Australia’s Therapeutic Goods Administration (TGA) has posted a public warning. Their goal is to warn the public about the risk of dangerous or contaminated melatonin products available online. The TGA reviewed over a dozen separate melatonin preparations. They identified serious mismatches between what was labeled on the products and the actual amount of melatonin contained within these products. This troubling discovery makes it clear that our children—our most vulnerable population—are becoming victims of this repeated carelessness.
Of the products tested, including some with as much as 400 percent more melatonin than advertised. For example, an analysis of Natrol Melatonin 5mg gummies revealed those gummies contained 170 percent over their claimed dosage. Some products like Live Natures Melatonin 10mg had zero melatonin. The TGA’s investigation highlighted that many online suppliers’ melatonin products could contain up to four times the amount that was indicated on their labels.
Prescription Requirement and Approved Uses
Here in Australia, melatonin is considered a prescription medication. As a result, it is only approved for very limited use, such as the treatment of children with autism. The TGA wants products to live up to their labels because everything goes into consumer safety if something isn’t what it claims to be.
Even as a medical expert herself, Dr. Raman shared her worries with the online products’ high stakes. “Many people do buy melatonin online, but there needs to be caution around this,” she stated. The TGA echoed these sentiments, advising that “consumers who import these unregistered ‘melatonin’ products from online stores for personal use or use by an immediate family member risk serious health problems.”
The TGA unequivocally advised that children with known pre-existing medical conditions, including sleep disorders or irregular sleep patterns, need to consult their healthcare professional. They should be careful about using medications they purchase from online pharmacies.
Alarming Spike in Calls to Poison Hotlines
The TGA’s findings come amid a troubling trend. Australian poisons hotlines received a record number of approximately 1,500 calls last year related to children ingesting melatonin. That’s a stunning figure as compared to prior years. It should sound alarms that melatonin can become unsafe when used unsupervised.
Dr. Raman emphasized that first and foremost our focus has to be on keeping children safe. “It is quite concerning. The medication should match the label to be safe,” she remarked. That variability in content makes Retrophin pose a heightened risk for accidental overdose, particularly for younger users. “The main concern is safety and the effects of this on children. The risk would be overdosing or the risk of poisoning,” she added.
The Need for Medical Oversight
The TGA’s research made some startling discoveries. Melatonin products tested had more than double what the label claimed, while a third of them had 83 percent less. This inconsistency poses serious safety risks.
Dr. Raman also encourages parents to speak with their child’s doctor before starting melatonin. This precaution is a good and necessary step given the recent findings. “Parents are strongly encouraged to consult their child’s treating medical practitioner regarding the use of melatonin, especially for children with seizure disorders as it may increase seizure frequency,” she advised.
The TGA reminds consumers that using melatonin products without the guidance of a healthcare professional can lead to severe effects. These benefit risks include the risk of hospitalization and accidental overdose. “This variability in melatonin content raises serious safety concerns for consumers, including the risk of hospitalization and accidental overdose, especially in children,” the TGA stated.
