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FDA Confirms Toxicity of Homeopathic Baby Products; Maker Refuses To Recall (arstechnica.com)

Last year in November, the Federal Trade Commission issued an enforcement policy statement that requires over-the-counter (OTC) homeopathic drugs and product makers to disclose in their advertisement and labeling that there is no evidence that homeopathic products are effective. At around the same time the FTC issued the statement, the Food and Drug Administration was investigating homeopathic teething gels and tablets, which may have been improperly diluted, thus causing serious harm to infants. The FDA investigated 10 infant deaths and more than 400 reports of seizures, fever, and vomiting and confirmed Friday that belladonna, also known as deadly nightshade, was the prime suspect. When the FDA notified the products' maker, Hyland's, the company would not agree to recall the products. Ars Technica reports: Hyland's has been defensive since the FDA first opened the investigation last September. In an October press release, the company referred to agency's warnings as a source of "confusion" and assured consumers that the products are safe and effective. Still, the company discontinued distribution in the U.S. The National Center for Homeopathy, which has ties with Hyland's, slammed the FDA, calling the agency's warnings "arbitrary and capricious." In an "action alert," the organization went on to suggest that warning was prompted by "groups interested in seeing homeopathy destroyed" and led to "fear mongering" by the media. As before, the FDA is urging parents to avoid the homeopathic teething products and toss any already purchased. The FDA does not evaluate or approve the homeopathic products, which have no proven health benefit. Belladonna is an active ingredient in those products, but is supposed to be heavily diluted. Homeopaths belief that ailments and diseases can be cured by trace amounts or "memories" of toxic substances that mimic or cause similar symptoms. Homeopathy is a pseudoscience that has been squarely debunked, offering no more than a placebo effect. In its announcement Friday, the FDA said it had found inconsistent amounts of belladonna in Hyland's products. Some of the amounts were "far exceeding" what was intended.

12 of 309 comments (clear)

  1. I know it's fun to make fun of Homeopathy by rsilvergun · · Score: 5, Insightful

    but from what I've heard there's been some deaths (10?). Why the hell don't we give our FDA enough power to shut this company down? They're still selling the stuff. And in packaging that makes it look like medicine.

    Cutting back on bureaucracy and regulations sounds great in theory but, well, this is what it gets you.

    --
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    1. Re:I know it's fun to make fun of Homeopathy by PCM2 · · Score: 5, Insightful

      There are over 7 billion people on this planet, we can afford to lose a few, especially ones as dumb as this.

      Ignoring for now the blatantly sociopathic nature of your comments, shouldn't it be the stupid person who suffers, and not the helpless child who depends upon that person for health care? Maybe the child isn't as stupid as the parent?

      --
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    2. Re:I know it's fun to make fun of Homeopathy by MightyMartian · · Score: 4, Insightful

      Children are not chattel, they are not property. Society and the law bequeath upon parents the right to raise their offspring, and gives them wide, but not infinite latitude in how that is done. Minors are still citizens, and still enjoy constitutional rights, and that means a parent has absolutely no right to cause their child injury, or more to the point, kill them, whether that be intentionally, or due to the parents' belief in some medical quackery. You hurt or kill your child by feeding them poisons, you are a killer, at the very least guilty of manslaughter.

      --
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  2. Re:Hyland's teething tablets by mmell · · Score: 4, Insightful
    I have anecdotal evidence that smoking cigarettes is harmless and non-addictive. I've been smoking Lucky Strikes for decades now with no ill effects, and I'm not addicted. I can quit any time I want to - I just don't want to because there are no harmful side effects. Just a cool, smooth smoke that calms my nerves and keeps me on top of my game.

    Be Happy . . . Go Lucky!

  3. Not homeopathic. by jcr · · Score: 4, Insightful

    If it has active ingredients at all, it's not homeopathy.

    -jcr

    --
    The only title of honor that a tyrant can grant is "Enemy of the State."
  4. Re:Hyland's teething tablets by MightyMartian · · Score: 2, Insightful

    People have used all sorts of things for centuries, that doesn't make them less toxic. You're feeding your children poison. You should be rotting in a jail cell, Mr. Christian Anarcho-capitalist.

    --
    The world's burning. Moped Jesus spotted on I50. Details at 11.
  5. Re:Hyland's teething tablets by guises · · Score: 3, Insightful

    Er... Um... huh. This is a weird thing to respond to.

    I'm not going to do a super long post here, but: "the effective ingredient in them is probably the belladonna rather than the homeopathic ingredients" is wildly off the mark. The point of homeopathic medications is that the active ingredients, including the belladonna, are present in such tiny amounts that they don't do anything. You can put poison in these things because there isn't enough to matter.

    This is why the FDA doesn't regulate them: because they don't do anything. This is also why over-the-counter homeopathic remedies for infants weren't removed: because they don't do anything, so they aren't dangerous. In principle you can give your baby as much as you want, because it doesn't matter.

    The problem here is a manufacturing defect, some of the pills contain too much poison. When you say that you want to know "what the current consistency of the belladonna levels in the product is" what you're asking is: "What are the odds that my baby will die if I give it some of these pills?" We don't know what the answer to that is, and you may find that frustrating but... what number is low enough for you here? If the FDA comes out and says, "0.0001%" are you going to shrug and say, "That's fine."?

    Interestingly, this isn't the first time that this product has been scrutinized by the FDA over this issue. Link.

  6. Re:Hyland's teething tablets by jdavidb · · Score: 1, Insightful

    I'm not aware of any alternative belladonna treatments. I didn't intend to sound like I was saying I'm not aware of any alternative treatments at all.

    I don't expect to change your mind. Mostly I'm just venting because articles like this makes my blood boil

    We all get less rational when we get like that.

  7. Re:TIL by james_gnz · · Score: 5, Insightful

    See it from their point of view: Homeopathy uses the same logic as vaccines.

    Superficially the idea may appear the same. The idea of vaccines, however, is to introduce a weakened form of the disease's cause, before the disease is contracted (or at least before it spreads), so the immune system can prepare for it. (Modern) homeopathy involves introducing (water which was indirectly in contact with) a substance which produces the same symptoms, after the disease is contracted. Notable differences are:

    • Homeopathy involves a substance other than the cause of the disease. The immune system could not learn about the cause of the disease this way.
    • Homeopathy is administered after the disease is already contracted. It may be too late for the immune system to learn about the disease at this time.
    • Homeopathic remedies are taken orally, not injected, reducing the likelihood that the immune system could learn anything from them.
    • (Modern) homeopathy actually only administers water, no active substance, so it does nothing (except act as a placebo, and hydrate, I suppose).

    These are significant differences.

    Also, I've never heard of a homeopath suggesting a similarity between homeopathy and immunisation. (I'd love to see this though, if anyone has a link to such.)

  8. Re:Hyland's teething tablets by lgw · · Score: 4, Insightful

    All medicines are poisons. The difference is dosage. When the FDA yanks normal cold products for infants because parents can't get the dosage right, it's a legitimate discussion.

    --
    Socialism: a lie told by totalitarians and believed by fools.
  9. Re:Exposing babies to peanuts by Anonymous Coward · · Score: 5, Insightful

    They're not diluting a peanut until there's barely any trace of the peanut left and then giving the barely-peanut water to the kid. They're using a peanut product that's of the appropriate texture and consistency for the age of the child.

    Good rule of thumb: If you can look at something and say 'Hey! That is or used to be a peanut!', it's not homeopathy. If it looks like water, it might be homeopathy.

  10. Re:Exposing babies to peanuts by ShanghaiBill · · Score: 4, Insightful

    My point was that this is an example of effective homeopathy.

    No it isn't. The difference is that if you give a baby some peanut butter, there are ACTUAL PEANUTS IN IT. But if you use the typical homeopathic dilution of 100 fold dilution 100 times, then there is only 100^-100th = 10^-200 of the original amount. For comparison, the number of quarks in the observable universe is roughly 10^80. So the probability of there being even a single molecule of the original harmful substance is closer to zero than the human mind can even conceive. The "theory" is that, although the harmful substance has been diluted out of existence, the water has a protective "memory" of it being present. The "theory", of course, doesn't explain how this "memory" is possible when none of the original water is still present either, or why just using tap water doesn't work since it is also an extremely diluted solution of every known poison.