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Makers of melatonin supplements have 18 to 24 months to voluntarily add child-deterrent packaging and improve cautionary language on labels of over-the-counter products, according to the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.
Melatonin is a hormone produced by the brain in response to darkness. It regulates the body’s natural sleep-wake cycle or circadian rhythm. As a dietary supplement, melatonin is not regulated by the US Food and Drug Administration, yet the demand for melatonin among both adults and children has skyrocketed over the last decade, according to experts.
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The council’s action follows recent reports of a massive rise in accidental ingestions of melatonin by children and an April 2023 study that found 25 products labeled as melatonin gummies contained dangerous levels of the hormone. One over-the-counter product contained up to 347% more melatonin than listed on the label, while another contained no melatonin at all — it was entirely composed of cannabidiol or CBD.
“What’s significant here is that the industry recognizes that melatonin supplements do pose serious risks — particularly to children— and that the industry needs to do a much better job at ensuring the products are safe and well-manufactured,” said Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, who authored the study on melatonin gummies.
“Whether this voluntary recommendation will be followed, is another matter entirely, and we’ll need to see,” Cohen said in an email.
Massive rise in childhood ER visits
A March 2024 report from the US Centers for Disease Control and Prevention discovered some 11,000 children had been seen in emergency rooms between 2019 and 2022 after ingesting melatonin while unsupervised. Melatonin gummies were involved in nearly 5,000 of those cases.
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More than half of accidental ingestions involved children between 3 and 5 years old, and the majority of visits did not involve additional medications other than the melatonin, the CDC said.
About three-quarters of the documented cases involved bottles — suggesting that young children were able to open the bottles or that the bottles were not closed properly. While the vast majority of unsupervised melatonin ingestions did not result in hospitalization, the number of accidental ingestions by children 5 and under may be underestimated, the report said.
Some melatonin gummies state on the label that they also contain CBD, even though it’s “currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” according to the US Food and Drug Administration.
According to Cohen, four of the gummies he tested contained levels of CBD that were between 4% and 18% higher than on the label.