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Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition;

CFSAN Constituent Update

August 13, 2013

The Food and Drug Administration (FDA) today issued a Federal Register notice announcing the availability of a draft guidance for industry Frequently Asked Questions About Medical Foods: Second Edition. Although comments can be submitted on any guidance at any time, the notice provides 60 days after the date of publication for comment on the draft guidance before we begin work on the final version of the guidance. We issued the first edition of this guidance in May 2007. This draft guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses.

Medical foods are foods formulated to be consumed or administered orally or enterally under the supervision of a physician. Medical foods are 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.

Medical foods are specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone. Medical foods are not those foods simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition like diabetes, for example.

We invite interested persons to submit comments by October 15, 2013.

To submit comments electronically visit:


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