If you have a complaint about a product regulated by the U.S. Food and Drug Administration (FDA), the agency wants to hear about it.
The FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.
The FDA's Consumer Complaint Coordinators (CCC's), located in FDA offices throughout the United States and Puerto Rico, will listen, document your complaint about an FDA-regulated product, and follow up as necessary. Consumers should report problems to the CCC for their geographic region. (See the list of CCC's on the FDA's website at Consumer Complaint Coordinators.)
Some examples of complaints that your CCC wants to hear about are:
The FDA takes seriously reports of illnesses or injury that appear likely to have been caused by an FDA-regulated product. As few as one or two complaints can make a difference. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.
Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information may be used during a future inspection of a company to help the FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.
MedWatch receives reports from the public and, when appropriate, publishes safety alerts for FDA-regulated products such as:
Other products that the FDA regulates, such as tobacco products, vaccines, animal drugs and devices, and pet food and livestock food, utilize different reporting pathways, and it is recommended that reports concerning these products be submitted directly to the appropriate portals. Adverse events associated with dietary supplements should be reported via the online Safety Reporting Portal.
When the FDA approves a drug, the agency has determined that the benefits of the product outweigh the risks, but every product that the FDA approves carries some risk. Sometimes there are risks that come to light only after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.
Because unanticipated adverse events may occur after a product is on the market, the FDA encourages people to report problems they think they’ve experienced from a product the FDA regulates.
Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public. Remember, reporting can help you, a family member, or someone else avoid harm, serious illness, or even death.
Reporting to MedWatch is easy, confidential, and secure. You provide information about your experience on a MedWatch form. The FDA encourages you to have your health care professional either complete the form for you or help you complete the form yourself.
"Health care professionals may have other clinical information, such as test results or a medication profile, that will help us evaluate the report,” says CAPT Beth Fritsch, Senior Advisor for Stakeholder Engagement.
Reporting by health care professionals is voluntary. If they choose not to report, or if you'd rather file the report yourself, you may use one of these methods:
If you or your health care professional do not want to complete a MedWatch report, you may report a problem with a health care product to your CCC. The FDA realizes there are instances when consumers want to explain their problem and have the agency record the complaint. This allows the FDA to ask questions and obtain important information that we might not get if the consumer only filled out a MedWatch report.
CCC's and MedWatch are for reporting problems; neither provides medical advice. If you experience an adverse event, you should contact your health care professional first and then report the problem to FDA.
FDA staff enter the report into a database so that it is available for review and comparison to other reports.
FDA actions may include:
The Safety Reporting Portal is another reporting tool. It is the primary way for people to report problems with any tobacco product, human dietary supplements, pet food or pet treats, and livestock food—all of which are regulated by the FDA.
The portal also has a routing page. If you have concerns about a product and are not sure where to go to report it, the routing page will direct you to the appropriate federal resource.