Melatonin industry asked to voluntarily tighten standards after dramatic rise in childhood ER visits

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Melatonin supplement makers have 18 to 24 months to voluntarily add child-deterrent packaging and improve warnings on over-the-counter product labels, according to the Council for Responsible Nutrition, the supplement industry’s leading trade association food and functional foods. .

Melatonin is a hormone produced by the brain in response to darkness. It regulates the body’s natural sleep-wakefulness circadian cycle or rhythm. As a dietary supplement, melatonin is not regulated by the U.S. Food and Drug Administration, but demand for melatonin among adults and children has skyrocketed over the past decade, experts say.

The board’s action follows recent reports of a massive increase in accidental ingestions of melatonin by children and an April 2023 study that found 25 products labeled as melatonin gummies contained levels dangerous of the hormone. One over-the-counter product contained up to 347% more melatonin than what was listed on the label, while 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 pose serious risks, particularly to children, and that it needs to do a much better job of ensuring that products are safe and well manufactured,” said Dr. Pieter Cohen, associate professor of medicine at Cambridge Health Alliance in Somerville, Massachusetts, author of the study on melatonin gummies.

“Whether this voluntary recommendation will be followed is another matter entirely, and we will have to see,” Cohen said in an email.

A March 2024 report from the U.S. Centers for Disease Control and Prevention found that approximately 11,000 children were seen in emergency rooms between 2019 and 2022 after ingesting melatonin unsupervised. Melatonin gummies were involved in nearly 5,000 of these cases.

More than half of accidental ingestions involved children between 3 and 5 years, and the majority of visits did not involve additional medications other than 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 properly closed. Although the vast majority of unsupervised melatonin ingestions did not result in hospitalization, the number of accidental ingestions by children ages 5 and younger may be underestimated, the report said.

Some melatonin gummies state on the label that they also contain CBD, even though it is “currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” according to the United States Food and Drug Administration.

According to Cohen, four of the gummies he tested contained CBD levels between 4% and 18% higher than on the label.

“There is no data supporting the use of CBD in children,” Dr. Cora Collette Breuner, a professor of pediatrics at the University of Washington Seattle Children’s Hospital, previously told CNN. “It is currently only recommended for very specific use in children over 1 (year) suffering from intractable epileptic disorders.

Besides CBD, consuming a gummy that unknowingly contains extremely high levels of melatonin – well beyond the 0.5 milligrams to 1 milligram per night that has been shown to induce sleep in children – is also dangerous , Breuner said.

Any discrepancies in melatonin’s ingredients or concentration “could pose additional risk” to children, CDC researchers wrote in their April report.

New and improved labels

The council’s guidelines call for new labels warning consumers of the danger of drowsiness after taking a melatonin supplement. Labels should also state that melatonin should not be taken with alcohol, the council said. Additionally, labels must tell buyers that melatonin is for intermittent or occasional use only.

The board also suggested that melatonin gummies should receive additional warnings, such as a warning that if not chewed properly, the product could pose a potential choking hazard for gummies sold to children under 4 years old.

The new guidelines also highlight the need for manufacturers to adopt child-safe containers for gummies and chewable tablets.

“While federal regulations do not require child-deterrent packaging for products containing melatonin, the revised CRN guidelines call on industry members to adopt child-deterrent packaging for products containing melatonin. melatonin which come in flavored chewable forms which may be particularly attractive to children,” the council said. in a report.

Candy makers would have 24 months to implement the changes. However, the council “urges its members and the entire 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.