september 2019 but not yet implemented. [inaudible conversations] the subcommittee will come to order without objection the chair is authorized a recess at any the subcommittee will come to order. we are allowed to declare a recess at a time. we are examining the federal response to the epidemic of youth e-cigarette used and fta food and drug administration compliance policy. i now recognize myself for five minutes for an opening statement. september 11 this year the administration

released disturbing results, the youth beta epidemic and at the vaping epidemic continues to grow to all-time highs. and that they use e-cigarettes the trends are alarming for high school students, as well as middle school students. here, i show you to visuals on your rank, that is 20% of high schools were vaping, in the 2019, only 28% of by schools are vaping, meaning there is 100 and 35% increase in vaping among highschoolers. on your right, there is another visual that is more disturbing. in 2017, 3.3% of middle schoolers

were vaping, and today it is almost 11%. that is a 218% rise in vaping among middle schoolers, as a parent of three children, these statistics are extremely disturbing. the data also shows that flavors are driving youth vaping use. 72% of youth who vape used flavors, and 64% of all kids who they use meant or mental, which by the way it is the most popular flavor. that makes sense because the data also confirmed and most people who they present. and with this data, the public health agencies convinced the president at least temporarily to do the right thing. with data linking the alarmingly high rates to flavors, the president and the

heads of hhs and fta announced their proposal on september 11th to essentially ban flavored e-cigarettes with the exception of tobacco flavored ones. they have put forward a sound and logical response to the problem, as eighties as secretary allen pledged to, quote, we require that all flavors other than tobacco flavor be removed from the market. this food and crews meant and mental flavoring, as well as candy flavors, bubble gum flavored, fruit flavor, and alcohol flavor. secretary azar explained that these products are still getting to kids, and we cannot get it let a whole generation get addicted tournament and mental and other flavors, close quote. during that same announcement, the president committed that this bold flavor ban would be issued within the next, quote, couples of weeks. when the president made this announcement, we let

the charge, a ban of all flavored e-cigarettes would deter new youth users from starting to vape. during a tumultuous time in our politics, i frequently referenced the president's announcements as bipartisanship at its best. it was a move to protect and preserve american youth but while it is our privilege to back the president when he took steps to strengthen public health, it is also our responsibility to hold him and his administration accountable to their bold promises. unfortunately, almost three months after the president's initial announcement, the flavor than has not yet been implemented. reports illustrate that big tobacco lobbyists are working to weaken the ban. there are indications that the administration is considering exempting mental, as well as exempting they shops. we

sincerely hope these reports are inaccurate, and in light of these allegations we try to find out what was happening. we first wrote the fta, asking it to finalize the flavor ban ban without exemption, the fda did finalize its guidance, but instead of publishing it, the fta send it to the office of information and regulatory affairs, also known as oh iraq. that was concerning because it often delays agency action., it is an office within the office of management and budget, so you will hear that being referred to repeatedly today. in fact, fta had submitted a flavor ban months before in 2016, and after a flood of industry lobbying, they eliminated that altogether. we've been wrote oira asking

them to complete their view, they complied, but then again, the guidance was not published. not publishing at that state is highly unusual, so the subcommittee wrote to both ally right and the fta to ascertain which agency currently controlled the guidance. neither answered, so far neither fta nor oira will clarify if the guidance is with their offense. however, we did get an update on december 3rd, that would be two days ago, which is that oira has said that they have completed their review so we assume that the guidance is with the fta again. the american people deserve answers. mr. cellar you, are the director of the fta center for tobacco products. today, parents expect that he will

provide them with the answers. once we get those answers we deserve immediate implementation of a flavor ban with no exemptions. and with that, i now recognize my ranking member mr. cloud for his opening statement, thank you. >> thank you for being here today, participating in what may not be the most watched hearing of the day, but one of the more important ones. let me say at the outset, thank you to the chairman for the focus on the issue and the cooperatives spirit which, for the most part, we've been able to maintain on this issue, even in today's polarized environment. having solutions oriented on this issue, i know that we are potentially united and our issue to and teen vaping. this is an epidemic that is troubling because it has caused harm in two ways, both fostering nicotine dependency and use, and also the onset of increasingly fatal lung injury. as a father, i can only imagine

the agonizing realization of understanding that your child has become addicted to something they had no idea was even harmful. or the pain of the devastating loss of losing a child or a loved one. my sincere condolences to those who have lost loved ones to this illness. over the last few months it has been obvious that something is making users of vaping products sick, when we think of the vaping epidemic, it's important to recognize that there are two tracks of concern that each need attention and required a tailor solution. there is a teen vaping epidemic that has enveloped 20% of our nations teenagers, on the issue of long damage that, according to the cdc, as tragically led to the deaths of 47 people in 25 states and the district of columbia. as well as 202,090 were fallen ill to vaping

related lung injury. this aspect has affected all ages. 38% were 1824, 20 4:25 to 34, and 23% were 35 years old and older. this has been a complex issue because while it is clear that vaping products are making young people on nicotine. it seems that a black market products are causing the lung injury. some of the challenges and dealing with this issue have been the rapidly developing nature of the epidemic, the lack of reliable data that definitively points to clear causes, counterfeit products that were the focus and understanding the origin of tainted products, on traceable supply lines, particularly within the black market, the lack of effective enforcement, and of course, the challenge we face as legislators in protecting the public from harm while protecting their

individual liberties. thankfully, we have had some breakthrough and findings over the past weeks that bring some understanding to what is causing lung injury. in the past update from the cbc, vitamin he has been identified as a concern among people who've gotten sick from vaping. the agency has been present and most of the recent samples tested, by the money acetate has been used as an additive, most notably as a thickening agent in thc e-cigarette products. these findings suggest that thc are the most likely culprit for the recent outbreak of lung injuries. news outlets including the associated press and wall street journal have reported on the availability and prayers a piece of nature of vaping products tainted by bad actors, the wall street journal reports there is a large market for those vaping products online, they're also made by bad actors to resemble those from legitimate manufacturers, but contain additives like pesticides. the cdc has warned

users not by any vaping products off of the street or on line, and i'm hopeful that the fda at the federal and state level can continue to broaden our understanding of pulmonary illness so they can be addressed appropriately. additionally, i would like to spend time on this hearing discussing on the progress they have made in curbing youth e-cigarette use. i believe that the focus on this issue in this committee as help to bring awareness, not just to the misconception you have had toward the health dangers associated with vaping, but also to the public safety issues that remain the quagmire of the supply chain. lastly, this committee considers solutions to those problems, i do hope will be perfectly balanced and protecting the public, or protecting the rights of consumers who still may find that vaping is a less damaging alternative to traditional smoking, i'd like to thank you mister seller for your testimony and being here

today, and that's always i'm grateful for the committee in being able to work together on this issue, i yield back. >> thank you. i now want to do recognize our new fischel chairman, carolyn maloney. congratulations. i look forward to working with her under her leadership, and i welcome her here today. i know this is an issue that she is very deeply concerned about, and i would like to recognize the chairwoman to say a few words at this. time >> thank you so much for holding this hearing, and ranking members for supporting it. and the entire subcommittee for your work on addressing this epidemic. e-cigarette manufacturers are learning a new generation of americans into a deadly, lifelong addiction. the centers for disease control and prevention found that tobacco use among high school students has

increased by nearly 40% in the past year alone. fueled by e-cigarette use, last year over 20% of teenagers reported e-cigarette use, a 78% increase from the year before. we are facing a public health crisis. thankfully, this subcommittee has stepped in to protect children's health, and hold this industry to account. briefly, it looked like we would have a very important strong partner in this fight, the president. but he has broken his promises walking back his commitment to take a quick decisive action to address youth vaping by imposing a flavor ban. it looks like, once again, they are going to put profits over people, and we will not allow this to happen. i look forward

to hearing your testimony, and i yield back. thank you. >> i'd like to recognize our witness. today, we are joined by mr. mitch's eller, the director of the tobacco products at the food and drug administration if you would please rise and raise your right hand, i will begin by swearing you in. >> do you swear or affirm that the testimony you are about to give is the truth, the whole truth and nothing but the truth so help you god? >> let the record show that the witness answered and the affirmative. thank you, and i'd like to invite you to give your opening statement, the microphones are sensitive, so please speak directly into them. without objection, your written statement will be made part of the record, and with

that, you are now recognized for five minutes. >> thank you so much. thank you chairman bologna, thank you for taking over my old committee, i worked on this committee for four and a half years from the 19 eighties to the early nineties, for one of the subcommittees. thank you for the opportunity to be here today. i like to recommend the subcommittee for its work to examine the causes of the epidemic. i'm here today representing hundreds of staff at the fta who are working tirelessly to prevent kids from starting to use any tobacco product, including e-cigarettes, i understand that we are interested in the subcommittees policy with respect to flavored issa cigarettes, and i assure that we are committed to doing everything that we can to prevent kids from using tobacco products, and will continue to

develop a policy approach that alliance with that concern. the administration held a listening session on the youth e-cigarette epidemic to help and foreign policy actions going forward. and help me happy to brief the full staff when updates are available. i'd like to provide some background in an update on the regulations. our nischelle efforts began more than one decade ago, long before the rise of youth use of e-cigarettes and the multi state lung injury outbreak. between 2008 in 2009, the fda attempted to regulate e-cigarettes as an approved drug device products. our action which talents and ultimately overturned. in the decades since the tobacco control act was passed, fda's center for the tobacco products has established a science based approach to the regulation of tobacco products. vigorously enforce to our authorities to target manufacturers and retailers that violate the law.

and designed innovative campaigns to educate kids on the dangers of tobacco products. cbp has also expanded his authority to address new challenges, and we have the authority to regulate them as tobacco products. e-cigarettes have been brought under the regulatory authority on august 2016. protecting our nations youth from the damages of tobacco products is among our important responsibilities, and we will continue to take aggressive steps to make sure tobacco products are not being marketed or sold to children. let me highlight some of the actions that we have taken to help address the epidemic of youth use of e-cigarettes. we have issued more than 10,000 warning letters, and filed over 1600 civil money penalties complaints against online and brick and mortar retailers, for the in legal sale of

e-cigarette products to children. we've issued warning letters that have resulted in the removal of dozens of illiquid products that resemble kid friendly foods, like jews boxes and cereal and candy. we issued a warning letter, informed by the work of this subcommittee for marketing unauthorized, modified products, including a presentation given to youth at a school marketing jewel products as a reduced risk of harm. we also issued a letter to juul, issuing several issues raised by this committee, including marketing practices targeted at students an employer. it's despite commitments they have made, juul products represent the overall use of e-cigarettes by children. last, year we launched the real cost, youth

e-cigarette campaign, which features hard-hitting ads on tv. and on digital and social media sites popular with the teens, as well as posters with secret messages and every high school across the nation. finally we, joined forces with scholastic to develop educational resources that have been distributed to over 1 million icicle educators. yet despite these efforts, the youth vaping epidemic continues to grow, and we know we need to do more. the subcommittee can the issues, it's important to remember that no e-cigarette product is lawfully on the market, because none have obtained marketing authorization from the fta. when we announced changes to our policy in august 2017, at the time, the nationally representative data suggested that youth use of e-cigarettes had declined, however, as we know, and as the chairman pointed out in his opening remarks, last year, at the national youth tobacco survey showed that from 2017 to 2018,

carney cigarette use among high school students had increased by 78%, and by 48% among middle school students. last month, we published a 2019 and paper, showing that currently securities had risen to 27.5% among high school students, and 10.5 among middle school students. as in previous years, the 2019 data shows a disturbing rate of youth use of flavored e-cigarettes, among current exclusive e-cigarette users, nearly three quarters of those in high school and more than half of those in middle school use flavored e-cigarettes. we are committed to doing everything that we can to prevent children from using tobacco products, and as i stated at the outset, we will continue to develop a policy approach that alliance that concern. i want to thank you for the opportunity to testify, and i will be happy to answer your questions. >> thank you. thank you for being here. today i'd like to recognize myself for five

minutes of questions, mr. zeleny you are aware that on september 11th age and secretary azar said the fda was going to issue guidance accusing the market of non tobacco flavored e-cigarettes, including mint and mental products, right? >> and you're aware that secretary azar announced the ban because, quote, the numbers from the nypd as show a continued rise and the disturbing rates of youth e-cigarette used, especially through non tobacco flavors that appeal to children, correct? >> and secretary azar further stated that, quote, more than one quarter of high school students were current e-cigarette users in 2019 and the overwhelming majority of youth e-cigarette users, i think is that 70% of highschoolers, with the overwhelming majority of youth e-cigarette user cited the use a popular fruit and mental or men flavors, right? >> that's correct. the purpose of banning, or as secretary

azar said, clearing the market of flavored e-cigarettes was to, and that fda guidance would come in a couple of weeks, right? >> that is what was said. >> there was an urgency that was felt at that time, right? >> it was a very high priority, and we're trying to promote work on it as quickly as possible.. you saw that on october 25th, but the guidance, this flavor guidance has not yet been published. >> according to a letter sent with me, fda granted guidance,

on october 25th, correct? >> the fta would clear the market of all non tobacco flavors, right? >> i'm not going to get into the substance of the document. >> okay, on what basis are not getting into the substance? >> because there's been no final decision made, i cannot get into the substance. >> who instructed you? >> this was based upon this question, that we don't talk publicly about what is under consideration and to walk you through everything, but this remains an open, ongoing set of

discussions. >> according to this, oira concluded its report on november 4th, right? >> correct. >> did they change the original guidance? >> and according to this catchphrase, the fta is not allowed to publish the federal register until they have completed the review, right? >> four things that are subject to the executive order. >> and this is one of them. >> when they talk about the

types of policies that would be submitted, and then sent back to fta, right? >> correct. >> but the market completed on the flip, side that means the policy is now back with the fta, right? >> they completed their review on them for fourth, and sent the documents back to us, but they did complete their review, as you stated, and sent back to us on november 4th. >> when they say they're policy discussions are ongoing, between who and whom? >> there a parallel policy discussions going on between fta and the apartment of the white house? >> when the policy order was issued, the fda it's not allowed to publish until they have completed their review, now that they have completed its review, the fta can publish

the guidance, right? >> if the complete executive branch review of the policy was done, but there were still other ongoing policy related discussions going on, in addition to the review of the guidance document. >> these parallel discussions, the sound like some kind of irregular channel of discussion, independent of the standard submission of the guidance from fta to iowa and back from o'hara to fta. is there some other review that is happening right now that has nothing to do with o'hara? >> there are ongoing discussions about what the policy should be. >> did they complete its review if they are still discussing

with you this document? >> oira completed its review but at other levels within the document and the white house and the agency, and in parallel there were discussions continuing about what the policy should, be even though they had completed their review. >> who is part of those discussions? >> that will be the leadership of the agency, and various parts of the white house. >> does that include you? >> i've been involved peripherally, it's mostly been the leadership of the agency. >> and at the white house, who is a leadership? >> i think it's a various offenses from the domestic policy council to the office meant of management and budget and others. i have not been directly involved in discussions with the white house. >> so you would agree with me, sir, and the white house domestic policy council is headed by joe rogin, is that

correct? >> correct. >> you would agree with me that the fda should be regulating tobacco products, right? >> that's our job. it's one of the most important issues. >> that's why i'm so concerned by a prior answer that the white house domestic council, headed by joe rogue and, it was part of these discussions, with mr. rogue and said it was, quote, a huge waste of time, close quote, for fta to regulate tobacco. i'm going to recognize others for questioning, mr. cloud, you're recognized, i took a couple extra minutes, so when we put some time on his clock. >> thank you. electronic statements have been available for a while. you mention for several years, and he's back to why we are now seeing cases of this illness? >> i don't think there's been a

definitive answer to why only within the last three or four months have we've seen so many cases of pulmonary illness. there's a working hypothesis, and so many of these cases are concerned about the vaping of, thc that there may be something that was added to the product more recently, and an increase in ration entry. >> there's many sources, especially when it comes to teen vaping, many of them getting from their friends that are old enough to buy them, and we have a better understanding of the source of the vaping products? >> it's important to

differentiate between the epidemic levels of kids use of e-cigarettes, where it is just a product that is delivering nicotine, versus some kind of vaping device, likely bought off of the street, possibly modified by the user and containing thc and these other compounds that are showing up increasingly in the samples that we in the cdc have analyzed. that's why the advice of the federal government is, don't pay thc. don't buy these products, be careful of what kind of modifications you make to them, that is separate and apart from the focus of the chairman's remarks about what to do about kids use of more conventional e-cigarettes. >> we've had some recent discoveries as far as what we think maybe causing the illness. can you speak to that? >> sure. we are working very

closely with the cdc, using our forensic chemistry center, which is a very sophisticated laboratory that fda has to support law enforcement that they would take. when we get samples from the states that have collected samples from victims and former them to us for analysis it's based upon the analysis of the samples at a chemistry level that were able to conclude it looks like within roughly 80% of the cases that have been linked to patients. thc has been identified. and in about three quarters of those cases, a deadly went known as light of an e. acetate, which is an oil has also been identified. because of some analysis of lung tissue, long fluid that cdc recently did within the last month or so, they were able to conclude that the

agency and biden many acetate may be linked to what's going on here. both agencies have been very clear to state publicly, that there may be one costs, but it's looking like some kind of combination of thc, with this vital many acetate is playing a role in a number of these cases. >> that's what i've been asking before. when it comes down to those cases that are causing injury, do we have a clear idea of which products in the supply line, have you been able to trace any of that information? >> we -- we are using the resources of our office of criminal investigations. we have boots on the ground, as we are trying to trace back the supply chain there, we are not going after partial, use who

was the responsible party for putting these thc products into the marketplace, and because this is an ongoing situation, all i can ask is that for making progress. it's not like a remain lettuce outbreak, where you have responsible, lawful entities that want to get to the bottom of what is causing the outbreak, and what would work with the regulatory authorities to get to the bottom of it, it is a challenge in doing this investigation, but our office of criminal investigations is making progress. >> you did mention some of the stuff that they have done to educate kids about the dangers, i think you've spent 60 million on the real cost campaign. you've highlighted some of those, if you want to touch on again, and in this or anything that the fda is considering to help mitigate? >> when it comes to addressing

kids use of e-cigarettes, a comprehensive approach is required. we are using, as many of the regulatory tools and resources that we have used, we've made a major investment in the campaign. what we learn from our research and this is in a real contrast to kids perceptions of the risks of combustible cigarettes, kids know that possible cigarettes are dangerous. >> they know that it's dangerous. by contrast, what we learned from our resource is that a lot of kids are walking around thinking that e-cigarettes are harmless. there are many kids that don't know that there is nicotine in e-cigarettes. the most important thing we can do is to communicate with kids, and we know how to do that. if you

think about the health consequences of vaping, whether it's becoming addicted, or the harmful compounds that are present. it's the investment and regulatory science to better understand the medium and the tools at the disposal that we are trying to make the best use of. >> thank you. >> i recognize congresswoman pressley for five minutes. >> thank you for your continued commitment to this issue, it is critical that we have both the vaping in big vaping, i work to end, this isn't always been an issue of racial justice. last week, my home state of massachusetts became the first in the nation to place a permanent ban on flavored e-cigarettes and mental cigarette products. this is

important, because if we are blaming flavors, we must ban all flavors, which includes it meant, and mental. do not do so would be discriminatory and, sentimental and particular has imposed a unique and deadly burden on the black community. we must clamp down on the production of mental products and not the individual possession of it, because there are real intergenerational dramatic consequences of broken windows policing that has historically over criminalized black and brown communities. something i called for in my people just this resolution, we must be attuned to both public health and public safety to ensure that there are no more eric garner's. four year, big tobacco companies disproportionately targeted more tobacco ads and specifically more mental tobacco ads in black neighborhoods. in some neighborhoods, as many as ten times more ads for mental products. cdc reports that nearly nine out of ten black

smokers prefer mental cigarettes. i think it's safe to say that the targeting was effective, correct? >> i would agree. >> today, nearly 45% of black mental smokers say they would quit smoking it mental cigarettes were banned, and almost two thirds of smokers would do the same. the fta announced plans to ban mental cigarettes, saying that it was necessary because mental products, quote disproportionally adversely affect underserved communities, so a year has passed in the fda has not followed through on this band. why? >> as you said we went through an advanced rulemaking on a variety of issues related to flavors, including the presence of mental in cigarettes and i would add to what you said that one of the public health concerns about ventilated cigarettes it's not just the

biggest proportionate use of mental cigarettes but the role of mental cigarettes play in attracting kids of any color to experiment with cigarettes. we continue to review the comments and explore what the regulatory options and policies should be but i absolutely hear you and as director, i share your concerns. >> just in the interest of time, to be clear on the record, does the fta planned to follow through with this ban? yes or no. >> i can i give you a yes or no answer in an open public hearing, all i can say is that we are continuing to review all the science as we come up with the right policy. >> previous attempts to ban

menthol have been overridden, why? >> you need to be more specific. i don't know you are referring to. >> don't want me to restate the? question >> i don't understand what and since you are referring to. >> okay, i'll move on. i think the point that i am reiterating and i can't underscore enough because we are talking about a life and death matter is that 47,000 black people die from smoking related illness. making this the largest cause of preventable death among black americans, even more than a gun violence or car accidents. so, we don't have more time, people are dying. so, in my final second, i just want to go to a different line for a moment. so, e-cigarettes are not -- are they recognized as a successful succession? aid >> no. >> they're not and successful

secession device, and menthol cigarettes are not an off ramp for existing smokers. >> but we can go back to 20 seconds you have left, there is a public health balancing act that the agency has to do with whatever policy emerges on flavors, and it's bouncing what are the flavors helping adult transition off of cigarettes, to e-cigarettes, what are flavors playing in that. it's part of the balancing that we need to do. it's an easy call on the negative side of the ledger when it comes to the role that flavors are playing in attracting committed to experiment, especially kids walking around thinking that these are harmless products. but it's a balancing act because we have heard repeatedly from former smokers that it was the presence of certain flavors that help them successfully transition completely away from cigarettes. >> thank you.

>> thank you congresswoman. i now recognize congressman calmer for five minutes of questions. >> thank you. nicotine vaping products must submit pretty tobacco market applications. those applications must be submitted to the fta by may of 2020. to my understanding, there are millions of vaping products sold that have registered, and are currently on the market. it's also my understanding that only a fraction of these products on the market today will have their pre-market tobacco applications filed with the agency by may of 2020, do you agree with that understanding? >> our door has been open for those applications to co-come in ever since we have asserted jurisdiction three and a half years ago, and few applications have come in. >> what plans do you have to remove product from the market for which a pre-market to baku

application has not been filed, and or to alert the public and retailers as to which products continue to be sold. >> if we are in a situation where a deadline has come and gone, and there are currently marketed products that failed to meet the deadline for getting those applications in, then that would be at the top of our enforcement list. we would monitor, it would start with a warning letter, telling them to remove the product from it and we can take action from then, and then it is up to the manufacturer to work with the retailers to get those products off of the market. >> does the fta plan a list, after may 2020 when the deadline passes, setting those products? to plan on making a list? >> i will have to take that back to the center. that is

something that could be considered, and i will get back to you as we think about that. >> thank you. it sounds like a good idea. >> so, when we talk about all the counterfeit product, which is where a lot of the problems occurred, i can say many of the problems occur with the deaths, especially with the thc products, many of which weren't 100 percent thc, many of the products had no thc in it or had all sorts of counterfeit ingredients in it, what actions will the fta plan to take against these counterfeit suppliers? >> let's draw a distinction between counterfeit and elicit, so what we are talking about with whoever the responsible

party is for putting these thc products on the market, these are illicit products, and as i said, but i can't talk publicly about, our investigation, we are making progress in working back the supply chain to find the responsible parties, when we find the responsible parties, we have a variety of authorities at our disposal, also working in consultation because there could be a role in this as well. it starts with finding the responsible parties, and that is the phase of this investigation that we are in, but we are making progress. >> i will close with saying this. i think every stakeholder must do the part and nobody wants to see under age vaping products, a lot of the future

of this depends on fta's rules and regulations. when do you think the fta will finalize and publish vaping products, as many have alluded to. >> i can't give a definitive answer, and the fda has considered to a policy. >> i yield the balance of my time. >> i want to ask another discussion about these parallel discussions happening. you are tangentially related to these discussions, who at the fta it's part of these discussions directly?

>> it is the leadership of the agency and the commissioner's office. >> so the acting commissioner is part of these discussions? >> yes. and then, at the white house, who is directing it from there and? >> i don't know. >> i would like to recognize congressman corona for his five minutes of questioning. >> thank you. mr. geller, you have had a long career in regulating tobacco, working with david cancer in the 1990s, so i want to ask you questions based on your expertise. the tobacco survey results showed that 27.5% of high school kids were using e-cigarettes, and 64% of kids were using meant or mental. do those numbers sound reasonable to? you >> yes. the data also showed that 72% of school users are using flavors, and most high school users use juul, is that correct? >> yes. so, based on your

entire career, going back to your work from david caterpillar, who i admire, if you're making a recommendation to the president, do you think that we should ban mint and mental? >> my recommendation in this process has been to follow the regulatory signs, and to come up with a policy that most closely aligned with what those numbers show. which is that we have an epidemic use of e-cigarettes by middle school and high school kids, they disproportionately favor flavored products and the percentage of kids that are using e-cigarettes more frequently it's also increasing. i will not go into the details of the policy but i can tell you speaking on behalf, our recommendation has been the policy needs to align with that

science and data. >> do you think that banning this would align with the data? >> the only thing i can say publicly is that it's what was said on september 11th by the administration, but i can't go into the specifics of the policy that is still under consideration. >> well, share your opinion, what is your opinion and dealing with a regulation of tobacco for 20 years. if you're talking to david castro, and he said that meant and mental should be abandoned, what would you tell them? >> i will tell you that there was a second reputable national survey that came out in the last month it measures 810 and 12 great use of all products listed and illicit. the survey instrument separates mint from menthol and asks those questions separately the national youth tobacco survey does not mint and

menthol are included in the same question so monitoring the future results what we saw from the analysis done of kids who used juul do a sub analysis that's probably an indication of what's going on throughout the entire category that analysis showed >> published in jama the last month that kids who used juul are way more likely to use the mint product than menthol. that was new information, >> and that was information that has to be accounted for i was having a conversation with a former

commissioner speaking under oath oath. >> but we don't know if they would default to >> menthol. >> that's correct that's part of the consideration. >> but you are not prepared to make a recommendation of your opinion? >> the only thing i can say publicly is that new information that came out in the last survey has to be factored into our thinking. >> you have any reason to suspect politics has gone into the decision-making advising the president he could lose battleground states if he >> bands vaping are flavors? >>

know. >> would you resign if you had any indication? >> i would commit to resigning if there was a fundamentally flawed policy for whatever reason. >> if you had information there is political considerations would you commit to resigning. >> it depends on the final policy is what i would consider regardless of the considerations that went into >> it. we have made a recommendation what we think the policy should be. no final decision has been made i will wait to see what that final decision is. >> thank you congressman. >> thank you for being here today with the past three hearings one issue we have agreed upon is to keep e-cigarettes and vaping products out of the hands of those who are underage. i do feel all these hearings have illustrated the important role e-cigarettes what happens with those who smoke cigarettes >>

it still seems as if it could be a vital tool in production and should remain an option for those who do need it. can you discuss the proactive steps cdc and fda have taken to prevent youth from accessing e-cigarettes? >> yes we are responsible for enforcing part of the law to all tobacco products and with ill legal marketing to kids so through office of compliance and enforcement we issued over 10000 warning letters and penalty complaints with the financial payment for illegal sales at the tobacco retail level in addition we made massive investment of public education to complement the ongoing enforcement actions. i

wish i could say public education in compliance alone would be sufficient to reverse the trend we are seeing in the survey but it's not. more needs to be done unfortunately we have to use our enforcement resources to go after companies that are selling liquids to purposely resemble juice boxes. we did that and a collaboration with the ftc that's also a violation. there's good news and bad news. we sent the first 17 of those warning letters on the issue of e-liquids purposely being marketed to resemble cereal and candy all 17 manufacturers immediately reformulated their packaging. that's the good news about a

month later were doing the monitoring and surveillance online and we saw there was a bunch of online retailer still selling those products. we had to put out an additional batch of warning letters to the online retailers continuing to sell products that manufacturers had agreed to reformulate. >> that leads me to my next question what is being done with enforcement efforts to give the illicit products off the market now? >> talking about thc that is separate. >> explain thc. >> i cannot give you the chemical name but it is a chemical derivative of marijuana there are a bunch of people that are purchasing this completely illegal product to get high. we have seen only in the last

three or four or five months is something changed or happen and how the products were being manufactured and sold because we were not seeing the incidence of lung injury and death even if they were vaping april or may this year the working hypothesis it's a completely illegal enterprise to begin with and agents are being used to cut it to make it go further and those >> agents are oils and if you inhale oil into your lungs that's a bad thing and can make you, >> very sick and in all of the cases the cdc can test they have found the vitamin e acetate oil is present so that leads me to my last question. acetate is fight different than vitamin e oil so do we have two products put together? to make vitamin

>> e acetate. >> i cannot answer that i have to get back to you. it stretches the thc. >> i yield, >> back. >> i don't know if the high nicotine content. >> that the product that is the most popular with kids is high, he recognize for questioning the witnesses wall. and i would like that objection we will enter this response

letter from the fta as well as -- to my letter and coughing mr. cloud, in acquiring about the status of the flavor guidance with that i will now recognize congresswoman to leave for five minutes of questioning. >> thank you for being here, yes or no it is the high nicotine contribute to on youth use. >> i don't know if it does. >> let me elaborate but the products that it seems to be the most popular with kids is very high indicating. >> so nicotine salt as well? >> that's difference nicotine souls may make it easier for you to go, it's part of our an ongoing investigation of tool. >> so do you think they would be kept it non addictive for addictive level it would help

increase this use. >> that is something we are certainly considering for combustible cigarettes, i'll just leave it at that. similarly if nicotine zones would help decrease this. >> i don't know but we have an active ongoing investigation in this. >> does fta have the authority to cap these levels. >> yes. >> do they have the authority to ban it insults any cigarettes. >> yes. >> well they commit to bring these ideas to the table? >> this is part of an ongoing investigation. >> but those specific bans. >> we would be happy to continue to talk about it and better understand the science, product is nine and how they work in the public impact. >> our chairman has taken the lead in sent a letter i think on september 5th aligning evidence that we uncovered about jewel legally marketing its products in schools a

number of places as smoking products and by claiming it was safer than cigarettes and so forth. hefty a responded saying that is making modified risk claims, what made you lead to this that jewel had broken the law? >> we have the marketing practices of juul and i would say that the information that the subcommittee put on the record and its two-day hearing in july law gave us additional information and additional concerns that the very specific examples that you just mentioned cross the line into what we call health claims, claims to reduce exposure to toxins reduce risk and in that area we were able to assemble to have that evidence and use it as the basis, separate and apart and additional level that

went to the same day making a massive request for documents. >> in your letter you did ask them to respond. >> they responded by the end of the mountain if they missed it designers only by a day or two. >> you get us that response. the >> i can discuss the outcome >> you can't provide the response? >> it's an ongoing investigation. were it to be closed i could come back and brief you on everything. the company responded and we are reviewing the response. if we close the letter we can give you more information. spin it could be years? >> iit wouldn't be. let's say an amount of time. >> sorry, i'm a mother of two young boys, i want to make sure we resolve this. fta can modify

companies, what are the maximum possible penalties they are permitted to impose in situations like juul? >> let me just talk hypothetically about the authorities we have at our disposal. they're both similar and criminal. we can work with our lawyers, and we can change the behavior of the company that broke the law. there are other instances where they can be massive fines to the federal government, and then working with the justice department, if we think there has been criminal activity, there can be a criminal investigation and prosecution. >> thank you so much. i yield the rest of my time. >> thank you, let me use the remaining time to further explore