top of page

USFDA Guidance: Homeopathic Drugs Products

Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry", that describes the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients.

FDA defines a “homeopathic drug product” as a drug product that is labeled as “homeopathic,” and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).

According to the agency, the majority of homeopathic drug products fall outside the categories of products for which it intends to prioritize regulatory action.

Currently, there are no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality.

Click this LINK to know more about FDA’s Risk-based Approach and Enforcement Policy on Homeopathic Drug Products.


bottom of page