Adverse Events for Food and Cosmetics
​[Posted on: Thursday, December 8, 2016]

This week FDA released a comprehensive list of all adverse events (AEs) reported to it related to food, dietary supplements and cosmetics for the last 12 years. This information was previously available only upon freedom of information request. The announcement “Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public” sounds ironic once one reviews the list of AEs. The downloadable Excel file lists about 77000 AEs reported to FDA in chronological order with no obvious categories, organization or any other way to easily review. The AEs range from very mild to life-threatening events. FDA announcement also had the disclaimer that the information contains incomplete reports and that FDA has not always “necessarily determined if the reported AEs were actually caused by the product in question” leading to us scratching our head as to what is the utility of such a list to the public. Manufacturers of food, dietary supplements, cosmetics, and other related products are required to investigate any AEs reported to them, and in turn report those AEs to FDA if the events are determined to be related to a marketed product. In turn, FDA’s clinical reviewers in the Center for Food Safety and Applied Nutrition (CFSAN) review the AEs reported to them, and evaluate for potential safety concern. Based on this evaluation, FDA take appropriate measures to address the concern such as taking action against the manufacturers of such products, make public announcement to create awareness for the risk, and even removal of the offending product from the market. FDA is entrusted with protecting the public and the above process makes sense. However, the utility of releasing a list of tens of thousands of AEs collected over 12 years for marketed products that are not directly regulated by FDA, is limited at best. The list can lead to misperception about the risk of marketed products since even FDA acknowledged that the reported information was incomplete. It would be useful if the list also includes FDA’s evaluation of the reported AEs, and which events lead to regulatory actions. Without such relevant information, the list is not very helpful. There are times when too much information is not useful, this seems like a good example of such a case.