FDA issues guidance on homeopathic drugs

A final guidance document from FDA details the agency’s efforts to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States. There are currently no FDA-approved products labeled as homeopathic.

The agency has created a risk-based approach under which it aims to prioritize certain categories of homeopathic drug products that potentially pose a greater risk to public health, such as those intended for populations at higher risk for adverse reactions as well as ophthalmic and injectable products, as the routes of administration for these products bypass some of the body’s natural defenses.

FDA noted it expects many homeopathic drug products will fall outside the types of drug products it plans to prioritize for enforcement and regulatory action.