Oxaloacetate CFS as a Medical Food

A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)) is “a food which is formulated to be consumed or administered eternally 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”.

Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition. Medical foods are foods that are specially formulated and processed for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.

The US FDA has established criteria that clarify the statutory definition of a medical food.

Found in FDA’s regulations at 21 CFR 101.9(j)(8), a medical food is exempt from the nutritional labeling requirements of 21 CFR 101.9 only if:

a. It is a specially formulated and processed product for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube, and

b. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impair capacity to ingest, digest, absorb or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;

c. It provides nutritional support specifically modified for the management of the
unique nutrient needs that result from the specific disease or condition, as
determined by medical evaluation;

d. It is intended to be used under medical supervision; and

e. It is 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.

Oxaloacetate CFS meets these requirements. Specifically, as per the orphan drug act requirements, Oxaloacetate CFS is a formulated food which is sold directly to physicians for patients with Chronic Fatigue Syndrome, for the distinctive nutritional need to supplement significantly diminished oxaloacetate levels, as found by clinical trial in ME/CFS patients. The oxaloacetate is for the dietary management of the disease.

The clinical trial that identified the shortage of oxaloacetate in the bloodstream of ME/CFS patients is:

  • Germain A, Ruppert D, Levine SM, Hanson MR. Metabolic profiling of a myalgic encephalomyelitis/chronic fatigue syndrome discovery cohort reveals disturbances in fatty acid and lipid metabolism. Mol Biosyst. 2017 Jan 31;13(2):371-379. doi: 10.1039/c6mb00600k.  PMID: 28059425; PMCID: PMC5365380. https://pubmed.ncbi.nlm.nih.gov/28059425/

The Clinical Trial looked patients that met the 1994 Fukuda definition for ME/CFS and compared normal patients to patients with Chronic Fatigue Syndrome. The QE-MS method was used to study Metabolomics in the Blood of these patients. The study found a statistically significant shortage of the energy metabolite “oxaloacetate”.

A shortage of oxaloacetate affects ME/CFS patients in five metabolic areas, all of which have been identified in ME/CFS patients. http://me-cfs.info/how-oxaloacetate-cfs-may-help-with-me-cfs

In regards to the FDA regulatory criteria:

a. Oxaloacetate CFS is a specially formulated and processed product for the partial feeding of ME/CFS patients via oral capsules, and

b. Oxaloacetate CFS is intended for the dietary management of ME/CFS patients who as a group have been shown to have a statistically significant chronic shortage of oxaloacetate in their bloodstream. Ordinary foodstuffs do not contain enough oxaloacetate to overcome this shortage, so the dietary management of ME/CFS patients cannot be achieved by the modification of the normal diet alone.

c. Oxaloacetate CFS provides nutritional support specifically modified for the management of the deficit of oxaloacetate needs that result from ME/CFS, as determined by Clinical Trial;

d. Oxaloacetate CFS is only sold to medical professionals, so that it can be used under medical supervision; and

e. Oxaloacetate CFS is intended only for a ME/CFS 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.