Legal status by country
Is Dimethyl fumarate legal?
Written by Aaron CuhaReviewed Sep 2026
How Dimethyl fumarate 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 | Approved | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Approved for relapsing multiple sclerosis. Requires lymphocyte monitoring because of progressive multifocal leukoencephalopathy risk with prolonged lymphopenia. No ageing indication. | None recorded | None recorded | None recorded |
US FDA status: FDA-approved as Tecfidera for relapsing forms of multiple sclerosis. Not approved for any ageing indication.. 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.