District Court Declines to Dismiss Challenge to FDA Denial of Americans for Homeopathy Choice Citizen Petition

By Alvin J. Lorman, AAHP Counsel

A U.S. District Court has ruled against all but one of the claims asserted by the Alliance for Natural Health (ANH) in its lawsuit challenging the Food and Drug Administration’s (FDA) regulation of homeopathic drugs. But the ANH challenge to FDA’s denial of the 2020 Americans for Homeopathy Choice (AFHC) Citizen Petition survived FDA’s Motion to Dismiss and will be the subject of further proceedings.

The lawsuit, filed in U.S. District Court for the District of Columbia in October 2024, alleged that:

• Subjecting homeopathic drugs to the new drug approval process is unlawful because it contravenes the CARES Act OTC monograph reform provisions and because it exceeds FDA’s statutory authority;
• FDA’s denial of the Americans for Homeopathy Choice Citizen Petition seeking a different regulatory scheme for homeopathic drugs was arbitrary and capricious because it was based on “fundamental errors of law and fact”;
• FDA’s imposition of heightened regulatory requirements is arbitrary and capricious because it is based on “unsupported safety concerns”; and
• The revised 2022 Final Guidance violates the plaintiffs’ Fifth Amendment Due Process rights under the Administrative Procedure Act (APA) and directly under the Constitution.

FDA moved to dismiss the complaint for lack of subject matter jurisdiction and failure to state a claim for which relief can be granted. FDA also asserted that that ANH and a homeopathic manufacturer co-plaintiff lacked standing to bring the lawsuit. The Court held that ANH and its co-plaintiff did have standing to bring the lawsuit, but found for FDA on all of the substantive counts save one.

In its July 15 ruling, the court held that FDA’s action did not contravene the CARES Act, which exempted homeopathic drugs from the revisions to the OTC Drug Review process but did not exempt homeopathic drugs from FDA regulation. The court also held that the 2022 Final Guidance was not final agency action because it simply set out FDA’s enforcement priorities and “has no direct legal consequences.” APA jurisdiction only extends to final agency action. The court also rejected ANH’s Due Process and Constitutional challenges.

The court did hold, however, that FDA’s denial of the AFHC Citizen Petition was final agency action reviewable under the APA and that the plaintiffs had standing to challenge FDA’s denial. But, the court said, “without an administrative record, the Court cannot rule on whether the FDA had sufficient safety concerns about homeopathic drugs to justify the petition denial.” The court ordered the parties to submit a proposed schedule for producing the Citizen Petition administrative record and for briefing summary judgment motions on that count by July 29.

Previous related articles:

AAHP’s update of the case details published January 22, 2025: https://theaahp.org/newsletter/update-lawsuit-challenges-fdas-homeopathic-regulatory-policy/

AAHP’s original summary of the case details published November 19, 2024: https://theaahp.org/newsletter/lawsuit-challenges-fdas-homeopathic-regulatory-policy/