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FDA Actions: More information is needed to better understand whether there is a relationship between any specific products or substances and the reported illnesses. To help gather and analyze as much information as possible, the FDA is working closely with federal and state partners to identify the products or substances that may be causing the illnesses. The FDA’s Forensic Chemistry Center is using state-of-the-art technology to analyze hundreds of samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, THC, other cannabinoids, and opioids along with cutting agents/diluents and other additives, pesticides, poisons, heavy metals and toxins. No one substance has been identified in all of the samples tested. Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about what is causing these illnesses. Federal and state partners are following any potential leads. The FDA is committed to taking appropriate actions as the facts emerge and keeping the public informed as we have more information to share.

Recommendations for the Public: Do not use vaping products that contain THC. Do not use vaping products—particularly those containing THC—obtained off the street or from other illicit or social sources. Do not modify or add any substances, such as THC or other oils, to vaping products, including those purchased through retail establishments. No vaping product has been approved by the FDA for therapeutic uses or authorized for marketing by the FDA. The agency recommends contacting your health care provider for more information about the use of THC to treat medical conditions. No youth or pregnant women should be using any vaping product, regardless of the substance. Adults who do not currently use tobacco products should not start using these products. If you are an adult who uses e-cigarettes instead of cigarette smoking, do not return to smoking cigarettes. If you choose to use these products, monitor yourself for symptoms (e.g., cough, shortness of breath, chest pain) and promptly seek medical attention if you have concerns about your health. If you are concerned about your health after using a vaping product, contact your health care provider, or you can also call your local poison control center at 1-800-222-1222. Health care providers also can contact their local poison control center.

Problem and Scope: A majority of the samples tested by the states or by the FDA related to this investigation have been identified as vaping products containing THC. Through this investigation, we have also found most of the patients impacted by these illnesses reported using THC-containing products, suggesting THC vaping products play a role in the outbreak.

Purpose: In its continued efforts to protect the public, the U.S. Food and Drug Administration (FDA) is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products. The FDA is working closely with the U.S. Centers for Disease Control and Prevention (CDC), as well as state and local public health partners to investigate these illnesses as quickly as possible. While the work by federal and state health officials to identify more information about the products used, where they were obtained, and what substances they contain is ongoing, the FDA is providing members of the public with additional information to help protect themselves.

Audience: Consumers and family members of consumers who use vaping products containing tetrahydrocannabinol (or THC), a psychoactive component of the marijuana plant. Consumers who have used vaping products of any kind obtained off the street or from unknown sources. Consumers experiencing symptoms such as cough, shortness of breath or chest pain after using vaping products. Health care professionals treating patients who use vaping products.

Vaping Illness Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street FDA strengthens warning to public to stop using THC-containing vaping products and any vaping products obtained off the street. https://www.fda.gov/consumers/consumer-updates/vaping-illness-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-vaping

FDA strengthens warning to public to stop using THC-containing vaping products and any vaping products obtained off the street. https://www.fda.gov/consumers/consumer-updates/vaping-illness-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-vaping

How Many Cases are There in Louisiana Outbreak Cases Deaths Age Range 20 0 17-45 years There are 20 cases reported in Louisiana 20 cases of pulmonary illness were reported to health officials between August and October of 2019. Those cases were reported from throughout the state with the ages ranging from 17-45. There have been no deaths in Louisiana associated with this illness. http://ldh.la.gov/index.cfm/page/3724

Pulmonary Disease Associated with Vaping Cases Reported for Investigation: 25 Ruled Out Cases: 2 Probable Cases: 3 Confirmed Cases: 1 Ruled out cases were reported but determined not to include a documented history of vaping or otherwise did not meet the case definition. Updated: Friday, October 4, 2019, 9:30 a.m. https://chfs.ky.gov/agencies/dph/dmch/hpb/Pages/pdinfo.aspx

Iowa Weekly Case Information (Numbers are cumulative) August 30, 2019 - 7 cases (young to middle-age adults); 5 of 7 cases reported vaping THC September 6, 2019 - 8 cases (young to middle-age adults); 7 of 8 cases reported vaping THC September 13, 2019 - 13 cases (young to middle-age adults); 12 of 13 reported vaping THC September 20, 2019 - 15 cases (young to middle-age adults); 14 of 15 cases reported vaping THC September 27, 2019 - 23 cases (ages range from 17 to 60); 18 of 23 cases reported vaping THC October 4, 2019 - 31 cases (ages range from 17 to 60); 27 of 31 cases reported vaping THC https://idph.iowa.gov/ehi/lung-disease-vaping

Total reported patients statewide: 108 (Updated: 10/4/2019) Breakdown of reported patients by region: Western New York: 28 Central New York: 9 Capital Region: 20 Northern New York: 1 Metropolitan Region (outside of NYC): 27 New York City: 20 Out of State: 3* *Patients treated at hospitals in NYS but are residents of another state. https://www.health.ny.gov/prevention/tobacco_control/campaign/e-cigarettes/

As of 10/03/2019, the Michigan Department of Health and Human Services has identified 30 (17 confirmed and 13 probable) cases of severe lung disease associated with vaping. The department is investigating an additional four possible cases that have been reported by health care providers. https://www.michigan.gov/mdhhs/0,5885,7-339-71550_5104_53072---,00.html

MDHHS reports first death in the state from vaping-related lung injury FOR IMMEDIATE RELEASE: Oct. 4, 2019 CONTACT: Lynn Sutfin, 517-241-2112 LANSING, Mich. – The Michigan Department of Health and Human Services (MDHHS) is announcing the first death associating with the outbreak of vaping-related lung injury in the state. MDHHS was notified about the death of an adult male on Oct. 2. No other information about the individual will be released due to confidentiality reasons. “We are saddened to announce a death associated with this outbreak,” said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health for MDHHS. “To protect public health, we urge people to consider refraining from vaping until the specific cause of the vaping-related severe lung injuries being reported nationwide has been identified. To help with this investigation, we are reminding health care providers to report patients that may have this condition to their local health department.” Since August 2019, 30 confirmed and probable vaping-related lung injury cases have been reported in Michigan. All cases have been reported in Michigan’s Lower Peninsula and most of the individuals have been hospitalized for severe respiratory illness. The age range of the cases is 16-67. As of Oct. 1, the Centers for Disease Control and Prevention (CDC) has reported 1,080 cases in 48 states and one territory. This includes 18 deaths from 15 states, but this count does not include the Michigan death and several deaths in other states reported to CDC after Oct. 1. According to the CDC, about 75 percent of the cases vaped with marijuana products in combination with nicotine or alone. MDHHS is working closely with the CDC and the federal Food and Drug Administration to get additional information that can help identify the ingredients in the vape materials that is making people sick. So far, no specific brand of device or e-liquid has been identified. E-cigarette and/or vaping users should immediately seek medical attention if they develop symptoms such as shortness of breath, chest pain, cough, fever and/or nausea and vomiting. Regardless of the investigation, MDHHS recommends the following: Anyone who uses an e-cigarette or vaping product should not buy these products off the street and should never modify or add any substances to these products that are not intended by the manufacturer. Youth, young adults and pregnant women should not use e-cigarette or vaping products. Adults who do not currently use tobacco products should not start using e-cigarette products. Adults who are vaping should not smoke combustible cigarettes as a replacement for nicotine. E-cigarettes are not FDA approved as a smoking cessation device. Free help is available for individuals who are ready to kick the tobacco habit at 800-QUIT-NOW (800-784-8669). Information about the vaping-related lung injury for the public is posted at Michigan.gov/ecigarettes and for providers at Michigan.gov/cdinfo.

The Michigan Department of Health and Human Services (MDHHS) is announcing the first death associating with the outbreak of vaping-related lung injury in the state. MDHHS was notified about the death of an adult male on Oct. 2. No other information about the individual will be released due to confidentiality reasons. https://www.michigan.gov/mdhhs/0,5885,7-339-73970_71692-509230--,00.html

Pennsylvania Reports 1st Vaping-Related Death Amid Lung-Illness Outbreak Pennsylvania is investigating dozens of lung sickness cases that could be related to e-cigarette usage. One death has been confirmed. By Dan Stamm Published 2 hours ago | Updated 12 minutes ago WHAT TO KNOW Vaping-related lung sickness has killed a person in Pennsylvania. The state has confirmed nine other lung illness cases and 12 probable cases to the CDC. An additional 63 cases are being investigated. "What we are seeing is truly a public health emergency," Department of Health Secretary Dr. Rachel Levine said. Pennsylvania has announced its first vaping-related death as health officials urge people not to vape amid dozens of lung injury cases. At a Friday news conference, Department of Health Secretary Dr. Rachel Levine didn’t reveal specific details about the death outside of saying the person died in late September. Health officials did, however, say the Keystone State has reported nine confirmed and 12 probable cases of vaping-related lung illness to the Centers for Disease Control (CDC). The health department is investigating an additional 63 cases. The first cases occurred in June. "What we are seeing is truly a public health emergency," Levine said, while noting that there currently isn't a way to officially declare such an emergency. NJ Announces First Vaping-Related Death in State Each person who became sick suffered serious lung injuries and many were hospitalized, the health department said. The average age of most of sickened people is in the low- to mid-20s across the state, Levine said. “The lung injury cases are very serious, life-threatening and even fatal,” Levine said in a new release. “We do not yet know what is making people sick, and whether the illnesses are related to products being used, or potentially the delivery of those products.” The message from health officials is to not use e-cigarettes, which contain an aerosol that is not harmless. Levine specifically called out THC vapes: Officials Report First Vaping-Related Death in Delaware “I strongly urge everyone who is vaping illegally bought products, in particular those with THC, to stop,” Levine said. “In addition, there could be possible risks with legally purchased products. We want to warn people that investigations are ongoing and we advise they use extreme caution before using any vaping product at this time.” Some of the signs and symptoms of potential lung injury includes chest pain, cough, diarrhea, fatigue, fever, nausea, shortness of breath, vomiting and weight loss, health officials said. Health officials urged anyone showing signs of lung illness to contact their health care provider. Investigators Focus on Rogue Vape Brand as Illness Spreads Levine also had a message for people using vaping devices containing THC as part of the commonwealth's medical marijuana program: "Many medications carry risk and vaping medical marijuana products sold in our dispensaries carries risk in the same way that other medications do," Levine said. "If you are vaping, whether as part of the medical marijuana program or not, it is essential that you have an honest conversation with your physician about the potential risk for serious illness." Despite the outbreak of vaping-related illness, Levine said it still doesn't come close to the deadly impact of opioids in Pennsylvania. https://www.nbcphiladelphia.com/news/health/Pennsylvania-Vaping-Death-E-Cigarettes-562180551.html

Local teenager hospitalized due to vaping by: Chelsey Withers Posted: Sep 19, 2019 / 06:27 PM EDT / Updated: Sep 19, 2019 / 06:27 PM EDT One local teenager is hospitalized after suffering lung damage due to vaping. So far, there have been seven deaths in the country due to vaping. Now, one local 19-year-old who recently graduated from Iroquois High School has spent the last four days in the intensive care unit. Like most, Anthony Mayo had aspirations for his future. He had hopes of being in the military. However, he got into the habit of vaping, which has now left his future uncertain. “He might have scarred lungs. He might not be able to join the military now. He might not be able to do this. We don’t know what is going to happen to him,” said Keith Mayo, Anthony’s father. According to his parents, when they originally took him to the emergency room he was diagnosed with bronchitis. “About a third of patients are having this sort of vaping induced Pneumonitis are getting sent home. Then, they come back five days later so much more sick,” said Anand Popuri, DO, Pulmonologist, LECOM. Anthony’s father explained they returned to the hospital once his symptoms got worse. They then found out that Anthony’s left lung was 80 percent congested. His right lung was 50 percent congested and his oxygen level was 37. A pulmonary specialist came in, who told them he had seen dead people with a higher oxygen level. “I was in denial myself. I would see different reports about somebody here getting sick or somebody there, and again it just didn’t seem like something that was really going to happen until we were here,” said Tanya Mayo, Anthony’s mother. As stories like Anthony’s are starting to come out across the country, one local doctor further explained this is something they are still learning about as well. “We do know that it may be some of the components of certain e-vaporized cigarettes, but we don’t know specifically what ingredients are causing it. So, I think its a bit of a scary time right now that we’re facing something that we just don’t know enough about,” said Pulmonologist Popuri. It is unknown how long Anthony will remain in the ICU. For more information on e-cigarettes you can visit https://www.cdc.gov/tobacco/basic_information/e-cigarettes/Quick-Facts-on-the-Risks-of-E-cigarettes-for-Kids-Teens-and-Young-Adults.html. https://www.yourerie.com/news/local-news/local-teenager-hospitalized-due-to-vaping/

Pennsylvania has reported nine confirmed and 12 probable cases of the lung illness to the Centers for Disease Control and Prevention and are investigating an additional 63 cases. Each of the individuals involved in the cases have suffered serious lung injuries and most have been hospitalized.

10/04/2019 Department of Health Provides Update on Lung Injuries Associated with Vaping, Urges Caution and Awareness Harrisburg, PA –Secretary of Health Dr. Rachel Levine today announced that the Pennsylvania Department of Health has confirmed one death and multiple cases attributed to lung injuries associated with vaping in Pennsylvania and recommends that people do not vape. "The lung injury cases are very serious, life-threatening and even fatal," Dr. Levine said. "We do not yet know what is making people sick, and whether the illnesses are related to products being used, or potentially the delivery of those products. I strongly urge everyone who is vaping illegally bought products, in particular those with THC, to stop. In addition, there could be possible risks with legally purchased products. We want to warn people that investigations are ongoing and we advise they use extreme caution before using any vaping product at this time." Pennsylvania has reported nine confirmed and 12 probable cases of the lung illness to the Centers for Disease Control and Prevention and are investigating an additional 63 cases. Each of the individuals involved in the cases have suffered serious lung injuries and most have been hospitalized. == "Many medications carry risk and vaping medical marijuana products sold in our dispensaries carries risk in the same way that other medications do," Dr. Levine said. "If you are vaping, whether as part of the medical marijuana program or not, it is essential that you have an honest conversation with your physician about the potential risk for serious illness. For those who are part of the medical marijuana program and have concerns, we encourage you to talk to your physician or the pharmacist at the dispensary. Signs and symptoms of a potential lung injury associated with vaping include: Cough; Shortness of breath; Chest pain; Nausea or vomiting; Diarrhea; Fatigue; Fever; or Weight loss. Please see your health care provider if you or a loved one are showing signs or symptoms. The department is continuing to work with the Poison Control Centers in Philadelphia and Pittsburgh, the Centers for Disease Control and Prevention, and the Food and Drug Administration as part of this widespread investigation. Generally, e-cigarettes are not safe for youth, young adults, pregnant women or adults who do not currently use tobacco products. It is also important to remember that e-cigarette aerosol is not harmless "water vapor." It can contain harmful substances, including nicotine and ultrafine particles that can be inhaled deep into the lungs; flavoring such as diacetyl, a chemical linked to a serious lung disease; volatile organic compounds; cancer-causing chemicals and heavy metals such as nickel, tin and lead. Additional information on e-cigarettes, the dangers of vaping, and how to quit smoking can be found on the Department of Health's website at health.pa.gov or follow us on FacebookOpens In A New Window and TwitterOpens In A New Window. MEDIA CONTACT: Nate Wardle, 717-787-1783 or [email protected]

Secretary of Health Dr. Rachel Levine today announced that the Pennsylvania Department of Health has confirmed one death and multiple cases attributed to lung injuries associated with vaping in Pennsylvania and recommends that people do not vape. https://www.media.pa.gov/Pages/Health-Details.aspx?newsid=671

Organization / Date Updated Confirmed and Probable Cases Cases Under Investigation Deaths ACHD / October 3, 2019 9 8 0 CDC* / October 1, 2019 1080 - 18 https://www.alleghenycounty.us/Health-Department/Resources/Data-and-Reporting/Chronic-Disease-Epidemiology/Lung-Disease-Associated-with-Vaping.aspx

New Mexico Department of Health Public Health Advisory – October 2, 2019 Vaping Related Lung Injury: A Summary of the Public Health Risks and Recommendations for the Public The New Mexico Department of Health (“NMDOH”) seeks to inform the public about the imminent public health risks posed by the use of electronic cigarettes (e‐cigarettes), or vaping, which has recently been linked to severe breathing problems, lung damage, and even death. NMDOH urges everyone to refrain from vaping, no matter the substance or source, until current investigations are complete. Background Vaping is inhaling aerosol from an e-cigarette or other vaping device that heats a liquid that can contain nicotine, tetrahydrocannabinol (THC), cannabidiol (CBD) or other substances. The shapes and sizes of these devices vary and include colorful vape pens, modified tank systems, and new pod-based devices that can look like USB flash drives, cell phones, credit card holders, and highlighters. These devices are frequently referred to as e-cigarettes, e‐cigs, vapes, vape pens, electronic vaporizers, pod mods, or pod systems. Since June 2019, NMDOH has received reports that 14 individuals in New Mexico have developed severe lung injury requiring hospitalization after vaping, with certain individuals requiring intensive care. Across the U.S., the Centers for Disease Control and Prevention (CDC) has reported over 805 cases of lung damage associated with vaping across 46 states and 1 U.S. territory. Twelve deaths due to severe lung injury associated with vaping have been reported by CDC. NMDOH, along with other states, the CDC, the U.S. Food and Drug Administration (FDA), local health departments, and healthcare providers are working hard to determine what is in the vape products that is making people sick. The FDA and the CDC have initiated investigations, including testing of a wide range of vapor products, and investigations into supply chains of vapor products. The CDC and FDA have not yet determined the specific cause of this outbreak and have recently advised consumers to consider refraining from vaping pending the outcome of their investigations. Although NMDOH regulates in-state manufacturers of medical cannabis vaping products to ensure they are as safe as possible for those who choose to vape, NMDOH warns that individuals put themselves at risk any time they inhale a foreign substance into their lungs. The risk of vaping now includes death. CDC continues to warn that any tobacco product use, including e-cigarettes, is unsafe, especially for youth, pregnant, and breastfeeding women. 2 Sudden and acute lung injury from vaping is a new health problem. We are learning from this investigation that lung injury can happen very suddenly to people who vape, including people who have not been vaping for a long time, and young, healthy people who do not have lung disease or other health problems. This is different from most other health issues caused by vaping and smoking, which happen over a long time and can be worse in people who have other medical conditions. Additionally, most patients do not have a recent history of smoking regular cigarettes, suggesting these lung issues are exclusively related to vaping. Many types of vape products may be causing the lung damage from vaping. Almost all people with lung damage from vaping say that they vaped or “dabbed” the cannabis products THC and CBD in cartridges, waxes, oils, and other forms. Some people report vaping only nicotine. Many people report vaping a combination of both nicotine and cannabis products. The investigation is still in process, but the one thing that people with the lung illness have in common is a history of vaping. The CDC, FDA and state health departments are contacting the people who had lung injury from vaping to find out which products they used, where they purchased the products, and to collect their vape products to test for harmful ingredients. Signs of severe lung injury include breathing problems and other symptoms. People with lung injury from vaping typically have symptoms that start a few days to a few weeks before they go see a doctor. All people hospitalized developed some type of breathing problems, but many people also have other symptoms. The symptoms reported by those who have gotten sick are: - Breathing symptoms: trouble catching their breath, coughing, chest pain - Gastrointestinal symptoms: nausea, vomiting, diarrhea, abdominal pain - Non-specific symptoms: feeling tired, fever, weight loss There is no test that a doctor can do to know that breathing problems are from vaping right away. Laboratory blood tests and an x-ray or CT scan of the lungs may be necessary. People with vapingrelated lung disease are usually admitted to the hospital because of their breathing problems. 3 Be aware that your child’s respiratory issues could be related to vaping. Parents should be aware that numerous cases involve children under age 18. E-cigarettes and vaping devices are available in more than 15,000 flavors that may be attractive to children. Preliminary results from the 2019 National Youth Tobacco Survey reported more than one in four high-school students use vapor products with an overwhelming majority reporting use of fruit, menthol, or mint flavors. The appeal of flavored nicotine vapor products, as well as advertising and promotional activities targeted at youth, are contributing to the dramatic increase in youth vaping. Be aware of the symptoms in case your middle or high school child develops symptoms and seek medical attention. No definitive cause for severe lung injury related to vaping. There are many different possible ingredients added to cannabis and nicotine to make the cartridges, waxes, and oils used for vaping. Multiple people who were diagnosed with lung damage from vaping say that they received the cannabis products from unlicensed smoke shops or individuals. Vape products sold by unlicensed retailers are not tested and can contain harmful ingredients. State and federal investigators do not know if all of the people in the country with this illness use the same vape products, or if the products were contaminated with the same substance. The long-term effects of vaping are still unknown, but these short-term effects are alarming. Recommendations for the public. 1. NMDOH urges everyone to quit vaping altogether, but particularly THC products. For those who continue, you are urged to avoid buying any vaping products on the street and never modify a store-bought vape product. 2. If you, or your child, have vaped at all in the past few months and are having new problems with breathing or other symptoms, you should seek medical care immediately and tell your healthcare provider about your history of vaping. 3. If you decide to stop vaping, do not replace vaping with smoking combustible cigarettes. Ask your doctor for FDA-approved quitting treatments. Resources: For additional information, please contact NMDOH or review the CDC’s recommendations about the vaping-related lung injuries.

Since June 2019, NMDOH has received reports that 14 individuals in New Mexico have developed severe lung injury requiring hospitalization after vaping, with certain individuals requiring intensive care. https://nmhealth.org/publication/view/policy/5350/

Cases reported in Tennessee (as of October 3, 2019): 39* https://www.tn.gov/health/cedep/vaping-illness.html

Transcript of CDC Telebriefing: Lung Injury Investigation Press Briefing Transcript Thursday, October 3rd, 2019 Audio recording media icon[MP3 – 6 MB] Please Note: This transcript is not edited and may contain errors. OPERATOR: Good afternoon, thank you for standing by. Welcome to CDC’s briefing. Today’s conference is being recorded. If you have any objection, you may disconnect at this time. Your lines are in listen only mode until the question and answer session. At that time you may hit star followed by the question. It is now my pleasure to turn the conference over to KD Hoskins at CDC. Thank you, you may begin. SHARON KD HOSKINS: Thank you, Michelle. Thank you all for joining us on the update on the lung injury investigation among people who use e-cigarette or vaping products. We are joined by Dr. Anne Schuchat – Principle Deputy Director of the Centers for Disease Control and Prevention. Dr. Schuchat will provide this week’s update on our support for the lung injury investigation. We are also joined today by Dr. Judy McMeekin, Deputy Associate Commissioner for Regulatory Affairs at the US Food and Drug Administration. In addition, during our Q&A session, Dr. Brian King, from CDC’s response team, will join us to answer any additional questions that you may have. I’ll now turn the call over to Dr. Schuchat. ANNE SCHUCHAT: Thanks so much, KD. Thank you all for joining us today. Unfortunately, the outbreak of pulmonary injury associated with e-cigarette use, or vaping, is continuing at a brisk pace. CDC is continuing our investigation together with state and local health departments and Federal partners including FDA. We are getting more information about cases that occurred earlier this year as well as more recent ones, and we’ve unfortunately surpassed 1,000 lung injury cases in this outbreak. As of October 1, 2019, 1,080 lung injury cases associated with use of e-cigarette, or vaping, products have been reported to CDC from 48 states and the U.S. Virgin Islands. This lung condition is serious, and we continue to learn of additional deaths. There have been 18 deaths confirmed and reported to CDC from 15 states and we know that additional deaths are under investigation. The increase of 275 cases since last week is a combination of new patients becoming ill in the past two weeks and recent reporting of previously-identified patients. Consistent with the case definition, all reported patients have a history of using e-cigarettes or vaping products. As we have continued to get data for additional cases, the trends we reported last week persist. Most patients report a history of using THC-containing products and most patients are male and young people. Out of the 1,080 cases, approximately 70% of patients are male. Approximately 80% of patients are under 35 years old. More than one-third of patients, or 37% are under 21 years old. We have continued to assess what products patients have used and now have information for 578 patients with information on substances used in e-cigarette, or vaping, products in the three months prior to symptom onset we found that about 78% reported using THC-containing products and 37% reported using only THC-containing products. About 58% reported using nicotine-containing products and 17% reported using only nicotine-containing products. I wish we had more answers regarding the specific harmful products or components that are causing these illnesses. Let me describe some of the recent actions we are taking to help get answers. Recently, CDC has deployed additional staff to several states to assist with the investigation. We’ve conducted broad outreach to the clinical community to increase awareness of this illness We’ve worked with clinicians and medical examiner community to provide timely updates, engage on their experience in caring for patients, and review assessments of those that have died from this concerning illness. We’ve convened clinical professional societies, both primary care and specialty, to help strengthen detection, reporting and management of cases. This ensures that our response and our interim clinical recommendations are informed by their direct experience caring for these patients. Together with FDA and public health partners, CDC has developed a comprehensive laboratory plan for continued testing of products, aerosol testing of substances produced by the products, and clinical/pathology lung specimens from patients. We hope that this laboratory effort will provide additional information on the products, potential substances and clinical findings associated with e-cigarette use or vaping. CDC is also leveraging the Laboratory Response Network to receive samples- this is an existing laboratory preparedness and response capability that has been a core component to the nation’s public health response infrastructure for 20 years. CDC continues to use various platforms to ensure the public is aware of the most current information on this outbreak, including weekly updates to our website and through social media, as well as through routine telebriefings like this one. I can’t stress enough the seriousness of these lung injuries associated with e-cigarette use, or vaping. This is a critical issue and even while we learn more, we need to take steps to prevent additional cases. Given continued occurrence of life threatening new cases, CDC recommends that people refrain using e-cigarette, or vaping, products, particularly those containing THC. Regardless of this investigation, e-cigarettes should not be used by youth, young adults, pregnant women, or people who have not previously used tobacco products. If you are concerned about your health after using an e-cigarette product, contact your health care provider, or you can also call your local poison control center at 1-800-222-1222. I’d like now to invite Dr. Judy McMeekin of the FDA to share an update about the FDA’s findings. JUDY MCMEEKIN: Thank you Dr. Schuchat, for those important updates and for the continued collaboration. My name is Dr. Judy McMeekin and I serve as the FDA’s Deputy Associate Commissioner for Regulatory Affairs. The FDA continues to work closely with our federal, state, and local partners as quickly as possible to gather more information about these destructing incidents. This is a critical public health investigation and collaboration is integral to our success. Today I want to provide a few updates on our extensive work. We remain focused on better understanding whether there is a relationship between any specific products or substances and the reported illnesses. Work includes collecting critical details about the products or substances involved, where they were purchased, and how they were being used. Based on our analysis of samples from the state, there does not currently appear to be one product or substance involved in all of the cases. For example, in many cases, but not all, patients have acknowledged recent use of products containing THC. And some have reported the use of e-cigarettes containing nicotine or both THC products and nicotine products. We are leaving no stone unturned in following all potential leads regarding any particular product, constituent, or compound that may be at issue. The FDA’s work to investigate the illnesses includes field sample collections, in coordination with state, sample analysis, criminal and civil investigations, and coordination with state and federal partners. The FDA has received or collected over 440 samples from 18 states to date. And those numbers continue to increase. We are working quickly and thoroughly to analyze the samples. As noted in a recent telebriefing, investigating this crisis is FDA’s top priority. Our investigators and agents are following every possible lead, which includes traveling throughout the country and attempting to gather any available evidence, including devices, pods, cartridges, diluting agents and more. The FDA is focused at identifying the products making people ill and following the supply chain to the source. The FDA is not pursuing any actions associated with personal use of any vaping products. Our interest is in the supply chain. But as acting FDA Commissioner Sharpless has said, if we determine that someone is manufacturing or distributing elicit adulterated vaping products that caused illness or death for personal profit, we would consider that to be a criminal act. Getting to the bottom of these respiratory illnesses is a top priority for all of the federal and state agencies involved. And we’re committed to taking appropriate action as the facts emerge. Thank you for your time. SHARON KD HOSKINS: Thank you. Michelle. We are now ready to take questions. OPERATOR: Thank you. At this time if you would like to ask a question, you may press star 1. Please state your first and last name when prompted. Again that is star 1 for any questions. One moment, please. Dr. John Torres from NBC news, you may go ahead, sir. NBC/DR. JOHN TORRES: Yeah, this is Dr. John Torres, thank you for taking the question here. Do you believe it’s the black market devices that are mostly responsible for these vaping-related lung injuries? ANNE SCHUCHAT: Thank you for that question. You know, we do have a lot of concerns about black market sources. I think it’s premature for us to rule out other concerning products. The Illinois and Wisconsin report from last week did find that most of the individuals had gotten their THC-containing products from informal sources off the street, not from brick-and-mortar shops. But at this stage in the investigation, we really need to keep an open mind and recognize that sources in one part of the country may not be the same as elsewhere. There is a lot we do not know about what’s in various e-cigarette or vaping products and what harms they can have. But i think this black market concern is a high one for us. OPERATOR: Thank you. Our next question comes from Lena Sun from WAPO, you may go ahead. WASHINGTON POST/LENA SUN: That would be “The Washington Post,” thank you. I have two questions. One for the FDA. It’s been a while since you’ve shared any of your findings with us of what you discovered in all of the sampling. I was wondering if you could offer a little bit more detail. And the second question is for both of you- the New England journal this week published a letter from Mayo Clinic pathologists who said that they didn’t see any evidence of markers for lipoid pneumonia in 17 of their patients. That contradicts or is in conflict with the MMWR that CDC put out a couple of weeks ago from North Carolina, where there were five patients diagnosed with lipoid pneumonia based on the lipoids and macrophages found in the lungs. Lipoids and macrophages were also found in the lungs of 6 patients with the University of Utah. I was wonder, Dr. Schuchat, if you could sort of help us understand that and whether the discrepancy could be a function of the way those biopsies were processed and is the CDC analyzing some of these autopsy results and analyzing? Is there anything you can share with us? ANNE SCHUCHAT: Yeah. Thank you for those two questions. I’ll answer the second one first. Then we’ll let the FDA talk about the additional laboratory results. Yeah, the report in the New England journal is quite helpful. A series of 17 patients with pathologic analysis. You also mentioned the small number, the five or six cases for North Carolina in the Utah report. I think its early days in understanding the full clinical spectrum and the pathology of lung injury following e-cigarette use or vaping. The part of the plan that I mentioned, the laboratory testing plan, includes pathology specimens with controlled specimens to try to get a better feel for the spectrum of conditions. The North Carolina report that was in our MMWR came from a group of clinicians in North Carolina and I think it was very helpful in raising questions and alarms. I think we really have the feeling right now, that there may be a lot of different nasty things in e-cigarette or vaping products. And they may cause different harms in the lung. We also know that pathology analysis needs to be done quite carefully with the appropriate stains and appropriate controls and we hope over the months ahead that we’ll learn a lot more about the spectrum of lung conditions that these exposures are having. I think the main point that I’d like to make is these are really serious injuries in the lungs and we don’t know how well people may recover from them, whether lung damage may be permanent. So the glimpses that pathologists are getting are helpful in trying to get to some kind of pathogenesis, but we have a lot more to learn. Let me go to Dr. McMeekin on the FDA question. JUDY MCMEEKIN: Sure. Just as a follow-up. This is a complex investigation unlike any we’ve seen and the FDA is working quickly and thoroughly in testing the samples. Many of the samples have contained little to no liquid, which limits the number and types of tests that are able to be conducted on each submission. The samples we are continuing to evaluate show a mix of results and no one substance has been identified in all of the samples tested. OPERATOR: Thank you. Our next question comes from Mike Stobbe with the Associated Press. Go ahead, sir. AP/MIKE STOBBE: Thanks Dr. McMeekin. Can you talk a little more of the samples, did you say 340? Was that the number? How many were you able to analyze and did you say even if no single substance was seen in all of them, is there a substance or chemical or anything that has been found most often? And Dr. Schuchat can you say a little bit more about the deaths and how many of those 18 autopsies were performed and what’s the median age and did they all vape the same thing or did they ll have a pre-existing condition? Any light to shed on those? JUDY MCMEEKIN: I just want to clarify that the FDA has received or collected over 440 samples from 18 states to date and those numbers continue to increase. Our samples include both devices and products that contain liquid collected directly from consumers, hospitals and from state offices. Thank you. AP/STOBBE: Whoa, I’m sorry. She didn’t answer the question, though, can you say a little more about what has been found most often in those samples and how many of them you have been able to analyze? JUDY MCMEEKIN: So our testing is not complete. However, preliminary results are revealing some products contain THC in concentrations ranging from 14% to 76% and some THC products that also contain a combination of THC and vitamin E acetate ranging from 31 to 88%. ANNE SCHUCHAT: So mike, as to the deaths, I don’t have individual line list underlying conditions. What I can tell you, though, is that the median age is nearly 50. It’s 49-and-a-half. So the fatalities that we are seeing tend to be a bit older than the overall disease burden. That probably isn’t that surprising. The other thing I can — the other thing that I can say is that the age range of fatalities that I’m aware of that have been reported to us is in the 20s to in the 70s. And so as you know, we don’t provide individual identifiable information, but it’s as old as the 70s that one of the deaths was apparently. But again the average age or the median age excuse me is almost 50. A bit higher than we are seeing in the overall population. The small numbers of deaths we have information on so far, I mean, it’s small in terms of statistics. It’s very large in terms of tragedy. But there is a higher proportion of female represented amongst fatal cases preliminarily than in the full population of people affected where we have about 70% male. I think that it wouldn’t be surprising for older people potentially with underlying conditions to not withstand an insult like this, a lung injury as well. But again, with only data on you know less than two dozen deaths, it may be too early to draw conclusions. We do think that the proportion hospitalized in intensive care units is just terrible with this condition and that we really want to prevent it. Next question operator. OPERATOR: Thank you. Dan Vergano with Buzzfeed News. You may go ahead, sir. BUZZFEED/DAN VERGANO: Thank you very much. Two questions. The first is, is this syndrome defined well enough that you can say the onset is rampant? You say you still have cases going on? Does that mean there are products out there still making people sick? The second question is what advice do you have for adult smokers who switch from tobacco to e-cigarettes as a way to wean themselves off? ANNE SCHUCHAT: Yes, thank you for those two questions. We are concerned that risky product is still available and that’s one of the reasons that we have intensified our recommendations or warnings. We haven’t seen a measurable drop-off in the occurrence of new cases and so we don’t feel that either individuals have changed their behavior or the products are gone. We know that there have been — that there is a lot going on to try to get risky products off the market. But we are worried there are plenty of risky products still out there. Now I think the special case of adults who have used e-cigarettes to help stop smoking cigarettes, we really don’t want people to turn to smoking cigarettes. Obviously, there is a lot of individual decision-making involved with adults who are currently using e-cigarettes and we recommend they consult with their healthcare provider. There are a number of FDA approved cessation devices or strategies that together with counseling can be helpful. We really don’t want people to go back to smoking cigarettes. Our recommendations are having intensified as we continue to see new cases, but we really don’t want people who are adult smokers to go back to smoking cigarettes. BUZZFEED/DAN VERGANO: Is it established from the new cases that the onset of this illness is rapid, people smoke and within a week they show up in the ER, or is it unclear that there may be longer term cases of onset? ANNE SCHUCHAT: What I would say from the information that is available so far is many people are long-time users or frequent users and may or may not have changed their habits. The symptoms, the time of symptoms to hospitalization can be fairly short in terms of a week or so. And the — but the question of which was the exposure or was it can accumulate exposure that led to the condition, we don’t know. What I meant by saying so many cases, you know of the 275 new cases this week, about half of them were hospitalized within the past two weeks suggests to me that there have been risky exposures out there in the past month or so despite the warnings we’ve made. OPERATOR: Thank you. Our next question comes from Helen Branswell for STAT News. You may go ahead. STAT/HELEN BRANSWELL: Thank you very much for taking my question. I want to ask the other side of the time line. Dr. Schuchat, you said some of the 275 newly reported cases are old cases that have been reported into the system. Can you talk about how far back you are seeing cases now because, of course, you know, it’s the big question is, has this always been happening and is this is just being the seen now? I’m just wondering if you think there was a point where it started or as evidence accumulates you are seeing cases further and further back? ANNE SCHUCHAT: Yes. Thank you. What we call the epidemic curve of the curve that shows the date of admission and the state date of symptom onset for individual cases, I believe we’re intending to be posting that each week on our website. That goes back to March 31st of this year, but what I would say is in the literature, we know that there is sporadic cases of the, of a condition that sound like it’s the same thing. But what we’ve seen is this increase in cases in terms of the epidemic curve that we have, it’s really June/July where we start to see a lot of cases. There are just a handful in the March/April/May time line compared to what we started to see June/July and of course in August. There is probably some recognition bias in terms of the summer because we have been raising the alarm on this. But you know there – there’s probably been isolated cases for much longer than going back. But I refer you to the website for that curve. OPERATOR: Our next question comes from Denise Grady from the New York Times, you may go ahead. NEW YORK TIMES/DENISE GRADY: Hi, thank you. In examining the — what people are vaping, are you looking at the devices as well as the fluids or other things that people are vaping? And is there any concern or much information about whether there is something going on with the devices, themselves? ANNE SCHUCHAT: Let me begin and then I’ll let FDA continue. The Illinois-Wisconsin group found that there was a common pathway in terms of pre-filled cartridges but not in terms of devices. But what I can say is that based on the intensive interviews that have been done in a couple of the states we’re modifying, simplifying and honing in our interview form to understand, to get better information about those devices and products. In terms of the testing in addition to testing substance, we think it’s important for us to test the aerosol that the substances produce. But in terms of device testing, let me let FDA make any comments that they’d like to. JUDY MCMEEKIN: Sure. Our samples include both devices and products that contain liquids, collected directly you know from the consumers and states. Many of the samples like I said contain very little to no liquid and that really limits the number and types of tests that we’re able to conduct. OPERATOR: Thank you. Our next question comes from Erica Edwards with NBC news. NBC/ERICA EDWARDS: Hey, thank you. One quick thing, I wanted to confirm what was said about the vitamin e acetate earlier. I believe i heard the percentage was between 31 and 88% of the THC products? And the other question I had was a little bit more broad? I mean, this is not like the other outbreaks of the seasonal flu where we know it’s going to get better in spring? So I’m wondering, do you expect these lung injuries and death to continue rising for the foreseeable future? What is it going to take to get this under control? ANNE SCHUCHAT: Let me start and I’ll let FDA answer. I just want to qualify a little bit about the testing of the specimens. There can be multiple specimens from an individual patient that were tested. So a range of vitamin E, you need to know that there may be multiple positives from one single person. The other thing is I believe the range that was presented wasn’t all the samples positive but in an individual sample what percentage of that liquid was vitamin E, rather than that full range of samples all had vitamin E or had you know. So let me stop and let FDA comment on the vitamin E results that they shared. JUDY MCMEEKIN: So, as a reminder, our testing is not complete. However, the preliminary results are revealing some products contain THC at concentrations ranging from 14 to 76% and some THC products that also contain a combination of THC and vitamin E acetate ranging from 31 to 88%. Thank you. ANNE SCHUCHAT: Thanks. And then I think your second question was a really important one was what is it going take for this to go away. You know, I think there is two issues to consider. One is, individuals using e-cigarettes or vaping products, if there is a decrease in use of potentially risky products, we would hope to prevent cases. And the second thing is identifying those multiple sources that are possibly problematic and getting them out of circulation. I think the second may take a lot longer than the first and to be on the safe side, right now we really want to caution people that it is pretty much impossible for you to know what is in the e-cigarette or vaping product that you are getting, particularly THC-containing products bought off the street or from social sources. And in light of the seriousness of this condition, we really don’t think using this product is safe right now. But i think we really need to work hard to get to the risky product and to ideally have our message be more targeted. But as long as you know people are getting this ill and dying, we want to make sure you know that we’re not optimistic, that tomorrow we’re going to be able to pull all the risky stuff off the market. But thank you for that question, because we are concerned with hundreds of new cases reported each week that we’re looking at a very concerning outbreak. It’s very difficult to control. So operator, last question. OPERATOR: thank you. Our last question comes from Kathleen Doheny from WebMD. You may go ahead. WEBMD/KATHLEEN DOHENY: Two quick question. Is there any way to predict if this has peaked? — and what would you say to the legions of people on social media that I see saying, it’s perfectly safe to vape THC that was bought from a licensed dispensary. What would you say to those people? ANNE SCHUCHAT: The data that we’re getting does not suggest this has peaked. It doesn’t suggest that it is declining and we’ll need more observations. In case this is going up, we wanted to intensify our warnings. We really are taking this very seriously. Obviously, individuals will make choices about their own health and their own behaviors and individual states that have licensed dispensaries are taking steps to assure that what they regulate is safe. So, we’re not interfering with state regulation. We’re just saying that right now, it’s very difficult for a consumer to know what they have. WEBMD/KATHLEEN DOHENY: even if it’s from a licensed? — ANNE SCHUCHAT: That’s really a state by state question, I think. And of course, just to reiterate, last week, the Illinois-Wisconsin report found most of the people got their THC containing products off the street, no from a licensed dispensary however that was a geographically focused outbreak. We don’t know if that generalizable yet. Of course, we know there is a lot of conversation out there about what is and isn’t safe. Personally, with all the data that I have been seeing I don’t know what safe is right now. So let me just thank everybody for being a part of today’s telebriefing and thank the FDA and state and local partners who are working so hard to try to understand this and get to the bottom of this, we are really working hard to try to get answers that we hope will be useful, but we think that given the continued occurrence of life-threatening new cases, we’re recommending people refrain from using e-cigarettes or vaping products, particularly those containing THC, particularly those bought off the street. Thank you all. KD HOSKINS: For reporters, if you have additional questions, you can call us at 404-639-3286 or send us an e-mail at [email protected]. This concludes our briefing. OPERATOR: thank you, this concludes today’s conference call. You may go ahead and disconnect at this time. https://www.cdc.gov/media/releases/2019/t1003-lung-injury-investigation.html

Audio https://www.cdc.gov/media/releases/2019/t1003-lung-injury-investigation.mp3