If you use homeopathic medicines, then you’ll know that changes in FDA policy threaten your access. For more than 30 years, FDA provided clear conditions under which these products could remain on the market. The agency withdrew that policy in 2019, and in its 2022 guidance declared that all homeopathic medicines are in effect illegal because they have not been through a full drug approval process. ANH and homeopathic manufacturer Meditrend have now filed a formal and detailed petition asking FDA to restore clear rules that protect consumer access while targeting products with genuine safety problems.
Our press release below explains what we’re asking for—and why it matters for your health choices.
ANH Petitions FDA to Restore Clear Protections for Homeopathic Medicines
Citizen Petition calls for reinstatement of CPG 400.400, formal rulemaking, and a science-based “traffic-light” enforcement framework
ALEXANDRIA, VA., October 1, 2026 — The Alliance for Natural Health USA (ANH-USA), together with homeopathic manufacturer Meditrend Inc., has filed a Citizen Petition calling on the U.S. Food and Drug Administration (FDA) to restore its longstanding enforcement policy for homeopathic medicines and halt implementation of its current framework pending formal public rulemaking.
For 31 years, FDA’s Compliance Policy Guide 400.400 provided a clear framework under which homeopathic products meeting specified standards could be marketed without being treated as enforcement targets solely because they lacked new drug approval. FDA withdrew that policy in 2019 and later finalized a risk-based enforcement guidance in December 2022.
ANH-USA and Meditrend argue that FDA’s replacement framework leaves responsible manufacturers unable to know what steps will protect compliant products from enforcement—even where products meet established homeopathic, labeling, and quality standards. The petition further argues that FDA failed to adequately account for decades of industry reliance on CPG 400.400 or undertake the notice-and-comment rulemaking required before adopting a policy with such broad practical effects.
“FDA cannot replace a clear, relied-upon compliance framework with an open-ended enforcement policy that leaves an entire lawful industry guessing,” said Jonathan W. Emord, General Counsel to ANH-USA. “The agency must either restore CPG 400.400 or engage in proper rulemaking so manufacturers, suppliers, retailers, practitioners, and consumers know where the legal lines are.”
Restore clear rules and protect consumer access
The petition asks FDA to take three actions pending completion of formal notice-and-comment rulemaking:
- Revoke its 2019 withdrawal of Compliance Policy Guide 400.400.
- Reinstate CPG 400.400 and its conditions for marketing homeopathic medicines.
- Cease implementation of the enforcement framework adopted in the December 2022 homeopathic drug guidance.
Focus enforcement on demonstrated product risks
The petition’s scientific exhibit examines 2,068 adverse event reports associated with homeopathic or purportedly homeopathic products. The analysis concludes that FDA’s own adverse event records do not justify treating properly manufactured, HPUS-compliant, correctly labeled homeopathic medicines as a broad public health risk.
The exhibit argues that FDA has relied heavily on isolated, unrepresentative examples involving improperly manufactured, mislabeled, contaminated, pharmacologically dosed, or otherwise non-compliant products. Such products were never entitled to the protections of CPG 400.400. Their defects support targeted enforcement against specific bad actors or risky products—not withdrawal of the clear compliance framework for responsible manufacturers.
“FDA’s own adverse event record fails to show any evidence of a class-wide safety problem with properly manufactured, correctly labeled, HPUS-compliant homeopathic medicines,” said Robert Verkerk, Ph.D., Executive and Scientific Director of ANH-USA. “The science points to a very different conclusion: enforce against adulteration, mislabeling, contamination, inappropriate routes, and genuinely risky products—but do not use those outliers to threaten the entire category. The FDA’s current stance on homeopathics works in direct opposition to this administration’s MAHA agenda.”
Regulatory uncertainty has concrete consequences
In a sworn declaration accompanying the petition, Meditrend President Seneca Savage describes lost investor support, difficulty sourcing ingredients, and manufacturing disruptions following FDA’s policy change.
ANH-USA warns that this uncertainty threatens consumer access to long-standing homeopathic products. The petition calls for a transparent, enforceable framework that preserves FDA’s authority to act against adulteration, misbranding, and genuine safety concerns while giving responsible manufacturers predictable conditions under which to operate.
The accompanying scientific exhibit proposes a practical “traffic-light” approach. Green products—those meeting defined homeopathic, labeling, manufacturing, and low-risk criteria—would be treated as lowest enforcement priority. Amber products raising unresolved concerns would be subject to additional scrutiny. Red products presenting clear risks, such as adulteration, contamination, misbranding, pharmacologically active exposure, or causally supported serious adverse events, would be prioritized for enforcement.
“FDA should focus its resources where the real risks are,” Verkerk added. “A clear Green-Amber-Red framework would protect consumers, preserve access, and give responsible companies the certainty they need to operate.”
ANH-USA is urging FDA to act without delay and to establish a transparent public process for defining the boundaries of lawful, responsible homeopathic drug marketing.
