Our new court filing exposes the FDA’s deeply flawed arguments against homeopathic medicine safety and details the harms done to industry and consumers in the agency’s actions. Action Alert!
THE TOPLINE
- ANH-USA has filed a major federal court brief challenging the FDA’s attempt to sideline homeopathic medicines, arguing the agency wrongly claims heightened safety risks and abruptly abandoned more than 80 years of regulatory practice recognizing homeopathy’s safety when properly manufactured.
- The filing shows the FDA relied on isolated enforcement cases to justify sweeping policy changes, despite data showing HPUS-compliant homeopathic products have an exceptional safety record with no documented deaths or serious injuries.
- The filing documents real harm to consumers and manufacturers from the FDA’s actions and is asking the court to force a reassessment based on full scientific and historical evidence.
ANH-USA has filed a major legal brief in federal court challenging the FDA’s aggressive campaign to marginalize—and effectively eliminate—homeopathic medicines.
Filed alongside homeopathic manufacturer Meditrend, Inc., the brief 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 heightened safety risks. ANH-USA argues that the FDA’s position represents an abrupt and unjustified break from more than 80 years of regulatory practice recognizing the safety of homeopathic products 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 ANH General Counsel Jonathan Emord. “That determination is precisely the kind of shoddy analysis the federal courts have found arbitrary and capricious in violation of the [Administrative Procedures Act] and should support reversal and remand of the FDA decision.”
A Proven Safety Record—Ignored
For decades, the FDA regulated homeopathic medicines under a distinct enforcement framework that acknowledged their long history of safe use and low toxicity. That framework was dismantled in recent years, culminating in the agency’s 2022 guidance declaring all homeopathic medicines to be “unapproved new drugs”—despite knowing full well that homeopathic products cannot realistically comply with pharmaceutical New Drug Approval requirements.
“Our filing contains extensive evidence that demonstrates that the FDA relied on isolated cases involving adulterated or misbranded products that are already illegal under existing law 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.”
Real Harm to Consumers and Manufacturers
The brief also documents the real-world consequences of the FDA’s actions. Sworn affidavits detail how regulatory uncertainty has disrupted supply chains, increased manufacturing costs, and caused major retailers to pull lawful homeopathic products from their shelves—without evidence of systemic safety risks.
According to the administrative record, properly manufactured homeopathic medicines account for only a tiny fraction of poison-control calls and are overwhelmingly associated with minor or no adverse effects. There are no documented deaths or serious injuries linked to HPUS-compliant homeopathic products, placing them among the safest 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 homeopathic safety based on the full body of scientific and historical evidence.
ANH-USA is also urging supporters to back the Americans for Homeopathy Choice legislation, which would restore legal clarity for homeopathic medicines and protect consumer access through congressional action.
Help Us Stop FDA Overreach!
We’re in a fight we can win—but only if we can fund it. Our 2026 litigation strategy—headed by our General Counsel Jonathan Emord—the most successful attorney in U.S. history in cases against the FDA—is designed to force accountability and stop FDA policies that chill lawful natural health options. Court deadlines don’t wait, and neither do legal bills.
Please give what you can today to the Litigation & Lobbying Fund via our secure donation portal to maximize our chances of successfully protecting your health freedom.
