The FDA announced last week that it will be making data available from adverse event reports dating on a going-forward basis with an initial release of data on adverse events from the present back to January 2004 involving food and cosmetics regulated by the Center for Food Safety and Applied Nutrition. You’ll no longer need to submit a FOIA request to see this data which is submitted primarily from health-care providers and consumers regarding products. This compiled list of grievances ranges from issues related to bad packaging, illnesses, and death, to complaints about the flavor, quality, color of foods/products.

The stated goal of the move is to increase transparency – even though this is consumer driven data and not vetted or determined to be truthful, let alone accurate, by the FDA. These are the reports that the investigative arm of the FDA then follows-up on in its efforts to keep the public safe from harmful products. In explaining itself, the FDA’s notice in the federal register offered this Q&A:

Why is CFSAN posting these data on the FDA Web site?

We are making this information available for the purpose of improving transparency by providing the public, including researchers and health care professionals, with online access to information from adverse event reports about CFSAN-regulated products. This information has previously been available only through the process of specific requests under the Freedom of Information Act, 5 U.S.C. 552. In addition, we believe that posting these data may increase the number and completeness of the adverse event reports we receive. For the most part, FDA does not have pre-market authority over foods and cosmetics. As a result, identifying through post-market surveillance possible risks associated with these products is critical.

Where and when will data be posted?

We will post CAERS data on a quarterly basis on the FDA Web site at http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm. Each posting will include adverse event reports entered in CAERS for the previous 3 month period, with a roughly one month delay. So for example, if we post data files on the CAERS Web page in February, the information would consist of adverse event reports entered (or revised) in CAERS during the previous October thru December time period. Data files from the January thru March time period would be posted in the following May, and so on.

As a public-friendly move granting greater access to important updates and consumer information, this is a welcome modernization in the world of regulatory transparency.

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