There have been a number of accidental poisonings.
Following a concerning increase in incidents where young children inadvertently consume melatonin supplements, an industry group has advocated for stricter safety measures regarding the packaging and labeling of these sleep aid products.
The Council for Responsible Nutrition (CRN) announced on Monday a set of enhanced guidelines, giving companies 18 to 24 months to voluntarily implement child-resistant packaging and enhance warning language on over-the-counter melatonin products.
These new guidelines also emphasize the importance of manufacturers adopting child-resistant packaging for gummies and chewable tablets, addressing specific concerns related to these products.
“The CRN’s latest recommendations, particularly tailored for melatonin gummy supplements, acknowledge the unique characteristics of these increasingly popular products,” stated the council. “The focus is on improving label clarity, minimizing access by unsupervised children, addressing potential choking hazards, and ensuring appropriate usage of the products.” Experts have lauded this initiative.
Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance, Massachusetts, and author of a 2023 study on melatonin gummies’ risks, commended the industry’s acknowledgment of the serious hazards posed by these supplements, especially to children. However, he remained cautious about whether companies would adhere to these voluntary recommendations.
Cohen’s study revealed alarming findings, including melatonin gummies containing dangerously high hormone levels. Some products had up to 347% more melatonin than indicated on the label, while others contained no melatonin at all, being solely composed of cannabidiol (CBD).
A March 2024 report from the U.S. Centers for Disease Control and Prevention uncovered over 11,000 cases of children seen in emergency rooms between 2019 and 2022 after ingesting melatonin without supervision. Nearly 5,000 of these cases involved melatonin gummies, with over half of the incidents occurring in children aged 3 to 5. Many cases resulted from children accessing improperly closed or easily openable bottles.
Experts caution against the use of melatonin in children without consulting a pediatrician. Melatonin, a hormone regulating the body’s sleep-wake cycle, is in high demand among both adults and children, yet it remains unregulated by the U.S. Food and Drug Administration as a dietary supplement.
The new CRN guidelines advocate for clearer labels warning of potential drowsiness and advising against consumption with alcohol. Additionally, labels should specify that melatonin supplements are for occasional or intermittent use only.
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