Melatonin industry voluntarily calls for stronger standards after dramatic increase in pediatric emergency department visits

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Manufacturers of melatonin supplements have 18 to 24 months to voluntarily add child-deterrent packaging and improve warning language on over-the-counter product labels. Council for Responsible Nutritionthe leading trade association for the nutraceutical and functional food industry.

Melatonin is hormone Produced by the brain in response to darkness.Regulates the body's natural sleep and wakefulness period or circadian rhythm. Experts say that although melatonin as a dietary supplement is not regulated by the U.S. Food and Drug Administration, demand for melatonin among both adults and children has skyrocketed over the past decade.

The council's action follows a recent report. Accidental ingestion has significantly increased Melatonin intake by children, April 2023 study found 25 products labeled as melatonin gummies contained melatonin dangerous levels of hormones. One commercial product contained up to 347% more melatonin than stated on the label, while another contained no melatonin at all, all with cannabidiol or his CBD. It was configured.

“What's important here is that the industry recognizes that melatonin supplements pose serious risks, especially for children, and that the industry is doing better to ensure that its products are safe and properly manufactured. It means you need to work,” he said. Peter Cohen, associate professor of medicine at Cambridge Health Alliance in Somerville, Massachusetts, is the author of a study on melatoning gummies.

“Whether or not we follow this voluntary advisory is an entirely different matter that we will need to assess,” Cohen said in an email.

March 2024 report A study by the Centers for Disease Control and Prevention found that between 2019 and 2022, nearly 11,000 children took melatonin without supervision and ended up in the emergency room. Approximately 5,000 of those cases involved melatoning gummies.

More than half of accidental ingestions involve children. The children were 3 and 5 years old, and the majority of their visits included no additional medications other than melatonin, the CDC said.

Approximately three-quarters of the documented incidents involved bottles, suggesting that young children were able to open the bottles or that the bottles were not closed properly. Although the majority of unsupervised melatonin ingestions did not result in hospitalization, the number of accidental ingestions by children under five may be underestimated, the report said.

Although some melatoning gummies say on the label that they also contain CBD, it is currently illegal to add CBD to food or sell CBD under the label of a dietary supplement. “is. US Food and Drug Administration.

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

“There are no data to support the use of CBD in children,” said Dr. Cora Collette Bruner, professor of pediatrics at Seattle Children's Hospital at the University of Washington. previously told CNN. “Currently only recommended for very specific uses in children over 1 year of age.” He has an intractable seizure disorder. ”

Apart from CBD, it can also be dangerous to unknowingly ingest gummies containing extremely high concentrations of melatonin, ranging from 0.5 milligrams to well over 1 milligram per day, which has been proven to induce sleep in children. Breuner said.

Inconsistencies in melatonin composition or strength “may pose additional risks” to children, CDC researchers wrote in an April report.

New and improved labels

The council's guidelines call for new labels that warn consumers about the risk of drowsiness after taking melatonin supplements. The council said labels should also state that melatonin should not be taken with alcohol. Additionally, the label must tell the purchaser that melatonin is intended for intermittent or occasional use only.

The council also suggested that additional warnings should be issued for melatoning gummies, such as a warning that gummies sold to children under 4 may pose a choking hazard if not chewed properly.

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

“Although federal regulations do not require child-deterrent sealed containers for melatonin-containing products, CRN's revised guidelines encourage industry stakeholders to include melatonin-containing products in flavored, chewable forms that may be particularly appealing to children. requires the use of child-deterrent packaging,” the council said. In a statement.

The gummy maker will have 24 months to implement the changes. However, the council urges its members and the industry as a whole to adopt these guidelines as soon as possible, and each guideline provides a specific implementation timeline to facilitate a smooth transition. There is.”

CNN’s Amanda Musa contributed to this article.