If You Have a Problem with a Food, Drug, or Health Product, Report it to the FDA
Voluntary consumer complaints often provide the first clue that a particular product needs to be investigated
What is MedWatch?
The FDA's MedWatch program processes information about adverse reactions and safety problems with FDA-regulated products. Because medical product studies only involve a relatively small number of patients, a product may be on the market for some time before problems begin to arise. That's why it's important for consumers like you to report problems. Voluntary consumer complaints often provide the first clue that a particular product needs to be investigated.
What kinds of products are covered?
Consumers can report potential issues to MedWatch involving any product that is regulated by the FDA, including:
- Prescription and over-the-counter medications
- Nutrition products, including infant formulas, dietary supplements, and herbal remedies
- Cosmetics or makeup products
- Medical devices, like contact lenses, blood glucose meters and pacemakers
- Biologics, such as human cells and tissues for transplantation
- Food, beverages and ingredients added to foods
Proof of Problem Not Required
When reporting a possible problem to MedWatch, it isn't necessary to provide proof that a particular product caused the problem. This misconception could lead people to avoid making a complaint because they don't believe the product was the cause of the issue. Any and all information that one can provide is worthwhile!
Consumers should report:
- Unexpected side effects from commonly-used products like Tylenol
- Medication errors
- Therapeutic failures when a product doesn't seem to work as well when you switch from a brand to a generic
- Product quality problems