New packaging guidelines for melatonin proposed after spike in ER visits among children

The Council for Responsible Nutrition announced new melatonin packaging guidelines Monday, but it will be up to manufacturers of the supplements to implement them.

The action taken by the council, a leading trade association for the dietary supplement industry, comes after the U.S. Centers for Disease Control and Prevention (CDC) put out a report last month stating that nearly 11,000 U.S. children ended up in the emergency room from 2019 and 2022 after ingesting melatonin they took without supervision, USA TODAY previously reported.

In a study published last year, researchers tested 25 melatonin products and found the majority of them were mislabeled. Some were found to contain over 300% more melatonin than what was listed on the bottle.

The new voluntary guidelines are focused on two things: the formulation, labeling, and packaging of melatonin-containing dietary supplements; and the labeling of gummy dietary supplements, the latter being crucial to the protection of kids.

Here's exactly what has been proposed.

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The CDC reported a spike in children ending up in the ER from 2019 and 2022 after ingesting melatonin they took without supervision.
The CDC reported a spike in children ending up in the ER from 2019 and 2022 after ingesting melatonin they took without supervision.

What the new guidelines will include

“These are just the latest in a series of voluntary guidelines that CRN members have adopted," council President and CEO Steve Mister said in a new release. "By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”

The new guidelines are as follows:

Recommendations for melatonin supplements:

  • Labeling: Cautionary label statements would alert consumers that melatonin may cause drowsiness, is not to be taken with alcohol, and that the products are intended for intermittent or occasional use only.

  • Overages: Any overages of melatonin added during manufacturing would be informed by data to support stability and safety.

  • Child deterrent packaging: Child-deterrent packaging for products containing melatonin that are in flavored chewable forms especially attractive to children would provide parents a tool to prevent unsupervised access to the products.

Recommendations for gummy form supplements:

  • Targeted advisories: Detailed labeling advisories for products aimed at both adults and children would include specific considerations for gummy supplements intended for young children and underscore the importance of using these products under appropriate conditions.

  • Avoiding potential choking hazards: For products intended for children under 4, a precautionary statement would be added to warn against choking if not taken correctly.

  • Packaging considerations: Manufacturers would be asked to consider packaging gummy products in containers with child deterrent closures.

The council urges its members and the broader industry to adopt the guidelines as soon as possible, the first set within 18 months and the second within 24 months, according to the council.

You can view a complete list of the council's voluntary guidelines and best practices here.

The risk of melatonin gummies for kids

Melatonin in gummy form can be dangerous because it looks and often tastes like candy.

From 2012 to 2021, reports of melatonin ingestion to poison control centers increased 530%, largely occurring among children under age 5, the CDC reported. More than 94% were unintentional.

Excessive melatonin consumption has not been shown to be fatal, but there is more risk involved when taking higher doses, Dr. Hal Alpert, telemedicine consultant for Blue Sleep, previously told USA TODAY.

Some of the risks include rebound insomnia, irritability, depression and sedations that last a couple of days, according to Alpert.

Melatonin isn't regulated by the U.S. Food and Drug Administration (FDA) in the same way that over-the-counter and prescription drugs are, but the agency still has regulatory authority over the product and other supplements because of the Dietary Supplement Health and Education Act of 1994, according to the council.

The FDA can regulate dietary supplements and dietary ingredients, and address any manufacturing or labeling issues, among other things.

Contributing: Josie Goodrich and Nada Hassanein

This article originally appeared on USA TODAY: Melatonin new packaging guidelines seek to protect kids from overdose