Health officials in the UK have issued an urgent recall for a brand of children's gummies, 'Kids Magnesium Glycinate Gummies', manufactured by Surrey-based company Nutrition Ignition, over fears they contain an undeclared, prescription-only sleeping drug: melatonin. The Medicines and Healthcare Products Regulatory Agency (MHRA) issued an alert after testing two batches of the raspberry-flavoured wellness supplement, finding melatonin levels of between 1.5 and 1.7mg in individual gummies. This substance was not listed anywhere on the product's packaging.

The recall impacts all batches of Nutrition Ignition Kids Magnesium Glycinate Gummies, and parents or caregivers are strongly advised to stop using the product immediately and safely dispose of any remaining stock. Dr. Alison Cave, MHRA Chief Safety Officer, stressed the importance of these actions and urged anyone who suspects that their child is experiencing a side effect from this product to speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme. This scheme allows the reporting of adverse reactions to medicines and can lead to product reviews or removal from the market.

Melatonin is a hormone naturally produced by the body to help regulate the sleep-wake cycle and is prescribed by doctors in the UK for treating specific sleep problems in adults and children over the age of six. However, its unlisted presence in a children's supplement raises significant safety concerns. Medics have frequently raised alarms over the number of patients admitted to hospital with alleged melatonin overdoses. Furthermore, US data reveals a alarming 500 percent increase in melatonin supplement-related overdoses in children over the past decade. When melatonin is prescribed for licensed indications, side effects such as headache, hyperactivity, dizziness, and abdominal pain have been reported in children.

The risks associated with undeclared melatonin are particularly grave, as it has been linked to at least two infant deaths. A 2019 study documented two cases, a nine-month-old and a 13-month-old, where blood toxicology tests showed high levels of melatonin. While other factors, such as co-sleeping and exposure to a hot room—known risk factors for sudden infant death syndrome (SIDS)—may have contributed to these deaths, the presence of high melatonin was noted. Sleep experts have voiced concerns that the demand for the supplement has 'gotten out of hand,' especially with a hidden market for melatonin gummies developing in the UK, often catering to parents of neurodivergent children.

Despite melatonin gummies being available without prescription in countries like China, the US, and some European nations, doubts about their long-term safety persist. In the UK, however, a synthetic version of melatonin is only authorised for prescription use for specific sleep disorders. Studies in rats and mice have only indicated potential toxic effects if melatonin is given in incredibly high doses exceeding 400mg, but the effects of unregulated and undeclared doses on children remain a serious public health concern.