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 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. 

The government normally has 60 days to respond to a complaint, but the parties have agreed to extend that time. In a joint motion for a scheduling order, which the court granted, the government defendants now have until Jan. 21, 2025 to file a motion to dismiss the complaint. (A motion to dismiss is based on the argument that, even if the plaintiffs’ facts are true, they don’t have a case legally.) The plaintiffs have until Feb. 21, 2025 to file their 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 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 at https://theaahp.org/newsletter/lawsuit-challenges-fdas-homeopathic-regulatory-policy/