FDA Amends Regulations to Clarify When a Substance is Considered Generally Recognized as Safe

August 17, 2016

On Wednesday, August 17th, the FDA issued a final rule regarding when a substance is generally recognized as safe.  FDA states that the final rule is intended to amend and clarify the criteria in its regulations concerning “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 (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use.”

In its notice, FDA announced that it is also replacing the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may alert the Agency of a conclusion that a substance is GRAS under the conditions of its intended use.

FDA notes that the clarified criteria will allow stakeholders to make more informed conclusions regarding whether or not a substance’s intended conditions of use comply with the FD&C Act.  Furthermore, FDA’s notification procedure will inform stakeholders as to whether the FDA is questioning the basis of a conclusion of GRAS status.

For more information and a detailed explanation of the Agency’s amended regulations, view FDA’s final rule.

Are you in the process of developing an FDA-regulated product? We can help ensure that your product is compliant with all FDA regulations and work with you to obtain a successful outcome with FDA.  To learn more about our services and how we can help you, contact us today.


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