Melatonin gummies linked to uptick in ER visits; CRN urges child-resistant packaging

The Council for Responsible Nutrition this week announced new guidelines for packaging melatonin supplements, especially those in gummy or chewable form, after a federal report released last month revealed a significant uptick in children ending up in the emergency room after ingesting them without supervision.

CRN, a trade association for the dietary supplement and functional food industry, adopted the voluntary guidelines, but individual manufacturers are not required to make the changes.

Last month, the Centers for Disease Control and Prevention issued a report revealing that from 2019–2022, melatonin was implicated in approximately 11,000 emergency room visits by infants and young children, representing 7% of all ER visits by infants and young children for unsupervised medication ingestions.

The CDC said in many of those cases, the children ingested flavored products, such as gummies.

Part of the rising prevalence is due to higher usage among adults. The CDC said that during 1999–2000 0.4% of U.S. adults used melatonin, compared to 2.1% during 2017–2018, a 530% increase.

But part of the problem is due to the fact that melatonin supplements, unlike medications, do not require child-resistant packaging.

The CRN issued two new sets of guidelines on Monday, one for melatonin products, and one for all gummy supplements.

Along with adopting child-resistant packaging, the CRN recommended revising melatonin labeling instructions to alert consumers that melatonin may cause drowsiness, not to take with alcohol, and that melatonin is only meant for occasional or intermittent use. The new guidelines also recommend that overages of melatonin added to the product during manufacturing be informed by data to support stability and safety.

New recommendations for gummy supplements include adopting child-resistant packaging, avoiding potential choking hazards with a cautionary statement on the label, and targeted labeling advisories for products aimed at both adults and children, underscoring the importance of using the products under appropriate conditions and guidance.

“These are just the latest in a series of Voluntary Guidelines that CRN members have adopted that underscore CRN’s unwavering commitment to the well-being of consumers and the integrity of the dietary supplement market,” CRN President and CEO Steve Mister said in a statement. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”

CRN members are being asked to adopt the new melatonin guidelines within 18 months, and the new gummy guidelines within 24 months.

Credit: TMX

This article originally appeared on Asbury Park Press: Melatonin gummy risks: What you need to know to keep your child safe