KANSAS CITY, Mo. – The US Food and Drug Administration (FDA) on Aug. 12 issued a final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe,” (GRAS). Unlike food additives, GRAS substances are not subject to FDA pre-market approval. At the same time, they must meet the same safety standards as approved food additives. A GRAS substance must be generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, the FDA explained.

Jay Sjerven 

The final rule, which will become effective 60 days after its publication in the Federal Register, addresses the types of scientific evidence that may be used to demonstrate a substance’s safety and its GRAS status as well as the role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted.”

The final rule also formalizes a voluntary GRAS notification procedure that originally was established under an interim policy and pilot program for human food in 1997 and animal food in 2010.

 Defining GAS
FDA issues final rule on how to determine a substance is generally recognized as safe. 

The FDA said it strongly encourages companies to inform the agency of their GRAS conclusions through the notification procedure finalized in the rule.

“While the FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts,” the FDA said.

In the executive summary of the final rule, the FDA explained while it has premarket review authority over food additives, “a food manufacturer can intentionally add a substance to human food or animal food if the substance is generally recognized as safe under the conditions of its intended use.”

Separately, the FDA has published a partial list of food ingredients whose use is GRAS while acknowledging “it is impracticable to list all ingredients whose use is generally recognized as safe.” The agency said the partial list provides an aid to industry and its understanding of what does not require approval.

Since the 1970s, the FDA has issued regulations clarifying the statutory provision for eligibility of a substance for classification as GRAS. The agency also in the 1970s outlined regulations governing a procedure for persons to voluntarily submit a petition asking the FDA to affirm the GRAS status of a substance under the conditions of its intended use. The petition process was supplanted by the voluntary notification procedure established as an interim policy in 1997 and confirmed under the final rule.

“Experience has shown that our regulations need further clarification to help stakeholders understand when a substance is eligible for classification as GRAS in human food or animal food under the conditions of intended use,” the FDA said. “Experience also has shown that streamlining our evaluation of conclusions of GRAS status will enable us to evaluate more and higher priority substances.”

The FDA said it will follow its GRAS final rule by issuing additional guidelines related to the GRAS regulations. Also, as part of the Foods and Veterinary Medicine Program’s Strategic Plan, it will develop and implement regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances.

The Grocery Manufacturers Association commended the FDA for issuing the final rule, which it said is “another step toward improving and updating the system to meet our shared goal of ensuring that Americans can continue to have one of the safest food supplies in the world.” The GMA said it would have further comment on the new final rule after it had time to review its details more closely.

The final rule was developed partly in response to a 2014 lawsuit brought by the Center for Food Safety (CFS) that charged the agency was operating under the 1997 interim process illegally. Among other things, the CFS sought mandatory as opposed to voluntary notice of a company’s adding a substance it asserted was GRAS to a food.

Cristina Stella, staff attorney at the center, said, “The final rule adopts the most problematic portions of a proposal that Center for Food Safety has been raising concerns about for nearly 20 years. FDA has now codified its practice of letting the fox guard the henhouse, and we are disappointed that FDA has thrown away a golden opportunity to bring meaningful reform to this sector of the food industry.”

Sen. Edward J. Markey of Massachusetts, a critic of the current GRAS procedures, said, “The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take-home exam that industry doesn’t even have to hand in. The FDA missed an opportunity to strengthen the GRAS process by requiring mandatory reporting of GRAS substances. I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply.”