A supplement adverse event report is a note to the US Food and Drug Administration (FDA) that says a product may have made someone sick. Anyone can file one. You do not need a doctor, and you do not need proof that the product caused the problem. This guide shows the steps.
First, get care
FDA says the first thing to do after a bad reaction is to contact or see your health care provider right away. The report comes second. It is a record for the agency, not a way to get treated.
FDA also says it wants to hear about a health problem that might be linked to a supplement, even if you are not sure the product caused it, and even if you never visited a doctor or clinic.
Where to file
There are two routes. The first is the FDA Safety Reporting Portal, the online route FDA names for reporting a supplement problem. FDA says consumers and health professionals can send reports to it, and that those reports go into its adverse event system for foods, supplements and cosmetics.
The second is MedWatch, the FDA program for reporting serious problems with human medical products. The MedWatch page lists dietary supplements among the products it covers, and it speaks to patients and consumers as well as health professionals.
Pick one route. For a supplement, the Safety Reporting Portal is the one FDA names in its supplement questions and answers.
What to keep on hand
Gather your facts before you start. A clear report is easier for FDA to use. Keep these items close:
- The product name and the brand name.
- The label or a clear photo of it, front and back, plus the Supplement Facts panel.
- The lot number or batch code, if the package shows one.
- Where and when you bought it.
- The date you started using it and the date the problem began.
- A short list of what happened, in order, and when it stopped.
- Other products you were using at the time, including medicines.
Keep the package itself, too. Do not throw it away. The label shows who made or sold the product and gives the contact details for it.
Your privacy
FDA states that the identity of the patient and the person who files the report are kept confidential. For a general complaint about a food product, including a supplement, FDA also points people to the consumer complaint coordinator at the nearest FDA district office.
What companies must do
A US law gives companies their own duty. The Dietary Supplement and Nonprescription Drug Consumer Protection Act became law on December 22, 2006. Under it, the maker, packer or distributor whose name is on a supplement label must send FDA any serious adverse event report it receives. The deadline is 15 business days after the report comes in.
The law calls an event serious if it involves death, a life-threatening experience, inpatient hospitalization, a lasting or major disability, or a birth defect. It also covers an event that needed a medical or surgical step to prevent one of those outcomes.
The same law requires the label to carry a US address or phone number for reporting. That is why the label matters. If you wish, you can contact the company too. Contacting the company does not replace a report to FDA, so you can do both.
A short checklist
- Get care from a health care provider.
- Save the package, label and lot number.
- Write down the timeline while you still remember it.
- File through the Safety Reporting Portal or MedWatch.
- Keep a copy of what you sent.
One honest limit: a report does not prove a product caused a problem, and FDA does not promise to reply to each one. It adds to a record the agency uses to look for patterns.