How does the U.S. Food and Drug Administration (FDA) regulate homeopathic remedies?
Because of their long use in the United States, the U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be regulated by the FDA in the same manner as nonprescription, over-the-counter (OTC) drugs, which means that they can be purchased without a physician’s prescription. Today, although conventional prescription drugs and new OTC drugs must undergo thorough testing and review by the FDA for safety and effectiveness before they can be sold, this requirement does not apply to homeopathic remedies. Remedies are required to meet certain legal standards for strength, quality, purity, and packaging. In 1988, the FDA required that all homeopathic remedies list the indications for their use (i.e., the medical problems to be treated) on the label.22,23 The FDA also requires the label to list ingredients, dilutions, and instructions for safe use. The guidelines for homeopathic remedies are found in an official guide, the Homeopathic Pharmacopoeia of the United States, w