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.

Comments

I know it's fun to make fun of Homeopathy

[rsilvergun]

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.

Re:I know it's fun to make fun of Homeopathy

[alvinrod]

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.

Re:I know it's fun to make fun of Homeopathy

[MightyMartian]

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.

Re:I know it's fun to make fun of Homeopathy

[MightyMartian]

Which would be fine if it was just morons poisoning themselves, but they're poisoning small children, and that's the chief problem here.

Re:I know it's fun to make fun of Homeopathy

[PCM2]

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?

Re:I know it's fun to make fun of Homeopathy

[amiga3D]

I see no shortage of dickheads either.

Re:I know it's fun to make fun of Homeopathy

[MightyMartian]

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.

Re:TIL

[rmdingler]

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

However, unlike vaccines, with homeopathy, the undereducated are only damaging the likelihood of diminishing the number of their own offspring. Ignoring vaccines designed to protect herd immunity hurts the rest of us, too.

Re:Hyland's teething tablets

[kencurry]

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. ...

Um, shouldn't your focus be on contraceptives?

Homeopathic Baby Products?

[Anonymous Coward]

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.

Re:Hyland's teething tablets

[mmell]

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!

Inevitable and unavoidable

[ilsaloving]

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.

Re:Hyland's teething tablets

[MightyMartian]

We read your post. You're trying to defend giving your children a toxin, Mr. Christian Anarcho-capitalist...

Re:Hyland's teething tablets

[MightyMartian]

There used to be this great Seattle-based comedy show called Almost Live (a sort of low-budget SNL), and they had this really hilarious skit with this tobacco company executive insisting "Smoking is completely safe. Leading chiropractors have found it in fact puts a protective lining on the lungs!"

Re: Hyland's teething tablets

[sound vision]

Benadryl (diphenhydramine) works similarly to belladonna. It also has the bonus of being a regulated product, properly labeled, and with a known dosage. Iirc that's 12.5 mg for children's benadryl. How much belladonna is in the hyland product? It probably doesn't say on the box, but it seems like its enough to kill the kids, sometimes.

Not homeopathic.

[jcr]

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

-jcr

Re:Hyland's teething tablets

[guises]

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.

Or "holistic"

[raymorris]

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.

Re:TIL

[james_gnz]

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.)

Re:Hyland's teething tablets

[lgw]

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.

Re:TIL

[sphealey]

The packaging for the product described in the OP looks no different from five similar and safe products that are on the shelf at your local drugstore. The word "homeopathic" is in small type compared to other marketing words - which are the same words used on much safer products - and many people have no idea what "homeopathic" means in any case.

So yeah, no. This is a clear case of misleading packaging and marketing; whether it is a criminal case remains to be seen.

Exposing babies to peanuts

[Geodesy99]

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. "

Re:Exposing babies to peanuts

[Anonymous Coward]

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.

Re:Exposing babies to peanuts

[ShanghaiBill]

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.

Re:Exposing babies to peanuts

[michelcolman]

Barely any trace? The chance of finding a single molecule of the diluted compound in a homeopathic product is less than winning the lottery several times in a row. (If the dilution is done properly according to homeopathic rules, which apparently was not the case for these teething gels).

Re:Exposing babies to peanuts

[Maritz]

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

No, it isn't. You're giving them peanut. Homeopathy is giving people nothing. N-o-t-h-i-n-g.

Lots of misinformation in the comments section

[slew]

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?

Re:TIL

[michelcolman]

Good occasion to watch Tim Minchin's "Storm" again, about alternative medicine and such. (Skip the first minute)

Best quote from that video: By definition, alternative medicine has either not been proved to work, or been proved not to work. Do you know what they call alternative medicine that's been proved to work?...
Medicine.