About Medical Foods
The Orphan Drug Act defines "medical food" as a food which is formulated to be consumed or administered 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, as established by medical evaluation.
Medical foods must:
- Be specially formulated and processed
- Be orally consumed
- Have a recognized scientific basis for use
- Be used under medical supervision
- Address the distinct metabolic requirements of patients with specific diagnosed disease(s) or condition(s)
- All ingredients must be Generally Recognized as Safe (G.R.A.S.) or approved food additives.
- The product must comply with general food safety and manufacturing standards.
CRONaxal is a medical food, available for the clinical dietary management of the metabolic needs of Glial tumor patients. After review, the US FDA designated Terra Biological's oxaloacetate (CRONaxal) as an "orphan drug" for the treatment of Glial tumors. Although recognized by the FDA as an "orphan drug", CRONaxal is not a drug, but a medical food. Medical foods typically have not undergone the extensive well designed, randomized, placebo controlled trials required for FDA approval as drugs. They are evaluated for safety, and do have a scientific basis for use. Unlike dietary supplements, which do not require medical guidance, and do not specifically address any disease, medical foods must be used under medical supervision and are formulated for a specific disease.
Often, medical foods are used to complement currently available prescription drug therapies. Animal tests indicate that CRONaxal (oxaloacetate) is most effective when combined with chemotherapy, providing a synergistic response to glioma, improving survival over the control group and chemotherapy alone. This increase in survival has not been proven in human clinical trials, but has been seen in some individual case studies. As with all things, individual results will vary.
CRONaxal contains oxaloacetate and ascorbic acid (Vitamin C) in easy to swallow veggie capsules. While you have probably heard of Vitamin C, oxaloacetate may be a new term to you. Oxaloacetate already exists in every cell of your body as a natural human compound. It is a critical metabolite in the Krebs Cycle within the mitochondria, providing your body with energy. Oxaloacetate is also in the food you eat, found in chicken, spinach, apples, potatoes and many other foods, and is used as a dietary supplement in many countries. This medical food provides your body with more oxaloacetate than you would normally consume on a daily basis. Oxaloacetate has been shown to reduce the levels of another metabolite, "glutamate", in the brain in multiple animal studies. Glial tumors are thought by many to spread in part by excreting excess glutamate, which kills surrounding neurons, allowing an area for tumor growth. Oxaloacetate reduces glutamate levels by combining with the glutamate to make the brain protective compound alpha-Ketoglutarate.