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A recent HBW Insight article centered on an interview with ANH-USA General Counsel, Jonathan Emord, Esq., spotlighted our ongoing legal battle with the FDA over its restrictive 2022 final guidance on homeopathic products. The FDA’s move made in 2022 under the Biden Administration effectively revoked the long-standing Compliance Policy Guide (CPG) 400.400 and classified all homeopathic drugs as “new drugs” subject to the FDA’s drug approval process.
As you may recall, our lawsuit challenges the FDA’s threat to homeopathic medicines in revoking CPG 400.400. The court recently dismissed several of our claims, but allowed one to proceed, acknowledging that our lawsuit met the threshold for standing—specifically noting the economic harm caused when Whole Foods removed Meditrend’s products following the policy change.
ANH’s General Counsel, Jonathan Emord, emphasized that if ANH and our co-claimant, homeopathic medicine company Meditrend, do not prevail in court, the case has strong grounds for appeal—particularly regarding the court’s decision to treat the facts as undisputed and to weigh the merits of the complaint before trial. Emord also pointed out the inconsistency between the FDA’s crackdown on homeopathy and broader government efforts to support consumer health and competitive markets, including the “Make America Healthy Again” agenda championed by HHS Secretary Robert F. Kennedy Jr.
Emord notes in the HBW Insight article that the FDA’s decision has chilled the entire homeopathic supply chain. Contract manufacturers and suppliers—facing heightened scrutiny and intimidation—have begun limiting or halting production of homeopathic remedies, leading to product shortages and fewer choices for consumers. Emord explained that these developments represent a basis for legal action.
The court has ordered the FDA to provide its full administrative record of its decision to reject our Citizens Petition, which will determine whether the agency had sufficient safety concerns to justify revoking CPG 400.400. ANH believes these safety concerns are unfounded—homeopathic products have a vastly lower rate of reported adverse events than conventional drugs or even supplements.
While a final decision in this case may not arrive until mid-2026, ANH remains committed to challenging what we see as an unlawful and harmful shift in policy—one that not only undermines consumer access to safe, time-tested natural health products, but also sets a dangerous precedent for overregulation by federal agencies.
