In response to the increasing incidents of accidental melatonin ingestions by children, the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry, has announced new guidelines for melatonin product manufacturers. These guidelines include implementing child-deterrent packaging and improving cautionary language on labels within the next 18 to 24 months.

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

The council's decision to introduce safety measures comes in the wake of recent reports highlighting a massive increase in accidental ingestions of melatonin by children. A study conducted in April 2023 discovered that 25 melatonin gummies contained dangerous levels of the hormone. Shockingly, one product had up to 347% more melatonin than indicated on the label, while another was found to be entirely composed of the unregulated substance cannabidiol (CBD).

Dr. Pieter Cohen, the author of the study on melatonin gummies and an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, emphasized the importance of this industry-wide response. He stated, "What's significant here is that the industry recognizes that melatonin supplements do pose serious risks - particularly to children - and that the industry needs to do a much better job at ensuring the products are safe and well-manufactured."

According to a report from the US Centers for Disease Control and Prevention (CDC) in March 2024, approximately 11,000 children were seen in emergency rooms between 2019 and 2022 after unsupervised melatonin ingestion. Out of these cases, nearly 5,000 were related to melatonin gummies. Most incidents involved children between the ages of 3 and 5, and the majority did not involve any other medications.

The CDC report also highlighted the issue of inadequate packaging, revealing that about three-quarters of the cases involved bottles. This either suggests that young children were able to effortlessly open the bottles or that they were not securely closed. While most unsupervised melatonin ingestions did not lead to hospitalization, the report stressed that the number of incidents among children under the age of 5 may be underestimated.

Moreover, some melatonin gummies on the market illegally state that they contain CBD, which only has limited approved use in children with certain seizure disorders. The study conducted by Dr. Cohen discovered that some tested gummies had higher levels of CBD than indicated on the label.

With these developments in mind, the Council for Responsible Nutrition's new guidelines advocate for labels that inform consumers about the potential drowsiness and advise against alcohol consumption alongside melatonin intake. They also emphasize the need for intermittent or occasional melatonin use only. Furthermore, the council recommends additional warnings for melatonin gummies, specifically cautioning about the potential choking hazard for children under 4 years old if the gummy is not chewed properly.

In terms of packaging, the council urges manufacturers to adopt child-safety containers for gummies and chewable tablets, even though federal regulations do not currently require them for melatonin products. Manufacturers have been given a 24-month period to implement these changes, but the council encourages swift adoption of the guidelines.

As the dietary supplement industry takes proactive steps toward ensuring the safety of melatonin products, experts emphasize the importance of parents remaining vigilant and keeping these supplements out of reach of children.