November 18, 2024 • 23 mins
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.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Unknown (00:00):
Hi everybody. I'm Dr Jessica Hochman, pediatrician
(00:02):
and mom of three. On thispodcast, I like to talk about
various pediatric health topics,sharing my knowledge, not only
as a doctor, but also as aparent. Ultimately, my hope is
that when it comes to yourchildren's health, you feel more
confident, worry less, and enjoyyour parenting experience as
much as possible. Are youcurious about your family's gut
(00:23):
health? You may have heard ofthe microbiome, which plays a
vital role in your digestion,immunity, overall, wellness and
more. I want to tell you about anew company called tinyhealth.
Tinyhealth makes it easy tolearn about the gut health of
all ages, even babies using asimple at home test. Their
personalized reports providetailored recommendations for
nutrition and probiotics to helpmake informed decisions for your
(00:44):
family's well being, whetheryou're addressing specific
health concerns or exploringways to optimize your wellness.
Tiny health empowers you to takecontrol of your health journey.
As a special offer for mylisteners, use promo code. Dr
Jessica, that's D, R, J, E, S,S, I, C, A, for savings on your
first test, visit tinyhealth.comtoday, it's quick, easy and
packed with actionable insights.
Hi everybody. Welcome back toAsk Dr Jessica on today's
(01:08):
episode, I'm thrilled to haveback Dr Peter Cohen, an expert
in dietary supplements and apracticing internist who also
serves as an associate professorat Harvard Medical School. Dr
Cohen is known for hisdedication to help patients
understand the potentialbenefits and risks of
supplements, earning him thenickname The toxic supplement
Hunter by Men's Health magazine.
(01:28):
Our conversation today talksabout melatonin, a widely used
sleep aid for both children andadults. Dr Cohen recently
conducted a fascinating study onmelatonin gummies that are
marketed for children, lookingat whether their labeling
accurately reflects what'sactually in them. His findings
may surprise you and shed lighton important safety
considerations. Andif you're interested in learning
more from Dr Cohen, Idefinitely recommend going back
to Episode 36 where we talkabout the safety of vitamins and
(01:51):
dietary supplements. So whetheryou're a parent considering
melatonin for your child, oryou've been using it yourself,
this episode will give youvaluable insights about
melatonin and help explain whatyou need to know to make
informed decisions.
All right, let's get started.
So I'm so I'm so excited to talkto you, because melatonin,
(02:11):
believe it or not, is a questionthat comes up all the time. In
my practice, parents have a lotof issues with kids and sleep.
It comes up a lot, especiallywith travel or if, if the
routine gets thrown off, somekids are just difficult in
general, getting into bed ontime, and they're looking to see
if melatonin would be an easy,safe, maybe temporary solution.
So I'm so interested to talkabout your study. So I guess
(02:33):
first I'll ask, can you telleverybody, 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 interestfrom a public health perspective
about these melatoninsupplements, because there was a
study that came out prior to us,which actually inspired us to
(02:54):
investigate the manufacturingqualities of supplements that
looked at how often kiddos wereending up in the emergency
department and doctor's officesdue to melatonin ingestions, and
found that over the last decadeor so, there had been 10s of
1000s of these doctors visitsdue to melatonin ingestions,
actually 1000s ofhospitalizations, and even, I
(03:16):
think, two deaths have beendescribed. So this is was a real
surprise to me, because inmedical school, I had always
sort of learned that melatoninwas just some benign, you know,
a benign substance, so I didn'tthink it was going to be
terribly effective, but I didn'tthink it was going to be
particularly harmful. So thatreally jumped out at me, and
(03:38):
that made us think, you know, isthere something going on with
the manufacturing, or some otherthings about the actual product
of melatonin that might beresponsible for part of this
problem leaving so many kidsending up in the emergency
department? And so what wedecide to do is we we say,
focus, focus. We don't have alot of funding, if any, so we
(04:01):
just dive into what we think ishighest yield, and what we
thought the kids would mostlikely be taking would be
gummies. We thought maybeparents would give their kids
gummy melatonins, and the kidsmight get into their older
siblings melatonin gummies. Sowe decided to look specifically
(04:22):
at the main fact, the quality ofmelatonin gummies. We looked at
several dozen brands ofmelatonin gummies to see if the
label matched the actualcontents, and what we found was
quite disturbing.
Just to summarize, I saw thatyour study showed that there was
an 88% discrepancy between whatwas labeled and what you found
(04:43):
was actually the melatonincontent in the gummies. That's
really astounding, right?
And 88% sounds like, oh, okay,well, maybe there was, like,
what? 88% of the melatonin thatshould have been there was
there. So, like, kind of, prettyclose, you know. But no, that's
not it. It's 88% of the time thelabel did not correspond,
(05:04):
correspond to what we found. Andthen, very Concerningly, the in
the 88% when it didn'tcorrespond, mostly, it was due
to much more melatonin thanthere should be in the products
to begin with.
And one product you even found,CBD, correct, right?
So what we what was interestingwhen we looked at we took the
(05:24):
data, this database we wereusing to find melatonin gummies,
and it turned out that therewere several brands being sold
as both CBD and melatonincombined. So we looked, and sure
enough, the actual CBD, when itwas listed on labels, actually
more accurately labeled andactually more likely to be
present than the melatonin was.
So we had a product that didn'teven have any melatonin, then
(05:47):
another product who had, like,three times more melatonin than
was list on thelabel. So in your view, what do
you think we can do to make thisbetter? Do you think this is a
policy issue? Do you think theUS should step in, or the FDA
should step in and improve howwe accurately label these
products.
We should improve this byensuring that consumers, the
(06:10):
consumers, should know for Well,let me step back and just say
that I do not think I thinkmelatonin should be available
over the counter like it is to Ithink that if a parent wants to
purchase a half milligrammelatonin, they should be able
to go to the store and purchaseit, just like they can purchase
aspirin 81 milligrams through 25right? The those are two things
(06:37):
that are riskier, right? Takingtoo much of Aspirin, Tylenol,
than melatonin, so I definitelythink it should be available
with freely available that's notthe issue. The issue is that the
situation is that when youpurchase melatonin today, it
doesn't have the qualitycontrols that those other over
(07:00):
the counter. Medications do so.
If you purchase aspirin in theUnited States, it's going to be
precisely what's on the label.
And I simply believe that thelaw should be that that's the
case for supplements, thatthey're available over the
counter, but precisely what's inon the label should be what
(07:23):
you're what you find in there.
And if you can't, if amanufacturer cannot guarantee
that they should not bemanufacturing supplements, and
the FDA should be acting toremove mislabeled that they
would be legally calledmislabeled supplements from from
the marketplace. That's part ofit. The other thing is that I do
think that there should be moretransparency about the amount of
melatonin products. So forexample, in a recent FDA study,
(07:47):
they found that they were justlooking at supplements marketed
to children, which they definedas like 18, younger, I think,
and they found that some on thelabel, I believe we're saying
that serving size was very high,higher than 10 milligrams,
higher than 20 milligrams, maybeup to 50 milligrams. This is so
much more melatonin than anychild or adolescent needs.
(08:12):
Parentsoften ask me at the dosing of
melatonin, and I often find thata half a milligram, maybe one
milligram will do the trick. Imean, there's some kids that
take more than that, butgenerally speaking, a very low
amount will satisfy what parentsare looking for. Sounds very
common sense to me, to want toknow exactly what you're giving
your child,yeah, when you're talking about
(08:33):
the thing to keep in mind isthat 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 theor a botanical supplement is
extracted from a plant, theyjust need to. We need to when
(08:53):
we're putting highlyconcentrated active ingredients
in our body that we can't smellor taste when we consume it,
we're reliant on the label totell us what we're putting in,
and we're relying on the labelto know what the potential risks
are and appropriate dosages. Ifwe're not going to limit the
(09:15):
amount that one could put in,there should be a state amount
labeled this is 10 times morethan 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 lotof follow up and press about it.
(09:38):
And I'm just curious, do youfeel like anything good came
from it? Have any changeshappened since you had this
information published and widelydispersed amongst Americans?
Well, I think that one thingthat we could potentially be
heading in the right direction,because it's clear that the FDA
has woken up and start at leasttheir sign. Scientists started
(10:00):
to investigate the samequestion. So in a follow up
study to our study, the FDAscientists have now published a
study that included much moreproducts, over 100 different
products, and they focusedentirely on ones marketed to
kids. So would that study havehappened without ours? You know,
hard to say, but that's the kindof steps now that would have to
(10:21):
be used. So the the FDAscientists are taking the next
step, but will the FDA decide todo anything with that data? Is a
totally different, differentstory and situation, so and one
that's that's worrisome. Anotherthing that's come out of the
development since we publishedour study is that the main
(10:45):
supplement manufacturinglobbying group has now embraced
or recommended that in any thatmelatonin products overall, but
are made in childproofcontainers are produced or sold
in child containers. Now that'sjust their kind of the vague
(11:07):
voluntary recommendation, butstill, that's also just
signaling that the industryknows there's a problem. So what
we've heard clearly is thatthere were signals that the
industry understands there's aproblem here, the FDA
understands there's a problemhere, and then the question is,
is anything actually done withall that?
I think that's a wonderful step,even though we don't know
(11:27):
exactly what's in the content ofeach gummy. Putting a child
proof top on them, I think is agood 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 ina vitamin jar, and they're
wondering, Is that safe fortheir child? That is a good step
(11:48):
in the right direction. And I'mso glad that the FDA jumped on
it, and have done follow upstudies looking into the same
question and the same concern.
The one thing to note and andyou might already cover this in
other episodes of your podcast,but it's this issue of child
proof. Child proofing thesebottles. One thing very
(12:11):
important for parents tounderstand is that there's a
certain requirement thatsomething is truly child proof,
meaning that that bottle hasbeen tested and is assured to
prevent, you know, someresistance, at least until you
know what. There's a good NewYorker cartoon, I think, like
last week that had a dad wasbringing up his like 12 year
(12:36):
old, no seven year old, anddemonstrated that he had grown
up now, and he could open up thechild proof, the child proof
bottle, in front of the in frontof the family. But with that
said, there are requirements.
And the problem, though, to beaware of is that parents should
be aware that there's languageused on a lot of different
bottles that mislead theconsumers that someone's child
(12:57):
proof what's not so it's reallyimportant to understand what the
technical language is that theFDA really means that it's child
proof, and make sure you lookfor bottles with that. Because
you if you say something likechild safe, you know, or put
something on that, there's a lotof like, names that are thrown
around that doesn't meananything other than the
manufacturer has decided it'schild safe, for example. So you
(13:19):
know, that's worthy of a wholenother discussion. Absolutely,
yeah, it's certainly, it's onestep, but it's very clear that
there's a lot more happeninghere that needs to be improved.
I just want to take it back inthe very beginning, you were
saying how, before you did thestudy, you were clued into data
showing that there were twodeaths from melatonin, and I
(13:42):
just want to clear the air onthat. Do you think that those
deaths happened because ofmelatonin, or because the
melatonin was mixed with someother product, or it was labeled
inaccurately? To me, that soundsunlikely that melatonin was a
sort was the sole source of adeath in a child because at the
correct at the correct dosages,it really should be a safe
(14:03):
product to take.
Well, my my read of one of thecases is that it probably was
significantly contributed. Sothis was but there, there's
extreme situations. So the youknow, if we take too much of
(14:25):
anything, people can die fromtaking a teaspoon of pure
caffeine or just drinking waterwithout a electrolyte. So let's
just keep that in mind whilewe're discussing this. So I'm
not talking about any inherentdanger to this melatonin. It's,
like we said, much safer thanaspirin or Tylenol. But, yeah, I
(14:46):
mean, my understanding of one ofthe cases was that there was a
little infant wasn't sleeping ina 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 someextra milk. Kept on giving more
(15:08):
and more liquid melatonin to thechild, and then child eventually
didn't wake up. Now was themelatonin let something else
happen? Is that the totalcoincidence? Or can you give so
much melatonin that, yes, maybesomething else, they rolled
over. They had a pillow in thewrong way, but, but, but they
couldn't maybe protect theirhead or roll over because they'd
(15:28):
had whatever, 100 times moremelatonin 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 atdosages that recommended by your
pediatrician, 0.5 milligrams,one milligram, it's never going
to kill anyone, and it's theworst case scenario. What makes
someone a little more groggy orupsets their stomach? There's no
(15:52):
risk of death whatsoever. But Ithink the idea to say melatonin
is totally safe is misguided,because if a kiddo downs a whole
bag of melatonin gummies. Andthose melatonin gummies are
formulated, are already at highdoses and then manufactured with
even more melatonin they'regonna be sick, um, I would
(16:16):
expect, you know, nauseous,vomiting, you name it, maybe,
totally out of it, and aresponsible parent is going to
bring them to the doctor, soit'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
(16:37):
clearly, like something'sentirely safe, and I think that
has a lot to do with the storageand melatonin. Around the house.
Well, like we were talkingabout, about the safety bottles,
all this melatonin should betreated. If it's treated like
Tylenol, then, then it's goingto be great. Yes,
no. And I to your point,anything in excess can have
(16:57):
potential risks. So, and I thinkthat's very important to
acknowledge. I guess my questionis for parents that ask, is
there a safe way that you knowof to buy melatonin? In other
words, is there a brand outthere that is regulated by the
FDA if parents want to purchasethe product in a way that they
know is safely labeled? Yeah.
So my recommendation is sobasically because the current
(17:19):
law and the FDA is lackenforcement law. Those two
things together lead to allthese manufacturing problems,
and 88% of things aremislabeled. We have to use
workarounds. The consumer has touse workarounds to find
accurately label melatoninsupplements. And fortunately,
(17:40):
that's possible because thereare a few very high quality
third party certifiers. So theseare, these are groups that the
manufacturer hires toinvestigate the quality of their
supplements, basically, kind ofdo a research study like we did,
and if they do their study andsay, Oh yeah, these are highly
manufactured, then they get thestamp from that firm that that
(18:05):
third party, there's like twovery high quality third party
certification programs. One isus Pharmacopeia. There'll be USP
stamp, and the other is NSFInternational, NSF stamp. Now
those are two very high qualityprograms. They both and just out
of just transparency. I doresearch in the past with the
(18:25):
NSF team, so I work well, veryclosely with them for years, but
I don't receive any funding orget paid by them at all. And I
have no no involve with the USP.
But those two programs, the wayto start would be to go to their
websites honestly and then lookup the melatonin products that
are certified. It's honestly tooconfusing just to try to look
(18:47):
for that the stamps on thebottle, because there's so many
misleading stamps. Everysupplement bottle has like five
different stamps on it, and howcan you sort all that out? So my
recommendations go to these veryhigh quality third party
certification programs, look atexactly and you have to look at
the details. It has to be theexact brand, the exact dose, in
the exact formulation. So ifthey're talking about gummy, if
(19:12):
they're talking about capsule,that does that, doesn't mean
that gummy from the same companyis going to be high quality. So
it's just one product line, thenyou can go and buy that product
line with more certainty thatit's going to be accurately
labeled. Thatis a really helpful tidbit,
because I know that it's tricky,because there are situations
(19:34):
where they might want to find asleep aid and they obviously
want to do it safely. So it'snice to know that there is a way
to do that. So that's that'sreally helpful. Thank you. You
know, what's interesting is,when I was first a pediatrician,
the way I was taught aboutmelatonin was that it was a very
safe, benign supplement. Becauseessentially, we're living in
this time now where we're aroundso much light, and the body
(19:55):
makes more melatonin when it'sdark, and because we're all
around. You know, TVs and cellphones and light and excess,
more than we were designed to bethat our body is not getting a
chance to make melatonin, andsimply by taking the supplement,
we're putting back in our bodywhat it's lacking. So I always
thought this is a really benignthing to tell parents to do,
(20:16):
but, you know, but something inmy gut also didn't sit right
that taking a supplement ortaking it relying on a
supplement would be a healthything to do. So your study was
really helpful. So thank you somuch. It's
my pleasure, but and I do wantto follow up one one item about
what you said, which is thatthat might make sense, but it
(20:40):
turns out, when you look at thedata, my understanding of it is
the amount of melatonin thatsomeone needs, like an
adolescent needs. This was astudy of young adults, like 17
to 19 years old, the amount thatthey needed to get their
melatonin to the completenighttime dose. The nighttime
level was very small dose, likewe're talking about half a
(21:04):
milligram. So this is in theseare infants, so you're talking
about an 18 year old, if theytook a half a milligram of
melatonin, they had theequivalent levels of night time.
That is fascinating, because Iwhen I see melatonin marketed
for adults, usually it saysthree to five milligrams, I
(21:24):
believe, andthere's zero data to support
that that's necessary. This hasjust been tradition, kind of
like because of the the medicalthinking that you we were both
taught in medical school, whichis that, since this is so safe,
why don't you just give three orfive milligrams, making sure you
get enough, right? Maybe there'ssome absorption problem. Maybe
there's this. Maybe there's amanufacturing problem. Just
(21:44):
always give enough, and then youdon't have to worry about you
get into the nighttime level.
But the fact of the matter isthat what we know is, like
anything and like we're talkingabout, if you get too much of a
substance, it's gonna can makeyou sick.
I'm so impressed. I'm sothankful for the work that you
did, because, you know, I thinkyou're you're making such a
difference, because not onlywith melatonin, hopefully the
(22:06):
FDA wakes up and realizes thatMelatonin is a is a situation
where we need to make sure thatwe're accurately putting on the
label what's in the substancethat that is being sold. But
hopefully this will extend toother supplements as well.
Because, as I know, You've donea lot of work with supplements.
This is not the only supplementsold that is not accurately
labeled. So I'm thankful becauseyou are making a true impact on
(22:31):
society. Well, that'sa slight, big overstatement, but
I appreciate your but it's true.
Your support. Jess,well, thank you so much. Dr
Cohen, Ireally, really appreciate your
time. Are there any otherclosing thoughts that you'd like
people to hear from you? Or doyou feel like we pretty much
covered it? Ithink we've covered it.
Thank you so much. Always greatto talk to you.
(22:54):
Great talking to you.
Thank you for listening. AndI 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 greatlyappreciate it. It really makes a
difference to help this podcastgrow. You can also follow me on
Instagram at ask Dr Jessica. Seeyou next Monday. You.
Hi everybody. I'm Dr Jessica Hochman, pediatrician
(00:02):
and mom of three. On thispodcast, I like to talk about
various pediatric health topics,sharing my knowledge, not only
as a doctor, but also as aparent. Ultimately, my hope is
that when it comes to yourchildren's health, you feel more
confident, worry less, and enjoyyour parenting experience as
much as possible. Are youcurious about your family's gut
(00:23):
health? You may have heard ofthe microbiome, which plays a
vital role in your digestion,immunity, overall, wellness and
more. I want to tell you about anew company called tinyhealth.
Tinyhealth makes it easy tolearn about the gut health of
all ages, even babies using asimple at home test. Their
personalized reports providetailored recommendations for
nutrition and probiotics to helpmake informed decisions for your
(00:44):
family's well being, whetheryou're addressing specific
health concerns or exploringways to optimize your wellness.
Tiny health empowers you to takecontrol of your health journey.
As a special offer for mylisteners, use promo code. Dr
Jessica, that's D, R, J, E, S,S, I, C, A, for savings on your
first test, visit tinyhealth.comtoday, it's quick, easy and
packed with actionable insights.
Hi everybody. Welcome back toAsk Dr Jessica on today's
(01:08):
episode, I'm thrilled to haveback Dr Peter Cohen, an expert
in dietary supplements and apracticing internist who also
serves as an associate professorat Harvard Medical School. Dr
Cohen is known for hisdedication to help patients
understand the potentialbenefits and risks of
supplements, earning him thenickname The toxic supplement
Hunter by Men's Health magazine.
(01:28):
Our conversation today talksabout melatonin, a widely used
sleep aid for both children andadults. Dr Cohen recently
conducted a fascinating study onmelatonin gummies that are
marketed for children, lookingat whether their labeling
accurately reflects what'sactually in them. His findings
may surprise you and shed lighton important safety
considerations. Andif you're interested in learning
more from Dr Cohen, Idefinitely recommend going back
to Episode 36 where we talkabout the safety of vitamins and
(01:51):
dietary supplements. So whetheryou're a parent considering
melatonin for your child, oryou've been using it yourself,
this episode will give youvaluable insights about
melatonin and help explain whatyou need to know to make
informed decisions.
All right, let's get started.
So I'm so I'm so excited to talkto you, because melatonin,
(02:11):
believe it or not, is a questionthat comes up all the time. In
my practice, parents have a lotof issues with kids and sleep.
It comes up a lot, especiallywith travel or if, if the
routine gets thrown off, somekids are just difficult in
general, getting into bed ontime, and they're looking to see
if melatonin would be an easy,safe, maybe temporary solution.
So I'm so interested to talkabout your study. So I guess
(02:33):
first I'll ask, can you telleverybody, 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 interestfrom a public health perspective
about these melatoninsupplements, because there was a
study that came out prior to us,which actually inspired us to
(02:54):
investigate the manufacturingqualities of supplements that
looked at how often kiddos wereending up in the emergency
department and doctor's officesdue to melatonin ingestions, and
found that over the last decadeor so, there had been 10s of
1000s of these doctors visitsdue to melatonin ingestions,
actually 1000s ofhospitalizations, and even, I
(03:16):
think, two deaths have beendescribed. So this is was a real
surprise to me, because inmedical school, I had always
sort of learned that melatoninwas just some benign, you know,
a benign substance, so I didn'tthink it was going to be
terribly effective, but I didn'tthink it was going to be
particularly harmful. So thatreally jumped out at me, and
(03:38):
that made us think, you know, isthere something going on with
the manufacturing, or some otherthings about the actual product
of melatonin that might beresponsible for part of this
problem leaving so many kidsending up in the emergency
department? And so what wedecide to do is we we say,
focus, focus. We don't have alot of funding, if any, so we
(04:01):
just dive into what we think ishighest yield, and what we
thought the kids would mostlikely be taking would be
gummies. We thought maybeparents would give their kids
gummy melatonins, and the kidsmight get into their older
siblings melatonin gummies. Sowe decided to look specifically
(04:22):
at the main fact, the quality ofmelatonin gummies. We looked at
several dozen brands ofmelatonin gummies to see if the
label matched the actualcontents, and what we found was
quite disturbing.
Just to summarize, I saw thatyour study showed that there was
an 88% discrepancy between whatwas labeled and what you found
(04:43):
was actually the melatonincontent in the gummies. That's
really astounding, right?
And 88% sounds like, oh, okay,well, maybe there was, like,
what? 88% of the melatonin thatshould have been there was
there. So, like, kind of, prettyclose, you know. But no, that's
not it. It's 88% of the time thelabel did not correspond,
(05:04):
correspond to what we found. Andthen, very Concerningly, the in
the 88% when it didn'tcorrespond, mostly, it was due
to much more melatonin thanthere should be in the products
to begin with.
And one product you even found,CBD, correct, right?
So what we what was interestingwhen we looked at we took the
(05:24):
data, this database we wereusing to find melatonin gummies,
and it turned out that therewere several brands being sold
as both CBD and melatonincombined. So we looked, and sure
enough, the actual CBD, when itwas listed on labels, actually
more accurately labeled andactually more likely to be
present than the melatonin was.
So we had a product that didn'teven have any melatonin, then
(05:47):
another product who had, like,three times more melatonin than
was list on thelabel. So in your view, what do
you think we can do to make thisbetter? Do you think this is a
policy issue? Do you think theUS should step in, or the FDA
should step in and improve howwe accurately label these
products.
We should improve this byensuring that consumers, the
(06:10):
consumers, should know for Well,let me step back and just say
that I do not think I thinkmelatonin should be available
over the counter like it is to Ithink that if a parent wants to
purchase a half milligrammelatonin, they should be able
to go to the store and purchaseit, just like they can purchase
aspirin 81 milligrams through 25right? The those are two things
(06:37):
that are riskier, right? Takingtoo much of Aspirin, Tylenol,
than melatonin, so I definitelythink it should be available
with freely available that's notthe issue. The issue is that the
situation is that when youpurchase melatonin today, it
doesn't have the qualitycontrols that those other over
(07:00):
the counter. Medications do so.
If you purchase aspirin in theUnited States, it's going to be
precisely what's on the label.
And I simply believe that thelaw should be that that's the
case for supplements, thatthey're available over the
counter, but precisely what's inon the label should be what
(07:23):
you're what you find in there.
And if you can't, if amanufacturer cannot guarantee
that they should not bemanufacturing supplements, and
the FDA should be acting toremove mislabeled that they
would be legally calledmislabeled supplements from from
the marketplace. That's part ofit. The other thing is that I do
think that there should be moretransparency about the amount of
melatonin products. So forexample, in a recent FDA study,
(07:47):
they found that they were justlooking at supplements marketed
to children, which they definedas like 18, younger, I think,
and they found that some on thelabel, I believe we're saying
that serving size was very high,higher than 10 milligrams,
higher than 20 milligrams, maybeup to 50 milligrams. This is so
much more melatonin than anychild or adolescent needs.
(08:12):
Parentsoften ask me at the dosing of
melatonin, and I often find thata half a milligram, maybe one
milligram will do the trick. Imean, there's some kids that
take more than that, butgenerally speaking, a very low
amount will satisfy what parentsare looking for. Sounds very
common sense to me, to want toknow exactly what you're giving
your child,yeah, when you're talking about
(08:33):
the thing to keep in mind isthat 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 theor a botanical supplement is
extracted from a plant, theyjust need to. We need to when
(08:53):
we're putting highlyconcentrated active ingredients
in our body that we can't smellor taste when we consume it,
we're reliant on the label totell us what we're putting in,
and we're relying on the labelto know what the potential risks
are and appropriate dosages. Ifwe're not going to limit the
(09:15):
amount that one could put in,there should be a state amount
labeled this is 10 times morethan 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 lotof follow up and press about it.
(09:38):
And I'm just curious, do youfeel like anything good came
from it? Have any changeshappened since you had this
information published and widelydispersed amongst Americans?
Well, I think that one thingthat we could potentially be
heading in the right direction,because it's clear that the FDA
has woken up and start at leasttheir sign. Scientists started
(10:00):
to investigate the samequestion. So in a follow up
study to our study, the FDAscientists have now published a
study that included much moreproducts, over 100 different
products, and they focusedentirely on ones marketed to
kids. So would that study havehappened without ours? You know,
hard to say, but that's the kindof steps now that would have to
(10:21):
be used. So the the FDAscientists are taking the next
step, but will the FDA decide todo anything with that data? Is a
totally different, differentstory and situation, so and one
that's that's worrisome. Anotherthing that's come out of the
development since we publishedour study is that the main
(10:45):
supplement manufacturinglobbying group has now embraced
or recommended that in any thatmelatonin products overall, but
are made in childproofcontainers are produced or sold
in child containers. Now that'sjust their kind of the vague
(11:07):
voluntary recommendation, butstill, that's also just
signaling that the industryknows there's a problem. So what
we've heard clearly is thatthere were signals that the
industry understands there's aproblem here, the FDA
understands there's a problemhere, and then the question is,
is anything actually done withall that?
I think that's a wonderful step,even though we don't know
(11:27):
exactly what's in the content ofeach gummy. Putting a child
proof top on them, I think is agood 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 ina vitamin jar, and they're
wondering, Is that safe fortheir child? That is a good step
(11:48):
in the right direction. And I'mso glad that the FDA jumped on
it, and have done follow upstudies looking into the same
question and the same concern.
The one thing to note and andyou might already cover this in
other episodes of your podcast,but it's this issue of child
proof. Child proofing thesebottles. One thing very
(12:11):
important for parents tounderstand is that there's a
certain requirement thatsomething is truly child proof,
meaning that that bottle hasbeen tested and is assured to
prevent, you know, someresistance, at least until you
know what. There's a good NewYorker cartoon, I think, like
last week that had a dad wasbringing up his like 12 year
(12:36):
old, no seven year old, anddemonstrated that he had grown
up now, and he could open up thechild proof, the child proof
bottle, in front of the in frontof the family. But with that
said, there are requirements.
And the problem, though, to beaware of is that parents should
be aware that there's languageused on a lot of different
bottles that mislead theconsumers that someone's child
(12:57):
proof what's not so it's reallyimportant to understand what the
technical language is that theFDA really means that it's child
proof, and make sure you lookfor bottles with that. Because
you if you say something likechild safe, you know, or put
something on that, there's a lotof like, names that are thrown
around that doesn't meananything other than the
manufacturer has decided it'schild safe, for example. So you
(13:19):
know, that's worthy of a wholenother discussion. Absolutely,
yeah, it's certainly, it's onestep, but it's very clear that
there's a lot more happeninghere that needs to be improved.
I just want to take it back inthe very beginning, you were
saying how, before you did thestudy, you were clued into data
showing that there were twodeaths from melatonin, and I
(13:42):
just want to clear the air onthat. Do you think that those
deaths happened because ofmelatonin, or because the
melatonin was mixed with someother product, or it was labeled
inaccurately? To me, that soundsunlikely that melatonin was a
sort was the sole source of adeath in a child because at the
correct at the correct dosages,it really should be a safe
(14:03):
product to take.
Well, my my read of one of thecases is that it probably was
significantly contributed. Sothis was but there, there's
extreme situations. So the youknow, if we take too much of
(14:25):
anything, people can die fromtaking a teaspoon of pure
caffeine or just drinking waterwithout a electrolyte. So let's
just keep that in mind whilewe're discussing this. So I'm
not talking about any inherentdanger to this melatonin. It's,
like we said, much safer thanaspirin or Tylenol. But, yeah, I
(14:46):
mean, my understanding of one ofthe cases was that there was a
little infant wasn't sleeping ina 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 someextra milk. Kept on giving more
(15:08):
and more liquid melatonin to thechild, and then child eventually
didn't wake up. Now was themelatonin let something else
happen? Is that the totalcoincidence? Or can you give so
much melatonin that, yes, maybesomething else, they rolled
over. They had a pillow in thewrong way, but, but, but they
couldn't maybe protect theirhead or roll over because they'd
(15:28):
had whatever, 100 times moremelatonin 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 atdosages that recommended by your
pediatrician, 0.5 milligrams,one milligram, it's never going
to kill anyone, and it's theworst case scenario. What makes
someone a little more groggy orupsets their stomach? There's no
(15:52):
risk of death whatsoever. But Ithink the idea to say melatonin
is totally safe is misguided,because if a kiddo downs a whole
bag of melatonin gummies. Andthose melatonin gummies are
formulated, are already at highdoses and then manufactured with
even more melatonin they'regonna be sick, um, I would
(16:16):
expect, you know, nauseous,vomiting, you name it, maybe,
totally out of it, and aresponsible parent is going to
bring them to the doctor, soit'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
(16:37):
clearly, like something'sentirely safe, and I think that
has a lot to do with the storageand melatonin. Around the house.
Well, like we were talkingabout, about the safety bottles,
all this melatonin should betreated. If it's treated like
Tylenol, then, then it's goingto be great. Yes,
no. And I to your point,anything in excess can have
(16:57):
potential risks. So, and I thinkthat's very important to
acknowledge. I guess my questionis for parents that ask, is
there a safe way that you knowof to buy melatonin? In other
words, is there a brand outthere that is regulated by the
FDA if parents want to purchasethe product in a way that they
know is safely labeled? Yeah.
So my recommendation is sobasically because the current
(17:19):
law and the FDA is lackenforcement law. Those two
things together lead to allthese manufacturing problems,
and 88% of things aremislabeled. We have to use
workarounds. The consumer has touse workarounds to find
accurately label melatoninsupplements. And fortunately,
(17:40):
that's possible because thereare a few very high quality
third party certifiers. So theseare, these are groups that the
manufacturer hires toinvestigate the quality of their
supplements, basically, kind ofdo a research study like we did,
and if they do their study andsay, Oh yeah, these are highly
manufactured, then they get thestamp from that firm that that
(18:05):
third party, there's like twovery high quality third party
certification programs. One isus Pharmacopeia. There'll be USP
stamp, and the other is NSFInternational, NSF stamp. Now
those are two very high qualityprograms. They both and just out
of just transparency. I doresearch in the past with the
(18:25):
NSF team, so I work well, veryclosely with them for years, but
I don't receive any funding orget paid by them at all. And I
have no no involve with the USP.
But those two programs, the wayto start would be to go to their
websites honestly and then lookup the melatonin products that
are certified. It's honestly tooconfusing just to try to look
(18:47):
for that the stamps on thebottle, because there's so many
misleading stamps. Everysupplement bottle has like five
different stamps on it, and howcan you sort all that out? So my
recommendations go to these veryhigh quality third party
certification programs, look atexactly and you have to look at
the details. It has to be theexact brand, the exact dose, in
the exact formulation. So ifthey're talking about gummy, if
(19:12):
they're talking about capsule,that does that, doesn't mean
that gummy from the same companyis going to be high quality. So
it's just one product line, thenyou can go and buy that product
line with more certainty thatit's going to be accurately
labeled. Thatis a really helpful tidbit,
because I know that it's tricky,because there are situations
(19:34):
where they might want to find asleep aid and they obviously
want to do it safely. So it'snice to know that there is a way
to do that. So that's that'sreally helpful. Thank you. You
know, what's interesting is,when I was first a pediatrician,
the way I was taught aboutmelatonin was that it was a very
safe, benign supplement. Becauseessentially, we're living in
this time now where we're aroundso much light, and the body
(19:55):
makes more melatonin when it'sdark, and because we're all
around. You know, TVs and cellphones and light and excess,
more than we were designed to bethat our body is not getting a
chance to make melatonin, andsimply by taking the supplement,
we're putting back in our bodywhat it's lacking. So I always
thought this is a really benignthing to tell parents to do,
(20:16):
but, you know, but something inmy gut also didn't sit right
that taking a supplement ortaking it relying on a
supplement would be a healthything to do. So your study was
really helpful. So thank you somuch. It's
my pleasure, but and I do wantto follow up one one item about
what you said, which is thatthat might make sense, but it
(20:40):
turns out, when you look at thedata, my understanding of it is
the amount of melatonin thatsomeone needs, like an
adolescent needs. This was astudy of young adults, like 17
to 19 years old, the amount thatthey needed to get their
melatonin to the completenighttime dose. The nighttime
level was very small dose, likewe're talking about half a
(21:04):
milligram. So this is in theseare infants, so you're talking
about an 18 year old, if theytook a half a milligram of
melatonin, they had theequivalent levels of night time.
That is fascinating, because Iwhen I see melatonin marketed
for adults, usually it saysthree to five milligrams, I
(21:24):
believe, andthere's zero data to support
that that's necessary. This hasjust been tradition, kind of
like because of the the medicalthinking that you we were both
taught in medical school, whichis that, since this is so safe,
why don't you just give three orfive milligrams, making sure you
get enough, right? Maybe there'ssome absorption problem. Maybe
there's this. Maybe there's amanufacturing problem. Just
(21:44):
always give enough, and then youdon't have to worry about you
get into the nighttime level.
But the fact of the matter isthat what we know is, like
anything and like we're talkingabout, if you get too much of a
substance, it's gonna can makeyou sick.
I'm so impressed. I'm sothankful for the work that you
did, because, you know, I thinkyou're you're making such a
difference, because not onlywith melatonin, hopefully the
(22:06):
FDA wakes up and realizes thatMelatonin is a is a situation
where we need to make sure thatwe're accurately putting on the
label what's in the substancethat that is being sold. But
hopefully this will extend toother supplements as well.
Because, as I know, You've donea lot of work with supplements.
This is not the only supplementsold that is not accurately
labeled. So I'm thankful becauseyou are making a true impact on
(22:31):
society. Well, that'sa slight, big overstatement, but
I appreciate your but it's true.
Your support. Jess,well, thank you so much. Dr
Cohen, Ireally, really appreciate your
time. Are there any otherclosing thoughts that you'd like
people to hear from you? Or doyou feel like we pretty much
covered it? Ithink we've covered it.
Thank you so much. Always greatto talk to you.
(22:54):
Great talking to you.
Thank you for listening. AndI 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 greatlyappreciate it. It really makes a
difference to help this podcastgrow. You can also follow me on
Instagram at ask Dr Jessica. Seeyou next Monday. You.
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