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  1. Public Health Focus

Lung Illnesses Associated with Use of Vaping Products

Information for the Public, FDA Actions, and Recommendations

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Background

Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory illness associated with use of vaping products. The FDA and CDC are working closely with state and local health officials to investigate these incidents as quickly as possible, and we are committed to taking appropriate actions as a clearer picture of the facts emerges.

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 consumers with some information to help protect themselves.


Incident Overview

  • The Centers for Disease Control and Prevention (CDC) is working with states to determine if cases are confirmed or probable after examining the medical records of suspected cases.
  • Please see the CDC’s website for updated cases. These numbers may change frequently.
  • While some cases in each of the states are similar and appear to be linked to vaping product use, more information is needed to determine what is causing the respiratory illnesses.
  • In many cases, patients reported a gradual start of symptoms, including breathing difficulty, shortness of breath, and/or chest pain before hospitalization. Some cases reported mild to moderate gastrointestinal illness including vomiting and diarrhea, or other symptoms such as fevers or fatigue.
  • In many cases, patients told healthcare personnel or health department staff of recent use of vaping products containing tetrahydrocannabinol (THC, a psychoactive component of the marijuana plant).
  • Even though cases appear similar, it is not clear if they have a common cause or if they involve different diseases with similar presentations, which is an issue central to our investigation.
  • CDC and the FDA are providing consultation to state health departments and are working closely with them to gather information on any products or substances used.
  • For example, our agencies are working to standardize information collection at the state level to help build a more comprehensive picture of these incidents. This includes investigating the brand, manufacturer and types of vaping products, whether any of them are products that would fall within the FDA’s regulatory authority, as well as where they were obtained.


FDA Actions

Acting FDA Commissioner Ned Sharpless, M.D. takes a tour of the FDA’s Forensic Chemistry Center. The Center serves as the FDA’s premier national laboratory and is playing a critical role in fact-gathering and analysis for the ongoing incidents of lung illnesses following vaping product use.

Former Acting FDA Commissioner Ned Sharpless, M.D. takes a tour of the FDA’s Forensic Chemistry Center. The Center serves as the FDA’s premier national laboratory and is playing a critical role in fact-gathering and analysis for the ongoing incidents of lung illnesses following vaping product use.

  • The FDA remains deeply concerned about these respiratory illnesses and deaths and is working closely with the CDC, as well as state and local public health partners, to investigate them as quickly as possible.
  • To help gather and analyze as much information as possible, the FDA’s laboratory is working closely with our federal and state partners to identify the products or substances that may be causing the illnesses.
  • The FDA is analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids, along with cutting agents/diluents and other additives, pesticides, opioids, 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, and the FDA is committed to taking appropriate actions as the facts emerge and keeping the public informed as we have more information to share.

FDA Preliminary Lab Analysis

  • To date, the FDA has received over 1,200 samples from 25 states and one territory with roughly 938 of these samples connected to patients. These samples have been collected directly from consumers, hospitals, and state offices. They have included vaping devices and products containing varied levels of liquid as well as packaging and other documentation. Many samples have contained little to no liquid, which limits the number and types of tests that can be conducted on each submission. The FDA has not found one product or substance that is involved in all of the cases; however, we do know that THC is present in most of the samples being tested. The following is a snapshot of lab activities most relevant to the samples containing THC, as of the date noted.
  • As of Dec. 11, 2019, 719 of the 938 samples connected to patients (77%) have undergone some level of testing and additional testing is likely to be conducted on many of these products.
    • 465 of these samples have been found to contain THC
      • 50% of the THC products have been found to contain vitamin E acetate as a diluent. The concentration of vitamin E acetate determined in a subset of these samples has ranged from 23% to 88%
      • 23% of the THC products have been found to contain another diluent such as medium chain triglycerides
  • The FDA labs are also doing work to focus on connecting the analysis of samples to particular patients with assigned CDC case numbers. As of Dec. 11, 2019, approximately 563 samples are directly linked to 74 patients with CDC case numbers and samples from 70 of these patients have been analyzed.
    • 80% of these 70 patients were connected to products containing THC.
      • Of these:
        • 77% of cases included products with vitamin E acetate as a diluent
        • 32% included products with aliphatic esters as diluent (e.g., triglycerides)
        • 7% included products with polyethylene glycol as diluent
  • It is important to stress that identifying any compounds present in the samples linked to patient cases is but one piece of the puzzle and will not necessarily answer questions about causality, which makes ongoing work critical at both the state and federal levels. Every day the FDA and partners are gathering more information and seek to use that information to better understand the relationship between any specific products or substances and the reported illnesses. Importantly, the variations of use patterns, products or substances reportedly used and the samples being tested may mean there are multiple causes of these injuries.

Information & Resources for Consumers

  • At this time, FDA and CDC have not identified the cause or causes of the lung injuries in these cases, and the only commonality among all cases is that patients report the use of vaping products, including e-cigarettes. No one compound or ingredient has emerged as the cause of these illnesses to date; and it may be that there is more than one cause of this outbreak. We do know that THC is present in most of the samples tested to date, and most patients report a history of THC-containing products. The latest national and state findings suggest products containing THC, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers), are linked to most of the cases and play a major role in the outbreak.
  • As such, we recommend that you do not use e-cigarette or vaping products that contain THC. And since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette and vaping products. Adults addicted to nicotine using e-cigarettes should weigh all risks and benefits, and consider utilizing FDA-approved nicotine replacement therapies. They should not turn to or resume using combustible tobacco. There is no safe tobacco product. All tobacco products, including e-cigarettes, carry a risk.
  • For more information on the outbreak and recommendations, please see the FDA’s consumer update on vaping illnesses.
  • A majority of the samples tested by states or by the FDA as part of this ongoing 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.
  • If you continue to use these THC-containing vaping 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.
  • If you experience vaping-associated respiratory illness, the FDA also encourages you to report this information, including providing any associated product, to your state or local health departments. Reporting to your state or health departments is crucial as federal and state partners work together to have accurate case identification and reported case counts. For more information regarding state and local health department directories, please refer to:
    https://www.cdc.gov/publichealthgateway/healthdirectories/index.html

    If you experience a problem with any tobacco product, such as an unexpected health or safety issue, report it online using the Safety Reporting Portal. You may submit reports about any tobacco product, including cigarettes, roll-your-own cigarettes, cigars, smokeless tobacco, electronic cigarettes and waterpipe tobacco. You can also report problems with the components and parts of tobacco products. The FDA website has more information on what to include in a report.
  • See here for general FDA information on vaporizers, e-cigarettes and other electronic nicotine delivery systems.


Information for Healthcare Providers

  • As this investigation continues, CDC and the FDA encourage clinicians to report possible cases of vaping-associated respiratory illness to their local or state health department for further investigation. Reporting to your state or health departments is crucial as federal and state partners work together to have accurate case identification and reported case counts.
  • If vaping product use is suspected as a possible cause for a patient’s lung illness, a detailed history of the substances used, the sources, and the devices used should be obtained, as outlined in the CDC Health Advisory, and efforts should be made to determine if any remaining product, devices, and liquids are available for testing. Health care providers also can contact their local poison control center.
  • Product-specific information related to possible cases may be submitted to the FDA online using the Safety Reporting Portal. The FDA website also has more information on what to include in a report to the SRP.


Information for State Health Departments

  • FDA would like to thank all State Departments of Health (and other partners) for their ongoing efforts, collaboration and communications on the recent respiratory illnesses associated with e-cigarettes and vaping products.
  • CDC and FDA are working together to coordinate analysis of vaping products, including e-cigarettes, to provide insight into the nature of the chemical exposure(s) contributing to the Lung Injury outbreak. FDA is analyzing e-liquids for the presence of a broad range of chemicals. When sufficient liquid product is available, CDC will conduct aerosol emissions testing of the e-cigarette or other vaping product. The graphic below outlines the process for states to submit product samples to FDA and CDC for testing.
  • Analysis of both e-liquid and aerosol emissions will complement each other, and together will help improve our understanding of exposure among case patients associated with the Lung Injury outbreak.
    This graphic outlines how states can submit product samples for testing at CDC and FDA for the lung injury response. In the first box to the left, a clipboard with a checkmark is shown to help illustrate the first step in the process. In this step, states collect product and link it with a CDC case ID. An arrow then leads users to the next box to the right to show the next step in the process, which is illustrated by an image of a computer receiving an email. In this step, states can request to submit product to either CDC or FDA. Product(s) must be linked to a confirmed or probable case and have a CDC case ID. An arrow then leads users to the next box to the right showing the third step, illustrated by a two people on a phone call speaking with each other. In this step, points of contact will review sample submissions using agreed upon criteria (e.g., volume of sample). These points of contact will then work with the state on next steps. From here, the graphic points to two different boxes, depending on how the sample is triaged. The top box shows the situation in which the product sample contains sufficient volume and CDC will conduct aerosol testing on it. This box is illustrated with an e-cigarette, or vaping product, with an arrow to CDC. CDC will then send remaining sample to FDA for e-liquid testing. The bottom box in this step shows e-liquid testing at FDA. It is illustrated with an e-cigarette, or vaping, product with an arrow to FDA. The last step is shown in the box to the right. It is illustrated by computers linking with the cloud. In this step, agencies report data to the states. Additionally, both CDC and FDA will enter data from their testing in a secure repository to link epidemiologic, clinical, and product sample information to cases.
  • States can request to submit product to either CDC or FDA. Product(s) must be linked to a confirmed or probable case and have a CDC case ID.
    • For information about collection and submission of e-cigarette or other vaping products, including e-liquids, associated with confirmed or probable cases for possible testing by FDA, contact: FDAVapingSampleInquiries@fda.hhs.gov.
    • For information about collection and submission of e-cigarette or other vaping products’ e-liquids associated with confirmed or probable cases for possible aerosol emissions testing by CDC, contact IncidentResponse@cdc.gov.


FDA Resources

stethoscope on keyboard


CDC Resources