Claims of therapeutic effect with respect to the treatment of any medical condition or disease are prohibited by the Food and Drug Administration in the US, and by the corresponding regulatory agencies in other countries, unless the substance has gone through a well established clinical trial with neutral oversight. In the United States, the following notice is mandatory on food, drug, and nutrient product labels that make health claims: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.[36]