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Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is now made available in the CFSAN Adverse Event Reporting System (CAERS) database.  This is information that was once only available through Freedom of Information Act (FOIA) requests.

CAERS captures any adverse events or complaints related to foods, dietary supplements, or cosmetics.  These can include minor to major medical events, but also complaints about off-taste or color of a product, defective packaging, and other non-medical issues.  The adverse event reports about a product, as well as the total number of adverse event reports for that product in CAERS, only reflect information as reported, and do not represent any conclusion by FDA about whether the product actually caused the adverse events.

Adverse event reports related to conventional foods, dietary supplements, and cosmetics come primarily from consumers and health care providers of these products; only dietary supplement manufacturers have a legal obligation to report serious adverse events to FDA.

The first posting from CAERS included data from reports submitted by consumers, medical professionals and industry from 2004 through September 2016.  Data voluntarily reported by industry were not included in this data file, but reportedly will be made available during the next quarterly update in February 2017.

FDA’s posting of CAERS data is intended to increase transparency and awareness about reporting adverse events to FDA, and to improve access to such government data for consumers, healthcare practitioners, industry, and regulatory/legal agencies.  The CAERS database reasonably should help facilitate industry research into use of ingredients and engagement of suppliers.

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