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.
TIL there are at least 410 idiots stupid enough to use this shit on their children.
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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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.
I am a father of 8, and I have plenty of anecdotal evidence that Hyland's teething tablets are effective, and I want to continue to use them for my baby. From what I have read, the effective ingredient in them is probably the belladonna rather than the homeopathic ingredients, but I am not aware of any alternatives, and as near as I can tell the FDA refuses to actually release their data, which doesn't sound much like science to me. Maybe that has changed.
It's misleading to say that Hyland's won't recall their product - they quit selling in the US months ago thanks to the FDA's pressure. There was a flap several years ago where Hyland's was yanked off of the market because of alleged inconsistent levels of ingredients and that was supposed to have been corrected or the FDA would never have let them back on the market.
I'd like to know if the product is really a problem here when used as directed and what the current consistency of the belladonna levels in the product is, but the FDA doesn't seem to be bending over backwards to provide that information to me. Several times since I became a father, useful medications for children and especially for infants have been pulled off the market simply because of claims that parents are using wrong dosages, and frankly while I wish other parents were literate enough to care for their children, I don't care about that enough to torture my own children by denying them effective medication. If infant tylenol cold and flu hadn't been yanked off the market for these ridiculous reasons years ago, I might give the FDA some more credibility, here. As it is, I see them as people who will willingly take away medicine from my babies, which is a special level of depravity.
Secession is the right of all sentient beings.
Good thing all those pesky regulations are just about to be signed off, hyland can no going back to selling its products.
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.
I don't see the reasoning here.
Sure, vaccines work on a similar principle, if you somehow accept teething is somehow related to belladonna. But somehow I'm having a hard time believing memory to a poison, of any kind, has any relationship whatsoever with the body's reaction to teething.
A more apt comparison would be with Botox. Now that's a sensible comparison. Both are deadly poisons aimed at killing you tissue. In teething belladonna, I'd venture it's killing the nerves that would otherwise signal pain. Botox kills muscles to make sure your face looks flaccid enough to be mistaken for a young one. But both are damaging your body and the world would probably be better if they were banned.
Why would this product be banned and not Botox? An interesting question. Should we block this ban because Botox hasn't been banned yet? I don't think so.
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.
Slashdot, fix the reply notifications... You won't get away with it...
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.
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 !
This is how corrupt or incompetent companies are nowadays*:
1) Companies selling aloe gel don't include aloe.
2) Companies selling homeopathic fluids include too much product.
Maybe they should get together and swap some employees. If you want a stronger solution you're better off buying from a corrupt homeopathic company rather than a normal company? I'm surprised the homeopathics even put any product in their items. I guess water prices have gone up too much?
*Well maybe it has always been like this since meat companies used to grind in human fingers and rats into your food.
Homeopaths belief that ailments and diseases can be cured by trace amounts or "memories" of toxic substances that mimic or cause similar symptoms.
That certainly has been proven to be correct at least in some cases with vaccines. Smallpox isn't a deadly epidemic anymore specifically because of using the same process described here. Up until now slashdot has led me to believe that Homeopathy were full of kooks.
Homeopathy is a pseudoscience that has been squarely debunked, offering no more than a placebo effect.
Edward Jenner would have disagreed and we all benefited as a result of his work. The smallpox vaccine certainly was more effective than a placebo. Use some common sense.
How can the FDA have investigated 10 deaths, not even to mention 400 seizures, and not know the cause? And if they DO have reasonable evidence that belladonna is the cause, wouldn't the manufacturer be facing crushing lawsuits and even homicide charges if they refuse to recall?
Obviously homeopathy is a noxious hoax, but I don't have any trust in the FDA's assertion that the homeopathic medicine is the culprit here. The FDA found belladonna levels far exceeding what was claimed on the package, maybe so. But Hylands claims "each complete teething tablet contains only approximately 0.0000000000002 mg of Belladonna alkaloids." In the absence of clear statements from the FDA as to how much they really found, I'm far from convinced the FDA has a case here.
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."
Giving your kids a preparation containing an unknown quantity of belladonna ? Yeesh, what's next - some nice leeches the next time one of them suffers from boils? Blood-letting to release the fever?
Carry on.
Only product I ever found that worked for my hemorrhoids was Hyland's Hemorrhoids tablets.
I don't care if it is pseudo-science or placebo effect or what, it works and nothing else has.
That being said, I wouldn't give an infant belladonna.
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.
Anons need not reply. Questions end with a question mark.
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.
Reading the way you wrote (as opposed to what you wrote), you do not seem to be a drooling idiot, so you must be misinformed / uninformed about the definition of homeopathy. In other words, a reasonably intelligent person who got scammed. I've seen intelligent people confuse "homeopathic" with "holistic", that can certainly happen.
Here's the theory of homeopathy, how proponents claim it works:
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.
Please double check to confirm my explanation is 100% correct.
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.
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.
it's here in case you missed it. I recommend comparing it to say, a package of neosporin. Just glance at them. Pick out the outlines. They looks about the same don't they?
/. and read the stories on Homeopathy.
Homeopath companies know what they're pushing is junk science. So they dress it up to look like real medicine. I've tried plenty of actual medicines that people swear by but that do nothing for me. I don't keep trying them, but still. There's a lot of OTC stuff out there. Now, as a nerd I'm intensely cynical (comes from the years of bullying). Take somebody who hasn't been shit on their whole life and it's not too hard to see them making the mistake. Especially if they don't frequent
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I wonder if an enterprising prosecutor will charge members of this company with murder, now that they are fully aware of how dangerous their product is, yet continue to sell it. I hope so: https://en.wikipedia.org/wiki/...
so how can it be toxic if its homeopathic and basically diluted nothing? (either it has real stuff in it, even if diluted wrong or it doesnt, you cant have it both ways) besides i want to buy some cause if it has really belladonna in, you will trip balls like mad!
yeah ac post, who cares, no one reads them
I looks like the FDA can't make up their mind what is actually wrong with these products, is it that they don't work or that the dilution is inconsistent, sling enough mud and some of it will stick.
We must have labeling for homeopathic products, but we dont need it for gmo products? I guess you get what you pay for.
Done! http://www.health.harvard.edu/...
"In 2015, a study showed that giving peanut products to babies could help prevent peanut allergy. This was exciting news, given that 1-2% of children suffer from peanut allergy, an allergy that can not only be life-threatening but last a lifetime, unlike other food allergies that often improve as children get older. "
That's the problem: they diluted them so much that what was left was far too strong for adults, let alone babies. But don't worry: you just need to dilute them by adding active ingredients and you'll be fine, apparently.
Um, shouldn't your focus be on contraceptives?
What's the point? As a homeopath he would end just up using highly diluted viagra.
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?
Nothing more appropriate and to be expected of a Trump America.
Leadership by example. My baseless and uneducated ignorance is just as worth as your data driven consensus research.
Keep fighting for the right to be wrong 'till a bunch of people die... it's also the age of not assuming responsibility for anything anyways.
Everything has become religion, and some human lives holds no sway on people's faith on just about anything.
It's time for a full reset.
As a rule there's two things that make a moron: lack of education and being mentally slow. In nearly all cases it's not entirely that person's fault. Sure, there's the occasional rich, lazy bum whose parents are well off. But most stupid people were either born that way or at least born into it. It's tough to escape your upbringing. It's even tougher to escape your genetics. We can celebrate the ones that do, but we shouldn't condemn the ones who don't.
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Everyone knows that Homeopathy uses alternative facts and so normal science just doesn't apply.
In a sane world, selling a product intended to be ingested which has been proven to be fatal when ingested would be considered murder.
The FDA does not evaluate or approve the homeopathic products....
To be fair, the FDA does not evaluate approved pharmaceuticals, either. In the vast majority of cases, the FDA just assumes that the pharmaceutical company is being completely honest about its research and testing, even when it is clearly lying.
Merck is a great example of such a lying company that gets blanket approval by the FDA without any outside verification required.
That being said, not everything labeled as Homeopathic is actually Homeopathic. Hyland's teething tablets, while definitely dangerous, are not Homeopathic since they contain an actual ingredient that is known to have an effect (for better or worse) on the human body.
Hyland's big problem is false advertising regarding ingredient quantity and quality.
You know, bullshit's good for a lot of things. I couldn't care less about any of this carp, but I despise the containment of the placebo effect.
The placebo effect is real. Every scientist believes it's real. Every scientific experiment is based on ruling out the placebo effect -- often that's the only purpose of the experiment in the first place.
So, for ailments that don't require treatment of the problem (we're not talking about transplant rejection here), like sniffles and minor pain, why not treat the person without treating the human?!
I'm fine with bottling the placebo effect. Here, take these two placebos and call me in the morning. Alternatively, you can train with the monks and learn to ignore the pain.
Can you imagine what would happen if science actually dedicated real experimental research into developing truly effective placebos? How cool would that be?
I've seen homoeopathy procedures, bring back my dad to heath many times. But I would definitely not recommend it to a child, period.
Here is an article on the topic from 2014:
http://www.abc.net.au/news/201...
From that article:
"Yowie has the only patent given by the US Food and Drug Administration for a chocolate-encased toy"
"But with the patent for Yowie's expiring in 2019, Kinder's strong brand awareness and deep marketing pockets could cause a melt-down for Yowie."
It's kind of stupid that something with so much prior art can be patented IMHO, but that's how it is at the moment.
I get what you are referring to now.
"The 1938 Food, Drug, and Cosmetic Act had outlawed, "non-nutritive items" inside confections, while the Consumer Product Safety Commission (CPSC) had specified that toys must be safe for children of all ages"
That law is why the toy parts are in plastic capsules in items such as Kinder Surprise, Yowies and Candy Treasure Choco Treasure surprise eggs.
The plastic capsule I think is a sensible solution but I'm convinced that a patent on putting a toy inside chocolate is a bit ridiculous.
It means grown without pesticides. Walmart's been caught multiple times cheating on this and forced to pull products each time
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Better yet, the parents should be charged with murder for feeding their kids poison.