Eight out of 18 inspected had considerably greater quantities of melatonin, whereas three had considerably lower than the quantity labeled.
Most of those melatonin merchandise got here from US manufacturers. One product contained no melatonin in any of the ten items examined, when the label said an quantity of 10mg.
The 18 imported merchandise have been intercepted on the Australian border between January and September this 12 months on suspicion that they have been substandard or falsified.
The TGA examined these merchandise by measuring the precise common content material of melatonin as in comparison with the labeled quantity, and the variation within the content material throughout particular person dosage items.
Out of the 18 samples examined, solely 5 have been discovered to have a suitable common content material – the place the melatonin ranges have been between 90% to 110% of the labeled quantity.
These merchandise have been Life Extension Melatonin 300 mcg Vegetarian Capsules, Sanofi Novanuit Triple Motion 1mg Melatonin + Plant extracts Tablets, MZS Melatonin Tablets, Metorip-20 Melatonin Mouth Dissolving Tablets 20 mg, and CURE-STRESS Melatonin 10 mg Softgel Capsules.
They have been discovered to include melatonin which was 89.1%, 85.1%, 97.1%, 95.3%, and 102.4% of the labeled quantity respectively.
Three merchandise have been discovered to include considerably decrease quantity of melatonin as in comparison with the labeled quantity.
Apart from the product the place no melatonin was detected, the opposite two had quantities that have been between 37% to 59% decrease and between 79% to 97% decrease than the labeled quantity.
Alternatively, some merchandise had quantities considerably greater than labeled.
One in every of them had melatonin content material that was between 209% to 417% greater than labeled and contained the best discrepancy.
Among the others additionally had quantities that have been between 155% and 170% and 140% and 170% greater than the labeled quantity.
Relative commonplace deviation
The TGA additionally examined the relative commonplace deviation (RSV) of the identical product in 10 particular person items.
A decrease %RSD signifies a decrease quantity of variation within the content material of the lively ingredient throughout the person dosage items, whereas a better %RSD signifies a broader unfold within the content material.
Out of the 18 merchandise examined, six had variation within the content material of melatonin (%RSD) of greater than 6.0% – which falls exterior of the appropriate restrict.
The biggest variations got here from three merchandise of the identical model, the place the %RSD was 33.2%, 24,3%, and 22.9%.
Security issues
The TGA has since issued a security advisory concerning imported unregistered melatonin merchandise, and highlighted of threat of taking such merchandise particularly amongst youngsters.
“The outcomes point out important discrepancies within the precise melatonin content material in comparison with the labelled quantities. One product contained greater than 400% of the labelled content material and one other containing no melatonin in any respect.
“This variability in melatonin content material raises critical security issues for customers, together with the chance of hospitalization and unintentional overdose, particularly in youngsters,” the regulator stated within the security advisory.
In Australia, melatonin merchandise are categorised as pharmacist-only medicines or prescription-only medicines.
