New lawsuit challenges FDA guidelines regulating homeopathy as unconstitutional

Caryn Lipson

November 10, 2024

Regulatory changes threaten homeopathy

The non-profit ANH (Alliance for Natural Health,) together with Meditrend, a company that develops and sells nutritional formulations and homeopathic remedies, filed a lawsuit on October 21st challenging the FDA’s recent regulatory changes that may make it illegal for pharmacies to sell homeopathic remedies over the counter. Plaintiffs named in the lawsuit include the United States, the FDA, and FDA Commissioner Robert M. Califf, all of whom, the organization avers, are violating the U.S. Constitution and threatening the $6 billion homeopathic industry.

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.

Background

Homeopathy is a unique form of natural medicine that operates on principles distinct from those of conventional pharmaceuticals and is produced through specialized methods. Developed in the 1800s, it initially gained popularity but saw a decline in the early 20th century with the rise of mainstream medicine. In recent decades, interest in homeopathy has surged as more people seek natural healing alternatives. Although Congress recognized homeopathy as a separate category of medicine and did not subject it to the same regulations as pharmaceuticals, the FDA has now issued guidelines requiring homeopathic manufacturers to conduct randomized controlled trials similar to those required for conventional drugs. This raises important questions: Is such regulation legal and/or necessary, and how does the safety and efficacy of homeopathic remedies compare to those of conventional medicines?

Homeopathy’s early history

Homeopathy was developed by Dr. Samuel Hahnemann (1755-1843) as a natural means of healing the body. According to the Compounding Pharmacy of America, Hahnemann was disillusioned with the bloodletting, purging, and toxic chemicals used by doctors at the time, leading him to look into alternative means of healing.

[Hahnemann] started his first homeopathic experiments in 1790, having become disillusioned by the current medical practices of bloodletting, purging and use of toxic chemicals. After translating William Cullen’s Materia Medica into German and doing experiments on himself with South American tree-bark (cinchona) which was being used to treat malaria-induced fever, he discovered that the bark induced the symptoms similar malaria. After other such experiments Dr. Hahneman came up with the homeopathic principle of ‘Like cures like’. It is known as the law of similars – a homeopathic practitioner would seek a substance that produced the same symptoms in a healthy person as his patient presented to him.

Homeopathic schools

Homeopathy was reportedly successful in treating ailments and combatting epidemics and homeopathic schools were created before allopathic medicine gained ground. The American Medical Association was, in part, responsible for the ensuing decline of homeopathy beginning in the early 20th century, as the Compounding Pharmacy of America recounts,

Homeopathy gained popularity since it cured many ailments and many homeopathic schools were founded across Europe and by the late 1800’s, the first school was founded in the U.S. By the early 1900’s, it had become so popular that 22 new schools had sprung up across the country. Homeopathy gained recognition for its success in treating the rampant epidemics of that time – including scarlet fever, typhoid, cholera and yellow fever. By the 1920’s though, the American Medical Association affected the decline of homeopathy’s popularity, as well as the newer drugs that were easier to administer to patients.

Congress recognized homeopathy as a distinct type of medicine

Congress recognized homeopathy as a different class of medicine than allopathic medicine in the Food, Drug, and Cosmetic Act (FDCA) (which established the FDA) noting that homeopathic remedies have a long-standing safety record and a different manufacturing process. However, the ANH explained, the FDA issued guidance in 2022 that would subject homeopathic remedies to the same pre-market approval standards as conventional drugs.

The ANH further claims that this goes against the Coronavirus Aid, Relief, and Economic Security Act of 2020 (CARES Act) which was instituted during the Coronavirus epidemic “to reduce regulatory burdens on OTC products,” and acknowledged homeopathy as a separate category of drugs.

‍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.

Homeopathy a threat to pharma

The non-profit believes the FDA’s changes came about in reaction to the increased demand for homeopathy during the coronavirus crisis, which threatened Big Pharma's bottom line.

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.

Homeopathy has its own system of regulation

Ethan Huff, writing in 2022 about the FDA's changed guidance for homeopathic remedies for Tyranny News, quoted the ANH's statement that homeopathic remedies have to go through their own system of regulation by the Homeopathic Pharmacopoeia of the United States (HPUS).

It is important to remember that homeopathic remedies are, in fact, already regulated. All of them that are currently available had to first undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), a process that ANH-USA explains “involves some clinical verification of the efficacy of the substance.”

There is also plenty of science-based research that backs the safe and effective use of homeopathy. In fact, it is one of the most well-studied fields of “alternative” medicine dating back centuries – this despite very little funding, generally speaking.

FDA hypocrisy

Madison Lyme Supporting Group (MLSG) raised concern about the FDA's hypocrisy in its 2023 article, “FDA Allows Deadly COVID Clot Shots But Targets Homeopathy and Peptides.” MLSG provided links to many sites that detail the adverse effects of the shots including a link to worldwide investigations that show that deaths from the mRNA injection are being covered up.

The MSLG article then goes on to state, before republishing ANH articles on the FDA’s attack on homeopathy and peptides, that the FDA is attacking them since it views them as a threat to pharma drugs.

But the FDA is doing what the FDA does best – attacks anything it views as a threat.

Is homeopathy safe?

Only four deaths

ANH pointed to a 2012 report in the International Journal of Clinical Practice by P. Posadzki, et al., as evidence that multiple studies have shown homeopathy to be safe. Per the abstract, after reviewing five databases from their inception to January 2012, and finding 38 reports that met their inclusion criteria, they could only find four deaths attributed to homeopathy.

In total, 38 primary reports met our inclusion criteria. Of those, 30 pertained to direct AEs of homeopathic remedies; and eight were related to AEs caused by the substitution of conventional medicine with homeopathy. The total number of patients who experienced AEs of homeopathy amounted to 1159. Overall, AEs ranged from mild-to-severe and included four fatalities. The most common AEs were allergic reactions and intoxications. Rhus toxidendron was the most frequently implicated homeopathic remedy

In their discussion, the authors noted that considering the worldwide use of homeopathy, the paucity of adverse event reports might be because their rate is indeed very low.

Our review of CR [case reports] and CS [case studies] is thus not comprehensive. Crucially, it does not tell us anything about the incidence of AEs. Considering the widespread use of homeopathy worldwide and the relative paucity of the reported AEs, it might be very low. Collectively, these limitations render our review less conclusive than we had hoped. (Emphasis added.)

'Positive overall result in favor of homeopathy'

A 2006 study by Gudrun Bornhöft, et al., “compiled on behalf of the Swiss Federal Office for Public Health (BAG)” regarding the effectiveness, safety, and cost-effectiveness of homeopathic medicines, found homeopathy to be safe and effective, although they could not comment on cost-effectiveness.

. . . Swiss regulations grant a high degree of safety due to product and training requirements for homeopathic physicians. Applied properly, classical homeopathy has few side-effects and the use of high-potencies is free of toxic effects. A general health-economic statement about homeopathy cannot be made from the available data. (Emphasis added.)

Are FDA-approved pharmaceutical drugs safe?

In his 2014 article published in the journal, Pol Arch Med Wewn (Polish Archives of Internal Medicine), Peter C. Gøtzsche, former leader of the Nordic Cochrane Center, wrote that pharmaceutical drugs are the third leading killer in the United States and Europe. Half of the deaths are from properly prescribed medicines and half occur due to error. He lambasts the regulatory agencies for allowing what he termed "fake fixes," long lists of warnings they know "no doctor can possibly "master."

Our prescription drugs are the third leading cause of death after heart disease and cancer in the United States and Europe. Around half of those who die have taken their drugs correctly; the other half die because of errors, such as too high a dose or use of a drug despite contraindications. Our drug agencies are not particularly helpful, as they rely on fake fixes, which are a long list of warnings, precautions, and contraindications for each drug, although they know that no doctor can possibly master all of these.

FDA: drugs 4th leading cause of death

As part of its learning module about the drug development and approval process, the FDA shared statistics on adverse drug events, as depicted in the image below. The huge number of ADRs it detailed, now found on archive.org, led the FDA to acknowledge adverse drug events (ADRs) as the fourth leading cause of death. The data is based on 1998 and 2000 statistics from hospitals and nursing homes, respectively. Each year, there are over 2 million serious ADRs and 100,000 deaths. This does not include ambulatory patients, whose ADR rate is unknown.

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⇒⇒ Considering the above, what factors should consumers prioritize when evaluating different treatment options, especially with regard to safety and side effects? Given the relatively low incidence of adverse effects reported in homeopathic remedies, is the FDA justified in assuming regulatory authority over homeopathy? Is a standardized regulatory framework truly necessary across all forms of medicine?

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The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial, or legal advice. Always consult a physician, lawyer, or other qualified professional regarding any questions you may have about a medical condition, health objectives, or legal or financial issues.

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