Melatonin, the hormone that regulates sleep, helps with issues like insomnia or jet lag. Supplements provide a natural boost to your sleep cycle and have long been available over-the-counter—but recent regulatory threats nearly changed that.
Regulatory Ruling Overturned
The Health Care Inspectorate (IGZ) proposed classifying melatonin products from 0.3 mg as medicines, requiring prescriptions for higher doses. The Netherlands Association of Natural and Health Products challenged this and won the legal battle.
Higher-Dose Melatonin Stays Freely Available
As a result, higher-dose supplements remain over-the-counter in the Netherlands. Packaging can still include information on their sleep benefits, permitted up to 0.5 mg doses.
Protecting Supplement Status
This victory benefits users relying on melatonin for stress or sleep issues. More broadly, it addresses whether supplements can be reclassified as medicines based solely on dosage, as noted by the director of the Netherlands Association of Natural and Health Products.
