United States: Manufacturers of melatonin hoping to avoid deadlines have 18 to 24 months to voluntarily improve labels and packaging or shun the child-proof packaging and provide more information, according to the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry. 

More about Melatonin 

Melatonin is one of the many hormones produced by the deep brain as a result of darkness. It regulates the natural sleep-wake rhythm or circadian rhythm that our body can experience. 

Melatonin, which is a dietary supplement, is not considered by the US Food and Drug Administration (FDA) a regulatory entity, yet some experts have reported an enormous increase in the use of this melatonin among both adults and children during the past decade. 

About Melatonin-related accidents in children 

The council’s move over the weekend came on the recent reports of large rate of kids accidentally taking melatonin and the April 2023 study which reported that 25 melatonin-gummies contain dangerous amounts of melatonin. 

An over-the-counter product made up of up to 347 percent of the stated melatonin amount listed on the label, while another contained no melatonin at all — it was entirely composed of cannabidiol or CBD. 

Melatonin Industry Faces Scrutiny Over Mislabeling and Child Safety. Credit | GETTY IMAGES
Melatonin Industry Faces Scrutiny Over Mislabeling and Child Safety. Credit | GETTY IMAGES

Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, who was also the author of a study conducted on melatonin gummies, said, “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,” as CNN Health reported. 

“Whether this voluntary recommendation will be followed is another matter entirely, and we’ll need to see,” Cohen added. 

Rise in Children’s ER visits 

March 2024 report findings remark that melatonin poisoning was considered life-threatening as not less than 11,000 children were taken to the emergency wards between 2019 and 2022 in the US after they ate melatonin without supervision. Melatonin capsules accounted for around 5,000 out of those recorded incidents. 

These data have demonstrated that the children of most accidents had been children ages 3 to 5 years, and most visits were not associated with other medicines besides melatonin, according to CDC information. 

Three out of four of the recorded cases were found to include bottles in which it appears that babies were able to open the bottles or they were not properly closed. 

However, the minor incidences that did not require hospitalization or even did not end up in hospitalization may be the ones that were underreported in the study, the report mentioned. 

According to the FDA, in some of the melatonin gummies, the label states that it contains CBD, even when t’s “currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” as CNN Health reported. 

As per Cohen, four of the gummies that he had tested possessed CBD levels between 4 percent and 18 percent higher than on the label. 

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

Other than CBD, ingesting a gummy that unknowingly contains exceptionally high levels of melatonin, consequently much more than the 0.5 mg to 1 mg suggested per night to induce sleep in kids, is also dangerous, according to Breuner. 

Any “discrepancies between ingredients or strength” of melatonin products could have “procedural” implications for children, according to the CDC researchers in their April report. 


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