Parents ordered to stop use of branded gummies and dispose at pharmacy

The medicines regulator has advised parents and caregivers to ‘stop all use’ of Nutrition Ignition Kids Magnesium Glycinate Gummies and take the product to a pharmacy for disposal, due to the presence of undeclared melatonin.

Two batches of the product were tested by the Medicines and Healthcare products Regulatory Agency (MHRA) and were found to contain between 1.5mg and 1.7mg of melatonin in each individual gummy.

Depending on the age of the child, the product packaging advised a dose of one or two gummies per day, and melatonin is not listed anywhere on the product’s packaging, the MHRA said.

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Melatonin is authorised in the UK as a prescription-only medication, used for specific sleep disorders in adults and children over the age of six years old, such as insomnia, delayed sleep wake phase disorder (DSWPD) and attention deficit hyperactivity disorder (ADHD).

If prescribed for children, the recommended starting dose is 1mg which can be increased to a maximum of 5mg per day before bed.

The detection of melatonin in this children’s gummies product means that it must be regulated as a medicine and must therefore hold a Marketing Authorisation (‘licence’) to be legally sold and supplied in the UK.

However, the Nutrition Ignition Kids Magnesium Glycinate Gummies had only been sold online as a food supplement to support ‘calm, focus, and digestion’, so the MHRA took action to remove it from sale and withdraw all listings.

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Consuming too much melatonin can cause drowsiness, headaches, dizziness, and nausea, but the effects are usually short-lived and clear within 12 hours.

Dr Alison Cave, MHRA chief safety officer, said: ‘Anyone who suspects that their child, or a child in their care, is having a side effect from this product is advised to stop taking it and speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme.’

The MHRA also advised anyone with the product at home to store it in a tamper-proof container out of reach of children until they can take it to a pharmacy for disposal.

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The Guardian reported in June that the magnesium gummy brand was owned by Sally Westcott, a Surrey-based clinical therapy lead at Epsom and St Helier NHS trust.

Nutrition Ignition could not be reached for comment as its website appears to not be in use, with a ‘coming soon’ message on its homepage.