FDA Begins Posting Adverse Events & Consumer Complaints

From January 1, 2004, through September 30, 2016, the FDA received 26,840 adverse event reports for conventional food through its CFSAN Adverse Event Reporting System (CAERS), which includes medical events as well as complaints about off-taste or color of a product, defective packaging, and other non-medical issues. Although the information in the database is exactly as reported to the FDA, and the agency has not necessarily determined if the products(s) in question were the actual cause of the events reported, FDA will now post data extracted from adverse event reports (for dietary supplements and cosmetics as well as food) on a quarterly basis.  

According to FDA, the purpose is to increase transparency and improve access to government data for consumers, health care providers, researchers and academics. The agency is also making available raw data files that can be downloaded in .csv format or through OpenFDA.gov as an application program interface (API).

CAERS is one of the post-market surveillance tools that the FDA uses to monitor the safety of foods and cosmetic products. 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 adverse events to the agency.

The FDA uses adverse event reports as part of its overall strategy to help monitor the safety of foods and cosmetics. The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public. Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny.

CAERS captures any adverse events or complaints related to foods 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. However, it’s also important to understand the information in the database is exactly as reported to the FDA, and the agency has not necessarily determined if the products(s) in question were the actual cause of the events reported.

From January 1, 2004 through September 30, 2016, the FDA received 56,574 adverse event reports. Of these, 26,840 adverse events were reported for conventional food; 25,412 were reported for dietary supplements; and 4,322 were reported for cosmetic products. FDA staff reviewed each of these reports and, collectively, initiated follow-up on hundreds of complaints to investigate potential safety signals.

The FDA is currently modernizing CAERS, improving the process for consumers, health care providers, and other members of the public to provide information to the agency, and expects to have a more user-friendly platform in one to two years. The move to post these data now is an important first step in increasing public access to such information, and the public can expect improved access to even better data in the future.

For additional information:

• Federal Register Notice: Posting Adverse Event Report Data Associated with Conventional Foods, Dietary Supplements, and Cosmetics on the Internet
• CFSAN Adverse Event Reporting System (CAERS)
• Frequently Asked Questions
• Blog: Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public
• MedWatch (FDA’s site for reporting adverse events)