The main issue is that GRAS allows companies to decide whether a substance meets the definition of GRAS without mandating a review by the U.S. Food and Drug Administration before being added to food.
The Natural Resources Defense Council (NRDC) has previously estimated that about 1,000 of the 10,000 additives used today are being used based on undisclosed GRAS safety determinations. NRDC’s latest report attempted to find out more about the chemicals reported as GRAS based solely on a company determination and to examine safety decisions of companies which voluntarily submit additives for FDA review.
The organization was able to identify 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations and found that, of the requests for FDA review, about one in five notices is rejected or withdrawn from review.
NRDC stated that communications between FDA and companies seeking agency review – information obtained under the Freedom of Information Act – revealed that FDA carefully reviews notifications and “asks tough questions. The agency’s reviews often raise serious safety concerns or reveal that the company’s scientific analysis is flawed or inconsistent with the law.”
If the agency rejects a GRAS notice, it sends an explanation of the safety concerns in a letter to the company and publishes the letter online.
“But when a company withdraws a notice and asks FDA to stop further review,” the report notes, “the agency issues a letter confirming the withdrawal without publicly explaining any of the concerns that could have prompted the withdrawal.”
Furthermore, such a withdrawal doesn’t prevent the company from marketing the product for use in food. The report details four chemicals with withdrawn GRAS notices – epigallocatechin-3-gallate (EGCG), gamma-amino butyric acid (GABA), theobromine, and sweet lupin protein, fiber, and flour – noting that, despite safety concerns, they have been listed as an ingredient in some food products.
“There are gaping holes in the safety net for chemicals that are added to our food supply,” said Erik Olson, NRDC senior strategic director for health and food.
Ultimately, the report concluded, “A chemical additive cannot be ‘generally recognized as safe’ if its identity, chemical composition, and safety determination are not publicly disclosed.”
NRDC recommends that FDA publish safety concerns even when companies withdraw notices, require that FDA be informed of GRAS determinations, and limit conflicts of interest.