Special Report: A.S.P.E.N.'s Response to FDA Advance Notice of Proposed Rulemaking

1. 21 U.S.C. § 360ee(b)(3).

2. 21 C.F.R. § 101.9(j)(8). The regulations also require that a “medical food” (I) be specially formulated and processed for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube; (ii) provide nutritional support specifically modified for the management of the unique nutrient needs that result from a specific disease or condition, as determined by medical evaluation; (iii) be used under medical supervision; and (iv) be intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

3. The Joint Commission for Accreditation of Healthcare Organizations recognized this and includes the use of “interdisciplinary nutrition therapy” in the 1996 Accreditation Manual for Hospitals, Volume II; Standard TX4.1 and TX.4.2.

4. The Life Sciences Research Office Federation of American Societies for Experimental Biology advanced this approach in its report Guidelines for the Scientific Review of Enteral Food Products for Special Medical Purposes. The report was prepared for the Center for Food Safety and Applied Nutrition, Food and Drug Administration in 1990.