Melatonin industry asked to tighten standards after spike in child ER visits

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FILE - Sleep aids, some of which are melatonin gummies, displayed for sale in a store on April 26, 2023 in Miami, Florida. (Photo by Joe Raedle/Getty Images)

Melatonin makers are being asked to tighten their production standards amid a growing increase of the product’s exposure to infants and young children in the United States.

Melatonin is a hormone that helps control the body’s sleep cycle and has become a popular over-the-counter sleeping aid.

As its popularity has increased, so have reports of melatonin’s poisoning in children.

Now, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, has released new guidelines it hopes some melatonin manufacturers will voluntarily adapt.

The guidelines involve stricter labeling, reporting manufacturer overages in dosage amounts and implementing child deterrent packaging.

"Parents may think of melatonin as the equivalent of a vitamin and leave it on a nightstand," said Dr. Karima Lelak, the lead author of a melatonin ingestion study published in 2022 by the Centers for Disease Control and Prevention.

"But really it’s a medication that has the potential to cause harm, and should be put away in the medicine cabinet."

In the U.S., melatonin is sold as a supplement, not regulated as a drug. The U.S. Food and Drug Administration (FDA) regulates dietary supplements under a separate set of regulations than foods and drug products. Regulation includes how much of the ingredient needs to be in the product (100% for the duration of its shelf life), along with both the Federal Trade Commission (FTC) and FDA regulating supplement label claims.

The U.S. Centers for Disease Control and Prevention says a recent investigation of melatonin products found that the actual content of the melatonin product was not always the same as the labeled ingredients or strength.

Another study in 2023 found one product containing 347% more melatonin than what was actually listed on the label – and some containing no melatonin at all and, instead, CBD.

CRN is asking the safety guidelines to be implemented within the next 18 months, with another set of guidelines also aimed at making gummy supplements safer over the next two years.

Melatonin overdoses

Many people can tolerate even relatively large doses of melatonin without significant harm, experts say. But there is no antidote for an overdose.

In cases of a child accidentally ingesting melatonin, experts often ask a reliable adult to monitor them at home. Slowed breathing or other worrisome signs can mean a child should be taken to a hospital.

In the 2022 study authored by Lelak, which looked at reports to poison control centers from 2012 to 2021, data showed U.S. poison control centers received more than 52,000 calls about children consuming worrisome amounts of the dietary supplement in 2021 — a six-fold increase from about a decade earlier.

In those cases, data showed more than 4,000 kids were hospitalized, five needed to be put on machines to help them breathe, and two — both younger than 2 — died.

Most of the hospitalized children were teenagers, and many of those were believed to be suicide attempts.

Reported melatonin poisonings have been increasing for at least a decade, but the largest increases happened after the COVID-19 pandemic hit the United States in 2020.

This story was reported from Detroit. The Associated Press contributed.

Editor's Note: This article has been updated to reflect current FDA regulations on dietary supplements.