The medical foods category is one regulatory pathway available to companies wishing to market foods intended for dietary management of patients unable to obtain nutrients through dietary modification. Typically, medical foods are used under medical supervision.

According to the U.S. Food and Drug Administration (FDA), medical foods are a regulatory category applicable to foods “formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

Our regulatory team can guide your product strategy for medical foods based on your project objectives and target markets of interest. We can help companies with product classification, regulatory compliance with FDA requirements (including Generally Recognized as Safe [GRAS]) and liaising with the FDA on your behalf.

Learn how we can help you overcome your research and regulatory challenges to successfully commercialize your medical food.


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