On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements. Adverse events can be any negative reaction to a product, such as a serious illness or allergic reactions, or other complaints like packaging problems, that are received through FDA’s voluntary adverse event reporting systems for these classes of regulated products (except for in the case of dietary supplement manufacturers, who have mandatory reporting obligations).
The CFSAN Adverse Event Reporting System, called “CAERS,” includes data from reports submitted by consumers, medical professionals, and industry. The initial data file made public by the Agency contains CAERS data from January 2004 through September 2016. Continue Reading FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods