HealthMap

FDA Monitoring of Dietary Supplement Adverse Events

• Yes, the FDA does monitor adverse event reports related to dietary supplements.
• Mandatory Reporting: Since the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, manufacturers, packers, and distributors are legally required to report serious adverse events associated with dietary supplements to the FDA.
• CAERS Database: These reports are collected through the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS).
• Public and Consumer Reports: Consumers and healthcare professionals can also voluntarily submit adverse event reports directly to the FDA through the Safety Reporting Portal.
• Post-Market Surveillance: This system serves as an early warning mechanism for the FDA to identify potential safety issues, adulterated products, or unexpected side effects that were not apparent during the initial product introduction.