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Tobacco Product Problem Reports

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What tobacco product problem reports have been submitted to FDA?

Consumers, manufacturers, and health professionals submit reports about tobacco products that are damaged, defective, contaminated, smell or taste wrong, or cause undesireable health effects.* These reports are posted quarterly below, and also available for the public on openFDA.

Download summary reports (compiled quarterly) *also available on openFDA

Reports specific to electronic nicotine delivery system products (also known as ENDS, e-cigarettes or vapes)

  • Neurological events and e-cigarette use reports submitted 9/27/2011-6/30/2019: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. 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.

*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.

Why is FDA posting this information?

FDA is making reports about tobacco product problems available on the website and in our openFDA database 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 upon request under the Freedom of Information Act (FOIA). Currently, these reports are made publicly available and posted quarterly to the Tobacco Product Problem page. 

What should I know about the information posted here?

  • Report identification (ID) numbers in summary reports are randomly generated.
  • The information in summary reports comes directly from the submitted reports. The posted information is directly from the submitted reports, without editing, and does not reflect analysis by FDA.
  • 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 inclusion of a report in this collection does not represent any conclusion about 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. Reporting rates have many influences and vary over time. The volume of use or exposure to specific tobacco products is generally not well characterized. Therefore, the accumulated reports cannot be used to calculate incidence (occurrence rates), to estimate risk, or to compare products.
  • 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.

How do I request a copy of a submitted report?

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.

How do I report a problem with a tobacco product?

Anyone can report a problem with any tobacco product, including damaged, defective, or contaminated tobacco products, or tobacco products that may have caused health or safety problems.

Report a tobacco product problem using the Safety Reporting Portal using its tobacco questions.

How can I get a tobacco product tested to find out what is in it?

You may wish to contact an independent testing laboratory. Your county or state health department or your state colleges and universities may be able to help you to find product testing laboratories that could meet your needs.

FDA may conduct focused product sample testing as part of a coordinated probe of a national public health threat. FDA informs the public of such probes through the media and through situation-specific web pages that may contain sample submission information.

How do I report other concerns about tobacco products?

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