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NHS manager ordered to stop selling ‘sleep drug-laced' children's gummies
An NHS manager has been stopped from selling children's gummies allegedly laced with undeclared levels of a prescription-only sleeping drug, the Guardian can reveal.
Magnesium glycinate gummies for children who have trouble sleeping have been sold since March last year by Nutrition Ignition, an Epsom-based company owned by Sally Westcott, whose other job is a clinical therapy lead at Epsom and St Helier NHS trust.
The Chinese-manufactured gummies are advertised as 'a natural way to help your child sleep better' and are described by Westcott on Facebook as 'especially beneficial in children with ADHD and autism'.
But the adverts and the packaging do not reveal that the raspberry-flavoured sweets allegedly contain significant levels of melatonin, a hormone used for treating sleep problems that is only available in the UK if prescribed by a doctor.
This week the drug regulator ordered Westcott to remove the gummies from her company's website and from the online retailer Amazon while it investigates. But the product remains available on eBay.
Westcott said she was complying with the investigation and denied knowingly selling a prescription-only substance.
The Medicines and Healthcare products Regulatory Agency (MHRA) was alerted to the gummies by two mothers who had bought the product online for their children.
Last week the Guardian was able to buy a tub of 60 gummies for £19.49, including postage and packing, via Amazon without a prescription. They came with glowing five-star online reviews. One parent of a sleep-deprived child described the gummies as a 'godsend', another as 'magic'.
The mothers, one a photographer and the other working in fintech, who both want to remain anonymous, had a hunch that the gummies contained more active ingredients than were listed on the label.
Their suspicions were heightened when their young children, one of whom has been diagnosed with attention deficit hyperactivity disorder and the other who is suspected of having ADHD and autism, fell asleep only 30 minutes after eating the gummies.
The women commissioned an independent company, Supplement Factory, to analyse the gummies. Its report, which the Guardian has seen, said they contained undeclared, but pharmacologically relevant, levels of melatonin. Each gummy contained 0.53mg of melatonin, the analysis estimated. The recommended starting dose for children is 0.5mg.
Supplement Factory concluded that the inclusion of melatonin was unlawful as it breached the human medicines regulations 2012.
'A single gummy may sedate a child without clinical oversight,' Supplement Factory's report concluded.
The mothers sent the report to the MHRA earlier this month. Amazon was also notified. This week the gummies were taken offline while the MHRA investigates.
A spokesperson for the MHRA said: 'Patient safety is our top priority. In the UK, melatonin is an authorised medicine, and any product containing it as an ingredient is likely to be classified as a medicine.
'If a product falls under the definition of a medicine, it must hold a marketing authorisation ('licence') in order to be legally sold and supplied in the UK, unless covered by a special exemption.'
It added: 'We take the reports very seriously and can confirm we are investigating these products further to determine what appropriate action is required. We are unable to comment further on the details of this investigation as it is ongoing.'
In a statement Westcott said: 'We take any concerns regarding product safety, regulatory compliance and consumer trust extremely seriously.
'We are currently reviewing the information you have provided regarding the magnesium glycinate gummies. We have initiated an investigation into the matter in order to properly understand the facts and are in the process of further independent scientific testing of our products.
'Nutrition Ignition is a small business and has never knowingly sold products containing undeclared ingredients and we only work with manufacturers who meet third-party assured industry standards; specifically NSF [National Science Foundation] certification of conformity.'
The photographer said: 'It's horrifying to read those reviews about children falling to sleep in minutes, when you know the reality of what's happening. It is scandalous that you can buy prescription drugs for children over the internet in this way.
'This case shines a light on how unregulated this industry is, and calls into question Amazon's responsibility in allowing misleading and potentially dangerous products being marketed and sold to the parents of children.'
Her friend said: 'I feel deeply concerned about what has been uncovered. Melatonin is a prescribed medicine in the UK and parents/carers need to be made fully aware of what they are feeding their children.'
She added: 'My daughter is diagnosed with ADHD and has been taking medication to manage. To assist with sleep at night, her doctor prescribed melatonin, which luckily she wasn't taking because along with the magnesium gummies, it could have been at a dangerous level in her system. The fact that the supplements market appears to be unregulated and being sold on Amazon with false claims is really worrying.'
Melatonin gummies are available in China, the US and in some European countries without prescription despite doubts about their long-term safety. In the UK a hidden market has developed for melatonin gummies, particularly among parents of neurodivergent children.
The ready availability of melatonin online has alarmed health experts who say its long-term health effects on children are unknown.
