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Melatonin supplement makers have 18 to 24 months to voluntarily add child-resistant packaging and improve warning language on over-the-counter product labels, according to the Council for Responsible Nutrition, a leading trade association for the dietary supplement and functional nutrition industry. .
Melatonin is a hormone produced by the brain in response to darkness. Regulates the body’s natural sleep and wakefulness patterns. Cycle or circadian rhythm. As a dietary supplement, melatonin is not regulated by the U.S. Food and Drug Administration, but experts say the demand for melatonin among both adults and children has increased dramatically over the past decade.
The board’s action follows recent reports of a massive increase in accidental melatonin use by children, as well as an April 2023 study that found 25 products labeled as melatonin gummies contained dangerous levels of the hormone. One over-the-counter product contained 347% more melatonin than stated on the label, and another contained no melatonin at all—it was made entirely of cannabidiol, or CBD.
“What’s important here is that the industry recognizes that melatonin supplements do pose serious risks, especially to children, and that the industry needs to do a much better job of ensuring the safety and quality of the products they make,” the doctor said. Peter Cohen, assistant professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, is the author of the melatonin gummies study.
“Whether this voluntary recommendation will be followed is an entirely different matter and we will have to see,” Cohen said in an email.
A March 2024 report from the US Centers for Disease Control and Prevention found that between 2019 and 2022, about 11,000 children were hospitalized in emergency rooms after taking melatonin without supervision. Melatonin gummies were involved in nearly 5,000 of these cases.
More than half of accidental ingestions occurred in children between The children are 3 and 5 years old, and most visits did not include additional medications other than melatonin, according to the Centers for Disease Control and Prevention (CDC).
About three-quarters of the documented cases involved bottles, suggesting that young children may have opened the bottles or that the bottles were not sealed properly. Although the vast majority of unsupervised melatonin ingestions did not result in hospitalization, the incidence of accidental melatonin ingestion in children aged 5 years and younger may be underestimated, the report found.
Some melatonin gummies indicate on the label that they also contain CBD, although, according to the U.S. Food and Drug Administration, “CBD is currently prohibited from being sold by adding it to food or by labeling it as a dietary supplement.”
According to Cohen, the four gummies he tested contained CBD levels 4% to 18% higher than what was listed on the label.
Catherine McQueen/Moment RF/Getty Images
Melatonin use can be especially dangerous for children and should only be used after consultation with a pediatrician, experts say.
“There is no data to support the use of CBD in children,” Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children’s Hospital at the University of Washington, previously told CNN. “It is currently only recommended for very specific use in children over 1 year of age. with intractable seizure disorders.”
In addition to CBD, consuming gum, which unknowingly contains extremely high levels of melatonin — significantly higher than the 0.5 to 1 milligram per night dose that has been shown to induce sleep in children — is also dangerous, Breuner said. Breuner.
Any discrepancies in the ingredients or strength of melatonin “may pose additional risks” to children, CDC researchers wrote in their April report.
New and improved labels
The board’s recommendations call for new labels to warn consumers about the dangers of drowsiness after taking a melatonin supplement. Labels should also state that melatonin should not be taken with alcohol, the council said. In addition, labels should indicate to consumers that melatonin is for intermittent or occasional use only.
The Board also proposed that melatonin gummies receive additional warnings, such as a warning that if not chewed properly, the product may pose a potential choking hazard for gummies marketed to children under 4 years of age.
The new rules also emphasize the need for manufacturers to use child-safe containers for chewable candies and chewable tablets.
“Although federal regulations do not require child-resistant closures for melatonin-containing products, the revised CRN guidelines encourage industry participants to adopt child-resistant packaging for melatonin-containing products that are in flavored chewable forms, which may be particularly appealing. for children,” the council said. in the statement.
Gummy candy manufacturers will be given 24 months to implement the changes. However, the council “urges its members and the wider industry to adopt these guidelines as soon as possible, with specific implementation timelines provided for each set of guidelines to facilitate a smooth transition.”
CNN’s Amanda Musa contributed to this story.
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