Released disturbing results, the youth beta epidemic and at the vaping epidemic continues to grow to alltime highs. And that they use ecigarettes 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 ecigarettes 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 ecigarettes 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. Weve 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, weve been able to maintain on this issue, even in todays 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, its 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 whove 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 ecigarette 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, theyre 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 im 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 ecigarette 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, id like to thank you mister seller for your testimony and being here today, and thats always im 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. Ecigarette 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 ecigarette use, last year over 20 of teenagers reported ecigarette use, a 78 increase from the year before. We are facing a Public Health crisis. Thankfully, this 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, 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. Id like to recognize our witness. Today, we are joined by mr. Mitchs 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 id 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. Im here today representing hundreds of staff at the fta who are working tirelessly to prevent kids from starting to use any tobacco product, including ecigarettes, 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 ecigarette epidemic to help and Foreign Policy actions going forward. And help me happy to brief the full staff when updates are available. Id 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 ecigarettes and the multi state lung injury outbreak. Between 2008 in 2009, the fda attempted to regulate ecigarettes as an approved drug device products. Our action which talents and ultimately overturned. In the decades since the Tobacco Control act was passed, fdas 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. Ecigarettes 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 ecigarettes. 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 ecigarette products to children. Weve 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. Its despite commitments they have made, juul products represent the overall use of ecigarettes by children. Last, year we launched the real cost, youth ecigarette campaign, which features hardhitting 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, its important to remember that no ecigarette 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 ecigarettes had declined, however, as we know, and as the chairman pointed out in his opening remarks, last year, at the National YouthTobacco 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 ecigarettes, among current exclusive ecigarette users, nearly three quarters of those in high school and more than half of those in middle school use flavored ecigarettes. 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 id 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 ecigarettes, including mint and mental products, right . And youre 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 ecigarette 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 ecigarette users in 2019 and the overwhelming majority of youth ecigarette users, i think is that 70 of highschoolers, with the overwhelming majority of youth ecigarette user cited the use a popular fruit and mental or men flavors, right . Thats correct. The purpose of banning, or as secretary azar said, clearing the market of flavored ecigarettes 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 were 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 . Im not going to get into the substance of the document. Okay, on what basis are not getting into the substance . Because theres been no final decision made, i cannot get into the substance. Who instructed you . This was based upon this que