Respiratory Illnesses Associated with Use of Vaping Products
FDA is seeking unpublished data and information related to the use of vaping products associated with recent lung injuries. FDA is seeking information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers.
Submit a public comment to docket FDA-2020-N-0597 by June 19, 2020.
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.
Reports of Adverse Experiences and Product Quality Issues
On this page:
- What tobacco product problem reports have been submitted to FDA?
- Why is FDA posting this information?
- What should I know about the information posted here?
- How do I request a copy of an original report?
- How do I report a problem with a tobacco product?
- How do I report other concerns about tobacco products and tobacco product regulation?
Consumers, manufacturers, clinical investigators, and health professionals submit reports about tobacco products that are damaged, defective, contaminated, smell or taste wrong, or cause unexpected health effects.*
Download summary reports for previous years
- Neurological events and e-cigarette use reports submitted 9/27/2011-6/30/2019: Following FDA’s request (see next bullet), the agency has identified additional reports of seizures or other serious neurological symptoms, including fainting or tremors, which may or may not be related to seizures. This does not necessarily indicate an increase in frequency or prevalence of such incidents. In addition, FDA has not identified any specific brand of tobacco product or product problem associated with these incidents. The agency is continuing to seek information to better understand the association between e-cigarette use and neurological events. FDA encourages the public to include as much detail as possible when reporting any adverse experience.
- View full redacted reports (PDF – 23 MB)
- Seizures and e-cigarette use reports submitted 12/19/2010-3/20/2019: Since June 2018, the FDA observed a slight but noticeable increase in reports from people who use e-cigarettes and have experienced seizures. Many of these reports involve youth or young adult e-cigarette users. The FDA is continuing to seek more information about seizures following e-cigarette use to identify common risk factors and understand if any e-cigarette product attributes such as nicotine content or formulation may contribute to seizures.
- View full redacted reports (PDF – 1.2 MB)
- View reports about ENDS products submitted from 2009 - 2014, requested via FOIA.
Report a tobacco product problem related to e-cigarettes.
*Note: Full redacted reports and summary reports with overlapping dates contain duplicate information. The posted data does not include information submitted by researchers, information submitted by manufacturers in response to FDA requirements or information reported as a potential tobacco product violation of the Tobacco Control Act.
FDA is making reports about tobacco product problems available on the website, so the public can more easily access this information. The reports allow interested parties to learn more about commonly reported potential tobacco product problems. Previously, tobacco-associated health and product problems reported to FDA were available to the public only upon request under the Freedom of Information Act (FOIA) or after FDA posted frequently requested reports in the FDA Center for Tobacco Products FOIA Electronic Reading Room.
- Report identification (ID) numbers in summary reports are randomly generated and may not be sequential.
- The information in summary reports comes directly from the submitted reports. The posted information does not represent an analysis, interpretation, or conclusion by FDA about whether the product actually caused the reported health or product problem.
- Submitted information may be inaccurate or incomplete. Reports to FDA may include inaccurate or incomplete information. For example, reports may not include information about whether the product was used correctly, or whether an individual also suffered from other medical conditions or used other tobacco products or medications at the same time.
- FDA has not determined causality. The FDA is making this information available without evaluating whether the product caused the adverse experience or simply coincided with it.
- Reporting adverse experiences is voluntary. Information posted on this web page is from voluntarily submitted reports.
- This adverse experience information cannot be used to estimate risk or incidence rates, or to compare products. The information as voluntarily reported may be inaccurate or incomplete and cannot independently form the basis of risk or incidence rates or product comparisons.
- Report content may change over time. Individuals reporting a problem with a tobacco product may correct or update their reports at a later date. Therefore, the content of reports may change after posting. FDA only posts information from initial reports.
If you submitted the report, you may view your submission by following the instructions found in the Frequently Asked Questions about the Safety Reporting Portal, see How do I view a submitted report?
You can request a copy of reports filed submitted by others under the Freedom of Information Act. Per the provisions of the FOIA and the Privacy Act, access to personally identifiable information cannot be given to unauthorized third parties without the individuals' written consent and will not be included in the responses to these requests.
Anyone can report a problem with a tobacco product, including damaged, defective, or contaminated tobacco products, or tobacco products that may have caused unexpected health or safety problems.
- Report a potential tobacco-related violation such as sales to minors, flavored cigarettes, or illegal marketing or advertising via the Potential Tobacco Product Violations Reporting System.
- Report a human health or product problem with a product that claims to help with quitting tobacco to MedWatch Voluntary Reporting
- Report animal drug side effects and product problems affecting an animal
- Submit comments on tobacco products and proposed regulation
- Send a complaint about CTP, an existing tobacco law (final regulation), or the government (CTP Ombudsman)
- Share tobacco product information not related to health or a product problem by contacting the product’s manufacturer or contact CTP
- Send other questions or concerns related to tobacco products to CTP