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Tobacco Product Problem Reports

Tobacco Product Problem Reports

Reports of Adverse Experiences and Product Quality Issues0

On this page:

What tobacco product problem reports have been submitted to FDA?

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 2019 summary reports (compiled quarterly)

Download summary reports for previous years

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

Report a tobacco product problem related to e-cigarettes.

Note*: 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 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.

What should I know about the information posted here?

  • Report identification (ID) numbers are randomly generated and may not be sequential.
  • The information comes directly from the submitted reports. The information provided does not represent an analysis, interpretation, or conclusion by FDA about whether the product actually caused the reported health or product problem.
  • 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 is voluntary. Information posted on this web page is from voluntarily submitted reports.
  • This information cannot be used to estimate risk or incidence rates. The information as voluntarily reported may be inaccurate or incomplete, and cannot alone form the basis of risk or incidence rates.
  • Report content may change. Individuals reporting a problem with a tobacco product may update or cancel their reports at a later date. Therefore, the content of reports may change after posting. FDA only posts information from original 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 a tobacco product, including damaged, defective, or contaminated tobacco products, or tobacco products that may have caused unexpected health or safety problems.

How do I report other concerns about tobacco products?

Additional Resources