'Significant discrepancies' found in imported melatonin products, medical regulator warns

Testing of unregulated melatonin revealed one product contained four times its labelled amount, while another did not have any at all.

The TGA warned the variations between the label and what was actually in the products posed serious safety risks. Source: AAP / Flavio Brancaleone

Melatonin sold by unregulated online suppliers contain up to four times their labelled amounts, prompting the medical regulator to issue a safety notice.

Testing by the Therapeutic Goods Administration (TGA) revealed "significant discrepancies" in the actual content of some unregistered melatonin products — commonly used as a sleep aid — compared to what was on the label.

The TGA warned the variations posed serious safety risks, including accidental overdose and hospitalisation, particularly among children.

Eight products contained higher amounts of melatonin than what was on their labels. Source: Supplied

Of the tested products, eight were found to have higher amounts of melatonin than their labelled amount, including one by more than 400 per cent.

Product	Variation from labelled amount
Spring Valley Melatonin 10mg	119 — 136 per cent
Natrol Melatonin 5mg gummies	140 — 170 per cent
CVS Health Melatonin 3mg	112 — 121 per cent
The Smurfs Kids Gummies Melatonin 1mg	155 — 170 per cent
Sleepose-3 Melatonin 3mg	209 — 417 per cent
Nutraceutical Sleepose-3 Melatonin 3mg	95 — 174 per cent
Vitafusion Sleep Well - Melatonin 3mg	106 — 124 per cent
Natrol Advanced Sleep Melatonin 10mg	112 — 123 per cent

Three products contained less than their labelled amount, including one which did not contain any melatonin at all.

Product	Variation from labelled amount
Life Extension Melatonin 300mcg	79 — 97 per cent
Sleepose-10 Melatonin 10mg	37 — 59 per cent
Live Natures Melatonin 10mg	No melatonin detected

Melatonin is a naturally occurring hormone that helps regulate the 'body clock'.

It can also be taken as a supplement to help with insomnia, but most products are prescription-only in Australia.

The TGA warned it was working with the Australian Border Force to seize and destroy unregistered products bought from overseas online suppliers.

"The TGA advises consumers to exercise extreme caution when considering purchasing medicines from overseas websites," the safety notice said.

"They may not meet Australian standards for safety, quality and effectiveness. These products may contain incorrect or undisclosed and harmful ingredients."

Earlier this month, the ABC reported Australian poisons hotlines received nearly 1,500 calls about children ingesting melatonin in 2024.

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