Reporting helps safety monitoring, but a form is never more urgent than getting appropriate care.
What should happen before a report?
If symptoms may be severe or life-threatening, contact emergency services or a poison control service as appropriate for your country. Do not wait for an online reporting form to load. A clinician can address the immediate situation and document relevant findings.
FDA tells consumers who think a supplement caused a serious reaction or illness to stop using the product and submit a report. Contact a qualified professional for medical advice, including whether and when any product should be restarted.
Which details make a report useful?
Keep the original container rather than transferring the contents. Record:
- complete product and manufacturer name;
- lot number, expiration date and package size;
- where and when it was purchased;
- serving amount, frequency, start and stop dates;
- what happened and the timing;
- other supplements and medicines used;
- relevant medical evaluation, if available.
Write observations rather than a diagnosis. “Symptoms began two hours after the second serving” is more useful than an unsupported statement that the product definitely caused the event.
Where do US consumers report?
FDA’s dietary-supplement reporting guidance directs consumers and health professionals to the Safety Reporting Portal. After signing in or continuing as a guest, select the voluntary-report option for a private citizen, business or veterinary provider. Use the current FDA instructions rather than a bookmarked generic MedWatch form because FDA routes electronic dietary-supplement reports through the portal.
Manufacturers also have reporting responsibilities for serious adverse events associated with dietary supplements. A consumer report does not need to wait for the seller’s internal process.
What does FDA do with a report?
Reports contribute to signal detection and regulatory monitoring. A single report normally cannot prove causation, and submitting one does not mean FDA has determined that the product caused the event. Accurate product identification and timing improve the information available for review.
What if I am outside the US?
Use your national medicines, food-safety or adverse-event reporting route. The Safety Reporting Portal instructions in this article are US-specific. In every country, urgent care comes first and local authorities may request different information.
This page awaits qualified clinical review and should be used only as a documentation and routing checklist.