ANH’s filing argues FDA acted on a flawed record— triggering market harm with no showing of systemic risk
Alexandria, VA — The Alliance for Natural Health USA (ANH-USA), together with homeopathic manufacturer Meditrend, Inc., has filed a comprehensive legal brief in federal court challenging the U.S. Food and Drug Administration’s (FDA) ongoing campaign against homeopathic medicines.
The filing responds to the FDA’s opposition to ANH-USA’s motion for summary judgment and forcefully rebuts the agency’s claim that homeopathic medicines pose an elevated safety risk. ANH-USA argues that the FDA’s position represents a dramatic and unjustified reversal of decades of regulatory practice recognizing the safety of homeopathic medicines manufactured in accordance with the Homeopathic Pharmacopeia of the United States (HPUS) and applicable Good Manufacturing Practices (GMPs).
“Our latest pleading in the homeopathy case before the U.S. District Court establishes, based on strong record evidence, that FDA relied on isolated and unrepresentative instances of HPUS and GMP violations as the basis for its conclusion that all homeopathic drugs are not demonstrably safe,” said Jonathan Emord, ANH General Counsel. “That determination is precisely the kind of shoddy analysis the federal courts have found arbitrary and capricious in violation of the Administrative Procedure Act and should support reversal and remand of the FDA decision.”
For more than 80 years, the FDA regulated homeopathic medicines under a distinct enforcement framework that acknowledged their almost unparalleled safety record. In recent years, however, the agency has dismantled that framework, asserting—without credible evidence—that homeopathic medicines are inherently unsafe and should be treated in the same way as high-risk drugs.
“There is still time for FDA Commissioner Makary to keep homeopathy available to the American people by settling our case and reversing FDA withdrawal of CPG 400.400, but that window of opportunity is closing fast,” continued Emord. “Our filing contains extensive evidence that demonstrates that the FDA relied on isolated cases involving adulterated or misbranded products to justify sweeping conclusions about the entire category of homeopathic medicines,” said ANH Executive and Scientific Director, Rob Verkerk, Ph.D. He continued, “That’s like shutting down every restaurant in America because a few of them failed hygiene inspections.”
The brief explains that these products were already unlawful under existing FDA authorities and do not reflect the safety profile of properly manufactured, HPUS-compliant homeopathic products. It also includes documentation of the real-world economic harm caused by the FDA’s actions. As detailed in sworn affidavits, FDA enforcement pressure has disrupted supply chains, increased manufacturing costs, and led major retailers to discontinue sale of lawful homeopathic products—despite the absence of evidence showing systemic safety risks.
According to the administrative record cited in the filing, properly manufactured homeopathic medicines account for a tiny fraction of poison-control calls and are associated overwhelmingly with no, and occasionally minor, adverse effects. There are no documented deaths or serious injuries attributable to HPUS-compliant homeopathic products—making them among the safest health products regulated by the FDA.
ANH-USA is asking the court to reverse and remand the FDA’s denial of a citizen petition filed by the American Homeopathic Consumer Freedom (AHCF) Coalition, requiring the agency to reassess the safety of homeopathic medicines based on the full body of scientific and historical evidence.
If successful, the case could have far-reaching implications for consumer access to homeopathic medicines and for the limits of FDA authority when agencies abandon evidence-based decision-making.
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EDITOR’S NOTES
ANH’s filing (January 22, 2026): https://anh-usa.org/wp-content/uploads/2026/01/REPLY-AND-OPP-fnl-pdf-1.pdf
ANH’s initiation of lawsuit (October 25, 2024):
https://anh-usa.org/anh-sues-fda-to-stop-u-s-homeopathy-ban/