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THE TOPLINE

• This week, the Alliance for Natural Health (ANH-USA), along with homeopathic manufacturer Meditrend, filed a lawsuit challenging the FDA’s new regulatory stance that could eliminate most over-the-counter (OTC) homeopathic products. We’re arguing that the policy violates federal law, threatens the $6 billion industry, and ignores decades of safety data.
• The lawsuit contends that the FDA’s policy shift is not only unlawful in that it violates federal law, it also ignores Congressional decisions that required that homeopathic products be treated differently to conventional drugs.   
• By treating homeopathics as “new drugs,” the FDA’s guidance requires that homeopathic medicines undergo pre-market approval and clinical trials in the same way as conventional drugs. This presents an insurmountable obstacle for the homeopathic industry, as these remedies cannot be patented and manufacturers cannot afford the high costs associated with approval.
• The lawsuit seeks to protect access to homeopathic remedies used by over 6 million Americans and prevent the FDA from enforcing its restrictive new policies.

ANH-USA, in conjunction with Meditrend, Inc. have filed a lawsuit challenging the FDA’s recent regulatory changes that could eliminate most over-the-counter (OTC) homeopathic products in the U.S. market. ANH and Meditrend argue that the FDA’s new stance on homeopathy conflicts with federal law, violates the U.S. Constitution, and threatens an entire industry valued at over $6 billion annually.

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Homeopathy, a centuries-old system of medicine based on highly diluted substances that stimulate the body’s natural healing process, has been formally recognized and protected by U.S. law for over 80 years. In the Food, Drug, and Cosmetic Act (FDCA), Congress recognized homeopathic medicines as distinct from conventional drugs, allowing them to be regulated differently due to their long-standing safety record and unique manufacturing processes.

However, the FDA’s guidance issued in December 2022 now subjects all homeopathic drugs to the same pre-market approval standards as conventional pharmaceuticals. Make no mistake—this requirement is a threat to the entire modality of homeopathy along with the millions that have  benefited from it—and the many more that might benefit from it in the future. Our lawsuit argues that this change is based on unsubstantiated concerns and ignores decades of data showing the safety and efficacy of homeopathic remedies.

Legal background of the case

ANH and Meditrend filed the lawsuit against Robert M. Califf, the Commissioner of the FDA, and the U.S. government, seeking a court ruling to reverse the FDA’s policy.

We argue that the agency has overstepped its legal authority by ignoring provisions of the Coronavirus Aid, Relief, and Economic Security Act of 2020 (CARES Act), which aimed to reduce regulatory burdens on OTC products.

The CARES Act acknowledges homeopathics as a “unique and separate category of drugs” and intended for them to be subject to different, less restrictive regulations than conventional pharmaceuticals. By requiring FDA drug approval for homeopathics, the FDA has disregarded Congressional intent and placed an unreasonable burden on homeopathic drug makers.

Further, the FDA excluded homeopathic drugs from the new drug approval process for decades because they were viewed, appropriately, as a separate category of medicine. The reason for the FDA’s change of heart, in our view, is the growth of the homeopathic industry—one catalyzed at a time of real need during the coronavirus crisis—growth which no doubt threatens the bottom line of the drug manufacturers that work closely with the FDA.

Constitutional violations

The lawsuit also asserts that the FDA’s new guidance violates the Due Process Clause of the Fifth Amendment. Under the current policy, the FDA has broad, discretionary power to remove homeopathic drugs from the market at will. This lack of regulatory certainty has created an unstable environment for the homeopathic industry and its consumers.

ANH and Meditrend are seeking a court ruling that would exempt homeopathic OTC products from the FDA’s pre-market drug approval requirements and prevent the FDA from enforcing its December 2022 guidance.

This lawsuit is critical not just for the survival of the homeopathic industry, but also for maintaining consumer access to these widely used natural remedies.

Threat to the homeopathic industry

The FDA’s shift in policy threatens to destroy the entire homeopathics industry in America. Unlike conventional drugs, homeopathic remedies cannot be patented, which means that manufacturers cannot afford the exorbitant costs of clinical trials and regulatory fees required for FDA approval. The FDA is requiring pre-market approval of homeopathic medicines, knowing full-well this is an insurmountable obstacle. These aren’t the actions of an agency looking to protect public health—they are the actions of monopolists looking to eliminate competition for their benefactors in the pharmaceutical industry.

We’re not going to let the FDA, on the flimsiest of pretexts, eliminate an entire modality of medicine that millions of people rely on for their health. We will keep you updated on the case as it progresses.

Fighting the FDA in court takes resources. Stand with us and support our fight against the FDA by contributing to our legal war-chest.

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