Oct 27 2010

FDA Warns Homeopathic Product Is Not Just Water

The one thing that is more absurd than homeopathy is the regulation of homeopathic products (at least in the US). Because of timely political pressure, homeopathic products were essentially grandfathered in to FDA approval. They do not require any testing for safety and effectiveness.

Here is NCCAM’s summary of homeopathic regulations in the US:

Homeopathic remedies are prepared according to the guidelines of the Homeopathic Pharmacopeia of the United States (HPUS), which was written into law in the Federal Food, Drug, and Cosmetic Act in 1938. Homeopathic remedies are regulated in the same manner as nonprescription, over-the-counter (OTC) drugs. However, because homeopathic products contain little or no active ingredients, they do not have to undergo the same safety and efficacy testing as prescription and new OTC drugs.

The U.S. Food and Drug Administration (FDA) does require that homeopathic remedies meet certain legal standards for strength, purity, and packaging. The labels on the remedies must include at least one major indication (i.e., medical problem to be treated), a list of ingredients, the dilution, and safety instructions. In addition, if a homeopathic remedy claims to treat a serious disease such as cancer, it needs to be sold by prescription. Only products for self-limiting conditions (minor health problems like a cold or headache that go away on their own) can be sold without a prescription.

The labeling requirements are almost Orwellian. They need to list ingredients – even the ones that are not actually in the preparation because they have been diluted past the point where there is likely to be a single molecule left. They must list the indications – despite the fact that there aren’t any. There isn’t a single proven indication for any homeopathic remedy. So homeopaths essentially have to make up multiple fictions to put on the label of homeopathic products – in the name of consumer information.

It might seem reasonable not to require safety testing, since most homeopathic preparations have “little or no active ingredients.” That has, in fact, been the core criticism of  – well, anyone with the slightest bit of scientific literacy and common sense. There is no there, there. Homeopathic pills are literal placebos – nothing but sugar and water. So why bother testing for safety?

However, the loose regulations allow anything to be sold as a “homeopathic” remedy that is listed in the Homeopathic Pharmacopeia of the United States- and its supplements. That’s right – homeopaths can make up new products (new combinations of ingredients that are not actually present in the product), write them down in a supplement, and they are magically approved by the FDA.

This has led to some products being sold under the label of “homeopathic” because it’s the magic carpet ride to the market. Recently Zicam, a cold remedy some formulations of which were sold as “homeopathic”, were linked to anosmia (loss of the ability to smell). The products contained zinc compounds in a 1x or 2x dilution (x meaning 1:10 dilution – in homeopathic nomenclature “C” is a 1:100 dilution). This is hardly diluted at all – meaning there was actual active ingredient in the product.

This violates the basic assumption of safety for homeopathic products.

This same situation has now occurred again. The FDA has issued a warning that:

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.

Teething tablets – for babies – contain measurable and variable amounts of an actual drug, in unsafe doses, and without safety caps (because, hey – they’re not real drugs). These tablets, like the Zicam products, were fakes of a fake. And in this case the double negative does equal a positive – measurable amounts of actual drugs capable of causing toxicity, but not regulated as such.

Clearly the regulations are broken. This seems unavoidable given that homeopathy is an unmitigated scam – the persistence of a pure pseudoscience into the modern scientific era due to cultural inertia and outdated but calcified regulations.

The optimal solution would be for the laws to catch up to the science (they are about a century and a half behind) and remove homeopathic remedies from automatic FDA approval. In fact, they should be banned as fraudulent, in my opinion. At the very least they should be labeled appropriately, with a clear statement that they do not work and do not contain any actual medicine or active ingredients; they are nothing but placebos. If there is actual active ingredient in a preparation – then it should be regulated like any other drug.

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