The GMA initiative includes the following elements:
- Development by independent technical experts of a science-based publicly available standard (PAS) framework 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.”
- Establishing a GMA-sponsored database listing information on all GRAS assessments conducted by the food industry using the procedures defined in the PAS. Information in the database will be made available to FDA and other stakeholders.
- Expansion of GMA’s curriculum of GRAS education and training programs, regarding both 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 initiative.
In response to GMA’s announcement, FDA said in a statement that it is "supportive of any initiative that promotes scientific rigor and transparency to independent GRAS determinations ..."
Pressure has been mounting for FDA to more closely monitor chemicals used in processed foods, as manufacturers are currently permitted to determine the safety of their ingredients through the use of publicly available science and paid industry expert panels—but aren’t required to notify FDA of their GRAS determination, although many do. (Of the roughly 10,000 chemicals allowed in food products, 43% are deemed GRAS, according to Pew Charitable Trusts.)
“The initiative implicitly recognizes that, at least when it comes to food ingredient safety, we live in a ‘show me’ era,” Ricardo Carvajal, FTC and FDA regulatory counsel at Hyman, Phelps & McNamara in Washington, D.C., wrote in a post on the law firm’s blog.
“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.”
CSPI: FDA shouldn’t treat this database as the last word
Some critics of the current system have pursued a more plenary approach to seeking change, demanding the FDA review the safety of any food chemical before it goes to market in a product.
Calling this proposed solution “unworkable” and “unattainable", Carvajal added: “the GMA initiative effectively calls their bluff.”
Still, the announcement drew skepticism from consumer advocacy group the Center for Science in the Public Interest, as chief regulatory affairs attorney Laura MacCleery questioned the initiative’s validity as a substitute for third-party evaluation of food additives.
“That this is seen as a step forward neatly illustrates the dysfunction built into the current system,” MacCleery said. “It is outrageous that FDA doesn’t already have the identity, much less the safety data, of all substances added to the nation’s food supply.”
MacCleery added that FDA’s over-reliance on companies’ own safety evaluations fails to fix the core problem, which is that there are no appropriately stringent scientific standards for companies’ private safety determinations on food additives, and insufficient review and oversight of those evaluations.
“Whether these companies’ evaluations are submitted on paper, assembled in a new database, or gift-wrapped with a bow tied around it, it’s no substitute for having independent and rigorous evaluations of suspect additives used in our food. We look forward to learning more about what the industry’s database will have to say about problematic additives. But the FDA shouldn’t treat this new database as if it’s the last word.”