Adverse Event Reporting

Adverse event reporting is the process by which serious side effects from dietary supplements are reported to the FDA's MedWatch/CAERS (Center for Food Safety and Applied Nutrition Adverse Event Reporting System). Since 2007, supplement manufacturers are legally required to report serious adverse events (death, life-threatening events, hospitalization, disability, birth defects) within 15 business days. Consumers and healthcare providers can also submit voluntary reports. This post-market surveillance is particularly important because supplements do not undergo pre-market safety trials. The FDA uses adverse event data to identify safety signals and take enforcement action.