TGA sounds alarm on fake melatonin imports

The Therapeutic Goods Administration (TGA) has updated its safety advice for melatonin after finding fake imports with more than 400% of the labelled melatonin content. 

‘This variability in melatonin content raises serious safety concerns for consumers, including the risk of accidental overdose and hospitalisation, especially in children,’ the TGA warned on Thursday. 

‘Health professionals also play a key role in identifying and managing the risks associated with unregistered melatonin products and should advise patients accordingly. 

‘Health professionals are encouraged to report adverse events involving medicines, including unapproved medicines.’ 

Last year, the medicine watchdog tested 18 imported melatonin products that were intercepted at the Australian border. 

It found 12 had an average melatonin content significantly different to the label’s claim. 

One product contained more than 400% of the labelled content and another contained no melatonin at all.  

The update follows an ABC investigation which found 1478 calls were made to the poisons hotline in 2024 relating to melatonin exposure for children aged 14 and younger. 

The American supplement website, iHerb, has also suspended sales of all melatonin products to Australia following the rise in reported overdoses. 

The TGA is now reminding patients that melatonin is a prescription-only medicine, except in specific circumstances for adults, and that products taken without appropriate medical oversight can cause serious side effects. 

‘Stop using unregistered melatonin products immediately and take any remaining items to your local pharmacy for safe disposal,’ it said.

‘If you have any concerns arising from the use of these or similar products, seek advice from your treating medical practitioner.’

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