Source: US Food and Drug Administration-1
Have you used an e-cigarette, cigar, cigarette, hookah, smokeless tobacco or other tobacco product that you believe is not working properly or that 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’s Center for Tobacco Products (CTP) regulates the manufacture and sale of 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 a problem.
This online tool is the Safety Reporting Portal (SRP). It gives a standardized way for users—including consumers, health care professionals, manufacturers, and researchers—to tell the FDA about unexpected health or safety issues with various products, including animal foods and animal drugs, dietary supplements, and tobacco products.
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 have caused unexpected health problems as well as reports about products that are damaged, defective, or contaminated.
“There is no known safe tobacco product, but the FDA can play a role in helping prevent certain unexpected health consequences,” explains Iilun Murphy, M.D., director of the Division of Individual Health Science in the Office of Science at CTP. “The FDA wants to prevent certain unexpected health consequences that could result from defective tobacco products, as well as health or safety problems beyond those typically associated with tobacco product use.”
What to Report About Tobacco Products
You can submit reports to the portal about problems with all tobacco products, including:
- tobacco used for roll-your-own cigarettes
- other smoking tobacco
- smokeless tobacco
- electronic cigarettes and other vape products
- hookah (waterpipe)
- other products made or derived from tobacco that are intended for human consumption
You also can report problems with components and parts of tobacco products, including problems like a vape battery overheating or exploding.
When answering questions in the portal, you can give information on several potential types of product and health problems.
Examples of unexpected health problems include:
- burns or other injuries
- allergic reactions, poisonings, and other toxic events
- 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 products that are faulty or do not work as intended
How to Report Problems with Tobacco Products
Access the Safety Reporting Portal to submit a report online. The portal has instructions and questions to lead you through each reporting section. You should be able to complete a voluntary report about a tobacco product within 10 minutes.
If you can’t report online, you can contact CTP by phone at 1-877-CTP-1373 or by email at AskCTP@fda.hhs.gov
How to Report About Potential Violations of Tobacco Product Regulations
If you would like to report potential violations of tobacco product regulations, you can use the FDA’s product violation reporting process. (Examples of violations include illegal sales of tobacco products to minors at a retail location and sales of cigarettes in packs of less than 20.)
How to Report Problems with Smoking Cessation Products
Smoking cessation products are regulated through the FDA’s Center for Drug Evaluation and Research, which ensures that the products are safe and effective and that their benefits outweigh any known associated risks.
These products include both nicotine replacement therapy (nicotine gum, patches, sprays, inhalers, or lozenges used to decrease withdrawal symptoms triggered by stopping smoking or chewing tobacco cessation) and prescription products to help you quit.
If you have a problem or adverse experience with a smoking cessation product, please submit your report to the FDA through MedWatch. (MedWatch is the FDA’s reporting system for medical product concerns.)
How to Report Problems with Other FDA-Regulated Products
If you have problems with other FDA-regulated products—such as food products, other human and veterinary drugs, biological products, medical devices, and products that emit radiation—the agency also would like to hear from you. You can learn more about this topic by reading “How to Report Product Problems and Complaints to the FDA.”
What the FDA Does with Reports—and other Reporting Facts
The FDA reviews all Safety Reporting Portal reports and takes steps, as appropriate, to protect the public health.
You do not need to give your contact information to make a report. But it is helpful, as FDA staff 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, please contact your health care provider.
Want to view reports made in the past? Know that the Freedom of Information Act gives you the right to request access to federal agency records or information, with some exceptions. You can learn more at www.foia.gov.
Also know that the FDA posts frequently requested adverse experience reports online. You can find these reports in the CTP FOIA Electronic Reading Room. Some information from tobacco product problem reports submitted since January 2017 also is also posted on the FDA’s website. Note: The FDA removes personally identifiable information before posting these records.