FDA Serves Up Another Helping of Draft Guidance on Medical Foods

On August 13th, the Food and Drug Administration (FDA) released a second version of its draft guidance on medical foods. The draft guidance, “Frequently Asked Questions About Medical Foods; Second Edition,” amends and expands upon the original draft guidance published in 2007 by incorporating 15 new questions and answers. Specifically, the FDA addresses medical food labeling, physician supervision, and the scope of permissible diseases or conditions that medical foods may be labeled or marketed to manage.

A “medical food” is defined in the Orphan Drug Act as “a food which is 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.” In accordance with the 2007 draft guidance and several recent Warning Letters, the revised draft guidance advises that it considers the statutory definition to “narrowly constrain” this category of food. The FDA has also provided criteria clarifying the statutory definition of medical foods in its regulations. See 21 C.F.R. § 101.9(j)(8). Products that qualify as medical foods are exempt from nutrition labeling requirements, as well as the requirements for health and nutrient content claims. Accordingly, medical foods may bear claims regarding the management of disease or meeting the distinctive nutritional requirements of disease patients.

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