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# Homeopathic Drug Products Enforcement Guide
- URL: https://www.fdaweb.com/homeopathic-drug-products-enforcement-guide/
- Published: 2022-12-07T12:00:00.000Z
- Updated: 2026-09-14T18:08:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153336

FDA has released a [final guidance](https://www.fda.gov/media/163755/download?ref=fdaweb.com) 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.*”