To the long history of determining which food additives are “Generally Recognized as Safe” (GRAS) by the federal government, we can now add a privately developed database that is open to the public, all in the name of transparency. AIBMR Life Sciences at the Supply Side West show in Las Vegas introduced the new GRAS Self-Determination Inventory Database (GSID) earlier this week. Among its business services, the Seattle-based AIBMR prepares GRAS determinations for review by the U.S. Food and Drug Administration (FDA). The GSID collates publicly available data on self-affirmed GRAS ingredients from trade publications and other public domain sources and provides the information in an open, online database that it wants businesses will help keep updated. John R. Endres, chief science officer, acknowledges that AIBMR has started out small with the GSID, but hopes it will catch on with industry and grow rapidly. FDA’s GRAS list goes back to 1958. Any substance that is intentionally added to food is considered a food additive requiring pre-market approval from FDA, unless it’s on the GRAS list. For a decade or so after the list was published, manufacturers could write the FDA for an “opinion letter” on whether something should be considered GRAS. Safety questions got cyclamate salts removed from the GRAS list before President Richard M. Nixon ordered the list reviewed. This led to FDA implementing a review and petition process before the current GRAS notification process whereby industry submits GRAS notices to FDA, which does a review and notifies the applicant by letter. According to FDA, its response will generally fall into one of three categories:
- The agency does not question the basis for the notifier’s GRAS determination;
- The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or
- The response letter states that the agency has, at the notifier’s request, ceased to evaluate the GRAS notice.
FDA’s GRAS Notice Inventory logs this activity, including whether an FDA letter has been issued. Critics argue that GRAS is too much of a self-certification process, allowing voluntarily withdrawals if challenged and not producing enough public information. The Food Additive Project at The Pew Charitable Health Trusts found about 1,000 substances on the list that FDA does not have any substantive informative about. Tom Neltner, who heads the Pew project, told Food Navigator that he is encouraging AIBMR to include all the chemicals it has determined are safe in food in its database.