, ms. Clarke, for five minutes. Thank you, madam chair. I thank Ranking Member guthrie for convening this subcommittee hearing today on the threats of ecigarettes. Id also like to welcome and thank our panelists for their expert testimony here today and for attending as we fight to protect the American People from the harmful effects of smoking but more specifically ecigarettes and vaping. Id like to jump right into my line of questioning. Dr. Schuchat, according to your testimony, december 19th, 2019, there were 530 confirmed cases of lung disease associated with ecigarette use in 38 states and one territory. So far, at least nine people have died as a result and the overwhelming majority of these cases, 83 of which the cdc has complete data are under the age of 35. These are young people. Its devastating that this disease has already taken nine lives that we know of. Its obvious tragedy. Ive also seen reports, however, of individuals currently still on life support or on respirators for days on end, so, dr. Schuchat, what do you know about the potential longterm Health Effects of this pulmonary illness associated with ecigarettes . We fear there may be longterm illness in a number of individuals. Were recommending individualized care for clinicians to follow patients after theyre discharged and check pulmonary function tests and so forth. Its so new that the clinical course is probably variable and some improvement is being noted in a number of individuals when they get steroid treatment but, you know, the issue of longterm effects is very serious because these are young people who were pretty much fine and may have a life thats quite altered. If they recover. Is it is it possible that there are cases that we have missed prior to the outbreak . Yes. We know there have been individual reports of serious lung injury following vaping or ecigarette use in the past. We believe that something new is happening to cause these many cases that woere seeing now an we know the states and clinicians are really looking backward in getting all the cases reviewed they can. New cases continue to occur and thats one of the reasons we feel this sense of urgency to get the Public Health messages out so we can prevent further cases. Dr. Schuchat and dr. Sharpless, youve both said that no single product, device or component has been identified as the specific cause of these illnesses, but youve reported at least some of the illnesses have been traced to street, quote, street, unquote, product s not sold by legitimate retailers. Dr. Sharpless, what authority does fda have to take action against counterfeit or unregistered ecigarette products . So, for counterfeit Tobacco Products, we have a range of authorities when we were able to identify them, this includes testing no, no, i mean the ecigarettes. Yeah. Well, so, for when the products involve thc, not a tobacco product generally speaking, ecigarettes. So ecigarettes, as the fda uses the term, fda regulated tobacco product, there we have the same authorities we have with old Tobacco Products. Okay. So you do have the ability to take action against this . If it is a tobacco product, we have significant authorities, yes. Im sorry, youre parsing words here. Were here specifically about these ecigarettes. Right . I apologize for the lack of clarity. The fda has significant authorities around Tobacco Products. Including ecigarette, nicotine delivery nicotine is a tobaccoderived substance. Those products, we have great, strong authorities from the 2009 Tobacco Control act. Thc and other, you know, things that might be vaped that are not nicotine are jurisdictionally more challenging. Substance like tch that is a schedule 1 drug is some shared regulation between the fda and the dea which is why we have been working with them on those sorts of products. Okay. Dr. Sharpless, products may have been sold to registered retailers, what ability does the fda have to order or recall or get these dangerous products off the shelves . So we can identify a manufacturers source. We can send warning letters and use other measures, civil money penalties and that like and even no tobacco sale order if we can identify a retailer thats selling a product that shouldnt be onn the market. So have you already begun that process . Early days in the investigation, right now our main focus is on testing the products, finding what they are, where they seem to come from then in many cases engage but if people are losing their lives right now, wouldnt it be prudent to do a recall to, you know, a moratorium on sales, something, that stops this until your testing is done . Let me that sounds a bit like a food outbreak, what wed do if there was a bad food. This is different in this way. How is it different . Well people are dying. Many of these products are elicit. People are not forthcoming. You can do a process of eliminationing righ elimination, right . Many of these products are not that. Thaurnk you, madam chair, i yield back. Chair now recognizes mr. Tonko. Thank you. And thank you to our witnesses for appearing before the subcommittee. The 2016 final deeming rule issued by fda brought ecigarettes within fdas Regulatory Authority. Under the Tobacco Control act. Fda is not exercising that authority to its fullest extent and ecigarettes only remain on the market today due to fdas Enforcement Discretion. As has been well established this morning, teen use of ecigarettes has skyrocketed over the past several years. In fact, the youth use rate of ecigarettes surpassed conventional cigarette use some five years ago. So, dlchr. Sharpless, can you explain why fda decided to in 2017 to extend the compliance deadlines of fda review of the Public Health risks of these products . Sure, as part of a broader comprehensive strategy regarding tobacco in general, the fda at that time looked at the data, were a sciencedriven organization, and concluded ecigarette use among children from 2015 to 2017 was going down or leveling off. That was before this explosion of youth use that weve now seen in the last two years. When the fda began to appreciate this sort of rocket was takie i off and needed to be more eng e engaged, stepped up enforcement activities and very broad policy activities that would have a major effect on the market. Well, in retrospect should the fda have acted more urgently . I believe in retrospect we should have acted more urgently. Okay. So, if i understand you correctly, fda decided to delay the compliance deadlines in 2017 because it was a brief decline in youth use rates in 2015 that was a potential Health Benefit to some individual addicted adult smokers. So my question to you, then, is now that we have a fuller understanding of the terrible epidemic that youth in this country are facing, have these considerations changed . The fdas always been very clear that as new facts emerge and we get new data, we will change our regulatory posture and i would argue ive done so, starting with the 2018 nyts data which was very concerning and the preliminary data weve seen from 2019 has sounded the alarms. If thats true, how will fda account for them in their eventual reviews of these products . We moved up the date for the premarket tobacco applications now to may 2020 so all products on the market today are illegal. To be legally marketed, they will have to come to the fda and have pmta approved. In addition, our compliance policy we announced the president announced his support for riecently would have the effect of removing flavored products which are particularly appealing to children from the market very soon. Well, dr. Sharpless, we will hear on the second panel that michigan has temporarily banned flavored products while massachusetts has banned all vaping products for four months. It seems to be the recognition that we have a Public Health epidemic requiring some urgency from our regulatory agencies. So, why has it taken a multistate outbreak of severe pulmonary illnesses and several deaths for this administration to take action to protect Young Peoples Health . Congressman, i would say the major point of data thats driving our, you know, compliance policy is the Youth Tobacco survey. The nyts. So this epidemic of youth use that we identified for multiple data sets, not just the nyts, showing youth use and that is i think the sense of urgency is further injected by this other problem, the vaping lung injuries but i think that, you know, the administration considers its duty to protect children a top priority and is really acting in response to the nyts data. Well, when fda finally reviews these products, it must assess whether they are, i quote, appropriate for the protection of Public Health. So, dr. Sharpless, will fda ban them if it ultimately determines that the dangers of youth use outweigh any potential benefits to adult smokers . Certainly. Weve issued guidances or a guidance to industry about what the information is to be included in a pmta. I think weve been very clear and already approved products through the pmta process. And thats the sort of thing we consider is the benefit the standard is what you mentioned. This product has to be good for the Public Health and if its not, it wont be authorized. I thank you for your responses. With all these new Tobacco Products flooding the market over the past few years, without a full understanding of the Public Health risks, it is not surprising that were in such a crisis situation today. And i have to echo my concerns over and over again how this administration has rejected science in many formats and ways and that is troublesome to me. So i would hope, again, that we approach this issue with all the sciencebased, evidencebased, data at our fingertips and those data speak to us boldly and we should respond in Public Policy forfat so as to protect the lives of young people and all people across the board by sound policy. So with that, i yield back, madam chair. Thank the gentleman. The Ranking Member and i now will just ask a few closing questions. Mr. Guthrie, recognized. Thank you, thanks, chair, for doing a second round real quick. And based on something i heard earlier, and i saw this yesterday, i think i saw it, i dont remember if i heard it or read it, somebody said if this was lettuce, itd be off the market tomorrow. And so if you want to look at the equivalent, if somebody bought tainted lettuce at a grocery store, you trace back to where that came from and you would shut that whole supply line down. If somebody bought tainted lettuce at a corner food or a drive through, kentucky people are on the side of the road selling vegetables in the summertime, its fantastic to get fresh vegetables. If somebody is out selling, you wouldnt shut down the supply line in the Grocery Stores because somebody bought tainted lettuce from somewhere where you cant trace. If you could trace that, you would shut it down. Just my its my guess on that. I agree with that characterization, congressman guthrie. I think the problem here we dont believe the cases are being totally forthcoming with us in all instances of what theyve been using and not eager to identify what products have been using and certainly manufacturers arent eager to identify to be known. In a food outbreak, the manufacturer has an interest in getting that food off the market. They dont want their product to get a bad reputation. This is very different a lot easier when it comes to a corporate chain because you can trace it as opposed to somebodys farm that just sold it to some hard to find. Harder to find that way. Thats right. You said the National Youth Tobacco Survey is what you used to make some decisions. And ive noticed that its increased greatly, but that information is really relatively new. Is it maybe it came out in september or so . You are using it to react to and i think what you said, gi givinggiv givigive ing where we are now, we should have reacted three years ago. Now that youre knowing it today. As new facts emerged, the fda changed its posture. Were clear, as we continue to monitor the science and gather new data. Nyts data from 2019 is preliminary. I would say its not the sole data source. Theres a study from naida and state studies that have been referenced. The fact that theres a striking epidemic of youth use of ecigarettes is i think noncontroversial. Absolutely. Supported by many data sets. Okay. One final thing, i was going to ask this in my previous questions, i was talking about thc previously in my questions. So is the fda involved in any federal investigation of vaping products containing thc . And or has the fda declined to be involved in any federal investigation of vaping products with thc . So we have engaged heavily with the dea, so weve had numerous joint tallcalls, our enforcement people, their enforcement people, our cyber crimes people, their cyber crimes people. They have a number of Ongoing Investigations represented to thc vaping products and sharing data with us. Our question is, where are the products coming from . Are they adulterated in nature . Ill fini isish with this. I was in your mail facility. The mail facility as americans, at jfk airport and your fda group was there. Its amazing the things they are finding elicit. They were finding different tablets we would consider brandname drugs today, how they copied the logos, logos were off center and things like that. Yo when you stand there and see the volume your brave people are dealing with, some dealing with fentanyl, they have to wear protective gear to find whats going through, they are, theyre working but its an enormous task. We ask a lot of them, but we appreciate the effort that you guys do and what the cdc is doing as well and just all the work that you guys are doing. Thank you, congressman. I might say thats a real pride of the fda, the imf,capacity th to generous support of congress the last few years. Thank you. I yield back. Dr. Sharpless, i want to cla clarify how this compliance policy on the fda on the flavors is going to work which is, if i understand, the same way it would work under the legislation that ive introduced and that is you send out your order then the companies are required to withdraw the flavored products and then and then they can come and make an application with the fda to try to show why they think that its safe to market them. Is that right . Thats correct. Upon finalization, the guidance would then go into effect some period later. We would send out warning letters and sorts of enforcement activity. Pull flavored products from the market. Anyone who thought that their product was good for the Public Health, could meet the standard, can file a pmta application any time, before may 2020, at least by may 2020, and if the product can demonstrate a Public Health use, then it would be authorized for sale. And what would the criteria that would be used to allow that to happen . So the pmta application we provided extensive guidance about what we expect industry to include on those. Its things like hows it manufactured, what are its components, nicotine levels that appeal to children and use by specific populations, risks for addiction and diversions and things like that. The reason why youre withdrawing it now is because theres substantial evidence that these flavors are getting are appealing to teenagers and youth and getting them hooked on nicotine, is that right . Thats correct. The data suggests that kids really like flavors. Nicotine is somewhat harsh straight and so flavors can mask that and make it more appealing to new users. Okay. Thats the evidence that would be used to counterweight any of the right. The evidence thats emerged from the nyts studies and other studies, very strong, flavors drives child use. Okay. I have to say, i havent heard anything today to show why these products should be marketed. Theres some anecdotal evidence maybe it can help some existing adult smokers not Smoke Cigarettes but other than that, i havent heard any reason why we shouldnt ban these flavors, why we shouldnt ban them ban kids from being able to get these and why we shouldnt aggressively pursue this from a Public Health perspective. But i think there has been some confusing questioning to both of our Witnesses Today implying maybe its just elicit drugs, maybe its just offmarket vaping devices or whatever. So i, you know, you guys have the forum right now. I would like to ask each one of you to tell us what is your message to the parents of america regarding whether their kids should be using any form of ecigarettes . Dr. Schuchat, we can start with you. We want parents to talk to their kids. They should not be using these products. Ecigarettes with nicotine or vaping products with other substances. Were very concerned. We have tip sheets for parents on how to talk to their kids about this. These are dangerous products for youth. Dr. Sharpless . I think these products are unsafe for children, whether they contain thc, nicotine. We would not recommend their use. We dont think anyone should be using ecigarettes unless perhaps the person who is using combustible cigarette. Because those are really bad and we want to limit their use as well. Thanks to both of our witnesses. Members will submit questions for the record. I would ask each of the witnesses to agree to respond promptly to those questions should you receive any. Panel one is dismissed and after the second panel has been set well invite our witnesses to come. Thanks to both of you for coming today
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