Most people don’t really know what homeopathy is, thinking it is some vague form of “natural” medicine. But those in the know understand that homeopathy is literally nothing – it is water. Any starting ingredients have been diluted to such an extent that effectively nothing is left. As I like to say, it is fairy dust diluted out of existence.

However, this fact not only leads to the ineluctable conclusion that homeopathy is worthless, it also leads to the conclusion that it is harmless, at least directly (there is always harm from wasting resources and depending on ineffective treatment). Unfortunately, we cannot count on this conclusion, because homeopathic products don’t always dilute their starting ingredients to negligible levels. Recent FDA warnings make this clear.

The FDA announced that they sent warning letter to four manufacturers of injectable products labeled as homeopathic for containing dangerous levels of known poisons.

“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labeled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”

The products in question contain mercury, lead, strychnine, and deadly nightshade. Diluting horrible toxins to negligible levels is standard homeopathic practice, so that in itself is not new. But the FDA found that these substances were present in wildly variable doses in tested product, and in some cases in potentially toxic doses. The four companies have 15 days to alter their practices or the FDA will take further action.

This is not the first time something like this has happened. In 2016 homeopathic teething gels were found to contain active ingredients like nightshade and were linked to the death of 10 infants. Also, we cannot assume that “just water” is harmless when the water itself is contaminated with pathogenic bacteria.

All of this is very concerning – but I was alarmed at the very fact that there are injectable homeopathic products. When you have an utterly worthless product, why raise the stakes of potential harm in this way? It’s reckless and unethical, and should itself be banned. Medical decision-making revolves around risk vs benefit – any potential risk of an intervention has to be reasonably outweighed by the potential benefit. But when a treatment has zero plausible benefit, like homeopathy, how do you justify any risk? I believe the only reasonable answer is – you can’t. The only way for the risk-benefit equation to balance when the potential benefit is zero is for the risk to be zero, and the only way for that to happen is to not use the treatment at all.

But the FDA has decided that as long as the risk is minimal they are happy. So they seem to be focusing on contamination and manufacturing quality, and all of the above examples indicate. They pay particular attention to injectables, because the inherent risks are higher.

There is a deeper problem here, however, that the FDA approach simply does not address. You cannot regulate a blatant pseudoscience – meaning, you cannot allow a pseudoscience in medicine to exist and think you are going to mitigate the harm by making sure the pseudoscience adheres to some standards. This is partly because there is an inherent contradiction here that cannot be overcome.

Effective regulation is science-based. So how can you have effective regulation of something that is inherently not science-based? I would argue that you can’t. What standards are you going to use? The FDA resorts to things like contamination, because that is something they can grab onto, but they can’t get to the core of the problem. In fact the risk is escalating under their watch.

The other main reason is that you cannot regulate con-artists – because the industry is based on deception and lies. If the entire industry functionally does not believe in science, then how can they adhere to scientific standards? This is why acupuncturists don’t wear gloves. We see the same thing in the herbal product industry, where contamination, substitution, and adulteration are rampant.

The only sustainable solution is not to think that you can regulate pseudoscience, but instead to ban it. The FDA should not seek to make homeopathy safe. Pseudoscience is inherently unsafe. They should use their authority, which they have, to protect the US public from obvious provable pseudoscience.

They write: “These warning letters reflect our continued commitment to patient safety”, but if they really were committed to patient safety they would simply use their authority to actually regulate homeopathy. Instead they choose to allow the industry to largely regulate itself, while they focus only on blatant cases of contamination and similar instances.

All the FDA would have to do is use their authority to regulate homeopathic products like they do all other drugs (homeopathic products are legally drugs in the US). Require evidence of efficacy above placebo effects, because only such efficacy would justify any potential risk, no matter how small. If they did that the homeopathic industry would vanish like one of their ingredients – diluted away to nothing. They apparently are not willing to fight that political fight, but they should be. Instead they make themselves feel like they are doing their job by occasionally trimming back the worst abuses.


Posted by Steven Novella

Founder and currently Executive Editor of Science-Based Medicine Steven Novella, MD is an academic clinical neurologist at the Yale University School of Medicine. He is also the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe, and the author of the NeuroLogicaBlog, a daily blog that covers news and issues in neuroscience, but also general science, scientific skepticism, philosophy of science, critical thinking, and the intersection of science with the media and society. Dr. Novella also has produced two courses with The Great Courses, and published a book on critical thinking - also called The Skeptics Guide to the Universe.