Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.
The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs. FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”
Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market. Even now, FDA has not conducted a formal review of homeopathic drugs. Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.
