Oxaloacetate CFS is a “Medical Food”— 500 mg Oxaloacetate capsules by oral administration.

A specially formulated Medical Food product, consisting of thermally stabilized oxaloacetate (an energy metabolite founding in nearly every cell of the body) in a hypromellose capsule shell.

This product is formulated for the nutritional management and distinctive medical needs of patients with Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Medical Food products are used under a physician’s care for the dietary management of diseases in patients with particular, unique or distinctive medical or metabolic needs due to their disease or condition.

Congress defined “Medical Food” in the Orphan Drug Act and Amendments of 1988 as “a food which is formulated to be consumed or administered eternally [orally] 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 used for patients receiving active and ongoing medical supervision who require medical care on a recurring basis, including instructions on how to use the medical food.

Oxaloacetate CFS has been manufactured and labeled in accordance with both the statutory definition of a Medical Food and FDA’s regulatory labeling guidelines.

Oxaloacetate CFS must be used while the patient is under the ongoing care of a physician, however, no prescription is required for patient purchase or use of Oxaloacetate CFS.

Independent clinical trial work has shown that patients with ME/CFS have significantly lower levels of the energy metabolite “oxaloacetate” in blood plasma samples as compared to normal healthy controls. 

Oxaloacetate CFS provides additional oxaloacetate for these ME/CFS patients. Clinical trials with ME/CFS patients and Long-COVID patients (that meet ME/CFS definition guidelines) have shown that oxaloacetate supplementation significantly reduces energy “crashes”, physical fatigue and mental fatigue (brain fog, cognitive impairment). 

Each bottle of Oxaloacetate CFS contains 90 hypromellose "veggie" capsules of 500mg of Thermally Stabilized Oxaloacetate (anhydrous enol-oxaloacetate).

Oxaloacetate is a compound found in nearly every cell of the body—this Medical Food provides the body with additional amounts of oxaloacetate.

Oxaloacetate is a critical component of the Krebs cycle and is involved in energy production. Oxaloacetate is in many of the foods consumed including chicken, spinach, apples, and potatoes.

This Medical Food provides more oxaloacetate in their diet have shown up to a 49% increase in average lifespan, thought to be achieved through the activation of the same molecular pathways as calorie restriction.

The ingredients in Oxaloacetate CFS are self-certified as "Generally Regarded As Safe" (G.R.A.S.). GRAS substances are distinguished from food additives on the basis of the common knowledge by experts about the safety of the substance for its intended use.

An independent Institutional Review Board (IRB) found that up to 6 grams of oxaloacetate was safe for infants (but with a different disease).

Oxaloacetate is also found as a nutritional supplement food in countries throughout the world.

The mixture of oxaloacetate and Vitamin C is approved by Health Canada with a "Natural Product Number" (NPN) of 80039432.

The following Structure/Function Claim for oxaloacetate has been submitted and allowed by the US Food and Drug Administration (US FDA):

Oxaloacetate may help alleviate physical and mental fatigue symptoms associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Veggie Capsule (Hypromellose).

Oxaloacetate CFS is a 500 mg white to orange-white powder in a clear dye-free “veggie” capsule.