Update — Lawsuit Challenges FDA’s Homeopathic Regulatory Policy

By Alvin J. Lorman, AAHP Counsel

The lawsuit filed last October challenging FDA’s characterization of homeopathic products as unapproved new drugs will not be decided before the second quarter of this year, at the earliest. Filed in federal district court in Washington, D.C. by the Alliance for Natural Health (ANH) and a homeopathic manufacturer, the lawsuit claims that a provision in the 2020 allopathic OTC monograph reform legislation exempts homeopathic drugs from the new drugs provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The plaintiffs also asked the court to enjoin FDA from taking enforcement action against OTC homeopathic drugs on the ground that they are unapproved new drugs. It also challenged the denial of the Citizen Petition filed by Americans for Homeopathy Choice.

On Jan. 21, the government filed a motion to dismiss the lawsuit. The government’s argument is based on the following:

• ANH lacks standing to bring the lawsuit because it failed to allege a concrete injury that satisfies the constitutional “case or controversy” requirement.
• The lawsuit does not challenge any “final agency action,” a requirement under the Administrative Procedure Act. The revised FDA guidance is not final agency action but, rather, it “merely informs the public about the law applicable to homeopathic drugs and the agency’s risk-based enforcement strategy.”
• ANH misreads the provision of the CARES Act that exempts homeopathic drugs from the new administrative order process applicable to the OTC Drug Review.
• The denial of the Americans for Homeopathic Choice Citizen petition was not “arbitrary and capricious,” but rather in accordance with the law.

ANH has until Feb. 21, 2025 to file its opposition to the motion to dismiss, while the government has until March 24, 2025 to file a reply brief. It is unknown at this point whether the court will hear oral arguments on the motion, or whether it will decide based solely on the written pleadings. So the case will be decided no earlier than the second quarter of 2025 and, potentially, a lot later unless the incoming administration decides on a different approach.

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