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 YouthTobacco 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