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Melatonin supplement makers have 18 to 24 months to voluntarily add child-resistant packaging and revise warning language on the labels of over-the-counter products, according to a 2016 report. Council for responsible nutritionThe leading trade association for the nutritional supplement and functional food industry.
Melatonin a hormone Made by the brain in response to darkness. It controls the body’s natural sleep Cycle or circadian rhythm. As a dietary supplement, melatonin is not regulated by the US Food and Drug Administration, but the demand for melatonin in adults and children has increased over the past decade, experts say.
The move by the council follows recent reports. A significant increase in accidental drinking A study by Children’s Melatonin and April 2023 found 25 products labeled as melatonin gum. Dangerous hormone levels. One over-the-counter product contains up to 347% more melatonin than what is listed on the label, while another contains no melatonin at all – it is composed entirely of cannabidiol, or CBD.
“The key thing here is that the industry recognizes that melatonin poses additional risks – especially to children – and that the industry needs to do a much better job of ensuring that the products are safe and well made,” he said. Peter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, wrote the study on melatonin supplements.
“Whether or not this voluntary recommendation is followed is another matter, and we will have to see,” Cohen said in an email.
March 2024 Report In the year Between 2019 and 2022, about 11,000 children were seen in emergency rooms after taking melatonin without supervision. About 5,000 of these cases involved melatonin resins.
More than half of the accidental food intake involved children 3- and 5-year-olds and most visits do not include supplements other than melatonin, the CDC said.
Three-quarters of the reported cases involved bottles – suggesting that young children could open the bottles or that the bottles were not properly sealed. While most unregulated melatonin ingestions do not result in hospitalization, the number of accidental overdoses in children 5 and younger can be estimated, the report said.
Some melatonin gels state that they contain CBD, even though it is “currently illegal to market CBD by adding it to food or labeling it as a dietary supplement.” US Food and Drug Administration.
According to Cohen, four of the gums they tested contained CBD levels between 4% and 18% of the label.
Catherine McQueen / Moment RF / Getty Images
Especially in children, the use of melatonin can be dangerous, so experts say that it should be used only after consulting a pediatrician.
“There is no data to support the use of CBD in children,” said Dr. Cora Collette Brenner, professor of pediatrics at Seattle Children’s Hospital at the University of Washington. He previously told CNN.. “Currently, it is recommended that it be used very specifically for children over 1 year old. with intractable seizures.”
In addition to CBD, unknowingly consuming gum that contains high amounts of melatonin — 0.5 milligrams daily to 1 milligram per night — is dangerous if it has been shown to induce sleep in children, Brenner said.
Any differences in melatonin content or strength “may pose an additional risk” to children, CDC researchers wrote in their April report.
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The council’s guidelines require new labels to warn consumers about the risk of drowsiness after taking melatonin supplements. Labels should also state that melatonin should not be taken with alcohol, the council said. Additionally, the labels must tell consumers that melatonin is intended for temporary or occasional use.
The Council also proposed that melatonin gummies should receive additional warnings, for example, a cautionary statement on gummies sold to children under 4 years of age that, if not chewed properly, may pose a choking hazard.
The new guidance urges manufacturers to adopt child-resistant containers for gums and chewable tablets.
“While federal regulations do not require child-resistant closures for melatonin-containing products, CRN’s revised guidelines require industry members to adopt child-resistant packaging for melatonin-containing products in chewable forms that may be particularly attractive to children,” the council said. In the description.
Gum manufacturers will have 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 a separate implementation period for each set of guidelines to facilitate a smooth transition.”
CNN’s Amanda Musa contributed to this story.