Legal status by country
Is Low-dose lithium legal?
Written by Aaron CuhaReviewed Sep 2026
How Low-dose lithium is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Classification | Sold as a supplement | Sold as a supplement | Available as a supplement / complementary medicine | Sold as a supplement |
| Note | Lithium orotate is sold over the counter as a supplement with no approved indication. Lithium carbonate is separately a prescription medicine for bipolar disorder requiring serum level monitoring, and the randomised cognition trials used that prescription form at 150 to 600 mg. | Prescription lithium salts are licensed for bipolar disorder; low-dose orotate products sold as supplements carry no licensed indication. | Prescription lithium is registered for bipolar disorder; trace-dose supplement forms are not registered medicines. | None recorded |
US FDA status: Lithium carbonate and lithium citrate are FDA-approved prescription medicines for bipolar disorder, with mandatory serum level monitoring. Lithium orotate is sold as a dietary supplement and has no approved indication and no monitoring requirement.. 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. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.