> ## 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.

# Homeopathic Drugs Not ‘New Drugs’: Trade Group
- URL: https://www.fdaweb.com/homeopathic-drugs-not-new-drugs-trade-group/
- Published: 2018-07-31T12:00:00.000Z
- Updated: 2026-09-15T00:23:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142005

Americans for Homeopathic Choice and three of its top leaders are challenging an FDA draft guidance on homeopathy that says it intends to treat all homeopathic medicines as if they are “new drugs.” In a citizen [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-2962-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com), the group says it believes that homeopathic medicines fall under the 1938 definition of “drug,” and that the law does not require premarket approval of homeopathic medicines already existing in the Homeopathic Pharmacopeia of the United States because they are not “new drugs.”

The petition asks FDA to: 

- establish an expert advisory committee on homeopathy;
- convert language supplied by the group into a regulation;
- simultaneous with review of the supplied regulation, withdraw the current pending guidance document “Drug Products Labeled as Homeopathic” issued 12/20/17;
- during the time that FDA considers whether to publish a proposed regulation and until such time as the petition is resolved, the agency continue to use the submitted language as the guiding document for homeopathy; and
- hold a public hearing on the matter before approving the 12/2017 guidance if it fails to grant the petition.