FDA to Begin Posting Adverse Event Report Data for Foods and Cosmetics
On December 7, 2016, the Food and Drug Administration published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements and cosmetics. Until now, such adverse event report data has only been publicly available by submission of a Freedom of Information Act request to the Agency. FDA has stated it is providing adverse event data to increase transparency and improve access to such data for consumers, health care providers, researchers, and academics.
The noted adverse event data is extracted from FDA’s “CFSAN Adverse Event Reporting System,” a database that include reports submitted to FDA by consumers, medical professionals, and industries. 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. Manufacturers of dietary supplements, but not conventional foods or cosmetics, are legally obligated to report adverse events that they receive to the Agency.
FDA uses the term “adverse event” as an umbrella term for a number of poor outcomes, including bad reactions, illnesses, or deaths, but also complaints about off-taste or color of a product, defective packaging, and other non-medical issues. Further, FDA uses adverse event reports as part of its overall strategy to help monitor the safety of foods and cosmetics. Moving forward, FDA anticipates that the above referenced 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.
FDA’s first posting of data covers reports submitted to FDA from 2004–September 2016. The Agency will begin posting updated data files on a quarterly basis (usually about 30-days from the end of the previous quarter). It is important to note that the report data from CAERS consists of the information that was initially reported to FDA, and should not be taken out of context. For example, the Agency has not determined that the events reported were actually caused by the product identified in the report. Further, the reports often do not include a complete description of the event.
FDA has noted that between January 1, 2004 and September 30, 2016, the Agency 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. Each of these reports has been reviewed by FDA staff which, collectively, has initiated follow-up on hundreds of these complaints to investigate potential safety issues.
At present, FDA is modernizing CAERS and working to improve the reporting process for consumers, health care providers, and other members of the public, It is expected that a more user-friendly platform will be in place within one to two years.
Arent Fox follows and reports on FDA developments related to the safety of foods and cosmetics. Please contact Georgia C. Ravitz, James R. Ravitz, and Brian P. Waldman for further assistance.