The Food and Drug Administration has issued a final rule that, effective Oct. 17, will amend and clarify the criteria for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug and Cosmetic Act because the substance is generally recognized as safe under the conditions of its intended use. Specifically, this 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 FDA states that the clarified criteria should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act.

This rule also replaces the voluntary GRAS affirmation petition process with a voluntary notification procedure that was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010. Under this procedure any person may notify the FDA of a conclusion that a substance is GRAS under the conditions of its intended use. The FDA states that this procedure will enable stakeholders to be aware of whether the agency has questioned the basis of a conclusion of GRAS status.

The FDA states that this final rule is its most recent step to strengthen oversight of substances added to human and animal food. Next steps include issuing additional guidances related to the GRAS regulations and developing and implementing 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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