homeopathic-teething-croppedThe FDA recently put out a consumer warning about homeopathic teething gels and pills. The warning states:

The FDA recommends that consumers stop using these products and dispose of any in their possession.

The warning is not because all homeopathic products are inherently useless. As we have discussed here often, the basic principles of homeopathy are pure pseudoscience. The practice of diluting substances so that almost no or no active ingredient remains means that most homeopathic products are just sugar pills. Further, clinical studies show that homeopathic products don’t work. There isn’t a single homeopathic product that has been shown to be effective for a single condition with rigorous clinical trials.

The FDA acknowledges this, writing in their warning:

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

This may sound confusing, since the entire homeopathic pharmacopoeia has been pre-approved by the FDA and are sold as drugs. What they are saying is that they are not approved, “for safety or efficacy.” So they are approved, but without any guarantee that they are safe or effective.

Homeopathic belladonna

In the case of homeopathic teething gels and tablet, the concern is not that they are worthless, without any proven benefit, but rather that they can be toxic to children and infants. Many people falsely assume that because most homeopathic potions are typically diluted so that no active ingredient remains, all homeopathic products therefore have no active ingredients; that is not always the case, nor is it a requirement to be considered homeopathic.

In this case, homeopathic potions can cause direct toxic harm, not just the indirect harm of fooling people into thinking a worthless sugar pill is effective medicine.

This has come up before. In 2009 the FDA issued a warning about homeopathic Zicam nasal spray, which contained real doses of zinc and was associated with anosmia, or loss of smell.

The homeopathic teething products contain, according to the FDA, real doses of belladonna, which is a toxic alkaloid. In fact, they issued a similar warning letter in 2010, although that warning was limited to Hyland’s Teething Tablets, while the new warning applies to all homeopathic teething products. In the 2010 warning they stated:

Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

Hyland’s Teething Tablets were reintroduced to the market in 2011 after it was “reformulated.” In response to the recent warning by the FDA, the company put out a statement in which they state:

There is no current recall of Hyland’s Baby Teething Tablets.
[and]
There is NO scientific link between homeopathically-prepared belladonna, or Hyland’s Baby Teething Tablets, and seizures.

There is no recall, but that may be the next step after the FDA warning. It is also ironic that Hyland’s will defend their product by saying there is no scientific link between their product and seizures, but ignores the fact that there is also NO scientific link between their product and any health benefit.

The FDA’s conundrum

Right at the bottom of the warning letter, the FDA describes itself as:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

They need to add to their standard self-description: “Except for homeopathic products, which we allow to be sold as drugs with unsubstantiated health claims, confusing or misleading labeling, and without evidence of safety, because we allow the homeopathic industry to regulate itself.”

The FDA has essentially abandoned its job to “protect the public health by assuring the safety, effectiveness,” of drugs when it comes to homeopathic potions.

However, last year the FDA announced that it was reconsidering its regulation of homeopathy. There was a public comment period – here is our open letter to the FDA. Now we are just waiting for the FDA to makes its decision. Will it finally do its job when it comes to homeopathy, or will it continue to take the politically easy path? You can be sure you will read about it here as soon as we know.

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 president and co-founder of the New England Skeptical Society, 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 contributes every Sunday to The Rogues Gallery, the official blog of the SGU.

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