In response to the increasing incidents of accidental ingestions of melatonin supplements by children, the Council for Responsible Nutrition has announced new guidelines for manufacturers. The leading trade association for the dietary supplement and functional food industry has given companies 18 to 24 months to voluntarily implement child-deterrent packaging and improve cautionary language on labels of over-the-counter melatonin products.

Melatonin, a hormone produced by the brain to regulate the sleep-wake cycle, has witnessed a surge in demand among both adults and children over the past decade. However, as a dietary supplement, melatonin is not regulated by the US Food and Drug Administration (FDA).

The council's decision follows recent reports of a significant rise in accidental ingestions of melatonin by children. An April 2023 study revealed that 25 products labeled as melatonin gummies contained dangerous levels of the hormone. Shockingly, one over-the-counter product had up to 347% more melatonin than stated on the label, and another was found to contain no melatonin at all, being solely composed of cannabidiol (CBD).

Dr. Pieter Cohen, the author of the study on melatonin gummies and an associate professor of medicine at the Cambridge Health Alliance, highlighted the significance of the industry's recognition of the serious risks posed by melatonin supplements, particularly to children. Dr. Cohen emphasized the need for the industry to prioritize safety and ensure better manufacturing practices.

Accidental ingestions of melatonin by children have resulted in numerous visits to emergency rooms. A March 2024 report from the US Centers for Disease Control and Prevention (CDC) revealed that 11,000 children had been seen in emergency rooms between 2019 and 2022 due to unsupervised ingestion of melatonin. Melatonin gummies were implicated in nearly 5,000 of these cases.

The majority of accidental ingestions involved children between the ages of 3 and 5, and most cases did not involve additional medications besides melatonin. The CDC highlighted that about three-quarters of the documented cases involved bottles, suggesting that either young children were able to open the bottles or the bottles were not securely closed. The report also suggested that the number of accidental ingestions by children 5 and under might be underestimated.

Some melatonin gummies openly mention the presence of CBD on the label, despite it being currently illegal to market CBD as a food or dietary supplement, as stated by the FDA. Testing conducted by Dr. Cohen found that four gummies contained CBD levels ranging from 4% to 18% higher than indicated on the label. However, experts caution against the use of CBD in children unless specifically recommended for certain medical conditions.

Consuming melatonin gummies with extremely high levels of the hormone can be dangerous, in addition to the potential risks of CBD. Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children's Hospital, emphasized that discrepancies in melatonin ingredients or strength could pose additional risks to children's health.

As part of the new guidelines, the Council for Responsible Nutrition has called for improved labeling. The labels should now include warnings about drowsiness after consuming a melatonin supplement and should caution against taking melatonin with alcohol. Furthermore, purchasers should be informed that melatonin is intended for intermittent or occasional use only.

The council has also recommended that melatonin gummies receive additional warnings regarding potential choking hazards for children under 4 years old if not chewed properly. To ensure the safety of children, the guidelines stress the need for manufacturers to adopt child-safety containers for gummies and chewable tablets.

Manufacturers have been given 24 months to implement these changes, with the council urging their members and the broader industry to adopt the guidelines as soon as possible. The specific implementation timelines for each set of guidelines aim to facilitate a smooth transition.

With these enhanced safety measures, the dietary supplement industry aims to mitigate the risks associated with melatonin products and safeguard the health and well-being of children who might accidentally ingest them.