Legal status by country
Is Betaine legal?
Written by Aaron CuhaReviewed Sep 2026
How Betaine 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 over the counter as TMG. Betaine anhydrous is separately FDA-approved as a prescription medicine for homocystinuria, which is an inherited metabolic disease and not the reason most buyers take it. | Sold as a food supplement; a licensed betaine anhydrous medicine exists for homocystinuria. | Available as a complementary medicine; the prescription indication is homocystinuria. | None recorded |
US FDA status: Betaine anhydrous is FDA-approved as a prescription medicine for the treatment of homocystinuria. The same molecule is separately sold over the counter as a dietary supplement, usually labelled trimethylglycine or TMG, with no approved 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.