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Is Melatonin legal?

Written by Reviewed Sep 2026

LongevityNo human studies cited
  • US: Sold as a supplement
  • UK: Sold as a supplement
  • AU: Available as a supplement / complementary medicine
  • CA: Sold as a supplement

US first because that is the default query. Each country has its own page with the regulator, the instrument and what the classification means in practice.

All four countries, side by side

AttributeUnited States · FDAUnited Kingdom · MHRAAustralia · TGACanada · Health Canada
StatusNot approvedNot approvedNot approvedNot approved
ClassificationSold as a supplementSold as a supplementAvailable as a supplement / complementary medicineSold as a supplement
NoteNone recordedNone recordedNone recordedNone recorded

US FDA status: Sold as a dietary supplement in the United States. Not approved as a hypnotic drug. Prescription melatonin-receptor agonists are separate medicines.. Reviewed Sep 2026.

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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. The Longevity Archive has no vendor relationships.