Apr 14 2015

FDA and Homeopathy

The skeptical community is abuzz with the announcement by the FDA’s announcement that they are reviewing the “regulatory framework” of homeopathic products and are open to public input. We have written about this at Science-Based Medicine, and as you can imagine, this is a serious topic of discussion among the editors.


The FDA regulates food, drugs, medical devices, supplements, and cosmetics for the purpose of protecting the public health and safety. Congress created the FDA and determines its powers. In the 1938 FDA act, one Senator, Royal Copeland, who was a physician and homeopath, included in the bill that the provision that the Homeopathic Pharmacopeia of the United States (HPUS) would be included in the list of official drugs.

What this means exactly is that homeopathic products are automatically considered drugs by the FDA. Further, any new homeopathic product added to the HPUS in a supplement also counts. All homeopaths have to do, therefore, to get a homeopathic product listed as a drug by the FDA is write it down in one of their supplements to the HPUS. That’s it. No research is necessary, no assurance of safety or efficacy.

However, that does not mean that the FDA has to approve the homeopathic remedy. They have the authority to require evidence for safety and efficacy, just like they do with real drugs. They simply chose not to enforce this authority. Apparently they thought it wasn’t worth the trouble 70 years ago so they simply outsourced the regulation of homeopathy to the homeopaths.

I can see the logic behind this. At the time homeopathy was such a small industry, and their products are literally just water or sugar pills, so why waste limited FDA resources?

However, homeopathy has grown into a multi-billion dollar industry. I would argue it is a multi-billion dollar scam. Pharmacies sell homeopathic potions on the shelf right next to real medicines, with claims that they treat specific diseases. Most people don’t even know what homeopathy means, and may not look for the small print indicating that the cold remedy they are buying is homeopathic.

Better Late than Never

Now, finally (I hope), the FDA has apparently realized that they are completely neglecting their mandate to protect the public from harmful or worthless medical products when it comes to homeopathy. If I would guess, I think the FDA understands that homeopathic products are utterly worthless pseudoscientific nonsense. They can’t possibly work, and when studied they don’t work.

If they couldn’t figure this out by themselves, the UK government recently did a massive review and concluded that homeopathy is nothing more than witchcraft. More recently the Australian government did a similar review and found that homeopathy does not work for anything.

There are indications that the FDA is serious about reform. They actually contacted the Committee for Scientific Investigation (CSI) and asked them to send an expert skeptic to their public hearing. There is also a period for written public commentary, and we at SBM are preparing a statement (which we will publish as an open letter also, so stay tuned).

Here’s the preview, however – it seems to me that the simplest thing for the FDA to do is to simply do their job. They have the authority to regulate homeopathic products like drugs, so do it. Don’t outsource to the homeopaths. Require evidence for safety and efficacy for all homeopathic products. It that’s simple. If they did that, homeopathic products would disappear overnight.

Well, I suspect they would give manufacturers a grace period of 1-2 years to provide such evidence, and if they didn’t provide adequate evidence by the deadline their products would be removed from the pharmacy shelves.

The homeopaths, of course, are going to fight back. What, however, are they going to say? Up to now they have been claiming that homeopathy works, and many even claim that the evidence shows that it works. Now they either have to admit that there isn’t evidence showing that it works, or that the FDA requiring evidence is OK.

Their only other option is to make some sort of conspiracy claim, that some nefarious force is using the FDA to shut down homeopathy. So, of course, I suspect that is what they are going to do. They will complain that homeopathy can’t be studied like regular drugs, and existing studies are not fair or adequate.

The thing is – they actually make the case for the FDA properly regulating homeopathic products. Homeopaths argue that you need a homeopath to individualize a remedy for each patient. While this is BS, if it were true that would be an argument against the over-the-counter homeopathic industry. In fact homeopaths routinely throw the homeopathic product industry under the bus to explain away the negative clinical trials of homeopathy.

Therefore, by their own logic, the OTC homeopathic industry is unscientific and is selling ineffective nostrums. So let the FDA regulate them away. The FDA does not have the power to regulate the practice of medicine, just the sale of medical products.


I hope that this move by the FDA is the historic opportunity it appears to be – meaning that the FDA is sincere and will listen to reason. Homeopathy is a scam that has been operating under the nose of the FDA for decades. They can end it with a stroke of the pen.

Now is the time to put the pressure on.

FDA – do the right thing.

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