FDA Issues Final Rule on GRAS

In a step to strengthen its oversight of food ingredients, FDA has 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; however, they must meet the same safety standards as approved food additives.

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.” 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.

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.

FDA intends to issuing additional guidances related to the GRAS regulations and develop and implement regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances.

For more information:

• Final Rule: Substances Generally Recognized as Safe Rule