January 3, 2017
The CAERS data file made available on December 6, 2016 included data reported by consumers, health care practitioners, and mandatory reports by industry from January 2004 through March 2016. Data voluntarily reported by industry were not included in this data file, but will be made available during the next quarterly update in February 2017. In the interim, these reports are available through Freedom of Information (FOI) requests to FDA.
Original Constituent Update
December 6, 2016
The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) will now post on a quarterly basis data extracted from adverse event reports, including conventional foods and dietary supplements, and cosmetics, in order 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).
The CFSAN Adverse Event Reporting System (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)