(W1030-11-60) Canada and the World: A Comparative Global Regulatory and Quality Variability Study of Melatonin Health Products

Purpose: This study aims to analyze and compare the regulatory requirements for melatonin products across different countries and explore how these differences affect market access and product quality. Melatonin is widely used to treat insomnia, adjust sleep cycles, and other sleep disorders, with varying regulatory frameworks classifying it as a dietary supplement, Natural Health Product (NHP), Over-The-Counter (OTC) drug, or prescription medication.

Methods: We investigated the regulatory policies of the United States, Canada, Europe, Japan, and China regarding melatonin products, including indications, target populations, dosage forms, and recommended dosages. Random samples of commercially available melatonin products were selected, and content and dissolution analyses were conducted using methods described in the United States Pharmacopeia (USP) for tablets, with necessary adjustments made for other dosage forms to ensure analytical accuracy.

Results: The study revealed that melatonin is primarily marketed as a prescription drug in Japan and Europe, as a dietary supplement in the United States and China, and as an NHP in Canada. Although the recommended dosage generally ranges from 1-10mg, there are significant differences in the defined indications and target user groups. Product testing showed that some products exceeded the melatonin content indicated on their packaging, while others had dissolution rates below the required standards.

Conclusion: Regulatory strategies for melatonin vary by country, but there is a general caution regarding its use in children. Japan is the only country that has approved melatonin for treating children with Delayed Sleep Phase Disorder after clinical trials. In terms of product quality, instances of melatonin content exceeding the specified levels are more common than instances of under-content, and products not meeting dissolution standards pose a potential risk of ineffectiveness.