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FDA Issues Its Final Rule on the Criteria of Substances Generally Recognized as Safe (GRAS) and Voluntary GRAS Notification Program

22 August 2016

On August 17, 2016, the U.S. Food and Drug Administration (FDA) issued its final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods. This long-awaited final rule, published nearly twenty years after the 1997 proposed rule, clarifies the criteria for when the use of a substance is not subject to the premarket approval requirements of the
Federal Food, Drug, and Cosmetic Act (FFDCA) because the substance is GRAS. It also establishes a new administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS. We commend the agency for upholding its statutory authority of the FFDCA and retaining the voluntary nature of the GRAS program.

We also support FDA’s efforts in providing more clarification of the basis of a GRAS decision and more flexibility with the voluntary GRAS notification program. The preamble of the final rule contains important comments related to FDA’s recent actions against substances with safety concerns and with the agency’s view on the GRAS criteria. Companies considering the addition of a substance to any food on the basis of a GRAS conclusion should carefully review the final rule and reevaluate the substance’s compliance with the FFDCA in light of the new regulations. The final rule becomes effective October 17, 2016.

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Authored by Martin Hahn, Xin Tao & Samantha Dietle.