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

(CNN) — 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.

Demand for melatonin, which is a hormone produced by the brain in response to darkness, has skyrocketed over the last decade, according to experts. It regulates the body’s natural sleep-wake cycle or circadian rhythm. As a dietary supplement, melatonin is not approved by the US Food and Drug Administration for safety, effectiveness or labeling before it is sold to the public.

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.

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.

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

Aside from CBD, consuming a gummy that unknowingly contains extremely high levels of melatonin — well over the daily 0.5 milligram to 1 milligram per night that has been shown to induce sleep in kids — is also dangerous, Breuner said.

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

New and improved labels

The council guidelines call for new labels that warn consumers about the danger of drowsiness after taking a melatonin supplement. Labels should also state that melatonin should not be taken with alcohol, the council said. In addition, the labels should tell purchasers that melatonin is intended for intermittent or occasional use only.

The council also suggested that melatonin gummies should receive additional warnings, such as a precautionary statement that if not chewed properly, the product could present a potential choking hazard for gummies sold to children under 4 years of age.

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

“While federal regulations do not require child deterrent closures for melatonin-containing products, CRN’s revised guidelines call for industry members to adopt child deterrent packaging for products containing melatonin that are in flavored chewable forms that could be especially attractive to children,” the council said in a statement.

Manufacturers of gummies would have 24 months to implement the changes. However the council “urges its members and the broader industry to adopt these guidelines as soon as practicable, with specific implementation timelines provided for each set of guidelines to facilitate a smooth transition.”

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