tv Hearing on Underage Vaping Legislation CSPAN July 11, 2021 1:56am-3:49am EDT
we talk with her about her in-depth book, "the rise and fall of the secret service." >> listen at c-span.org/podcast or wherever you get your podcast. >> acting fda administrator testified before congress about the impact of leaping. the fda has a september 9 deadline to complete interview vaping products. senator dick durbin, who sponsored legislation to crackdown, also testified.
helm at fda. the youth vaping epidemic unfortunately continues today. more than 20% of those are the same levels that compel the surgeon general to declare a youth vaping epidemic three years ago in 2018. for as long as the subcommittee existed, we have been investigating this epidemic. this is our fourth hearing on the matter. investigating this epidemic. this is our fourth hearing on the matter and i sincerely hope it's our last because the problems are solvable. our first in 2019 involved putting juul on trial, it's marketing to children, it's attempted use of native americans as experimental guinea pigs and its responsibility for fueling the youth vaping epidemic. we presented evidence from our
investigation to fda and fda agreed that juul was breaking the law. it sent juul a warning letter regarding its marketing practices and declared them illegal. now juul's fate is again in your hands at the fda. juul's products and all e-cigarettes need fda's approval for their products to stay on the market through what's called the premarket tobacco application process, also known as the pmta process. fda's decisions are due by september. juul's marketing to children was simply unacceptable. the attorney general of north carolina is taking juul to trial over that as we speak, but beyond marketing juul hooked kids for three other reasons, first, kids were attracted to the flavors juul cigarettes came in. second, kids got hooked because juul came in nicotine levels
much higher than anything else on the market. and third, juuls were easy to conceal from adults. companies copied juul's model. when you look at the list of products that are on -- that are the subject of pmta applications, there are many, many even now in kid-friendly flavors. there are many that matches -- match juul's high nicotine formulation and many that match juul's concealability. to the fda i would say this, no matter what your decision is on juul's pmta you know that the problem does not end there. to end the youth vaping epidemic you will have to deny the applications for all products with the same characteristics that made juul so popular with a generation of children because we've watched in realtime that whenever a popular flavor is removed from the market, other flavored high nicotine products
take their place. so i say to acting commissioner woodcock, i believe you want to do the right thing, that you want to keep nicotine out of the hands of children. when you decided to ban menthol cigarettes, you took a strong action to strengthen public health and racial equity. when this subcommittee exposed the prevalence of toxic heavy metals in baby foods you made that issue a priority and created the closer to zero initiative. and we are appreciative. however, now fda has the opportunity to step up and finish the fight against the youth vaping epidemic. don't let any flavored products from any e-cigarette companies stay on the market. not mango and not menthol. if you leave a single flavor on the market kids will use it and that will not be because of the destruction that occurred before you took the helm, it will be because of an affirmative
decision that you and the fda make. don't make that decision. don't let any flavored products on the market. don't let any high nicotine products on the market. other countries kaepernick teen at one-third of what's in a juul. those countries do not have anywhere near the youth vaping epidemic problem that we have in this country. do these things and in the next three months we can help stamp out an epidemic. we saw this movie before with big tobacco and the opioid epidemic. let's not let it happen with vapes. have the courage to say no to big tobacco, the health of a nation depends on it. thank you. i now recognize ranking member cloud for your opening statement. >> we have known for decades that cigarette smoking a dangerous and linked to cancer and other illnesses. it causes 480,000 preventable
deaths each year, more than 1,400 deaths a day. i cannot think of another product on the market where 50% of its users want to quit the product. if you are under 21 you should definitely not use tobacco or begin using vaping products or any other drug or anything else nefarious you should put in your body. it's really important to understand that especially for young teens as your bodies are still developing these products can have an even outsized greater negative impact on your body as you're growing and learning and those sort of things. unfortunately as we've covered in past hearings severely misguided marketing efforts have contributed to a vaping epidemic among teens and communities across our nation. social sourcing coupled with nefarious count fit and black market products found their way to hands of teens and led to heart breaking outcomes for families. we made some progress with the pass ak of 221 but there's still more work to be done. there is some evidence that this is a new industry and some evidence is coming forth that
may lead -- that vaping products could help with smoking cessation. if that's true, i hope the fda will take a good look at the science based on t but we need to do everything we can to make sure that our youth do not have access to these products. i share along with the chairman our first role ever being a member of congress is that of a father and we do not want to see a world where kids have access to these sort of products. i want to thank you all for being here today, i want to thank you for attending this hearing and i want to thank you also, dr. woodcock, for appearing for us today. i do hope that we will be able to have a good healthy discussion that we will be able to hear from you, but also make sure we are not unduly influencing improperly a process that is supposed to be evidence based and hopefully it will be
and will be able to do the right kind of science of being able to divide how we can protect our kids yet if the science does point out that this is a smoking cessation device, that we will be able to have the right adults have access to that product as well. thank you, chairman, for this hearing. thank you for your passion on this topic and i yield back. >> i want to applaud mr. cloud for being part of the bipartisan bicameral congressional caucus [ inaudible ] which myself, senator durbin and others are chairing. so thank you so much, mr. cloud. now, chairwoman maloney, thank you for being with us and thank you for your distinguished leadership of our committee. i want to just recognize you for a brief opening statement as well. >> thank you. our nation's youth are experiencing a public health crisis. according to data collected by fda and cdc more than 3 million
high school students and half a million middle school students use e-cigarettes and according to the office of surgeon general, an estimated 5.6 million children in this country will die early from a smoking-related illness if cigarettes can continue to be used at this rate. that's one in every 13 young people alive today. these numbers are horrifying. they threaten years of progress in reducing youth tobacco use and the e-cigarette industry is to blame. companies like juul and puff bar knowingly and deliberately pushed tobacco products on to our nation's youth. they deployed deceptive dishonest tactics to get our young people hooked on these products. they even went so far as to promote their products directly in our nation's schools. e-cigarette manufacturers have acted with a complete disregard for the health of young people across this country.
their actions are appalling and the federal government can no longer allow this industry to foster youth addiction as a long-term marketing strategy for its deadly products. our nation's regulatory agencies must take immediate action to turn the tide on this crisis. fda can build on the steps its taken so far by prohibiting the sale of remaining flavored products, capping nicotine level in e-cigarettes and pulling illegal products like those sold by puff bar off the market. i strongly urge the agency to take these common sense steps. let me conclude by commending the leadership of of the chairman. the subcommittee's investigation has brought to light the dangerous practices of e-cigarette manufacturers across the country and it has underscored the urgent need for the federal government to act on
america's youth vaping epidemic. thank you for your leadership, chairman. i look forward to hearing the system from all of our esteemed witnesses today and i yield back. >> thank you for your distinguished leadership. thank you for your opening statement. now i'd like to begin by introducing our first panelist, someone i know very well, the distinguished senator from my own home state of illinois. for decades senator dick durbin has fought to protect all americans including our societies most vulnerable from the dangers of tobacco and e-cigarettes. his work dates back to leading the congressional effort to have smoking banned on airplanes, a measure that went into full effect in 1990, more than 30 years ago. today i'm grateful to consider senator durbin a champion and a partner in our shared effort to curb youth vaping. he is the senate lead of the congressional caucus to end the youth vaping epidemic, he is the
senate lead of our legislation, the tobacco tax equity act which will raise taxes on all tobacco products for the first time in over a decade to protect public health. he is the senate lead of the prevent act, legislation to create youth vaping prevention programs in schools and this is just a small snippet of the work that senator durbin has engaged in in this space for decades. senator durbin in his spare time is the majority whip, the chairman of the senate judiciary committee and a long-standing dean of the congressional delegation from illinois. we are so fortunate to have him here today and thank him for his participation. senator durbin? >> thanks, chairman, and ranking member cloud for allowing me to testify today on the youth vaping epidemic and the role of the food and drug administration. the campaign to reduce tobacco use and prevent our kids from
lifetime addiction to personal to me. my father died from lung cancer, he was 53 years old. he smoked two packs of camels a day. as a young high school student i will never forget how he struggled to breathe during my visits to the hospital in his last days. cigarettes are responsible for 480,000 deaths every year in the united states. my family is certainly not the only one who can tell this story. so ever since i came to congress starting in the house i've dedicated my career in public service to this fight. holding the tobacco industry accountable for its lies and deception, empowering families, schools and health care providers to prevent kids from this addiction and working to build and strengthen a regulatory framework that really does focus on public health. when last i testified before the subcommittee in july of 2019, seems so long ago, most of our focus was on the skyrocketing rates of youth e-cigarettes
fueled by the kid-friendly flavors, aggressive promotion and high nicotine concentration of the product. since that time my office, the subcommittee and the public health community have shown a bright light on the abusive tactics by juul that contributed to this foot hold with our children. we now have uncovered the disgusting tactics used by this company to addict our children on these e-cigarette products. i'm pleased our public health and antitrust regulators have started to step in but what i want to focus today is the record of the fda over the last several years and the opportunity that sits before the agency today to correct its missteps in the past and put public health and kids at the forefront of its mission. flavored e-cigarette products have exploded in popularity among our kids. nearly 4 million now vaping, a 361% increase in just eight
years when only 800,000 kids were vaping. one in five high school students use e-cigarettes. these alarming trends are erasing the historic progress we've made reducing youth tobacco use. who is the cop on the beat to whom we entrust our children? it's the food and drug administration and this agency has been timid and reluctant for way too long. for years the fda delayed implementation of its requirement that companies submit pmta applications for review. at the same time the fda allowed cigarettes to proliferate essentially unregulated, e-cigarettes to proliferate essentially unregulated failing to enforce its own deeming role which required that all new products entering the market after august 8, 2016, undergoing a public health review. since my last testimony we had a glimmer of hope on that day in september 2019 when president trump promised to ban all
e-cigarette flavors. as part of that the fda in january of 2020 had a golden opportunity to finally clear the market of these addictive kid-friendly products, the vast majority of which were on the market illegally, but instead the food and drug administration took a half-measure only partially clearing the market and leaving major loopholes for this powerful industry. the result, kids migrated to these loopholes, to the products that remained unregulated on the market, menthol flavored e-cigarettes and disposable vaping products. the use of disposable e-cigarettes, one of the loopholes which the fda lost which were exempted from the fda's 2020 action increased 1,000% last year. make no mistake, kids get it. if we don't take this seriously across the board they will find those loopholes and continue their addiction. pause the fda allowed menthol flavored cartridges from juul
and others to stay on the market, listen to this, the use of these menthol flavored juul products, cartridges increased from 11% to 62% of the market. another failure by the fda, now we approach one of the biggest milestones in fda tobacco regulation here in history. i'm worried the fda will fail again. after years of delay the fda under court order -- under court order finally required e-cigarette and tobacco manufacturers to submit applications for their vaping products on september 9th, 2020. this is the long awaited opportunity for the fda to apply a public health standard that congress passed long ago as 2009 in the tab key control act to evaluate whether a product can stay on the market and whether it is, quote, appropriate for the protection of public health. that is a high bar. it requires the fda to balance the risk of youth initiation
with potential benefit battled cessation and the burden is on the manufacturer, the murder is on the murer to show their products will not lead to youth use, show their products do not harm the user and to show they actually help adults quit smoking. remember that claim, made over and over again? prove it. you can't. they know they can't. i'm deeply troubled with what i've heard from the response of the fda to my letters. i fear they're going to once again overvalue the unproven potential benefit of cessation for adult smokers while undervaluing the clear evidence of what's happening to our kids. only 4% of adults use these cigarettes. 20% of high school students. kids who never would have picked up a tobacco product are vaping. it's simple, any product with a history of increasing youth use must be rejected by the food and drug administration, especially flavored products that we know hooks the kids. this is the super bowl for the
fda's tobacco effort. i'm afraid they are not ready for prime time. i hope they prove me wrong. the fda recently announced plans to ban menthol cigarettes, an important public health action and i want to commend the acting commissioner who sits behind me when she called me with the news. but just like that step the time is now for fda to take meaningful action on how it applies public health standards to e-cigarettes. we know fda's after the fact enforcement, warning letters and game of whack-a-mole doesn't work. fda slow walking and refusal to forcefully act has enabled these e-cigarette companies to addict a new generation of our kids. it's time for the fda to be a partner in public health not a partner to big vape and take these products off the market. as a -- continues to examine the youth e cigarette epidemic and the role of fda i hope we prioritize our kids. let me close with a personal note.
it's been a few years but i once served in this house of representatives in this building, in the house appropriations committee and one day i decided to offer an amendment on the transportation subcommittee bill that i served on to ban smoking on flights two hours or less. why did i pick two hours? because one of the leaders on the democratic side in the house appropriations committee martin sabol of minneapolis was a chain smoker. i asked him how long could you go without a cigarette? he said two hours and that's what i put in the first bill. flights of two hours or less, ban smoking. what happened afterwards is incredible. even with the opposition of the house republican and democratic leadership, i managed to get this to the floor thanks to a man by the name of claude pepper who was chairman of the rules committee and basically ignored the speaker's direction to give me a chance on the floor. how about that? i had bill young of florida republican as my co-sponsor, we went to the floor and we won.
it shocked everybody that we won. why did we win? because it turned out that the house of representatives was the biggest frequent flier club in america and they were sick of smoking on airplanes. well, eventually we banned it on all flights going beyond two hours. i didn't know it at the time, i really didn't know it at the time, that was the tipping point. at that point people said to themselves, if it's unsafe, if secondhand smoke is dangerous on an airplane why is it safe on a train, on a bus, in an office, in a restaurant, in a bar? and the dominoes started to fall. we're at a much different place in america today because as a junior member of the house of representatives i tried something that was considered politically impossible and it worked. you can do the same thing. you have that power at your hands. i hope you will use t i know this hearing is an indication of your interest in the subject. not only give the fda the tools, but make them use it if they won't.
bring them around to the side of protecting public health. you will be glad you did. thanks for letting me testify today. >> thank you, senator durbin, for your excellent remarks and we very much appreciate your second visit on this topic, hopefully your last. hopefully this will be our last hearing because now we are going to adjourn this panel and invite commissioner woodcock to come to the table and tell us how we're going to get the fda to do the right thing here. so thank you. thank you, senator. clerk, could you please play the video that has been prepared for the public here. i started vaping at 17 years old with a juul and i then proceeded
to use sorens, air bars, puff bars, boulders, anything type of vaping device that there is out there, i probably bought and used it. i think it's really, really important for older generations, people in schools, state governments, federal governments, people working for the fda, it's so important for them to understand the severity of the epidemic that's going on with vaping with people of my generation. it almost seems like everything about the product, the color, taste, smell, marketing of it is all comprised to get people my age and younger addicted and luckily i quit six months ago and i haven't touched anything since. it's been quite an adjustment to explain to people in my peer group why i quit nicotine, why it's bad for us and what they just can't understand is happening or might happen to their bodies because that's the other thing with nicotine is we
just don't have any long-term research with these vaping devices what will happen to our bodies and what will happen to people -- what will happen to people with long-term use. >> hi, my name is samantha boy and my daughter is 18 years old, she's been addicted to the juul product since she was about 13, 14 years old. she started out vaping mango, but now her favorite flavor is menthol because she can no longer get her hands on mango. i would like the fda not to legalize menthol. i will tell you that all the kids that are vaping are only vaping because of flavors, including menthol. >> i used products that were primarily the fruity flavors of juul, enjoy, alto, puff bar and
even some of the menthol products. i definitely believe that the industry marketed to people like myself, people that were in high school and unfortunately they were very, very successful in getting a lot of my friends and myself addicted to their products. >> and it's very interesting because within my peer group we are all health science majors so we know the effects of vaping, we know that it is not better for you than cigarettes, we know it's still harming our bodies, but they're so easy to get access to, they're so easy to carry around, you can vape literally in a classroom and no one would know unless they're looking at you blowing smoke out. you can just have it in your pocket, transport it with you everywhere and it tastes good. there's different flavors, mango personally was one i really liked when i was vaping. again, like i said, everyone
else around me despite the fact that they knew better were also vaping. >> hello, my name is paula costello i live in wilmington, delaware, this is my son walter. he passed away when he was 19 years old. he started vaping when he was 16. i found some juul pods in his room, that's how i discovered he was -- he started with fruity flavors, like mango and mint, and i then found out that he was severely addicted to this and he was unable to stop. he was so addicted, in fact, that he was rushed to the er on several occasions, the last time before he passed away he was rushed to the er and they had to bring him back to life, and he still was unable to quit vaping. that's how addicted he was.
the fda should have been looking out for me and my family, my kids, all the kids in the u.s. those products never should have been on the market and never should have been marketed to kids. walter died way too young, his death was unnecessary, and now the fda has a chance to make a difference. so please don't allow those products, products like this, on the market ever again. thank you. >> the fda pushed back by several years the deadline for please e-cigarette and vaping companies to have the fda determine whether or not these products are safe for public use. i along with many other kids in my generation got addicted to nicotine and these products in that time that you allowed these
companies to sell their products. what do you have to say now to me and everyone else who got addicted and now we know that these things aren't safe? >> thank you for playing that moving video. good morning. we are now introducing panel two, we are joined today by the honorable dr. janet woodcock. dr. woodcock is the acting commissioner of the food and drug administration. commissioner, thank you for being with us today. i will begin by swearing in the witness. if you would please rise and raise your right hand. 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? thank you. let the record show that the
witness answered in the affirmative. thank you and please be seated. the microphones are sensitive so please speak directly into them. without objection your written statement will be made part of the record. with that, commissioner woodcock, you are now recognized to provide your testimony. >> thank you. and good morning, chairman and ranking member cloud. thank you for the opportunity to be here today. this is a very important issue to me. i'm here today representing hundreds of staff at the fda who are working every day to prevent kids from using any tobacco products, including e-cigarettes. while i've only been in my current position for about six months, i've been with the agency in various capacities for over 30 years. while director of the fda center for drugs i played a central role in the agency's initial attempts in the early 2000s to regulate e-cigarettes under our
drug and device authorities, particularly i was worried that flavors would entice children to use these products and that would cause harm. the issue ultimately was adjudicated in the 2010 saterra court case where the d.c. district court ruled that products made or derived from tobacco could only be regulated under our tobacco authorities. now as acting commissioner i'm happy to continue to work closely with my colleagues from the center for tobacco products. it is a new day and we now have a tremendous opportunity and indeed a responsibility to keep and elevate kids at the forefront of our efforts to prevent death and disease from tobacco products. with the september 9th, 2020, premarket application deadline behind us, we're taking steps to transform a tobacco marketplace towards one where deemed new tobacco products on the market
like e-cigarettes will have undergone careful science-based review and oversight by fda. this is truly significant. we have received and initially processed submissions that cover more than 6.5 million products. congress granted us vital public health tool with our premarket review authorities and i can assure you we intend to use that authority to protect kids and optimize public health as directed in the statute. we are working furiously on application review in order to move on from sort of a wild west unregulated marketplace. we will complete thorough evaluations to ensure that any products that are granted marketing orders meet the statutory standard of appropriate for protection of the public health as senator durbin said a high bar. if data for a product do not clearly support that standard which includes an evaluation of the impact on youth initiation
and use, we will not issue a marketing order for that product. at the end of the day we're going to do everything we can to end the epidemic of youth use and prevent another generation of kids from becoming addicted to tobacco products. importantly we're going beyond premarket review while a 2020 national youth tobacco survey showed an encouraging and significant decline in youth e-cigarette use last year there's still 3.6 million middle and high schoolers who currently use these products. the epidemic of youth vaping threatens to undermine decades of progress and reducing the impact of tobacco on public health. so we're also focusing our enforcement efforts against any product where the manufacturer fails to take adequate measures to prevent youth access and any product that is targeted to youth and we've been doing that. for example, we've issued warning letters to companies for illegally marketing unauthorized
and kid appealing tobacco products such as a backpack and sweatshirt with hidden pockets to conceal e-cigarettes, or those that resemble smart watches or children's toys. in addition as of may 31st we've issued over 120 warning letters to firms selling or distributing unauthorized electronic nicotine delivery systems that includes e-cigarettes that did not submit premarket applications by september 9th deadline. collectively these companies have listed a combined total of over 1.2 million products listed with the fda. we are also expanding our critical public education efforts through the real cost youth e-cigarette prevention campaign, we are targeting over 10 million teens who have used or may use e-cigarettes. the most recent impact assessment of the real costs are promising, indicating the various elements of the campaign have received over 5 billion
views and that 75% of youth are aware and receptive to our ads. over time increased exposure to the campaign is expected to increase population level shifts and youth beliefs about e-cigarettes. as a science-based agency we now support more than 145 e-cigarette research projects. this research helps us better understand and regulate these products that include investigation of use behaviors, addiction and health effects. we also continue our yearly surveys and studies we undertake with federal partners at cdc and nih. in closing i give you my commitment and speak on behalf of my colleagues at the agency that we will do all we can to prevent kids from using tobacco products and to address the current youth vaping epidemic. we will do the hard work, we will support innovative and informative research and make science-based data driven decisions as we follow through
on this very important aspect of our public health mission. thank you for the opportunity to testify. i appreciate the subcommittee's efforts on support of the agency and your efforts to protect kids, especially from the dangers of tobacco and i'm happy to answer questions. >> thank you, commissioner woodcock. i now recognize myself for questions. if you could please put the first chart up. commissioner, i'd like to start by directing you to the nih monitoring the future survey data published in 2019 and 2020. this is a chart showing that among a subset of almost 9,000 high schoolers this nih study found that the percentage who said they vaped in the past 30 days equaled 22.5% in 2019 and 22% in 2020.
now, back in may 2019 you described youth e-cigarette use as a, quote, alarming problem. do you -- i assume you continue to believe that sentiment, correct? can you repeat that? i think your mic is -- >> sorry. yes, i do. >> at the same meeting in 2019 you said, quote, e-cigarette use among youth also increases the risk that they will use combustible cigarettes, closed quote. you still believe that, correct? >> i believe that is the case. >> according to fda's website, quote, nicotine exposure during add less epps can disrupt normal brain development and may have long-lasting effects such as increased impulsivity and mood disorders. you don't disagree, correct? >> i don't disagree with that assessment. it's very concerning. >> now, as you mentioned in your opening statement you've received millions of applications under the pmta standards and one of the things that the fda must assess is,
quote, the increased likelihood that those who do not use tobacco products will start using such products. when youth who use e-cigarettes that might be subject to the pmta process have an increased likelihood of using other tobacco products such as combustible cigarettes, that's a problem under the pmta standard, right? >> yes. >> the pmta standard also states that you must consider the, quote/unquote, risks to, quote, people who would use proposed new tobacco products under the pmta. we just talked about the health risks to youth. i presume that, again, those health risks, those significant long-term health risks to youth are, again, a problem under the pmta standard, right? >> absolutely. that's the harm bar. that's the bar that has to be overcome by benefits in order to have a net benefit in the public health. >> very good. in your june 22nd letter, so last night the good folks at fda
sent me a letter late saying, quote, the assessment of a new product's likely impact on addiction, especially among youth, is critical to determining whether allowing a new tobacco product would be, quote, appropriate for the protection of the public health. and then the letter goes on to state, one of the issues bearing on your assessment of addiction was, quote, the levels of nicotine in the finished product, closed quote. i'd like to now present you with some documents that juul produced to our committee during this investigation. i seek unanimous consent to enter exhibits a, b and c. without objection so entered. clerk, can you please display the next slide. >> thank you. >> this is a march 2016 juul document that was produced as part of their document
production to us on this committee. it says, quote, this is an internal document from an employee at juul. it says, quote, based on feedback from retailers, customer service and social media, many consumers feel that 5% nicotine strength is too strong. our current nicotine level in pods is much higher than other e-cigarettes and, by the way, as you know, this 5% strength is the strength of current juul products. that was in 2016, five years ago. now let's go to 2018 when 20% of high school students and 5% of middle school students were vaping. can you please present the next slide, rich. juul convened something called a youth advisory council to ask why so many children are using its product. this is what kim said. kim said, very high concentration of nicotine. then she has some other
interesting comments there. i didn't put this up on a slide, but brett said, quote, social acceptance to start addiction to nicotine keeps them. noah said, quote, social to start, nicotine to stay. besides this anecdotal evidence, commissioner woodcock, there's objective data that even as late as 2020 the national youth tobacco survey that came out from the fda shows an increase in nicotine addiction. according to fda almost 40% of high school users are using an e-cigarette on 20 or more days out of the month. that's every two of every three days. these numbers are up from 2019 when that number was roughly 34%. so in your assessment of a new product's likely impact on addiction going back to the standard that you set forth in your letter to me with regard to pmta, you would be very concerned about youth perceptions as well as the reality of a product's addictive
qualities, correct? >> absolutely. that has to be in the fore front of our assessment of harm, potential harm. >> you would also be concerned about a company's knowing decision to keep its nicotine levels high even in the face of internal employee as well as retailer feedback that it's too high? >> obviously for substances that can cause addiction, exposure is very important and higher exposure is a problem. >> and also you would be concerned about youth data showing that it's hooking or addicting kids, right? >> absolutely. >> when a company has such internal data and continues to keep its nicotine levels high does that fact present evidence that the company intended to hook kids? >> i guess that's -- i'm not a lawyer so that's beyond my area of expertise. i'd say that the facts of the case show that these products
had real dangers to kids. >> and the companies knew about the dangers? >> according to what you show here, absolutely. >> in february 2020 fda implemented a new we call it flavor ban, there is a very much -- there is a much longer title. you're familiar with that flavor ban, correct? >> yes. >> according to the policy, however, it made two exemptions, first it made an exemption for tobacco and men toll flavors for juul and other cartridge-based devices and second it made an exemption for all disposable e-cigarettes to be in any flavor whatsoever. let's talk about menthol for a second, commissioner. can you present the next slide. 44% of youth in 2019 used mint juuls and when mint was banned in february 2020 under your partial flavor ban, guess what,
44.5% of youth used menthol juul. so we went from 44% of juul users using mint to 44.5% of juul users using menthol. and as senator durbin said in his testimony, 62% of all users regardless of which company ended up using menthol. now, commissioner, this was before you became commissioner, but i spent an entire hearing in december 2019 with your colleague mitch zeller telling him that this was such a bad idea to create an exemption for menthol. i said this is exactly what's going to happen, people are going to migrate from mint to menthol and that's what happened. now, i was so pleased that you banned menthol combustible cigarettes, which was the right thing to do. will you pledge to clear the market of menthol e-cigarettes? >> again, i can't pre judge or
decisions. what i can say is that menthol has additional properties and pharmacologic properties that i believe potentiate the effects of nicotine addiction and make it harder to stop either vaping or smoking and so it's to my mind like actually having a higher concentration of nicotine in your -- whatever delivery system. >> well, that's enlightening. it basically heightens the addictive properties of the e-cigarettes. >> that is my belief based on the data. i don't think it's a totally settled, but evidence shows it's harder for people who smoke menthol cigarettes to stop smoking, even though they smoke fewer cigarettes. those facts are compatible with that hypothesis. >> let's talk about disposable e-cigarettes. according to the 2020 nyts that you folks presented at the fda
in 2019 only 2.5% of high school students -- i'm sorry, 2.5% of high school vapors used disposables, but after fda banned most flavor for cartridge devices but allowed all flavors for disposables, guess what, disposable use surged to almost 27% in 2020. you don't dispute that data, correct? >> no. >> the decision to exempt disposables again was made before your time as commissioner. exempting disposable e-cigarettes was a huge mistake, exempting them from the flavor ban was a huge mistake. i assume that you consider that problematic. will you pledge to close the disposables loophole in the flavor ban? >> again, i can't pre judge our decisions which are coming up very quickly, however, i think this switch to a different alternative method of flavored cigarette rather than staying
with the, say, tobacco flavored juul is another piece of evidence that the youth really prefers the flavors and that that is a really important factor for the youth in sustaining their use of these products. >> and, in fact, the percentage of youth who use flavored e-cigarettes went up over the last year since the partial flavor ban, now it's up to 80% of youth use flavored products, correct? >> i can't remember all these numbers exactly, but it's a very high number. i believe it is 80%, yeah. >> very good. let me now recognize ranking member cloud. i'm sorry i went -- i think we forgot to turn on the timer. we will give you some extra time here. >> it's a liberal five minutes. thank you, again, for being here and thank you, chair, for the important discussion on this topic as we all have agreed we
don't want to see these in the hands of our kids and we want to see what we can do to have it -- you mentioned that some progress has been made in 2020 and that there has been some reduction in youth vaping. according to the data now, granted on whatever topic we're talking about 2020 is a year that's hard to really -- >> that's right. >> -- put any stock in a lot of definite data. so i'm curious to know why you think that happened. did the 221 legislation that we passed have anything to do with that? was it some of the administrative actions that were taken? also curious to know as we're looking ahead, i think we said 2020 is kind of a hard year to be definitive about when it comes to data on any topic, but when we can expect to see data that we can kind of see if those are -- trends are moving in the right direction or if it was a
blip because of covid and all those kind of things. what are your thoughts? >> well, the data from surveys should come out, hopefully we will have some indication of that later this year to give us another year of data. i think because the survey has already been conducted so the analysis must be done and so forth. i believe that apparent decrease last year was multi-factorial so it's hard to say what the contribution of any given factor was. children a lot of them were at home, they weren't suffering as much peer pressure, they were very unhappy about not being around their peers but a lot of them were not in conjugate situations and we heard from the film that you showed, we heard that peer pressure in this find
peer pressure is a very important factor in some of these kids use be vaping products. so the ban on t-21 i think is very helpful. fda had to stop its compliance checks in the middle of the pandemic because we used underage children as part of the test subjects, along with a trained adult to go in and attempt to purchase and we couldn't send children into those circumstances with covid. but i will say that even before, even when we had the limit at 18, we saw thousands of cases where sales were made to underage, under 18 individuals. so that's a problem out there that those are, those retail outlets still will sell to underage individuals.
>> there's been -- i'm a little concerned about the timing of this hearing, while i think it's a very important topic that we cover and you to be here is great. just because courts have frowned upon in the past congress weighing in while there's an agency investigating or reviewing a topic and as a matter of fact, pillsbury company versus ftc. how do we make sure today's hearing is informative for us, informative for the american people but that your decisions are going to be evidence-based. i noticed some comments you made talked about what you believed the to be the case but didn't cite any data. i realize you have a team and a staff and you can't be expected on every topic you cover to know everything. but how are you going to ensure as we move forward in this
process that it's going to be evidence-based if? >> as i said, i can not in this hearing pre-judge any decisions we make or commit to any given actions. congress has laid out in is a at any time -- statute what the statutory bar is and it's a rather high bar. i don't think that's a matter of dispute. but certainly the agency scientists are hard at work at evaluating these applications against the criteria that are laid out in the statute and that's the process that we'll follow. >> is there evidence coming in to play to show that there's a use for adults? we're talking over 21 to use vaping products as a smoking cessation device. is there early evidence of that? >> i think the studies are somewhat mixed as far as how
effective vaping is. >> it's a new industry so i realize it's developing. >> no company has come to the fda, center for drugs, to go through the process of smoking cessation, right, which would be a drug indication and is a different process it would go threw as a drug. we have a number of cessation products on the market. they've all been shown in clinical studies to help people stop smoking, although the adherence to stopping smoking over years may not be that good. but these including certain drugs as well as different nicotine products that people can use as nicotine replacement and help stop smoke. in all those cases people are urged to also get counselling or be in a program or something like that, that helps a lot of people with smoke.
so none of the vaping products have been the through that kind of process which requires clinical trials to prove that you can actually allow, get people to stop smoke. >> they could advertise it as that kind of product. >> they would have claims. it would be a drug and then can advertise, absolutely. they would have to do toxicology studies on their products and so forth. so the statute for tobacco products that we're reviewing under says -- it also has an evidentiary statement in the statute that say there should be studies that should support the fact, the benefits and the those could be clinical studies or other type of studies. so the burden as senator durbin said is on the manufacturer to
show that by some studies and data that their product has some public health benefit. >> i don't know if you would have this data handy. if not i would be very curious to have your team look into it and see. coming through this year with covid-19, a respiratory illness, and we know that it affected particularly seniors and other demographics particularly hard but there were some cases where young people were tremendously affected by some died which was much more rare than other segments of our population. have you all cross referenced that with vaping to see if there was a connection to be susceptible and then, you know,
in the past we covered this in a number of hearings so we understood there's a distinct difference in black market products and others not that you should have any of them. that's well established, i think. at least among us who are talking about this issue. have you found any sort of connection? >> i don't think the data are available to link covid, severe it wouldn't be in the medical record of vaping, so then it's hard for people to make that connection. >> right. okay. thank you. yield back, mr. chairman. >> thank you, mr. cloud.
notice reckoning woman porter for five minutes. >> thank you very much mr. chair. commissioner, does the research clearly establish that flavored e-cigarettes appeal to children? >> yes, i believe it does. >> in fact the fda banned nondisposable flavored e-cigarettes except menthol in order to quote limit children's access to certain flavored e-cigarette products we know are so appealing to them. >> yes. >> but we're having this hearing because disposable flavor e-cigarettes and both disposal and nondisposable menthol products are still on the market and the inevitable result of this is e-cigarette use in middle school and high school students are high. 3.6 million children use vapers in 2020. are those middle and high school kids who smoked e-cigarettes
what percentage used flavored products? >> i believe eight out of ten e-cigarette users report use of flavored products. >> that's what i have too. right around 88%. that was an all time high. so if any flavor other than tobacco flavor of e-cigarette is left on the market, is it likely to encourage youth to start vaping? >> the statutory bar that we're talking about is that harm, okay, the harm of -- >> i'll get to that. >> okay. >> i'll let you do that balancing. so you're going to have to balance. what we're balancing on the other side, i want to establish, any flavor of e-cigarette left on the market is likely to encourage youth to start vaping. we have to balance that against to some other things we'll get to, is that correct >> that's correct. >> if the fda banned all flavored e-cigarettes would kids be less likely to start?
>> i can't predict the future. we think that's likely. we have to limit advertising and sales and targeting children. >> if they are not on the market tough to advertise. >> so -- >> if kids have the choice of any tasty flavor, they are going to go for it and i'm speak towing from experience here as a mom of three school-aged kids. if there was no strawberry they will take mango. but if their only choice was a brown tobacco snow cone they will walk away. in short this is what you were hinting at, you have to decide whether or not an e-cigarette can bring or keep a product on market and doing that you have to do that only if it is appropriate for the protection of public health. that is the standard. and what this means is the fda
is required as you were saying to balance youth vaping against any good that e-cigarettes might do in getting adult smokers to quit tobacco products. commissioner, do you know what percentage of adult smokers use e-cigarettes instead of traditional cigarettes? >> no. >> it's about 4.5%. we're talking about a very small fraction of adult smokers in general who use e-cigarettes. do you know, of that small group of adult e-cigarette smokers do you know what percentage for menthol or mango or if there's a blue raspberry over tobacco flavor? >> no. >> so a study in great britain, we don't have a study yet in the u.s. found 56% of adult vapers, people over 55 prefer tobacco. do you know how many kids like
tobacco flavor? >> i believe it's a very low percentage, but i don't know the exact amount the. >> 1.1% of youth vapers the. the number of kids who like broccoli is many, many more. so it's really important that it think you have that information as you go to do that. the surgeon general said there's zero real evidence, scientific evidence that proves e-cigarettes in general help adults quit smoke. that's what the surgeon general said. you have testified that kids are drawn to flavored e-cigarettes based on the evidence. and as a mom of three hopefully nonvaping kids this is pretty personal for me, the only way to protect our kidsed is to deny pre-market tobacco product application for every flavored e-cigarette other than tobacco flavor. will you commit to doing that? >> as i have said already i can't pre-judge -- >> dr. woodcock you may not be willing to do it but i want to
make sure america understands. you have the authority to commit today to preventing millions of kids from becoming addicted to vaping and making the decision and commitment today to us and if you don't make that decision today in this oversight hearing, then the alternative is years and years of delay while congress tries to pass a bill and lose millions of more kids getting addicted. i hear you're not willing to make that commitment to youth today but i do want the american people to understand you do have that power. i yield back the. >> youth vaping is an epidemic that puts the health of our children at risk, even after the federal minimum age of the sale of tobacco products of raised to 21 years old, and flavor bans were enforced in 2019.
in january of 2020 the cdc found that almost 20% of high school students vaped in the past 30 days. that's not acceptable. we need to focus on getting disposable e-cigarettes out of the hands of our children while tobacco itself is not an illegal product, we must ensure guardrails are set in place for the overall health and benefit of all americans, especially those too young to understand the danger. these products are not subject to the same flavor guidance as closed system electronic nicotine delivery systems. we need smart and targeted solutions for these problems. so, dr. woodcock, i appreciate you being here today. thank you for that. i was wondering can you give us an update on what actions the fda plans to take to protect the health and safety of kids while taking into account the mom and pop or small operations around
the country that require sensible regulations? >> well, according to the law and the court order that we're under by september 9th we'll come to a decision on these various applications that we have received and they have to meet the bar that we have been talking about, showing that overall having the product on the market is present to protect the health of the public which is fairly high bar as we just heard. so we're working -- we got applications for 6.5 million products and of course some of them are for small businesses. now we have given out a lot of assistance. we have a small business assistance. we've tried to help. but under the statute, these businesses must submit information that shows, among other things, that their
products meet this bar and are appropriate for the protection of public health. >> okay. looking at disposable e-cigarettes, clearly a big part of the problem. how can congress and the fda work together to keep our kids safe? is there something we can do to help collaborate with the fda some tools or something that would be helpful to work together? >> i think congress has passed the statute. we need to implement that statute. we're in the process ever doing that for the -- for the products. hopefully that will come to a conclusion very soon. there are still problems, many problems with addiction. we have also, the group of kids who are now addicted to nicotine that we now to think about ways, how we can assist them in
recovery, getting off of nicotine. i think as the chairman said there's evidence that early exposure to various addictive products or drugs will act on the brain in ways that may make it more difficult for these individuals to stop those behaviors. so if we can get to the end of this activity, in addition, fda hopes to get started again as the counties become, you know, the pandemic subsides in the u.s. to rigorously enforce the issues about sales to minors, because we found a large number selling to people even when it was under 18. we need to change the federal identity standard. there are many additional things
that can to be done. i think recovery is something we should also think about. >> absolutely. we should be very careful as we set policy forward. there's a lot of talk across the nation about recreational cannabis or marijuana. we're talking about addiction. we're talking about making sure our kids aren't exposed to this some of the policies being discussed by policymakers on that front should also be taken into account as we move forward. i know that's not what we're here to talk about today but addiction is a disease. not a character flaw like it may have been thought about back in the '70s and we need to be very serious and careful how we move forward on things that are clearly now not legal for recreational use and i certainly wouldn't want to expand or i don't think our government should be expanding those things that would be more available and more readily available to people and also potentially able to get in the hands of our kids.
i appreciate your time today. >> absolutely. you know, alcohol is probably one of the worst substances and also widely available as far as the toll of addiction on people. substance that causes addiction exposure is very important, how prevalent it is. >> caffeine is one of the most addictive drugs isn't. >> it they got nothing like caffeine. >> be careful, mr. keller. >> the scientists have tried to follow this and we have nothing on caffeine. >> i read somewhere that's the most addictive thing there is because it's in so many things. >> i was going to cut your mic right about there. but, okay. mr. johnson, congressman johnson you're recognized for five minutes. >> okay. thank you, mr. chairman.
commissioner, the fda has received over 6 million pre-market tobacco applications, tobacco product applications, or pmtas, a significant number of those pmtas were submitted by vape shots which are required to submit a pmta for every flavor that they mix. this means that a single small vape shop might have applications for say 30,000 products. the vape shops of pmtas are overwhelming majority of 6 million pmtas, is that correct? >> that's my understanding, yes. >> the fda recently published the entire list of pmta applications and this committee has whittled down that tloits the applicants who are most responsible for putting these
vaping products into the hands of our children. and when you do it like that, the list of the pmta applicants goes down to about 44 companies, which is a much more manageable number, which the committee will share with you those 44 companies. these are the pods and disposables that are making their way into high schools and middle schools. commissioner, the fda is under court order to finish ruling on applications by september 9th of 2021. but has signaled that it will likely miss that deadline. can you commit today to ruling on all of those applications from the 44 companies that create products that children are most likely to use by that september 9th deadline? >> well, i cannot commit, but i
have to see the list. i will tell you we have prioritized by market share, so that we have made sure that we're looking at the companies with large market share that would have the most impact on -- >> and how many of those companies have you identified? >> well i think there are only about five companies that have vast majority of the market share and then there's a very large number of small, as you said vape shops and other type of enterprises that constitute the rest. >> can you name those five >> no. i'm sorry. i can get back to you with that information. >> well, can you commit to ensuring that their pmta applications are all processed and ruled upon by the september 9th deadline? >> i will commit to do everything i can to make sure
that we have reviewed and finished all the high market share company applications, because that will have the most impact on this problem that we're all mutually face. >> thank you. i would like to discuss further the details of the pmta reviewal process. the possibility that a company like puff bar might gain months of profit off children because of a backlog at the fda is troubling and unacceptable. if you failed to rule on all pmtas from the five companies, and the 44 companies with pod and disposable applications that the committee has identified by the september deadline will you commit to pulling those products from the market until the
applications have been reviewed? >> technically the products are currently only marketed under enforcement discretion and after the september 9th deadline if they don't have an approved marketing authorization they are, again, only on the market under enforcement discretion. by the fda. thank you. >> juul dominates the pre-filled pod market and ibts growth in market share has driven the rise in youth vaping rates. yet juul's pmta application proposes lifting marketing restrictions after just one year even though juul is currently on trial for marketing addictive and harmful products to children. juul has proven untrustworthy to continue selling its products and greatly contributed to the epidemic that we face today.
so madam secretary, is the fda considering allowing juul products to be marketed again or has it made a decision to ban that practice or continue to ban that practice? >> those products are subject to a marketing application something newly introduced in to the market would have to go through the review process, as i understand it. >> has that happened yet? >> well, again, i can't discuss any single action that we might take. >> all right. thank you. >> if an application cannot prove with scientific evidence that the product will not contribute to or increase youth e-cigarette use will you deny the pmta application? >> that's one bar and it would have to have as the other prong
of the evidence, it would have to have extremely compelling evidence that it was uniquely positioned to reduce people, to contribute to smoke cessation. >> the gentleman's time has expired. thank you, congressman johnson. i now call on congressman clyde for five minutes. >> i want to thank chairman and ranking member for holding this hearing today. this is my first hearing. are we getting some feedback here? okay. great. thank you. this is my first hearing on vaping products i understand this is probably the fourth or fifth hearing in the last couple of years on this exact same subject. i think i can speak for my
colleagues on both sides of the aisle when i say no one wants children to have access to tobacco fruits. i want the fda to crack down on companies targeting children. dr. woodcock, i understand certain types of tobacco products are less risky than others, like smokeless products than traditional cigarettes. would you zblee. >> that's likely conclusion of scientific evidence right now. it's not definitive but very probable. >> all right. thank you. would you agree that marijuana is a more dangerous product than date of birth could? -- than tobacco? >> i don't know a direct comparison has been made. i can't answer that question. >> marijuana is certainly illegal right now at the federal level and tobacco is not so i
would assume that based on that fact alone that marijuana is a much more dangerous product than tobacco. >> well depends on the tobacco. i men cigarettes are the number one cause, preventable cause of death in the united states. when you take that figure into account the fact that marijuana is a schedule 1 drug, it's hard, it's apples and oranges. there's a great more morbidity from cigarette smoke egg that's been well established. >> thank you. while the health risk of tobacco is certainly a huge concern for my colleagues and i, i find i want interesting that all of my democratic colleagues that were in office last congress voted in favor of h r3884 the marijuana opportunity reinvestment and
expungement act and would legalize marijuana on a federal level. further i am concerned that our chairman recently sent a letter to the fda to you commissioner, acting commissioner asking to act, to ban menthol cigarettes and e-cigarettes and i quote from the letter the european union banned menthol cigarettes a year ago and the very last line of the letter says if you allow menthol flavored cigarette sales to continue you fail. that is really strong language. so, you know, this hearing comes so soon after that letter being sent. that letter was sent on april 21st. i'm concerned the committee's goal of this hearing is not to address the concern of youth vaping but strong arm the fda, you, ma'am, into banning menthol
cigarettes and e-cigarettes. so dr. woodcock, is it true the fda is taking steps to prevent children from using e-cigarettes. >> yes. >> absolutely. do you think that any of those steps are hampering the adult use of e-cigarettes for the those who want to kick the habit of traditional cigarettes? >> no. >> no. okay. all right. great. so we think e-cigarettes are a safer alternative to traditional combustible signatures at least what the science currently says. for those who are the trying to quit smoking. do you believe that putting limitation on the amount of nicotine in e-cigarette cartridges would hinder adult from switching from more dangerous combustible cigarettes
to e-cigarettes? >> i don't think we have concluded our deliberations on that particular factor. >> okay. all right. then going back to the decriminalizing of march jarngs with many states legalize are or decriminalizing marijuana what are fda's plans to quell youth from smoking marijuana? >> i don't think the fda regulates marijuana. >> there's no, nothing that the fda is doing? >> currently it's a schedule 1 drug. so we would -- we don't regulate as a medical product or tobacco congress passed a special law fda regulate tobacco products. >> okay. >> so generally fda regulates
food and drugs medical products devices. >> does the fda have any concern with legalization of marijuana? >> well i think all in the biomedical community are concerned about availability and managing availability of any drugs that have the potential, psychoactive drugs, yeah and potential impact on youth in particular. >> i think that's very, very dangerous path to go down, the legalization of marijuana. thank you very much. with that i yield back. >> now i reckoning woman bush for five minutes. >> thank you, mr. chairman for convang this critical hearing today. as a nurse i know just how important shaelt for our young adults whose minds and bodies are still growing every single day. vaping products by juul present an immediate threat to juvenile
health. users age 15 to 24 don't know juul contribute nicotine. the fda must take drastic steps to ban the use of juul products and minimize the impact on our youth. dr. woodcock, big tobacco has a long history of twisting science to meet its needs. i was dismayed to learn that juul brought itself an entire issue of american health behavior to bolster its application for fda approval. 12 of the 13 papers in the journal issue were either written by either juul employees or their associates. so yes or no, do you agree that the fda should take into consideration the source of a supposed scientific study before giving weight to its findings? >> fda always takes into account the source. obviously many of the studies are medical products are done by
the sponsors of the products and there are many safe guards that are put into place. so we look very carefully at the validity of any data published. >> because of the 12 of 13 papers in one journal how can the fda trust the scientific method and the conclusions of the 12 typhoon activists who were directly funded by juul? >> well, i think we have many sources of information that only being one. as we've been discussing in this hearing, the statutory bar that congress has put into place is a pretty high bar, and we must look at all sources of evidence, and any evidence that is sponsored by the company gets additional scrutiny. >> okay. so will the fda take into
consideration these possible conflicts. like look at it this way. this conflict of interest is what i call them before giving any weight to juul scientists conclusions in their application or just a yes or no answer for that one? >> yes. >> okay. and will you consider big tobacco's history of creating junk science to serve its needs while reviewing juul's application, yes or no >> yes. >> okay. thank you. thank you for that, dr. woodcock. after many years of big tobacco lying to people about the safety of its products i would hope that the fda will take this cautious approach to this research bought and paid for by a company. so dr. woodcock, do you believe that additional fda regulations on vaping products will be effective in cushing youth vaping rates even more? >> i believe that we have to do something.
i mean we can't continue with this epidemic. it's very dangerous to children. >> yes. and that's exactly my next question. considering the impact on these products have on children especially middle and high school children, is that a big part of the consideration, like that group specifically? >> absolutely. that's one of the statutory standards that we have to look at, which is potential for harm, particularly to children in initiating these products. >> yes. because we know that -- because juul is really popular amongst teens but that seven surveyed -- the research surveyed only adult use of its products. so, you know, as policymakers we must be equipped with the current data, the accurate data about vaping products from text the health he and safety of our children. and let me just ask, despite not
having the answer to everything that we would want right now at this moment but juul's paid researchers concluded e-cigarettes would save lives, so commissioner, do you agree that the fda should closely evaluate these scientific finding from big tobacco regarding its full impact on public health? >> absolutely. and i would reiterate we have other source of information including a lot of studies we have sponsored under our programs. >> okay. thank you. the information provide by juul does not meet the levels of scientific rigor. there's not enough information to predict health on vulnerable youth but e-cigarettes have hooked a generation of young people and fda has an obligation to protect our children. thank you and i yield back.
>> thank you congresswoman bush. i would like to recognize our distinguished ranking member mr. culver. >> thank you, mr. chair. dr. woodcock, smoking cigarettes is at an all time low and use of e-cigarettes has declined. do you agree the passage of t-21 which raises the purchase from 18 to 21 has contributed towards this downward the trend? >> i don't know. we hope so. we have a lot of data that many vape shots and other outlets continue to sell underage youth even when it was at 18. >> overall youth use has declined for both combustible and e-cigarettes there's been an increase in use using flavored disposable e-cigarettes. other than sending warning letters to several companies marketing flavored disposables in 2020, what has the fda done to prioritize clearing the
market of these types of flavored products, particularly those who have not submitted their pmta? >> well, we have further actions that we can take after a warning letter, to my knowledge. those have not been taken yet. >> have you taken those actions yet? >> no, not to my knowledge. >> prohibition didn't work for alcohol. yet many of my colleagues argue that prohibition is not working for marijuana. would it make more sense for the fda to achieve the intended health benefit by sending time and effort getting more reduced harm nicotine products to market and educating smokers about the benefits of switching their nicotine source while continuing to drive down smoke rates with education and efforts to support total cessation? >> well, i believe the fda is working in all those areas to try and not, you know, have
anti-smoking campaigns along with the cdc, smoking is continuing to decrease, combustible smoke, so that's very good. we're very interested in additional smoking cessation products. there's quite a few on the market. and other methods for recovering such as digital health methods that are under investigation. so hopefully we can get addicted adult smokers off of combustible cigarettes. that should be a goal. >> one of the biggest problems we face are not from the legitimate companies but bad actors who are taking advantage of our current regulations and selling vaping products containing vitamin e, acetate, thc. these illicit products have been
known to cause serious illness or death. my question, what steps has the fda taken to crack down on these kind of illicit e-cigarette markets and are other countries like china playing a role? >> yes. we work with custom and border patrol. we seized fraudulent products coming from china and other place. we make every attempt to keep these from crossing our border. we do send warning letters. many warning letters to companies who failed to submit applications they then did submit an application in response to that warning letter. >> that's one thing i want to bring to the attention of everyone who is watching this haerks if they are flavored, the cotton candy brand that's been banned, if they are still on market those are illegal?
>> the -- >> the pods and stuff being sold, right >> right. the cartridge. >> the cartridge. what was the enforcement action fda take against companies and individuals that sell illicit e-cigarettes? >> our steps that are illegally on the market so our steps are warning letter and then potential other civil actions against them including an injunction. >> do you know today how many companies the fda has issued warning to? >> yes. probably somewhere in my facts here. it's quite -- it's a very large number. >> let me ask enthusiast. can you get that answer to me. how many products has the fda removed from the market through enforcements action? >> that i don't know. i can get back to you. >> i'm about to run out of time. i have one more question.
i understand that fda has a very large number of product reviews and application. which have been filed and are subject to the september 9th deadline. from a pragmatic standpoint, how and when might the fda communicate to the public and to the applicants about the status of those products? >> so, we have listed all the products that have been submitted and made it through the initial filing process and those are listed online. and they all have the september 9th deadline under court order for us to make a marketing decision about them. does that answer your question? >> so i may have a follow up or two, if you don't mind afterwards, after the hearing. my time has expired. mr. chairman, i yield back. >> thank you very much. i want to associate myself with the comments of enforcement
action. too many warning letters are sent and not enforcement is and the. i hope that's something you will take under advisement. without objection congresswoman wasserman-schultz shall be permitted to join the subcommittee. you're recognized for five minutes. >> thank you. i appreciate the opportunity. dr. woodcock, a plea sure to be able to talk with you. i know you know the youth e-cigarette usage remains at epidemic levels and i know and my colleagues, many of my colleagues here have worked hard through legislation and repeated calls to the fda for productivity. my colleagues and i wrote to you on march 23rd asking the fda end its enforcements exemptions for menthol and disposable e-cigarettes and clear the market of all flavored e-cigarettes until properly reviewed. we asked the fda to deny any
pre-market applications for flavored e-cigarettes or any e-cigarette that pose an increased risk of youth addiction. i trust we'll be getting an answer and responsive actions are forthcoming. certainly hope so. look forward to hearing back from you. i have several questions concerning high nicotine content and how this has worsened this crisis. dr. woodcock, are you aware that jurisdictions likes european union and israel capped nicotine at 20 milligrams per liter >> yes. >> in the uk 94% of kids have never vaped and only 1% youth are using e-cigarettes. in the u.s. there is the no limit to nicotine levels in these cigarettes. juul has 59 milligrams per
liter. would fewer kids become addicted if there were no e-cigarettes in the u.s. over 20 millimeter? >> likely yes. >> in reviewing pmta would you consider how drawings high nicotine cigarettes are to public health >> that is certainly part of the statutory framework, yes. >> so you are reviewing that? >> yes. >> the possibility exists you would lower the allowable level of nicotine. >> again i can't comment what actions we'll take. >> the possibility exists. the high nicotine levels in juul and other e-cigarettes are leading to increased youth addiction. does the use of nicotine by adolescent have negative consequences? >> undoubtedly. >> 15 to 24 individuals who have
vaped never used cigarettes. the only reason to authorize a pmta for a high nicotine tobacco product if there's overwhelming evidence it's necessary for adult smokers to quit smoking and the product is not likely to be used by youth. that's not the real world of juul. first adults don't use juul, kids do. juul is the referred brand of 5.6% vapers but 45% of youth vapers. juul is helping to fuel an epidemic of e-cigarette use there was no discernible decline in adult smoke rates. secondly adult smokers don't need higher nicotine e-cigarettes. in one study that juul purchased as congresswoman bush mentioned they purchased it for its pmta. researchers found smokers transitioned away from cigarettes to juul at the same
rates whether using juul's 3% nicotine product or 5% nicotine product. if that's true there would be no reason to approve their 5% product, correct >> the statutory requirement is that the prong about, that it would help in some way protect the public health, right, encouraging smokers to transition. so there has to be an incorrectmentsal benefit there, right, in order to outweigh harm. >> again, if researchers found that smokers transitioned away from juul whether 3% or 5% nicotine in their prults then that would show there's no discernible difference and a lesser, lower nicotine level would be appropriate >> that's the kind of data that needs be evaluated, absolutely. >> based on what you just said, what the logical result should be. to be clear, you should reject
all of juul's products, all of them, given what we know how juul marketed addictive kids to their product and i encourage you to reject every pmta application over 20 milligrams per litre. there's a direct correlation to a precipitous drop in youth vaping when you have a much lower not 59 milliliters but 20 nene discernible difference whether you have a higher nicotine product in reduction of smoke by adults. that would seem to me in the statutory framework that's established by the fda to really result in those decisions being made. thank you mr. chairman. i appreciate the time. i yield back. >> i would like to recognize the congressman for five minutes. >> thank you, mr. chairman. thank you for your attention
this came issue and your passion for it. as you know i feel very strongly that the actions of juul is despicable. being from northern california i'm proud of what we did both at the state and local level to partner with legislators and local government around the country to make a significant positive impact on the public health issues around smoking. and to see san francisco based company which founders graduated from the school of design at stamford do what they did as i said is despicable and shouldn't be allowing them from my view, the ability to don't market and distribute this product to young people, in particular. but we should be personally holding them accountable. but commissioner, in 2018 the surgeon general declared a youth vaping epidemic, 2018.
youth vaping rates in 2020 were the same as in 2018. as we know and we know what started it. between 2017 and 2018 the number of high school vapers doubled. in the same period juul's market share grew 29% to 76%. in november of 2018, the centers for disease control confirmed the obvious pointsing to juul as the cause of this surge. even after taking away all of its flavors except menthol and tobacco, over a million children are still using juul. still getting addicted to juul in a lifetime consequence of that. still the most popular youth vaping brand used by 41% of youth vapers and research shows many of these young people are unaware of the danger they are expose themselves to. so, commissioner, do you agree
that by the metrics i just mentioned we're still experiencing youth vaping epidemic? >> yes. >> do you agree that juul is an e-cigarette company most responsible for creating this epidemic? >> that's how it would appear. >> will you commit to consider past bad acts in marketing to children and popularity with children when you go through your decision-making process? >> we have to adhere to the criteria laid out in the legislation that congress passed and we will do that. you're talk about the validity of data that's submitted to us. we take a very close look at the validity of the data. >> i appreciate that. if there are changes to the statute, you think would help you to enforce a spirit of the legislation, i would greatly appreciate it, and communicate
with you. do you agree nicotine product used by 54% of youth vapers is hurting overall public health for generations to come >> most likely it's hurting that generation. i can't comment on generations to come but definitely a public health problem of significance. >> thank you, doctor. do you trust the tobacco products scientific advisory committee and their advice? >> which -- >> the tobacco products scientific advisory zmeet >> the fda committee? >> yes. >> likely, i do. i'm not familiar with this committee, i'm sorry. i'm kind of new to the job. >> i would like more information on that. >> certainly. >> madam commissioner, appreciate your response. juul helped a nafgs children in the light of day but is asking
fda to approve its product under a sheefld darkness. this subcommittee has repeatedly asked juul for its pmta and juul has refused to provide it. juul knows the junk science is bought and paid for and cannot with stand scrutiny. if juul's pmta was referred to the tobacco product advisory committee the application would be subject to public scrutiny. do you have any comments on this or on the trial in north carolina if you're familiar with it, against juul for creating a nicotine product for children? the judge has already entered a partial summary judgment against juul and instrucking the jury that as matter of law all of juul's social media post were youth oriented, evidence from that trial would be tropical your decision. would you admit to gather all document from that case?
>> yes we should look at all documents. i can't comment on the ongoing case. >> thank you, commissioner. my time super. i yield back. i want to thank the chair again. >> thank you so much congressman. i would like to recognize congresswoman spear. >> in your role as acting commissioner you were not involved in the regulatory process before january of 2021. i appreciate that. i am deeply concerned that this scandal that has been promoted under a previous administration is going to scar the lives of these children for the rest of their lives and all you hear about now are these double lung transplants on 13 and
14-year-olds and it takes my breath away. so a federal judge has ordered the fda to speed up recognizes. really the fda has be a die baited its regulatory authority. would you agree he was correct in that regard? >> as you said i was not involved in these previous discussions, but currently i'm committed to getting this done, if possible, by the date set by the court. >> so the previous administration at one point said they were going to ban fruit flavors and then they reversed themselves and as a result menthol juul pods were increased by 1,000% amongst high school students. was it a mistake to exempt disposables? >> you know, i wasn't involved in that decision at all.
you missed my oral testimony. >> i guess die. i was in a house arms committee. >> certainly important. i was theinstigaor of the original vapers on drug charges very early in 2000 that was settled that we couldn't take drug charges because these were tobacco products. so the subsequent actions after that from 2010 on i was not involved in and so, i mean certainly in retrospect it seems, okay, children switch over to disposables, right, and although youth vaping has decreased in the past year it might be multi-factorial there was certainly continued youth using of these products in really unacceptable levels.
>> so, it appears that there are some companies now that are just basically ignoring the requirements puff bar being one of them. based on their prior conduct, are you prepared to reject their application? >> yeah. i can't comment on individual -- >> how about this? if there are bad actors who have previously shown that their conduct is violative or thumbing its nose to the government regulation would that be taken into account? >> it would definitely be taken into account, yes. >> all right. thank you very much. one of the biggest concerns is that these young people don't appreciate there's nicotine in
these cigarettes. >> i think most likely we should make sure that people are aware of the nicotine content that would be an extremely important thing to do. as we discussed earlier, i really think we're going to have to focus on recovery for teens to get them off their nicotine addiction. i don't know the health care communities are well aware in what ways might work for youth who are addicted to nicotine but not to cigarettes. >> the amount of nicotine in e-cigarette is 12 milligrams, is that what it read? somewhere? >> there are various -- there's various content -- >> how does that compare to a cigarette in term of the amount of nicotine? >> i think there are some vaping products that have extremely high content within them, up to
maybe a whole pacific cigarettes. you wouldn't get that in one draw, that they are very high. i've heard from families whose children have had very serious experiences after using these very high nicotine products. >> thank you. i yield back. >> thank you. i just have one last question. will you admit or acknowledge that the flavor ban exemptions that were created were just a fundamentally flawed policy? >> it appears to have unintended consequences. >> negative consequences. >> very negative, yes. >> so you admit or acknowledge i should say, you were not the acting commissioner at that point, but those flavored ban exemptions had very negative consequences. >> correct. the >> mr. clyde, do you have one more question?
eastern. >> washington journal continues. host: our first guest is david gantz, with -- a professor of law emeritus at the university of arizona. anchor for joining us this morning. guest: my pleasure. host: we are under, when it comes to trade concerns, something called the u.s. fda. it is the one year anniver.