Transcripts For CSPAN3 Acting FDA Commissioner Testifies On

CSPAN3 Acting FDA Commissioner Testifies On E-Cigarettes July 13, 2024

The somebody on oversight and investigations hearing will now come to order. Today the committee is holding a hearing entitled sounding the alarm, the Public Health threats of ecigarettes. The purpose is to examine the Public Health impacts related to ecigarette manufacturing, sales and use. The chair recognizes herself for purposes of an opening statement. Our country is facing a serious Public Health epidemic, one that is causing severe harm. This hearing will examine the cause of that epidemic, the uncontrolled and rising use of ecigarettes. As lifethreatening illnesses sweep the country and the use of products by yunoung people soar we must protect the American People from these products. First the data is now clear, over the past several years, weve seen an unacceptably high proportion of young people facing nicotine addiction. This year alone, more than 27 of High Schoolers report theyre using ecigarettes or vaping as its also known. From 2011 to 2015, there was a 900 increase, a 900 increase in youth vaping and from 2017 until today, the use the rate of High School Use doubled. The vaping epidemic and its impact are personal to me. My home state of colorado has the unfortunate distinction of leading the country in teen vaping. A major factor contributing to the rise of ecigarette use among teens is that inundation of flavored products. Data from the centers for Disease Control and prevention indicate that 60 of students using ecigarette, used popular flavors. Young people may also have the false assumption that these products are safe or harmless. But contrary to many manufacturers claims, ecigarettes pose risks to young people and can lead to addiction, harm brain development, affect respiratory health and can lead to heart disease. Ecigarette use increases the risk of youth turning to conventional cigarettes. As much as we do know. The more troubling concern may be how much we dont know about these products. For example, in some cases, we dont even know what chemicals and toxins are being inhaled. The ecigarette industry has launched a massive Public Health experiment on our country of which its outcomes and consequences remain unknown. A recent spade of serious vaping illnesses epitomizes just how much were in the dark about these products. These illnesses, numbers 530 so far, and increasing daily, have led to hospitalizations, Longterm Health Complications and several deaths. While cdc and fda are here today, and i want to thank both witnesses, and theyll provide more information about the status of the investigations and what products may be the culprit no specific causes of the illnesses have been determined. With these agencies engaged and in collaboration with state partners i have confidence that the root cause of this outbreak eventually will be identified. But even if the cause is isolated to a product sold on the street or the use of thc, we must keep in mind that branded ecigarette sold in stores are not harmless. This brings me to my next concern. Given the potential risk associated with these products it would be reasonable to assume they have been approved by the fda but they havent. Ecigarette products are only on the market today because fda is temporarily giving them a pass by exercising its Enforcement Discretion. Let me be clear no ecigarette currently on the market in the United States today has been fully reviewed by fda for its impact on Public Health. Fda needs to do its job examine these products, tell the public what the risks are and how they can be legally sold. Fda must go forward with conducting its repeatedly delayed premarket reviews for all ecigarette products and determine whether the sale of the product is, quote, appropriate for the protection of Public Health. After years of delays around the regulation of ecigarette, the administration announced that the fda would prioritize enforcement and clear the shelves of nontobacco ecigarette products pending review. I am encouraged by this recent action. Fda needs to provide details and a timeline for action and ensure that this policy will be implemented and enforced in a reasonable way. In the meantime nothing is stopping manufacturers from submitting their applications to fda today. The burden is on the Cigarette Companies to demonstrate that these products meets the fdas health standards. And regardless of the administrations recent announcement legislative action is not off the table. I and others have introduced bills to tackle this Public Health priority including chairman pallone who has been a stedfast leader on these issues. States on the front lines of the youth epidemic have been taking action on ecigarettes. Were going to hear some of their plans today. The industry has been swift to rail against efforts to restrict the products claiming they assist adult smokers. That evidence, however, is far from conclusive and fda has not approved ecigarettes for cessation purposes. Any benefits to adult smokers has to be weighed against the generation of young people for which vaping represents an on ramp to use. I want to thank the witnesses for being here today for their service and look forward to hearing how we can Work Together to address this serious public issue and yield to mr. Guthrie from kentucky. Thank you for holding this hearing and i want to say i know a lot of our members will have to go back and forth for whatever reason, this committee scheduled two important subcommittee hearings at the same time and so we have drug pricing upstairs, i think everybody agrees its an important issue and a lot of member share that subcommittee. Thats where we are. I want to say im deeply concerned about the outgoing break of lung illness with vaping and ecigarette use as well as the marketing of ecigarettes to kids. We need to understand the causes and ensure that ecigarette are not marketed to kids. Its important that we understand the Health Implications of vaping in ecigarette use more broadly whether an adult is vaping thc, to derive from marijuana, nicotine or another substance. So far the Available Evidence of the 553 reported cases of lung illness and Health Deaths do not point to a conclusive cause. The test samples overwhelmingly suggest involvement of illicit ecigarette devices, the psycho active ingredient in marijuana called thc and other black market products. For example, according to the centers for Disease Control most patients have reported a history of using ecigarette products containing marijuana or thc. However, some have reported products that contain thc, marijuana with nicotine and others reported only using products with nicotine. Separate from the outbreak of lung illnesses according to the food and Drug Administration the United States has a youth ecigarette epidemic. The most recent data from the National Youth Tobacco Survey show 27. 5 of use reported using ecigarettes compared with 20. In 2018. These trends are unacceptable. The marketing of products to children must be stopped. This epidemic is driving legislation and regulatory responses. Last september the fda issued more than 1300 warning let and fines to brick and mortar retailers who illegally sold ecigarette products to minors and five warning letters to ecigarette manufacturers about their plans to address youth access of their products. 18 states have increased the legal age to purchase Tobacco Products to 21. Michigan, new york and the District Of Columbia have issued a proposed regulation to ban flavored ecigarettes. On september 11th, 2019, the Trump Administration announced that the fda would finallyize a compliance policy to prioritize enforcement against the marketing of unauthorized nontobacco flavored ecigarettes including mint and menthol ecigarettes. With these responses, while these responses are aimed at reducing the attraction of ecigarettes to youth, wide bands will create black markets. In that vain we will need a response to an increased black market demand for flavored pods to address the growing trade in illic illicit cannabis marijuana vaping products. Revealed a very advanced and mature market for marijuana, vape cart rims and distribution of contaminated marijuana based vape carts. I am told these illicit operations are using a tactic and other illegal drug operations. Theyre cutting their product with other substances including some that could be dangerous. Public Health Advocates said a particular cutting agent is an oil that could cause breathing problems and lung inflammation if not heated fully during the vaping process. Using smaller amounts of the expensive thc or marijuana and diluting it with oils that cost much less, one can increase their profit by selling the product. Medium grade thc can cost 4,000 a kilogram but additives may cost pennies on dollars. These operations rely on pin factories that buy empty vape cartridges and counterfeit packaging from chinese factories and fill them with thc liquid they purchase from the United States market. Empty cart rims and packages are available to purchase on the internet. While federal and state authorities are working on effective response, we must ensure that our youth is educated on the dangerous of using ecigarettes. In Massachusetts Governor bakers administration launched a campaign in 2019 and the Massachusetts Department of Public Health launched a campaign to highlight the dangers of vape pens of ecigarettes in july 2018. These actions are commandable and i look forward to seeing the results of these campaigns. With regard to adults trying to quit smoke something studies suggest ecigarettes are less harmful than traditional sigs. According to the cdc they have the potential benefit sensation for adult smokers but the cdc cautions ecigarettes are not safe for youth, young adults, pregnant women or adults not currently using Tobacco Products. Additional research should look at the effect of this. I want to thank our witnesses for being here on both panels today and i look forward to this important discussion and sorry well be back and forth between hearings. I yield back. I thank the gentleman. The chair recognizes the chairman of the full committee, mr. Pallone for five minutes. Thank you. I want to thank chairwoman goodette for having this important hearing today. Were coming the growing Public Health crisis involving ecigarettes and the proliferation of these products amongst kids and teens and im deeply concerned about the recent outbreak of lung ills in that have killed eight people and sickened 530 in the u. S. Im also frustrated by the fact that ecigarette usage has reached epidemic proportions of kids. You know our nations ecigarette problem is real and getting worse and its long past time for Public Health agencies to address vaping and ecigarette usage in a meaningful way. I look forward to hearing about what the fda and the cdc can tell us about how theyre addressing the tragic mystery illnesses and the recent actions to combat youth ecigarette use but make no mistake, i firmly believe many aspects of the youth vaping epidemic could have been addressed if the fda had moved forward with reviewing all skigs on the market when it first had the chance two years ago. In july of 2017 fda announced it would delay implementation of key provisions of the agencys final rule which ensured the agency would review all ecigarette products on the market. That same day i issued a statement expressing deep concerns that these delays would mean that ecigarette products would continue to lack needed Public Health oversight for several years and risk continued exposure to a new generation. Here we are over two years later and unfortunately my concerns have come to fruition. Since that decision, youth ecigarette usage has sky rocketed more than one in four High School Students say theyve used ecigarettes in the past 30 days. These products have been marketed and targeted to kids without our knowledge of the full Public Health consequences and as a result we could lose a new generation to a lifetime of nicotine addiction. At the same time hundreds of people throughout the country have developed unknown lung illnesses following the usage of Vape Products. Many instances these products were manipulated beyond the products intended use but still remains unclear what these products contain and how exactly they were manipulated. The lack of certainty on the root cause of these illness speaks to a larger problem. We do not know the full spectrum of Health Consequences associated with the use of ecigarettes. Ten years ago the family smoking prevention and Tobacco Control act was signed into law after coming out of this committee. This law gave fda the tools that it needed to effectively regulate all Tobacco Products. Unfortunately, that is not happening. Therefore, its critical that fda and cdc explain today what actions theyre taking and what more we can be doing to protect consumers. I also look forward to hearing from states that have forced their own responses in the wake of the inaction at the federal level. Flavored ecigarette products for kids consumption are putting the interests of industry above the health of our kids and im pleased by the administrations announcement it plans to pull all flavored ecigarette products from the market until the end of full review i believe the ban should occur immediately. Above all else we must get to the bottom of what is causing lung illnesses and ensure that Vape Products are kept out of the hands of our kids at the same time its become clear to me we must enact new comprehensive legislation to address this growing youth epidemic. We must eliminate flavors, prohibit online sales that make it easy for kids to buy ecigarettes and ensure the products are not being marketed to anyone underage. Legislation reversing Youth Tobacco epidemic act as each of these things raising the age to 21 to buy Tobacco Products. Its my intention to move this critical legislation forward and hope it will receive the strong bipartisan support it deserves. Its long past time to address the Public Health risks associated with ecigarette use. We have to use every tool at our disposal to solve this crisis. If i could say, madam chair, i am although its true as you mentioned that we do want to move legislation, i also think that its very important for the oversight and investigation subcommittee to find out whats happening and what the agencies are doing, whats actually causing this epidemic, so i really appreciate the fact that youre having this hearing. I think we need to have this hearing as much as i want to move forward with the legislation to get to the bottom of this. Thank you, again. I yield back. Chairman yields back. The chair recognizes the Ranking Member of the full committee, mr. Walden, for five minutes. Thank you, madam chair. Thanks for holding this hearing. Electronic cigarettes, the current outbreak of lung illnesses with the youth vaping epidemic are a front and Center Health concern in the United States and in my state of oregon. In recent weeks and as yet unidentified lung illness has killed seven people, sickened more than 500 across 38 states. As we will hear from dr. Sharpless and dr. Schuchat today, the investigation of the cause or causes of the illnesses is ongoing but appears to be vaping related. Many of the individuals who have gotten sick seem to have used black market products that contain thc. Earlier this month Public Health officials in oregon announced a person who died in july of severe respiratory illness used an ecigarette containing marijuana oiled purchased from a licensed dispensry, meaning the product sold in the store should have gone through a testing process, regulated by the state of oregon. It was the first death in the u. S. Tied to a vaping product bought in a marijuana shop. Much is still unknown, however including which dispensary sold the product and whether it was contaminated or something was added into the liquid into the device after the purchase. In july an 18yearold young man went to a hospital complaining of breathing problems. Within 48 hours he was sent to the intensive care unit diagnosed with acute respiratory syndrome associated with acute lung injury. He was connected to a breathing tube and placed in a medically induced coma. The patients mother found an ecigarette cartridge based in california that sells thc products. The cartridge was found to be a counterfeit of that companys product. In North Carolina five individuals bought marijuana oils that made them sick on the street from unlicensed and likely illegal dealers. All five hospitalized, three in intensive care. It took a battery of tests to figure out all have acute pneumonia, lung inflammation caused by breathing oil. Luckily the individuals in new york and North Carolina survived but not all have been so lucky including the individual from oregon who died. These cases, young seemingly healthy young adults ge

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