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FDA Confirms Toxicity of Homeopathic Baby Products; Maker Refuses To Recall ( 309

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.
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FDA Confirms Toxicity of Homeopathic Baby Products; Maker Refuses To Recall

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  • by rsilvergun ( 571051 ) on Monday January 30, 2017 @07:30PM (#53769879)
    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.
    • by alvinrod ( 889928 ) on Monday January 30, 2017 @07:42PM (#53769939)
      I'm reminded of an old IRC quote []: The problem with America is stupidity. I'm not saying there should be a capital punishment for stupidity, but why don't we just take the safety labels off of everything and let the problem solve itself?

      Modern society has made the world such an overwhelmingly safe place compared to earlier periods in human history that the universe has to find new ways to work in natural selection. It says homeopathic right on the box, and I would imagine that this was something the parents sought out and wanted to buy. So just let them remove themselves from the gene pool or just regulate who gets to be a parent because I have a feeling that single regulation would remove the need for a lot of other stuff.
      • Evolution happens even in a relatively fixed environment. If nothing else, you'll have neutral drift.

      • by amiga3D ( 567632 )

        The problem is they've found evidence the product is defective and the poison is not properly diluted. From this point if anyone dies it's a murder case. It's not the kids fault the parents are deranged and there have been many cases where crazy/stupid fools have somehow managed to have offspring that far exceed expectations given their bloodline. Humanity is a crap shoot.

      • I would imagine that this was something the parents sought out and wanted to buy

        I'm not so sure about that. I doubt most people actually know the true definition of homeopathic. A lot of people get that confused with "organic" (which is an entirely different argument). A while back I had to explain this to my mother-in-law. She had totally confused "organic" and "homeopathic" with "natural". She had no idea that these were 3 completely unrelated things. I doubt that she's an outlier; quite a lot of people get their medical advice from Oprah and Dr. Oz.

        In the case at hand, the sol

        • Or "holistic" (Score:4, Informative)

          by raymorris ( 2726007 ) on Monday January 30, 2017 @08:42PM (#53770291) Journal

          It seems some people confuse "homeopathic" with "holistic". Those are of course two very different things.

          A short explanation of homeopathy for those unfamiliar:

          For any ailment, you find something that will *cause* that ailment (ie a poison).
          You then place a drop of the poison in a bucket of water and mix it up.
          Then you take a drop from that bucket and put it into another bucket of water.
          Do this several hundred times. (This is why it's labeled "300X", it's been diluted 300 times).
          In the end, they'll be no poison left the last bucket, but because you had put poison in the other bucket, the water in the last bucket will do the opposite of what the poison does.

          That is of course, utterly and completely ridiculous. If done correctly, there will be zero molecules of the poison in the bucket - it's 100% water. You just paid $8.99 for WATER. If it's done incorrectly, as Hyland's did, you end up with poison in the product.

        • by dbIII ( 701233 )

          I doubt most people actually know the true definition of homeopathic

          Does it matter since it's all a scam? The problem here is instead of the usual grass clippings the scam artists involved believed their own bullshit and put a real poison in there. Do them for manslaughter like any other poisoners.
          They managed to fuck up a placebo. How fucked up is that?

      • by gweihir ( 88907 )

        I'm reminded of an old IRC quote []: The problem with America is stupidity. I'm not saying there should be a capital punishment for stupidity, but why don't we just take the safety labels off of everything and let the problem solve itself?

        In principle, I like the idea, but the victims here are not the ones being stupid.

    • by MightyMartian ( 840721 ) on Monday January 30, 2017 @07:43PM (#53769947) Journal

      I think the United States will be lucky if there is an FDA. Remember, it's all about deregulation now. Who needs food safety anyways? Only fucking Commies.

      • by sjames ( 1099 )

        I'm generally left leaning, but in the case of the FDA, I think we'd do well do away with it. Where I part ways with the deregulaters is that I would like to see a smaller and more sane replacement.

    • by mmell ( 832646 )
      Give the FDA enough power to shut them down? That sounds like it would be bad for business. I don't think that'll sit too well with the current regime, er . . . administration.
    • by sjames ( 1099 )

      Because if recent history is a guide, they'll make another power grab and grant someone an exclusive on drinking water which will then be a bargain at the low-low price of $100/liter.

    • by AaronW ( 33736 )

      I watched a documentary (Frontline) [] discussing how a bad strain of Samnoinella Heidelberg was being distributed by Foster Farms chickens and how powerless the FDA was to put an end to it. Basically the FDA is powerless unless they can prove a smoking gun. Despite thousands of people getting sick and them tracking it down to certain farms they could do nothing until one person who got sick happened to have another batch of chicken from the same lot that they froze. It took something like 18 months and the FD

    • The problem is that you are still thinking of facts as "true" or "false". And obviously this has been popular since the Renaissance. But we are now in the Age of Alternative Facts, and if someone disputes the efficacy of a quack product, they can be debunked using ad hominem arguments without reference to factual information. The framework of law in which you live now works this way, better get with the program!

    • by c ( 8461 )

      At this point, it sounds like it's not longer an FDA problem... call it what it is, which is "conspiracy to commit murder" and kick it over to the FBI.

  • by surfdaddy ( 930829 ) on Monday January 30, 2017 @07:35PM (#53769907)

    It is a grandfathered legality from the days before the FDA. Homeopathic "drugs" have not been through clinical trials or been shown to be efficacious. They are based on a principle that somehow if you have a substance you can dilute it until perhaps only a couple of MOLECULES in your liquid will somehow cure your problem.

      The FDA should shut down this sham of a company once and for all.

    • by gweihir ( 88907 )

      Actually, the problem here is shoddy manufacturing in conflict with homeopathic principles. I do not defend their scam, but the same problem, say, in Paracetamol, would also have killed people. Hence these people are guilty, both by homeopathic standards and by sane standards.

  • by Anonymous Coward on Monday January 30, 2017 @07:46PM (#53769973)

    Is that where you start out dissolving one baby per unit of inert carrier fluid, and then perform series of repeated dilutions until you are left with a substance that statistically contains no atoms of the original baby?

    Does this have anything to do with the making of baby oil? I've always been afraid to know what happens inside those factories.

  • That proves the only way homeopathy might have some effect is when the acting product is still present in the final pills. Which is generally not the case.
  • by ilsaloving ( 1534307 ) on Monday January 30, 2017 @07:55PM (#53770013)

    As long as North America insists on persisting their "My ignorance is just as valid as your knowledge", this problem will never go away, and people will continue to die.

    Quite frankly, I'm at the point now where I don't think the FDA should do anything. These people are just so god damn willfully stupid that there's absolutely nothing that can be done short of putting them in an asylum. But since we won't... let them make their choices and suffering the consequences.

    The FDA is "obviously" being paid under the table by Big Pharma(tm) to keep homeopathy down because homeopathy is such a clear threat to Big Pharma profits. So basically they're damned regardless of what they do. If they try to regulate homeopathy, that would effectively give homeopathy unwarranted legitimacy. If you try to shut it down, 10s of thousands of brazenly stupid idiots will start shouting and flailing pitchforks about with the usual battlecries of... well... the kinds of stuff already mentioned in the article/summary.

    I don't think this should even fall under FDA juristiction anyway. It should be treated like the criminal matter that it is. The gov't should charge these parents with child endangerment and manslaughter for knowingly giving their kids poison, because that is exactly what they did.

    • Didn't the British NHS recently stop paying for homeopathic and chiropractic treatment?

      Begs the question: 'How long did they waste money on bullshit?' Did they let it decimate their patient population first? Irregardless of who pays, bullshit thrives. I could care less.

      • Hey chiropractic treatment works if it is just getting something straightened out. When I was pushing my trailer back around my house after deer season I slipped on some snow covered leaves and got my back a little out of alignment and ended up probably pinching a nerve with a shooting pain into one of my legs still the next day. Went to see a chiropractor who went and popped everything back into place. It cost $25 and took like 15 minutes and afterwards the pain was gone. For stuff like that they are a goo
  • Homeopatic meds have very highly diluted principal ingredient. Supposedly the more diluted the stronger the medicine. In this case why not just drink tap water it already contains and has interacted with every possible poison at some time. Thus it should be the most potent medicine of all !
  • Not homeopathic. (Score:5, Insightful)

    by jcr ( 53032 ) <> on Monday January 30, 2017 @08:12PM (#53770131) Journal

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


  • Darwinism doesn't stop just because we live in societies and take care of the weak, it's just changes. Now survival of the fittest means you know enough to help your offspring. People who get goods that are not FDA approved are not selected for.

  • The literally have the power. Only takes them a day to get a court order, come out with the sheriff, escort everyone out and lock down a building.

  • by carvalhao ( 774969 ) on Monday January 30, 2017 @08:55PM (#53770409) Journal

    On one hand, I truly believe that homeopathy doesn't work. Period.

    But I also support the use of the placebo effect to address minor problems. All drugs carry a risk associated with them, and if we can cure your mild headache with a pill that does nothing, that beats curing a mild headache with a molecule that may have side-effects.

    The problem is that placebos only work if you believe in them. And they work better if they are expensive. And to have people make money out of ignorance makes me cringe.

    So I choose to support ending the whole homeopathy deal. But I would be looking into other, ethically reasonable ways to make use of that effect by modern medicine.

  • by slew ( 2918 ) on Monday January 30, 2017 @10:29PM (#53771025)

    In the forest of anti-FDA and/or pro-homeopathic comments above, I was curious, so as far as I can determine, this is the FDA timeline for this...

    September 30, 2016 []

    The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert [] about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

    Reference to adverse event reports here []. Multitudes of reports reference events of seizures by infants.

    January 27, 2017 []

    Laboratory Analysis of Homeopathic Teething Tablets

    FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.

    This is despite Standard Homeopathic Corporation (the manufacturer of Hyland brand Teething Tablets) insistent claims in voluntary reports that "Manufacture and processing occurred within established procedures to ensure product quality."

    So you are the administrator of the FDA and are sitting on the pile of adverse event reports and have this completed laboratory testing report.... What would you do?

Make it myself? But I'm a physical organic chemist!