Transcripts For CSPAN3 House Oversight Subcommittee Hearing On Vaping E-Cigarettes 20240713

Member collins will hear from democrats and Republican Council on the findings of the inquiry. Our coverage starts live at cspan or cspan. Org or you can also find it on the free radio app. The director of the sen for for Tobacco Products testified about eliminating ecigarette use. This Committee Hearing focused on the status of the proposal to ban ecigarette flavors that was suggested by President Trump in september, but it has not yet been implemented. This subcommittee will come to order. Again, the chair is allowed to stop the Hearing Committee at any time, and this hearing is about youth ecigarette use, and fda and food and Drug Administration compliance policy. I now recognize myself for five minutes for a opening statement. The administration released deeply disturbing results from the National Youth poe back coe survey otherwise known as the nyts. And the data confirmed our fears that the youth vaping epidemic continues to grow the alltime highs. 5. 3 Million High School students are alarming both among the High School Students and middle school students. Here, i will show you two visuals. On your right, we said in 2017 roughly 1,200 high schools, and in 2019, almost 28 of High Schoolers are vaping meaning that there is a 135 increase in vaping among High Schoolers. On the left, there is another visual which is even more disturbing. Today that figure is up to 18 and this is a 218 rise of vaping in middle schoolers. As parent of three children, these statistics are extremely disturbing. And the nyts data shows that the flavors are driving the youth vaping use. 72 of the youth who vape use flavors. And 64 of all kids who vape use mint or menthol. That makes sense, because nyts data said that juul is the most popular youth brand with most kids who vape using it. Armed with this data, the heads of americas Public Health agencies convinced the president at least temporarily to do the right thing. The data linking the alarmingly high vaping rates to flavors, the president and the heads of hhs and fda announced the proposal on september 11th to essentially ban flavored ecigarettes with the exception of tobaccoflavored ones. They put forward a sound and logical response to the problem. As hhs secretary alex azar pledged, quote, we require that all flavors other than tobacco flavor be removed from the market. This would include mint and menthol flavoring as well as candy flavors, bubble gum flavor and fruit flavor and alcohol flavor. Secretary azar explained that these products are still getting to kids, and we cannot let a whole generation get addicted to them through mint and menthol and other flavors, close quote. In the same announcement the president committed that this bold flavor ban would be issued within the next quote couple of weeks, close quote. When the president made this exciting announcement on september 11th, i and many members of the Committee Led the charge in commending a ban of all flavored ecigarettes would deter all youth vapors from starting. In a tumultuous time in our politics, i referenced the announcement from the president at bipartisanship at its best to preserve the youth of america, and while it is our privilege to back the president to take steps to strengthen Public Health, it is also our responsibility to hold him and the Administration Accountable to the bold promises. Unfortunately almost three months after the president s initial announcement, the flavor ban has not yet been implemented. Reports illustrate that big tobacco lobbyists are working to weaken the ban, and indications as well that the administration is considering exempting menthol as well as exempting vape shops. We sincerely hope that the reports are inaccurate. In light of the allegation, we tried to find out what was happening, and we first wrote the fda and asking it to finalize an issue that the flavor ban would have without exemptions. The fda did finalize the guidance and instead of publishing it, they sent it to the office of information and Regulatory Affairs also known as oira, and that is important, because they gut and delay agency action. By the way, oira is an office within the office of management and budget within the white house, and that is referred to repeatedly today. In fact, fda has submitted these requests for bans before, and after a flood of lobbying, they eliminated the prior ban of flavoring all together. We wrote oira and they would not again fall victim to lobbying, and they complied, but again, the guidance was not published. Not publishing at that stage is highly unusual, and so the subcommittee wrote to both oira and the fda to ascertain which agency controlled the guidance. Neither answered. So far neither the fda nor oira will clarify if the guidance is with their office. However, we did get an update on december 3rd, and that would be two days ago which is that oira has said that it has completed the review, and so we assume that the guidance is now with the fda again. The American People deserve answers. Mr. Zeller, you are the director of fdas center for Tobacco Products. Today parents across the country expect that you will provide them with 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, mr. Chairman, and thank you mr. Zeller for being here to participate in what may not be the most watched hearing of the day, but certainly one of the more important ones. Let me say at the outset, thanks for the chairman for the focus on this issue, and the cooperative spirit for the most part we have maintained in this issue even in the polarized environment. In having Solutions Oriented discussion on this issue. I know that we are especially united on the goal to end teen vaping, and it is an epidemic that is uniquely troubling, because it has caused harm in fostering the nicotine depen r dependency of youth, and as a father, i can only imagine the agonizing realization that understanding that your child has become addicted to something that they had no idea was even harmful or the pain of the devastating loss of losing a child or loved one. My sincere condolences to those who have lost loved ones to this illness. Over the past few month, it is obvious that something is making the users of the vaping products sick. When we think of the vaping epidemic, it is important to recognize two tracks of concern that need attention and require a tailored solution. There is the teen vaping epidemic enveloping as much as 20 of our nations youth, and then the lung damage according to the cdc has led to the deaths of 47 people in 25 states and the District Of Columbia as well as 2,290 who have fallen ill to vaperelated lung injury. This aspect of issue has affected all ages. Of those hospitalized, 15 under age 18, and 38 were 18 to 24, and 24 , 25 to 34 and 23 were 35 years and older. This has been a complex issue, because while it is clear that vaping products are hooking young people in nicotine, it is appearing that a tainted black market products are likely causing much of the lung injury. Some of the challenges in dealing with these issues of course have been the rapidly development of the epidemic, and the day that is pointing to clear causes and the counter products that are blurring the origin of the tainted products, untraceable supply lines and particularly within the black market, and the lack of effective enforcement, and of course, the challenge that we have faced as legislators in protecting the public from harm while protecting their individual liberties. Thankfully, we have had some breakthroughs in the findings of the past few weeks to bring understanding to what is causing the lung injury. In the last update, the vitamin e acetate is identified as a chemical of concern. And thc is present in some of the samples, and there is a most notably thickening agent in the thc products, and these are showing that the ecigarettes products are the most recent culprit for the outbreak of lung injury. From the Associated Press and wall street journal have been reporting on the availability of ecigarettes and vaping products that are widely available, and also online. These are often made by bad actors and include additives like pesticides. The cdc has warned user ns not buy Products Online or off of the street. And we are hoping that the federal and state enforcement can tell us what is the cause of these illnesses and to be addressing them appropriately. And we are interested in what fda has been making in progress to curve the vaping use. And we are hoping this committee will bring not only misconceptions of the Health Dangers associated with vaping, but the Public Health issues relating to the a quagmire of the chain. And lastly, we are hoping to consider these concerns to balance the rights of the teens and the consumers who find that vaping is a less damaging alternative to traditional smoking, and before closing, i would like to thank you, mr. Zeller, for the testimony and being here today. As always, i am grateful for the committee and the chair and us being able to Work Together on this issue. Thank you, chairman. I yield back. Thank you. Congressman cloud, i now want to recognize our new full Committee Chairwoman caroline maloney, and congratulations. I look forward to working with her leadership and this is a issue that she is concerned about. And i invite you the say a few words at this time. And i would like to thank the committee for working on this and the entire subcommittee of addressing the epidemic. Ecigarettes are luring a new generation of americans into deadly lifelong addiction. The centers for Disease Control and prevention found that tobacco use among the High School Students has increased by nearly 40 in the past year alone. Fueled by ecigarette use, and last year over 20 of the teenagers reported ecigarette use, and 78 increase from year before and we are facing a Public Health crisis. Thankfully the subcommittee has stepped in to protect Childrens Health and hold this industry to account. Briefly, it looked like we would have a very important Strong Partner in this fight, president donald trump. But he has walk back his commitment of favoring a flavor ban. 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 the questioning of the witnesses. I yield back. Thank you. Thank you, chairwoman. Now, id like to recognize our witness. Today, we are joined by mr. Mitch zeller, the director of the center for Tobacco Products at the food and Drug Administration. Sir, 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 that you are about to give is the truth, the whole truth and nothing but the truth so help you god . I do. Let the record show that the witness answered in the affirmative. Thank you, and id like you, id like to invite you the give us your opening statement. The microphones are sensitive, so please speak directly into them. Without objective, your entire statement will be entered into the record. You may begin. Thank you, and chairman and chairwoman maloney, and i have worked on this committee from the 1970s into the 1980s and Ranking Member mcleod and the committee and thank you for the opportunity to be here today. I wanted to be clear in recognizing the subcommittee for the work to examine the potential causes of the epidemic of the youths use of these ecigarettes. I am here to represent hundreds of staff who are working ti tirelessly to prevent kids from being started in tobacco and including ecigarettes. I understand that you are concerned about the administrations policy of ecigarettes, and i wanted to assure the subcommittee that we are doing everything that we can to prevent the kids from using Tobacco Products and to have an approach to align with that. Recentlyed a ministration had a listening session to help inform the policy actions going forward. I will be happy to return the brief and subcommittee and staff about the updates. I would like to talk about the initial efforts to regulate ecigarettes and this began over a decade ago long before the rise in youth use. The fda attempted to regulate the ecigarettes as drug combined products. It was challenged and ultimately overturned in court. In decade since the Tobacco Control act was passed, fdas center for Tobacco Products, ctp, has established a sciencebased approach to the regulation of tobacco approach. And vick rousely enforced our targeting of the manufacturers and the retailers who violate the law and designed innovative campaigns to educate the kids on the dangers of tobacco use. And ctp has expanded the use and focus of authorities to address new challenges of products such as ecigarettes, and the control act is going to provide the authority of the tobacco product, and the publication of the final deeming rule brought the ecigarettes under the fda regulatory august 2016. Protecting the youth from the dangers of Tobacco Products is one of our most important responsibility, and we will continue the take aggressive steps to make sure that Tobacco Products are not advertised or targeted towards kids. This is what we have done to help curve the use by youth. We have filed over 1,600 civil money complaints, and against online and brick and mortar retailers for the illegal sale of ecigarette products to kids. We have issued the warning letters that have resulted in the kid friendly foods like juice boxes and cereal and candy to be prevented. We have issued juul lab for marketing unrecognized and modified products to market juul products as producing reduced or no harm compared to cigarette smoking. We sent a second letter to juul to talk about the issues raised be i this subcommittee regarding the juul marketing practices targeted at students, tribes and Health Insurance employers. And we have shown that despite the efforts, juul products are representing a significant proportion of the overall use of ecigarettes by children. Last year we launched t ed thed cost which is featuring hardhitting ads on tv and digital and media sites popular with teens and posters with the ecigarette prevention messages across the nation. And finally, we join forces with scholastic to develop resources that have been distributed to a Million Middle School educators. And yet, the epidemic continues to grow and we have to do more. So as the subcommittee is considering the use of ecigarette, it is important to know that no ecigarette product is lawfully on the market, because they have not received authorization from the fda. When we announced the changes of the enforcement discretionary policies, at the time, the youth use of ecigarettes had declined, but as we all know and the chairman pointed out last year the National Youth Tobacco Survey showed that from 2017 to 2018, the current ecigarette use in high schools increased by 78 , and by 48 among middle school student, and last month we published the 2019 data showing that the current ecigarette use had risen to 28. 4 among high school, and 10. 4 in middle school. As in previous years the 2019 data is showing a disturbing use of flavored ececigarettes. And among the current use, 3 4 of them in high school and more than 1 2 in middle school used flavored ecigarettes. We are committed to do everything that we can to prevent the kids from using the Tobacco Products and as i stated in the outset, we will continue a policy approach that aligns with the concern. I want to thank you for the opportunity to testify today, and id be happy to answer any questions that grow have. That you have. Thank you, mr. Zeller, and thank you for being here today. Id like to recognize myself for five minutes of questions. Mr. Zeller, you are aware that on september 11th, hhs secretary azar said that the fda would issue a guidance of clearing the market of nontobacco cigarettes including mint and menthol products, right . Yes. And you are aware that secretary azar announced the ban, because the numbers from the nyts is showing a continued rise of the use of ecigarettes and especially the nontobacco flavors that appeal to kids . Correct. And secretary azar further stated that more than a quarter of the High School Students were current ecigarette users in 2019 and the overwhelming majority of the ecigarette u r users and 75 of the high sch l schoolers and overwhelming majority of the youth ecigarette users cited fruit or mint or menthol flavors . That is correct. The purpose of banning or as you, the secretary azar said, clearing the market of flavored ecigarettes was to decrease the youth vaping, right . That is consistent with what the secretary said, yes. And there is urgency, and urgency and that why the president said on september 11th, that the fda action would come in a couple of weeks, right . That oes os what was said. That is correct. That is what was said. And that it would be done. That is correct. And then you stated that the work on the guidance was a very, very high priority and trying to complete work on it as quickly as possible, right . I dont remember the date, but yes, i said that. E yo, yyes, you said it on o 25th to the hill. But the flavor guidance has not been published yet, has regardi to me and oira, they drafted a guidance and sent it to oir, a an office within the omb on october 25th, correct . Yes, sir. And to be clear, fdas guidance document followed through on secretary azars september 11th announcement that the fda would clear the market of all nontobacco flavors, correct . I wont get into the substance of the document that was submitted. Okay. On what basis are you not getting into the substance . Because there is no final decision made on the policy, because there are ongoing discussions taking place, and it wont get into the substance of what was in that document. And who instructed you not to get into the substance of it . It is based upon discussions internally at the agency, aed it is Standard Practice when theres ongoing policymaking, and that we dont talk publicly about what is under consideration. I said in the remarks that i would be happy to come back the brief you and the staff when there is a final decision and walk you through everything, but this remains an open and ongoing set of discussions. So according to the fda letter sent to me yesterday, and oira and fda, they concluded the review by oira on november 5th, kr ekt . Correct. And did oira make any changes to the initial guidance again, i cant go into the details of what is remaining ongoing discussions. Now, you are familiar with something called the executive order 12866. Correct. Yes, sir. According to the catchy phrase eo 8866, they are not allowed to publish until oira has completed the review . For things that are subject to the executive order. Correct. And this is one of them . This is a policy that is because of the significance, we sent to omb for review, yes. And it is basically eo12866 is going to apply and basically talking about the types of the policies that would be submitted to oira and then sent back to the fda . Correct. And oira has marked the review quote, unquote completed on the website. Its website. That means mr. Zeller, the policy is now back with the fda, right . They completed their review on november 4th, and sent the document back to us. But there were still other ongoing policyrelated discussions going on in parallel. But oira did complete its review and sent it back to us. When you say there were policy discussions ongoing, between who and who . There were parallel policy discussions going on between fda, the department and the white house. So according to executive order 12866, the fda is not allowed to public until the review is complete. Now that its completed its review, the fda can publish the guidance, right . If the complete executive branch review of the policy was done, but there were still as i said in parallel other ongoing policyrelated discussions going on in addition to the oira review of the guidance document. So these parallel discussions, this sounds like some kind of irregular channel of discussions independent of the standard submission of the guidance from fda to oira and back from oira to fda . Is there some other review that is happening right now that has nothing to do with oira or fda . There are ongoing policy related discussions between the agency, the department and the white house, about what the policy should be. Okay. So did oira really complete its review if they are still discussing with you this document . Oira completed its review, but at other levels within the department and the white house and the agency, and again in parallel, there were discussions continuing about what the policy should be even though oira had completed its review. And who is part of those discussions at the fda . The leadership of the agency, the leadership of the department and various parts of the white house. That includes you . Ive been involved peripherally. Its mostly been the leadership. And at the white house who has it involved . I think its various offices, from the domestic policy counsel to the office 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 counsel is headed by joe growingan is that correct . Correct. You would agree with me that the fda should be regulating Tobacco Products, dont you . Thats our job, yes. Its not a waste of time . Its one of the most Important Health things a Regulatory Agency can do. Ive devoted the last 25 years of my life to. Thats why i am so concerned that your prior answer that the white house domestic counsel headed by joe grogan, when he said it was a huge waste of time, closed quote, for fda to regulate tobacco. Im going to recognize others for questioning. Mr. Cloud, youre recognized. I took a couple extra minutes so why dont pe put some time on his clock . Thank you. Electronic cigarettes have been available in the u. S. For awhile now. Youve mentioned that. For several years. Could you speak to why were just now seeing cases of this illness . I think that theres a definitive answer to why only within the last three or four months that weve seen so many cases of pulmonary illness. Theres a working hypothesis and that is that because so many of these cases are associated with the vaping of thc that there may be something that was added to the product more recently, that is associated with the more recent rash and increase in both injuries and deaths. And do we have a clear understanding . This has been a developing issue, a rapidly developing issue, theres many sources especially when it comes to teen vaping, many of them getting them from their froziends old enough to buy them. Do we have a better understanding of the sors of the vaping products that are leading to illness yet . As you said in your opening remarks, mr. Cloud, its important to differentiate between the epidemic levels of kids use of ecigarettes where its just a product thats delivering nicotine, versus some kind of vaping device, likely bought off the street, possibly modified by the user, containing thc and these other compounds showing up increasingly in the samples that we and the cdc have analyzed. Its why the advice of the federal government is, dont vape thc. Wont buy these products. Be careful about what kind of modifications you make to them. Thats separate and apart from the focus of your and the chairmans remarks about what to do about kids use of more conventional ecigarettes. Right. And weve had some recent discoveries i guess as far as what we think may be causing the illness. Could you speak to that . Sure. Were working very closely with cdc, using our forensic chemistry center, which is a really sophisticated labry that fda has, to support Law Enforcement action that the ladies a agency would take. When we get samples from the states when theyve forwarded them for analysis, its based upon the analysis of the samples ats a chemistry level that were able to conclude that it looks like in roughly 80 of the cases that have been linked to patients, thc has been identified. And in about 3 4 of those cases, a duelutant known as vit min e acetate which is an oil has been identified. And because of a lung tissue that cdc did within the last month or so, they were able to conclude that thc and vitamin e acetate may be linked to whats going on here. But both agencies have been very clear to state publicly that there may be more than one c cause. But its looking like some combination of thc with this vitamin e acetate is playing a role in a number of these cases. Kind of what i was trying to ask before. When it comes down to the specific cases causing injury, do we have a clear idea of which products and the supply lines for those products yet . Have you been able to trace any of that information back to we are using where theyre most likely coming from . Im sorry. We are using the resources of our office of criminal investigations. We have boots on the ground as were trying to trace back the supply chain here. We are not using the office of criminal investigations resources to go after personal use or possession of these products. Its, who was the responsible party for putting these thc products into the marketplace. And since this is a very sensitive and Ongoing Investigation the only thing i can report to the committee, subcommittee, is were making progress. But its not like a romaine lettuce outbreak where you have responsible, lawful entities that want to get to the bottom of whats causing the outbreak and 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. Now, you did mention some of the stuff the fda has done recently to help educate you kids about the dangers. I think weve spent what, 60 million on the real costs campaign . Youve highlighted some of those if you want to touch on those again. And is there anything else the fda is considering to help mitigate . I think when it comes to addressing this, a comprehensive approach is required. Were using as many of the regulatory statutory tools and resources that we have. Weve made a major investment in a Public Education campaign, what you see what weve learned from research, this is in real contrast to kids perceptions of the cigarettes, kids know combustible cigarettes are dangerous. There are still kids at risk of smoking. They know. But by contrast what weve learned from our research a lot of kids are Walking Around thinking that ecigarettes are harmless. Amazingly in some surveys, there are kids who dont even know that theres nicotine in ecigarettes. The most important thing we can do in our Public Education efforts is to communicate to kids, and we know how to do that from the work weve done in the Real Cost Campaign going back the last five years, to communicate the Health Consequences of vaping ecigarettes, whether its the risk of becoming adirkted to nicotine or the harmful compounds present. Public education, the science to better understand the meetium and longterm Health Consequences, are the tools that we have at our dispose ail that were trying to make the best use of. Okay. Thank you. I yield back. Thank you, mr. Cloud. I now recognize congresswoman presley for five minutes of questioning. Thank you, mr. Chairman, for your continued commitment to this issue. It is critical that we hold both big tobacco and vaping accountable for targeting young people and knowingly hooking generations of black and brown americans to nicotine. Our work to end this is not simply a matter of Public Health. This is also 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 and menthol cigarette products. This is important because we must been all, which includes mint and menthol. To not do so would be discriminatory. Because its imposed a unique burden on the black community. We must clamp down on the products and not the possession of it. There are intergenerational consequences of broken windows, which has historically over criminalized black and brown communities. We must be simultaneously attuned to both Public Health and safety to ensure there are no more erik garners. For years Big Tobacco Companies disproportionately targeted more tobacco and menthol adds in black neighbors. As many as ten times more. The cdc records that nine out of ten black smokers prefer. The targeting was effective, correct . I would agree with that. So today nearly 45 of black menthol smokers say they would quit smoking if Menthol Cigarettes were banned. And almost 2 3 under 24 would do the same. A year ago the fda said they would ban saying a ban was necessary because menthol products disproportionately affect under served communities. A year as passed and its not followed through on this ban. Why is that . We went through an advanced notice of proposed rule making on a variety of issues related to flavors including the presence of menthol in cigarettes. And i would add to what you said, that one of the Public Health concerns about mengtlated cigarettes is not just a disproergsat use by africanamericans but the role that menthol skraets cigarettes plays in attracting kids of any color to experimenting with cigarettes. And we continue to review the comments and explore what the regulatory options and policies should be. But i absolutely hear you. And as center director, share your concern from a Public Health perspective. Just to reclaim my time for a moment in the interest of time. To be clear on the record. Does the fda plan to follow through with this ban, yes or no . I cannot give you a yes or no answer in an open public hearing. All i can tell sue that were continuing to review all of the evidence related to flavors in all Tobacco Products as we try to follow the science and come up with the right policy. So previous attempts to ban mentholel thol have been over ridden by the office of management and budget. Why . You need to be more specific. Do you want me to restate the question . I dont understand what specific instance youre referring to. Ill move on. I think the point im reiterating, and i cant underscore enough because were talking about life and death, is that 47,000 black people die every year related plaurking this the largest cas of presentable even more than gun violence or car accidents. We dont have more time. People are dying. So in my final second, i just want to go to a different line for a moment. So ecigarettes are not are ecigarettes recognized as an effective smoking ses saigs aid or not . They are not approved by fda as that. Theyre not an effective device. Menthol are not an offramp for adult menthol smokers, they are an onramp to hooking a new generation of smokers . If we can go past the 20 seconds you have left, theres a Public Health balancing act the agency has to do with whatever. And its balancing well are flavors helping adults successfully transition off of cigarettes completely to ecigarettes . What role are flavors playing in that . Its part of the balancing that we need to do. Its an easy call on the negative side of the ledger when it comes tote role that flavors are playing in attracting kids to experiment, especially kids who are Walking Around thinking that these are harmless products. But its a balancing act because we have heard repeatedly from former spoke thaerz it was the presence of certain flavors that helped them successfully transition completely away from cigarettes. Thank you. I yield back. Thank you, congresswoman. I now recognize congressman comber for five minutes of questioning. Thank you. Mr. Zeller, nicotine vaping products must submit pretobacco market applications. Those applications miust be submitted to the fda by may of 2020. Its my understanding that there are millions of vaping products sold that have registered with the fda and are currently on the market. Its also my understanding that only a fraction of these products on the market today will have their premarket tobacco am kagtss filed with the agency by may of 2020. Do you agree with that understanding . Mr. Comber, our door has been open for those to come in every since we asserted jurisdiction three and a half years ago and precious trfew have come in. What plans does the fda have plans to remove products on the market for which an application has not been filed and to alert the product and retailers as to which ones can continue to be sold . If we are in a situation where a deadline has come and gone and there are currently marketed products that fail to meet the deadline for getting those applications in, then that would be at the top of our priority list for enforcement action. We would monitor the marketplace. It would likely start with a warning letter to the company telling them to remove the product from the market, and we could take stepped up enforcement action from them. Then its up to the manufacturer and distributor to work with the retailers to get those violative products off the market. Does the fda plan to post a list in the weeks after may 2020 when the deadline passes setting forth all those products for which a premarket application has been made . You plan on making a list . I will have to take that back to the center. Thats something that could be considered. And ill get back to you as we think about that. Okay. All right, great. Sounds like a good idea. So how when we talk about all the counterfeit products which is where a lot of the problems occurred, most, i could say many of the problems have occurred with the deaths, especially with the thc products, many of which werent 100 thc, many of the products had no thc in it or had all sorts of counterfeit ingredients in it. What actions will the does the fda plan to take against these counterfeit suppliers . Lets draw a distinction between counterfeit and illicit. What were talking about with whoever the responsible party is for putting these on the market, these are illicit products. And as i said i cant talk pub looibly about our investigation, were 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. Were working in consultation with the Drug Enforcement administration because there could be a role for them as well. It starts with finding the responsible paerntsst parties and thats the face of this investigation that we are in but we are making progress. Thats great. Thank you. Ill close with saying this. I think every stakeholder must do their part. Nobody wants to see underage youth use vaping products. No one wants to see Companies Marketing to youth. When will be but a lot of the future of this depends on fdas rules and regulations. When do you think the fda will finalize and publish the guidance on vaping flavors when were talking about regulating the flavors or a flavor ban, as many have already alluded to up here . I cant give a definitive answer, other than to say that the discussions that have been taking place continue. And fda is committed to a policy that aligns with our Public Health concerns about whats going on with kids and flavored ecigarettes. Okay. All right. Thank you, mr. Chairman, i yield the balance of my time back. Im going to use the balance of your time to ask another question about these parallel discussions that are happening. You are tangentially related to these discussions. Who at the fda is part of these discussions directly . Its the leadership of the agency and the commissioners office. The acting commissioner is part of these discussions . Yes, he is. Okay and then at the white house, whos directing it from their end . I dont know. Okay. Id like to recognize congressman khanna for his five minutes of questioning. Thank you, mr. Chairman. Mr. Zeller, youve had a long career in regulating tobacco, working with David Kessler in the 1990s. I want to ask you questions based on your expertise. Results showed that 27. 5 of High School Kids were using ecigarettes and 64 were using mint or mengt ol. Do those numbers sound reasonable to you . Yes. And the data showed that 72 of users are using flavors and most high school users use juul. Is that correct . Yes. So based on your entire career of regulating tobacco, going back to your work for David Kessler, who i admire, if you were making a recommendation to the president , do you think that we should ban mint and menthol . My recommendation in this process has been to follow the regulatory science and to come up with a policy that most closely aligns with what those numbers show, which is that we have an epidemic use of ecigarettes by middle school and High School Kids. They disproportionately favor flavored products. And the percentage of kids that are using ecigarettes more frequently is also increasing. Im not going to go into the specifics of the policy. But i can tell you speaking on behalf of the center for Tobacco Products that our recommendation has been that policy needs to align with that science and that data. So do you think that banning mint and menthol would align with that science and data . The only thing i can say publicly is that that is what was said on september 11th by the administration. I cant go into the specifics of the policy thats still under consideration. But you could share your opinion. What is your opinion . Weve been dealing with the regulation for 20 years. If you were talking to David Kessler and he said do you think mint and menthol should be banned, what would you tell him . Ill tell you what i would tell him, and that is, there was a there was a second representable National Survey that came out within the last month called the monitoring the future survey. Representutible, been around for years. It measures eight, tenth and 12th grade use of all kinds of products, licit and illicit. And the survey instrument in the monitoring the future survey separates mint from menthol. It asks those questions separately. The National Youth Tobacco Survey doesnt. Mint and menthol are included in the same question. So in the monitoring the future results, what we saw from an analysis that was done of kids who used juul been but since the majority of kids who use ecigarettes use juul, doing a sub analysis is probably a good indication of whats going on throughout the entire category. And what that showed and that was published in the journal of American Medical Association last month, was that kids who used juul are way more likely to use the mint product than the menthol product. That was new information. And that was information that has to be accounted for, whether i was having a conversation with the former commissioner speaking under oath but we dont know if they dont have the mint option whether they would just default to the menthol option . Thats correct, and that would have to be part of the considerations. Youre not prepared here to make a recommendation of your opinion, what you would recommend . The only thing i can say publicly is that that new information that came out in that survey has to be factored into our thinking. Do you have any reason to suspect that politics and electoral politics has gone into the decision making, people advising the president that he could lose battleground states if he banned vaping or banned flavors . No. Would you commit to resigning if you ever had any indication that that was a consideration . I would commit to resigning if there was a if we wound up with a fundamentally flawed policy for whatever reason. But if you had heard information that there was political considerations, would you commit to resigning . I think it would depend on the outcome of the policy. Im talking about the final policy. Regardless of what the considerations that went into that. We have made a recommendation as to what we think the policy should be. No final decision has been made. And ill wait to see what that final decision is. Im out of time. Thank you. Thank you congressman. Now i recognize congresswoman miller for five minutes of questioning. Thank you, chairman krishna moorgty and Ranking Member cloud. Thank you for being here today. In our past three hearings one issue that we all have agreed upon is to keep ecigarettes and vaping products out of the hands of those who are underaged. I do feel that all of these hearings have illustrated the Important Role that ecigarettes can play in helping people quit smoking cigarettes. It still seems as if it can be a vital tool in reduction and should remain an option for those who need it. Can you discuss the pro active steps the cdc and fda have taken to prevent youth from accessing ecigarettes . Yes, and thank you for the question. Were responsible for enforcing the part of the law that staebds a federal minimum age of sale to all Tobacco Products and for enforcing the law about illegal marketing of ecigarettes to kids. And so through our office of compliance and enforcement, we have issued over 10,000 warning letters and over 1,600 civil penalty kplans. Thats seeking a financial payment to the federal government for repeat illegal sales at the retail level he to minors in our what we call our compliance check program. In addition weve made a massive investment in Public Education to complement the ongoing enforcement actions. I wish i could say that Public Education and compliance and enfoeshsment alone would be sufficient to revoers the trend that were seeing in the annual surveys. But its not. More needs to be done. Unfortunately weve had to use our enforcement resources to go after companies that were remarkably selling elick wids to purposely sell joyce boxes. We did that in collaboration with the federal trade commission because those were violations of the federal trade commission act. Theres good news and bad. The good news is when we sent the first 17 of those warning letters just on the issue of eliquids that were purposely being marketed to resemble juice boxes, serial and candy, all 17 manufacturers immediately reformulated their packaging. That was the good news. When a month later we were doing the kind of monitoring and surveillants we do online with the techniques we had, and we saw that there were a whole bunch of online retailers still selling those products. So we had to put out a whole additional batch of warning letters to the online retailers that were continuing to sell products that manufacturers had agreed to reformulate. That sort of leads know my next question which is what enforcement efforts are being done to get the illicit and illegal Vape Products off the market now . When were talking about the illicit problem thats going into thc. Will you please explain what thc is . I cant give you the chemical name but its a camcal derivative of marijuana. So that people do know . There are a whole bunch of people who are purchasing this completely illegal product to get high. And what weve seen only in the last three, four or five months is something changed, something happened, in how these products were being manufactured, if you will, and sold, because we werent seeing the incidents of lung injury and death even if people had been vaping thc earlier than april or may of this year, something changed earlier this year. The working hypothesis is, well its a completely illegal enterprise to begin with. And agents are being used to cut the thc to make it go further. And the agents that are being used are oils. And if you inhale oil into your lungs, thats a really bad thing. And it can make you very sick. And in all of the cases that the cdc has been able to test lung fluid, they have found this vitamin e as stittate, this oil, present in every one. That leads me to probably my last question. Acetate is different than vitamin e oil. Do we have two products being put together to make vitamin e acetate . I cant answer that. Ill have to get back to you. But it is an oils that being added as a dilutant to stretch the thc. Thank you. I yield back. Okay. Without objection id like to have congresswoman Wasserman Schultz and congressman saur banes permitted to join the dais and id like without objection will enter this response letter from the fda as well as oira to my letter, and copying mr. Cloud be inquiring about the status of the flavor guidance. With that, i will now recognize congresswoman tlaib for five minutes of questioning. Thank you so much for being here. Mr. Zeller, yes or no, does the high nicotine content contribute to youth use . I dont know if the high nicotine content contributes. How about nicotine let me elaborate. The product that seems to be the most popular is very high in nicotine. So in nicotine salts as well . Thats different. Nicotine salts may make it easier for the nicotine to go down. Its part of our Ongoing Investigation of juul. Yes or no, do you believe if they were capped at nonaddictive levels it would help did he krooes youth use . Thats something were considering for combustible cigarettes. Similarly if nicotine salts were banned would that help decrease youth use . I dont know. We have an active Ongoing Investigation into the role of nicotine salts and the nicotine levels. Does fda have the authority to cap nicotine levels . Yes. Does it have the authority to ban nicotine . Yes. Will it commit to bringing these ideas to the table . This is part of an Ongoing Investigation. But those specific bans and wed be happy to come back and talk to you when were further along in the investigation so we can better understand the science, product design, how these products work and the Public Health impacts. Our chairman has taken a lead and he sent a letter on september 5th outlining evidence we uncovered about juul illegally marketing its products in schools, a number of places that were directly to youth both as smoking sessition products and claiming it was safer than cigarettes. Fda promptly responded by issuing a warning letter declaring it had broken the law. Briefly, what led to you conclude juul had broken the law . We had our own Ongoing Investigation of the marketing practices of juul. I would say that the information that the subcommittee put on the record at its twoday hearing in july gave us Additional Information and additional concerns that the very specific examples you mentioned crossed the line into what we called illegal modified risk health claims, to either reduce exposure to toxins or risk. In that area we were able to assemble all the evidence that we had that you had provided on the Public Record, and use it as the basis for a warning letter to the company. Separate and apart from an adpigsal letter that went to the same day making a massive request for documents. You all did ask them to respond within 15 days. Did they . They responded by the end of the month. If they missed the deadline it was only by a day or two. And will you get us that response . I can discuss the outcome of that you cant provide the response from juul to this committee . Not while its an Ongoing Investigation. It has not been closed. Were it to be closed i could come back and brief you on everything that we found. The skp responded. We are reviewing their response. If we close that warning letter i can come back and give you that. How long can cases go by . Can it be years . It would not be years. Lets just say a voluminous amount of information im just trying to make sure we resolve this before not only juice boxes were going to have candy or suckers out there with this stuff. Fda can punish companies. What are the possible penalties theyre permitted to impose in situations like juul . Let me just talk hypothetically about the authorities that we have at our disposal, and theyre both civil and criminal. On the civil side, we can work with our lawyers and the lawyers at the Justice Department, and there can be seizures and injunctions to completely change the behavior of the company that broke the law. There are other instances where there can be massive fines to the federal government. And then working with the Justice Department if we think theres been criminal activity there can be criminal prosecution. I yield the rest of my time, mr. Chair. Thank you, congresswoman. Let me use the remaining time to further explore. Why are ecigarettes so dangerous to youth . Two fundamental reasons. Our brains dont fully develop until were like 25 or 26 years old. And its clear that any exposure to nicotine in the still developing addless ept brain is harmful regardless of what the other hazards, chemicals in the vapor, in the liquid are. Just the nicotine alone is reason enough to be concerned that no kid should be spreermting with this product because of the armful impact of nicotine. Then what you add what is known about some of the harmful compounds in the aerosol, those bring additional risks. The Harm Reduction debate, is there a role to help people switch to ecigarettes, thats a different and separate question when we make a relative Risk Assessment if you switch youll be exposing yourself to fewer toxins. No kids should kids are Walking Around thinking its water vaipor and dont even know that nicotine is present. I now recognize congressman grassman for five minutes of questioning. Thank you. Were going to go over some territory youve already considered. You see the list behind you, the number of middle school and High School Kids who are using these. Do you know how many of the people are using these are using what ill call legal products that i could pick up at my local Convenience Store and the number that are using illegal products including thc . The data that the chairman has put up is use of lawful ecigarettes delivering nicotine. That is separate from kids who are vaping and vaping thc. So i assume, though, that say of the 27 , some of those people are using thc . They could be. But this is almost always. I would assume. And is it your belief, i mean weve had this is like the third hearing weve had on this in this building. Is it your belief that almost all or all of the hospital zblaikss that take place have come from people using these thc cartridges . In the samples that we have analyzed sent to us by the states, were seeing thc in about 80 of them. Okay. Im glad see a high school in my district had some billboard or something or other up talking about the danger of combining ecigarettes and thc. These legal cigarettes, there are different amounts of nicotine from one cigarette to the next . You can buy a 10 or 50 . Cigarettes or ecigarettes . Ecigarettes . Yes, the nicotine content can vary. Do we know how many are sold at each of the levels much 100 of the ecigarettes that are sold, how many are at 50 or how many are at a 10 or whatever . No. But what we do know is that juul is the highest nicotine product on the market and kids who use ecigarettes are most likely to use juul. And therefore theyre using the highest nicotine available. Juul only has high nicotine . I was under the impression from somebody i know who stopped smoking that you can adjust and start at 40 and work to my understanding is that while there may be a 3 nicotine juul product out there the overwhelming majority are the 5 which are extraordinarily high level of nicotine per pod, the thing that you insert into the device. You sure of that . Yes. I was under the impression that people stopped smoking the whole purpose was to work their way down from the top . If they are, theyre not with juul. They could be working their way down to other products that have lower nicotine products. Okay. Are you worried if you ban legal ecigarettes, people will run to the illegal ecigarettes just, a, with probably inferior product in there, and b, with more thc . Were not talking about a ban, congressman. Were talking about a policy to deal with currently marketed ecigarettes that havent gotten the authorization from fda and what of the kournltly marketed product should be put into a category where the only way they can be sold is if they go through a premarket evaluation and remove process. None of these products are lawfully on the market. Do you know people who have used ecigarettes and stopped smoking because of it . Yes, sir. And whats your opinion of that . Is that a good thing . A bad thing . Is it something we should be discouraging . To me, it seems to me thats a good thing. My whole life im told, you know, smoking lose seven years of your life. All of a sudden we have something thats effective and were looking for ways to have less people use it . We have heard what are compelling but allby it only ecigarettes are not approved by the food and Drug Administration as a cessation aid. The United States health saskss task force has not recommend it as a cessation aid. Theres a regulatory pathway for this product to be authorized as a cessation aid if a Company Wants to go through the center for drugs at fda. Its why the leadership of the agency and department have been talking over the last year or more about the onramp and offramp and the balancing act. Yes, there are an ek doetdt doetal reports that some former smokesers have transitioned to ecigarettes. But the onramp for kids is getting wider and wider and wider. And our job as regulators is to figure out how to balance those two uses of the product. And the question for all of us, not just for fda is at what price . At what price as we balance this technology, if ecigarettes have become more and more of an on ramp for kids . And those are the things that we are grappling with with the data. I have one more question here, thanks for letting me go over. Is it possible that as less kids or if you found a way to ban ecigarettes from kids, what would happen, given that theres a little bit of a Natural Inclination of kids to rebel and instead of smoking ecigarettes theyd Smoke Tobacco cigarettes . Weve made such progress in reducing the number of kids who smoke cigarettes, the numbers that are coming out will report historically low rates of kids smoking cigarettes. And kits are aware of the hazards of smoking cigarettes. I guess my concern just speaking for myself based upon the data that ive seen is that the kids who are at most risk when it comes to experimenting with ecigarettes are kids who would never have thought twice about smoking a cigarette. Thank you, mr. Zeller. I now recognize congressman connelly for five minutes of questioning. Thank you, mr. Chairman. But if its all right id like to yield to my good friend miss Wasserman Schultz who was here before me. No. You sure . Ill go next. All right. Im happy to um, all right. Thank you. Give me back my 15 seconds. I was trying to be gracious here. So mr. Zeller, welcome. Im going to ask a series of rapidfire questions to establish just a record if you dont mind. Did the compliance policy that fda sent to oweii exempt vape shops . As i said to the chairman earlier i cant get into the details of the policy. That remains under review. You cant even tell us as a as a matter of fact it either did or did not include vape shops . Your view is thats exempt from congressional scrutiny at a hearing . When there has not been a final decision made yet on this policy and its clear its not been made, we dont discuss publicly what the considerations are. Its been accurately reported that the agency submitted the guidance to oira. Its been accurately reported including on the omb website that oira cleared the guidance. But as i said earlier to the chairman, there are these parallel ongoing policy discussions going on. Mr. Chairman, i think that answer raises a whole host of other questions about the jurisdiction of this committee. I would just say to you, mr. Zeller, i think youre treading on very thin ground with your answer. I appreciate that, sir. And we will revisit that as a committee. Fda, however, does have the authority to regulate flairz . Correct. Has jurisdiction over any device that can be used to derooib nicotine, is that correct . Thats correct. Different types of authorities, but yes. Fda has jurisdiction over eliquids, is that correct . As long as points part of something that meets the statutory definition. Even over nicotine free elick wids as a component if its reason blooeb expected to be used with a tobacco product . Exactly. That appears to cover the range of things sold at a vape shop. So fda has the authority to regulate flavors wherever theyre sold, the gas station, Convenience Store or a vape shop following that logic . Correct. In fact the law prevents fda from prohibiting the product in facetoface transactions by any special category of retail outlets. It couldnt ban gas stations from selling flavors while allowing vape shops to continue . I think thats accurate. I cant envision any way to exempt vape shops from a flavor ban in light of those previous answers, youre a lawyer, is there any legal way for hypothetical flavor ban to conceivably exempt vape shops . I think that youre reading an interpretation of the statute is accurate. And i think that under the law we would not be able to differentiate between types of retail outlets. According to fda and cdcs 2018 National Youth Tobacco Survey almost 15 of kids reported buying ecigarettes from a vape shop in the last 30 days compared to just 8. 4 who bout them from a gas station or Convenience Store. If the data shows twice as many underage kids by them illegally at vape shops compared to Convenience Stores, how would that support a hypothetical plan that allows flavors in vape shops but bans them in gas stations when the numbers would suggest exactly the opposite in terms of where the problem is . I think youre making a very good point. I think youre a good lawyer. Thank you, sir. Final a california study published in jamma showed that half the vape shops did not check ids in youth. 45 of vape shops sold to youth. Found vape shop sales to youth significantly higher than other types of stores. If the goal is to keep kids from vaping how does that support a plan that allows flavors in vape shops but bans them in gas stations and Convenience Stores . As i said in some of my earlier responses, our job is to follow the regulatory science. And to put forward policy recommendations that align with the science that do the best possible job of protecting kids from the hazards of all Tobacco Products including ecigarettes. Right. Thats a very good bureaucratic answer, but i prefer it when you wear your lawyers hat and answer, thats a very good question. That was a very good question. Yes, i thought so. All right. Thank you. I mean we clearly do have a problem here and were going to have to take cognizance of the actuality of the problem and where kids are going so that we can target effective strategies to address it. Mr. Connelly, i agree. While we have chuckled in our exchange that shouldnt belie the seriousness with which we are trying to do the right thing. I now recognize congresswoman Wasserman Schultz for five minutes of questioning. Thank you, mr. Chairman. When dr. An shooket of the cdc testified, i asked her about whether nonsmokers are being drawn by their flavors. She said flavors are pretty much always what brings youth into starting use of ecigarettes. She testified that for a flavor ban to effective all flavors including menthol must be included. Do you agree with the assessment that in order to be effective it must include menthol . Again, i think much to the consternation of the subcommittee i cant get into the specifics of the policy under consideration. I wasnt asking about the specifics of the policy under consideration. I am asking your opinion if you agree with dr. Shookets assessment . Youre not prohibitinged in any way, shape or form from offering your opinion. As i said in an earlier response, one of the things that were trying to account for is the data that came out in the monitoring of the future survey that only came out recently. And ill just repeat it very briefly. Breeze briefly because i am familiar. I was here when you said it and i dont need it repeated. I wont. Ill cut to the chase and say we now have data that shows that for kids who use juul, theyre far more likely to use mint than menthol, far more likely. And how do we account for that as were trying to make the right policy here to do the best job of protecting kids. Reclaiming my time did the idea of reclaiming menthol originate from the fda . Thats an awfully long pause. The issue of what the scope of the policy should be, what it should include, was the subject and remains the subject of ongoing decisions. The idea of exempting menthol from a potential ban on ecigarettes originate from the fda or somewhere else . Fda put the science forward. Thats not what im asking you. The idea to exempt menthol, was it an idea that was generated by the fda . Yes or no . Let me try to answer your question in a more general and hypothetical way. I have other questions for you and i want an answer. Its not a trick question. Did the idea to exempt menthol from a flavor ban come from the fda or did it come from somewhere else . There were there have been a variety of options for scope of this policy that have been under discussion. Youre talking about options. Im asking, the idea please let me finish. Im trying to get an answer to your question and you are obfuscating. The options that fda put on the table for consideration going to what the scope of this guidance should be, went to the went to the issue of menthol in or menthol out. We put but is that did it come did the idea the answer to your question is who put the options on the table menthol in or out, yes, we put it on the table. It wasnt an idea brought to you from the outside . It was your idea with no at a point in time when all options were being explored. So there was influence from the outside, and it was not you are not answering that this was an idea that was exclusively generated by the fda . I dont think thats what i said. When we were i want to make sure i understand what you are saying. When we were identifying options, we put a variety of options on the table for consideration that included menthol in or out. Reclaiming my time. Mr. Chairman we are going to have to make sure that the fda understands what they are required to answer when we ask them questions because mr. Zeller is not complying with whats required of him. Do you have any reason on november 15th doctor shooket testified that the survey didnt differentiate between menthol and mint. Do you have any reason to believe that kids can differentiate between menthol and mint flavors . Im aware of the litter sure that says they might not be able to. We know they may carry unique harms. Theres a cancer causing agent in mint oil. The fda banned it as a food attive . Yes. And a University School of duke medicine found high liflz in menthol. It found the level inhaled is as much as a thousand times higher than menthol cigarette users. Shouldnt we be concerned about that . Weve been looking into that science. We have questions about the study. Wyou banned it as a food attive. I would think you have pretty good science that its dangerous . Were looking into it. That study came out on september 16th. Weve heard a decision may have been made by october 31st. Were you ai are with a of that when you made the decision . Im not going to refer to any decision but we were aware by october 31st. When you were considering pulling wouldnt that be a good reason to pull them from from the market to determine if they are safe . It would be part of the consider aigts we would make about what the scope should be. I yield back the balance of my time. Thank you for your indulgence, mr. Chairman. Thank you. Now i recognize congressman saur banes for five minutes of questioning. Thank you, mr. Chairman, and thanks for the opportunity today. Mr. Zeller, thanks for being here as we said now many times, in september this year we saw the announcement from the Trump Administration that fda would be releasing a compliance policy to ban all flavored ecigarette products including mint and menthol products. And this would not be the first time the fda moved forward with a policy to ban ecigarette flavors, correct . Isnt it true that a similar policy was crafted in 2015 . I wouldnt call it a ban, but its a matter of Public Record that there was a version of a regulation that would have treated flavored products differently. Restricts would have been put on those. In 2015, you were director of the fda center for Tobacco Products as you are today. Were you involved in that rule making process . Yes, sir. And we know that in october of 2015, fda sent its flavor ban to the office to oira for review and oira has an open door policy meaning it will meet with any lobbyist as long as the rule is under review. We now know that oira met with over 100 lobbyists to discuss the 2015 policy and as a result, im not going to say cassation but some correlation at least it eliminated the flavor ban policy. Were you satisfied with that result and oiras justification back in 2015 . I was prepared to explain the final policy. It did not square with the policy we put forward earlier in the process. Im reading between the lines on that answer. That was very diplomatic. Now lets return to the 2019 flavor ban that was promised in september which of course was accompanied by the startling figures from the National Youth Tobacco Survey showing that over a quarter of High School Students now had used ecigarettes in 2019, many of the fruit mint flavors. Despite those trends the recent policy seems doomed to the same fate as the 2015 policy. Now that the current flavor guidance has left oira, the president has taken at least one meeting on the topic. Do we have any way of knowing whether the president or the white house are meeting with industry lobbyists . Thats a question youd have to ask dont know. Of course the administration, which is the least transparent in my memory has eliminated the white house visit or logs, so there is really no way to know who is showing up there for these meetings and lobbying the president. But even if that was public, thats not really the main problem. The problem and what i think people are fed up with across the country is that their government, this government wont tackle important issues without getting permission from special interests. I think were i think thats whats playing out here. Just would be very candid with you. Im not asking you to comment on it. Were facing a Youth Tobacco crisis. To two decades of progress in reducing Youth Smoking is being reversed almost overnight. The president promised to act quickly promises to do something to protect American Kids from these dangerous products, but as soon as he says hell take action, here come the lobbyists, the influencers, and suddenly this particular ban is in purgatory, it is not happening. And the impression i get, i think a lot of people in the public when they read a headline one day and then 72 hours it is completely flipped around is that the Tobacco Industry lobbyists are calling the shots. And it is not Public Health professionals, unfortunately, it is not as it should be. An agency like the fda leaning in to protect consumers and fulfilling its mission in every possible way. Because of this influence peddling that goes on. So it is just another, you know, long list of examples of what is broken about this place. And the public gets this. They may not understand all of the intricacies of how influence flows through the executive branch, through congress, et cetera. But they can feel in their gut that policies getting made up here for the very powerful people and for them. We have to fix this and so many arenas, especially when it comes to protecting the health of our kids. With that, mr. Chairman, i yield back, thank you for the opportunity. Thank you, congressman. Thank you, all, for coming today. I just want to close with a couple of remarks which is that these figures are alarming. Absolutely alarming. And unacceptable. The fda is charged by the American People to stop this epidemic. And youre failing on the job. We know what will stop it. And that is banning these flavored ecigarettes. We know it. Those flavored ecigarettes are what get kids to take up these ecigarettes and the nicotine is what gets them hooked. For a lifetime of nicotine addiction. And so for you to come in here and tell us you submitted guidance to oira, they concluded its review and pofor parallel discussions to be happening, but for us to have zero transparency into who is part of these discussions, how long these discussions are going to happen, when this policy is going to come out is unacceptable. This is wrong. And the parents of all of these k kids are still waiting for answers. And the answers you provided today are not going to do. So i suggest you go back to the fda, and you tell them that the American Public is up in arms about this youth ecigarette epidemic. And you tell the white house and you tell all those who are part of these parallel irregular, unusual, opaque discussions that times up. It is time to get their act together and put this flavor ban out, immediately. Without delay, before another child gets hooked to these ecigarettes before another middle schooler gets hooked to an ecigarette and certainly before any high schooler or any child whose brain is still developing to the age of 25 or 26 as you said gets hooked to an ecigarette. Without objection, all members will have five legislative days within which to submit additional written questions for the witnesses to the chair, which will be forwarded to the witnesses for responses. I ask our witnesses to please respond as promptly as you are able. This hearing is adjourned. Today, 2020 president ial candidate Pete Buttigieg speaks with College Students during a town hall event at Grinnell College in iowa. Live coverage at 3 30 p. M. Eastern on cspan. American history tv on cspan3 looks at the impeachments of president s nixon and clinton. Sunday, starting at 6 00 p. M. , on oral histories, former u. S. Representatives trent lott and elizabeth holtsman reflect on their experience serving on the House Judiciary Committee during the impeachment inquiry of president Richard Nixon. Here is a guy that had an influence on my decision to run for office, and was helpful in my winning. And that i looked up to as a president. And i wound up then having to sit in judgment on him and eventually even having a say i would vote for an article of impeachment. At 8 00, we look at the impeachment of president bill clinton with a portion of the 1998 House Judiciary Committee debate. I think you denigrate the role of the senate which has the important ajudicatory role to weigh the evidence to study what it wants and agree and disagree and then our Founding Fathers made it extraordinarily difficult to eliminate a president from office by requiring a twothirds vote and thats why i have always said unless this is done bipartisanly, and there is no bipartisanship here, but im hopeful if it gets to the senate, there would be bipartisanship. Absent that, there will be no will the gentleman yield . Explore our nations past on American History tv. This weekend, the impeachments of president s Richard Nixon and bill clinton. Americans are coming out and getting engaged and politics is feeling a little bit less like a spectator sport for people on the left. And that a lot of the same social issues that the book covers are still the ones that are relevant today, people in this book were really outraged by issue like family separation and, like, Sexual Assault on women, and the devaluation of black lives, et cetera, and this period provides a really crucial precursor to our moment. University of massachusetts professor holl