Your Guide to Reporting Problems to FDA

The U.S Food and Drug Administration protects the public health by helping to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and products that emit radiation—and by helping to ensure the safety and security of our nation’s food supply and cosmetic products. The FDA also regulates tobacco products.

If you have a problem or concern about any of the products that the agency regulates, the FDA wants to hear from you.

Which products should you report on?

FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers, and you can report problems about any products that the FDA regulates. These products include:

• human prescription and over-the-counter (OTC) drugs
• medical devices
• foods, including dietary supplements, infant formulas, beverages, and ingredients added to foods
• veterinary products, including foods and drugs for animals
• electronic products that give off radiation
• biologics, including vaccines, blood and blood components, and tissues for transplantation
• cosmetics
• tobacco products

Why should you report problems?

Information about problems or unexpected reactions can help the FDA protect the public health.

For instance, if you report a problem to the FDA, you could help identify an unknown risk. And your report could help the FDA know when to carry out preventive and protective actions, which can include requiring labels to provide new warning information and issuing safety messages to the public. Products also can be potentially removed from the market.

What kinds of problems can you report—and when?

If you have a medical emergency related to an FDA-regulated product, call 9-1-1 and seek medical assistance immediately. After you’ve received the medical attention that you need, you can report the issue to the FDA.

Note: Even if you have a problem and do not seek medical attention, you still can report the issue to the FDA. Similarly, you can report problems with animal drugs or devices or animal food, whether you sought veterinary assistance or not.

Examples of problems you can report include:

• Unexpected side effects or adverse events. These can include everything from skin rashes to more serious complications.
• Product quality problems. These issues can happen if a product isn’t working properly or if it has a defect.
• Potentially preventable mistakes. These can be caused by various issues, including choosing the wrong product because of labels or packaging that look alike. (For instance, confusing two products that have similar brand or generic names.) Mistakes also can be caused by difficulty with a device due to hard-to-read controls or displays, which may cause you to record a test result that is not correct.
• Therapeutic failures. These problems can include when a medical product does not seem to work as well when you switch from one generic to another.
• Food concern. These can include illness or serious allergic reactions related to any food product. (Note that certain categories of foods, such as most meat and poultry products, are regulated by the U.S. Department of Agriculture.)

“If it’s serious to you, we want to know,” says Anna Fine, Pharm.D., M.S., director of the FDA’s Health Professional Liaison Program. She adds that you should report an issue even if you’re not sure a particular product was the cause.

How should you submit your report?

You can report a problem to the FDA online, via phone, or via mail.

For emergencies:

• Call 9-1-1 immediately.
• In limited emergency situations (which are urgent but not life-threatening), you or your health care professional can report problems to the FDA’s emergency line at 1-866-300-4374 or 301-796-8240. The line is open 24 hours a day, every day of the week.

For non-emergencies:

• If you have questions, or want to talk with someone, call the FDA Consumer Complaint Coordinator who works with your state. Phone numbers are listed online.
• To report online or via mail, visit the FDA non-emergency reporting page. There you’ll see exactly where to report problems with specific, regulated products. (For instance, you can submit reports to MedWatch, The FDA Safety Information and Adverse Event Reporting Program or the Safety Reporting Portal, depending on the product.)

“We recognize it can be challenging to figure out where to report concerns or problems to the FDA,” Fine notes. “Ideally you will submit a report through the designated reporting system, but if you submit a report through any of our systems, it will ultimately get to the right place in the agency.”

How can you make a complete and accurate report?

Submit as much detailed information as possible.

For products for humans, try to provide the following information.

• Name or other identifier of the person affected—including age, sex, and ethnicity—to help the agency determine if particular groups are especially affected. (The FDA is committed to protecting confidentiality of patients. For privacy reasons, do not use a person’s social security number as an identifier.)
• If reporting about a prescription or over-the-counter drug, the name of the drug, manufacturer, and the strength of the drug.
• If reporting about a tobacco product, the product type, brand name, and manufacturer.
• Name and address of the store where you bought the product and the date of purchase.
• Details about the problem, such as symptoms and whether the issue went away after you stopped using the product.
• Any medical treatments and outcomes.

Similarly, for products for animals, detailed information about the affected animal(s), the product, and the health problem(s) noted is helpful.

Include any product codes, numbers, and dates on the packaging and labeling. If needed, this can help the FDA trace the product back to the place of manufacture.

In addition to reporting to the FDA, consider reporting the problem to the manufacturer and the store where you bought the product.

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