FDA Rules on GRAS Ingredients
Today, the U.S. Food and Drug Administration (FDA) issued a final rule outlining the criteria that will decide whether or not an ingredient meant for use in human or animal food is generally recognized as safe (GRAS).
The GRAS criteria require that 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.
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.
So what does this all mean for food companies?
The FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with today’s 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 GRAS final rule is the most recent step we are taking to strengthen the FDA’s 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, the 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.
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