FDA Announces Posting of Adverse Event Report Data for Foods and Cosmetics
Wednesday, December 7, 2016
  • FDA’s CFSAN Adverse Event Reporting System (CAERS) is a post-market surveillance system that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. Adverse event reports come primarily from consumers and health care providers, and can include minor to major medical events, as well as complaints about off-taste or color of a product, defective packaging, and other non-medical issues.  Of the covered products, only dietary supplement manufacturers have a legal obligation to report adverse events to the Agency in the case of serious adverse events associated with the use of a dietary supplement (see 21 U.S.C. 379AA-1).

  • Today, FDA published a notice (81 FR 88244, Dec. 7, 2016) announcing the availability of data extracted from adverse event reports from January 2004 to the present involving food (including food additives, color additives, and dietary supplements) and cosmetics regulated by FDA’s CFSAN.  The Agency’s notice further indicates that it will now post on a quarterly basis data extracted from adverse event reports, including conventional foods and dietary supplements, and cosmetics, to help increase transparency and improve access to government data for consumers, health care providers, researchers and academics. FDA also plans to make available raw data files that can be downloaded in .csv format or through OpenFDA.gov as an application program interface (API).

  • Increasing public access to adverse event information certainly represents an important step in transparency for the Agency; however, it also raises issues as to whether the information will be used to benefit consumer class action plaintiff’s lawyers as they search for their next target in the food, dietary supplement or cosmetic industries.

 

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