The Pew Health Group (part of The Pew Charitable Trust) recently made national news during its three-year investigation into food additive regulations by directing criticism at the GRAS self-determination process.
A key criticism of the food additive regulatory program is that companies opting to self-determine GRAS status for their ingredients are not legally required to notify the FDA. According to the Pew Health Group, this procedure raises questions as to whether the FDA would concur with the safety of GRAS-determined ingredients since the agency does not review the data itself.
The Group also claimed that of 10,000 chemicals added to food, “3,000 have never gone through an FDA review and for at least 1,000 of these, the FDA has received no notification at all." This leaves the FDA “completely in the dark.”
To shed light on what ingredients have been self-determined GRAS, AIBMR Life Sciences, with extensive expertise in preparing GRAS determinations and submitting FDA GRAS notifications for companies around the world, has created the first GRAS Self-Determination Inventory Database (GSID). The database was released during SupplySide West, following a presentation by AIBMR’s senior director of Research and CEO, Alexander Schauss PhD, FACN, on Wednesday, Nov. 7, 2012, at booth #19078. The database will be available on AIBMR's website, aibmr.com.
AIBMR's creation of the GSID database addresses the recent calls for transparency in the self-affirmation GRAS process, as well as the recommendation of the U.S. Government Accountability Office (GAO) that “at least some basic information, such as the substance's identity” be made known.