NHS manager ordered to stop selling ‘sleep drug-laced’ children’s gummies | Children’s health

An NHS manager has been prevented from selling children’s gummies that would have been interrupted with unconcluded levels of a prescription only sleeping drug, the Guardian can reveal.

Glyccinal magnesium gammies for children who have trouble sleeping have been sold since March of last year by ignition nutrition, a company based in Epsom belonging to Sally Westcott, the other job of which is a clinical therapy manager in Epsom and St Helier NHS Trust.

Gammies manufactured by Chinese are announced as “a natural way to help your child sleep better” and are described by Westcott on Facebook as “particularly beneficial in children with ADHD and autism”.

But advertisements and packaging do not reveal that raspberry candies contain significant melatonin levels, a hormone used to treat sleep problems that are only available in the United Kingdom if they are prescribed by a doctor.

This week, the medication regulator ordered Westcott to withdraw gumies from the website of his company and the Amazon online retailer during his survey. But the product remains available on eBay.

Westcott said that she was complying with the investigation and that she had denied a prescription substance.

The Regulatory Agency for Medicines and Health Products (MHRA) has been alerted to gammies by two mothers who had bought the product online for their children.

Last week, the Guardian was able to buy a bathtub of 60 gummies for £ 19.49, including shipping costs and packaging, via Amazon without prescription. They came with five -star online glowing criticisms. A parent of a child deprived of sleep described gummies as a “bargain”, another like “magic”.

The mothers, one a photographer and the other working in the Fintech, who both want to remain anonymous, had an intuition that gummies contained more active ingredients than those listed on the label.

Their suspicions were reinforced when their young children, one of whom were diagnosed with a hyperactivity disorder with attention deficit and the other suspected of having ADHD and autism, did not fall asleep only 30 minutes after eating gum.

The women ordered an independent company, supplement Factory, to analyze gummies. His report, which the Guardian saw, said that they contained unconvolved, but pharmacologically relevant melatonin levels. Each gum contained 0.53 mg of melatonin, estimated the analysis. The recommended starting dose for children is 0.5 mg.

Supplement Factory concluded that the inclusion of melatonin was illegal because it violated the regulation of human medicines 2012.

“A single gum can subscribe to a child without clinical supervision,” concluded the Factory supplement report.

Mothers sent the MHRA report at the beginning of the month. Amazon has also been informed. This week, the gummies were withdrawn offline while the MHRA inquiry.

An MHRA spokesperson said: “Patient safety is our top priority. In the United Kingdom, melatonin is an authorized drug, and any product which contains it as an ingredient is likely to be classified as a medication.

“If a product is the definition of a drug, it must contain a marketing authorization (” license “) in order to be legally sold and provided in the United Kingdom, except covered by a special exemption.”

He added: “We take the reports very seriously and can confirm that we are investigating these products later to determine which appropriate action is necessary. We are unable to comment more on the details of this investigation as it is in progress.”

In a press release, Westcott said: “We take any concern about product safety, regulatory compliance and consumer conformity very seriously.

“We are currently examining the information you have provided with regard to glycine magnesium gammies. We have launched an investigation into the issue to fully understand the facts and we are doing scientific tests independent of our products.

“Nutritional ignition is a small business and has never knowingly sold products containing unconnected ingredients and we only work with manufacturers who meet industry standards provided by third parties; especially NSF [National Science Foundation] Conformity certification. »»

The photographer said: “It is horrible to read these criticisms about children who join in a few minutes, when you know the reality of what’s going on. It is scandalous that you can buy prescription drugs for children on the Internet in this way.

“This case highlights how unregulated this industry is, and calls into question Amazon’s responsibility by authorizing the deceived and potentially dangerous products sold and sold to parents of children.”

His friend said: “I feel deeply concerned about what has been discovered. Melatonin is a medicine prescribed in the United Kingdom and parents / caregivers must be fully aware of what they feed their children.”

She added: “My daughter is diagnosed with ADHD and took medication to manage.

Melatonin gammies are available in China, the United States and certain European countries without a prescription despite doubts about their long-term security. In the United Kingdom, a hidden market has developed for melatonin gammies, especially in parents of neurodivergent children.

The ready -made availability of online melatonin has alarmed health experts who say that its long -term health effects on children are unknown.