Drugs

Homeopathic Drug Products Enforcement Guide

FDA has released a final guidance entitled “Homeopathic Drug Products” that describes how the agency intends to prioritize enforcement and regulatory actions for such products marketed without the required FDA approval. The document outlines a risk-based approach for prioritizing enforcement and regulatory actions. For example, the following unapproved homeopathic products are top priority:

Products with reports of injury that, after evaluation, raise potential safety concerns.
Products that contain or purport to contain ingredients associated with potentially significant safety concerns.
Products for routes of administration other than oral and topical that can pose serious risks to the patient.
Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions. These raise public health concerns, in part, because they may cause users to delay or discontinue approved medical treatments
Products for vulnerable populations.
Products with significant quality issues.

The guidance 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.”

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