How To Use FDA Consumer Complaint System

If you have any complaint related to a product regulated by the Food and Drug Administration (FDA), you can report the issue to the FDA department. Reporting to the FDA can be accomplished by using two systems.

  • Consumer complaint reporting system
  • Medwatch

Consumer Complaint Reporting

Consumer Complaint Coordinators (CCC’s) of FDA department reports your complaint about FDA-regulated products and will follow up as necessary. Here are some issues on which CC Coordinators look into:

  • Food-related illnesses, especially when a person is allergic to some ingredient and that ingredient is not mentioned on the product label.
  • Issues related to infant formula
  • Issues related to baby food
  • Swollen or leaking canned goods
  • Suspected product tampering
  • Adverse events after taking dietary supplements
  • problems related to prescription or over-the-counter medications problems related to pet food and treats

FDA coordinators take immediate action against the report. Moreover, an FDA investigator may visit the person who has made a complaint, depending on the seriousness of the issue. An investigator will collect samples of the product, and then will begin an inspection.

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and that information is used for future inspection. This inspection report helps the FDA to find out problematic areas in the production plant. The complaints are also discussed with company management during these inspections.

MedWatch Reporting

MedWatch is for reporting any adverse events (unexpected side effects) that occur while using human health care products and other FDA-regulated products such as

  • Medical devices (such as contact lenses, pacemakers, glucose tests, and medical x-rays)
  • Human drugs (both prescription and over-the-counter)
  • Blood products, human cell and tissue products, and other biologics (except vaccines, which are reported to another system)
  • Special nutritional products (dietary supplements, infant formulas, and medical foods such as nutritional supplements used under medical supervision)
  • Cosmetics

The FDA approves a product after testing it, but that product might have some risks. These risks come to light when:

  • A large number of people use it for a long period of time
  • patients (whose characteristics are different from those on whom a product is tested before approval) use

So continued monitoring of adverse events is essential and depends on reporting of these events to FDA so they can be entered in MedWatch. Each and every MedWatch report is important for FDA. This report is recorded in an FDA database for review and is also compared with similar previous reports.

How to Report to MedWatch?

Anyone can report to Medwatch easily. You just need to share your experience on MedWatch form. Make sure that your health care professional either fills the form for you or helps you fill that form. Health care professionals have test results and other clinical information that will help them better to evaluate the report. Various methods, you can use to report are:

  • Online – You can get the MedWatch form atfda.gov/medwatch/report.htm. FDA encourages online reporting because it is the quickest and most direct route.
  • Mail – You can download the pre-addressed, postage-paid form (FDA Form 3500) at fda.gov/medwatch/getforms.htm or call 1-800-FDA-1088 to request the form.
  • Fax—Get the form (as above) and fax to 1-800-FDA-0178.
  • Phone – You can call FDA at 1- 80 0 -F DA-1088 from Monday–Friday between 8:00 a.m. and 4:30 p.m. EST.

Problems for which you can report to MedWatch

Here are some problems for which you can report to MedWatch:

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