It’s been almost twenty years since I first wrote about my concerns with the sale of homeopathy, particularly in in retail pharmacies. Anecdotally, based on what I’ve seen walking pharmacy aisles, it feels more widespread and less niche today. Where few chain pharmacies used to even carry homeopathy, I now see homeopathic products shelved amongst actual medicines. While it seemed to have ignored the issue for decades, the U.S. regulatory backdrop for these products has shifted more in the past several years than in decades previously.The U.S. Food and Drug Administration’s approach has become one that’s worth watching, not only because of the FDA’s outsized influence on medicines regulation worldwide. A recent piece in Skeptical Inquirer prompted me to take stock of where things currently stand with this practice.
A recent piece by Robyn Blumner in Skeptical Inquirer argues that the U.S. homeopathic industry has lost significant ground over the past few years, despite an estimated $6 billion in annual revenue. Blumner, who leads the Center for Inquiry, (and whose organization is separately suing a manufacturer of homeopathy), argues that the industry is “on the ropes”. I hadn’t been tracking the regulatory side of homeopathy closely myself, so it seemed like an appropriate time to get caught up on developments.
The Air Guitar of Alternative Medicine
Samuel Hahnemann invented homeopathy in the early 1800s. While the practice of medicine was then progressing to a scientific model based on objective observations, homeopathy never progressed or evolved: It remains frozen in prescientific thinking. Homeopathy is based on the idea that “like cures like”, in that a small dose of what causes a symptom can actually cure that symptom. Like-cures-like may sound familiar: It’s sympathetic magic, a pre-scientific belief.
Homeopathy proponents also believe that water has memory, and the more you dilute a substance, the more powerful its effects. The 30C “potency” is a common dilution used in homeopathy – that’s a dilution of 10-60. If something has been diluted this much, you would have to give two billion doses per second, to six billion people, for 4 billion years, to deliver a single molecule of the original, pre-diluted material. The explanation for this is that water has a “memory” of the original material. This extreme dilution means that most homeopathic remedies are completely inert, and don’t contain a single molecule of the original reference material. And that original reference material can range from table salt to sunlight to vacuum cleaner dust. There is no product so bizarre that a remedy hasn’t been created from it. The scientific evidence is clear: No homeopathic product has been convincingly demonstrated to provide actual therapeutic effects.
The regulation of homeopathy in the U.S. differs from prescription or over-the-counter drug products. For decades, despite their regulatory status as “drugs” the FDA long allowed many homeopathic products to be sold under a permissive enforcement posture.
That is changing.
Over the past few years, the U.S. approach has shifted from this informal tolerance toward more active enforcement. The FDA’s guidance, Homeopathic Drug Products issued 2022 described how the agency would prioritize regulatory action for these products:
As a result of the Agency’s evaluation of its regulatory framework, including consideration of the information obtained as a result of the public hearing and the recent growth of safety concerns associated with some homeopathic drug products, FDA believes that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to homeopathic drug products marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally.
The Final Guidance noted that many marketed homeopathic products no longer meet the agency’s standards and may be treated as “unapproved new drugs”.
In response, the industry sued. The FDA then moved to remove homeopathic injectables and homeopathic eye drops that FDA considered high-risk or not lawfully marketed. I blogged about this back in 2023. The FDA warnings have put pressure on seller platforms like Amazon to remove listings it deems “unapproved new drugs” (like injectable products, or eye drops) or face enforcement action. Skeptical Inquirer notes, in their latest piece:
Under homeopathy’s medical theory, the more dilute a substance, the more potent it becomes. That is absolute nonsense, and no one knows that better than the homeopathy pushers themselves. They would rather spend every dime they have on lobbying and lawsuits than expose their products to the rigors of medical testing.
That is why the homeopathic industry is desperate to change this new regulatory environment. And so, another lawsuit was filed by homeopathic interests. This time, the Alliance for Natural Health (ANH), an advocacy organization for homeopathic medicine, and Meditrend, Inc., a homeopathic drug developer and distributor in Albuquerque, New Mexico, brought suit in a D.C. District Court claiming again that the FDA acted illegally.
Alliance for Natural Health, USA vs. United States is still ongoing, but the initial ruling by a U.S. District Court is promising. In July 2025, Federal District Judge Christopher Cooper dismissed all but one of the plaintiffs’ claims—and expressed little sympathy for the remaining one.
The final claim made by ANH is that the FDA did not have sufficient safety concerns about homeopathic drugs to justify its actions. Judge Cooper responded:
[The FDA] lists several examples to substantiate its safety concerns, including “99 cases of adverse events consistent with belladonna toxicity,” “more than 130 reports of anosmia (loss of sense of smell) associated with the use of Zicam homeopathic intranasal zinc products,” and a worry that consumers may forgo other treatments for homeopathic drugs. (Alliance for Natural Health, USA vs. United States 2025)
The final claim didn’t appear to survive because the judge was sympathetic to it, it survived because it hasn’t been tested yet. Judge Cooper’s citation of the belladonna and Zicam numbers, in the context of explaining why that question needs a full record, is why Blumner argues it “doesn’t look too good” for the industry.
Challenges with Post-Marketing Surveillance
The FDA’s 2022 risk-based guidance framed homeopathic drugs as unapproved new drugs subject to enforcement discretion. But enforcement discretion can only work if a regulatory knows where the risk is. For approved pharmaceuticals, the FDA has several mechanisms to collect data: mandatory adverse event reporting from manufacturers, the FDA Adverse Event Reporting System (FAERS), and periodic safety updates tied to an approved product’s labeling and indication. Homeopathic products, having never gone through that approval process, sit largely outside that scaffolding. There is no manufacturer obligation to report, no ongoing clinical trials or real-world evidence that is generating data, and if a product is diluted appropriately, no reason to think that there is an active ingredient that can cause harm. The overall consequence is that there is no homeopathy-specific postmarketing evidence base comparable to that for approved drugs.
The two examples cited in the ANH litigation illustrate the problem. The 99 reported cases of belladonna toxicity and the more than 130 reports of anosmia linked to Zicam’s homeopathic intranasal zinc products didn’t surface because a functioning surveillance system caught them early. They surfaced because the harms were severe and specific: Permanent loss of smell and infant toxicity. Patients, families and clinicians eventually connected these to a product, despite having no reason to suspect a homeopathic remedy of pharmacological activity in the first place. That’s a structural issue: A product marketed on the premise that it has no active medicinal or drug ingredients is likely among the last things a clinician would investigate when a patient develops an unexplained symptom. Passive reporting systems already capture a small fraction of actual adverse events industry-wide; homeopathic products are likely even more likely to generate reports, because the causal link is harder to imagine before it’s demonstrated.
As recently as 2026, legislators have moved to create protections for the homeopathic industry:
U.S. Senators Mike Lee (R-UT) and Tommy Tuberville (R- AL) today introduced legislation building an FDA framework for homeopathic medicine to protect Americans’ access to natural health solutions. The Homeopathic Drug Product Safety, Quality, and Transparency Act will provide a pathway for homeopathic medicinal products to be lawfully marketed by the Food and Drug Administration without needlessly banning safe products that simply do not fit into the same legal categories as traditional pharmaceuticals.
Skeptical Inquirer describes it as follow:
No surprise that the legislation withdraws the Final Guidance from 2022, saying that it “shall have no force or effect with respect to homeopathic drug products.”
The bill would also bar lawsuits that call out the industry’s deceptive labeling and marketing practices. And it explicitly states that “no premarket approval” may be required before homeopathic drugs are sold to consumers.
A newly established “Homeopathic Drug Product Advisory Committee” charged with providing advice to the Secretary of Health and Human Services would be made up of representatives of the industry—a classic fox guarding the henhouse scenario.
This legislation would give legal cover to a gigantic medical fraud industry that targets sick vulnerable people, including children. Passage would be an unconscionable abandonment of American medical consumers by Congress.
If this Act is successful, it would clearly narrow FDA discretion, creating a bespoke pathway for homeopathic products.
Conclusion
The current state in the U.S. could be said to be one of regulatory action – with pushback. The industry is not “on the ropes” in the sense of imminent collapse, but it undoubtedly is facing a more hostile U.S. regulatory and marketplace environment than it has in years. Higher risk products, like injectables and eye drops may not be as accessible, but I could fine no data confirming or refuting changes in sales. For other products, like OTC products marketed for self-limiting conditions, like colds, I don’t see any signs that substantive changes should be expected, federally, anytime soon.