The Center for Food Safety, fresh off reaching an agreement with FDA on a timeline for FSMA implementation, filed a lawsuit challenging the agency’s Generally Recognized as Safe (GRAS) rules. The center accuses FDA of failing to protect the public through its fast-track system for ingredients that manufacturers believe should be GRAS.
GRAS dates from 1958, when Congress added a Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. The amendment required manufacturers to demonstrate a proposed ingredient’s safety through scientific testing. Approval power rested with FDA, and a petition period allowed public comment.
A rule proposed by FDA in 1997, but never finalized, gave manufacturers the ability to claim an item is GRAS by submitting a GRAS Exemption Claim. The Center for Food Safety says FDA’s review of these claims is cursory, allowing manufacturers’ assertions about the safety of their products to guide final determinations. The lawsuit asks the court to vacate the 1997 rule and revert to the original 1958 amendment until new regulations on GRAS approval can be drafted.
“It has been 15 years since FDA handed authority to determine GRAS status over to the corporations it is meant to regulate,” says Andrew Kimbrell, executive director for the Center for Food Safety. “FDA has an obligation to provide the regulatory scrutiny the public deserves. FDA’s failure to appropriately regulate food additives has had serious consequences, exposing the public to risky products without adequate due process.”
FDA declined to comment on ongoing legislation.