Table 2.

Regulations of Melatonin per Country

Country	Regulations	Prescription/Non-prescription (Melatonin)	Comments
United States	Considers all supplements safe until proven unsafe. Not regulated prior to market availability.	Non-prescription dietary supplement	FDA not required to test new ingredients/supplements in clinical trials.
Canada	Medications fall under the Food and Drug Regulations issued by the Canadian Government25	Non-prescription health product	Must contain Natural Product Number.
European Union	Medications are regulated through the European Regulatory Network, which consists of 50 regulatory authorities from across Europe26	Prescription for sustained release; less than 2 mg immediate release has variable status based on country	European Medicines Agency has set specific guidelines for use. Some countries, such as Poland, consider melatonin non-prescription
Non-European Union Countries in Europe (Norway)	Medications are regulated by the Norwegian Medicines Agency27	Prescription27
United Kingdom	Follows the European Union Guidelines	Prescription
Taiwan	Medications are regulated under the Pharmaceutical Affairs Act	Controlled-substance