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# FDA Denies Homeopathy Petition
- URL: https://www.fdaweb.com/fda-denies-homeopathy-petition/
- Published: 2022-12-07T12:00:00.000Z
- Updated: 2026-09-14T18:08:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153334

FDA has denied a 6/5/2020 petition submitted by Americans for Homeopathy Choice that asked the agency to approve a regulation proposed in the petition to exempt some homeopathic drugs from premarket review and take other steps. The FDA 12/6 [response](https://downloads.regulations.gov/FDA-2020-P-1510-29367/attachment%5F1.pdf?ref=fdaweb.com) says the advocacy group had six requests:

- adopt the regulation proposed in the petition;
- recognize as safe and effective homeopathic drugs that are properly manufactured and labeled and listed in or formally pending approval for listing in the *Homeopathic Pharmacopoeia of the U.S. (HPUS)*;
- prohibit any drug product not listed in or formally pending approval for listing in the *HPUS* from using the term homeopathic in any form that states or implies that the product is homeopathic;
- ensure that any drug product listed in or formally pending approval for listing in the *HPUS* is manufactured following the determinations of the *HPUS* and FDA good manufacturing practices;
- if FDA applies a risk-based policy to homeopathic drug products and drug products labeled as homeopathic, ensure that such a risk-based policy is formulated and applied with generally accepted standards and procedures of risk assessment; and
- if FDA denies the petition, hold a public hearing to consider the petition’s contents.

FDA says the petition’s stated purpose is to have the agency recognize that properly manufactured, labeled, and evaluated homeopathic drugs do not meet the legal definition of a “new drug” and thus are not subject to premarket review. The response says the agency declines to issue such a regulation absent a determination that all homeopathic drugs and drug products are exempt from existing premarket approval requirements.

The request that FDA prohibit some drugs and drug products from using the term homeopathic was denied because the Federal Food, Drug, and Cosmetic Act does not define homeopathic drugs and does not restrict them to those listed in the *HPUS*.

After similarly denying the petition’s fourth and fifth requests, FDA denied the request for a public hearing, noting that it held a two-day hearing in 4/2015 to obtain information and comments from stakeholders about the current use of homeopathic drug products and the agency’s regulatory framework for such products. The docket from the hearing remained open until 11/2016 and FDA received more than 9,000 comments from a wide variety of stakeholders, the response says, leading to the issuance of a draft guidance in 12/2017 for public comment. FDA issued a revised draft guidance in 10/2019 to enable more public input and received more than 50,000 additional comments, it says.

“Given the broad, extensive feedback the agency has already received from relevant stakeholders, as well as the thorough consideration the agency has brought to these issues, FDA finds that an additional public hearing is not necessary at this time,” the letter concludes.