US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about adverse events involving CFSAN-regulated products.The CAERS database receives both mandatory reports for dietary supplements as well as voluntary reports from both consumers and health care practitioners for dietary supplements, cosmetics, foods, and other products regulated by CFSAN. CAERS receives reports through MedWatch, emails, telephone calls, faxes, letters, and electronic transfers from the Office of Regulatory Affairs (ORA) District Offices’ Field Accomplishments and Compliance Tracking System (FACTS).
Each data extract covers reports received by CAERS through the previous quarter of the year. The posted data extracts contain information from adverse event reports associated with CFSAN-regulated products (foods, dietary supplements, and cosmetics). The CAERS extract provides a file of data in CSV format (delimiter separated text).