A federal court just gave ANH-USA the green light to challenge the FDA’s attack on homeopathy—keeping hope alive for millions who rely on natural remedies.
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THE TOPLINE
- A federal court has ruled that ANH-USA and Meditrend have standing to challenge the FDA’s attempt to regulate homeopathic medicines as conventional drugs—a move that could devastate the $6 billion homeopathy industry.
- The court dismissed three claims but allowed a key argument to proceed: that the FDA failed to justify its claim that homeopathics pose a safety risk when revoking long-standing protections under CPG 400.400.
- ANH-USA will continue the legal fight while calling on FDA and HHS leadership to reconsider the policy that threatens access to natural, time-tested remedies used by millions.
This week, the Alliance for Natural Health USA (ANH-USA) cleared a major legal hurdle in its lawsuit to preserve access to homeopathic medicines in the United States. On July 15, 2025, the US District Court for the District of Columbia ruled that ANH-USA and its co-plaintiff, homeopathic manufacturer Meditrend, Inc., have standing to challenge the FDA’s aggressive move to regulate homeopathic products like conventional pharmaceuticals—a move that could destroy the $6 billion homeopathic industry and cut off access to natural remedies used by millions of Americans.
While the Court dismissed three of our four legal claims, it allowed a crucial argument to proceed: the FDA lacked adequate justification that homeopathic medicines were a safety risk when it revoked Compliance Policy Guide 400.400—a policy that had protected homeopathic remedies from being subjected to the same prohibitively expensive approval requirements as conventional drugs.
“FDA’s safety justification for revoking CPG 400.400 lacks merit and substance,” said ANH General Counsel Jonathan Emord. “[ANH Founder and Executive Director] Dr. Rob Verkerk and I are convinced based on the evidence cited by FDA and the long history of safety associated with homeopathics and recognized not only by FDA in the past but by the World Health Organization, that FDA lacks sufficient evidence of safety to justify the revocation order.”
He further said, “while we disagree with the Court’s decision concerning the three other counts of our complaint, we will vigorously fight to overturn the FDA’s revocation order before this Court and on appeal.”
The lawsuit, filed against FDA Commissioner Robert Califf and the US government, argues that the FDA’s 2022 guidance fundamentally mischaracterizes homeopathic medicines by lumping them in with conventional drugs and applying the same regulatory requirements. This includes a multi-billion-dollar approval process that is economically unfeasible for homeopathic manufacturers, as their remedies—being natural and unpatentable—generate far less profit and cannot support the costs of pre-market approval and clinical trials. (See our previous coverage here and here for more background.)
A Threat to an Entire Medical System
The FDA’s policy shift puts the entire modality of homeopathy at risk. For more than 80 years, homeopathy has held a distinct legal status under the Food, Drug, and Cosmetic Act (FDCA), with Congress recognizing its unique safety profile and manufacturing practices. But the FDA’s current approach erases that distinction, allowing the agency essentially to declare that all homeopathic medicines are illegal, and any one of them can be targeted and removed from store shelves at any time.
ANH and Meditrend still hold out hope that FDA Commissioner Makary and HHS Secretary Kennedy will act to resolve this dispute without need for a decision on the merits of the ANH/Meditrend suit.
“It is an odd, anti-MAHA thing for Dr. Makary and Secretary Kennedy to be arguing that homeopathy is unsafe and must go through the $2 billion drug approval process, thus protecting Big Pharma from competition,” said Emord. “I do not believe they support that, and, so, I think once fully apprised of this case, they should settle with us.”
ANH-USA Will Keep Fighting—With Your Help
The court’s ruling means the fight is far from over. The surviving claim will allow ANH and Meditrend to bring critical evidence before the Court to expose the FDA’s lack of justification for its actions. ANH-USA will also continue to press the agency to reconsider this dangerous policy before the courts are forced to decide.
We are hopeful that reason will prevail—and that the FDA and HHS will come to the table to resolve this dispute without continuing down a path that puts corporate profits over public health.
In the meantime, we need your help. Legal battles of this magnitude require significant resources. Stand with us and help protect access to homeopathic medicines by contributing to our legal war chest today.
