The Food and Drug Administration (FDA) announced in December of last year that it would begin releasing data related to Adverse Event Reports (AERs) received by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), which oversees food and cosmetic safety. In the past, the CFSAN Adverse Event Reporting System (CAERS) has not made this information public, except through Freedom of Information Act requests. However, in December CFSAN released the raw data for all AERs from Jan. 1, 2004, through Sept. 30, 2016, with plans to continue to release data on a quarterly basis.
The public availability of this data is seen as a win for both consumers and health care professionals hoping for more transparency with regard to food and cosmetics. The ability to compile and review AERs about a particular product may assist in spotting hazards. In a blog post about the release, FDA officials stated, “We’re hoping that this increased transparency will result in more detailed and complete reports that will help us to more rapidly identify red flags about a possible safety issue with products we regulate.”
However, the release of data comes with several caveats. First, the FDA will only release the raw data associated with an AER. There is no conclusion of causation or risk. Second, the information is not filtered or verified in any way. Finally, there is currently no requirement that food and cosmetic manufacturers report adverse events to the FDA. Therefore, it is possible that many adverse events go unreported and will not be included in this data. Therefore, while consumers can use this information as one means of identifying potential risks, it does not provide a full picture.
For now, it is too early to see how this data will be used, including how it will affect regulations, recalls and litigation, but the FDA has indicated that it will continue to modernize and streamline the adverse event reporting process in hopes of creating a more effective database.
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