Physicians’ Use of Dietary Supplements and Nutrients as Therapy that May Benefit
Update: Certification Course for HCP Now Available
Medical Foods Webinar Now Available
"…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....” Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))
"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
a. be intended to meet distinctive nutritional requirements of a disease or condition,
b. used under medical supervision and
c. intended for the specific dietary management of a disease or condition."
"The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality."
"In general, to be considered a medical food, a product must, at a minimum, meet the following criteria:
a. the product must be a food for oral or tube feeding;
b. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and
c. the product must be intended to be used under medical supervision..."
(1) the Orphan Drug Act pre-empts the regulation of Medical Foods*;
(2) products protected under DSHEA can be considered Medical Foods, and
(3) it is appropriate for health care providers to recommend dietary management of various nutritional and metabolic syndromes that are being identified by advanced health care practitioners.
“distinctive nutritional requirements, based on recognized scientific principles… established by medical evaluation…”
“For the Dietary Management of ___________.” and “To be used under medical supervision.”
The Vitamin Lawyer.com Consultancy