GRAS (Generally Recognized as Safe) Requirements
GRAS is a strict safety standard established by the FDA, requiring technical demonstration of non-toxicity and safety, as well as a general recognition and agreement by experts that the ingredients are safe for consumption. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations(CRF) Sections 182, 184, and 186. Other ingredients may achieve self affirmed GRAS status via a panel of independent experts in the pertinent field who co-authors a GRAS report. Several ingredients have been specifically permitted by the FDA as safe Medical Foods ingredients, e.g. Folic acid, in Volume 21 CFR Section 172.345(f). Some experts believe that achieving GRAS status is an even higher standard of safety than the standard applied to prescription drugs where a given compound is considered safe for a specific indication in a particular patient population at a specified dose, for a specified period of time. Dietary supplement, OTC drugs, and prescription drugs are not required to have GRAS ingredients. All Physician Therapeutics products ingredients have been safely consumed by widespread populations for long periods of time.