Legal status by country
Is Urolithin B legal?
Written by Aaron CuhaReviewed Sep 2026
How Urolithin B 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 | Sold as a supplement ingredient and as a research chemical. The established mitophagy product on the market, Mitopure, is urolithin A, a different molecule with different human evidence. | Sold as a food supplement ingredient. | Available in complementary medicine products. | Sold as a natural health product ingredient. |
US FDA status: Not an approved drug. Sold as a supplement ingredient and as a research chemical. No registered human trial has administered it.. 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.