September 2019 but not yet implemented. [inaudible conversations] 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 identified and because of that analysis of lung fluid that cdc did in the last month or so we could conclude thc and vitamin e acetate is linked to whats going on both of stated clearly there may be more than one cause but it looks like a combination of thc vitamin e acetate plays a role in these cases. When it comes down to those specific cases do we have a clear idea what the supply lines are . Can you trace that information. We are using the resources of criminal investigation so we have boots on the ground we are trying to trace back the supplychain. We are using the not going after personal use or possession but who is the responsible party for putting the thc products into the marketplace and since this is a sensitive Ongoing Investigation the update is we are making progress its not like a an outbreak with responsible lawful entities that want to get to the bottom of whats causing the outbreak and work with the regulatory authorities to get to the bottom of it it is a challenge during this investigation but our office is making progress so educating kids about the dangers the Real Cost Campaign you have highlighted is there anything else the fda is considering to help mitigate. When it comes to addressing the kids use a comprehensive approach is required we are using as many of the regulatory statutory tools and resources we have we made a major investment in a Public Education campaign because what we learned from our research and real contrast to the risks of combustible cigarettes kids know they are dangerous they know that is dangerous but by contrast what we have learned from our research is that a lot of kids are Walking Around thinking ecigarettes are harmless amazingly some dont even know there are nicotine in them. The most important thing we can do in Public Education is to communicate to kids from the Real Cost Campaign to communicate the Health Consequences of vaping ecigarettes whether the risk of becoming addicted Public Education investment regulatory science the medium and longerterm for the at the disposal to make the best use. Spent thank you for your continued commitment to hold vaping accountable and with black and brown americans to end the smoking epidemic this has always been an issue of Racial Justice my home state of massachusetts is the first in the nation to have a permanent ban on menthol cigarette products this is important because we must ban all flavors meant and menthol not to do so would be discriminatory since menthol has a unique and deadly burden on the community. We must crackdown on menthol products and not be an individual possession their intergenerational consequences of broken windows that has over criminalize the black and brown communities. That talk about the justice guarantee resolution with Public Health and Public Safety to ensure there are no more eric garners. Big Tobacco Companies are targeting more tobacco ads and menthol in black neighborhoods. There ten times is more. Nine out of ten black smokers prefer Menthol Cigarettes it is safe to say the targeting was effective. Correct . I would agree. 45 percent of black smokers say that if Menthol Cigarettes were banned and two thirds black smokers one year ago fda plan to band menthol that was necessary because those products disproportionately disaffected underserved communities. Why is that . And including the presence of menthol and cigarettes and i would add to what you said of a Public Health concern of mentholated cigarettes is not just the disproportionate by africanamericans but the role it plays in attracting kids of any color of any color we continue to review the comments of what those policies should be and share your concern from a Public Health perspective. Just to reclaim my time just to be clear does the fda plan to follow through on this van ban. I cannot give you a yes or no answer but we are continuing to review all evidence of all Tobacco Products as we follow the regulatory science. Those attempts have been overrated by omb why is that . You need to be more specific i dont understand what specific instance you are referring to. I will move on im just moving on because talking about a lifeanddeath matter 47000 black people die every year from smoking related illness making this the largest cause of preventable death even more than gun violence or car accidents. We dont have more time people are dying. R ecigarettes as a secession aid . They are not approved. And those with the generational smokers. There is a Public Health balancing act with the agency has to do with ever the policy is on flavors that is balancing with those adults that successfully transition off completely to ease cigarettes what role are flavors playing in that and as part of the balance we need to do. With the roles that they especially those that are thinking they are Harmless Products because they heard from former smokers it is the presence to help them transition completely away from cigarettes. Mister zeller. Nicotine vaping products has to have the Tobacco Market applications they must be submitted to the fda may 2020. And is currently on the market. Its also my understanding only a fraction of these today would have it filed with the agency by may 2020 do you agree with that . s. So to assert jurisdiction three and a half years ago. What plans does the fda to remove products from the market that has not been filed which products can continue to be sol sold. If a deadline has come and gone and there are currently marketed products that failed to meet the deadline of those applications than that is at the top of our priority list for enforcement action and likely start with a letter to the company and its up to the manufacturer to get the products off the market so after the deadline passed for which the pre Market Application has been made. We will have to take that back to the center that could be considered. It sounds like a good idea. Talk about the counterfeit products especially with the thc products hundred percent thc they had no thc or counterfeit ingredients does the fda plan to take with these counterfeit suppliers. Talk about counterfeit and illicit when we talk about whenever the responsible party those are illicit products. To work back the supply chain and then have a variety of authorities at your disposal for consultation there can be a role for dea as well it starts starts that we are making progress. Every stakeholder must do their part to see underage use youth use those products to market them. The feature of this depends on fda rules and regulations when will they finalize and publish guidance on vaping flavors or a flavor ban . I cannot give a definitive answer other than to say the discussions that have been taking place continue and fda is committed to a policy that alliance with our concerns with whats going on with flavored cigarettes ecigarettes. I will use the balance of your time to ask another question about parallel discussions that you are related to these discussions. So who at the fda as part of these discussions directly . The leadership of the agency and the commissioner office. The ash the acting commissioner . Yes and the white house who was directing . I dont know. I would like to recognize the congressman. So based on the expertise the Tobacco Survey results show 25 percent were using ecigarettes those that were using mentor menthol for go the data shows high school users are using flavors and most used juu juul. Correct. Based on your entire career if you are making a recommendation to the president do you think we should band menthol . To be the regulatory science and come up with a policy that most closely aligns with what they show that there is an epidemic use disproportionately favor flavored products and those that are using more frequently is also increasing that the recommendation has been it has to align with that science and data. Will banning mint and menthol allied with that data . Dont think i can say publicly i cannot go into the specifics of the policy still under consideration that was from the september 11. What is your opinion you have been dealing with the regulation for 20 years if they said mint and menthol should be banned what would you tell them . I will tell you that there was a second Reputable National survey that came out in the last month it measures 810 and 12 great use of all products listed and illicit. The survey instrument separates mint from menthol and asks those questions separately the National Youth Tobacco Survey does not mint and menthol are included in the same question so monitoring the future results what we saw from the analysis done of kids who used juul do a sub analysis thats probably an indication of whats going on throughout the entire category that analysis showed published in jama the last month that kids who used juul are way more likely to use the mint product than menthol. That was new information and that was information that has to be accounted for i was having a conversation with a former commissioner speaking under oat oath. But we dont know if they would default to menthol. Thats correct thats part of the consideration. But you are not prepared to make a recommendation of your opinion . The only thing i can say publicly is that new information that came out in the last survey has to be factored into our thinking. You have any reason to suspect politics has gone into the decisionmaking advising the president he could lose battleground states if he bands vaping are flavors . Know. Would you resign if you had any indication . I would commit to resigning if there was a fundamentally flawed policy for whatever reason. If you had information there is Political Considerations would you commit to resigning. It depends on the final policy is what i would consider regardless of the considerations that went into it. We have made a recommendation what we think the policy should be. No final decision has been made i will wait to see what that final decision is. Thank you congressman. Thank you for being here today with the past three hearings one issue we have agreed upon is to keep ecigarettes and vaping products out of the hands of those who are underage. I do feel all these hearings have illustrated the Important Role ecigarettes what happens with those who Smoke Cigarettes it still seems as if it could be a vital tool in production and should remain an option for those who do need it. Can you discuss the proactive steps cdc and fda have taken to prevent youth from accessing ecigarettes . Yes we are responsible for enforcing part of the law to all Tobacco Products and with ill Legal Marketing to kids so through office of compliance and enforcement we issued over 10000 warning letters and penalty complaints with the financial payment for illegal sales at the tobacco retail level in addition we made massive investment of Public Education to complement the ongoing enforcement actions. I wish i could say Public Education in compliance alone would be sufficient to reverse the trend we are seeing in the survey but its not. More needs to be done unfortunately we have to use our enforcement resources to go after companies that are selling liquids to purposely resemble juice boxes. We did that and a collaboration with the ftc thats also a violation. Theres good news and bad news. We sent the first 17 of those warning letters on the issue of eliquids purposely being marketed to resemble cereal and candy all 17 manufacturers immediately reformulated their packaging. Thats the good news about a month later were doing the monitoring and surveillance online and we saw there was a bunch of online retailer still selling those products. We had to put out an additional batch of warning letters to the online retailers continuing to sell products that manufacturers had agreed to reformulate. That leads me to my next question what is being done with enforcement efforts to give the illicit products off the market now . Talking about thc that is separate. Explain thc. I cannot give you the chemical name but it is a chemical derivative of marijuana there are a bunch of people that are purchasing this completely illegal product to get high. We have seen only in the last three or four or five months is something changed or happen and how the products were being manufactured and sold because we were not seeing the incidence of lung injury and death even if they were vaping april or may this year the working hypothesis its a completely illegal enterprise to begin with and agents are being used to cut it to make it go further and those agents are oils and if you inhale oil into your lungs thats a bad thing and can make you very sick and in all of the cases the cdc can test they have found the Vitamin E Acetate Oil is present so that leads me to my last question. Acetate is fight different than Vitamin E Oil so do we have two products put together . To make vitamin e acetate. I cannot answer that i have to get back to you. It stretches the thc. I yield back. I dont know if the high nicotine content. That the product that is the most popular with kids is high in nicotine. What do they have the authority to caffeine nicotine levels . Does the fda have the authority to ban . Yes. Will be committed to bringing these ideas to the table . This is part of an Ongoing Investigation. We would be happy to come back and talk to you when we are further along in the investigation to understand the science, product designs and Public Health impact. Outlining evidence we uncovered about illegally marketing products and in schools a number of places directly into by claiming that its safer than cigarettes and so forth and the warning letter declaring they broke the law by modifying. Modifying. What led you to conclude they had broken the law . We have our own Ongoing Investigation practices and i would say that the information the subcommittee put on the record at its hearing in july gave us Additional Information and additional concern that the specific examples you mentioned crossed the line into what he called illegal claims to reduce exposure to toxins or reduce risk and in that area we were able to assemble all of the evidence that we have that you have provided on the Public Record and views it as the basis for a warning letter to the company. Separate and apart from an additional letter that went on the same day making a massive request for documents on other things in the letter you did request a response within 15 days. Did they . By the end of the month. If they missed the deadline was only by a day or two. Can you get a start response . I can discuss the outcome you cant provide the response . Its an ongoing investigati investigation. Were it to be closed i could come back and brief you on everything. The company responded and we are reviewing the response. If we close the letter we can give you more information. Spin it could be years . It wouldnt be. Lets say an amount of information story of the mother of two young boys making sure we resolve this before not only juice boxes but candy suckers out there with this stuff. So they can punish companies for making these claims. What are the possible penalties they can be permitted to impose on situations like juul . Let me talk hypothetically about the authorities at our disposal and they are both civil and criminal. On the civil side, we can work with our lawyers and the lawyers at the Justice Department if there could be seizures and injunctions to completely change the behavior of the company that broke the law. There were other instances where there could be massive fines and then working with the Justice Department if we think theres been criminal activity than there could be a criminal investigation and prosecution. Thank you so much. I will deal back the rest of my time. Thank you, congresswoman. Let me use the remaining time to further explore why are ye cigarettes so dangerous to use . For two fundamental reasons. Our brains dont fully develop until we are 25 or 26yearsold and its clear any exposure to nicotine in the still developing adolescent brain is harmful regardless what the other hazards, chemicals in th the vaporware the liquid are. Just the nicotine that alone is reason to be concerned no kids should be experimenting because of the harmful impact of nicotine. Then when you add what is known about some of the harmful compounds in the aerosol ca, the bring additional risks. We have the socalled Harm Reduction debate. Is there a role to help addicted to cigarettes smokers completely switch, that is a completely different and separate question when we make a relative Risk Assessment if you switch will be exposing yourself to fewer toxins. No kid should be initiating on any product and as i said earlier kids are Walking Around with a mindset that its harm us and some dont even know that nicotine is present. I know recognize congressman for five minutes of questioning. Thank you. I may be going over territory that youve already covered that you see the list behind you the number of middle school and High School Kids that are using these. Do you know how many people using that product they can pick up this Convenience Store and those that are using thc . The data of the chai that thn has put up his use of nicotine. That is separate from kids using thc. So i would assume that say of the 27 , some are using thc. They could be. I would assume. Is it your belief it is the third hearing we have had in the building is that your belief that all or almost all of the hospitalizations that take place come from people using thc cartridge is . In the samples that we have analyzed we are seeing thc in the 80 of them. There was a billboard or something up talking about the dangers of combining the cigarettes and thc. As i understand there are different amounts of nicotine from one success to the next. You can buy ten, 50, whatever. Are you talking about cigarettes or ecigarettes . The content can vary. Do we know how many are sold at each of the levels of the 100 of the ecigarettes are sold how many are at 50 or ten or whatever . No, but what we do know is that juul is the highest Nicotine Products on the market and kids who use the ecigarettes are likely to use juul therefore they are using the highest available. I was under the impression from someone that i know that stop smoking but can adjust and start at 44 to 20. But you are saying that all of juul there may be a 3 of nicotine product out there that the overwhelming majority of the sales are the 5 which is an extraordinarily high level of the nicotine per pod for the thing that you insert into the device. Are you sure of that . Yes. I was under the impression you work your way down to the top. If they are they are not working their way down with juul. It could be others that have other nicotine levels. Are you worried that if you ban legal ecigarettes people will run to the products and with more thc . To currently marketed to cigarettes that havencigaretten the authorization from the fda and one of the currently marketed products should be put into the category were the only way they can be sold this if they go through a premarket evaluation process by the fda because technically none of these products are on the market. Do you know people that have used this because of his . What is your opinion of that . Is it a good thing, a bad thing, something we should be discouraging facts to me it seems a good thing and we have something effective and looking for ways to have less people use it. We have heard but i would say our ongoing but albeit anecdotal reports from individuals that said it was only because of these that i was able to get off of cigarettes. Ecigarettes are not approved by the food and Drug Administration as a cessation aid. The United States Preventive Service task force has not recommended ecigarettes as a cessation aid. There is a regulatory pathway for the product to be authorized as a cessation aid if the Company Wants to go through thee center for drugs fda. Its why the leadership of the agency and the department have been talking over the last year or more about the onramp and offramp and balancing act. Yes there are anecdotal reports of some form or smokers have transitioned completely to ecigarettes, but the onramp is getting wider and wider to learn how to balance the uses of the product into the question for all of us, not just fda is at what price . At what price as we balance the technology if they have become more and more of an on ramp for kids and those are the things we are grappling with internally. Thanks for letting me go over. Is it possible if you found a way to ban ecigarettes from kids what woul what would have n that there is a little bit of a Natural Inclination to rideau that says smoking them spoke tobacco cigarettes . We have made such progress in reducing the number of kids Smoke Cigarettes. The numbers that are coming out well report historically low rates of kids smoking cigarett cigarettes. And kids are aware of the hazards of smoking cigarettes. My concern speaking for myself based upon the data is that the kids that are most at risk when it comes to experimenting with ecigarettes are kids that never would have thought twice about smoking a cigarette. Thank you. I now recognize congressman connolly for five minutes of questioning. Thank you mr. Chairman. But if it is alright i would likall right i wouldlike to yie, ms. Wasserman schultz who was here before me. Im going to ask rapidfire questions. Did the compliance policy exempted dating shops . As i said earlier, i cant get into details of the policy e policy that remains under the review. You cant even tell us as a matter of fact if it did or did not include dating shops . It is exempt from scrutiny of the hearing . When there hasnt been a final decision yet to meet on the policy coming and its clear that a final decision has not yet been made. We dont discuss publicly what the considerations are. Its been accurately reported that the agency submitted the guidance if its been accurately reported including on the website that they cleared the guidance, but as i said earlier to the chairman, there are these parallel ongoing policy related discussions going on. Mr. Chairman, i think that answer raises a whole host. They have the authority to regulate flavors is that correct . They have jurisdiction over any advice to deliver tobacco and nicotine is that correct . Thats correct. Different types of authorities that guess. The fda has jurisdiction over these liquids is that correct . As long as it is part of something that meets the statutory of the product. They have jurisdiction over the nicotine liquids as a component or part of a tobacco product that is reasonably expected to be used is that correct . Exactly. That covers the range of the sold it to the shop. The sale of any product in facetoface transactions by any specific category of retail outlets. Is there anyway to exempt the shops from the flavor than is there any legal way for a hypothetical flavor van to exempt shops . I think that you are reading and interpretation of the statute that is inaccurate and under the law we wouldnt be able to differentiate the type of retail outlets. According to the fda and the cdc 2018 Tobacco Survey, over 15 of kids reported by ecigarettes from evading the shop in the last 30 days compared to just 8. 4 who bought them from a gas station or Convenience Store. So come if the data shows twice as many biases illegally to compare the Convenience Stores, how would that support a hypothetical plan that allows the flavors in the shops that bans them in gas stations when the numbers were just exactly the opposite in terms of where the problem is. I think you are making a very mr. Zeller i think you are making a very good point. Mr. Conyers california study showed that half the vape shops did not check this and 45 of vape shops. E study found that failed to youth significantly hire. If the goal is to keep kids from bans them from gas stations and Convenience Stores . Mr. Zeller as i said in my earlier responses, our job is to follow the regulatory science and put regulations and protecting kids from the hazards of all Tobacco Products. Mr. Conyers that is a good bureaucratic answer and thats a. Mr. Connolly i thought so. We clearly do have a problem here and have cognizance of the problem and where kids are going so we can target effective strategies. Mr. Zeller i agree. And while we have chuckled, that shouldnt belie the seriousness and trying to do the right thing. Congresswoman wasserman schultz. Schultz schultz when the doctor of the c. D. C. Testified on september 24, i asked her whether nonsmokers are being drawn and she said flavors are always what brings youth in. And keeping kids off cigarettes and metropolitan ol should be included. Mustder to be a flavor ban include menthol . Mr. Zeller i cant get into the specification. Ms. Wasserman schultz im asking your opinion if you agree that the doctor in order to a lavor ban should be effective. Mr. Zeller as i said in an earlier response, one of the things we are trying to account for is the data that came out in the survey that came out cently and ms. Wasserman schultz i was ere. Scope of the policy should be. What it should include. What was the suband remains the ubject of ongoing. Ms. Wasserman schultz and originates from the f. D. A. Or did it come from somewhere else. Thats not what im asking you, the idea toics ement menthol was it an idea generated by the f. D. A. , yes or no . Mr. Zeller let me try to answer your question in ms. Wasserman schultz i want an answer. Tos is not a quick question, exempt menthol come from the f. D. A. Or did it come from somewhere else . Mr. Zeller there have been a variety of options for the scope of this policy. Ms. Wasserman schultz im asking the idea mr. Zeller please let me finish. The options that f. D. A. Put on the fail tore consideration for the scope of what this guidance should be but went to the issue of menthol. If the answer is to your question who put the questions on the table, yes, we put it on the table. Ms. Wasserman schultz it wasnt an idea but generated by the f. D. A. And your idea . Mr. Zeller all options were being exploited. Ms. Wasserman schultz and it dr you are not answering this was an idea that was generated by the f. D. A. Mr. Zeller thats not what i said. When we were identifying options we put a variety of options that included menthol and menthol out. Ms. Wasserman schultz we are going to have to make sure that the f. D. A. That they are required to answer when we ask them questions because mr. Zeller is not answering. Do you have any on november anda doctor testified a the can nt know if kids differentiate. Kids differentiate . . Mr. Zeller kids may not be able. Ms. Wasserman schultz they may carry unique harm. And a can ser and they banned it as a food administrativetive. Nd found high levels in both liquids and uses thousands times higher. Shouldnt we be we concerned . Mr. Zeller we have questions about it. Ms. Wasserman schultz you have pretty good science. Mr. Zeller we are looking into it. Ms. Wasserman schultz we heard the decisions that may have been made by october 31. Were you aware of the study . Mr. Zeller we were aware of that study. Ms. Wasserman schultz and a light of high level causing cancer. Would you know that be a good reason to pull it from the market . Mr. Zeller it would be a good consideration. Ms. Wasserman schultz i yield the balance of my time. I recognize congressman sarbanes for questioning. Mr. Sarbanes thank you for the opportunity. Thanks for being here as we said many times, from september in this year we saw the announcement that the f. D. A. Will be to ban products including menthol products and wouldnt be the first time that they move to ban. Isnt it true that a similar policy was crafted. Mr. Zeller i wouldnt call it a ban but there was a version that would have treated that restrictions would have been put in those. R. Sarbanes and you are involved in the rulemaking process . In october of 2015, f. D. A. September a flavor ban to the review and it will meet with any lobbyist as long as the rule is under review. We now know that they met with 100 lobbyists to discuss the 22015 policy and as a cautionation but some correlation, they eliminated the flavor ban policy. Were you happy with that result . Mr. Zeller i was prepared to. Plain the plafere policy mr. Sarbanes im reading between the lines. Ets turp to the 2019 that was promised in september that was accompanied by these figures by he survie that students have ed and used fruit or menthol figures. And seems that is. 2015 policy. Now that the current flavor guidance, the president has taken one meeting on the topic, do we have any way of knowing that the president or the whougs are meeting with industry lobbyists . Mr. Zeller you have to ask the white house . Mr. Sarbanes the administration which is at least transparent in my memory, are there logs and there is no way to show up who is showing up there and lobbying the president. If that was president. That is not the main problem. The main problem and what people this up with is that government wont tackle without getting from special interests. I would be candid with you. We are facing a Youth Tobacco crisis. Two decades of progress is being reversed almost overnight. The president promised to act quickly and promises to do to protect kids but as soon as he says hell take action, here come the lobbyists, the influencers and suddenly this particular ban is in purchasing georgia tower and the impression ap when i read the headline its completely flipped around is that the tobacco lobbyists are calling the shots and not Public Health prolvingsals and not as it should be, appear agency like the f. D. A. To fulfill its mission in every possible way because of this influence peddling. It is another in a long list of examples of what is broken about this place. And the public gets this. They may not understand how influence flows through the executive branch, congress, but they can feel in their gut that policy is getting made up here for a group of very powerful people and not for this them. We have to fix this in so many arenas and when it comes to protecting the health of our kids. Thank you for the opportunity. Thank you all for coming to today. I want to close with a couple ofry marks. These figures are alarming, absolutely alarming and unacceptable. The f. D. A. Is charged by the American People to stop this epidemic and you are failing on the job. We know what will stop it and flavoredanning these e cigarettes. We know it. T gets kids to take up ecigarettes and nicotine gets them hooked for a lifetime of addiction. For you to tell in here you submitted guyance and for parallel discussions to be happening, but for us to have zero transparency and who is part of these discussions and how long these discussions are going to happen is unacceptable. This is wrong. And the parents of all of these ds are still waiting for answers. And the answers you provided today are not going to do. So i suggest you go back to the f. D. A. And you tell them that the american pun is up in arms about this use of easterncigarette use epidemic and you tell the white house and you tell all those who are part opaqueparallel, unusual, discussion that time is up. It is time to get their and put this flavor ban out immediately without delay before another child gets hooked before another middle schooler gets hooked and certainly before any high schooler or child who is veloping gets hooked to an ecigarette. Without objection, all members may have five legislative days to submit additional questions to the witnesses which will be forwarded to the witnesses. I ask our witnesses to respond as promptly as you are able. This hearing is adjourned. [captions Copyright National cable satellite corp. 2019] captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org on congresswomen and the devaluation of black lives, et cetera. And this period provides a really crucial precursor. Holly jackson talks about her book american radicals. Cspanubpoenaed night at. Earlier today nancy pelosi
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