The Grocery Manufacturers Association ("GMA") announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe ("GRAS") determinations of ingredients added to food.” The initiative includes the following five elements:
- Development by independent technical experts of a publicly available standard to provide guidance on the conduct of ingredient safety assessments. The standard is intended to be “suitable for accreditation using an independent official accreditation body.”
- Establishment of a database listing information on GRAS assessments conducted pursuant to the aforementioned standard. Information in the database will be made available to FDA and other stakeholders.
- Expansion of GMA’s curriculum of GRAS education and training programs, both with respect to regulatory requirements and the scientific procedures used in safety assessments. The expertise of the recently established Center for Research and Ingredient Safety (CRIS) will be made available to stakeholders.
- Adoption of a Code of Practice that addresses the conduct of assessments, maintenance of the GRAS assessment database, and training of employees on GRAS procedures.
- Outreach to inform stakeholders and consumers of the above-described measures.
The initiative implicitly recognizes that, at least when it comes to food ingredient safety, we live in a “show me” era. The increased flow of information on safety assessments to FDA and others, coupled with greater clarity about the conduct of such assessments, should help address the principal concerns that have been raised about the current system.
Of course, we also live in a “my way” (or the highway) era. As we’ve noted in prior postings (here and here), some critics of the current system have pursued a no-holds-barred approach to seeking change, and would prefer nothing less than mandatory premarket approval – a solution that is both unworkable and unattainable. The GMA initiative effectively calls their bluff.