Melissa Velasquez Loaiza
(CNN) Tests on more than two dozen melatonin “gummies” sold as sleep aids found that some have potentially dangerous amounts of the hormone that help regulate sleep, according to a new study.
“One product contained 347% more melatonin than was actually listed on the gummy label,” said study co-author Dr. Pieter Cohen, an associate professor of medicine at Cambridge Health Alliance in Somerville, Massachusetts.
A jar of gummies could also contain ingredients you didn’t already have, Cohen said: “One of the products that mentioned melatonin had no melatonin at all. It was just cannabidiol or CBD.”
According to the US Food and Drug Administration (FDA), “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” However, several of the products tested for CBD-containing in the study openly advertised the addition of that compound to their melatonin product, Cohen said.
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“Four of the products tested contained CBD levels between 4% and 18% higher than on the label,” Cohen said.
The use of CBD in over-the-counter medications is particularly worrisome because parents can buy gummies to give to their children that would help them sleep, said Dr. Cora Collette Breuner, a professor of pediatrics at the University of Washington Children’s Hospital Seattle.
“There are no data to support the use of CBD in children,” said Breuner, who was not involved in the study. “It is currently only recommended for very specific use in children older than 1 year with intractable seizure disorders.”
In addition to CBD, consuming a gummy that unknowingly contains extremely high levels of melatonin, well in excess of 0.5 to 1 milligram daily per night—which has been shown to induce sleep in children—is also dangerous, said Breuner, who serves on the committee on medicine for the american academy of pediatrics, which is currently writing new guidelines on supplements in children.
Side effects of melatonin use in children can include drowsiness, headaches, anxiety, and increased bedwetting, or urination at night. There is also the possibility of harmful drug interactions and allergic reactions to melatonin, according to the National Center for Complementary and Integrative Health, a department of the National Institutes of Health.
The agency also warns that supplements could affect hormonal development, “including puberty, menstrual cycles, and overproduction of the hormone prolactin,” which causes breast and milk development in women.
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According to the study, gummies sold as sleep aids have much higher levels of melatonin than indicated on the label, as well as CBD.
The gummies were carefully chosen from the government database
In the study, published Tuesday in JAMA, researchers sent 25 products labeled as melatonin gummies to an outside laboratory that tested levels of melatonin and other substances.
However, the research team did not choose Internet products “lightly,” Cohen said. The scientists handpicked the top 25 melatonin gummy products listed in the National Institutes of Health database, which the public can refer to for labels of dietary supplements sold in the United States.
“We chose gummies over other products because we thought parents would choose edibles to give their children,” Cohen said. “We also wanted to take a closer look at those products after last year’s report that poison centers received more than a quarter of a million calls about pediatric ingestion, hospital miles, ICU visits, and even some deaths.” .
A 2022 report from the US Centers for Disease Control and Prevention (CDC) found that calls to poison control about melatonin ingestion by children increased by a 530% between 2012 and 2021. The largest increase in calls (38%) occurred between 2019 and 2020, according to the report.
Most of the calls were about children under the age of 5 who had accidentally eaten gummies that had not been properly stored by caregivers.
“The gummies appeal to young children, who see them as candy,” Cohen said. “We wondered if there was something going on with the products that might be contributing to calls to poison control centers.”
The new study found that 88% of the gummies were mislabeled and only three contained an amount of melatonin that was within 10% of what was listed on the label, said Cohen, who has studied invalid supplement labeling for years. .
“The regulatory framework for supplements is broken,” he said, “manufacturers are not complying with the law and the FDA is not enforcing the law. So what that means is that we have a lot of poor quality products.”
An FDA spokesperson told CNN that the agency would review the study findings, adding that the FDA generally does not comment on specific studies, but rather “evaluates them as part of the body of evidence to improve our understanding of a study on a subject.” particular”.
“It is important to stress that, under current law, the FDA does not have the authority to approve dietary supplements before they are marketed, and companies have the primary responsibility to ensure that their products are not adulterated or misbranded before they are distributed. the spokesperson said in an email.
Steve Mister, president and CEO of the Council for Nutrition, a trade association for the dietary supplement industry, issued a statement stating that manufacturers may add additional melatonin to ensure that the product remains at the levels indicated on the label. as degradation occurs naturally over time.
“Although there may be some need in surplus as companies adhere to FDA requirements regarding shelf life and potency, it does not mean there is a risk in taking these products as intended,” Mister said.
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Melatonin is a hormone
People often view melatonin as an herbal supplement or a vitamin, experts say. Instead, melatonin is a hormone produced by the pineal gland, located deep in the brain, and released into the bloodstream to regulate the body’s sleep cycles.
Studies have found that using melatonin can be helpful in inducing sleep if used correctly (take a small amount at least two hours before bed), but the actual benefit is small, Breuner said.
In six randomized controlled trials of melatonin treatment in the pediatric population, he said, melatonin reduced the time it took to fall asleep, ranging from 11 minutes to 51 minutes.
“However, these were very small studies with highly variable results,” Breuner said. “So I say to parents, ‘You’re really looking at just 11 minutes to decrease the amount of time it takes your child to fall asleep.'”
Anyone considering melatonin should ensure that the packaging bears the United States Pharmacopeia (USP) seal, which manufacturers contract to test and verify products.
“If you have a USP seal on the label, you can be sure that the product is accurately labeled,” Cohen said. “However, that doesn’t mean that melatonin products are going to work or that it’s a good idea to take them.”
“That’s not what USP is about,” he said. “But at least checking the label should eliminate the problems we’re seeing here in our study.”
The CNN Wire
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