First Self-Affirmed GRAS Database Debuts at SupplySide West from Regulatory Consultant AIBMR

November 7, 2012

AIBMR says it introduced the database in response to public calls for more transparency surrounding the self-affirmed GRAS process.

The first database tracking which nutraceutical ingredients have been self-affirmed GRAS debuted at SupplySide West today from nutraceutical scientific and regulatory consultant AIBMR Life Sciences (Puyallup, WA). The company, which has extensive experience preparing both self-affirmed and FDA GRAS notifications, says it introduced the database in response to public calls for more transparency surrounding the self-affirmed GRAS process.

Under the self-affirmed GRAS process, qualified experts outside of FDA can review the safety data concerning an ingredient’s use for food and beverages. If an ingredient is determined safe for use, companies can declare the ingredient self-affirmed GRAS. Self-affirmed GRAS designations are not necessarily forwarded to FDA for review. However, companies have the option of notifying FDA of their determination, in which case FDA will review the notification and provide a response.

According to AIBMR, the self-affirmed GRAS process has seen recent criticism from The Pew Health Group, part of The Pew Charitable Trust, following a three-year investigation of U.S. food additive regulations. AIBMR says that The Pew Health Group criticized the self-affirmed GRAS process for not requiring FDA notification.
The company says, “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.” In fact, AIBMR reports, The Pew Health Group said that of 10,000 chemicals added to food, 3,000 have never gone through an FDA review and that the agency has received no notification at all for at least 1,000 of these ingredients.

Additionally, AIBMR says, the U.S. Government Accountability Office (GAO) has also recommended more transparency regarding the self-affirmed GRAS process, including that “at least some basic information, such as the substance’s identity” be made known.

AIBMR’s GRAS Self-Determination Inventory Database (GSID) was released during SupplySide West, following a presentation by AIBMR’s Senior Director of Research and CEO, Alexander Schauss PhD, FACN.