The trash. That’s where the FDA’s newest press release on homeopathic teething tablets found itself. In fact, I had such a hard time keeping track of the circular reasoning and inconsistencies in their release, that I had to read it twice. Then I laughed. Then I cried (but mostly laughed). And then, I felt the need to set the record straight because a whole lot of moms are going to toss-up and freak out over a whole lot of nothing.
As a mom of five, I like to make decisions based on facts, science, and common sense. The last thing I’m going to do is throw out something that works for my kids and my life (and quite frankly, millions of other parents since 1945) because of some off-the-cuff propaganda that’s got an agenda.
So, before you do something crazy and throw out your lifeline of “homeopathy doesn’t work and it’s dangerous” teething tablets, allow me the pleasure of breaking down the stupidest press release I’ve ever read, from an organization I wouldn’t trust the cat I don’t have with (let alone my children):
Red Flag #1
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. They didn’t say what these risks are, because … let’s be clear, they admitted in their statement that they have no idea. So, they planted the idea that a group of symptoms that could be attributed to any number of things – could be caused by your child’s teething tablets.
“Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.”
Clever phrasing, but does that mean homeopathic teething tablets cause any of these things? No, it does not. Did the FDA cite any scientific study to support its position? No, it didn’t. Was its statement based on facts and science – the “gold” standard the FDA supposedly adheres itself to? Of course not … unless you count the unsubstantiated report(s) that made up the a prior safety alert from 2010, forming the basis of whatever it is you call this.
That’s SIX years ago people. A safety alert from 2010 that was so legit, they never got around to looking into it until now.
Red Flag #2
The FDA’s original beef was that these teething tablets are manufactured to contain a small amount of belladonna, a substance that can cause harm at larger doses; yet the amount of belladonna in a teething tablet is minuscule and there is NO scientific link between these tablets and seizures, just like there’s no scientific link between staring at an ice cube, and turning into Elsa from Frozen.
According to Hyland (which knows far more about homeopathy than the FDA), a 10-pound kid would have to ingest more than a dozen bottles of teething tablets to experience even a symptom like dry mouth. There’s 0.0000000000002 mg of belladonna alkaloids in a baby teething tablet (about two trillionths of a milligram in each tablet), which is thousands of times below what is commonly prescribed in conventional medicines, like anti-spasmodics.
So let me get this straight, I’m supposed to freak out over two trillionths of a milligram of belladonna and not think twice about injecting hazardous wastes, carcinogens, and neurotoxins at far greater levels, on a schedule that has never been tested for safety or efficacy, into my children?
I can buy Tylenol (which the FDA was also wrong about) like it aint’ no thing, drown my kids in antibiotics, and give them water to drink each morning with a side of poison (fluoride), but I should throw out my teeny, tiny, never-been-proven-harmful teething tablets? Say what?
Speaking of water, do you know what else can cause harm if you take too much? Some good, quality, H2O.
Red Flag #3
While we’re talking about the FDA trying to pull a fast one, do you know what is linked to seizures during those terrible teething years? Vaccines. I can’t make this stuff up. It’s all right there in the studies, package inserts nobody reads, and in the database that stores all of the reported adverse events the FDA pretends doesn’t exist (because they’re super busy trying to create one for homeopathic baby teething tablets). You know what else can cause seizures? Fevers caused by the illnesses that vaccines induce.
It’s ironic that they’re training parents to think “teething tablets” when they witness a seizure, dry mouth, or constipation, instead of the most obvious causes like vaccines, vaccine-induced fevers, and dehydration. Yes, the rise in childhood disorders has been solved: It was the teething tablets all along … or at least it will be since they’re finally testing samples of a formula that Hyland actually CHANGED in 2011 (since the cited 2010 safety alert) to “manufacture” a link that doesn’t exist.
They already know they won’t find anything suspicious, which is why they hurt the bottom line of a successful company and scared millions of mothers everywhere away from something that is safe when used properly and might actually work.
Fear … it gets us every time.
Red Flag #4
And let’s not forget, the FDA made the bold claim that teething can be managed without prescription or over-the-counter remedies, while giving no alternatives, straight up stated they haven’t evaluated the teething tablets before literally destroying a business and the sleep-filled nights of infants and mothers everywhere, and made it oh-so-easy to report a potential adverse reaction to a teething tablet. But that’s red flag #5.
Is there a new pharmaceutical something in the pipeline to help teething babies? You tell me.
Red Flag #5
The FDA practically begged physicians to file a report for all things teething tablets. Seriously, they give you the form, several ways to submit it, and a fax number. They practically filled it out for you. If that’s not suspect of a witch hunt … I don’t know what is.
If a parent brings their kid in for seizures or any other symptom, the first question should be: “Was your child recently vaccinated?” This makes the most logical sense since homeopathy has been used for over 200 years and is associated with almost zero side-effects, unlike vaccines.
Red Flag #6
The FDA acts like homeopathy is some rogue version of woo, but it’s actually regulated by its own agency. Homeopathic products have to comply with the FDA’s labeling requirements (21 CFR §201), must be manufactured in accordance with Current Good Manufacturing Practices (21 CFR §210 and §211), must register with the FDA, and manufacturers must comply with FDA inspections and report any serious reactions as a matter of course.
It’s funny that the press release called out Hyland for indicating that their product is intended to relieve teething symptoms in children, because their own agency requires that OTC homeopathic medicines list a therapeutic indication on the product label. Hello? Anyone?
Should you throw out your teething tablets?
I can’t tell you what to do, but I’m not throwing out my teething tablets (or my essential oils, which have zero medicinal properties whatsoever). I’ve read Hyland’s own 411 on their teething tablets and I’m not a fan of pretending that a company is guilty of a crime it hasn’t committed or that it’s product is dangerous when the evidence doesn’t support that.
I expect a little something more than an issued press release that tells me to dispose of something that may cause nothing, based on a six-year-old hunch that it could cause something it doesn’t, and a solicitation to submit a report if my child has a seizure, so they can manufacture a connection to take the heat off of what we all know is actually causing them.
I saw right through that press release. Chances are, if you read it twice … you will too.
So happy my kids got to use these! I recently recommended them to a mommy with a teething babe. Turns out she told me that it was discontinued. I suspected the government did it and it was the belladonna. Turns out I was right. But it is such a tiny amount. I believe it was vaccine injury. I think all the insane inflammatory non natural people who comment here just don’t know anything. Right now I do not have any cartilage in my hip. I’ve been in pain for a year and the surgeon is hot for my money without proper consultation and drawbacks so until I find the right person to do it. I am taking medicinal doses of some things I’m glad I found the right natural combination that works, But I’m informed and research stuff. Even though I a natural person and will always turn to this first, I don’t believe stem cell will work. It’s risky non insured procedure being touted as the new alternative to hip replacement where they take thousands of dollars with no guarantees. So keeping a balance of practical and allopathic. I’ve taken my kids to a d.o. When the homeopathy regimen wasn’t working at least a d.o knew about homeopathy and wasn’t over quick to prescribe but did because it wasn’t helping the problem. people are crazy! I had a client say organic food was from the devil because it was a test to see if we actually trusted god with regular non organic food. Why are people loosing their minds so easily to organized pharma, religion, FDA, politics….thanks for your article.
Why is this missing critical information so that people can form educated decisions?
Missing info: the few conclusive testing shows inconsistent amounts of the drug commonly known as deadly nightshade and sometimes far exceeded the amount claimed on the label. This is violates at minimum labeling laws meant to protect those who buy over the counter.
Also, their symptom list wasnt made up or pulled out of thin air! It was based on the link of hundreds of kids coming in with these side effects after overdosing on Belladonna which contain alkaloids, which have anticholinergic effects. Classic signs of anticholinergic toxicity include fast heart rate, increased body temperature, dry skin and dry mouth, skin flushing, constipation, decreased urination, agitation, disorientation, hallucinations, and dilated pupils. Drowsiness may also be seen in infants. FDA received reports of serious adverse events in children taking this product that were consistent with belladonna toxicity. 400 kids with nightshade symptoms immediately after taking night shade. 10 died. These mislabeling and impossible to know dosages lack safety warnings and risk vs benefit purposes, and the overuse of the product because they are seen as safe and natural, are all major problems since teething is never deadly and NOT comparable to life saving vaccines which *do* prevent deadly childhood diseases by millions each and every year. Death over teething pain, and unexpectedly__ because the bottle is mislabled and the product is unreliable in dosing is not positive risk vs benefit. By any means. It’s a dangerous finding.
But you know…whatever. This blog isn’t irresponsible at all. Putting babies lives at risk for pseudoscience
1. Correlation doesn’t equal causation. Are you against vaccines?
2. Citations
3. Insufficient evidence to remove a product that has been used for an extensive amount of time and is associated with literally no side-effects from the shelves.
4. How do you know the symptoms were caused by the teething tablets and not the correlating vaccine schedule?
5. The FDA (and possibly you though I would hate to judge) clearly do not understand homeopathy or how it works.
6. The FDA received complaints consistent with vaccine injury. Again … please look up how homeopathy works.
7. Bottle was not mislabeled.
8. Complaints were from 2006. 11 years ago …
I could go on …
I agree with this article. Any baby can have a reaction to any food you give them. Also the doctors say that you can’t give a baby water until he/she is at least 6 months. Water?? God forbid we can’t give our babies water!!! What else can we not give our babies? I have 2 kids and every year it is something new. When my first baby was born, Mylecon was recalled, and now Mylecon is back and Hylands is recalled. Sippy cups were recalled last year! Back in the days there weren’t so many issues. I honestly feel that the government doesn’t understand babies and their body digestive system and they are trying to instill fear on parents.
Because water affects absorption and digestion in young babies…
The FDA’s original beef was that these teething symptoms tablets are manufactured to contain a small amount of belladonna.
That’s not how homeopathy works.
…….how does homeopathy work then? Id love ti hear your answer. A talented blogger would at least explain when arguing his/her point, not just blurt something out.
Completely agree. This makes my blood boil! Only problem is now I can no longer get these and my little guy has lots of teeth to go still.
Korina, if you do a little searching you can find companies that still sell them. I found some on a site called Clickhere2shop.com and bought several bottles to stock up.
I’d like to purchase some too to stock up but the looks of that website make me a little nervous. Did you order come in as expected? Are they the actual Hylands brand?
I am a firm believer in the value of homeopathic product. My now 40 something kids used them for everything, colds, teething, fevers, and they actually do what they’re supposed to do. Back then we ordered from a catalog, Whole Earth maybe? Never a problem. I would be interested to know if they’ve done any studies on the effectiveness of CBD for teething symptoms.😉
yea i’m about to call all area drug stores to see if any still carry them. the sad part is that, these things more than likely happened to poor innocent kids because parents didnt want to deal with them crying so much and gave them too much. i recomend these to everyone i know. my daughter is about to be one and she gets one teething tablet a day, if needed. we prefer her to tough it put, bur if we see it’s getting to be too much we give her a tablet. i call them her happy pills, cause she becomes happy instantly. I wish I had known about these when i had my other 2 kids. these are definitely a great product in my book and should be brought back.
Use Camilla teething pods they’re great
You can get them online 😂
I have a 2 month old & was upset to find out they’d been recalled AGAIN!!! WHEN they’ve ALWAYS worked just fine for my kids!!! Of course I’m not stuffing them down their throat all day I’m guessing quite a few parents must of been feeding them to theirs baby’s as meals in order to od… 😒 anyways lol i seen them for like $20
Pretty darn spendy… 😒😒😒
I never had problems giving to my 2 kids 14yrs ago! Also, I didn’t feed it to them like a meal but thought it was safe from giving as needed without fear of overdosing!Which never even crossed my mind! Funny,not really funny..but my daughter when she was almost 11months started having seizures &I know I used it hylands tabs With both kids &with new baby only thought of hylands….but the seizures were februal,some times had a fever before seizure,sometimes not,but she grew out of it&never did Dr’s bring up teething tabs,they never found anything wrong with her,because it’s a common thing with young kids under 5yrs old.
Look on amazon…i thought there was some on Amazon thru 3rd party company’s. I fell into the scare trap but i thought i saw some hylands.
Actually, I can’t find them! I was pretty sure I saw them in the last few months.
Hylands has calming tabs,They are not saying they are for teething but other people in reviews are saying They are using for teething, cranky or irritability . If anyone does find them , let us know .
Update*** they are thru 3rd party companies on walmart. walmart.com.
It is confusing….some bottles say 6x,or 30x….meaning potency?I’m not sure….
We have them at our local walmart!
My thoughts exactly! Thank you for having the bravery to speak the truth.
Thank you!!!
I won’t give up the tablets. I trust a family owned, 100+ year old company over a bought and paid for government agency.
You’re nuts. The FDA said it received reports and complaints regarding these homeopathic tablets. They are warning people that the tablets could potentially be problematic, and as such, you should be cautious.
Yes, they did not do studies, but they received enough complaints to warn us of possible issues. Now, just because they didn’t do studies, it doesn’t mean that the causal relationship is not there. It could very well be. If it turns out that there is a connection, and the FDA ignored the complaints they received by not sending out this press release, then they would be in deep trouble.
The press release asks you to look at alternative ways to help your baby, just be cautious of this particular product.
Also, just because it worked for you and your kids, and millions of other kids for that matter, it doesn’t mean other kids can’t and won’t have adverse reactions to the same drug. Everyone is different, you know, and parents have the right to know that there might be these types of side effects.
You’re nuts too. Here’s some data from the CDC. By your own logic, that means we should all stop administering vaccines.
ccording to the CDC, from 2006 to 2015 over 2.8 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 4,374 petitions were adjudicated by the Court, and of those 2,847 were compensated. This means for every 1 million doses of vaccine that were distributed, 1 individual was compensated.
Since 1988, over 17,935 petitions have been filed with the VICP. Over that 27- year time period, 16,187 petitions have been adjudicated, with 5,269 of those determined to be compensable, while 10,918 were dismissed. Total compensation paid over the life of the program is approximately $3.6 billion
Ugh yes it’s a cover up for vaccine injured babies!! Duh ! First thought before I saw this article which I found googling it bc I knew there were moms who knew dang well the tablets most likely more than half of our kids have eaten way too many off by accident before are healthy as can be and living !!! Homeopathic anything isn’t harmful manmade toxic bs they force you to pump in your kids is! Ugh blood boiling subject! Anti vax organic gmo free everything and homeschool for life!
Medicine is done via risk vs need. Many of is take meds to save our lives\quality. Vaccines which you will so obviously deny, save millions of lives. Your comparison is medically and scientifically invalid.
Vaccines saves lives? Why is there a vaccine compensation fund? Why is mercury, aluminum, aborted fetal cells, formaldehyde, god knows what else in vaccines? Ohhhh and guess what, Marijuana is a medicine and millions of people take it to improve lives and save their lives. Big Pharma wants your money. Open your eyes.
YES!! Thank you for writing this!
We recently ran out of tablets and it makes me sad every time we pass the aisle they were on at the store! Lol
I was told too many times by people who’d never even heard of Hylands that I should not buy what was in my buggy. I can’t imagine what they’d have said if I’d told them that not only was I going to buy them, but use them. My children also aren’t vaccinated and won’t be until they fix way too many problems that will never be addressed! On average, people don’t do their own research and just go off what the news tells them or the post they saw on facebook. Thank you for putting the truth out in the open for people to easily access! There is an agenda, and people should be made aware of it.
I never read that the FDA tested the Homeopathic teething solution. Please be mindful when making statements. The use of Belladonna has been in practice for many years. The way it appears to me how the FDA is stating their story, sounds more like assumptions, and a desire to link the adverse reactions to Belladonna. By referring to it as a poison that is is being used as medicine. It also states that their has been no FDA testing of Belladonna to prove that it has any health benefits. This is a bunch of mumble jumble psychological babbling. It really sounds more to me like envy and a desire to gain power to meddle in natural healthcare for potential financial gains. Why because more and more people are returning to the natural way of allowing the body to heal itself by giving it what it needs. In any situation where one wishes to accuse someone of anything, one has to prove that what one is speaking is actual facts, if it is based on speculations with no actual proof then it is nothing more than pure propaganda set forth to sabotage what is believed to be the competition.
The problem is ultimately anything that is natural and works, ticks the government off because the pharmaceutical companies aren’t allowed to patent anything that is natural. That’s why they have to create a chemical copy, which they can in turn patent it for 20yrs and make a ton of money off of it.
Haha was a silly comment. Have you even read the amount of money these “natural remedies” take in each year? Americans have spent over $32 BILLION dollars on “natural remedies” and you want to call pharma companies the greedy cash cows. $32 billion dollars is about 1/3 of what American spend on prescription drugs. The only difference is, these prescription drugs have gone through testing and it is known how it works in the body. That testing costs millions to billions of dollars. Yet your precious, “natural remedies” are raking in billions without having to dish out any proof that it actually works, how it works, what it interacts with, and what antidote, if any should be used. This item was recalled because certain Lot numbers had more than the recommended dose of belladonna in it. No the FDA did not run studies, you know why, because if something is labeled as a supplement they are not allowed to until there is a problem. Your precious teething tabs are allowed to market themselves as safe until there are reports. And side effects from supplements are greatly under reported because people like you assume: “supplement = safe” so they don’t report these items to their physicians or the hospitals. Go ahead and take a look at the Dietary Supplement Health and Education Act, you will see that companies are allowed to sell and market anything without FDA interference until a problem is found. I’ll go ahead and save my $32 billion dollars for something that has been proven to work. I’m not saying all pharmaceuticals are safe or without risk, but I’m also not naïve to think that natural = safe either. Poison Ivy is natural, but I’m not about to throw some of those leaves in my salad.
Who cares if natural remedies make a lot of money if they work? It costs money to produce and bring a product to market. We all recognize people need to be paid for their work. My problem is when companies sacrifice integrity for the sake of profit. As for the “proof” you speak of, you should probably take that up with the government because it takes a significant amount of money to fund these studies and they aren’t dishing out the money for natural supplements that can’t be patented and conflict with their interests.
P.S – None of us who believe in natural medicine consume poison ivy.
With respect,
Megan
Megan,
I’m not against making a profit I understand people need to get paid. However this is a lot of money to be pocketed for a product that hasn’t actually been proven to be safe or effective, it’s just assumed. I’m also not saying you would consume poison ivy…… I’m saying I know the harmful effects of poison ivy and because of that I would ingest any amount in any form so I’m not about to give my baby a known poison, regardless of what miniscule amount the package says…… at the end of the day it is still a deadly poison. Not to mention that Hyland’s has already been dinged in the past for having unregulated amounts of belladonna in their product. You mention the recall from 2010, you have yet to touch on the reports since then. Your comment like, “there is NO scientific link between these tablets and seizures” seemed to null in void based on your above statement. Your right there is no link because the product hasn’t been tested. A product that does bring in millions of dollars in sales each year, you’d think they would be willing to fund a study to clear their name, but instead they will just move overseas where the regulations aren’t so stringent. That doesn’t cause a red flag for you? Next comment, “straight up stated they haven’t evaluated the teething tablets before literally destroying a business and the sleep-filled nights of infants and mothers everywhere, and made it oh-so-easy to report a potential adverse reaction to a teething tablet.” There is a reason for this, it’s called the DSHEA, the FDA is not allowed to step in and evaluate anything until these events have been reported, what’s more is I find it interesting that you say the FDA makes it so easy to report these events. The FDA is doing their part, I guess I miss the part where Hyland’s provides the phone number or website to report the any adverse events…… oh that’s right they left that out leaving it up to the family and physicians to report on Hyland’s behalf. You are so quick to jump on the FDA but don’t realize they aren’t not allowed to intervene in these types of agents until there is a problem, how is that safe for children? Next comment, “The FDA practically begged physicians to file a report for all things teething tablets.” Actually only 1/3 of American physicians know that they are responsible for reporting adverse events suspected to be related supplements. So the FDA obviously isn’t begging for anything, when you do go on there yes the form is simple because they are only capturing what the event was and what the physician feels caused it. The FDA isn’t focusing on anything in particular, the physician is. Also, “If a parent brings their kid in for seizures or any other symptom, the first question should be: “Was your child recently vaccinated?”” actually physicians actually ask this, I know because I take my child for medical care. They ask for all recent medications, or illnesses. The use of supplements and homeopathic agents is actually drastically underreported because people don’t feel these are medications or that they have any side effects, “because they’re natural” so they don’t share this information with medical professionals, it’s usually shared when parents are asked specifically about their use. So again blaming the FDA doesn’t make sense, your argument should then be the physicians are on a witch hunt not the FDA. Lastly, “It’s funny that the press release called out Hyland for indicating that their product is intended to relieve teething symptoms in children, because their own agency requires that OTC homeopathic medicines list a therapeutic indication on the product label.” is actually false. Homeopathic agents do not fall under FDA regulations they actually fall under DSHEA which clear state the label must state the following: “: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”. These teething tablet are for the FDA what is called, burden of proof. Meaning that the FDA can not interfere with market or distribution until they are proven to be unsafe, the only way the FDA can do that is by consumers reporting adverse events. Once consumers report these events then the FDA is allowed to step in issue warning and then recall. So while you want to raise all the red flags on the recall your red flags should also be noted to have their own red flag as you want to just call our the FDA, when really they aren’t exactly the bad guy you are portraying them to be.
Amen they’ll go broke if everyone did an ounce of real research!