Have you used a tobacco product—an e-cig, cigar or cigarette, hookah or smokeless tobacco—that you believe is defective or is causing an unexpected health problem? Does the product have a strange taste or smell, has your vape battery exploded, or is there some other problem or concern?
The U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) regulates tobacco products. If you have a problem with these products, the FDA wants to hear from you—and has an online tool you can use for reporting.
This tool is the U.S. Department of Health and Human Services’ Safety Reporting Portal (SRP). It gives a standardized way for consumers, health care professionals, manufacturers, and researchers to tell the FDA about unexpected health or safety issues with tobacco products.
“There is no known safe tobacco product, but the FDA can play a role in helping prevent certain unexpected health consequences,” explains Ii-Lun Chen, M.D., director of the Division of Individual Health Science in the Office of Science at the FDA’s Center for Tobacco Products. “The FDA wants to prevent certain unexpected health consequences that could occur from defective tobacco products, as well as health or safety problems beyond those typically associated with tobacco product use.”
You can submit reports to the Safety Reporting Portal about problems with all tobacco products, including cigarettes; tobacco used for roll-your-own cigarettes; other smoking tobacco; cigars; smokeless tobacco; electronic cigarettes and other vape products; hookah (waterpipe); and any other product made or derived from tobacco intended for human consumption.
You also can report problems with components and parts of tobacco products, including problems like battery overheating and explosions. (Learn more about vape battery explosions, and how to prevent them, on the FDA’s website.)
What to Report
As part of its mission to protect public health and reduce harm from tobacco products, the FDA is interested in reports about tobacco products that that have caused unexpected health problems as well as reports about products that are damaged, defective, or contaminated. When answering the questions in the Safety Reporting Portal form, you can give information on a number of potential types of product and health problems.
Examples of unexpected health problems include:
- burns or other injuries
- allergic reactions, poisonings, and other toxicities
- an unusual reaction in a long-time user
- pregnancy or fertility problems
- harm to children or non-users, including accidental poisoning
Examples of product problems include:
- fire caused by tobacco product use
- tobacco product mix-ups (such as labeling or packaging errors)
- quality problems, such as unexpected appearance, smell or taste; foreign objects or other contamination in products; or defective or malfunctioning products
You can learn more about which information the FDA would like you to report on the FDA’s website.
How to Report
Access the Safety Reporting Portal online to submit a report. The portal has instructions and questions to lead you through each reporting section.
If you can’t report online, you can contact the Center for Tobacco Products at 1-877-CTP-1373 or AskCTP@fda.hhs.gov
Note: If you have a problem or adverse experience with nicotine replacement products, such as those that claim to help smokers quit, please submit your report through MedWatch. (MedWatch is the FDA’s reporting system for medical product concerns.)
What the FDA Does With Reports
The FDA reviews all Safety Reporting Portal reports and takes steps, as appropriate, to protect the public health. Your contact information is not required to make a report. But it is helpful, as the FDA may contact you to request more information about your issue, if needed.
The FDA cannot give individual advice to consumers. If you have an issue that requires medical attention, contact your health care professional.
The Freedom of Information Act (FOIA) requires federal agencies to disclose records requested in writing by any person. The FDA posts frequently requested adverse experience reports. The posted reports from June 22, 2009, to March 12, 2014, are available in the CTP FOIA Electronic Reading Room. (Note that the FDA removes identifying information of the person submitting the report before posting these records.)
If you have problems with other FDA-regulated products, the agency also would like to hear from you. Learn more about how to report other product problems or complaints on the FDA’s website.
This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: April 19, 2017
Published: December 3, 2013
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