The Orphan Drug Amendments of 1988 defines a “medical food” 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.
The following criteria must be met for compliance to the definition of a medical food:
The active ingredients must be present in/derived from a food
Efficacy/dosing/safety must be proven in peer-reviewed scientific literature
It is intended to be used under medical supervision; and
Addresses the distinct metabolic requirements of patients with a specific diagnosed disease(s) or condition(s)
All ingredients must be approved food additives or Generally Recognized as Safe (GRAS)
Nutritional Requirements in Diabetic Neuropathy
The need for nutritional support in the management of many clinical conditions is well appreciated, including endothelial dysfunction associated with diabetic neuropathy. Patients with diabetic neuropathy are characterized by reduced blood flow (nitric oxide deficiency) to the peripheral nerves and a progressive loss of nerve fibers leading to symptoms.
Examples of MEDICAL FOODS & Their Therapeutic Uses
Metanx® provides the nutritional support for patients with diabetic neuropathy by aiding in the biosynthesis of nitric oxide and maintaining blood flow to the peripheral nerves to facilitate peripheral nerve repair and nerve regeneration.
Metanx®, a combination of the bioavailable forms of B vitamins, L-methylfolate, Methylcobalamin, and Pyridoxal 5’-phosphate is classified as a medical food. Metanx® is specifically formulated for the distinct nutritional requirements of patients with endothelial dysfunction who present with loss of protective sensation and neuropathic pain associated with diabetic peripheral neuropathy.
NéevoDHA® provides dietary management of impaired metabolic processes in women under a doctor’s care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid.
NéevoDHA® is a combination of L-methylfolate, Methylcobalamin, Iron, and DHA along with other essential vitamins and minerals needed during pregnancy. NéevoDHA® is the only medical food specifically formulated for the dietary management of women with high risk recurrent pregnancy loss and impaired folic acid absorption.
What is a Medical Food?
The Orphan Drug Amendments of 1988 defines a “medical food” 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.
The following criteria must be met for compliance to the definition of a medical food:
Nutritional Requirements in Diabetic Neuropathy
The need for nutritional support in the management of many clinical conditions is well appreciated, including endothelial dysfunction associated with diabetic neuropathy. Patients with diabetic neuropathy are characterized by reduced blood flow (nitric oxide deficiency) to the peripheral nerves and a progressive loss of nerve fibers leading to symptoms.
Examples of MEDICAL FOODS & Their Therapeutic Uses
Metanx®, a combination of the bioavailable forms of B vitamins, L-methylfolate, Methylcobalamin, and Pyridoxal 5’-phosphate is classified as a medical food. Metanx® is specifically formulated for the distinct nutritional requirements of patients with endothelial dysfunction who present with loss of protective sensation and neuropathic pain associated with diabetic peripheral neuropathy.
NéevoDHA® is a combination of L-methylfolate, Methylcobalamin, Iron, and DHA along with other essential vitamins and minerals needed during pregnancy. NéevoDHA® is the only medical food specifically formulated for the dietary management of women with high risk recurrent pregnancy loss and impaired folic acid absorption.
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