Melatonin industry asked to voluntarily add child-proof packaging after huge spike in ER visits

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Manufacturers of over-the-counter melatonin supplements, which boost the hormone responsible for naturally regulating the body’s circadian rhythm or sleep-wake cycle, have voted to adopt a deadline to make their packaging more child-proof as concerns grow about a sharp rise in the number of hospital visits involving kids accidentally ingesting them.

The trade association the Council for Responsible Nutrition (CRN) recommended brands take 18 to 24 months to amend their existing packaging to safeguard infants and carry more prominent warning labels, according to CNN.

The development comes after the Centers for Disease Control and Prevention (CDC) reported last month that 11,000 American children were taken to hospital between 2019 and 2022 after consuming melatonin supplements unsupervised, with gummy versions that resemble enticing candy accounting for almost half of those incidents.

Children aged between three and five made up half of the total while three-quarters of cases involved products sold in bottles, suggesting to the council that they were too easy to open and therefore posed a risk.

The CRN has told The Independent its guidelines were crafted independently of the CDC’s findings.

Demand for supplements to boost sleep has risen sharply over the last decade but a study published last year exposed 25 products labelled as melatonin gummies that contained unhealthy quantities of the hormone or, in one instance, no melatonin at all and cannabidiol (CBD) used in its place.

Dr Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, who authored the study, told CNN: “What’s significant here is that the industry recognises 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.

“Whether this voluntary recommendation will be followed, is another matter entirely, and we’ll need to see.”

Just 0.5mg to 1mg of melatonin per night has been shown to induce sleep in children so larger doses are thought to pose a threat to their wellbeing, while CBD is not recommended for children at all.

Hence the need, according to the CRN, for better preventative measures to be taken to stop gummies and chewable tablets falling into the hands of those for whom they were not intended.

The council’s new recommendations call for labels to carry better warnings about the likelihood of drowsiness after taking the supplements, advise users not to combine their intake with alcohol and to remind them that the supplements are intended for occasional use only.

With regard to gummies and tablets specifically, the CRN advises manufacturers to pivot towards child-proof containers and bear warnings that they further pose a choking hazard to young children.

“While federal regulations do not require child deterrent closures for melatonin-containing products, CRN’s revised guidelines call for industry members to adopt child deterrent packaging for products containing melatonin that are in flavoured chewable forms that could be especially attractive to children,” the body said in a statement.

While the CRN gives manufacturers two years to implement the changes it recommends, it says it “urges its members and the broader industry to adopt these guidelines as soon as practicable, with specific implementation timelines provided for each set of guidelines to facilitate a smooth transition.”

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