Consumer Advocacy Groups Recommend Fixing GRAS

By Melissa Lind, contributing writer

In 1997, the Food and Drug Administration issued a proposed rule which clarified the way food additives could be classified as generally recognized as safe. The FDA never finalized the rule, but has been operating under the procedure since the proposal.

An estimated 10,000 food additives are currently used in food production. The FDA has up to 3,000 generally recognized as safe (GRAS) notifications that have not been reviewed and up to 1,000 additives may be in use without any notification at all. The rule changed the traditional pathway for manufacturers seeking GRAS status for food additives from a petition process to a notification procedure. Under the proposed rule, any person can notify the FDA that a particular food additive is GRAS.

That said, last year, the agency agreed to finalize the rule by 2016 as part of a settlement in a lawsuit filed by the Center for Food Safety (CFS). CFS claims the agency was lax in its regulatory enforcement and consumers may have suffered by not having a voice in the rulemaking process.

As the rule finalization approaches, a coalition of consumer advocacy groups, including the Center for Science in the Public Interest (CSPI), the Consumers Union, the Environmental Working Group, and the Natural Resources Defense Council have submitted an 80 page commentary document claiming the 1997 proposed rule is an “invalid interpretation of the Food Additives Amendment (FAA) of 1958.”  The coalition further states that the “FDA has an affirmative obligation to fix its proposal” in order to protect the public from “unsafe chemical additives.”

The groups want the FDA to modify the proposed rule to limit substances eligible for GRAS exemption. They have also stated that GRAS ingredients should not be added until enough scientific data regarding safety has been collected from valid, publishable, and unbiased sources. Additionally, the groups suggest that companies should be required to notify the FDA of determinations, safety data, and adverse event reports.

The settlement of the 2014 lawsuit filed by CFS requires that the proposed rule be finalized by 2016 and allows for CFS to ask the court to order finalization if not done by the deadline.