FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizontal rule

Consumer Update

red envelope Sign up for Consumer Updates by e-mail

RSS feed RSS feed for Consumer Updates [what is RSS?]

Main Consumer Health Information Page

Your Guide to Reporting Problems to FDA

Printer-friendly PDF (366 KB)
Cover page of PDF version of this article, including photo of a telephone and a laptop computer with the FDA home page displayed on the screen.

On this page:

Consumers play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product. The following tips and chart will help you make your report.

back to top

Tips for Reporting

1. Report what happened as soon as possible after you discover a problem. Be prepared with the following information:

2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that will help FDA trace the product back to the plant.

3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.

4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator listed at www.fda.gov/opacom/backgrounders/complain.html.

back to top

Quick-Reference Chart for Reporting Problems to FDA

Type of Problem

Type of Product

Report to

  • emergency (serious, life-threatening event)
  • FDA-regulated products (human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics, radiation-emitting electronic products)
  • FDA's 24-hour emergency line at 301- 443-1240 or
  • FDA Consumer Complaint Coordinator in your geographic area. (See list at www.fda.gov/opacom/backgrounders/complain.html)
  • Also contact your health care professional for medical advice.
  • serious adverse event (side effect)
  • product quality problem (such as a medication having a suspicious odor)
  • product use error (such as mixing up products with similar drug names or packaging)

human health care products:

  • human drugs
  • medical devices
  • blood products and other biologics (except vaccines)
  • dietary supplements
  • infant formulas
  • medical foods such as nutritional supplements
  • food-related non-emergency (such as allergic reaction to a product with no allergens listed in ingredients; a non-life-threatening foodborne illness)
  • food products (except meat, poultry, and frozen, dried and liquid eggs)
  • illness or injury related to a vaccine
  • human vaccines
  • blood transfusion-related fatality
  • blood products
  • cosmetic problem
  • novelty makeup
  • face paint
  • other cosmetics
  • product sold online (such as product you suspect is being illegally sold or promoted on Web)
  • FDA-regulated products sold online (human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics, radiation-emitting electronic products)
  • animal food problem
  • pet food
  • animal feed
  • animal drug or device problem
  • veterinary drugs or devices

back to top

Types of Problems FDA Doesn't Handle

Contact the agencies listed to report or complain about the following problem areas. See your local phone directory for phone numbers not provided here.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

back to top

For More Information

Protect Your Health
Joint FDA/WebMD resource

FDA 101: How to Use the Consumer Complaint System and MedWatch

Date Posted: June 10, 2008

horizontal rule