FDA Issues Final Rule on Criteria for Food Ingredients GRAS Status

FDA today issued its final rule detailing the criteria for concluding whether the use of a substance in human or animal food is “generally recognized as safe" (GRAS). The announcement comes just one day after the agency published a new document aimed at improving compliance with notification requirements for new dietary ingredients (NDIs).

Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives. The final rule clarifies the criteria for the use of a substance to be eligible for classification as GRAS and establishes a new administrative procedure for any person to notify FDA of the basis for a conclusion that a substance is GRAS under the conditions of its intended use.

Specifically, the rule addresses the types of scientific evidence that can be used to demonstrate safety as well as the role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted." GRAS criteria requires the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts. The final rule also formalizes the voluntary GRAS notification procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010.

FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with today’s rule. While 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 GRAS final rule is the most recent step FDA is taking to strengthen its oversight of substances added to human and animal food. Next steps include issuing additional guidances related to the GRAS regulations. As part of the Foods and Veterinary Medicine Program’s Strategic Plan, FDA will develop and implement innovative regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances. The final rule will take effect 60 days from the when it is published in the Federal Register.

Interested in learning more about what’s happening at FDA around dietary supplements? Join FDA’s Cara Welch, Ph.D., senior advisor in the Office of Dietary Supplement Programs, in the SupplySide West Featured Speaker session on Thursday, Oct. 6, at SupplySide West 2016.