For years, the FDA has been threatening the future of homeopathic medicine; it’s now time for it to stop.
Listen to the audio version of this article:
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.
>>> Download ANH Media Pack including press release
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.
We are not stupid. I an not a child. And I can judge for myself what to put into my body.
In due respect, no leading homeopathic organization, including the Homeopathic Pharmacopeia Convention of the USA, has interpreted that FDA document to even suggest that “most” homeopathic medicines will be banned.
As the author of 10 books on homeopathic medicine, I too would be screamed from the rooftops if the FDA was proposing such things…but THEY ARE NOT.
Homeopathy is a life-saver.
It should not be banned.
Cordially,
Great Work against the Great Medical Monopoly War circa 2024.
This issue is not if the FDA will regulate the homeopathics but will they regulate them when the drug companies have purchased them?
So if we fight to keep the FDA from regulating the homeopathics, the drug companies buy out the homeopathics, then we have just let the drug companies put whatever they want into a vitamin we think is natural and healthy.
So unless stock holders and investors associated with the drug companies are prohibited from owning any homeopathic buisnesses or stocks etc. what is the point?
Since homeopathy is based on entirely different manufacturing procedures than pharmaceuticals, it should be allowed different methods of evaluation than those used by the pharmaceutical industry. There is no reason why both methodologies cannot coexist, and viewed a complementary rather than subjecting attempting to force homeopathics to adhere to the methods employed by big pharma to validate their products.
This is America! We need choices!! Big Pharma does not provide what I am needing or wanting for lasting health!
Please post a pdf of the lawsuit or a link. This is a VERY important lawsuit!
Thank you~
Sorry – you did post a link. TY!!!
There’s a big problem that isn’t addressed here: Homeopathic remedies are not DRUGS. Period. They are a completely different modality and work differently than the drugs mentioned in “FDA,” a.k.a. “Food and DRUG Administration.” Between the acknowledgement from Congress in both the Food, Drug, and Cosmetic Act (FDCA), and the CARES act, and the recent court decision that federal agencies do not have powers of enforcement independent of the specific job Congress gave them when it set them up, There should be no way that the FDA can regulate homeopathics as if they were pharmaceuticals.
The idea that running pharma-type clinical trials would be cost prohibitive should not even be mentioned, as it is totally irrelevant. Homeopathics are tested in a completely different way than are pharmaceuticals, and they don’t come to market without that testing. The FDA is waaay out of its lane on this one.
Homeopathy is an ancient health support modality that does not threaten traditional allopathic medicine practices. In fact, homeopathy complements the miracle of modern medicine; why not honor the synergy of the two approaches instead of vilifying one over the other.
FDA requiring clinical trials for homeopathic medicines is so hypocritical. Childhood vaccines have never had clinical trials, yet the government mandates them or children can’t attend public school.
What about the 30% of people who cannot metabolize the synthetic drugs? The 30% has been acknowledged in nursing and medical journals for years! Big pharma’s solution is to give them more drugs for the “side effects”. This is a major reason why America has such an unhealthy population and big pharma has such a healthy bank account. Greed, not health, is the motivating factor in these actions.
The USA is below / at the bottom of the 10 wealthiest countries on planet earth comparing longevity, birth and infant mortatlity, and population longevity – and, we spend mre on ealth for these inferor results.
This is primarily due to pharmacutical influence on politicians, influence on physicians, and nfluence on the general population.
WE need to go to RFK to bring about change…..
Don’t touch homeopathy, STOP KILLING US FOR MONEY!!!!
GREAT WORK. KEEP IT UP. WE NEED YOUR VOICE.
CORDIALLY,
Big Pharma is buying influence. Homeopathy works, and it is choice. I am pro-choice in everything. And it hurt noone, so let it be!
the decades of data showing that homeopathy is safe is not supported by the Wiley library page that you linked to, quite the opposite.