tv Hearing on Underage Vaping Legislation CSPAN July 1, 2021 2:07pm-4:01pm EDT
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september 9 deadline to complete its review of vaping products. sponsored legislation crackdown on youth vaping also testified. this meaning comes to order durbin and acting commissioner what crops, thank you for joining us this morning. we are starting on time some thank you and ranking member for making that happen as well. i recognize myself for an opening statement.
for the last year end a half, the depo-provera's pandemic has stripped all aspects of the american life. as we see progress against the virus, we emerge with insight about other threats to public health. it's time to reevaluate public health trust that are entirely within our ability to control. there was a used baby epidemic before the congress. before the subcommittee even committed. before flip-flops took it at the fbi. youth vaping epidemic unfortunately continues today. more than 20% of high schoolers vape and 5% of middle schoolers do. those of st. thomas that compels the first declare of a used vaping epidemic three years ago in 2018. for as long as this subcommittee has existed, we've been investigating this epidemic. this is our fourth hearing on
the matter and i sincerely hope it is our last because problems are solvable. our first in 2019 involved putting fuel on fire and exposing disturbing scope of the company's behavior. it's marketing the children from its attempted use of native americans experimental guinea pigs and its responsibility for fueling youth vaping epidemic critically presented evidence fda and fdada agreed school plus breaking the law and e sent juua warning letter and declared them illegal. now juul is in your hands of the fda. tools, products and eno cigarets meet fda's tuesday on the market through the pre-market tobacco application process, the pmt a process. fda's decisions are due by septembero.
juul's working to children was simply unacceptable. the attorney general in north carolina taking juul to trial as we speak but beyond marketing juul hope the kids were three other reasons. kids were attracted to the flavors the cigarettes came in. second, kids got hooked because juul came at nicotine levels much higher than anything c else on the market third, juul from adults. companies copied their model. when you look at the products that are theop subject of these applications, there many, even now in kid friendly flavors. many match juul's high nicotine formulations in many match juul's conceal ability. to the fda, i would say this.
no matter what your decision is on juul's pmt i, you know the problem doesn't end there. two and the use they think epidemic, you would have to deny applications for all products with the same characteristics that made juul so popular with the generation of children because we watched in real time whenever popular flavor is removed from the market, other flavored high nicotine products take their place. i safe to acting commissioner what crops, i believe you want to do the right thing, you want to keep nicotine out of the hands of children. when you decided to ban mental cigarettes, who took a strong action to strengthen public health and racial equity. when this committee exposed toxic heavy metals and vaping foods, you make that a priority created closer to zero initiative and we are appreciative.n however, now fda has the opportunity to step up and finish the fight against youth
vaping epidemic. don't let any flavored products from any e-cigarette companies stay on the market, not manga and not menthol. if you leave a a single flavor n the market, kids will use it in fact will not be because of the destruction that occurred before, it will be because of an affirmative decision you and the fda make. don't make that decision, don't let any flavored product on the market. don't let any hike nicotine product on the market. other countries have nicotine at one third of what's in dual juul. they don't havema. anywhere prom we have in this country. do these things in the next three months we can help stamp out and epidemic. we's office movie before with big tobacco and the opioid epidemic. let's not let it happened with
vape. have to courage to say no to addictive 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've known for decades cigarette smoking is dangerous and linked to cancer and other illnesses. smoking causes for 80000 preventable deaths in america each year, more than 1300 deaths ao day. i cannot think of another product on the market where 50% of its users want to quit the product. if you're under 21, you should not use tobacco or beginer using vacant products or any other truck or anything else. you should put in your body. it's important to understand especially for young teens as outside negative impact on your body as you t are growing in the things. unfortunately as we have covered in past hearings, the efforts contributed to mustdy become the vaping epidemic teens in
communities across our nation.nt nefarious black-market products found their ways in the handsdsf teens tragic and heartbreaking from spread far too many families. we need progress but there is still more work to be done.e. there's some evidence this is a new industry and some evidence is coming forth that may lead to the baking products could help with smoking cessation. if that's true, i hope the fda will take a good look at the signs based on it but we need to do everything we can to make sure our use do not have access to these products. i share, along with the chairman our first role before being a member of congress, that of a father, we do not want to see a world whereer kids have access o these products so thank you all for being here today, thank you
for attending this hearing and ithank you all for appearing before us today. i do hope we can have a good healthy discussion that will be able to hear from youe but also make sure we are not influencing improperly a process with evidence-based and hopefully it will be and we will be able to do the right kind of science being able to divide how we can protect our kids. if the signs doesn't show smoking cessation devises it, we can have the right adult access to that. thank you for this hearing and your passion on this topic. i yield back. [inaudible] bipartisan bicameral -- which myself, senator durbin and
others for sharing so thank you so much. chairwoman maloney, thank you for being with us and thank you for your distinguished leadership of our committee, i want to recognize you for a brief opening statement as o we. >> our nation is expressing a public health crisis, according to data collectednk by fda and cdc, more than 3 million high school students half a million middle school students use e cigarettes and according to the office of surgeon general, estimated 5.6 million children in thisig country will die early from smoking related on us sigrist continue to be used at this rate. that's one in every 13 young people alive today, these numbers are horrifying. they threatened years of progress in tobacco use and e-cigarette industry is to blame. companies like juul puff bark
knowingly and deliberately pushed tobacco products onto our nation's use. thank deploy dishonest tactics to get young people hooked on these products. they even went so far as to promote their products directly our nations schools. e-cigarette manufacturers have practed with complete disregardo the health of young people across this country. their actions are appalling and federal government can no longer allow this industry to foster youth addiction as long-term marketing prodigy for it deadly products. nations agencies must take immediate action to turn the tide on this crisis. fda can build upon the steps taken so far by prohibiting the sale of remaining flavored products capping nicotine level and e-cigarette and polling illegal products like those sold by puff bark off the market.
i strongly urge the agency to take these steps. let me conclude by amending the leadership of chairman's and the subcommittee on economic consumer policy, the subcommittee's investigation to life the dangerous practices of e cigarettes, manufactures across thehe country and its underscore urgent need for the federal government to act in america's youth vaping epidemic. thank you for your leadership, chairman. i look forward to hearing the testimony and fromin all distinguished witnesses todayip and i yield back. >> thank you chairwoman and thank you for your distinguished ownership in your opening statement. i'd like to begin by introducing our first panelist, someone i know very well, this english senator from my own home state of illinois. for decades, senator durbin ought to protect all americans including our society's most vulnerable from the dangersk of
tobacco and e cigarettes. his work dates back to pleading congressionale efforts to have smoking ban on airplanes, a measure that went into full effect in 1990. more than 30 years ago. today i'm grateful to consider senator durbin champion and partner in our shared effort to decurb youth vaping. he's the lead of the congressional caucus and he is saving legislation, tobacco equity acts which will raise taxes on tobacco products for the first time in over a decade to protect the public health. he's a senate lead up event act, legislation to create youth vaping prevention programs and goals and thisea is just a small snippet of thehe work senators durbin engaged in in this space for decades senator durbin, in his spare time, majority, the senate judiciary committee and
long standing dean of the congressional delegation from illinois. we are fortunate to have him here today andis thank him for s participation. senator durbin. >> thank you for allowing me to testify today on the youth vaping potomac, the role of the fda. the campaign to reduce tobacco use and prevents our kids from time addiction personal to me. my father died from lung cancer, he was 53 years old. he smoked two packs of camels a day. as a young high school students, i will never forget how he struggled to breathe during my visit to the hospital in his last days. cigarettes were responsible for 480,000 deaths every year in the united states. my family is certainly not the only one who could tell this story. ever since i came to congress starting in the house, i've dedicated my career in public service to fistfight.
holding the tobacco industry accountable for its lies and deception, empoweringy families, schools and healthcare providers to prevent kids from this addiction, working to build andn strengthen regulatory framework that does focus on public health. i testified before the subcommittee in july 2019, it seems so long ago. most of our focus was on the skyrocketing rates of use e cigarettes. fueledse by kid friendly flavor, aggressive promotion and height nicotine concentration of the product since that time from my office, the subcommittee and public health community have shown a bright light on the abusive tactics by juul and contributed to this foothold of our children. we have uncovered disgusting tactics used by thiss company to addict our children on these e-cigarette products pleased our public health antitrust
regulators started to step in but when i want to focus today on is the record of the fda the last several years and the opportunity that sits before the agencyco today to correct its missteps in the past and put public health at the forefront of its mission. flavored e-cigarette products exploded in popularity among our kids nearly 4 million now they been, 361% increase in just eight years, but only 800,000 kids. one in five high school students use e cigarettes, these alarming trends are erasing historic progress we've made reducing use youth tobacco products. was on the cover? the food and drug administration this agency has been reluctant for way too long. for years, the fda delayed implementation of requirements that companies submit these applications for review. at the same time, the fda
allowed cigarettes to proliferate unregulated e-cigarette to proliferate unregulated billing to enforce itsli own rule which required al new products entering the market after august 8, 2016 article public health review. since my last testimony, wete hd 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 2020 called an opportunity to private where the market of these addictive kit from the products, the vast majority of which were on the market illegally but instead, the fda a half measure only partially hearing the market and leaving major loopholes for this powerful industry. the result? get migrated to the loopholes. the products that remained unregulated on the market,
mental flavored e-cigarette and disposable vaping products. the use of disposable e-cigarette, onela whole, which the fda was exempted from the fda's january 2020 action increased 1000% last year. make no mistake, kids get it if we don't take this seriously across the board, they will find loopholes and continue their addiction. because the fda allowed mental flavored cartridges from juul and others to stay on the market, listen to this, the use of these mental flavored jewel products juul products increaseo from 11% to 62%. another failure by the fda. we approach one of the biggest milestones in fda tobacco regulation history and i rate the agency is going to fail again. after years of delay by theob administrations party, the fda under court order finally required e-cigarette and tobacco manufacturers to submit
applications vaping products september 9, 2020. this is the long-awaited opportunity for the fda to apply public health standards that congress passed as long as 2009 and the tobacco control act to evaluate whether a product can stay on thehe market and where, whether it is appropriate for the protection of public health. that is a high bar that requires the fda toec balance the risk of youth initiation with potential benefit sensation. the burden is on the manufacturer, the burden is on the manufacturer to show their products will not lead to acute use. they shelter products do not harm the user and choke they help adult quit smoking. remember that claim made over and over again? prove it. they can't. they know they can't. i'm deeply troubled by what i've heard from the response of the fda to my letters. i fear there went to once again over value ofo the unproven potential benefit sensation for adult smokers while undervaluing
the clear evidence of what's happening to our kids. only 4% of animals adult use e cigarettes. 20% of has questions. kids who would never have picked up tobacco products are they been pretty simple, any history in increasing youth use, should be taken out. this is a super bowl for the fda tobacco effort. i'm afraid they're not ready for prime time i hope they prove me wrong. fda recently announced plans to ban menthol cigarettes. i want to commend acting commissioner who sits behind me when she called me with the news but just like that, the time is now for fda to take meaningful action on the public health standards to e cigarettes. we know fda is after-the-fact appointment wanting letters and this doesn't work. to put it bluntly, fdada slope
working and refusal to forcefully act is enabling 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 partner and take these off the market. as it continues to examine youth e-cigarette epidemic in the role of fda, i hope we prioritize our kids. let me close on a personal note, it's been a few years but i served this house of representatives in this building in the house appropriations committee. one thing i decided to offer an amendment on the transportation subcommittee bill that i served on. ban smoking on flights to hour or less. why did i pickgh two hours? one of the leaders on the democratic side, committee from minneapolis was a chain smoker i asked him once, how long could you go without a cigarette? he's had two hours and that's what i put in the first bill. flights of two hours or less,
and smoking. what happened "afterwards" was incredible. even with the opposition of the house republican democratic leadership, i managed to get this to the floor thanks to a man by the name of claude pepper, basically ignored the speakers direction to give me a chance on the floor how about back? young of florida, republican cosponsor, we went to the poor f and weak one. it shocked everybody that we want. why did we went? turned out the house of representatives was the biggest frequent flyer club in america they were of smoking on airplanes. eventually we banned it on all flights. i didn't know it at the time, i really didn't know at the time that wasng tip, at that time people said to themselves, it's unsafe, secondhand smoke is dangerous on an airplane, why is it safe on a train, a bus, in an office, in a restaurant, in a bar?
the dominoes started to fall. we are in a much different place in america todayan because as a junior member of the house of representatives, i tried something considered politically impossible but it worked. can do the same thing. you have the power at your hands. i hope you use it, i know this hearing is an indication of interest of the subject. not only for the fda theth tools but make them use them if they want, bring them to the side of protecting public health. you'll be glad you did. the time to testify today. >> thank you for your excellentl remarks. we appreciateti your second vist 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 are going to get the fda to do the right thing here so thank you.
>> corporation, could you please play theyo video that's been prepared for the public? ♪♪ >> i started fading at 17 years old with juul and i proceeded to use airpark, tufts, boulder, any type of vaping device out there, i probably bought and used it. something that's very important for older generations, people in schools, i people who work with the fda, it's so important for them to understand the severity of what's going on in this generation it seems like everybody about the product, the color, taste, smell, marketing
of it is to get people my age and younger addicted. luckily i quit six months ago and i q haven't touched anything since. it's been quite an adjustment to explain to people in my. groups why i quit nicotine, why it is bad for us they can't understand what is happening or what might happen to their bodies. we just don't have long-term research with these devices, what will happen to our bodies to people with long-term use. >> my daughter is 18 years old, she's been addicted to the jewels product since she was about 13, 14 result. she started out fading manga but not her favorite flavor is menthol because she could no longer get her hands on manga.
i would like the fda not legalize myself but i will tell you all the kids they think are only facing because the flavors, including menthol. >> i used products primarily flavors, juul, even some of the mental products might definitely believe the industry did it to people like myself, people in high school and on they were verypl successful getting a lotf my friends and myself addicted to their products. ♪♪ >> it's interesting because within my. group, we are health science major so wet' know the effects f her vaping in his better than cigarettes, we notice still farming our bodies but they are
so easy to get access to, they are so easy to carry around, you can do it literally in the classroom and nobody would know unless they are 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 is one personally i really liked when i was vaping and againan like i said, everyone else around me, despite the fact that they knew better were also vaping. ♪♪ >> hello, i live in delaware. my son passed away when he was 19 years old. he started beeping when he was seen. i found juul pods in his room, that's how i discovered, he does started with three flavors event
i found out he was severely addicted to this and unable to stop. it's so addictive, he was rushed to the er on several occasions. the last time before he passed away, he was rushed to the er and they had to bring him back to life and still was unable to quit paving, that's how addicted he was the fda was working out -- not looking out for me and my product should never have been on the market and never should have marketed m kids. he died way too young. so unnecessary now the fda has a chance to make a difference so please don't allow the products like this on the market ever again.
;-). >> the fda pushed back by several years. the deadline for these each cigarette and paving companies have the fda determine whether or not the 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 you are allowed these companies to sell their products. what you have to say now to me and everyonee else who got addicted not we know that these are not safe. ♪♪ >> thank you for playing that moving video. good morning, we are now introducing panel two. we are joined by the honorable doctor janet woodcock.
the acting commissioner off 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.y. do you swear or affirm that the testimony you are about to give is the truth, the whole truth and nothing but the truth soy help you out? thank you. let the record show the b witnes answered in the affirmative. thank you and please be seated. the microphones are sensitive so please speak directly into them. without objection, written statement will be made part of the record. you are now recognized to provide your testimony. >> thank you and good morning. thank you for the opportunity to be here today this is a very important issue to make. i'm here today representing
hundreds of staff at the fda working everyday to prevent it from using any tobacco products including e cigarettes. while i've only been in my current position for about six months from the pen of the agency in various capacities for over 30 years. while director of the fda center for drugs played a central role in the agency's initial attempt in the early 2000 a month to regulate cigarettes under device authority, particularly flavors would entice children to use these products and that would cause harm. the issue ultimately was adjudicated in the 2010 court case where the d.c. patristic court wrote make or derived from tobacco could only be regulated under tobacco authorities. now is acting commissioner, i'm happy to continue closely with my colleagues from the center for tobacco products. it's a new day and we now have a
tremendous opportunity and responsibility to keep and elevate kids forefront of our efforts to prevent disease from tobacco products. with the september night, 2020 premarket application deadline behind us, we are taking steps to transformative the tobacco marketplace part one deemed tobacco audits on the market like he cigarette will have undergone careful science -based review and oversight by fda. this is truly significant. we've receivedsc and initially processed submission covers more than 6.5 million products. congress granted us vital public health tool with premarkets review authorities and i can assure you we intend to use the authority to protect kids and optimize public health as directed in the statute. we are looking seriously on application review in order to move on for a wild west
marketplace. we will seek thorough evaluation for any products plaintiff marketing statutory standard of appropriate for protection of the public health as senator durbin said, i far. if data products does not clearly support the standard including evaluation of the impact on youth initiationif and youth, we will notlu issue marketing order for the product. the information you're going to do everything we can do it after the youth use and prevent another generation of kids from becoming addicted to tobacco products. for we are going beyond premarket review while the 2020 national youth tobacco survey showed encouraging significant decline in the use e cigarette use last year. 3.6 million middle and high schoolers who currently use these products. uthe epidemic friends under my
decades of progress in reducing impacts of tobacco on public health. we are focusing enforcement efforts against any product manufacture failing to take adequate measures to prevent youth access and targeting use and we havent been doing that. we've issued warning letters to companies illegally marketing unauthorized kitfo appealing tobacco products such as a backpack and a sweatshirt hidden pockets to conceal e-cigarette for those who resemble smart watches or children's toys. in addition, we've issued over 120 warning letters 2007 unauthorized nicotine delivery systemsli including e cigarettes that did not submit premarket application by september 9 deadline. collectively, these companies listed combined total over
1.2 million products listed the fda. we are expanding critical public education efforts through the wheel cost from e-cigarette prevention campaign targeting over 10 million teams who have used or may use e-cigarette. most recent impact assessments ofti the wheel cost are promisi, osindicating various elements fr the campaign receiving over 5 billion years and 75% use are aware and receptive to our ads. over time, increased exposure to the campaign is expected to increase population level shift and beliefs about e-cigarette. as a science -based agency, we support 145 e-cigarette research projects. recent research helps us better and regulate these products including investigation of abuse regulation and health effects. we continue our yearly surveys,
undertaking federal partners at cdc and nih. in closing, i give you my commitment speak on behalf of my colleagues at the agency that we want to all we can to prevent kids from using tobacco products and to address current use vaping epidemic. we will do the hard work and support innovative formative research and t make science -bad 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 subcommittees efforts on support of the agency and efforts to protect kids, especially from the dangers of tobacco and i'm happy to answer questions. >> thank you, commissioner, woodcock's. i recognize myself for question. i would like to start by directing you to the nih monitoring the future survey
data published in 2019 and 2020. this is a chart showing among a subset of almost 9000 high schoolers, this nih study found the percentage who said they are paving in the past 30 days equals 22.5% in 2019 and 20 bruised 2% in 2020. in may 2019, he described e-cigarette use as a alarming problem. i assume you continue to believe that you repeat that? >> i do spirit same meeting, he said he cigarette use, use increases the risk that they will use combustible cigarette. you still believe that? >> i believe that according to fda's website, nicotine exposure
during adolescence disrupts normal brain disruptive element and long-lasting effects such as increased mood disorders. you don't disagree, correct? >> i don't disagree, it is very concerning. >> as you mentioned in your opening statement, he received millions of applications under these standards one of the thingsin fda must assess his increase we heard that those who do not use tobacco products will start using these products. when youth use e-cigarette that might be subject to this process have increased likelihood of using other tobacco products that combustible cigarette, it is a problem under this standard, right? the pmc standard you must consider the risk to people who propose new tobacco products. we just talked about the health
risks to youth. i presume i t can health risks, significant long-term health risks are a problem under this standard, right? >> absolutely from about us harm bar, that has to be overcome by benefit to have met the public health through june 22 letter, last night the folks at fda sent a letter going -- a new product likely impact on addiction especially among youth, it's critical determining whether allowing tobacco product would be appropriate for the protection to the public health. the letter says one of the issues bearing on your assessment of addiction was the levels of nicotine in thehe finh product. i like to present you with documents jewell produced to our
committee during this investigation. icq numbers content exhibits a, b and c c without objection, so entered. kirk, can you please display the next slide? this is a march 2016 jewell document produced as part of their document production on the subcommittee assess this is an internal document from an employee at jewell that says based on feedback from retailers, customer service and social media, many consumers feel 5% nicotine strength is too strong. our current nicotine level and pot is much higher than other e cigarettes. by the way, as you know, this 5% is the strength of current juul products, fest 2015. five years ago.
let's go to 2018 mapap when 20%f high school students 5% of middle school students work vaping. please present the next slide juul convened something called youth advisory council to asksk why so many children are using it products. this is what kim said. kim said very high concentration of nicotine. she has other interesting comments there, i didn't put this up on a slide but brett said social acceptance start addiction to nicotine then. noah said social nicotine -- besides this anecdotal evidence, there is objective data that even as late as 2020, the national survey from the fda shows increase in nicotine addiction. according to fda, almost 40% of high schoolam users use in e-cigarette 20 or more days out
of the month, that's every two of every three days. these numbers are up from 2019 from the number was roughly 34%. in your assessment of a new product likely impacting addiction, going back to the standards set forth in letter to me with regard to, you would be very concerned about youth perceptions as well as the reality of a product addictive qualities. >> absolutely, that has to be the forefront of our assessment of potential harm. >> it also be concerned about companies knowing decision to keep it getting levels hi, even in the face of internal employee as well as detail the fact that it's high. >> obviously for substances that can cause addiction exposure is very important and higher exposure is a problem. >> also you would be concerned about youth data showing it's
addicting kids, right? >> absolutely. >> when a company has internal data that continues to keep its nicotine levels high from the site present evidence the s company intended to hook kids? >> i'm not a lawyer so that is beyond my area of expertise but lacks show products been dangers to get. >> the company knew about the dangers. >> according to what you shall hear, absolutely. >> veblen 2020, at the implemene a new, we call it labor ban, there is a much longer title, you are familiar with that man? >> yes. >> according to the policies, first an exception for tobacco and menthol flavors for juul and otherpt proctors are church basd devices and second, and
exemption for all disposable e cigarettes to be in any flavor whatsoever. let's talk about mental for a second, can you present the next slide? 44%si of use in 2019 use mint juul. when mint was banned february 2020 under your partial flavor fan, guess what -- 44.5% of youth used on thoughts that we went from 44% of juul users music meant to 44.5% juul users using methyl. senator durbin said in his testimony 62% of all users, regardless of which company ended up using methyl. this is before you became commissioners but i said in entire hearing with your colleague, picked telling him this was a bad idea to create an
exemption for menthol. i said thiss is exactly what's going to happen, people will migrate meant to menthol and that's what happened. i was sora pleased you band menthol combustible cigarette, which was the right thing to do, will you pledge to clear the market menthol e-cigarette? >> again, i can't prejudge our decision. what i can say isci menthol has additional properties and pharmacological properties that i believe potentiate the effects of nicotine addiction and make it harder stop either vaping smoking so to my mind, having a higher patient of nicotine in whatever delivery system -- >> basically has the addictive
product. >> that is my belief based on data, i don't think it's totally settled but evidence shows it is harder for people with mental cigarette to stop smoking even by smoke fewer cigarette. most facts are compatible with that. >> let's talk about disposable e cigarettes. according to the mips you presented at the fda, 2019,20 oy two and a half% of high schools students -- i'm sorry, two and a half% of high school vapors use disposables but after fda and most diverse for these devices, disposable use surged almost 27% 2020. you don't dispute that? >> no. >> the decision to accept disposables again was made before your time as commissioner. exempting disposable e cigarettes was a hugespe mistak,
exempting them from the flavor fan was a huge mistake. i assume that you consider that problematic. will you pledge to close this disposable loophole in the flavor band? >> again, i can't prejudge decisions which are coming up quickly. however, i think that switch to a different alternative method of flavored cigarettes robin stank with the tobacco flavored dual is another piece of evidence that use refers those flavors and that is an important factor in sustaining use of these products. >> the percentage of youth who use flavor e-cigarette went up over thehe last year since the partial flavor fan, now it's 80% of all youth used flavored
products, correct? >> i can't remember all these numbers exactly but it is a very high number, i believe it is 80%. >> very good, let me now recognize ranking member cloud and i'm sorry, i think we forgot to turn on the timer so we will give you some extra time. >> a liberal five minutes. [laughter] thank you for being here and thank you for this important discussion on the topic as we have all agreed we don't want o these in the hands of our kids. you mentioned progress has been made in 2020, some reduction in use saving. according to the data, whatever topic we are talking about 2020 is a year it's hard to put any thought into definite data so i curious to know why you think that happened in this legislation passed from it doesn't have anything to do with
fact wanted some of the administrator actions taken also, curious to know as we look ahead to 2020, it is hard to be definitive about this when it comes to data on any topic but when we can expect to see data that we can see if they are trend moving in the right direction or slipped because of public and all those things, what are your thoughts? >> , the data from surveys should come out, hopefully we will have some vacation 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. i believe the decrease posture
is multifactorial so it's hard to say with a contribution of any given affect, a lot of the children were home, not suffering as much. pressure, they were not happy rent andng around no we heard from the film you show, we heard. pressure in this. pressure was an important factor and the use of vaping products so the ban on t21, i think it's very helpful. fda stopped its compliance checks in the middle of the pandemic because we used under aged children part of the test subjects along with trained adult to go in and attempt to purchase and we couldn't send children into those circumstances with covered but i will say even before, even when
we had limited at 18, we saw thousands of cases w where sales were made to ages under 18 so that is a problem, those retail outlets will still so to under aged individuals. >> there's been -- i'm a little concerned about the time of the hearing, it's an important topic we cover you here is great because courts have frowned upon in the past, congress weighing in while there is an agency investigating or reviewing a topic. there's a congressional investigation focused on intervening in agencies functions. how are we going to make sure today's hearing is informative for us, informative for the
american people but your decisions are going to be evidence based, i've noticed in the comments you've made talking about what you believe to be the case despite any data. i realize you have a team and a staff and you can't be expected on every topic to know everything but how are we going to ensure as we move forward in this process is going to be evidence based? >> as i said, i cannot prejudge any decisions we will make or commit to any given action, congress played out in statute with the statutory far is for this review program and it is a high bar, i don't think it is a matter of dispute but certainly the agency scientists are hard at work evaluating these application against criteria laid out in the statute and that
is the process week will follow. >> 's are evident plate that shows there is a use for adults, over 21 to use vaping products as a smoking cessation? early evidence i think the studies are somewhat mixed as far as how effective saving is. >> a new industry so i realize it's developing. >> no company has come to the fda center for drugs to go through process smoking cessation which would be a drunk indication and a different process you go through is a drug, we have a number of cessation products on the market and they have been shown in clinical studies to help people stop smoking although the adherence to stopping smoking over years may not that but
these, including concern drugs as well as different nicotine products people can use as a team placements and stop smoking. in all those cases, people are urged also to get counseling or be in a program or something like that that helps a lot of people smoking so none of the products which requires clinical trials tove prove that you can allow people to stop smoking. >> they could advertise as that. >> they would have claims that they would be a drug and they could advertise, absolutely but they would also have to do toxicological studies onuc their products so forth so the statute
for tobacco products we are reviewing under also has evidentiary statement in the statutes that says there should be studies that should support the fact the benefit, they could be clinical studies or other studies so the burden is on the manufacturer too show by some studies andso data that their product has health benefits. >> i don't know if you would have this data handy, if not, i'd be curious to have your team look into and see but coming through this year with covered as a respiratory illness, and we know it affected particularly seniors and other demographics particularlyt hard, there were some cases where young people
were tremendously affected by, some died, much more rare than other segments of our population, have you all cross referenced that with vaping to see if there was a connection x to be susceptible in the past we've covered this in a number of hearings so we understood a distinct difference even with the effect of black-market products versuss others, not tht you should have any of them well established, at least among what we are talking about this issue, have you found any connection? >> i don't think the data are available to think covered catching of it having a severe practices we can look at what
data might be available but i don't think the data are available. this wouldn't be an medical record. use of vacant wouldn't be in the medical record so it is hard to make that connection. >> okay. thank you. i yieldld back. >> thank you, i recognize congresswoman porter for five minutes. >> thank you very much, mr. chair. is the research clearly established that flavored e cigarettes appeal to children? >> yes, i believe it does. >> infect thehe fda and disposae labor e cigarettes except when to limit children's access to certain labor e-cigarette products we know are so appealing to them. >> yes. >> having this hearingng because disposable flavor e-cigarette
disposable and non- disposable mental products are still on the market and inevitable result is that e-cigarette used from highr school and middle school is incredibly high. 3.6 million children they bring in 2020. middle and high school kids who smoked e cigarettes, what percentage use flavored products flex. >> i believe eight ten e-cigarette users report use of flavored products. >> that's all i have, too. 88%. that's an all-time highh so any flavor other than tobacco flavor of e-cigarette left market, is itit likely to encourage youth o start they think? >> the statutory far we are talking about -- >> i'm going to get to that. iha went to but you do not self
you're going to have to balance. any flavor of e-cigarette left on the market is likely to encourage to start and we have to balance that, correct? the fda band e-cigarette, what less is continue to do vaping? >> i can't predict the future, i think that might be ugly, we also have to, regardless, limit advertising and sales and targeting children and other practices. >> they are not on the market so to summarize, if kids have the choice of any flavor, they are going to go for a and i'm speaking from expense as a mom of three school-aged kids. if there's no watermelons from my kids he get blue raspberry. luke raspberry, finkel. no single? strawberry. it only twice, around tobacco flavored no, they are going to
walk away. right now the fda is analyzing market productive tobacco products and you have to decide whether or not in e-cigarette can bring or keep a product on the market and doing that, you have to do that only if it's appropriate for the protection of public health. that is ay standard. with the fda, as you were saying, required to balance youth they bring against any good e cigarettes might do in getting adult smokers quit toba. you know what percentage of adult smokers used e cigarettes and set of traditional cigarette? >> no. >> it's about 4.5%. we are talking about small fraction of adult smokers group
of e-cigarette smokers, you know what percentage for menthol or mango or if there's blue raspberry, tobacco flavor? >> no. >> a city in great britain, we don't have a study yet in the u.s. but 56% of adult vapors, people over 55 prefer tobacco. 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 vapors. the number of kids who like broccoli is higher than that. it's important to have the information as you go up to do that. the surgeon general set there is zero evidence, scientific evidence that proves e-cigarette in general help adult quit smoking. you've testified that kids are drawn to flavor e-cigarette based on the evidence and as a mom of three hopefully
nonthinking kids, this is personal front me, the only way to protect our kids is to deny free market productive with every flavor e-cigarette other than tobacco, would you commit to doing that? >> as i've said already, i can't prejudge. >> you may not beav willing to o it but i want to make sure america understands, you have the authority to commit today to prevent millions of kids from becoming addicted they think by making the decision and commitment today to ask if you don't make that decision today in this oversight hearing in the alternative is going to be years and years of delay to pass this bill millions of markets to be evicted. i hear you, you're not willing to make that commitment today i want the americann people to understand you do have thatng power. i yield back.
>> thank you, i now recognize congressman ash for five minutes. >> thank you, mr. chairman. youth vaping is an epidemic with the help of our children at risk. tobacco products raised 21 yearl old and flavor bands were enforced in 2019. january 2020, the cdc found almost 20% of high school students vape past 20 days. we need to focus on getting disposable e cigarettes out of the hands of our children. tobacco itself is not an illegal product message work guardrails are set in place from of the overall health and benefit of all mankind, especially those too young to understand danger. these products are not subject to the same flavor guidance as
nicotine livery systems. we need smart and targeted solutions for these problems so i appreciate you being here today, thank you for thatar andi wonder, could you give an update on what actions the fda plans to protect the health and safety of kids while taking into account mom and pop small operations around the country to require regulation? >> well, according to the law and court order we are under by september 9, we will come to a decision o on various applicatis we have received. they have to meet the bar we have been talking about showing that overall, having it on the market is appropriate to protect the health of thewi public which is a fairly high bar as we heard so we are doing is diligently
working cap through, we got applications for 6.5 million products and of course some are from small businesses. we have given a lot of assistance small business assistance, please try to help but under the statute, these businesses must submit information that shows, among other things, that there product this bar and are appropriate for public health. >> looking at e-cigarette, clearly a big part of the problem, how can congress and fda work together to keep our kids safe? is there something we can do to help collaborate with the fda, some tools arere things we can o to the helpful and work together? >> i think congress has passed the statute, we need to implement that statute, we are in the process of doing that for
the deemed product and hopefully that will come to the conclusion very soon. there is no problems, many problems with addiction, we have a group of kids who are not addicted to nicotine that we probably need to think about ways, how can we assist them in recovery getting off of nicotine? the chairman said there's evidence that early exposure to various addictive products or drugs will act on the brain in ways that make it more difficult for these individuals to stop those behaviors so if we can get to the end of activity, in addition fda hopes to get started again as counties become, a pandemic in the u.s.
to rigorously enforce issues about sales to minors because we found a large number of retail outlets sound to other underaged children so we need to get a rule out about t21 that will change photo identities and/or so i think there are additional things that can be done but recovery is something we should think about. >> absolutely and i think we should be careful as we set policy forward, because a lot of talk across the nation about recreationalar cannabis marijua, we should be careful about that, too. we're talking about addiction and while we talk about making sure our kids are exposed, i think the policies we discussed by policymakers on that front should be taken into account as we move forward. i know not what we are here to talk about today but it is a
disease, not a character felt like it might have been thought about in the 70s. i think we need to serious and careful how we move forward on things that are clearly now not legal for operational use and i wouldn't want to expand, i don't think government should expand those things to be available people and potentially being able to get into the hands of our kids. appreciate your time today. >> alcohol probably one of the worst substances and also widely available as far as the toll of addiction on people. any substance this addiction exposure is important how prevalent it is. >> i would say kathleen is one of the most addictive drugs. >> they've got nothing on kathleen. [laughter] >> be careful. [laughter] >> epidemiologists have tried and we have nothing on kathleen.
>> i did read somewhere it's the most addictive thing there is because it's in so many things. >> i was going to cut your mike right about that. okay, mr. johnson, you are recognized for five minutes. >> thank you, mr. chairman. commissioner, the fda received over 6 million week market tobacco applications, tobacco product applications. a significant number p mtas were submitted by shaping chops required to submit this for every flavor that they mix. thisui means that a single small bakeshop might have applications with 30,000 products. the multiplicity of these are
the overwhelming majority 6 million p mtas. is that correct? >> that is my understanding, yes. >> the fda recently published an entire list of these applications this committee has whittled down the list to the applicant must responsible for putting these vaping products into the hands of our children. when you do it like that, the list of pmt a applicant goes down to about one of our companies which is a much more manageable number which the committee will share with you those 44 companies. these are the disposables that are making their way into high schools and middle supposed. commissioner, fda is under court order to finish ruling on
applications by september 9,in 2021 but signal it will likely miss that deadline. can you commit today rulings on all of those applications from the 44 companies that children are most likely to use private september 9 deadline? >> i cannot commit, i'd have to see the list. i will tell you we have prioritized my market share so we've made sure we are looking at companies with large market share, the most impact -- >> how many of us companies have you identified? >> i think there are only about five companies that have the vast majority of the i market share there's a very large a number of other types of
enterprises that constitute the rest. >> can you name those five? >> no, i'm sorry. i could get back to you with that information. >> can you commit to ensuring their applications are processed by the september 9 deadline? >> i will commit to doo everything i can to make sure have reviewed and finished high market share companies applications. the most impact on this. >> i'd like to discuss the details of this review process. the possibility a company might gain months because of a backlog the fda is troubling and
unacceptable. if you fail to rule on all p mtas from the five companies and 44 companies, disposable applications that the committee has identified, by the september deadline, will you commit to pulling the products on the market until the applications have been reviewed? >> technically the products are currently only marketed under enforcement discretion after the september deadline, if they don't have an improved marketing authorization, they are again only on the market under enforcement discretion by the fda. >> utthank you. juul dominates prefilled pod market and growth and market sharee has driven the rise in youth saving rates yet the
applications in the marketing restrictionst after just one year, even juul is currently on trial but marketing addictive armful products to children. juul has been untrustworthy to continue selling his products and it's contributed to the epidemic we face today so matter secretary, how could -- is the fda considering allowing juul products to bead marketed againt or has it already made a decision to ban that practice and continue to ban that practice? >> the products reviewed would have to be subject to a marketing application, something newly introduced into the market. it would have to go through the review process, as i understand it. >> has not happened yet? t >> i can't discuss any single
action we might take. >> think it. if an application cannot prove with scientific evidence that a product will not contribute to or increase e-cigarette use, where you deny this application? >> that is one far and it would have to have the other prong of evidence, it would have to have extremely compelling evidence that it was uniquely positioned to reduce, contribute to smoking cessation. >> the judgment time has expired. thank you. i now call on congressman clyde for five minutes. >> i want to thank chairman and ranking member cloud for holding this hearing today.
this is my first -- >> to target -- >> are weakening feedback? okay, great. thank you. this is my first hearing on vaping products and i understand the fourth orly fifth hearing on the last couple of yearsng on the same subject. i think i can speak for my colleagues on both sides of the aisle when they say no one wants children to have access to tobacco products including e-cigarette. i want to thank the fda for cracking down on enforcement against companies targeting children. doctor woodcock, i understand certain types of tobacco products are inherently less risky than others for example, smokeless tobacco products are less risky than traditional address, would you agree? >> that is a likely conclusion
of scientific evidence, it not definitive but it's probable. >> all right, thank you. would you agree that marijuana is more dangerous than tobacco? >> i don't know the direct comparison has been made, i cannot answer that. >> well, marijuana is certainly illegal at the federal level and tobacco is not so i would assume based on that alone that marijuana is a much more dangerous product than tobacco. >> it depends on what tobacco.e cigarette are the number one cause, preventable cause of death in the united states so when you take that into account, the fact that marijuana, a schedule one drug, it's apples and oranges, there's a great deal of mortality and morbidity from cigarette smoking that's well established. >> okay. thank you.
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 in office class congress voted in favor of hr 3884, marijuana opportunity reinvestment and expungement more active 2019 which effectively belies marijuana on federal level and i think if my colleagues were truly concerned about this epidemic, it would not have voted for this act. i am concerned that our chairman recently sent a letter to the fda, to you, acting commissioner, asked asking to act to ban mental and e cigarettes and i quoteio from a letter, european union band mental cigarettes figureig out e very last line of the letter says if you allow mental labor
cigarette sales to continue, you failed. that is really strong language. so this hearing comes so soon after that but are being sent, april 21, i am concerned the committee's goal of this hearing is not to address the concern of youth they think but strong armed the fda into banning mental cigarettes and e cigarettes. so doctor woodcock, is it true that the fda taking steps to prevent children from using e cigarettes? >> yes. >> absolutely. do you think any of those steps are hampering adult use of e-cigarette for those who want to kick the habit of traditional cigarettes? >> no. >> all right, great.
we think e cigarettes are april alternatives to additional combustible cigarettes, at least that's what the client currently says. for those trying to quit smoking, do you believe putting limitations on the amount of nicotine e-cigarette cartridges would hinder adults from switching from the more dangerous combustible cigarettes to e cigarettes? >> i don't think we have concluded on that particular fact. >> all right. going back to decriminalizing marijuana, with many state decriminalizing now want to, what are the fda's plans stop them from participating in marijuana? >> i don't think the fda
regulates marijuana. >> so there is nothing the fda is doing? >> currently it's a schedule one drug so we don't regulate as a medicale product. tobacco congress passed a special law regulated tobacco products are generally fda regulates foodal and drugs, medical products, devices. >> does the fda have any concern with legalization of marijuana? >> i think all in the biomedical community are concerned about availability and managing availability of any drugs that have potential psychoactive drugs and so forth an individual impact on youth in particular. >> i think it's a very dangerous path to come down from legalization of marijuana thank you and i yield back.
>> thank you. now i recognize commerce woman bush for five minutes. >> thank youow for convening ths critical hearing today. as a nurse, i know how important health is for our young adults whose minds and bodies are growing every summer break. they think products factual present immediate threat to adolescent health. two thirds ofdss juul users h 15th -- 24th don't even know juul contains nicotine which can contribute to lungs, heart disease and partial brain damage. drastic steps must be taken to ban the use of juul products is minimized negative impacts on our doctor woodcock, tobacco a long history of twisting science to meet needs? was dismayed to learn juul have this issue of american health behavior to bolster applications for fda approval. twelve of the 13 internal issues
either written by either juul employees or associate so yes r no, do you agree fda should take into consideration the source of supposedly scientific studies before giving way to the findings? >> fda always takes into account the source of the studies medical products done by the sponsors safeguards put into place. ... >> in conclusion who are directly funded by jewel printed. >> i think we have many sources of information not only than
being one and as we have been discussing from this hearing, the statutory bar the congress has put into play, it is a pretty high bar and we must look at all sources of evidence in any evidence despite by the company for additional scrutiny. >> so will the fda take into consideration the possible conflict and look at it this way, this conflict of interest is what i would call them before giving wait to the premarket and i was wondering if he could answer to that one party. janet: yes printed. >> and creating just the service while jewel has this yes or no. janet: yes printed. >> thank you very much for thaty doctor printed after many years of this tobacco lying to people
about the safety of this product, i would hope that the fda would take the cautious approach and considered this a company in your 30 percent decline in 2020 and doctor janet woodcock do you believe additional relations in these reducing in the vaping rates reducing more. janet: i believe that we have to do it something. cannot continue with this epidemic, is very dangerous to children. >> cyes our unit is my next thing, considering the impact of these products a special middleo and high school children like you said, big part of this in the generation specifically. janet: absolutely and that is one of the statutory standards that we have to look at which is the potential for harm her particular two children. [inaudible]. >> in yes because we know that
the popular among teens but the research, that they surveyed, research only surveyed the products so as policymakers we need to make sure it's accurate data about the vaping products but help protect the safety of our children. the me just ask despite not having the answers to everything that we would want right now at this moment, but jewel research concluded that it would save lives. so commissioner see you agree that the fda should evaluate the scientific findings from big tobacco the full impact in public t health. janet: helps a little late i would reiterate that we have other sources and information including a lot of. studies we have sponsored under our program. john: thank you. the information provided by
jewel is not meet the level of science rigor and peer review study so there's not enough information to be able to predict the impact of public health especially on vulnerable youth, we do know is that it and fax the generations and at the fda has an observation and protect our children. thank you and i yield back. >> thank you congresswoman butch and i would like to recognize distinguished ranking member. >> thank you and doctor janet woodcock e-cigarettes smoking is an all-time low significantly declined by the years as well predict raising the minimum wage for tobacco purchases from 18 to that 21. a. janet: we have am lot of data that many shops and other
outlets continue to sell 200 aged youth even when it was at 18. >> overall use has declined in both the e-cigarettes and also there's been an increase used in vaping disposable. hundred and 70n morning letters marketing flavored disposables in 2021 has the fda done to particular those who have not submitted their p.m. ta. janet: we have further action is that we can take after a warning letter, to moment knowledge that is not been taken yet. >> commuting those actions yet. janet: no, of the nine oh up. >> prohibition didn't work for alcohol and yet many of my colleagues argued that prohibition is not working for marijuana. when make more sense for the fda
to achieve the intended health benefits for spending time and effort getting more reduced harm negative products to market in educating smokers about the benefits of switching their negative source while continuing the ban on smoking rates with education efforts to support total cessation predict speech of my belief yes the fda is working and all of those areas to try not or antismoking campaigns along with the cdc and smoking is continuing to decreae combustible smoking so that is a very good at. and we are very interested in additional smoking cessation products but there are quite a few on the market. other method printed but that's recovery such as digital health methods are under investigation so hopefully we can get addicted
adult smokers off combustible cigarettes as well. >> one of these problemsad we fe is not from the legitimate companies who have filed but from bad actors who have taken advantage of our current regulations and selling the vaping products and containing vitamin e acetate and mostly thc. not nicotine products in these markets. these illicit products have been known to cause serious illness or death printed so my question is what steps is the fda taken to crackdown on these type of illicit market east of prison are imports from other countries like china o playing a role in these markets predict. janet: yes we certainly work with customs and border patrols we have seized fraudulent products coming from china among other places and we make every attempt to keep them from crossing our borders and we also of course send morning letters and many of the warning letters
to companies who failed to submit applications and then they did it in application response to the warning letter. >> and this one thing that i want to remind everyone that to my attention to this hearing that the flavored cotton andy brand and if there still market, those are illegal. the pod us and stuff that are being sold right predispute if yes the cartridge. >> what is the enforcement action process that the updated casing is companies and individuals to sell illicit eat cigarettes. janet: our steps would be in part open market illegally sore steps would be warning letter and then the potential other civil actions against them him predict. >> you know today how many companies the fda has issued
warnings to pretty. janet: yes, probably some work and my facts here but it is a very large number. >> let me ask you this what you're looking come you. can get an answer to me. how many products has the market removed through enforcement actions. janet: that i don't know, i can get back to you answer that question prayed. >> i'm running out of time and i have one more question. i understand it that the fda has a very largeme number products reviews applications which have been filed and are subject to the deadline is september 9th from a pragmatic standpoint how might the fda communicate to the public into the applicants about the status of those products. janet: we have listed all of the products that have been submitted and made it through the initial filing process and those listed online.
they'll have september 9th deadline in a court order for us to make a marketing decision about them. does that answer your question. >> some what, i may have a follow-up or two if you don't mind afterwards. the hearing but my time is expired. i yield back. >> thank you and i just want to associate myself with a comment about the enforcement actions, there is perception of reality that of too many warning letters are sent and not enough enforcement actions taken. so that is something that i hope you will takeco under advisemen. without objection, shall be permitted to join the subcommittee and questioning the witness and congresswoman, and you are recognized for five minutes pretty. >> thank you and iha appreciate the opportunity to be on this committee today predict and to be able to talk with you i know that you know that e-cigarette use remains at epidemic levels oand i know that many of my
colleagues here have worked had through legislation and repeated calls for the fda for productivity and size based policies in fact we wrote to you in march 23rd asking that the fda and the exemptions for both mental and is disposable e-cigarette includes market of all flavored cigarettes until properly reviewed it. we also asked the fda to deny any premarket tobacco applications the flavored e-cigarette night authorizing the marketing of many e-cigarette suppose an increase risk of use the discussions. the trust will be getting an answer in response actions are forthcoming. i certainly hope so and i lookk forward to hearing backng from u for that letter. have several questions though considering nicotine content and help this is worse than the crisis furnishes youth predictin are you aware of victims like the european union the uk and israel kept the amount of nicotine about any cigarettes at 20 milligrams per milliliter pretty. janet: guest pretty.
>> do you agree these countries have produced e-cigarette youth by capping nicotine levels predispute if it appears that way printed. >> my 4 percent of kids have never vaping in only 1.8 are using e-cigarette more than likely because of lower dsbeginning levels payment jewel in the uk and u.s., there's no limit nicotine levels in the cigarettes and jewel is 59 and three times the uk amount yes or no, would your kids become addicted to e-cigarette if there were not in the u.s. over 20 milligrams per milliliter of nicotine. janet: likely yes. >> and in reviewing will you commit to considering how dangerous high nicotine e-cigarette certainin public health compared to lower beginning e-cigarette predispute if that is certainly part of the statutory framework, yes printed, reviewing it predispute and. >> and the possibility he would
lower the allowable level of nicotine>> predispute if i can, and what actions we will take. >> but your reviewing at the possibility pretty in the high nicotine's levels and jewel aree leading to youth vaping but also addiction and thus the use of nicotine have negative health consequences predict speech of undoubtedly. >> over half never smoked cigarettes and it helped to them on nicotine and that's evident of the product as an on-ramp, not enough ramp to use business predispute if yes. >> the only reason to authorize it for a high nicotine tobacco product is if there is overwhelming evidence that is necessary for adult smokers to quit smoking in the product is not likely to be used by youth predict but that is not penned of real-world experience for jewel on the market. first, and also music t kids do edit the 5.6 percent of adult late hundred vaping the 40 percent of youth vaping and well jewel is the secret use,
there's no discernible decline in adult smoking rate rated second, the smokers do not need-getting a cigarettes, anyone study that jewel purchased is congresswoman first mentioned, they purchased it for its the mta and is researchers found that smokers transitioned away from cigarettes to jewel at the same rate but are using jewel 3 percent nicotine products are the 5 percent nicotine products of doctor, i think there would be no reason to approve the 5 percent products correct printed. janet: the statutory requirement is that the prong about that it would help in some way protect the public health, and encouraging smokers to transition pretty so that has been a mental benefit there. in order to outweigh harms. >> so again, if the researchers
found the smokers transitioned away from cigarettes to jewel whether they were up three nicotine or 5 percent nicotine, and their products and that would show there is no discernible difference in a lesser or lower nicotine level would be appropriate predispute this is dated that need to be evaluated absolutely pretty. >> but it seems that based on just what youro said that with a logical result should be. see tip conference to be clear, you should reject all of jewel's products even what we know about how they marketed in addicted kids to their product and i encourage you to reject every application it for or 20 milligrams per milliliter. it's very clear that there's a direct correlation it to a precipitous drop in youth vaping when you have a much lower, 2959 for no discernible difference whether you have a higher nagging product and reduction in
smoking brought by adult. so that would seemce to me, and statutory framework that's established by the fda to really result in those decisions being made as a result of the evidence brightest thank you and appreciate the indulgence. i yield back. >> i would now like to recognize sonia for five minutes. >> thank you for your attention to this issue in your passion for it. it is as you know, i think very strongly actions of jewel is despicable. being from northern california, i am proud of what we did both the state level and local level to partner with legislatures and local governments around the country to really make a significant positive impact in the public health issues are te smoking prayed in a sea of san francisco-based area openings and founders graduated from the school design. and at stanford, with a due date
is as i think despicable. we should not be talking about for my view the ability to continue to market and distribute this product todn you with people in particular. but we should be personally holding them accountable. but, commissioner in 2018 the surgeon general declared a youth vaping epidemic. and in 2020, we've also seen it doesn't 218 and also as you know. [speaking spanish]. between 22017 and 2019 a number of high school vaping doubled from 12 percent to 29 percent and in the same period of time, the jewel went from 29 percent to 76 percent predict in november of 2019 the center for disease control confirming the obvious, we need jewel is the cause of this surge. and even after taking away all of its flavors except for menthol and tobacco, over
million children are still using jewel. still addicted to jewel in a lifetime consequences and is still used by 40 percent of the vaping and research shows that many of these young people are unaware of the danger that they are exposing themselves to pretty so commissioner, do you agree that biometrics, just mentioned we are still experiencing youth vaping epidemic. janet: yes. >> do you think that jewel is possible for creating epidemic predispute if that's how it would appear. >> and premarket tobacco product applications, when he committed considering passing bad acts in the marketing to children in a popularity to children when you go through decision-making process. janet: we have to adhere to a
interior laid out in the legislation that congress passed. and we will do that and you're talking about the validity the data submitted to us, we take a very close look at the validity of the data. >> i appreciate that and there's changes to the statute, you think it would help you to enforce legislation, i would greatly appreciate communicating with you. do you agree that a nicotine product used by 41 percent of these vaping is hurting overall public health for generations to come. janet: most likely, it's hurting that generation, cannot comment on generations to come but it's definitely a health problem of significant. >> thank you doctor printed to trust that this tobacco product scientific advisory committee and their advice. janet: to which advice.
>> tobacco product scientific committee. janet: the fda committee read likely i do. i'm not familiar with this committee, i am sorry. >> providing for the record, intervention in on that pretty known to be more that predispute if certainly pretty. >> and it jewel hooked children in the light of day but it's asking you to get the fda to approve the product in the darkness in this. [inaudible]. we've repeatedly asked jewel for its information and jewel has refused to provide it and they knows the joke science is bought and paid for would not withstand scrutiny and if there jewel was referred to the tobacco product scientific advisory, the application would be subject to public scrutiny and you have any comments on this for on the trial north carolina that you are familiar with, that
identifies jewel that's creating products for children and also provided against jewel. [inaudible]. all of jules social media products were youth oriented. it would be relevant to your jury pretty can we work together no documents in thee case including expert reports pretty. janet: certainly, we should look at all documents but i cannot comment on what is ongoing case. >> thank you and my time is up and i want think the chair again i yield back. >> thank you so much and now i would like to recognize congress woman for five minutes. >> thank you and dr. janet woodcock is good to see you. and in your role as acting commissioner, you really are not involved in the regulatory processr.. before january 2021 so i appreciate that but i'm deeply
concerned that the scandal that is been promoted under previous administration is going to scar the lives of children for the rest of their lives. and what we are hearing about how is that double lung transplant on 13 and 14 -year-olds. it takes my breath away. a federal judges were the fda to speed up regulations and knowing they have advocated regulatory authority and do you agree that he was correct in that regard. janet: as you said i was not involved in the previous discussions that currently am committed to getting this done it possible but that dates set byby the court. >> so the previous administration at one point said they were going to be in
proclaimers they reversed themselves and as a result, menthol jewel caught his increased by thousand percent among hostile hundred school students. was it a mistake to exempt disposal. janet: i was not involved in that decision at all. you missed my oral testimony pretty. >> yes, i did, i was in a different meeting and i apologize. janet: certainly and i was the instigator of the original lawsuit against the inland original trend one early in 2000 that was settled and that we cannot take drug charges because these are tobacco product. so the subsequent actions after that, from 2010 when i was not involved t in and so, certainlyn
retrospect, it seems okay that children a switch over to disposables. and although youth vaping is decreasing faster, might be full-time - and there was certainly continue youth using of these products and really unacceptable levels. >> it appears that there are some companies basically ignoring the requirements. based on prior product, are you prepared to reject their applications. janet: yes, can't comment on individual. >> how about this, there are bad actors who have previous leak different junk that they conduct
as violent or even the government regulations without be taken into account for the application. janet: it would definitely be taken into account. >> one of the biggest concerns is that these are people known appreciate that there is in these he cigarettes. do you think we need to improve the labeling requirements for these he cigarettes or should we disband them outright. janet: i think most likely that we should make sure the people are aware of the nicotine content, they would be an extremely important thing to do. as we discussed earlier, i really think were going to have to focus on recovery for teens to get them off the nicotine addiction. i don't know that the healthcare communities as well aware of what ways might work for youth who are addictedre to nicotine t not to cigarettes.
and the amount of nicotine in e-cigarettes 12 milligrams. somebody read. janet: there's various content rated. >> so how does it compare to a cigarette of the amount of nicotine. janet: i think some haveom extre high content up to maybe a whole pack of cigarettes. you can get that in one a draw high i've heard from families whose children who had very serious experiences after using these very high nicotine products. >> thank you and i yield back. >> i have one last question. we admit that or acknowledge the flavor man exemptions that were created were just a fundamentally flawed policy.
janet: it appeared to have unintended consequences very fnegative consequences. >> so you admit or acknowledge oror should say that you are not the acting commissioner at that point but, those flavor man exemptions have very negative consequences. janet: right. >> you have one more question. >> i consummate it for the record. >> thank you very much for your testimony. and it was a marathon session and i really appreciate your time and thank you again. and we are adjourned. [inaudible]. full. [inaudible]. [inaudible].
[inaudible]. [inaudible]. [inaudible]. >> tonight on book tv, biographies on conservative intellectual, the late supreme court justice ruth bader ginsburg and former first lady, nancy reagan printed book tv on c-span to start tonight at 8:00 p.m. eastern. saturday on the communicators. information and communication technologies are being used to
further political agendas basically the technologies being used it to courage and another means to accomplish critical goals critically for those leaders who are our democratic, anti- democratic inspirations. to watch the communicators, senior fellow at the carnegie and gap in front endowment and author of the rise of digital oppression and saturday 6:30 p.m. eastern on c-span. >> c-span is in cases, explore the stories and constitutional, behind significant supreme court decisions. sunday at 9:45 p.m. eastern, landmark case in arizona, brenda was arrested for suspicion of kidnapping and rape and everything confession written and about the convention was inadmissible because he was not