US-sold kids melatonin supplements pose potential safety risk owing to mislabelling, study finds

Published: 21-Nov-2024
Research & Development Dietary supplements

More than 50% of the sleep-focused supplements assessed had incorrect dosage labelling, with one product containing 667% more melatonin than the label declared

A study conducted in part by FDA researchers has found that a vast number of melatonin supplements sold in the US do not meet their label claims in terms of dosage.1

Notably, more than 50% of the 110 supplements assessed incorrectly depicted the product’s dose of melatonin, with some containing up to 50mg. 

Currently, the Sleep Foundation recommends that infants and adolescents do not ingest more than 5mg of melatonin per day, meaning that these supplements could pose as a potential safety issue.2

70% of the products assessed in this study are marketed towards children, so researchers are calling for further investigation into the quality of supplements on the market, and how regulation should be approached in the future.


The current issues with melatonin supplements

Throughout the US, melatonin supplements are widely available, and there has been a significant uptick in children taking this type of sleep aid.

Poison control centres across the region have also seen an increase in reports of excessive melatonin ingestion.1

As melatonin is currently regulated as a dietary supplement by the FDA, these products do not have to undergo the stringent quality and safety checks that pharmaceuticals do, meaning products with inaccurate label claims can still be sold. 

With true dosages of melatonin varying between supplement brands, it can be difficult for parents and healthcare professionals to make informed decisions about melatonin usage in their children. 


Looking at melatonin-free solutions

Although the use of melatonin supplements has been proven to be effective in helping users sleep well, there are some side effects associated with its use, including daytime drowsiness, headaches, dizziness and nausea.3

As well as having the potential to trigger unwanted side effects, this study also suggests that many melatonin-based products available on the market contain an unpredictable dose of the sleep hormone.

Therefore, there is an opportunity for nutraceutical companies to develop a natural, clean-label alternative to melatonin supplements free of side effects.


 

  • Companies:
  • US Food and Drug Administration (FDA)
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