Melatonin Makers Recommended To Adhere New Labeling Guidelines Amid Rise in Children ER Visits

melatonin Melatonin Makers Adhere to Updated Labeling Regulations Safeguard Children children

By Jackelyn Cornejo , Parent Herald Apr 19, 11:03 am

Photo: (Photo : Joe Raedle/Getty Images )

The Council for Responsible Nutrition, representing the dietary supplement and functional food industry, has circulated new guidelines persuading melatonin manufacturers to improve labeling and packaging standards for their products.

New Guidelines on Melatonin Products Labeling, Packaging

These guidelines, issued lately, affirm the need for child-resistant packaging for melatonin-containing items and inform consumers about possible side effects like drowsiness and the significance of using them under irregular supervision.

Specifically targeting melatonin gummy products, which may be enticing to children, the guidelines call for similar child-resistant packaging and clear labeling regarding appropriate usage conditions. Furthermore, products designed for children under four years old should contain warnings about probable choking hazards.

While melatonin supplements are readily accessible in the United States as dietary supplements, these guidelines are voluntary, leaving the decision to resolve them up to the manufacturers.

Latest data from the Centers for Disease Control and Prevention (CDC) emphasize a concerning trend of heightened emergency room visits and poison control calls due to individual melatonin ingestion among young children. This emphasizes the importance of establishing safety measures and displaying responsible medication usage. The probable long-term impacts of melatonin, specifically on children's hormonal growth, remain ambiguous, requiring further studies.

Parents are suggested to keep medications out of reach and sight of children and to inform them about medication safety to avoid unintended swallowing and probable risk.

Increase Children's Safety Through Improved Product Labeling

Melatonin supplement manufacturers have been given a window of 18 to 24 months to willingly improve safety measures by incorporating child-resistant packaging and enhancing cautionary language on product labels, as outlined by the Council for Responsible Nutrition, the prominent trade association for the dietary supplement and functional food industry.

The surge in demand for melatonin, a hormone formed by the brain to regulate the sleep-wake cycle, has been noted over the past decade. However, as a dietary supplement, melatonin is not subject to pre-sale safety, efficiency, or labeling approval by the US Food and Drug Administration.

The council's initiative follows the latest reports of important growth in unintended melatonin ingestions by children, as well as research in April 2023 disclosing dangerous levels of melatonin in certain melatonin gummy products.

Dr. Pieter Cohen, who directed the research on melatonin gummies, emphasized the significance of industry identification regarding the danger similar to melatonin supplements, specifically for children, and stressed the demand for enhanced safety and manufacturing standards.

A report from the US Centers for Disease Control and Prevention in March 2024 emphasized a surge in emergency room visits by children who swallowed melatonin independently, with nearly 5,000 cases containing melatonin gummies. Most of these occurrences involved children aged 3 to 5 years, and most cases did not include additional medications.

The council's guidelines recommend new labels warning consumers about potential drowsiness and advising against melatonin consumption with alcohol. They also advocate for intermittent or occasional use only and suggest additional warnings for melatonin gummies, particularly regarding potential choking hazards for children under 4 years old.

Furthermore, the guidelines stress the adoption of child-resistant packaging for gummies and chewable tablets, although federal regulations do not mandate such closures for melatonin-containing products.

Manufacturers have been given 24 months to implement these changes, with the council urging swift adoption of the guidelines to ensure consumer safety.