CONSUMERS and health professionals are being warned about imported unregistered melatonin products in an updated safety advisory from the Therapeutic Goods Administration (TGA).
Testing on a range of products confirmed that they are counterfeit, with results showing significant discrepancies in the actual melatonin content compared to the labelled amounts.
One product contained more than 400% of the labelled content while another contained no melatonin at all.
"This variability in melatonin content raises serious safety concerns for consumers, including the risk of accidental overdose and hospitalisation, especially in children," the TGA stated.
These unregistered therapeutic goods can be purchased online or from local retailers, and do not have an AUST R or AUST L number.
The TGA has previously raised concerns about the increase in Australians purchasing melatonin products from online stores, particularly for use in children, and has included it on its priority list for compliance and enforcement activities the first three months of 2026 (PD 23 Jan).
Melatonin products approved in Australia include some scheduled as pharmacist-only medicines - up to 2mg modified release for short-term treatment of primary insomnia, or 5mg for treatment of jetlag - or prescription only.
Details on the tests are HERE. KB
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