Legal status by country
Is Osteocalcin legal?
Written by Aaron CuhaReviewed Sep 2026
How Osteocalcin 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 | Not a medicine; endogenous signalling molecule | Not a medicine; endogenous signalling molecule | Not a medicine; endogenous signalling molecule | Not a medicine; endogenous signalling molecule |
| Note | Measured as a bone formation marker in clinical laboratories. No approved drug is an osteocalcin agonist, and no osteocalcin preparation has been administered to a human in a registered trial. | Laboratory analyte, not a medicine. | Laboratory analyte, not a medicine. | Laboratory analyte, not a medicine. |
US FDA status: Not a drug. Osteocalcin is an endogenous protein measured as a bone turnover marker in clinical laboratories. No osteocalcin product is approved anywhere and none has been given to a human in a trial.. 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.