The subcommittee will come to order without objection the chair is authorized a recess at any time this hearing examines the federal response to youth cigarette use and fda compliance policy. I now recognize myself for five minutes for an Opening Statement. September 11 this year the administration released disturbing results and at the vaping epidemic continues to grow to alltime highs. And that they use ecigarettes the trends are alarming for High School Students and to show you two visuals in 201712 percent were vaping and a 2019 almost 20 percent that 135 percent increase among High Schoolers. On your left is another visual which is more disturbing in 2173. 3 percent of middle schoolers were vaping today its almost 11 percent 218 percent rise in vaping among middle schoolers and as a parent of three children the statistics are extremely disturbing the data also shows that flavors are driving youth vaping 72 percent whove ate use flavors they use meant or mental which is the most popular flavor by t14 it is the most popular youth brand for those that use t3. Those that have the president to do the right thing with data linking the vaping rates to flavors the head of hhs and the fda announced a proposal to essentially ban flavored ecigarettes with the exception of tobacco flavored they put forward a sound and logical response to the problem and alec cesar pledged we require all flavors other than tobacco flavored to be removed including mint and menthol and candy and bubblegum fruit and alcohol flavors secretary as are explains these products are still getting two kids we cannot let a whole generation get addicted to them through mint and menthol and other flavors. During that same announcement the president committed the flavor ban would be issued within the next couple of weeks when the president made this exciting announcement septembe september 11 i and many members led the charge commending him a band of all flavored ecigarettes would deter them from starting to vaping i frequently referenced as bipartisanship at its best to protect American Youth while it was our privilege to back the president its also our responsibility to hold him in his Administration Accountable unfortunately almost two months after the president s initial announcement the flavor ban has not yet been implemented. Reports illustrate big tobacco lobbyist are working to weaken the van. Their indications administration is considering exempting menthol as well as faith dash vape shops. We first wrote to the fda asking you to finalize to issue the flavor ban without exemptions they did finalize guidance but instead of publishing it they sent it to office of information and Regulatory Affairs because then it delays Agency Action it is an office within office of omb sewell here that repeatedly today. After a flood of lobbying he and tired the flavor ban all to gather and that the flavor ban would not fall victim to lobby they complied but again the guidance was not published not publishing at that stage is highly unusual so the subcommittee wrote to both agencies asking which controlled the guidance either answered so far neither will clarify if who has the guidance however we did get an update on december 3rd saying that the oversight has been reviewed so now its back to the fda you are the director for the center for Tobacco Products people expect you will provide them with answers with immediate implementation with their exemptions with that i now recognize the Ranking Member for an Opening Statement. Thank you thank you for participating not the mostwatched hearing of the day but one of the most important thank you to the chairman for the focus on this issue in the cooperative spirit that we could maintain on this issue in this polarized environment to have solutions and discussions on this issue we are united in our goal to end teen vaping it is troubling with increasingly fatal long injury as a father i can only imagine the agonizing realization understanding your child has become addicted to something they had no idea was harmful or painting the devastating loss my sincere condolences for those who have lost loved ones to this illness the last few months it has become obvious the dangers vaping products we think of the epidemic its important to realize theres two tracks of concern the teen vaping epidemic and then the issue of lung damage has tragically led to the death of 47 people and in the District Of Columbia as well as 2290 who have fallen ill to vape related long injury 38 percent were 18 to 2424 percent were 25 and 34 this is a complex issue that vaping products it appears the tainted black market is likely to be causing the long injury from the challenges of dealing with these of this epidemic the lack of data those causes understanding the origins of the tainted products particularly within the black market the lack of enforcement and the challenge we protect the public from harm from their individual liberties thankfully we had some breakthroughs in findings to understand what is causing long injury vitamin eacetate as the chemical of concern thc has been it is an additive in thc ecigarette products thc from nonregulated sources is the most recent outbreak of lung injury the Associated Press have reported on the availability of pervasive nature that are tainted by bad actors the wall street journal reports theres a large market for the counterfeit vaping Products Online they are made by bad actors to resemble those of legitimate manufacturers my pesticides. And to broaden that understanding to be addressed appropriately. And then to discuss to curb them with the Public Safety with the vaping product supply chain for her to protect the public to find that vaping is less damaging alternative thank you for being here today and i look forward to us working together on this issue. A full Committee Chairwoman congratulations for quite look forward to working with her under her leadership this is an issue shes very different on concerned about or to the entire subcommittee with the epidemic. Ecigarette manufacturers to a deadly lifelong addiction to find that tobacco use among High School Students has increased by nearly 40 percent in the past year alone field by ecigarette use 20 percent of teenagers reported usage and increase from the year before we are facing a Public Health crisis. Thankfully the subcommittee has stepped in to protect Childrens Health to hold this industry to account we would have an important Strong Partner and President Donald Trump but he has broken his promises walking back his commitment to take quex and Decisive Action to address youth vaping by imposing a flavor ban putting profits over people we will not allow this to happen we look forward to hearing your testimony and questioning of our witnesses and i yield back. Thank you chairwoman like to recognize our witness today we are joined by the director for center of Tobacco Products and fda please rise and raise your right hand i will begin to swear human do you swear the testimony are about to give is the truth the whole truth and nothing but the truth so help you god . Let the record show that a witness answered in the affirmative thank you i would like to invite you to give us your Opening Statement please speak directly into the microphone your written statement will be made part of the record and with that you are now recognized for five minutes and i thank you so much chairman and chairwoman maloney congratulations taking over my old committee. I am here today representing hundreds of staff at the fda working tirelessly to stop kids from using any tobacco product including ecigarettes. I went to assure they are committed to do anything we can to prevent kids from using Tobacco Products and continue to develop a policy approach holding a listening session on the epidemic to help to enforce policy actions Going Forward with the full Committee Staff are available and then to regulate the initial efforts began more than a decade ago long before the rise of the long injury outbreak between 2008 and 2010 fda attempted to regulate ecigarettes as unapproved drug device product action was challenged and overturned in court. In the decades the Tobacco Control act was passed we established a science based approach vigorously enforcing our authorities for retailers to violate the law and design innovative campaigns to educate kids on the dangers of tobacco use we also expanded the focus of authorities to new challenges posed to product such as ecigarettes it provided the authority to regulate as Tobacco Products publication of the final rule brought ecigarettes under the Regulatory Authority in 2016 protecting our nations youth is among the fda most important responsibility we will continue to take an aggressive stance to make sure Tobacco Products are not marketed or sold to kids let me highlight the actions we have taken to help address the epidemic with use of ecigarettes we have issued more than 10000 warning letters filing over 1600 complaints online brick brick and mortar retailers for the illegal sale of products to kids warning letters resulted in the removal of liquid products that resemble kid friendly foods like candy and juice boxes we issued a warning letter to juul labs for marketing unauthorized Tobacco Products including a presentation given to you that a school as a reduced risk of harm compared to cigarette smoking also issuing a second letter expressing our concern to request Additional Information of several issues raised by the subcommittee regarding the marketing practices including those targeted at students and tribes and employers get notes despite commitments juul has made to address the epidemic they continue to represent a significant proportion of ecigarettes by children last year we launch the real cause of the Prevention Campaign which has hardhitting ads on tv and digital social media sites as well as posters with ecigarette prevention finally we joined forces with scholastic to have Educational Resources distributed to Million High School educators despite these efforts the epidemic continues to grow and we need to do more as a subcommittee considers the issues its important to remember that no ecigarette product none has obtain the marketing authorization as of yet when we announce changes to our policy august 2017 at the time the National Representative data suggested it had declined as a chairman pointed out last year the s Tobacco Survey showed 2017 through 2018 current ecigarette used increase by 70 percent and 40 percent among High School Students last month we published 2019 data showing the current ecigarette use ten. 5 percent among middle school as in previous years the 2019 data shows a disturbing rate of flavored ecigarette nearly three quarters of those in high school more than half in middle school used flavored ecigarettes we are committed to doing everything we can to prevent kids from using Tobacco Products as i stated at the outset we will have a policy approach aligning with that concern. Thank you for the opportunity to testify im happy to answer any questions. Thank you for being here today you are aware september 11 hhs secretary said the fda blood issue guidance as nontobacco flavored ecigarette including mint and menthol. Yes. You are aware secretary as are announced because the numbers show continued rise of the youth ecigarette use through the use of non tobacco flavors that appeal to kids. Correct. And further stated that more than a quarter of High School Students were users and the overwhelming majority 75 percent of High Schoolers they cited the use of popular mint or menthol flavor. Correct. The purpose of banning or clearing the market of flavored cigarettes was to decrease youth vaping to make that would be consistent with what the secretary said. With the urgency thats why the president said on september 11 fda guidance would come in a couple of weeks. That is what was said. October 25th you stated fdas work on flavor guidance issue was a very very high priority we are trying to complete work on it as quickly as possible. I dont remember the date but i said that. You said october 25th. But the flavored guidance has not yet been published yet. No. According to a letter sent yesterday fda drafted guidance within the omb as we talked about before on october 25t october 25th, correct . Yes sir fda documents followed through on secretary a czar announcement the fda would clear. I will not get into the substance of the document. And on what basis . There has been no final decision made on this policy there are ongoing discussions so i would like into the substance of that document. This was based on discussions internally and its under practice with ongoing policymaking that we dont talk publicly what is under consideration prick i will be happy to come back and review and your staff when there is a final decision and walk you through but this is an over an ongoing set of discussions. So concluding its review on november 4th did t19 make any changes from the initial guidance . I cannot go into the details of ongoing discussions. Talking about executive order 866 according eo 12866 the fda is not allowed to publish in the federal register until oira has completed its review. For those of the executive order. This is one of them. This was a policy because of its significance and to apply to talk about the types of policies submitted to oira and then sent back. So oira has completed on its website that it is back with the fda they completed their review november 4th and sent the document but there are still other ongoing policy related discussions but oira didst dash did complete their review. But their policy discussions ongoing there were parallel policy discussions going on between fda and the department of the white house. According to executive order the fda is not allowed to publish until oira has completed the review the fda can publish the guidance . If the complete executive branch review of policy but as i said there were still in parallel other discussions going on in addition to the oira review. So these parallel discussions with this irregular channel of discussions independent of the standard submission of guidance from fda to oira and then back to fda. Is there some other review happening right now having nothing to do with oira or fda . Their ongoing policy related discussions between the agency and the white house what the policy should be. Did t19 really complete their review if they are still discussing . They are but at other levels and agency in parallel there were discussions continuing what the policy should be even though oira completed. That would be the leadership of the agency in various parts of the white house. That includes you . I was involved peripherally most are leadership with the agency. And at the white house . Various offices Domestic Policy Council to omb i have not been directly involved with discussions with the white hous house. So you would agree with me the white house domestic policy house is led by joe rogan that the fda should be regulating Tobacco Products. Thats our job. Is not a waste of time . Is something i have devoted the last 25 percent of my life. Im so concerned white house domestic counsel headed by joe grogan is part of these discussions he said it was a huge waste of time for fda to regulate tobacco i will recognize others for questioning took a couple extra minutes so that some time on your clock. We have been trying to figure out the events for a while. Can you speak to why we just know see cases of this illness . I dont think there is a definitive answer only why in the last three or four months we have seen so many cases of pulmonary illness but there is a working hypothesis that because so many cases are associated with the vaping of thc something was added to the product more recently that is associated with a rash of injuries. Do we have a clear understanding this is a rapidly developing issue especially coming from teen vaping if theyre getting it from their friends do we have a better understanding of the source of the vaping products leading to illness . As you said in your remarks is important to differentiate between ecigarette swear is just a product delivering nicotine versus some kind of vaping device likely bought off the street possibly modified by the user and then these thc are showing up increasingly that we have analyzed any samples that is why the device of the fed loan the advice of the federal governments dont buy thc be careful of the modifications that is separate and apart from the focus of your remarks what to do of the more conventional ecigarettes. We have had some recent discoveries of this illness. We are working closely with cdc using our center which is a Sophisticated Laboratory the fda has two support Law Enforcement action the agency would take when we get samples from the states and forward for analysis and to cdc based upon the analysis of the samples we can conclude it looks roughly 80 percent of cases thc has been identified and three quarters of those vitamin e acetate is an oil has also been ide