Regulatory Open Forum

Hello,

Can anyone tell me the necessary inclusions in a "physician's letter" related to a medical food?  Can you please direct me to the appropriate reference?  I have reviewed the FDA compliance program and FDA website related to medical foods with no luck.  the compliance program states this "physicians letter" is to be collected by the FDA investigator during the inspection and it will be forwarded to CFSAN.  I am having trouble determining what should be included in this letter.  Thank you for your help.

For compliance purposes, I would suggest the letter be written pursuant to  USC360ee(b)(3) and 21 CFR 101.9(j)(8).

As a medical food, it should be accurately communicated that your medical food is a specifically formulated and processed product; intended for the dietary management of a patient; it provides nutritional support modified for the management of the unique nutrient needs; intended to be used under medical supervision; and intended only for a patient receiving active and ongoing medical supervision..

Further, communication should be based on "medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, and must be intended to be used under medical supervision. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition."