In December 2022, the U.S. Food and Drug Administration (FDA) issued a final guidance that describes how it intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the U.S. without the required FDA approval. FDA's risk-based approach will be used to prioritize enforcement and regulatory actions involving categories of products that FDA says may pose a higher risk to public health.
FDA noted that it anticipates that many homeopathic drug products will fall outside the categories of drug products that it intends to prioritize for enforcement and regulatory action. The final guidance can be accessed here.
