> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Cracks Down on Homeopathic Drugs
- URL: https://www.fdaweb.com/fda-cracks-down-on-homeopathic-drugs/
- Published: 2019-10-24T12:00:00.000Z
- Updated: 2026-09-15T01:58:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145330

FDA acting commissioner **Ned Sharpless** and CDER director **Janet Woodcock** say the agency has taken steps to clarify its risk-based enforcement approach to drug products labeled as homeopathic. In a [statement](https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-protect-patients-potentially-harmful-drugs-sold-homeopathic-products?ref=fdaweb.com), Sharpless and Woodcock say FDA has revised its 2017 draft guidance to give additional information on the risk-based enforcement approach. The revised [draft guidance](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-23335.pdf?ref=fdaweb.com), *Drug Products Labeled as Homeopathic*, describes how the agency intends to prioritize enforcement and regulatory action with regard to drug products, including biologics, labeled as homeopathic and marketed in the U.S. without the required FDA approval.

In response to comments received, the 2017 draft was revised to add a definition of “homeopathic drug product” for the purposes of the guidance, add additional explanation of the safety issues that contributed to development of the draft, and clarify the intent to use risk-based factors to prioritize enforcement and regulatory actions involving homeopathic products that are marketed without required FDA approval, FDA says.

A second step announced is withdrawal of a compliance guide entitled “Conditions Under Which Homeopathic Drugs May Be Marketed.” The statement says that since the compliance guide was issued in 1988, FDA “has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described” in the guide. Sharpless and Woodcock say the guide is inconsistent with the risk-based approach to regulatory and enforcement action generally and does not reflect the agency’s current thinking.

The statement also discusses more than 10 Warning Letters issued in 2019 to companies for violations concerning homeopathic products. “These Warning Letters should alert all companies that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and agency regulations,” it says.