Legal status by country
Is Niacin legal?
Written by Aaron CuhaReviewed Sep 2026
How Niacin 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 | Not approved | Not approved | Not approved |
| Classification | FDA-approved prescription lipid drug, also sold over the counter as a supplement | Available as a supplement; the extended-release niacin plus laropiprant product was withdrawn | Available as a supplement; prescription lipid indication largely abandoned | Prescription extended-release product historically available; also sold as a supplement |
| Note | Guideline use for cardiovascular prevention has effectively ended following AIM-HIGH and HPS2-THRIVE. Supplement-dose nicotinic acid remains freely available. | Tredaptive, the niacin-laropiprant combination tested in HPS2-THRIVE, was withdrawn from the market after the trial. | Niacin-laropiprant was withdrawn. Nicotinic acid remains available as a listed complementary medicine. | Clinical use for cardiovascular prevention has substantially ended on the basis of the outcome trials. |
US FDA status: Extended-release nicotinic acid is an FDA-approved prescription lipid drug in the United States, though its clinical use collapsed after AIM-HIGH and HPS2-THRIVE. Lower-dose nicotinic acid is also sold over the counter as a supplement. The extended-release niacin with laropiprant combination used in HPS2-THRIVE was withdrawn worldwide after the trial reported.. 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.