The gummies were for sale on the Nutrition Ignition brand website, which removed all products and now reads “coming soon.” All products were also removed from online retailers, including Amazon and eBay.
Magnesium glycinate typically helps regulate neurotransmitters, such as GABA, which can support feelings of calm and improve sleep quality. The product in question was marketed for children aged four and older to support calm, focus and digestion.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) tested two batches of the magnesium glycinate gummies following concerns raised by parents of children who had consumed the product. The tests revealed that the raspberry-flavored gummies contained between 1.5 mg and 1.7 mg of melatonin.
As the product was sold online as a food supplement, the MHRA took action to remove the it from sale and worked with online retailers to withdraw all listings.
Dr. Alison Cave, MHRA chief safety officer, said in a statement that parents and caregivers should stop use immediately and dispose of the gummies.
“Side effects such as headache, hyperactivity, a feeling of dizziness and abdominal pain have been reported in children when melatonin is prescribed and used for its licensed indications,” she 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.”
How does melatonin get into a product accidentally?
The amounts of melatonin found when the product underwent testing suggested manufacturers added the ingredient deliberately rather than accidentally contaminating the product, Luca Bucchini, managing director at food safety consultancy Hylobates Consulting, told NutraIngredients.
“In some cases, manufacturing or packaging errors may be to blame,” he said. “This is either a gross manufacturing mistake or fraud.”
He explained that one possible reason for its inclusion is to enhance the product’s desired effect. While the practice of secretly adding pharmaceutical drugs to supplements is definitely not common, he noted that it does happen from time to time.
“It has been shown in other cases that unscrupulous manufacturers, in order to deliver products that are efficacious, add other substances which may be medicinal,” he said.
“Sometimes the brand, which may not have selected the supplier carefully and done independent testing, is not even aware of the issue but is just pleased that the product ‘works’.”
In fact, in previous cases, substances from antibiotics and slimming drugs to antidepressants and erectile dysfunction medication were found in products marketed as purely botanical or vitamin-based.
This, he said, is more likely to happen outside of the EU and the UK. In the EU, melatonin is a medication, not a dietary supplement, and in the UK, it is prescription-only.
“While European and UK manufacturers are rarely involved in these practices—and the few who were have been shut down by authorities—the situation differs outside Europe,” Bucchini said.
“For example, in the US, melatonin is freely sold and commonly used at doses up to 5 mg, so many non-European manufacturers may not even view such additions as a safety concern.”
NutraIngredients reached out to the company owner of Nutrition Ignition, but no comment was provided by the time of publication