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.

11 responses so far

11 Responses to “FDA Warns Homeopathic Product Is Not Just Water”

  1. Todd W.on 27 Oct 2010 at 11:58 am

    Perhaps a small step in the right direction would be to eliminate homeopathic dilution labeling and require them to list ingredient amounts in easy-to-understand units, e.g., mg.

    That would allow people to see just how little (or how much, in the case of Hyland’s Teething Tablets and Zicam) active ingredient is really there.

    It’ll never happen, but one can dream.

  2. Joeon 27 Oct 2010 at 1:41 pm

    I have heard that AP Grollman (Stony Brook) has been testing homeopathic preps in the USA and finding many are adulterated. The added drugs are usually OTC products such as aspirin and caffeine. Unfortunately, it does not yet show up in a PubMed search.

  3. chaos4zapon 27 Oct 2010 at 4:09 pm

    I had a discussion with an Indian fella that was doing his residency to become a MD, Homeopathy came up. It was quite clear that he had no idea what Homeopathy really was. He had the same notion of Homeopathy=all natural supplement, or some such non-sense, as the general public. When i tried to discuss with him the history of Homeopathy and what it really is, he flat out refused and acted as if I was an idiot. He played the “I’m the doctor here and don’t you think i know more than you” card and went as far as insisting Homeopathy was created by someone in India (As opposed to the reality that it was a German). My point (a little off topic) is how can someone make it through medical school without ever finding out what Homeopathy really is? Worse yet, he was very defensive of Homeopathy. What happens when he starts working this into his practice down the road? Ironically enough, I had a roommate in college that ended up going to Drexel Med School (formally MCP Hahnemann Medical School), and he knew exactly what Homeopathy was and that it was based on magical thinking.

  4. superdaveon 27 Oct 2010 at 5:59 pm

    I tried a google search for more information on this issue and the news stories that came up were pathetic at best. Not a single one went further than stating that this pill is not approved by the FDA

  5. daijiyobuon 27 Oct 2010 at 8:47 pm

    ‘Absurd, scam, fraud.’

    Guess who disagrees, labelling homeo. a “core clinical science”?

    (hint: http://www.nabne.org/nabne_page_23.php )


  6. HHCon 27 Oct 2010 at 10:43 pm

    Toxic teething tablets and Drugs which take away your sense of smell? Sounds like the Wicked witch of Homeopathy is up to her tricks again in time for Halloween.

  7. ebohlmanon 28 Oct 2010 at 1:21 am

    What is it with teething products? About 100 years ago mercury-based teething powders were widely used, and kids developed symptoms of mercury poisoning (Pink Disease), but, of course, not autism.

  8. stompsfrogson 29 Oct 2010 at 2:39 pm


    I tried explaining that to my mom, too, and she treated me the same way!

    Of course, that’s kind of a typical attitude from her… Maybe the lesson here is that some people are stupid dicks. Or that I’m not good at explaining stuff.

    And Steve, you’re getting pretty good at this writing stuff. That piece was quite elegant and powerful.

  9. MaikUniversumon 30 Oct 2010 at 8:33 pm

    “Clearly the regulations are broken. This seems unavoidable given that ”

    let me finish… given that government regulations ALWAYS achieve the opposite.

    Yes, homeopathy is a scam, but so is the “successful regulation”. It’s a myth.

  10. saburaion 03 Nov 2010 at 12:51 pm

    “Homeopathic pills are literal placebos – nothing but sugar and water.”

    “In fact, they should be banned as fraudulent, in my opinion.”

    Sort of a weird contradiction here. If the remedies are just sugar and water (at least, um, the “real ones” that don’t contain belladonna and zinc by mistake), then how can you ban them? Surely you can’t ban sugar and water.

    What you’re really saying is you want to ban people from holding up vials of water and jars of sugar and saying “hey, this stuff is magical, you should try some. $10.”

    Since it’s just sugar and water and someone’s interpretation of magic, that seems like a freedom of speech thing.

    I mean, someone could hold up a pair of Red Sox tickets and say “hey, next year is THE year, so I want $100 for these $20 tickets.” Just because the guy is delusional doesn’t mean he doesn’t have the right to believe his empty water is magical.

    I do agree the labeling should be clear: “This product contains water. That’s it. Good luck with it.” If people are stupid enough to pay huge mark-ups for plain old water, I think there’s something wrong with the buyers, not necessarily the seller.

    But people would never pay a huge mark up for something clearly labeled as plain water, would they?

    Wait, does Dasani count?

  11. Todd W.on 03 Nov 2010 at 7:11 pm


    What you’re really saying is you want to ban people from holding up vials of water and jars of sugar and saying “hey, this stuff is magical, you should try some. $10.”

    Since it’s just sugar and water and someone’s interpretation of magic, that seems like a freedom of speech thing.

    Except that commercial speech is not protected. They should be banned from making claims that their product can actually do anything. However, if, as you suggest, they clearly state in no uncertain terms that their product is just a bunch of sugar pills with some filler and that it won’t actually do anything, then buyer beware. However, making actual health claims (e.g., cures/prevents the flu) runs afoul of FTC and/or FDA regulations…or at least it should.

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