>> the house will be in order for 40 years, c-span has been providing america unfiltered coverage of congress, the white house, the supreme court and public policy events from washington dc and around the country so you can make up your own mind. created by cable in 1979, c-span is brought to you by your local cable or satellite provider. c-span : your unfiltered view of government. >> next, a hearing of the house energy and commerce subcommittee on potential health effects of these cigarettes with the fda's acting commissioner and the cdc's principal deputy director. the hearing included public health officials from north carolina, massachusetts, minnesota and kansas specifying how their faith are responding to a rise in vaping related illnesses.

>> subcommittee on oversight and investigations hearing will now come to order. today the committee is holding a hearing entitled sounding the alarm, the health threats of e-cigarette. the purpose oftoday's hearing to examine the public health impact and regulatory authorities related to e-cigarette manufacturing , sales and use. the chair recognizes herself for purposes of an opening statement. our country is facing a serious public epidemic. one that is causing severe harm. this hearing will examine the cause of that epidemic, the uncontrolled and rising use of e-cigarette and life-threatening illnesses ripped the country and the use of e-cigarette products young people sort, we must act to protect the american people from the myths and misunderstandings about these products.

first, the data is now clear. over the past several years seen an unacceptably high proportion of young people facing nicotine addiction. this year alone, more than 27 percent of high schoolers report using e-cigarette or vaping as it is also known. from 2011 to 2015 there was a 900 percent increase, 900 percent increase in youth vaping and from 2017 today the rate of high school use double . the vaping epidemic and impact are personal to me. my home state of colorado has the unfortunate distinction of leaving the country in the vaping. a major factor exhibiting to the continued dramatic rise of e-cigarette use among teenagers is the inundation of ulater products. data from the centers for disease control and prevention indicates that 60 percent of students using e-cigarette in the last month

cited using popular fruit, menthol or make flavors young people turning to e-cigarette also may have a false assumption he fox are safe or relatively harmless but contrary to many manufacturers claims, e-cigarette pose risks to young people and can lead to addiction, harm brain development, affect respiratory health and can lead to heart disease. additionally, these use increases the risk of use turning to conventional cigarettes. as much as we do know o, the more troubling concern maybe how much we don't know about these products. for example in some cases we don't even know what chemicals and toxins are being inhaled when vaping and in a very real sense the industry has launched a massive public health experiment on our country of which its outcomes and consequences remain unknown recent of serious vapingb& of

the demises how much we are in the dark aboutthese products . these illnesses numbering 530 so far and increasing daily have led to hospitalization, potential long-term health complications and deaths s. while cdc and fda are here and i want to thank both witnesses and they will provide more information about the status of the investigation and what products may be the culprit, no specific causes of the illnesses yet been determined but these agencies engage in collaboration with 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 told on the streets or the use of thc, we must keep in mind that brandon e-cigarette's sold in storesare not harmless . this brings me to my next concern. given the potential risks

associated with these products, it would be eo reasonable to assume the e-cigarette have been closely reviewed and approved by the fda but they haven't. e-cigarette products are only on the market today because fda is temporarily giving them a pass bby exercising its enforcement discretion. let me clear, no e-cigarette 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 or even if they can legally be sold. in other words, fda must go forward with conducting its repeatedly delayed premarket reviews are all e-cigarette products and determine whether the sale of the product is appropriate for the protection of public health. after years of the delays around the regulation of e-cigarette, the administration recently announced that the fda would

prioritize enforcement and clear the shelves of nontobacco flavored e-cigarette products. i am encouraged by this but the fda needs to provide additional details adand a timeline for action. we have to ensure this policy will be implementedand enforced in a reasonable way . in the meantime, manufacturers, nothing is stopping manufacturers from submitting their applications to fda today . the burden is on the cigarette companies to he determine and demonstrate that these products meet the fda's 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 alone who's been a steadfast leader on these issues . based on the frontline of the youth epidemic have also been taking action on e-cigarette, we're going to hear some of their plans today. the industry has been swift to rail against efforts to restrict products , claiming

they have helped adult smokers in quitting traditional cigarettes but that evidence is far from conclusive and fda has not approved e-cigarette or 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 you. i want to thank the witnesses for their service and i look forward to hearing how we can work together very serious public health issue and i will yield to mister dockery from kentucky. >> chair holding this hearing and i want to say i know a lot of our members are going to be have to be going back and forth for whatever reason , this committee scheduled two important subcommittee hearings at the same time so we had drug pricing upstairs and i think everybody thinks it's an important issue and this is an important issue as well and a lot of members care membership in that subcommittee so i apologize we're going tobe in and out .

>> i'm deeply concerned about the outbreak of lung illnesses associated with vaping. as well as the market, we need to understand the causes of this vaping illness and ensure e-cigarette are not marketed to kids. it is important we understand the health implications of vaping and e-cigarette used more broadly whether an adult is vaping thc derived from marijuana, nicotine or another arsubstance. so far the available evidence of the 553 reported cases of lung illness and eight deaths do not point to a conclusive cause . but the debt samples overwhelmingly suggest involvement of illicit e-cigarette devices, the psychoactive ingredient in marijuana called thc and another black-market product. for example according to the centers for disease control patients have experienced lung illnesses have reported

a history ofusing e-cigarette products containing marijuana or thc .however, have reported using products that contain thc, marijuana with c nicotine while others have reportedusing products with nicotine . the operative illnesses the united states has a youth e-cigarette epidemic. the most recent data from the tobacco survey shows 27 and a half percent of the youth reported using e-cigarette compared with 20.8 and 2018 . the rate was only 11.3 percent years ago. thesetrends are unacceptable . a marketing of e-cigarette products must be stopped and use access to products must be blocked more effectively. this epidemic is already driving legislation and giregulatory responses. last september the fda issued more than 1300 warning letters to brick-and-mortar retailers who illegally sold products to minors and warning letters to e-cigarette manufacturers

about their plans to address you access. 18 states have increased the legal age to purchase tobacco products to 21. michigan, new york and the district of columbiahave issued relations demand labor e-cigarette . september 11, 2019 the top administration announced that the fda will finalize compliance policy to prioritize enforcement against the marketing of unauthorized nontobacco labor e-cigarette including menthol cigarettes. with these responses, while these responses areaimed at reducing the attraction of e-cigarette's to youth , they will almost certainly create black-market and in that vein we will need a response to that and address the growing trade in it was canada's marijuana vaping products. a new york times article reported a recent bus of thc oil operation in wisconsin revealed an advance and

mature illicit market from marijuana the cartridges and contaminated marijuana carts. i am told these illicit operations are using a tactic in other illegal drug operations, cutting their product with other substances including some that could be dangerous . public health advocates said a particular cutting agent vitamin d acetate is an oil that could cause breathing problems and lung inflation if not meaningfully during the vaping process. eaby using smaller amounts of the expensive thc or marijuana, and diluting it with oils thatcost much less , they can increase their profit by selling the product . median grade thc costs $4000 a kilogram. but ideas may cost pennies on the dollar. these operations rely on thin factory by empty vape cartridges from chinese factories and fill them with thc liquid that they purchase from theunited states market

. the cartridges and packaging are available to purchase on the internet . while federal and state authorities are working on an effective response against team e-cigarette use we must make sure our teenagers are educated . for example in massachusetts governor baker's administration launched a campaign to combat vaping and e-cigarette use. in the massachusetts department of public health once the campaign to highlight the dangers of vape pens in 2018. these actions are commendable and i look forward to the results of these campaigns. with regard to adults trying to quit smoking somesuggest there less harmful than traditional cigarettes . according to the cdc e-cigarette have a potential benefit on combustible cigarette for adult smokers but cautions e-cigarette are not safe for use, young adults, pregnant women or adults not currently using tobacco products. additional resources will look at the effectiveness. i want to thank eyewitnesses

for being here on both panels and i look forward to this important discussion. ideal back. >> chair recognizes the chairman of the full committee misterpollard for five minutes . >> i want to thank chairwoman get for having this very important hearing today. we're examining a growing public health crisis involving e-cigarette and the proliferation of these products among kids and teenagers and i'm deeply concerned about the recent outbreak of lung illnesses that have killed eight people and sickened more than 530 in the us. i'm also frustrated by the fact that the usage has reached epidemic proportions in recent years among kids. if you talk to any parent of high school students you know our missions e-cigarette problems real and getting worse and it's past time for public agencies to address vaping and e-cigarette usage

in a meaningful way. i look forward to hearing about what the fda and cdc and tell us about how they're addressing the tragic mysteryb and the recent actions to combat youth e-cigarette 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 e-cigarette on the market when they had the chance two years ago. instead in july 2017 the fda announced it would delay implementation of key provisions of the agencies final rule which ensured the agency will review all e-cigarette products on the market. that same day i issued a statement expressing the concerns that the delays would mean products would continue to lack needed public-health oversight for several years and risk continued exposure to a new generation and here we are over two years later and unfortunatelymy concerns have come to fruition . that decision youth

e-cigarette usage has skyrocketed one in four high t school students have used e-cigarette in the past 30 days. these products have been targeted to kids without our knowledge of the health consequences and as a result we can lose an entire generation to a lifetime of nicotine addiction. at the same time hundreds of people throughout the country have their love unknown lung illnesses following the usage of vape products and in many instances these products were manipulated beyond the products intended use but it still remains unclear what these products contain and how they were manipulated. lack of certainty on the root cause of these illness speaks to a larger problem. we do not know the full spectrum of consequences associated with the use of e-cigarette and years ago the family smoking prevention control was signed into law after coming out of this to me . tit gave the fda the tools it needed to regulate all tobacco products but unfortunately that has not happened.

it's critical that fda and cdc explain what actions they're taking and what more we can be doing to protect consumers and i also look forward to hearing states that have forced their own responses in the wake of action at the federal level the wide availability of flavored products designed for kids consumption are putting the interests of industry the health of our kids. i'm pleased the administration's announcement that it plans to pull all flavored products from the market until they undergo full fda review but i believe that man should occur sh immediately. above all else we must get the bottom of what is causing these illnesses and ensure that vape products are kept out of the hands of our kids and at the same time it's become clear we must end new comprehensive legislation to address this growing youth epidemic. we must eliminate flavors, prohibit online sales and easy for kids to buy e-cigarette and ensure these products are not being marketed to anyone under age. my legislation in reversing

you tobacco epidemic act is also raising the age to 21 provide tobacco products. it's my intention to move this legislation forward and i hope it will receive the strong bipartisan support deserves. it's long past time to address the public health risk associated with e-cigarette and we have to use every tool at our disposal to solve this crisis and although it's true as i mentioned we want to move legislation i think it's very important for the oversight and investigations subcommittee to find out what's happening and what the agencies aredoing . what's causing this epidemic so i really appreciate the fact that you're having this hearing. i think we need to have this hearing as much as i want to move forward with legislation, we need to have this hearing toget to the bottom of this so thanks again . >> ideal back. >> the chair recognizes the ranking member of the full committee mister rollins for five minutes.

>> thanks for holding this hearing. electronic cigarettes for e-cigarette, the current outbreak of illnesses associated with e-cigarette and the youth vaping are a health concern and particularly in my state of oregon. in recent weeks and as yet unidentified young one the list is killed seven people, ansickened more than 500 across 38 states. as we will hear from doctor anne schuchat today the causes unknown but it appears to be vaping related. many individuals 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 and use any e-cigarette containing marijuana oil purchase from a licensed dispensary meeting that 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 us tied to a vaping product by a maryland teshop. what is unknown including which dispensary sold the product and whether it was contaminated or whether something was added into the device after the purchase. in july and 18-year-old young man went to a hospital complaining of reading problems. in 40 hours it was the intended unit, diagnosed with respiratory distress and conditions associated with lung injury. it was connected to a breathing tube and placed in a medically induced,. the patient's mother found and e-cigarette cartridge from a company based in california that sells thc products but the cartridge later was found to be a counterfeit of that company's product . in north carolina five individuals bought the marijuana oil that made them sick on the street from unlicensed dealers . all five hospitalized, three in intensive care and it took

a battery of tests to figure all five had acute lipid pneumonia and lung inflammation caused by breathing oil. luckily the individuals in new york survived but not all have been so lucky including the individual from organon who died. in these cases the young really healthy adults getting sick after tsvaping are having far too quickly. these cases are shining light on the most recent data from the national youth tobacco survey which is troubling, found 27 and half percent of youth reported using e-cigarette, and 11.3 percent jump in three years. given these administrations, they state and this committee are right to look for solutions to curtail youth access to e-cigarette. i appreciate the combat ministrations pursuant and effective solution to the problem as well as a partnership between the administration and states to investigate these outbreaks teof lung illnesses.

however there is another overlay of this problem and that's the counterfeit productsincluding counterfeit thc products , leg countries is becoming to comment on the market and advertising counterfeit products on social media platforms such as cash and instagram and according to press reports the state that appear to be the most inundated with cover products are states where recreational marijuana is legal. according to the california department of public health 20 potential cases of acute lung disease among people who recently vaping and in august the california department of health reported a cluster of at least seven kids in king county california all admitted to hospitals with symptoms of lung disease asand all seven were linked to thc vape is. lab tests conducted by a third-party testing company common contaminants in counterfeit vape is including pesticides, fungicides that when vaporized converts into a substance heused as a chemical weapon by the french

during the first war. world war i. in addition the ongoing work we need a full investigation into counterfeit thc cartridges madam chair as well as the vaping black-market that needs to be part of this investigation so that the whole set of facts tito ensure we get it right while we move forward on policy solutions. i appreciate the witnesses are going to testify today and others who have weighed in and back on the comments of the top republican on the subcommittee esther guthrie, unfortunately we have two very important subcommittees, the majority decided to schedule one on top of the other, one onprescription drugs that begins in eight minutes upstairs , a very partisan bill and this one though i'm sorry but we will be going back and forth as we work on both theseissues and ideal back . >> the chairman yields back and the chair asks unanimous consent at the opening

statements be made a part of the record. without objection, so ordered. i'd like tointroduce our first panel for today's hearing . doctor darman shark list and doctor and schuchat, deputy director for centers of disease control. i wantto thank both of you for appearing before the subcommittee today . i know you both appeared before this committee before and it's great to see you. you're daware i know this committee holds an investigative hearing and when it does so and has the practice of taking testimony under oath. do you have any objections to testifying under oath? let the record reflect the witnesses have responded no. the chair advises that under the rules of the house and the rules of the hcommittee your title will be accompanied by counsel. do either of you desire to be accompanied by counsel? the witnesses have responded no so if you would, raise

your right hand soyou may be sworn in . do you swear the testimony you're about to give is the truth, whole truth and nothing but the truth ? you may be seated. let the record reflect the witnesses have responded affirmatively and your now under oath and subject to the penalties set forth in 18, section n 1001 of the united states code. the chair will recognize our witnesses for a five-minute written of their statement .. >> .. lo

as you know prior to coming to be at that was directed national cancer institute a longtime cancer doctor. my experience presentations has informed all of my work i including before the agency today. we are here to discuss the ongoing investigation into t the cause of the long interests us with use of vaping products and second fda's ongoing efforts to address an epidemic of youth use of end products including the administered announcement about our intention to issue a policy ntthat would address ongoing marketing of flavored products. let me start by discussing the vaping illness outbreak. what with state partners and if he had been investigating an outbreak of interests us with the use of vaping products. most cases of been reported recent most containing thc, ingredient in marijuana. although these cases seem similar it is not clear if that common cause or if that different pathogens with similar presentation. investigation has not been fighting specific substance or products that is linked to all

cases. let me outline the proponents of investigation. we're activated incident management group to coordinate across the agency work alongside cdc management system. the field forces playing a critical role in fact, gathering and i was just with state health departments collecting samples for analysis at our forensic chemistry center. additionally where what you with customs and border protection to identify a licit vaping products at the international mail facilities.it our office of criminal investigation is focused on identifying the products making people feel and following the supply chain to the source. fda is not pursuing action so see stay with personal use of any vaping products. our interest is in the suppliers but to be clear if we determine some of his manufacturing or distributing illicit adulterate vaping products that caused it

illness or death for personal profit, we would consider that to beul a criminal act. because many of the products associated contain thc as we've engage dea to help. let me turn to the efforts to address the disturbing rate of injuries by children. this summer worked with 60 agency received preliminary datt from the 2019 national youth tobacco survey. education strategy 2019 data it aggressive and issues warning letters and we collaborated to remove the products on the market in the pursuit of the manufacturing on the coast by the social media influencers. a week earlier this month it's a

warning letter to the inc. marketing of authorized modified risk tobacco products including a presentation of children. we also expanded efforts to the prevention campaign and cost campaign and efforts targeting 10.7 million. despite the efforts of the preliminary data and another study supported continued to rise through the use of the non- tobacco flavors. more than a quarter of the students were current e-cigarette users in 2019 and scientific leaders being the most popular. in short come of the data indicate they must do more. that's why the president announced his support for the intention to finalize a policy related and it would prioritize the enforcement of the premarket

authorized nation for the non- tobacco flavors. they are not banning flavors that have been described in some news outlets. rather they intended to force the existing law. the policy wouldn't mean they could never be marketed. the specific product keeps it set forth in congress the fda would authorize the product for sale. two prioritized the actions the markets are appropriate protection and i want to ensure the subcommittee that i am committed to a point all and we will not rest until we get answers to questions for the investigation and we dramatically reduce the access. >> thank you, doctor sharpless.

>> thank you chairwoman and ranking member guthrie and members of the subcommittee. i've had the chance to update you about the ongoing investigation of the lung injury as well as what they are doing. i want to talk you what we know and what we don't know and what we are doing about the lack of knowledge and also what we are doing about the use of the e-cigarette problem. first, the first time we learned of these cases, the cdc had been working 20/accident with the state and local public health as well as getting to the bottom of it. the ability to do this type of investigation relies on a critical underlying public health infrastructure including data systems the need of modernization a trained public health workforce including the

data savvy workforce. the cdc has made important recommendations to the public already including the comment that while it is ongoing, people that are concerned about health risks consider refraining from using products or vaping. people should not acquire products off the street. you shouldn't modify it further beyond what is intended by the manufacturers. a bold step e-cigarettes or vaping products because they've quit cigarette smoking should return to smoking cigarettes. fourthly, this outbreak reinforces the need to address the broader academic of -- cigarette usage. it's a striking young people. half the cases are under 25. about three out of four are male, but the numbers are changing as we get more data. we are getting new cases reported every day, and i expect

this week's numbers to be hundreds higher than the reported last week. what we don't know unfortunately is the cost. we know that most of the reported cases with information available so far described the use of containing thc or thc and nicotine usage. but no single product brand the substance or attitude has been identified with all the uses at this point. if need be that there is one cause or there are many independent may be complex. they are working vigorously together with states to respond. we've dispatched the disease detectives to assist some of the state and local public health and we have been coordinating the definition data collection and analysis. we've issued clinical guidance and we are working with the committee to update that new information as it becomes

available. we activated the emergency operation center as we do for various public health emergencies, and we are coordinating the public health and clinical community as well as doing frequent media to keep the public informed us all. we are working closely with the fda on the trace back of the products equal halves years and while our laboratories are not testing the patience product collected that is, the tobacco lab is working to develop the aerosol reduced and some of the products. there are challenges in the response. the investigation includes trying to gather information about exposure if so some responses may not be totally forthcoming. state law varies regarding the thc cannabis use the public hate the collections.

e-cigarettes or vaping are part of a marketplace that is very wide and diverse. you heard a multitude of product varieties and different subs consists of ten used. they are often the issue with counterfeiting. public health data collection response is relying on fragmented numbers the need of modernization. the disease unfortunately is moving faster than the data at this point and that is a barrier to us getting quick answers. let me turn briefly to what we are doing about the use of this issue. we know that they are much but likely than adults. the cdc has been messaging about the concerns since 2013 when we got the initial data about the alarming increase from 2011 to 2012 with the use of cigarettes. so, we have been at this and we continue to be at this in terms

of our concern. finally, the cdc is dedicated working around-the-clock with fda and state and local health officials to identify the cause or causes of the outbreak and we will continue to keep the congress updated. thank you. >> it's now time for the members of the committee to ask questions and share will recognize herself for five minutes. in 2015, the cdc stated, young adults, pregnant women, as well as adults who currently do not use tobacco products should not use e-cigarettes. i think that was also echoed by you, doctor sharpless. so, my question come about or schuchat, does the cbc really think that these e-cigarette products are safe? >> we are concerned about the use of e-cigarette use among young people, pregnant women,

young adults and people with innocuous products -- >> even someone that isn't smoking or using them now it's not like they are safe for people to use, is that right? >> for the aerosol produced can have a lot of potentially harmful substances. we have a lot to learn about long-term and short-term effects. >> so your answer is no it isn't safe, but if it? >> dr o are not saved in those categories. >> are they safe for other people? >> we are focused on those categories because there is the most data about them and particularly -- >> we don't know if they are safe for the other people. >> right. we are concerned about people going back and smoking cigarettes. >> is it true that the youth are more likely than adults to use these products? >> that is correct. >> the 2009 tobacco control act

gave the fda the authority to cigarettes under the regulatory authority which the fda did is that correct? and the administration extended the deadline by four years for companies to submit materials to the fda for the review of the public health is that right? is it accurate to say that they are on the market because the fda exercised its discretion and not because the products have been reviewed by the fda? you also agree with the cbc but the products are not safe is that right?

here's my concern the fda and cdc we are seeing an explosion of people using the product and now we are seeing serious illnesses around the country, but the fda still allows products to stay on the market even though they haven't undergone the review i think time is of the essence. the science driven organization would have been the same epidemic and now we've accelerated the enforcement --

>> but what is your timeline >> the finalizing which would have the effect of the long tobacco flavors in the market we expect that to be weeks. >> and what are you going to do after that? >> it has 30 days to go into effect and then we applied the enforcement strategy. >> is the flavor strategy the only thing the fda intends to? >> i can't speak to the guidance in the process, but it certainly may target the effort. >> and why is that? do you think that will solve the youth vaping academic? >> we do not think that any single policy is going to. we have enforcement, education and multiple policies. >> are you continuing to review the products disease they are inherently safe or unsafe?

>> all products will have to sub an application by may, 2020. how far are they prepared to go to protect the health and well-being of young people if it determines that these are safe? >> they are science driven organizations i now recognize the ranking member for five minutes. >> the testimony is informative. you said in all of the cases that you have data for there is no consistent. this is the cause, these are the bottom of things that we found. is there a trend line developing that you are seeing?

>> the data are coming in. we believe that most people that have exposure history that we gathered described using the thc or nicotine e-cigarettes. i think it's important to say what people said they used may not be fully descriptive of what the problem is. maybe as you heard a cutting agent or something related to the device and how it changed over product they used and we may not know what was in the product they go. >> it's been reported over 80% of the cases the person report reported. that was in a report from illinois and wisconsin about the first cases and those numbers are from about 40 people but the trend is continuing as we get additional data. it's also important to recognize

there may be a particular problematic source in the midwest and a different one in california. and i think we really need to be on top of this investigation to make sure that we understand all of the causes. >> they are not combining. >> one individual might have many different products that are being tested so it is a very complex investigation and understanding exposure versus the cause of the something we are trying to get out. >> we have specific lung injuries we are looking at and i know a lot of people are talking about the flavor and general e-cigarettes we need to address, but also the thc or marijuana some states made it legal i think massachusetts that they are going to pull back a flavors but i don't know that they are going to undo a policy moving forward. in the testimony you said many

suggest the need to understand the health effects of increasing the use in the u.s. that was in your testimony? with concerns? >> the brain is still developing all the way through to about age 25. whether it is nicotine or marijuana we really want to know the effects that occur. there are data to suggest sugget conference induced behavioral data, but this is one of the reasons that there is a focus for the use. we don't know as much as we need to know about the short and long-term effects. and there are harms associated the adolescent brain is almost marijuana. >> what does the fda think about the effect of the brain on thc

and vaping? >> there is animal data and human data to suggest the developing work brain is sensitive to these so i think we will learn more. [inaudible] the testimony states i that will be shared with the fda to assess which of the products fall into regulatory authority. has the cbc shared such product information? >> we are sharing information continuously. one of the things we are doing is getting examples linked to the cases for the testing directly to see -- >> i know there are not many. >> there are about 300 samples we tested about 150.

a significant fraction of the products like maybe half has no business being in the product as a cutting agent. >> ten you tell us those that were tested or testaverde secor bootleg or were they actual commercially purchased? >> that is difficult to ascertain. the time is expired and i will yield back.

lightweight pneumonia that has been seen as the case. >> i have a pediatric pulmonologist tell me what happens is it impairs the developed and if she has even seen kids whose lungs are like those of the 80-year-old david is never going to resolve itself. that is going to be what happens. the chair now recognizes the gentleman from massachusetts and the subcommittee for five minutes. >> thinking chair and i want to thank you for calling this important hearing. yesterday c-charlie baker announced a public health emergency and a four-month ban on the sale of all of the products. to date we know nine people have died.

help me answer some of those questions how is it what do we know and how is it that we don't know more? >> the first cases were in july and a relatively new entity. i think the progress and federal cooperation has been good. we had a rigorous case definition. we began to test a lot of the product both in interview the cases. we started a criminal investigation to learn more and i think we will gather more information quickly. i don't know if -- >> how do we get to the point

where we are backtracking on this rather than putting in place the right consumer protections on the fun and if you're telling me it's putting people's longs to the extent children's lungs look like at they're the ones of an individual. where was the failure to allow that to happen in the first place? >> we believe adulterating product would be an illicit activity, it would be illegal and tough to regulate illicit drug dealers effectively. that is people are cutting the product to sell it for greater profit. >> you're saying with regards to those specific cases, with -- no evidence of any that has approved commercial sale? >> no. it's not approved for inhaled use. i should be clear though it's wholly present in about half of the thc product. with cases not associated with it. what about the causes anything or just a marker for all

adulteration or a marker for a bad product. to the point we have a widely used consumer product getting people sick and understand it is a massive regulatory failure to allow this to happen, was there not? now we are open through business to receive applications and we are going to catch up. >> i'm extremely frustrated with the pace of the investigation. i wish we had answers already. >> you are frustrated with the pace of the investigation and what can we do to speed it up?

>> we have more than 100 people working on this and making it a top priority to do the product sourcing can help, but i also think that there may be a complex set of root causes that were going to be difficult for us to address as a nation and we need to take it very seriously. there is a set of supply chains that are underground and are adulterating products in ways that are just experimental. and building on top of the population the last few years. one of them posed for the regulatory process >> there could be implications that we will have adverse health impacts.

>> as you know, the agency containing issues are regulated at the state level and not the federal level. i would put the fda described that. we've been raising these issues since we first saw the rise and also supports state and local health departments for the comprehensive approaches. >> thc is a schedule one drug. to the extent those products are reviewed not all of these were linked and my concern is on the front and it should have been foreseeable that some aspect

would be used or cut or otherwise. i want to understand where the process broke down. >> i now recognize the gentleman from west virginia. >> thank you, madam chair. your remarks earlier were missed because we have another meeting upstairs and we've been back and forth. i apologize if your testimony may explain some of this but i'm trying to follow the chronology because what i gathered from the internet is they were introduced in 2003, some set of 2006. when do we confirm these things came along? >> they began to be marketed in

2007. >> back to you now. >> i heard the chairman's remarks, but i can't agree more with the concerns. there's no link between the two of us. why has the fda not finalized some kind of determination that allows these things, how do you describe the permitted use? >> they are not authorized to be sort of the on the market for discretion to prioritize the

enforcement. the history, e-cigarettes contains products -- is one of the byproducts get into people's lung, we've had members of debates and the committee the last ten years, not what is happening with the cool combustion, but from what i understand, my research on this is that these e-cigarettes are introducing not only 2.5, but even smaller and getting down so if we take action that are affecting and impacting the industry across america, why are we not finalizing and saying until we know more about the

carcinogens, heavy metals and other things, why aren't we stopping this until the final determination? why are these still on the market if they are causing this kind of a health risk? twelve years after they've been introduced. >> we don't consider the products safe. we think they have harm. we don't think anyone should be using them other than people in place of the tobacco. tit has to be said to -- >> but you know that it is naïve to think that is what is happening. why aren't they just off the market until you make a final determination? >> what is good for the public health in some small offramp of

the transition for combustible cigarettes but we want to limit the ability of children getting access to the product because of the epidemic use. >> would it be more beneficial for you if they were taken off the market? >> we would like to make it possible for no youth to be using these products. >> why isn't congress working on a? if you are saying you think they should be better, why aren't they out there, what is your opinion if they are causing this kind of problem introducing particular matter into the hour-long contest at the station in the industry and fossil fuels but yet we are allowing children

at a higher concentration level and we're putting it directly into someone's mom and saying that's okay. -- someone's lung saying that's okay. >> these products will be off the market as we finalize this policy. >> i have run out of time. i will yield back. >> you can cosponsor money bill to raise the age to 21 if you haven't already. >> we now recognize mr. ruis. >> thank you, chairwoman. there is a misleading notion when people say that it's safer than tobacco cigarette, that somehow it is safe. you said, and i believe that you agree, and i wholeheartedly agree that vaping and e-cigarettes is not safe.

in fact, there've been numerous scientific studies by different medical schools that have tried to elucidate whether or not vaping has any public health benefits. and so far, the vast majority of researchers have concluded that they believe there is more population level harm van benefits with e-cigarettes. on the one hand, you both know that e-cigarettes have a very narrow benefit in that it helps tobacco smokers off cigarettes to quit smoking, period. not just to convert the market from tobacco to vaping for an industry's benefit.

.. >> those who were never smokers now smoking and babying and then they start smoking tobacco.

, tobacco cigarettes. so you count those never smokers those who are stopping that's why they say there is a net public health harm in this industry to begin with. then there are other study showing that the e-cigarettes and vaping have those compounds that are considered - - carcinogenic and a young adult who has more propensity to be a deck - - addicted and then you can start to see they can acquire lung cancer and other types of cancer. not to mention the concentrations have higher

nicotine than tobacco when you start to see reports in the emergency department of teenagers coming in with cardiac arrest. i am a emergency medicine physician. swears the benefit of this industry to our nation's health? except for the very small narrow area to stop get them to using tobacco and e-cigarettes forgot the best case scenario is that new non-smokers that the industry would love to take tobacco's market on - - smokers because it is safer or that it is safe. and then no longer preventing you from getting their hands on their and a mention introducing legislation that would do that to help increase the fines for first time

penalties for selling these and i am also introducing legislation to do more research on the long-term effects. so what are the secondhand smoke effects of vaping quick. >> you bring back critical issues the aerosol includes many toxic things the direct and indirect effect are not fully understood and the issue of additional research to get at the long-term effects that we absolutely share nobody should be using e-cigarettes. >> i ran out of time. >> thank you i appreciate it. you said earlier there's a lot of different issues going on.

one question may not lead to the next. but let me start by saying those that talk with some issues that is dea because for 20 years for medicinal marijuana they have not been able to do adequate studies to find out the benefits. and then you have no data. so we really don't know when you add thc into these products long-term consequences of thc as a youth like you said because the brain is developing. and then raising the age for all tobacco products through the age of 21. and also mentioning there is a bill at the federal level that seems to be a proper step. in reality we have two

problems with serious lung disease with the flavor issues and i have written that up in particular because my wife is a district court judge they are seeing all kinds of problems because unlike the regular cigarette the teacher can identify where it comes from they don't get that with the other cigarette they have no idea vaping is going on in the classroom. but really we're talking about two different issues here today. >> yes two separate critically important issues. >> e-cigarettes have been on the market for quite some time about 12 years at least.

so does the cdc or the fda no if the current outbreak is a new phenomenon or with awareness that people started to work one for these lung disorders quick. >> increasingly the data suggest there have been individual cases but nothing like we see now. >> in my correct the knockoffs or the ill legal imports is a relatively new development as well quick. >> even the pods would be new as well. >> previously we may not have had as much of the various chemicals added in or have we quick. >> i don't know. >> we really don't know. >> so now whether that's new

or an older practice. >> i am aware there are a number of vapor products coming onto the market after the august 82016 deadline that means they were already sold illegally what is the fda doing right now to get those illegal products and those after the period that you alluded, we did that it can be difficult to ascertain. >> i mean this as a friendly question. and with that importation of illegal substances coming across the border currently do

you have much hope we will have much success to keep imported possibly tainted pods coming across the border? i'm trying to say how can you haven't stop this. you can't stop fentanyl how do you stop pods? >> i agree it is a challenging issue. our facilities to see what's going in to find out what vaping products are sent to the united states. >> i think we will have more hearings i appreciate your time. this is a serious issue we are all concerned and i healed back. >> to the chairman of the full committee. >> earlier in september the

president announced the fda will finalize the policy in the coming weeks with market review and i agree with the statement the doctor has made and the point that it has taken so long to get to this point it has been over three years since they were brought under regulatory authority and during this time the e-cigarette market has become more attractive and accessible for children and teens e-cigarette use in demonstrating one third of 12th graders are e-cigarette users. and that minimum purchase age could also help reduce it is my strong belief that congress

now has questions of guidance but first let me start with doctor sharp to outline the administration's policy of sale of nontobacco flavored products. >> in my opinion the lack of permanence with the issue by the agency. >> they will describe and how we will prioritize enforcement. >> and so with legal force of that statute. >> and by the act of congress. >> you will now enforce the underlying law. >> what kind of steps can the

fda take to ensure they are complying given what you just said quick. >> the fda has experience with this problem we sent warning letters to the manufacturers they come into compliance usually that will have a dramatic effect. >> i still don't understand how you force them to comply with the guidance. >> the way that it works is that no longer subject to enforcement discretion. >> but what if they don't quick. >> and we have other activities that escalate like further warning letters. >> and you intend to impose those enforcement measures quick.

>> yes we would in those other enforcement measures. >> we would impose those of needed. >> is the proposed flavor ban including mint and menthol flavor? you admit that as part plan finalized quick. >> i cannot describe what will come out of that guidance but for certainty i can tell you data suggest menthol was very popular with children. >> but you are not committed if that is part of the compliance. >>. >> it sounds like you say you are not committed to it unfortunately. the only way we could realistically verify if it is flavored or not flavored, this question the only way you can verify that tobacco products

that it don't flow to kids as direct face-to-face sales lie would ban sales for online and remote sales. can you commit to any guidance banning the sale of the e-flavored cigarettes online quick. >> the guidance we envision what extend to all channels. >> okay so three distinct e-cigarette products does the fda face any capacity challenges to monitor the market that is entirely funded off of user fees with the user fee program and then to enforce these activities that you describe the make those

that you are available to monitor from e-cigarette's quick. >> we are using the appropriate monies. >> what about the user fees quick. >> on trying to find out if the money you are getting from user fees is available to monitor e-cigarettes are you just using that money quick. >> that is for the use of monitoring. >> sorry to go over but this is important i apologize. >> thank you madame chairwoman for hosting this hearing. according to the indiana state department of health in a recent publication the commissioner stated the numbers are staggering. nearly one out of five high school students one out of 12 middle school or say they use e-cigarettes in the tobacco

survey 350 percent increase since 2012. she also writes that one e-cigarette can contain in one - - the amount of nicotine of one cigarette there is a much it is a known and so my question for both of you is how little we knew about e-cigarettes and their effects what research studies are currently underway to help educate everybody about e-cigarettes cracks when we expect the studies to be complete in which studies are underway quick. >> there is a number of studies the composition of e-cigarettes as that cessation

device of both nih and fda but these are products and you don't have the long-term experience with them. and to launch a very vigorous information campaign like recent online ads. >> and just doing surveillance if we do test that aerosol. >> while in fact right after they did choose this report it indicated announcing a 2 million-dollar campaign talking about this a long injury death happen within the week of this incident and this

has impacted others in our state with 400 cases. my concern is all of the research being done on marijuana still isn't conclusive. for the federal government really to come up with conclusive studies to be furnished on marijuana why do we think this is any different? why do we think the research will be different or faster? >> this is a tough topic study it is a long-term effort. that the answer is it will take a while but with that

regulatory framework. >> whether surveillance or investigations being done is there a consistence consistent process identified so far quick. >> one of the reasons is it may take a while to get answers and we wanted to warn the public in the meantime. >> i agree the majority of projects some that are nicotine only. >> in the study you are doing how many report buying them versus online why are they getting counterfeit quick. >> anecdotally and from where

they know when they are concerned about that what the ultimate supply chain may be. >> have there been questions from them whether or not they have modified the device or the product quick. >> i don't have yet the results because they are actually doing the interviews with their patients. >> thank you. i understand you say we don't have any evidence that this on the website, smoke-free.gov, which is part of the department of health and human services it says quote, e-cigarettes are not

approved by the fda as a quit smoking aid. so far the research shows there is limited evidence that e-cigarettes are effective for helping t smokers quit here that are other proven safe and effective methods for quitting smoking. that's the quote. clearly e-cigarettes are not proving to provide smokers, smoking cessation and it seems to me that if we are unable to limit cigarette use the existing mookers, that we should just ban it. i don't understand why the default position right now should be to allow it to continue in any shape or form. dr. schuchat, who went remember out of uniform, we should be saying no right now and then if there's a way to face and some of it, okay.

in the 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 iswe and we just say no? i would like to to hear from bh of you. >> i'll start if you don't mind. i agree with what you said. these are not approved cessation devices. the fda does have other approaches that are approved. the fda driven decision making, the argument against banning all e-cigarettes is that we think in that instance there are people, millions of americans using e-cigarettes today, who mayil fd no other source of nicotine that is satisfying to the other than moving back -- >> but dr. schuchat, you said the aerosols have toxins in them. i understand what you are saying and maybe that's true but in the meantime we have an epidemic of people ending up in hospital and

eight people who are dead. let me ask dr. schuchat that. >> what i would say of course cdc doesn't 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.ta our recommendations they do have concerns about health risks. we suggest you not use vaping or e-cigarette -- >> that's nice, but, so i want to ask another question. i understand, and referred from several media outlets out of what to put some articles into the record, that reports 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 presidents reelection. and so it seems that no public health groups are on the list and you were not invited, as i understand. you think that's appropriate, the industry groups and organizations that support the president and support vaping should be in a meeting? >> i can't really comment on meetings at the white house at this time. >> cdc is a data driven organization and we aredc gathering the data and alerting people about risk. >> well, i do want to ask that we put into the record some articles about this potential meeting. and let's hope that the whole -- >> without objection, so ordered. >> thank you. let's just hope that all of this is data-driven. but do you have any metrics on

at what point we say we're going to address this, not just by education? are we going tooi see an implementation of taking this away? did you send the letter yet that you said isy? going out, and wht have the responses been? i don't feel a a sense of urge. i just don't feel a sense of urgency here. >> we are very come have a strong sense of urgency on this topic. we sent a letter to manufacture i mentioned to juul labs regarding marketing practices. this compliance guidance as we finalize it in a few weeks will have a dramatic effect on the marketing of flavored products come what's available to the american today. it would be good for kids because we know flavors are attractive to young kids. >> they will be banned in a few weeks? >> we will exercise come will stop exercising enforcement

discretion over those products. >> and they will best banned? >> that will have the effect of removing them from the market, yes-man. >> i yield back. >> recognize mr. duncan for five minutes. >> the use of e-cigarettes is common among our youth and the reported deaths and illnesses that been associated are incredibly worrisome. .. i believe the immediate answer is for our youth to stop buying black market pods and start trying to get high by lacing these pods with thc. that seems to be the common thread. crucial that we look further into the thc counterfeit lot market products

and buying and mapping. they were short history but will need to have all of the facts before we can fully remedy the situation. i will thanks both witnesses here today, i understand the patient's with the reported lung illnesses have reported using e cigarettes, thc and nicotine and just nicotine. but the cdc fda believe that the counter fit black-market poses a higher risk than the nicotine cartridgese any cigarettes. both witnesses. >> were concerned about both right now. it is ongoing investigation about the lung injury outbreak. were very concerned about the cigarettes and youth on ongoing basis because the trends arego increasing. >> i agree, no single product can link all of the products. we test cases, products that are actually linked to the cases in our lab, we find the majority

thc products but not all of them. there certainly nicotine products as well. >> thank you for that. other any enforcement actions that cdc and fda believes that we should be taking against the manufacturers? >> challenging issue for the fda can be around th c which has jurisdiction jurisdictional challenges. something borders. fda regulated tobacco product we certainly have significant enforcement authorities. we have engaged the dea for their help on products that are challenging. >> i really think this is an extremely challenging issue. i don't have the tools i'm not sure what the tools are but i think out of entering and clearly are a lot of dangerous products out there. what little no let researchers studies are currently underway to help us understand more. what are you all doing to help us understand more question and

more. >> just briefly, the state and local health are interviewing patients associated with lung injury outbreak and identifying what they used when they got it and how they used it. in providing that product information to fda or is appropriate to dea. >> were taking the data from cdc and integrating that and wave across agency effort involving all of our scientists to think about what is the cause of this outbreak and what can we do to prevent further cases. where doing extensive testing in our criminal labs and are forensic labs to identify possible contaminant. i think there needs to be a strong public service announcement. a marketing effort targeting the age groups of middle school and high school that are using these and even college and even young adults. two weeks ago the cdc put out a statement regarding both of users should consider not usingh e-cigarette products at all. while the investigation is ongoing.

conversely the fda put a statement out to urge consumers from modifying using anyng substance or adding any substance products purchased in the stores. the cdc and the fda iss putting putting out conflicting warnings and recommendations to the public. >> i would say there is no live between recommendations that the two agencies have been been putting out. it's been interpreted as different we want to correct that. >> the avoidance of these products by those people may be to not use combustible singers. we do look at slightly different data sets and data emergencies at real-time, we want to make it as quickly as possible as the public imported this information. we are in substantial agreement. >> concerning it all public health officials are putting conflict conflicting statements.

but the ones who are buying the black-market or adding things to it, the confusion over those that are illegally using vaping products. does thatt concern you at all more.on and >> we strive for clear communication and we want to do that. >> i would agree. with constant medication we strive for very coordinated communication. >> i think the message here today is stopping thc products and legally purchase pods, and set buying black market pods, there is a health risk and is cutting the lungs of our children and keeping them the oxidant for making it into their system to provide oxygen to the brain for it is damaging the health of our kids. that's the message today. stop doing this. >> time has expired. [speaking in native tongue] thank you for holding this critical hearing and thank you to our witnesses for joining our committee. while we seek answers from the public about this public health emergency and i think you are hearing and bipartisan way, the

research is really important communication and transparency of the data to the american people and i can certainly say is apparent, this is the very scary time in terms of, will i personally don't think we should be holding out any of these products.e they're not safe to the public. we haven't had a research and we have not thoroughly tested them. based on the data, just as we are in the presidents of minimizing tobacco tools in our nation his use, the tobacco industry has devised a new way to place her children once again in the crosshairs. as a result e-cigarette are now the most commonly used tobacco product among you, surpassing conventional cigarettes five years ago in 2014. e-cigarette use among youth double from 2017, 22019. it doubled. demonstrate this problem is only

getting significantly worse. state of new hampshire, the department of health and human services estimates that is at least one quarter of all high school students use vaping products and the number is on the rise. now you may know that our state is still in the throats of an opioid epidemic. that began with misleading marketing and lack of regulatory oversight. my fear is that we are repeating the same mistakes and making way for a new generation battling with addiction. and that's why i'm proud to confront into the reversing of the tobacco act of 2019 which includes numerous important provisions to curb the rise of youth tobacco use. with that i want to thanks a few questions. doctor sherrick, based on cdc's surveillance and research, what do you believe are the reasons that young people are smoking e-cigarette as such alarming rates. >> we know the flavors are principle attracted to people.

the latest generation of a cigarettes also are extinct lehigh and nicotine content in there often include nicotine cells which are a little bit more palatable or less better. the flavors are really targeted at youth. we think the addictiveness of the high nicotine loophole, and the appeal of the flavors are key. we also think some of the companies have had youth targeting ads. >> according to the national institutes of health, 81 percent of adolescents who never use tobacco products, began with the flavored product. doctor what can you tell us more about the contribution of flavors to this dramatic rise and eve mentioned this and you have anything more to add. >> yes, we have seen a little bit of a shift in the most birecent sleep remnant preliminy data and an increase in the

mental and meant flavors among white youth are using so we do think flavors are critical beginning to youth use in the nicotine provides that a addictive substance that has them going back. >> doctor charlotte we you ensure that the newly announced policy to clear the shelves of the cigarette products will be effective? >> we believe this policy will have a dramatic effect on the flavored product sold in the market today. student does not include menthol and meant cigarettes will be cleared from the shelves. >> we are finalizing the policy and i don't want to prejudge the policy and an aberration with the data support meant to menthol being significant problems have been very popular to children. >> thank you. last year and part of the fda's comprehensive a plan for the regulation the agency launched youth prevention plan.

one of the plans and status of some of the efforts like the real cost campaign that fda has or plans to implement. >> is anti- tobacco campaign. initially it was about combustible cigarettes and we believe we've been very successful in that regard campaign reaches 11 billion kids in ages 12ou to 18. in the last year or so, we have really shifted that focus to e-cigarette his to catch up with this epidemic. new tv ads and really tested off of the charge of the youth markets. strong adds to discourage youth to discourage them from using these products. some dueling is becoming a verb in high school. it's not understood to be a dangerous product. so there's really a lot of education effort.

>> remind you that manufacturers are creating new generation of consumers that are addicted. and when our youth need obstacles now more than ever. it's important to constrain furtherth reversals and protect our youth. and that went out a yield back.e >> turned the chair now recognizes up the lady florida. five minutes. >> thank you chairwoman. this is the very important hearing thank you to healthcare. mecca has a serious and growing vaping problem. i've seen it firsthand. my two daughters are just a couple of years out of high school. i noticed a steep change in behavior among high school kids middle school kids over the past decadede and it reflects the research and the yearly florida youth tobacco survey that is run

health.epartment of 2012 to 2018, there was a 31601 percent increase of kids ages 11 to 17 who have tried electronic vaping. even worse, there's been a 582 percent increase in kids that currentlyer use. electronic types. and 651 percent increase when the survey focused only on high school students. on top ofon that, the survey alo found that e-cigarettes are by far and away the most common forum of e smoking so clearly this is the very serious public health problem. do you determine an epidemic or emergency? >> yes it's an epidemic. >> as our way. >> on september 10th, how you know regulating e-cigarettes. you wrote that there is a rise

in the products. aerosol possible practices of the manufacturers. who have targeted children in particular. give somes examples. of these insidious practices by jewel and other manufacturers. >> on september 9th we sent a letter to jewel labs inc. detailing their use of unauthorized marketing flames. modified risk product flames. see like their product is potentially save or much safer or 99 percent safer. some of these were made in presentations to children. >> purchased outright staying things that are untrue. >> there is no data to support those flames. >> that's untrue. yes. how are these manufacturers specifically targeting case. what dive boat marketing are they using.

it's really alarming. >> were aware of presence on social media and in recruiting youth and social influencers. influential people celebrities and flows so far to make this lookr cool or fun. and certainly as doctor was mentioning, a lot of youth are not even aware that there is nicotine and e-cigarettes. flavored water that's what i thought i was getting. i think we are seeing the kind of tactics that were used with cigarettes being used again. and we think we need to take really aggressive action. >> he said that we need all of the regulatory tools that have been mentioned here but you said in your public relations campaign you know going to use tbs. that's not going to do it. you know what they are using. they are in instagram, snapchat, they're using these influencers. don't you have plans for a more modern dive boat education campaign to really get to young people ? >> totally agree this is the

market that requires a lot of different channels to reach. we have done this. it's the federal trade commission for example, we took down some sites that were using social media that were hyping that went out didisclosing they contain nicote which is the violation. one public health influencers that you know all going to bri bring. these products, young people think they are cool, they think they're not so harmful, they think of that just happen somewhere else. it's not happening in my friend group. s in terms of public health, of course the surgeon general is really been out there and our partners of state and local public health there's a lot of kids behind me who might be influential as well. >> you gotta get with the program here. you know not going to be able to combat this with the same old ways to communicate young people these days.

any modern techniques. i don't think congress has all of the answers not either. so i really encourage you and committee to move aggressively onon this. otherwise other people are going to die and other young people are going to get hooked. and they think it's cool based in the think it's not harmful. and now all of the evidence is just not the case. i will yield back my time and i encourage you to be more hip. >> i recognize the gentleman from maryland for five minutes. >> thank you madam chair, thanked the witnesses for being here today. i would like you to speak both of you, maybe doctor to begin on

map out for me, because i think this is horrifying what is happening. it sort of playing the same reel over again. that we saw with cigarettes before the tobacco settlement with opioids before now the heightened scrutiny that is receiving. and all of the litigation that is ensued and presumably some kind of compensation that willy come is it too late for many families in many communities. but even as we are dealing with those things, the after affects, of those crises, those public health crises, we got a new one unfolding before our eyes. you can predict were going to be having hearings ten years from now. going to be looking back and picking up the pieces of the terrible public health crisis.

with incredible impacts on communities across the country the fact that it is starting its breeding ground is among children. this is what makes it even more horrifying. there's a lot of discussion about how we need to better regulate this this industry his practices and marketing and all of the rest of it which is important. maybe you can map out the scenario of what the public health crisis could look like. maybe ten years out five years out ten years out, if we don't take really dramatic steps now to address this on what is arguably still kind of the front end of it. off of kind of getting into the

thing. not that out for me. because in a way what i am asking you to do is put on the record, a scenario that weekend come back to. i don't have to do that. but sadly, we need to maybe find ourselves coming back later and staying this was all predictab predictable. so talk about that. >> women wearing e-cigarette his to youth when i first saw our data and increase going up. this is the fourth generation and he cigarettes are now much much more risky even than the earlier ones. in terms of nicotine levels, flavors, the nicotine cells in the concealable products that make it really hard to know that anybody is even using class is the fourth. since these trends continue and we don't turn this tide, we have

a generation of addicted to nicotine with potentially the impacts on the adolescence brain, or the developing brain, the less for live in terms of memory attention and difficulties learning problems and the applications of that as adults workers. we have the potential of progression to cigarette smoking which we know is incredibly legal and people who smoke. we have all of the signs of that happening in terms of the last few years of data. the issue right now with the lung injury outbreak is having people died. assignment a question of 20le years from now, is question of now. things that have led to that, we fully don't understand what just with the opioid epidemic. we didn't understand this prescription drugs and analogues in stimulus and all that. we've a lot of people are getting. >> one thing we have come to

understand, and we probably could've understood in theto moment, with the opioid crisis if we hadn't in effect had the wool clove dirt our eyes by in industry with very effective marketing w techniques. it's how a whole industry canada there affirmatively be trying to encourage dependency on the product or at a minimum, turn a blind eye to alarming trends that are happening. happening.re and look for sort of plausible deniability about their own responsibility. i think we are seeing it all play again. the same movie. anyway, want to keep our focus on the best. thank you very much for convening the hearing.

a young buck my time. >> thank you manager and i think ranking member guthrie for convening the subcommittee hearing today. on the threats of e-cigarette his auto also like to we will and thank our panelists for their expert testimony here today and for attending as we fight to protect the american people on the far harmful effects from smoking but more specifically he cigarettes in vaping and i would like to jump right into my line of questioning. according to your testimony, as of september 19th 2019, number 530 confirmed cases of lung diseases associated with e-cigarette used in 38 states and one territory. so far at least nine people have died as a result and the overwhelming majority of these cases,pl 83 percent of which the

cdc is complete data on the age of 35, these are young people. in his devastating that it's alright taken nine lives that we know of. this obvious tragedy. i've also seen a report however of individuals currently still on live support or respirators for days on end. so what you know about the potential long-term health effects of this pulmonary issue illness associated with the cigarettes. >> we fear there may be long-term illness among individuals. recommending individual care with follow-up to check the pulmonary testing. some improvement is being noted in the number of individuals when i get steroid treatments but the issue of long-term

effects is very serious because these are young people are pretty much fine and they have a live now that is quite altered if they recover. >> is it possible that there are cases that we must prior to the outbreak. >> yes we know other than individual reports of serious lung injury following vaping or e-cigarette used in the past we believe that something new is happening is causing this many cases that we are seeing now. we know the states and clinicians are really looking backwards and getting all of the cases reviewed that they can. the new cases continue to occur and that's one of the reasons we feel the sense of urgency. to get the public health messages out so that weekend prevent further cases. >> no single product or suffice have i been identified specifically. only some of the illnesses have street uncle t

products and not sold by legitimate retailers. what authority does fda have to take action against counterfeit or unregistered e-cigarette products. >> counterfeit tobacco problems products have we were able to identify them. includes,. >> no no no, i mean, the e-cigarette. >> with the product containing thc, not a tobacco product. >> generally speaking e-cigarette. >> so e-cigarette his as the fda regulated tobacco products. >> see you do have the ability to take action. >> tobacco of the product, yes. >> your crossing words here.

this is specifically about these e-cigarette his.ci >> i apologize for the lack ofet clarity. the fda has significant authorities around tobacco products. including e-cigarette nicotine delivery.o those products we have strong authorities in the 2009 control act as well as now. thc and other things that might be mates that are not nicotine are jurisdictionally more challenging. substance like thc schedule one drug and is some shared regulation between the f fda and the dea. >> to some of these products contribute to the illness may have been sold by the registered retailers. what authority do you have two recall these products and get them off of the sales. >> can send warning letters in these other measures and even

tobacco sell order if we can identified the retailer that is selling the product that we shouldn't be. >> ibra begun that process. >> an army focuses testing the products. finding what they are and where they seem to come from and and re many cases .-ellipsis. >> people are losing their lives right now. wouldn't it be prudent to do a recall a moral totally sale or something that stops this until your testing is done. >> sounds a little bit like a food outbreak. what would we do if there were a band food. this is different. >> people are dying. how is this different. >> people are not forthcoming. >> but you know that addictions to a process of elimination right. >> we have better authorities but many of these products are not that. >> thank you very much i yelled

back. >> thank you manager for the subcommittee hearing and thank you witnesses forou appearing before the subcommittee. the 2016 final gaming rule brought he cigarettes with authority, the tobacco control act. fda it's not exercising that authority to its fullest extent that he cigarettes only remain on the market today duea to fds enforcement discretion. this has been well established this morning, genius of these use of the cigarettes have been sky ride getting over these past few years. the youth rate of the cigarettes can't surpassed conventional cigarette use from five years ago. can you ace plain fda's decided in 2017, to extend the compliance deadlines for fda review of the public health risks of these products. >> is part of a broader strategy regarding tobacco in general. nsthe fda, look to the data,

science driven, concluded that e-cigarette use among children, was going down or leveling off. this was before the explosion of the last few years. when the fdast began to apprecie that this sort of profit was taking off and be more engaged, stepped up our enforcement education activities and now very broad policy activities that would have a major effect on the market. >> in retrospect, should the f fda, attacked more urgently. >> in retrospect we should've acted more urgently. >> the fda decided to i leave te compliance deadlines to 2017, because it was a brief decline in youth utes rates. as a potential health benefit so my question to you then as now that we have a fuller understanding of the terrible epidemic for the youth in this country are facing, have these considerations changed t-mac.

fax emerge, we will change our regulatory posture. a very do so. starting withl 2018, the date of which was very concerning, and that in 2019, in large part. >> then how will fda account for their eventual reviews of these products. >> we have moved up to date, or premarket applications, so may 2020, so all products on the market today are illegal. the legally marketing will come to the fda and be approved. in addition the compliance cut policy that we announce the presidents, more recently, would have the effect of routing flavored products which are particularly assuming to children. >> michigan has temporarily banned flavored products. massachusetts have they upped band vaping products for fourth four months.

>> it seems to me like we have an emergency from these agencies. why is it taking a multistate outbreak of severe pulmonary outbreaks words and several deaths for this administration to protect young people his health. >> , see thele major.of data is driving our compliance policy is youth tobacco survey. this epidemic in youth is identified from multiply date is. youth use. urgency is further rejected by this other problem, the vaping lung injuries but i think that the administration is considers it duty to protect children a top priority. they are reacting responsible. >> when they finally review these products, they must assess both of they are appropriate for the protection of public health. will fda then ultimately

determine the dangers of youth use outweigh any potential benefits to adult smokers. >> we've issued guidances to industry but with the information is to be included, we've been very clear and we've already approved products through that process. thus a sort of things that we consider. the benefit, the standard is what you mentioned. has to be goodef for the public health. >> thank you for your responses. with all of these newu tobacco products flooding the market over the past few years, you've got a full understanding of the public health risk, it's not surprising that we are now any crisis situation today. mys concern over and over agai, how this administration has rejected science in many formats in ways. that is troublesome to me. i would hope again that we approach this issue with all science -based evidence-based data at her fingertips and this data speak to us boldly and we should respond in a policy format so as to protect the lives of young people and all people across the board.

by using sound policy. i yelled back. >> the ranking member and i and now will thanks a few closing questions. >> ewthank you. based on something i heard earlier, i saw this yesterday, i don't remember if i heard it and read it were 70 said this is let us it would be off of the market tomorrow. so if you want to look at the equivalent, they bought lettuce and cut it at the grocery story you would be subject to grocery store and shut that supply down. kentucky people are selling vegetables on the side of the road but is somebody just, you would go shut down all of the supply line in the grocery stores until somebody bought lettuce that you can't trace you can't figure out where it all came from. i think of you trace that, you set it down.

is my guess on that. >> i agree. i think the problem here is that we don't believe that the cases are being totally forthcoming with us at all. in that this is what they're using. they're not eager to identify. in the manufacture it's not eager to be known. if it outbreak, i met you factor has an interest in getting that food product off the market. but with a substance like this, it's different. >> you can trace it. it's just harder to find. >> is that the national youth tobacco survey is what you use to make some decisions. i noticed is increased greatly but that information is really relatively new. maybe he came out in september or so. so you know all using this to react to. i think what you said giving where we are now, we should've reacted three years ago. question reacting into it now. now you know the information

today. >> as new facts have emerged, fda's changes posture. we are very clear that we going to continue to monitor and gather new data. 2019 is still preliminary. we are reacting as quickly as possible. it's not the sole data source. as a study from dyna, studies that have been referenced. the fact that there is a strike epidemic of youth use of e-cigarettes is non- contribution euro. syria and one final thing. was going thanks this in my previous questions. thc. is the fda involved in any federal investigation making products containing thc or have they declined any of this. >> we have engaged heavily with the dea. we had numerous joint calls. the chemists are communicating.

in the cyber crisis people as well. a number of ongoing investigations. where are thesein products comig from. it's good couple ration between the federal agencies. >> finished with this. i was in your facility. your fda group is there. soso amazing that they were branding drugs today and how they copied the logos and they were off-center and all of that. we do stand there and see the volume they are people who great people that are growing through those things and be more protective define what is to going going through. it is an enormous task. we appreciate the effort that you guysec do and what the cdc s doing as well.

>> we have a real pride. it substantially increased orcas cassidy. >> il back. >> i just want to clarify how this compliance policy at the fda on the flavors is going to work. as i understand, the same way it would work on the new legislation of introduce. and that is you send out yourk order and the companies are required to withdraw the flavored products. then, they can come and make an application with the fda to try to show why they think it is safe to market them. as i write. >> that's correct. final location guidance would be going to affected. later. was sent out learning warning letters. then he would pull the products from the market.

he can file at any time, may 2020, and if the product can human straight public health use, and would be authorized for sale. she met in the criteria to be usedha ? >> application, we provide an extensive guidance about what we expect to be included on there. how does it manufactured, nicotine levels, appeal to children, population risk for diversion. a. >> with a reason why you know withdrawing it now is because there is substantial evidence that these flavors are getting in our appealing to teenagers and youth in getting them hooked on nicotine is that right. >> yes that's correct. nicotine is harsh so the flavors make it more appealing to youth. that evidence is emerged from

the studies is very strong the flavors drive the child use. >> i gotta say that i haven't heard anything today to show why these products should be marketed. there some antidotal evidence that maybe it could help some existing smokers not smoke cigarettes but other than that, haven't heard any reason why we shouldn't ban these flavors why we shouldn't band them kids from being able to get these why we shouldn't aggressively pursue this. from a public health perspective. i think there has been some confusing questioning to both of our witnesses today and maybe was it drugs or maybe off market vaping devices or whatever you guys have the forum right now i would like to thanks each one of you to tell us what is your message to the parents of

america regarding both of their kids should be using any forum of e-cigarettes. >> we want parents to talk to their kids, they should not be using these products. e-cigarettes with s nicotine or vaping products with other substances, we are very concerned. we have tipped sheets for parents on how to talk to your children about this. these are dangerous use. >> i largely agree. we think these products are unsafe for children. we would not recommend their use. we don't think anybody should be using e-cigarette except for b perhaps the person using and this instead of a combustible cigarette. sooner thank you. i think both of our witnesses for participating today. you know the drill, first wolf submit questions for the record and i would s thanks each of the witnesses to agreement with the response.

with that the subcommittee will dismiss panel one and now that the second panel has been set, we will invite our witnesses to come up. thank you for coming today. [background sounds] [background sounds] >> i'm now delighted to introduce our second panel witnesses for today's hearing.