dinners. i saw this same dynamic in play with the bill clinton campaign with vernon jordan. how they were of equal stature. what that allowed clinton to get from jordan in the way that he couldn't from anybody else who worked on the campaign and then in the administration itself. >> the aide and author of first friends talks about the political influence wielded by confidantes and close friends of u.s. comfort danlts. sunday night on q & a. you can also liberty to q & a as a podcast wherever you get your podcasts. next, the testimony from acting fda administrator janet woodcock on the impact of vaping on underage users. she testified before a house oversight and reform subcommittee.

>> good morning. this committee will come to order. the title of today's hearing is -- [ inaudible ]. >> i want to welcome our witnesses, the distinguished senator from illinois, dick durbin and of course, acting commissioner woodcock. thank you for joining us this morning. we are starting on time. so thank you, mr. cloud, the ranking member for making that happen as well. i now recognize myself for an

opening statement. for the last year and a half, the deadly coronavirus pandemic has gripped all aspects of american life. as we see progress against the virus, we emerge with new insights about other threats to public health. it is time to re-evaluate the public health threats that to revalley the public health threats that are entirely within our ability to control. there was a youth vaping epidemic in this country before the coronavirus, before this subcommittee was even created, and before acting commissioner woodcock took the helm at fda. and the youth vaping epidemic unfortunately continues today. more than 20% of high schoolers vape, and 5% of middle schoolers vape. those are the same levels that compelled the surgeon general to first declare a youth vaping epidemic three years ago in 2018. for as long as this subcommittee has existed, we have been 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 joule on trial and exposing the disturbing scope of the company's behavior, its marketing to children, its attempted use of native americans as experimental guinea pigs and its responsibility for fuelling the youth vaping epidemic. we presented our investigation to the fda, and fda agreed that joule was making the wall. it sent, juul a warning letter regarding marketing practices and declared them illegal. now juul's raitt fate is again in your hands at the fda. juul's products need your approval through what's called the premarket tobacco process.

applications 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. 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 from easy to conceal from adults. companies copied juul's model. when you look at the list of products that are the subject of pmta applications, there are many, many even now in kid-friendly flavors, there are many that 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 watched in real time 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 i think haven public health and racial equity. when this subcommittee exposed the prevalence of toxic heavy metal in baby foods you made that issue a priority and made the lowser 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 company 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 cap nicotine at one third of what's in a juul. those countries do not have anywhere near the youth vaping epidemic 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 tobyio and the opioid

epidemic. let's not let it happen with vapes. have the courage to say no to big tobacco. the health of the nation depends on it. thank you. i now recognize ranking member cloud for your opening statement. >> thank you, mr. chairman. we have known for decades that cigarette smoking is dangerous and linked to capser and other illnesses. smoking causes 48 0,000 preventable deaths in america each year. that's more than 1,300 deaths a day. i cannot think of another 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 for that matter any other drug or anything else nefarious that you should put in your body. teens bodies are developing and these products can have an impact on your body as you are growing and learning and those sort of things. unfortunately, as we have

covered in past hearings severely misguided market has resulted in what has become a epidemic. products found their ways in the hands of too many teens and led to tragic and heart breaking outcomes for too many families. we made progress with the passage of t-21 but there is still more work to be done. there is some evidence 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 it. 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, before being a member of congress, is that of a father. 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. i want to thank you, also, dr. woodcock for appearing before us today. i hope we will have a good, healthy discussion, that we will be able to hear from you, also make sure we are not unduly influencing improperly a process that's supposed to be evidence based. and hopefully it will be and that we will be able to do the right kind of -- 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. i yield back. >> i want to just applaud mr. cloud for being part of the bipartisan, bicam ral congressional caucus against

youth vaping which myself, senator durbin and others are chairing. thank you so much mr. cloud. >> 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 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 push tobacco products onto 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 school. e-cigarette manufacturers have acted with a complete disregard for the health of young people across the 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 it has 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 chairman krishnamoorthi and the subcommittee on economic and consumer policy. 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 act on america's youth vaping epidemic. thank you for your leadership chairman krishnamoorthi. i look forward to hearing the testimony from all of our distinguished witnesses today. and i yield back. thank you. >> thank you, chairwoman maloney, thank 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 society's most vulnerable from the dangers of tobacco. >> e-cigarettes. his work goes back to having smoking banned on airplanes, a measure that went into full effect in 1990, more than 30 years ago. today i am 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 the congressional delegation from illinois. we are so fortunate to have him here today and thank him for his participation. senator durbin? >> thanks, chairman krishnamoorthi and ranking member cloud for allowing me to testify today on the youth vaping ep democratic and the role of the food and drug administration. the campaign to reduce tobacco use and prevent our kids from lifetime addiction is personal to me. my father died from lung cancer. he was 53 years old. he smoked to 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 have 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 toll build and strengthen a regulatory framework that really does focus on public health. when last i testified before this subcommittee in july of 2019 -- seems so long ago -- most of our focus was on the skyrocket, 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, this subcommittee, and the public health community have shone a bright light on the abusive tactics by juul that contributed to this foot hold of our children. we now uncovered the disgusting tactics used by this company the addict our children on these e-cigarettes products.

i am pleased answered trust regulators have started to step on. what i want to focus on 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 have made reducing youth tobacco use. who is the cop on the beat could whom we entrust our children? it is the fda. this agency has been timid and reluctant way too i think lo. for years the fda delayed the implementation of its requirement that companies

submit pmta application force review. at the same time, the fda allowed e-cigarettes to proliferate essentially unregulated, failing to enforce its own rule which required that all new products entering the market after august 8th, 2016 undergo 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. 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, menthol flavors e-cigarettes and disposable vaping products. the use of disposable e-cigarettes, one of the loopholes which the fda lost 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. and because 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 product, 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 history. i worry the agency is going to fail again. after years of delay by administrations of both parties, 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 passed as long ago as 2009 in the tobacco control act to evaluate whether a product can stay on the market and whether it is, quote, probe for the protection of public health. that's a high bar. it requires the fda to balance the risk of youth initiation with -- and the burden is on the manufacturer. the urd abouten is on the manufacturer 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 am deeply troubled with what i have heard from the response of the fda to my letters. i fear they are going to once again overvalue the unproven potential benefit of cessation

for adult smokers while undervaluing the clear evidence of what is 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 is simple. any product with a history of increasing youth use must be rejected by the food and drug administration, especially flavored products which we know hooks theist 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 perpetual game of whack a mole just doesn't work.

to put it bluntly, 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 they 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 it. 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, any 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, njoy, alto, puff bar and even some of the menthol products. and 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 e.r. on several occasions. the last time before he passed away he was rushed to the e.r. 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 these 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 a 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. as a science-based agency we now support more than 145 e-cigarette research projects. this research helps us better 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-cigarettes 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. >> 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

adolescence 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, close 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 forefront 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 menthol 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 prejudge 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 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 vapers used disposables, but after fda banned most flavors 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 prejudge 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 t-21 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 the 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 congregate situations. and we heard from the film that you showed, we heard that peer pressure, and in this binder, that peer pressure was a very important factor in some of these kids using 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.

so -- 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. held that at that congressional investigation cannot be focussed on intervening in the agency's adjudicate function. 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? >> as i said, i cannot in this hearing pre-judge any decisions we make or commit to any given actions. the congress has laid out in statute what the statutory par is for this review program. 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. >> are you -- 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 through 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 smoking. 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 smoking. 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 smoking. >> they could advertise it as that kind of product. >> they would have claims. it would be a drug and then could advertise, absolutely. they would have to do toxicologic studies on their inhaled 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 says there should be studies that should support the fact, the benefits, and 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. but 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 it, 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 even in the effects of 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? >> yeah, i don't think the data are available to link covid, severity of covid or catching

covid by youth or having a severe case with vaping practices. i can get back to you. we can look at what data are available, but i don't think those data are available. the youth use of covid wouldn't usually be in the medical record. i mean, the youth use of vaping wouldn't be in the medical record, so then it's hard for people to make that connection. >> right. okay. thank you. yield back, mr. chairman. >> thank you, mr. cloud. now i recognize congresswoman 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 flavoredrf 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 used vapers in 2020. dr. week woodcock, of those middle and high school kids who smoked e-cigarettes, what percentage used flavored products? >> i believe 8 out of 10 e-cigarette users report use of flavored products. >> that's what i have too. right about 80, 83%. 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. >> yes. >> so you are going to have to balance. but 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 some other things we'll get to, is that correct? >> that's correct. >> and if the fda banned all flavored e-cigarettes would less kids start to vape, in your opinion? >> well, i can't predict the future. i think that would be likely. we have to limit advertising and sales and targeting children. >> if they are not on the market it's tough to advertise them, right? well -- yeah. >> if kids have the choice of any tasty flavor, they are going to go for it, and i'm speaking to you 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 flavored snow cone they are going to walk away. right now, the fda is analyzing premarket tobacco product applications. 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 in 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%. so 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 -- prefer 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. >> 1.1% of youth vapers. the number of kids who like broccoli is many, many multiples of that. so it's really important i think that you have that information as you go to do that. the surgeon general has 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 kids is to deny premarket tobacco product applications for every flavored e-cigarette other than tobacco flavor. will you commit to doing that? >> as i have said already, i can't prejudge -- >> reclaiming my time. dr.eck 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 by 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 going to be years and years of delay while congress tries to pass a bill and millions and 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. >> thank you congresswoman porter. i now recognize congressman keller for five minutes. >> thank you, mr. chairman. 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 was 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 that 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 product on the market is appropriate to protect the health of the public, which is a fairly high bar, as we just

heard. so we are -- what we are doing is we are diligently working to get through. we got applications for 6.5 million products. and, of course, some of them were from 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? >> well, i think congress has passed the statute. we need to implement that statute. we're in the process of doing

that for the -- for the deemed 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 probably need to think about ways, how can we 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 --

as the pandemic subsides in the u.s. to rigorously enforce the issues about sales to minors, because we found a large number of retail outlets selling to people even when it was under 18. we need to get a rule out about the t-21 that will change the photo identity standard. there are many additional things that can to be done. i think recovery is something we should also think about. >> absolutely. i think we should be very careful as we set policy forward. there's been a lot of talk across the nation about recreational cannabis or marijuana. we should be talking about that too. we're talking about addiction. while 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. it's not a character flaw like it may have been thought about back in the '70s. i think 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 of course it's also widely available as far as the toll of addiction on people. any substance that causes addiction exposure is very important, how prevalent it is. how available -- >> i would say caffeine is probably one of the most addictive drugs, isn't it?

>> they have got nothing on caffeine. >> be careful, mr. keller. >> the scientists have tried to -- and tried, and i 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 appreciate your time. >> congressman keller, 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 premarket tobacco applications, tobacco product applications, or pmtas. a significant number of those pmtas were submitted by vape shops, 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 multiplicity of vape shops pmtas are the 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 list to 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 -- 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. 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 the 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. >> and 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 -- have reviewed and finished all the high market share company applications because that will have the most impact on this -- this problem we're all mutually facing. >> thank you. i'd like to discuss further the details of the pmta review process. the possibility that a company like puff bar might gain months of profits off children because of a backlog at the fda is

troubling and unacceptable. if you fail 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 its growth in market share has driven the rise

in youth vaping rates and 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 it's greatly contributed to the epidemic that we face today. so, madam secretary, how could -- i mean, is the fda considering allowing juul products to be marketed again, or has it already made a decision to ban that practice or to continue to ban that practice? >> those -- the products that we're reviewing have to be subject to a marketing application, something that would be newly introduced into 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. >> okay. all right. thank you. >> yeah. >> 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 smoking cessation. >> the gentleman's time is expired. thank you, congressman johnson. i now call on congressman clyde for five minutes. >> i want to thank chairman krishnamoorthi and ranking member cloud for holding this hearing today.

this is my first -- >> one theory to target -- but luckily it's not necessary -- >> are we getting some feedback here? okay. great. thank you. though 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 that no one wants children to have access to tobacco products, including e-cigarettes, and i want to thank the fda for cracking down on enforcement against companies who are targeting children. dr. woodcock, i understand that certain types of tobacco products are inherently less risky than others, for example, smokeless tobacco products are less risky than traditional cigarettes. would you agree with that assessment? >> that is the likely conclusion of the scientific evidence right

now, it isn't definitive, but it's very probable. >> okay. all right. thank you. would you agree that marijuana is a more dangerous product than tobacco? >> i don't know that a direct comparison has been made. i cannot answer that question. >> okay. well, 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, it depends on the tobacco. cigarettes are the number one preventable cause of death in the united states. >> okay. >> so when you take that figure into account, the fact that marijuana is a schedule i drug, it's apples and oranges. there is a great deal of mortality and morbidity from cigarette smoking and that's been well-established. >> okay. thank you.

while the health risks of tobacco is certainly a huge concern for my republican colleagues and i, i find it interesting that all of my democratic colleagues that were in office last congress voted in favor of hr-3884, the marijuana opportunity reinvestment and expungement or m.o.r.e. act of 2019 which effectively would legalize marijuana on a federal level. i think if my colleagues were worried about the childhood smoking epidemic they would not have voted for the m.o.r.e. act. further, i am concerned that our chairman krishnamoorthi 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, that i am concerned that the committee's goal of this hearing is not to address the concern of youth vaping, but to strong arm the fda, you, ma'am, into banning menthol cigarettes and e-cigarettes. so, dr. woodcock, is it true that 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 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 cigarettes, at least that's what the science currently says. for those who are trying to quit smoking. do you believe that putting limitations on the amount of nicotine in e-cigarette cartridges would hinder adults from switching from the more dangerous combustible cigarettes to e-cigarettes? >> i don't think we have concluded our deliberations on that particular factor. >> okay. all right. all right. then going back to -- to the decriminalizing of marijuana, with many states legalizing or decriminalizing marijuana, what are the fda's plans to quell youth from participating in smoking marijuana? >> i don't think the fda regulates marijuana.

>> so you are not -- there's no -- there's nothing that the fda is doing in that regard? >> right now currently it's a schedule i drug as we said. >> right. >> so we don't regulate it as a medical product, where tobacco, congress passed a special law that caused fda to regulate tobacco products. >> okay. >> so generally fda regulates food and drugs, medical products, devices. >> does the fda have any concern with the 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, you know, psycho active drugs and so forth, yes. >> okay. >> and the potential impact on youth in particular. >> i think it's a very, very dangerous path to go down, the legalization of marijuana. so thank you very much and with that i yield back.

>> thank you, congressman clyde. now i recognize congresswoman bush for five minutes. >> thank you, chairman, for convening this critical hearing today. as a nurse, i know just how important health is for our young adults whose minds and bodies are still growing every single day. vaping products by juul present an immediate threat to adolescent health. nearly two-thirds of juul users age 15 to 24 don't even know that juul contains nicotine which can contribute to lung disease, heart disease and partial brain damage. the fda must take drastic steps to ban the uses of juul -- usage of juul products and minimize the negative 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 bought itself an entire issue of american journal of 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 supposedly scientific study before giving weight to its findings? >> fda always takes into account the source, obviously many of the studies of medical products are done by the sponsors of the products and there are many safeguards that are put into place. so we look very carefully at the validity of any data that might be published. >> so there were 12 of the 13 papers in one journal, how can the fda trust the scientific method and the conclusions of the 12 scientists who were directly funded by juul? >> well, i think we have many sources of information that only being one and as we've been

discussing in this hearing, the statutory bar that the 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, these conflicts of interest is what i call them, before giving any weight to juul's scientific conclusions in their premarket tobacco application. just yes or no answer for that one. >> yes. >> and will you consider big tobacco's history of creating junk science to service needs while reviewing juul's application, yes or no? >> yes. >> okay. thank you for those. thank you. 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 research bought and paid for by an e-cigarette company. the u.s. saw a near 30% decline in youth vaping rates in 2020. dr. woodcock, do you believe that additional fda regulations on vaping products would be effective in curbing 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. yes. and that was my next thing. just the -- considering the impact that these products have on children, especially middle and high school children, like 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 the potential for harm. particularly to children, in initiating these products. >> yes. and because we know that --

because juul is really popular among teens -- amongst teens but that research surveyed -- the research only surveyed adult use of its products. so, you know, as policymakers we must be equipped with our current -- with the current data, the accurate data about vaping products to protect our health and the health and safety of our children. 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 that e-cigarettes would save lives, so, commissioner, do you agree that the fda should closely evaluate these scientific claims from big tobacco regarding it's impact -- it's full impact on public health? >> absolutely, and i would reiterate that we have other sources of information including a lot of studies we have sponsored under our programs. >> okay.

thank you. the information provided by juul does not meet the levels of scientific rigor required by actual peer reviewed studies. if we don't know the potential harms of e-cigarettes there is not information available to predict their impact on public health especially our vulnerable youth, but we do know that e cigarettes have hooked a generation of young people on nicotine. the fda has an obligation to protect our children. thank you and i yield back. >> thank you congresswoman bush. i'd like to recognize our distinguished ranking member of the full committee, mr. comer. >> thank you, mr. chair. dr. woodcock, youth smoking cigarettes is at an all time low and their use of e-cigarettes was significantly declined over the use of the past couple years. do you agree that the issuance of t 21 has contributed to this

downward trend? >> i don't know. i would hope so. we have a lot of data that many vape shops and other outlets continued to sell to underaged youth even when it was at 18. >> overall youth use has declined for combustible and e-cigarettes. there has been an increase in youths 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. wouldn't it make more sense for

the fda to achieve the intended health benefit by spending 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 smoking rates with education and efforts to support total cessation? >> well, i believe the fda is working in all those areas to try and, you know, have campaign -- anti-smoking campaigns along as with the cdc, smoking is continuing to decrease combustible smoking so that's very good. we are very interested in additional smoking cessation products but there are quite a few of those on the market. other methods for recovering such as digital health methods and so forth they 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 here is not from the legitimate companies who have filed their pmtas but from bad actors taking advantage of our current regulations and selling vaping products containing vitamin e, acetate, found mostly in thc, not nicotine products in elicit markets. into he is elicit products have been known to cause serious illness or death. my question, what steps is the fda taking to crack down on these kinds of elicit market e-cigarettes? and are imports from other countries like china playing a role in these elicit markets. >> yes, and we certainly work with customs and border patrol, we have seized fraudulent products coming from china, among other places. we make every attempt to keep these from crossing our border.

we also, of course, do send warning letters. many of the warning letters to companies who failed to submit applications. they did, then, submit an application in response to that warning letter. >> that's one thing i want to remind everyone that's paying attention to this hearing, that if there are flavored -- the cotton candy brand and all that that's been banned, if they're still on the market those are illegal? >> the -- >> -- pods and stuff that are being sold, right? >> right. right. the cartridge -- >> the cartridges? >> right. >> what's the enforcement action process the fda takes against companies and individuals that sell illicit e-cigarettes? >> well, our steps would be -- these are illegally on the market and so our steps would be warning letter and then potential other civil actions against them including injunction. >> do you know to date how many

companies the fda has issued warnings to? >> yes, probably somewhere in my facts here. it's -- it's a very large number of warning letters. >> okay. >> let me ask you this while you're looking, you can get that answer to me. how many products has the fda removed from the market through enforcement action? >> that i don't know. i can get back to you with an answer to that question. >> i'm about to run out of time. mr. chairman, i have one more question. i understand that the fda has a very large number of product reviews and applications 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, you know, filing

process, and those are listed online, and they all have a september 9th deadline under court order for us to make a marketing decision about them. does that answer your question? >> somewhat. i may have a follow-up or two if you don't mind afterwards, after the hearing, but my time is expired. mr. chairman, i yield back. >> thank you, mr. comer. i just want to associate myself with the comments about the enforcement actions. there is a perception and reality that too many warning letters are sent and not enough enforcement action is taken. so that's something that i hope that you will take under advisement. without objection congresswoman wasserman-schultz shall be permitted to join the subcommittee and participate in questioning the witness. congresswoman wasserman-schultz you are recognized for five minutes. >> thank you, mr. chairman. i appreciate the opportunity to waive on to the committee today. dr. woodcock, it's a pleasure to be able to talk with you. i know that you know that

youth's e-cigarette usage remains at epidemic levels and i know that i and my colleagues, many of my colleagues here, have worked hard through legislation and repeated calls to the fda for pro activity in science-based policies. in fact, my colleagues and i wrote to you on march 23rd asking that the fda end enforcement exemptions for menthol and disposable flavored cigarettes. and clear the market of all flavored e-cigarettes until properly reviewed. we also asked the fda to deny premarket tobacco applications for flavored e-cigarettes and deny authorizing the market of any e-cigarette that poses an increased risk of youth addiction. i trust that we will be getting an answer and the responsive actions are forthcoming. certainly hope so. look forward to hearing back from you to that letter. i have several questions, though, concerning high nicotine content and how this has worsened this crisis for our nation's youth. are you aware that jurisdictions like the european union, the uk and israel capped the amount of nicotine allowed in an e-cigarette at 20 milligrams per milliliter.

>> yes. >> do you agree that these countries have helped reduce use by capping nicotine levels. >> appears that way. >> in the uk, 94% of kids have never vaped. and 18% of youth are using e-cigarettes more than weekly because of the lower levels even juul are not popular. in the u.s. there is no limit to nicotine levels in e-cigarettes. juul has 59 milligrams per milliliter of nicotine three times the uk amount. yes or no would fewer kids become addicted to e-cigarettes if there were no e-cigarettes in the u.s. over 20 milligrams per milliliter of nicotine? >> likely, yes. >> likely yes. in reviewing pmtas, will you

in reviewing pmtas will be commit to considering how dangerous high nicotine cigarettes are. >> that is certainly part of the statutory framework. >> so you are reviewing that. >> yes. >> and the possibility exists that you would lower the allowable level of nicotine? >> again, i can't comment on what actions we're going to take. >> if you're reviewing it the possibility exists presumably. the high nicotine levels in juul and e-cigarettes are leading to increased youth vaping but increased youth addiction. does the use of nicotine by adolescents have negative health consequences? >> undoubtedly. >> over half of 18 to 24 year olds who vape never smoked cigarettes vaping introduced and hooked them on nicotine. that's evidence of the products as an on ramp not an off ramp to nicotine use. >> yes. >> the only reason to authorize a pmta for a high nicotine tobacco pro product is if there is overwhelming evidence that it is necessary for adult smokers to quit smoking and the product is not likely to be used by youth. that's not the real world experience on the market.

first, adults don't use juul, kids do. juul is the preferred brand of 5.6% of adult vapors, but 41% of youth vapors, and while juul was helping to fuel an epidemic of youth e-cigarette use there was no discernible decline in adult smoking rates. second, adult smokers don't need high nicotine -- higher nicotine e-cigarettes. in one study that juul purchased as congresswoman bush mentioned they purchased it for its pmta its researchers found that smokers transitioned away from cigarettes to juul at the same rates whether using juul's 3% nicotine product or 5% 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. >> right. >> by encouraging smokers to transition. so there has to be an incremental benefit there, right, in order to outweigh the harms. >> but, again, if researchers

found that smokers transitioned away from cigarettes to juul at the same rates whether they were at 3% nicotine or 5% in their products, then that would show that there is no discernible difference and a lesser -- a lower nicotine level would be appropriate. >> those are the kind of data that need to be evaluated, absolutely. >> okay. but it would seem, based on what you just said, that that's what the logical result should be? to be clear, you should reject all of juul's products, all of them, given what we know about how juul marketed and addicted kids to their product and i encourage you to reject every p mta application for products over 20 milligrams per milliliter. it is clear that there is a direct correlation to a precipitous drop in youth vaping when you have a much lower not 59 milliliters but 20 and that there's no discernible difference whether you have a higher nicotine product in the reduction in smoking by adults.

so that would seem to me in the statutory framework that's established by the fda to really result in those decisions being made as a result of the evidence. thank you, mr. chairman, i appreciate the indulgence. i yield back. >> thank you, congresswoman. i'd like to now recognize congressman desaulnier for five minutes. >> thank you, mr. chairman, and thank you for your attention to this issue and your passion for it. it is, as you you know, i feel very strongly that the actions of juul is despicable. being from northern california i am proud of what we did both at the state level and local level to partner with legislatures and local government around the country to really make a significant positive impact on the public health issues around smoking and to see if san francisco based, bay area based company whose founders graduated from the school of design at

stanford do what they did is, as i said, despicable and we shouldn't be talking about allowing them from my view the ability to continue to 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 vapors doubled from 12% to 29%. in the same period juul's market share grew from 29% to 76%. in november of 2018 the center for disease control confirmed the obvious, pointing 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 and a lifetime consequence of that. it's still the most popular youth vaping brand used by 41% of youth vaperes, and research shows that many of these young people are unaware of the danger that they're exposing themselves to. so, commissioner, do you agree that by the metrics i just mentioned, we're still experiencing a youth vaping epidemic? >> yes. >> do you agree that juul is the e-cigarette company most responsible for creating this epidemic? >> that's how it would appear. >> in ruling on premarket tobacco product applications will you commit to considering past bad acts in marketing to children in 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 talking 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 that you think would help you to enforce the spirit of the legislation i would greatly appreciate communicating with you. do you agree that a nicotine product used by 41% of youth vaperes is hurting the overall public health for generations to come? >> most likely it's hurting that generation. i can't comment on generations to come, but it is definitely a public health problem of significance. >> thank you, doctor. do you trust that tobacco products scientific advisory committee and their advice? >> the -- which -- which advisory -- >> the tobacco product

scientific advisory committee? >> this is the fda committee? >> yes. >> likely i do. i'm not familiar with this committee, i'm sorry. >> okay. >> i'm kind of new to my job. >> i will provide for the record more information on that. >> certainly. >> madam commissioner, i appreciate your responsiveness and your succinctness. juul hooked a nation of children in the light of day, but it's asking fda to approve its product under a shield of darkness. this subcommittee has repeatedly asked juul for its pmta and juul has refused to provide it.

juul knows the junk science it's bought and paid for cannot withstand scrutiny. if juul's pmta was referred to the tobacco product scientific 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 in a partial summary judgment against juul and is instructing the jury that as a matter of law all of juul's social media posts were youth oriented, quote/unquote, evidence from that trial will be relevant to your -- will you commit to gathering all documents from that case including expert reports -- expert reports? >> certainly. i think we should look at all documents but i can't comment obviously on any ongoing case. >> thank you, commissioner. my time is up. i yield back. i want to thank the chair again. >> thank you so much, congressman. now i would like to recognize congresswoman speier for five minutes. >> mr. chairman, thank you. dr. woodcock, great to see you and in your role as acting commissioner you really were not involved in the regulatory

process before january 2021 so i appreciate that, but i'm deeply concerned that this scandal that has been promoted under a previous administration is going to, you know, 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, you know it takes my breath away. so a federal judge has ordered the fda to speed up regulations ruling that the fda has abdicated its regulatory authority. would you agree that 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% among high school students. was it a mistake to exempt disposables? >> i wasn't involved in that decision at all. you missed my oral testimony. >> yes, i did. i was in the house armed services committee. i apologize. >> certainly important. i was the instigator of the original satara lawsuit against 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.

i mean, certainly in retrospect it seems okay that children switched over to disposables, right, and although youth vaping has decreased in the past year it might be multi-factorial, but there is certainly continued youth using of these products at 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? >> i can't comment on individual -- >> how about this, if there are bad actors who have previously

shown that their conduct is violative or is thumbing its nose to the government regulation would that be taken into account on their application? >> it will definitely be taken into account, yes. >> thank you. one of the biggest concerns is that these young people don't appreciate there's nicotine in these e-cigarettes. do you think we need to improve the labeling requirements for e-cigarettes? or should we just ban them outright? >> i think most likely we should make sure that people are aware that -- of the nicotine content. that would be an extremely important thing to do. as we discussed earlier, i really think we are going to have to focus on recovery for teens, too, to get them off their nicotine addiction. i don't know that the health care community is well aware of what ways might work for youth who are addicted to nicotine, but not to cigarettes.

>> the amount of nicotine in an e-cigarette is -- is it 12 milligrams? is that what i read somewhere? >> there are various -- there's various content depending on -- >> so how does that compare to a cigarette in terms of the amount of nicotine? >> i think there are some vaping products that have extremely high content within them, up to maybe a whole pack of cigarettes. you wouldn't get that in one draw, but they are very high and i've heard from families whose children have had very serious experiences after using these very high nicotine products. >> that's alarming. thank you. i yield back. >> thank you. i just have one last question. will you admit that the -- or acknowledge that the flavor ban exemptions that were created

were just a fundamentally flawed policy? >> it appeared it had unintended consequences -- >> negative consequences. -- very negative, yes. >> so you admit -- or acknowledge i should say, i mean, you were not the acting commissioner at that point, but those flavor banning exemptions had very negative consequences? >> correct. >> mr. clyde, do you have one more question? >> i can submit it for the record. >> well, thank you very much for your testimony, and it was a marathon session and i really appreciate your time. thank you again. >> thank you. >> we are adjourned.

c-span has your unfiltered view of government. we are funded by these television companies and more, including spark light. >> the greatest town on earth is the place you call home. at sparklight it's our home, too, and right now we are all facing our greatest challenge. that's why sparklight is working around the clock to keep you connected. we're doing our part so it's a little easier to do yours.

>> sparklight supports c-span as a public service along with these other television providers. giving you a front row seat to democracy. >> sunday c-span series january 6th, views from the house, continues. three more members of congress share stories of what they saw, heard and experienced that day, including california democrat zoe lofgren who served as a teller on that day. >> the capitol officer came and said it was necessary to evacuate, and that we should take the hoods. you know, there are hoods under the seat of each -- each seat in the chamber. particular them out and be prepared to put them on. so everybody did. and i think when you pull the little red tag, it activates it

and, so -- people weren't wearing them. there had been tear gas released in the chamber -- in the rotunda which was why we were advised that we might need to wear them. but there was this tremendous whirring hissing noise from all of these hoods that was the background of the moment and of course the pounding and the noise from the mob had become much louder. at some point someone up in the chambers, in the gallery, a member, was yelling at the republicans to call trump and have trump call -- call off his mob and there was some little yelling back and forth among members in the gallery. >> call trump. tell him to call off his -- call trump. call your friend. tell him to do something.

>> this week you will also hear from republican rodney davis of illinois and pennsylvania democrat madeleine dean. january 6th, views from the house, sunday at 10:00 p.m. eastern on c-span, c-span.org or listen on the c-span radio app. next, we hear from the ceo of the drug company abbvie, richard gonzalez. he spoke about drug price force two of the company's products, hue mara and ambruvica. many lawmakers criticize the pharmaceutical company for hue mira's price increase through the years. this hearing is a little more than 3:30.