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August 5, 2015

FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals

Lynn L. Bergeson Carla N. Hutton

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled “Guidance for Industry:  Use of Nanomaterials in Food for Animals.”  The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.  FDA states that the Guidance is applicable to food ingredients intended for use in animal food that:  (1) consist entirely of nanomaterials; (2) contain nanomaterials as a component; or (3) otherwise involve the application of nanotechnology.  FDA states:

This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient.  This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP.  At this time, we are not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).