U.S. Food & Drug Administration (FDA)
September 13, 2019
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
- 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, including the presence of Vitamin E acetate found in many of the samples containing THC. The FDA is committed to taking appropriate actions as the facts emerge and keeping the public informed as we have more information to share.
Information & Resources for Consumers
- For more information on the outbreak and recommendations, please see the FDA’s consumer update on vaping illnesses.
- Many of the samples tested by states or by the FDA as part of this ongoing investigation have been identified as vaping products containing THC, and further, most of those samples with THC tested also contained significant amounts of vitamin E acetate.
- Vitamin E acetate is a substance present in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.
- While the FDA does not have enough data presently to conclude that vitamin E acetate is the cause of the lung illness in these cases, the agency believes it is prudent to avoid inhaling this substance.
- 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.
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.
- The FDA is testing samples at our Forensic Chemistry Center (FCC) lab. FCC has a history of partnering with the states and the CDC on domestic and international adverse public health incidents requiring analytical problem solving and is currently engaged in the CDC-FDA-States investigation into vaping-associated respiratory illnesses.
- The FCC is currently prioritizing samples that are most likely to enhance our understanding of these illnesses, i.e., vaping product samples that are associated with cases of patient lung injury.
- Moving forward, FCC plans to issue regular summary updates on its findings to its federal and state partners. The investigation of these illnesses remains an urgent priority for the FDA.
- If you have identified product samples with direct association to case-illnesses in your state as part of your ongoing investigations, please reach out your local FDA District Emergency Response Coordinator or write to [email protected] for follow-up, collection, and shipment of samples to FCC through FDA field staff.
- FCC will provide results directly to the office which submitted the vaping product samples once testing results are finalized. Only final, verified results will be released on specific samples.
Resource List
