Transcripts For CSPAN2 Acting FDA Commissioner Testifies On

CSPAN2 Acting FDA Commissioner Testifies On E-Cigarettes July 14, 2024

Next, the hearing on the house energy and commerce subcommittee on the potential Health Effects of e. Cigarettes. It also includes Public Officials from North Carolina, massachusetts, michigan and kansas testifying how the states are responding to the rise in vaping related illnesses. The subcommittee on oversight and investigations hearing will now come to order. Today the committee is holding a hearing entitled sounding the alarm the Public Health crisis of cigarettes. The purpose is to examine the Public Health impacts the regulatory authorities related to key cigarette manufacturing sales and use. The chair now recognizes for purposes of an opening statement. Our country is facing a serious Public Health epidemic one that is causing severe harm. It will examine the cost of the epidemic and the uncontrolled rising use of e. Cigarettes lifethreatening illnesses and the use of products we must work to protect the American People from the misunderstanding about these products. The data is clear over the past several years, we have seen an unacceptably high proportion of people facing nicotine addiction. This year alone more than 27 of High Schoolers report they are using ecigarettes or vaping as it is also known. 2011 to 2015, there was a 900 increase, 900 increase in vaping and from 2017 to today, the rate of High School Use of double. The vaping epidemic are personal to me. My home state of colorado has the unfortunate distinction of leading the country in teen vaping. A major factor contributed to the dramatic rise of ecigarettes use among teens is that of the flavor products. Recent data from the center for Disease Control prevention indicates 60 of students within the last month cited using popular fruit, and all on mint flavors. People turning to ecigarettes also have a false assumption that these products are safe or relatively harmless. But contrary to the manufacturers claims, they pose risks to young people and can lead to addiction, brain development, affect respiratory health and lead to heart disease. Additionally, the cigarette use increases the risk of youth turning to conventional cigarettes. As much as we do know that troubling survey could be how much we dont know about the product. For example in some cases we dont even know what chemicals and toxins are being inhaled. The cigarette industry has launched a massive publichealth experiment on the country of which its outcomes and consequences remain unknown. The recent state epitomizes how much we are in the dark about these products. Number 530 so far increasing daily has led to hospitalizations come , longtem Health Complications in several deaths. Cdc and fda are here today and they will provide more information about the status of the investigation and what products may be the culprit. No specific classes of the illness have been determined that these agencies engage in a collaboration and i have confidence that the cost of the outbreak eventually will be identified. But even if it is isolated to the products sold on the streets or the use of thc we must keep in mind that they are not harmless and this brings me to my next concern given the potential risk associated it would be reasonable t reasonable that they have been reviewed and approved by the fda that they havent. The products are only on the market today because the fda is tempered only giving them a pass by exercising its enforcement discretion. With me be clear no ecigarette on the market today has been fully reviewed by fda for its impact on Public Health. They need to do their job, examined the products cant tell the public what the risks are and how or if they can even be solved. In other words, the fda must go forward with conducting the reviews for all ecigarette products and determine if the sale of the product is close, appropriate with the protection of Public Health. After years of delay around the regulation of the cigarettes, the administration recently announced the fda would prioritize enforcement in small to back off the flavored product review. I am encouraged by this action but the fda needs to provide Additional Details and a timeline for action. We have to ensure that there will be implemented and enforced in a reasonable way. If in the meantime nothing is stopping manufacturers from submitting their applications to the fda today, the burden is on the Cigarette Companies to demonstrate that these products meet the Health Standards coming up regardless of the administrations recent announcement, legislative action is not on the table. I and others have introduced bills to tackle the publichealth priority including the chairman who has been a steadfast leader on these issues. Based on the frontline of the epidemic, ive also been taking action on ecigarettes we are going to hear the plans today. The industry has been swift to rail against efforts to restrict products claiming and that evidence however its far more conclusive than fda has not approved. Any benefit to the adult smokers has to be weighed against the generation of young people for which vaping represents an on ramp for use. I want to thank the witnesses for being here today for the service and i look forward to how we can Work Together to address this very serious Public Health issue and i would yield back. For whatever reason the committee is scheduled, we have drug pricing upstairs and i think everybody supported the issue for the country and this is important to the country as well. Well. A lot of members share that so i apologize we are going to be in and out, but thats where we are. I am deeply concerned about the outbreak associated with vaping and ecigarette use. The marketing to kids, we need to understand the causes of this illness and ensure that they are not marketed to kids. Its also important that we understand the Health Implications more broadly whether an adult is vaping thc from marijuana, nicotine or other substances. So far, the evidence of the 553 reported cases and eight deaths do not point to the conclusive cost. But the involvement of illicit devices according to th the cenr for Disease Control most patients have experienced these illnesses and have reported a history of using ecigarettes products containing marijuana or thc. However some have reported using products that contain marijuana, thc with nicotine while others reported using products only with nicotine. Separate from the outbreak of illness according to the u. S. Food and druG Administration, the United States has a youth epidemic. The most recent data from the Tobacco Survey shows 27. 5 reported using them compared with 28. 8 in 2018. It was only 11. 3 just three years ago and the trends are unacceptable. It must be stopped and access must be blocked more effectively. The epidemic is already driving legislation and regulatory responses. Last september the fda issued more than 1300 warning letters to the brick and mortar retailers originally sold them to minors and the letters to the manufacturers about the access of their products. 18 states have increased the legal aid purchase Tobacco Products to 21. Michigan, new york and columbia issued a proposed legislation to ban flavored ecigarettes. 2019, the Trump Administration announced the fda would finalize the compliance policy and prioritize enforcement against the marketing of unauthorized long tobacco cigarettes including menthol. With these responses they are aimed at reducing the attraction of ecigarettes to use and its like a black market. In that and we also need a response to the increased demand from flavor to address the growing trade in illicit cannabis marijuana gaping products. The New York Times article reported that the recent operation was constant and revealed a very advanced market for marijuana, cartridge cartridges. Im told these observations are using a tactic in other observations cutting the product with other substances including some that could be dangerous. Advocates for examples of a particular agent that could cause breathing problems and long inflammation is not healed fully. Using smaller amounts of the extension and diluting it with oil costs much less one could increase by selling the product. Medium grade of thc can cost 4,000 a kilogram. Additives may cost pennies on the dollar. These operations rely on factories that by empty cartridges and counterfeit product packaging and fill them with thc liquidity purchased from the United States market. The packaging are also available for purchase on the internet. While federal and state authorities were gone for a response against this, we must ensure they are educated on the danger of using ecigarettes. When governor bakers administration lost the campaign in april 2019 at the department of Public Health to highlight the dangers in july 2018 of these actions are commendable and i look forward to seeing the results of the campaigns with regards to adult trying to quit smoking some are more than traditional cigarettes. According to the cdc and they have a potential benefit from combustible cigarettes with the cdc cautions that they are not safe for youth, young adults, pregnant women or adult that are not currently using Tobacco Products. Additional research is to look at the effectiveness. I want to thank the witnesses for being here on both panels today, and i look forward to this important discussion so i will be back and forth between hearings. Thats where we are and i will yield back. The chair recognizes the chairman of the full committee for five minutes for purposes. I want to thank the chairwoman for having this important hearing today. We are examining the publicHealth Crisis involving ecigarettes and the proliferation of the products among the kids and teens and im deeply concerned about the recent outbreak of the lung illnesses that have killed eight people and sickened more than 530. Im also very frustrated by the fact that the usage has reached epidemic proportions in recent years among kids if you talk to any parent of a high school student, you know that the nations ecigarettes problem is getting worse and its long past time for agencies to address the usage in a meaningful way. I look forward to hearing about what the fda and cdc can tell us about how they are addressing these tragic mystery illnesses and the recent actions to combat the use but make no mistake i believe many aspects could have been addressed if they moved forward reviewing all of them on the market when they had the chance to years ago but instead in july, 2017 the announced that it would delay implementation of the provisions of the agencies final rule to ensure all products on the market. The same day i issued a statement explaining deep concerns that it would mean the products would continue to lack oversight for several years and was continued exposure to a new generation. Here we are over two years later and my concerns have come to fruition. The usage skyrocketed more than one in four High School Students say theyve used them in the last 30 days into the products have been marketed and targeted without knowledge of the consequences and as a result we could lose an entire generation to a lifetime of nicotine addiction. At the same time people have developed illnesses following the usage of a product many instances they are manipulated beyond the year used it still rs unclear what the products contain and how exactly they were manipulated. Lack of certainty speaks to a larger problem. We do not know the full spectrum of the consequences associated with the use of the cigarettes. Years ago, the prevention act was signed into law after coming to the committee and gave the tools they needed to effectively regulate all Tobacco Products but unfortunately that isnt happening there for it is critical that fda and cdc actions are taken and what more we can be doing to protect consumers. I look forward to hearing from states that forged their own responses at the federal level and the availability of the products clearly designed putting the interest above. Im pleased by the administrations announcement that it plans to hold all products from the market until the review and that should occur immediately. We must get to the bottom of disclosing these and ensure that they are kept out of the hands of our kids and at the same time its become clear to me we must enact new comprehensive legislation to address this and prohibit online sales and make it easier for kids to buy the cigarettes and ensure that the products are not being marketed to anyone under age. This critical legislation moving forward i hope that there will received strong bipartisan support that it deserves to address the publichealth risk with ecigarette use we have to use every tool available to find out whats happening and what is actually causing the epidemics think we need to have this hearing and to move forward as a legislation we need to have this. Thank you again. I will yield back. The Ranking Member of the full committee mr. Waldron for five minutes. Recent weeks and as yet unidentified killed seven people sickened more than 500 across 38th state as we will hear the investigation of the cause or causes of the illness is his ongoing but it appears to be vaping related. Many of the individuals seem to use black marke blackmarket prt contain thc. They announced the person who died in july of severe respiratory illness used a cigarettes containing Marijuana Oil purchased from a licensed suspensory meaning that products sold and should have gone through a Testing Process regulated by the state. Much is unknown including which dispenser they sold the product and whether it was contaminated or something was added into the liquid after the purchase. July and 18yearold young man went to a hospital complaining of breathing problems. 48 hours of the intensive care unit. He was connected to a breathing tube in a medical coma for a week. To be a counterfeit of the companys product North Carolina, five individuals bought the oil that made them sick on the street for unlicensed and likely illegal dealers in all five hospitalized intensive care take a battery of tests all five had acute exogenous lipid pneumonia caused by breathing the wheel. Luckily the individuals survived, but not all have been so lucky including the individuals that died. The cases are young and seemingly healthy adults getting sick after vaping are piling up too quickly. Compared to 20. 8 for this 11. 3 in just three years. Given these trends, the Trump Administration states in this committee the right for solutions to curtail access to ecigarettes. The pursuit of the solution to the problem of access as well as the part worship and the administration states investigate these outbreaks of bonuses. Theres anothethere is another f blessed are the problem and thats counterfeit including counterfeit thc products. Cartridges are becoming too common on the market with members advertising the bootleg products and social media platforms on snap chat and according to press reports, the states that appear to be the most inundated with counterfeit products are states where Recreational Marijuana is legal. According to California Department of Public Health, there are a 28 cases among those that recently taped a cannabis products anthe cannabisproductse department of Public Health report of a cluster of seven healthy kids in king county california all admitted to hospitals with symptoms of lung disease in all seven were linked and purchased from the black market. Lab tests conducted by the Testing Company showed a contaminant including pesticides and when vaporized converged to a substance is a chemical weapon during the first war, world war i. In addition the ongoing work we need a full investigation into the counterfeit cartridges as well as the markets that need to be part of the investigation. A full set of facts to make sure we get it right Going Forward on the policy solutions. I appreciate the witnesses are going to testify today and others that have weighed in and echo the comments of the Top Republican on the subcommittee and we have two subcommittees the majority decided to schedule one on top of the other one on perception drugs that begins in about eight minutes upstairs and a very partisan so sorry that we will be going back and forth as we work on both of these issues and i yield back. The gentleman yields back into the chair asks unanimous consent the return statements he made a part of the record. Without objection, so ordered. I would like to now introduce the first panel of witnesses for todays hearing acting commissioner of thcommissioner G Administration and the principle director. I want to thank both of you for appearing before the subcommittee today. I know you both appear before the committee and its great to see you. This committee holds an investigative hearing and when it does so because the practice of taking testimony under oath. The witnesses have responded no under the rules of the house ane into the Kennedy Committee were entitled to be accompanied. Let the record reflect the witnesses have responded no. If you wer you would please rair right hand so that you may be sworn in. Do you swear the testimony you are about to give is the truth, the whole truth and nothing but the truth . You

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