Dangerous to youth . Two fundamental reasons, our brainstorm fully develop until 4 25 or 26 years old, and its clear that any exposure to nicotines in the still developing adolescent brain is harmful, regardless of what the other hazards, chemicals in the vapor are. Just the nicotine alone is reason enough to be concerned that no good should be concerned. Then, when you add what is known, those bring additional risks. We have to still called Harm Reduction debate, that is a different question, when we ask about if we switch to ecigarettes, well be exposing itself to fewer toxins. As i said, kids are walking away with this mindset that its harmless, that its water vapor, and some of them dont even know that its nicotine. I now recognize congressman grasp for five minutes of questioning. Were going after some territory, you see the list behind you, the number of middle school kids and High School Kids that are using these. Do you know how many of these people are using illegal products that i can think about my local convenience store, the number of years . The data that the chairman has put us up is use of lawful ecigarettes to delivering nicotine, that is separate from kids who are raising. Up to 27 , some of those are using thc . They could be. Is it your belief, this is like the third hearing weve had on this, is it your belief thats almost all of the hospitalizations that take place are using these thc cartridges . In the samples that we have analyzed that have been sent to us by the states, we are seeing thc in about 80 of them. They had some billboard or something or other up, talking about the danger of combining ecigarettes. There are different amounts of nicotine from one to the next, you can buy it, you can buy ten or 15, or whatever. , do we know how many are sold in each of the levels . How many are at a 50 or 100 . What we do know is that juul its the highest nicotine product on the product, and kids that use ecigarettes are more likely to use juul, their for their using the highest nicotine available. Juul only has high nicotine . I was under the impression that you can adjust and start at 40 and a record 20 or whatever, but you are saying all juul cigarettes . There may be a 3 . The overwhelming percentage is the 5 , which is an extraordinarily amount of nicotine, the thing the you answered into the device. Are you sure . Yes. I was under the impression that people wanted to work it way down from the. Top if they, are not doing it with juul. Are you worried that if you have been illegal, people will run to the illegal ecigarettes, just a, and be with more thc . Are you talking about a ban, congressman . Were talking about a policy to deal with currently marketed ecigarettes that have not gotten the marketing authorization, and of the currently marketed products should be put into a category where the only way they can be sold as if they go through a review process by fta. Do you know people that have use ecigarettes enough stops smoking it . Is that a good thing, or something we should be discouraging . To me, it seems thats a good thing. All of a sudden, you have something thats effective, and we are looking for ways to have less people. We have heard, what i call are compelling, but albeit anecdotal reports who have said that its only because of ecigarettes that i was able to get off. The United States is Preventative Services task force has not recommended ecigarettes as a cessation aid. There is a regulatory pathway for this product to be authorized as a cessation aid if a Company Wants to go for the, its why the leadership has been talking over the last year or more about the on ramp and offer have, and the balancing act. Yes, there are anecdotal reports that some former smokers have successfully transitioned to ecigarettes, but the on ramp for kids is getting wider and wider and wider, and our job as regulators is to figure out how to balance those two uses of the product, and the question for all of us, not just for fta is, at what price, at what price if ecigarettes have become more and more of an on ramp for kids, and those are the things that we are grappling with internally with the data . I have one more question, thanks for letting me go over. Is it possible that if you found a way to ban a cigarettes, what would happen, given that there is a little bit of a natural inclination, they would Smoke Tobacco cigarettes . Weve made such progress in reducing the number of kids he smoked cigarettes. The numbers that are coming out well report historically low rates of kids smoking cigarettes. Kids are aware of the hazards of smoking cigarettes, but my concern, speaking for myself based upon the data that ive seen, is that the kids who are most at risk are kids who never have thought about smoking a cigarette. Thank you. I now recognize congressman connolly for five minutes of questioning. Thank you, but if its all right id like to yield to my friend. Are you sure . Okay. So, welcome. Im gonna ask you a series of rapid fire questions to establish direction. Do you mind . Was the compliance policy sent to oira, the exact . As i say to the chairman, i can get into the details of the policy that remains under review. You cant even tell us if they did or did not include vaping . You say thats exempt from congressional scrutiny at a hearing . When there has not been a final decision made yet on this policy, and its clear that has not been made, we dont discuss publicly what the considerations are. It has been accurately reported that the agency submitted the guidance to oira, it has been accurately reported that oira cleared the guidance, but as i said, to the chairman, there are these parallel, ongoing policy related discussions. That answer raises a whole host of other questions. Youre treating a very thin ground here. We will revisit that as a committee. The fta does not regulate flavors, is that correct . The fta has jurisdiction over illiquid, is that correct . As long as it meets the statutory definition. Fda has jurisdiction over nicotine free liquid as a component are part of its Tobacco Products, if it is reasonably expected to be used, is that correct . That appears to cover the things and the vape shot. So the fta can regulate Convenience Stores following that logic. It prevents the sale of any tobacco product, by any specific category of retail outlets, so they cannot ban gas stations from selling flavors, while allowing the shops to continue, credit . I think thats an accurate reading. In light of those previous answers. You are a lawyer. Is there any legal way for a hypothetical taliban to conceivably exempt vape shops . I think that youre reading is accurate and i think that under the law we would not be able to differentiate between types of retail outlets. According to fta and cdcs 2018 National Tobacco survey, almost 50 of kids in the last 30 days, compared to just 8. 4 who bought them from a gas station. So if the data shows that twice as many show we legally, compared to Convenience Stores, how would that support a hypothetical plan, but bans them in gas stations, with the numbers would suggest the opposite in terms of where the problem is . Youre making a good point. I think you are good lawyer. Thank you. Finally, a california study showed that half of the day perhaps did not check ideas. At 45 , the study found they shots significantly higher than other types of stores, if the goal is to keep kids from vaping, how does that allow flavors and vape shops, but vandalism in gas stations . As i said, and so my earlier responses, and to put forward policy engagement that protect kids including ecigarettes. Thats a very bureaucratic answer, but thats a very good question. We clearly do have the actuality of the problem, and where kids are going. So that we can target effective strategies. I agree, and what we have chuckled and our exchange that should not blind the seriousness with which we are trying to do the right thing. Thank you, and i now recognize congresswoman schultz for five minutes of questioning. Thank you. When the doctor testified before the subcommittee i asked her about whether non smokers or being drawn to ecigarettes by their flavors, she said quote flavors our web ring youth into starting this with ecigarettes you also testify we would be effective for keeping them all flavors must be included, do you agree with his assessment that in order to be effective and must include mental . Again i think to the consternation of the subcommittee i cant get into the specifics of the policy thats under consideration all i can tell you is. I was in asking about the specifics of the policy im asking your opinion if you agree with his assessment that in order to be effective a flavor ban must include mental, you are not prohibited from offering your opinion. As i said an earlier response one of the things that we are trying to account for is the data that came out in monitoring the future survey, it only came out recently and i will just repeat a very briefly. Briefly i was familiar when you said it and i dont need a repeated. Okay then i dont need to repeat it all just cut to the chase and say that we now have data that shows that for kids who used to rule they are fire more likely to use mint then mental, far more likely and how do we account for that as we are trying to make the right policy to do the best policy to the kid. The idea of exempting mental original late from the fta . The issue of what the scope of what the policy should be what it should include law was the subject and remains the subject of ongoing discussions. Did the idea of exempting mental originate from the fta or today come from somewhere else . Fda put the science forward that i just described to you. Thats not what im asking you, the idea, to exempt mental was it an idea that was generated by the fda, yes or no . Let me ask you this in a more general or hypothetical way. Its not a trick question, did the idea to exempt mental from a flavor ban come from the fta, or did it come from somewhere else . There have been a variety of options for the scope of this policy that have been. Im asking the idea. Please let me finish. You are off escaping. The options that they put on the table for consideration going to what the scope of what this guidance should be went to the issue of mental in or mental out. But did it come, did the idea. If the answer to your question is who put the options on the table mental inner and all out. Yes you put it on the table. So it wasnt an idea brought to you from the outside who is generated by the fda, it was your idea with no at a point of time with more options we explored. So there was influence from the outside and it was not, you are not answering that this was an idea that was exclusively generated by the fda. I dont think thats what i said. I want to make sure i understand what you were saying. When we were identified options we put a variety of options for consideration that included mental in ornamental out. Mister chairman we are going to have to make sure the fta require he is not complying with what is required of him. On november 13th doctor shook it testified that it didnt read justify between the two and we dont even know if kids can differentiate, you have any idea or to believe that they can differentiate . I am aware of the literature that says kids may not be able to differentiate. And mental and mint may carry more harm, mysteries all or the fda band it as a food additive . Yes and a recent study found extremely high levels in both mental adamant, it found the level is as much as 1000 times higher than mental cigarette users, should we be concerned about that. We have been looking into that science. You banded as a Food Additives i think you already have good science and it is dangerous. We are looking at the methodology in the adequacy, we heard the decision to exempt mental was made on october 31st, where you aware of this when he made that decision . Im not going to refer to any decision but we were of where of the study. When a real revelation comes to light about cancer causing an menthol liquids wouldnt that be good to determine whether it is safe . They would be part of the negotiation. Thank you congresswoman now i recognize congressman. Thank you for the opportunity mr. Sala thanks for being here as we said now many times in september this year we saw the announcement the fda releasing a policy to plan ecigarette products including mental products in this would not be the first time the fda moved forward with the policy to ban ecigarette flavors, correct . Isnt it true that a similar policy was crafted in 2015 . I wouldnt call it a ban by the it is a matter of public read a record that there is a version that wouldve treated flavor differently. Restrictions wouldve been put on those. In 2015 you are director of the fta center for Tobacco Products as you are today, where you involved in that rule making process . Yes. Or i know on october 2015 they had a flavor ban for review and they have been open door policy meaning it would lead with any policy as long as the interview is going on. We now know that they met with over 100 industry lobbyists to discuss the 2015 policy and as a result im not gonna say causation but some correlation at least they eliminated the flavor ban policy. Were you satisfied with that results and the justification back in 2015 . I was prepared to explain the final policy. Did not square with the policy they put forward earlier in the process. Okay im reading between the lines, that was very diplomatic. Lets go to the flavor ban in september that was accompanied by the startling figure is showing that over a quarter of High School Students now had used ecigarettes in 2019, many have used the popular fruman ornamental flavors. Despite those trends the most recent policy now seems doomed to the same fate as the 2015 policy. Now that the current flavor guidance has left, the president has taken at least one meeting on the topic. We have any way of knowing if the president or the white house are meeting with industry lobbyists . Thats a question i need to ask the white house. So you dont know. I dont know. Of course the administration that is the least transparent in my memory as eliminated the white house visitor logs so there is no way of knowing who showed up there and lobbying the president in these meetings. Even if that was public thats not really the main problem. The problem and i think when people are fed up with across the country is their government, this government wont tackle important issues without getting permission from special interests. I think that is whats playing out here and speak very candid with, you im not gonna ask you to comment on it and we are facing a Youth Tobacco crisis. Two decades of progress in reducing smoking is being reversed almost overnight the president promised to act quickly. Promises to do something to protect American Kids from these dangerous products but as soon as he says he will take action here come the lobbyists the influencers and suddenly this particular band is not happening and the impression i get and i think a lot of people in the public when they read a headline one day and 72 hours its completely flipped around is that the Tobacco Industry lobbyists are calling the shots and its not Public Health professionals unfortunately. Its not as it should be an agency like the fta leaning in to protect consumers and fulfilling its mission and every possible way because of this influence peddling that goes on. So its just another in a long list of examples of what is broken about this, the public gets this they may not understand all of the intricacies of how influence flows through the executive branch and through congress etc but they can feel in their gut that policy getting meet up here for a group of very powerful people and not for them. We are going to have to fix this and so many arenas but certainly when it comes to protecting the health of our kids and with that mister chairman i yield back. Thank you for the opportunity today. Thank you congressman, thank you all for coming today and i just want to close with a couple remarks which is that these figures are alarming. Absolutely alarming and unacceptable, the fda is charged by the American People to stop this epidemic and your failing on the job. We know what will stop it and that is banning these flavored ecigarettes. We know it. Those flavored ecigarettes is whats get kids to take up the cigarettes and the nicotine is what gets them hooked. For a lifetime of nicotine addiction. So for you to come in here and tell us that you submitted guidance, oh iowa concluded its review and then from parallel discussions to be happening but for us to have zero transparency into who is part of these discussions. How long they are going to happen, when this policy is going to come out is unacceptable. This is wrong and the parents of all these kids are still waiting for answers and the answers you provided today are not going to do so i suggest you go back to the fta and you tell them that the American Public is up in arms about this youth ecigarette epidemic. You tell the white house and you tell all those that are part of this parallel irregular unusual opaque discussions that time is up. Its time to get their act together and put this flavor ban out immediately without delay before another child gets hoped to these ecigarettes before another middle school or gets hoped to an ecigarette and certainly before any highschooler or any child whose brain is still developing to the age of 25 or 26 as you said, gets hooked to any cigarette elite. Without objection all members will have five legislative days within which to submit additional questions which will be forwarded to the witnesses for responses. I ask our witnesses to respond as promptly as youre able, this hearing is adjourned. [inaudible conversations]