Keeping with spirit of open government and that people deserve to know, Food and Drug Administration took an additional measure to spread knowledge through Adverse Event Report Data. According to FDA’s press release, “[t]his is information that was once only available through Freedom of Information Act (FOIA) requests, but will now be easily available to researchers, consumers, and health professionals.” The data comes in the form of .csv file. From producer’s / distributor’s stand point, the most harmful piece of information comes in the column marked as “PRI_Reported Brand/Product Name.” While at times overly broad, some line items list in sufficient details the product name and brand. For example, “POLAND SPRINGS SPRING WATER” is on the list to have allegedly caused “DIARRHOEA, ABDOMINAL PAIN, RIGORS, NAUSEA” to a 29 year old male on December 2, 2003.” Good question is how it will affect imports or prospective food imports? FDA’s press release potentially provides answer as follows:
The goal of CAERS is to provide indications, or “signals” of potential hazards. FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics. This information can, and has, led to investigations of specific products, targeted inspections and product testing, import alerts, warning letters, and enforcement actions.
In other words, the list was used for years for FDA investigations, but now it is made available to the public (including the international trade community) to get a sneak preview of potential product inspections by FDA of the product in question. So the food compliance community can now add additional list to their list of FDA checks, which should include among other things; import alerts, warning letters, untitled letters.
