Ep 161: Melatonin use in children: a cause for concern or a helpful supplement? with Pieter Cohen, MD

In this episode, Jessica Hochman MD and Pieter Cohen MD discuss melatonin use in children! Dr Cohen recently authored a study on melatonin use in children,  and the study revealed significant discrepancies in the labeling of melatonin supplements. They explore the safety concerns, regulatory issues, and the need for better quality control in the supplement industry.

Dr. Pieter Cohen, a graduate of Yale School of Medicine, is an associate professor of Medicine at Harvard Medical School and a practicing internist at Cambridge Health Alliance (Somerville, Massachusetts).  His area of research is the safety of dietary supplements.  Along with analytic chemistry colleagues, he has spent more than a decade exploring the boundaries between drugs and supplements.  His work has been published in the New England Journal of Medicine, JAMA, JAMA Internal Medicine, American Journal of Public Health and Annals of Internal Medicine.   

Read his article on melatonin gummies here:
https://pmc.ncbi.nlm.nih.gov/articles/PMC101

Dr Jessica Hochman is a board certified pediatrician, mom to three children, and she is very passionate about the health and well being of children. Most of her educational videos are targeted towards general pediatric topics and presented in an easy to understand manner.

For more content from Dr Jessica Hochman:
Instagram: @AskDrJessica
YouTube channel: Ask Dr Jessica
Website: www.askdrjessicamd.com

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Do you have a future topic you'd like Dr Jessica Hochman to discuss? Email Dr Jessica Hochman askdrjessicamd@gmail.com.

The information presented in Ask Dr Jessica is for general educational purposes only. She does not diagnose medical conditions or formulate treatment plans for specific individuals. If you have a concern about your child's health, be sure to call your child's health care provider.

Transcript

Unknown: 0:00

Hi everybody. I'm Dr Jessica Hochman, pediatrician and mom of three. On this podcast, I like to talk about various pediatric health topics, sharing my knowledge, not only as a doctor, but also as a parent. Ultimately, my hope is that when it comes to your children's health, you feel more confident, worry less, and enjoy your parenting experience as much as possible. Are you curious about your family's gut health? You may have heard of the microbiome, which plays a vital role in your digestion, immunity, overall, wellness and more. I want to tell you about a new company called tinyhealth. Tinyhealth makes it easy to learn about the gut health of all ages, even babies using a simple at home test. Their personalized reports provide tailored recommendations for nutrition and probiotics to help make informed decisions for your family's well being, whether you're addressing specific health concerns or exploring ways to optimize your wellness. Tiny health empowers you to take control of your health journey. As a special offer for my listeners, use promo code. Dr Jessica, that's D, R, J, E, S, S, I, C, A, for savings on your first test, visit tinyhealth.com today, it's quick, easy and packed with actionable insights. Hi everybody. Welcome back to Ask Dr Jessica on today's episode, I'm thrilled to have back Dr Peter Cohen, an expert in dietary supplements and a practicing internist who also serves as an associate professor at Harvard Medical School. Dr Cohen is known for his dedication to help patients understand the potential benefits and risks of supplements, earning him the nickname The toxic supplement Hunter by Men's Health magazine. Our conversation today talks about melatonin, a widely used sleep aid for both children and adults. Dr Cohen recently conducted a fascinating study on melatonin gummies that are marketed for children, looking at whether their labeling accurately reflects what's actually in them. His findings may surprise you and shed light on important safety considerations. And if you're interested in learning more from Dr Cohen, I definitely recommend going back to Episode 36 where we talk about the safety of vitamins and dietary supplements. So whether you're a parent considering melatonin for your child, or you've been using it yourself, this episode will give you valuable insights about melatonin and help explain what you need to know to make informed decisions. All right, let's get started. So I'm so I'm so excited to talk to you, because melatonin, believe it or not, is a question that comes up all the time. In my practice, parents have a lot of issues with kids and sleep. It comes up a lot, especially with travel or if, if the routine gets thrown off, some kids are just difficult in general, getting into bed on time, and they're looking to see if melatonin would be an easy, safe, maybe temporary solution. So I'm so interested to talk about your study. So I guess first I'll ask, can you tell everybody, what was your study about? What did you find? Yeah, well, we were also, you know, like your like your clinic. There's also a lot of interest from a public health perspective about these melatonin supplements, because there was a study that came out prior to us, which actually inspired us to investigate the manufacturing qualities of supplements that looked at how often kiddos were ending up in the emergency department and doctor's offices due to melatonin ingestions, and found that over the last decade or so, there had been 10s of 1000s of these doctors visits due to melatonin ingestions, actually 1000s of hospitalizations, and even, I think, two deaths have been described. So this is was a real surprise to me, because in medical school, I had always sort of learned that melatonin was just some benign, you know, a benign substance, so I didn't think it was going to be terribly effective, but I didn't think it was going to be particularly harmful. So that really jumped out at me, and that made us think, you know, is there something going on with the manufacturing, or some other things about the actual product of melatonin that might be responsible for part of this problem leaving so many kids ending up in the emergency department? And so what we decide to do is we we say, focus, focus. We don't have a lot of funding, if any, so we just dive into what we think is highest yield, and what we thought the kids would most likely be taking would be gummies. We thought maybe parents would give their kids gummy melatonins, and the kids might get into their older siblings melatonin gummies. So we decided to look specifically at the main fact, the quality of melatonin gummies. We looked at several dozen brands of melatonin gummies to see if the label matched the actual contents, and what we found was quite disturbing. Just to summarize, I saw that your study showed that there was an 88% discrepancy between what was labeled and what you found was actually the melatonin content in the gummies. That's really astounding, right? And 88% sounds like, oh, okay, well, maybe there was, like, what? 88% of the melatonin that should have been there was there. So, like, kind of, pretty close, you know. But no, that's not it. It's 88% of the time the label did not correspond, correspond to what we found. And then, very Concerningly, the in the 88% when it didn't correspond, mostly, it was due to much more melatonin than there should be in the products to begin with. And one product you even found, CBD, correct, right? So what we what was interesting when we looked at we took the data, this database we were using to find melatonin gummies, and it turned out that there were several brands being sold as both CBD and melatonin combined. So we looked, and sure enough, the actual CBD, when it was listed on labels, actually more accurately labeled and actually more likely to be present than the melatonin was. So we had a product that didn't even have any melatonin, then another product who had, like, three times more melatonin than was list on the label. So in your view, what do you think we can do to make this better? Do you think this is a policy issue? Do you think the US should step in, or the FDA should step in and improve how we accurately label these products. We should improve this by ensuring that consumers, the consumers, should know for Well, let me step back and just say that I do not think I think melatonin should be available over the counter like it is to I think that if a parent wants to purchase a half milligram melatonin, they should be able to go to the store and purchase it, just like they can purchase aspirin 81 milligrams through 25 right? The those are two things that are riskier, right? Taking too much of Aspirin, Tylenol, than melatonin, so I definitely think it should be available with freely available that's not the issue. The issue is that the situation is that when you purchase melatonin today, it doesn't have the quality controls that those other over the counter. Medications do so. If you purchase aspirin in the United States, it's going to be precisely what's on the label. And I simply believe that the law should be that that's the case for supplements, that they're available over the counter, but precisely what's in on the label should be what you're what you find in there. And if you can't, if a manufacturer cannot guarantee that they should not be manufacturing supplements, and the FDA should be acting to remove mislabeled that they would be legally called mislabeled supplements from from the marketplace. That's part of it. The other thing is that I do think that there should be more transparency about the amount of melatonin products. So for example, in a recent FDA study, they found that they were just looking at supplements marketed to children, which they defined as like 18, younger, I think, and they found that some on the label, I believe we're saying that serving size was very high, higher than 10 milligrams, higher than 20 milligrams, maybe up to 50 milligrams. This is so much more melatonin than any child or adolescent needs. Parents often ask me at the dosing of melatonin, and I often find that a half a milligram, maybe one milligram will do the trick. I mean, there's some kids that take more than that, but generally speaking, a very low amount will satisfy what parents are looking for. Sounds very common sense to me, to want to know exactly what you're giving your child, yeah, when you're talking about the thing to keep in mind is that there there is no clear cut difference between aspirin, which happens to be synthetically made in a factory, in melatonin that might be produced in a factory, or if the or a botanical supplement is extracted from a plant, they just need to. We need to when we're putting highly concentrated active ingredients in our body that we can't smell or taste when we consume it, we're reliant on the label to tell us what we're putting in, and we're relying on the label to know what the potential risks are and appropriate dosages. If we're not going to limit the amount that one could put in, there should be a state amount labeled this is 10 times more than what doctors recommend. Sounds that makes sense to me, absolutely. So first, I want to say a big congratulations, because you did this study and you got it published in JAMA, which is such a reputable journal, and then you had a lot of follow up and press about it. And I'm just curious, do you feel like anything good came from it? Have any changes happened since you had this information published and widely dispersed amongst Americans? Well, I think that one thing that we could potentially be heading in the right direction, because it's clear that the FDA has woken up and start at least their sign. Scientists started to investigate the same question. So in a follow up study to our study, the FDA scientists have now published a study that included much more products, over 100 different products, and they focused entirely on ones marketed to kids. So would that study have happened without ours? You know, hard to say, but that's the kind of steps now that would have to be used. So the the FDA scientists are taking the next step, but will the FDA decide to do anything with that data? Is a totally different, different story and situation, so and one that's that's worrisome. Another thing that's come out of the development since we published our study is that the main supplement manufacturing lobbying group has now embraced or recommended that in any that melatonin products overall, but are made in childproof containers are produced or sold in child containers. Now that's just their kind of the vague voluntary recommendation, but still, that's also just signaling that the industry knows there's a problem. So what we've heard clearly is that there were signals that the industry understands there's a problem here, the FDA understands there's a problem here, and then the question is, is anything actually done with all that? I think that's a wonderful step, even though we don't know exactly what's in the content of each gummy. Putting a child proof top on them, I think is a good step, because especially with something like gummies, it's so appealing to kids, if they see a bottle of gummies, they're going to have more than one. I see this all the time, especially with vitamins. I'll get a phone call from parents. They'll eat multiple gummies in a vitamin jar, and they're wondering, Is that safe for their child? That is a good step in the right direction. And I'm so glad that the FDA jumped on it, and have done follow up studies looking into the same question and the same concern. The one thing to note and and you might already cover this in other episodes of your podcast, but it's this issue of child proof. Child proofing these bottles. One thing very important for parents to understand is that there's a certain requirement that something is truly child proof, meaning that that bottle has been tested and is assured to prevent, you know, some resistance, at least until you know what. There's a good New Yorker cartoon, I think, like last week that had a dad was bringing up his like 12 year old, no seven year old, and demonstrated that he had grown up now, and he could open up the child proof, the child proof bottle, in front of the in front of the family. But with that said, there are requirements. And the problem, though, to be aware of is that parents should be aware that there's language used on a lot of different bottles that mislead the consumers that someone's child proof what's not so it's really important to understand what the technical language is that the FDA really means that it's child proof, and make sure you look for bottles with that. Because you if you say something like child safe, you know, or put something on that, there's a lot of like, names that are thrown around that doesn't mean anything other than the manufacturer has decided it's child safe, for example. So you know, that's worthy of a whole nother discussion. Absolutely, yeah, it's certainly, it's one step, but it's very clear that there's a lot more happening here that needs to be improved. I just want to take it back in the very beginning, you were saying how, before you did the study, you were clued into data showing that there were two deaths from melatonin, and I just want to clear the air on that. Do you think that those deaths happened because of melatonin, or because the melatonin was mixed with some other product, or it was labeled inaccurately? To me, that sounds unlikely that melatonin was a sort was the sole source of a death in a child because at the correct at the correct dosages, it really should be a safe product to take. Well, my my read of one of the cases is that it probably was significantly contributed. So this was but there, there's extreme situations. So the you know, if we take too much of anything, people can die from taking a teaspoon of pure caffeine or just drinking water without a electrolyte. So let's just keep that in mind while we're discussing this. So I'm not talking about any inherent danger to this melatonin. It's, like we said, much safer than aspirin or Tylenol. But, yeah, I mean, my understanding of one of the cases was that there was a little infant wasn't sleeping in a crib, and because the parent believed that melatonin was 100% safe like giving Gatorade or. Water to their child, or milk, no one would ever be worried about their child drinking some extra milk. Kept on giving more and more liquid melatonin to the child, and then child eventually didn't wake up. Now was the melatonin let something else happen? Is that the total coincidence? Or can you give so much melatonin that, yes, maybe something else, they rolled over. They had a pillow in the wrong way, but, but, but they couldn't maybe protect their head or roll over because they'd had whatever, 100 times more melatonin than they should have. So I think the thing is, like, it's not like black or white at just like we're talking about at dosages that recommended by your pediatrician, 0.5 milligrams, one milligram, it's never going to kill anyone, and it's the worst case scenario. What makes someone a little more groggy or upsets their stomach? There's no risk of death whatsoever. But I think the idea to say melatonin is totally safe is misguided, because if a kiddo downs a whole bag of melatonin gummies. And those melatonin gummies are formulated, are already at high doses and then manufactured with even more melatonin they're gonna be sick, um, I would expect, you know, nauseous, vomiting, you name it, maybe, totally out of it, and a responsible parent is going to bring them to the doctor, so it's not a matter of, like, that's going to kill them, but, or they need to be, you know, intubated to breathe. But, um, yeah, I think it's not just clearly, like something's entirely safe, and I think that has a lot to do with the storage and melatonin. Around the house. Well, like we were talking about, about the safety bottles, all this melatonin should be treated. If it's treated like Tylenol, then, then it's going to be great. Yes, no. And I to your point, anything in excess can have potential risks. So, and I think that's very important to acknowledge. I guess my question is for parents that ask, is there a safe way that you know of to buy melatonin? In other words, is there a brand out there that is regulated by the FDA if parents want to purchase the product in a way that they know is safely labeled? Yeah. So my recommendation is so basically because the current law and the FDA is lack enforcement law. Those two things together lead to all these manufacturing problems, and 88% of things are mislabeled. We have to use workarounds. The consumer has to use workarounds to find accurately label melatonin supplements. And fortunately, that's possible because there are a few very high quality third party certifiers. So these are, these are groups that the manufacturer hires to investigate the quality of their supplements, basically, kind of do a research study like we did, and if they do their study and say, Oh yeah, these are highly manufactured, then they get the stamp from that firm that that third party, there's like two very high quality third party certification programs. One is us Pharmacopeia. There'll be USP stamp, and the other is NSF International, NSF stamp. Now those are two very high quality programs. They both and just out of just transparency. I do research in the past with the NSF team, so I work well, very closely with them for years, but I don't receive any funding or get paid by them at all. And I have no no involve with the USP. But those two programs, the way to start would be to go to their websites honestly and then look up the melatonin products that are certified. It's honestly too confusing just to try to look for that the stamps on the bottle, because there's so many misleading stamps. Every supplement bottle has like five different stamps on it, and how can you sort all that out? So my recommendations go to these very high quality third party certification programs, look at exactly and you have to look at the details. It has to be the exact brand, the exact dose, in the exact formulation. So if they're talking about gummy, if they're talking about capsule, that does that, doesn't mean that gummy from the same company is going to be high quality. So it's just one product line, then you can go and buy that product line with more certainty that it's going to be accurately labeled. That is a really helpful tidbit, because I know that it's tricky, because there are situations where they might want to find a sleep aid and they obviously want to do it safely. So it's nice to know that there is a way to do that. So that's that's really helpful. Thank you. You know, what's interesting is, when I was first a pediatrician, the way I was taught about melatonin was that it was a very safe, benign supplement. Because essentially, we're living in this time now where we're around so much light, and the body makes more melatonin when it's dark, and because we're all around. You know, TVs and cell phones and light and excess, more than we were designed to be that our body is not getting a chance to make melatonin, and simply by taking the supplement, we're putting back in our body what it's lacking. So I always thought this is a really benign thing to tell parents to do, but, you know, but something in my gut also didn't sit right that taking a supplement or taking it relying on a supplement would be a healthy thing to do. So your study was really helpful. So thank you so much. It's my pleasure, but and I do want to follow up one one item about what you said, which is that that might make sense, but it turns out, when you look at the data, my understanding of it is the amount of melatonin that someone needs, like an adolescent needs. This was a study of young adults, like 17 to 19 years old, the amount that they needed to get their melatonin to the complete nighttime dose. The nighttime level was very small dose, like we're talking about half a milligram. So this is in these are infants, so you're talking about an 18 year old, if they took a half a milligram of melatonin, they had the equivalent levels of night time. That is fascinating, because I when I see melatonin marketed for adults, usually it says three to five milligrams, I believe, and there's zero data to support that that's necessary. This has just been tradition, kind of like because of the the medical thinking that you we were both taught in medical school, which is that, since this is so safe, why don't you just give three or five milligrams, making sure you get enough, right? Maybe there's some absorption problem. Maybe there's this. Maybe there's a manufacturing problem. Just always give enough, and then you don't have to worry about you get into the nighttime level. But the fact of the matter is that what we know is, like anything and like we're talking about, if you get too much of a substance, it's gonna can make you sick. I'm so impressed. I'm so thankful for the work that you did, because, you know, I think you're you're making such a difference, because not only with melatonin, hopefully the FDA wakes up and realizes that Melatonin is a is a situation where we need to make sure that we're accurately putting on the label what's in the substance that that is being sold. But hopefully this will extend to other supplements as well. Because, as I know, You've done a lot of work with supplements. This is not the only supplement sold that is not accurately labeled. So I'm thankful because you are making a true impact on society. Well, that's a slight, big overstatement, but I appreciate your but it's true. Your support. Jess, well, thank you so much. Dr Cohen, I really, really appreciate your time. Are there any other closing thoughts that you'd like people to hear from you? Or do you feel like we pretty much covered it? I think we've covered it. Thank you so much. Always great to talk to you. Great talking to you. Thank you for listening. And I hope you enjoyed this week's episode of Ask. Dr Jessica also, if you could take a moment and leave a five star review, wherever it is you listen to podcasts, I would greatly appreciate it. It really makes a difference to help this podcast grow. You can also follow me on Instagram at ask Dr Jessica. See you next Monday. You.