Australians, especially children, are at risk of overdosing on imported versions of a commonly used supplement which helps them fall asleep.
Unregulated melatonin is being sold in Australia at a strength four-times greater than what is stated on their labels, the Therapeutic Goods Administration has warned.
Typically melatonin supplements require a prescription but many parents instead opt to buy the pills and gummies online to avoid this.Â
The Therapeutic Goods Administration (TGA) is now requesting Border Force seize and destroy incoming melatonin products to avoid harm for children.
TGA officials came to their stark conclusion after testing eight melatonin products which all contained ‘significantly more’ of the chemical than their labelled amount.
Another three products tested has less melatonin than advertised.
One had no melatonin at all despite its label.Â
These ‘significant discrepancies’ have sparked the TGA towards warning parents of the dangers inherent in circumventing prescriptions.Â
Unregulated melatonin supplements pose a risk for children with the TGA claiming some brands had a strength more than triple what was on the label and other brands having far less
The TGA highlighted its serious concerns with these off-market products.   Â
‘This variability in melatonin content raises serious safety concerns for consumers, including the risk of hospitalisation and accidental overdose, especially in children,’ it said.
Sleepose-3 Melatonin 3mg were found to be have the highest discrepancy between what was on its label and what was inside its product.Â
The supplements contained 209 to 417 per cent of its labelled content.
The second worst offender was Nutraceutical Sleepose-3 Melatonin 3 mg which has a 95 to 174 per cent variation.
Third was the Smurfs Kids Gummies Melatonin 1mg which had a 155 to 170 per cent variation.
TGA officials ‘strongly encouraged’ parents to consult doctors before purchasing any supplements for their children.
This warning was especially encouraged for parents whose children suffer seizure disorders ‘as it may increase seizure frequency’.
Eleven unregulated melatonin products had inconsistencies between what was advertised on the label compared to the potency of the supplements themselves (stock pictured)
The agency also warned that melatonin products taken without ‘appropriate medical oversight’ could cause serious side effects.
These side effects could include hospitalisation and accidental overdose, ‘especially in children’, it said.
Increasing numbers of non-fatal melatonin overdoses in children have been recorded in recent years.Â
A primary outlet which has been circumventing doctor-written prescriptions has been the popular international online retailer iHerb.Â
This retailer has since paused Australian shipments.
Overdosing on melatonin can result in drowsiness, nausea, vomiting and diarrhoea.
Melatonin supplements are typically used to counteract sleep problems including insomnia and jet lag.
None of the products tested by the TGA had been listed on the Australian Register of Therapeutic Goods.
The TGA warns that unregistered products ‘may not meet Australian standards for safety, quality and effectiveness’.
PRODUCTS THAT VARIED FROM THE STATED STRENGTH
These products contained significantly more than labelled amount:
Spring Valley Melatonin 10mg 119 per cent -136 per cent
Natrol Melatonin 5mg gummies 140 per cent -170 per cent
CVS Health Melatonin 3mg 112 per cent -121 per cent
The Smurfs Kids Gummies Melatonin 1mg 155 per cent -170 per cent
Natrol Advanced Sleep Melatonin 10mg 112 per cent -123 per cent
Sleepose-3 Melatonin 3mg 209 per cent -417 per cent
Nutraceutical Sleepose-3 Melatonin 3 mg 95 per cent -174 per cent
Vitafusion Sleep Well – Melatonin 3mg 106 per cent -124 per cent
These products contained significantly less than labelled amount:
Life Extension Melatonin 300mcg 79 per cent -97 per cent
Sleepose-10 Melatonin 10mg 37 per cent -59 per cent
Live Natures Melatonin 10mg No melatonin detected
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Urgent warning issued over a popular health supplement – with some brands containing four times the label strength