Is Niacin legal?
Written by Aaron CuhaReviewed Sep 2026
- US: FDA-approved prescription cholesterol drug, also sold over the counter as a supplement
- UK: Available as a supplement; the slow-release niacin plus laropiprant product was withdrawn
- AU: Available as a supplement; prescription cholesterol use largely abandoned
- CA: Prescription slow-release product was once available; also sold as a supplement
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Not approved | Not approved | Not approved |
| Legal category | FDA-approved prescription cholesterol drug, also sold over the counter as a supplement | Available as a supplement; the slow-release niacin plus laropiprant product was withdrawn | Available as a supplement; prescription cholesterol use largely abandoned | Prescription slow-release product was once available; also sold as a supplement |
| Note | Guidelines no longer advise it to prevent heart disease, after AIM-HIGH and HPS2-THRIVE. Supplement doses of nicotinic acid are still freely sold. | Tredaptive, the niacin and laropiprant mix tested in HPS2-THRIVE, was pulled from sale after the study. | The niacin and laropiprant mix was pulled from sale. Nicotinic acid is still sold as a listed complementary medicine. | Doctors have largely stopped using it to prevent heart disease, because of the large studies that counted heart attacks and deaths. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Slow-release nicotinic acid is an FDA-approved prescription cholesterol drug in the United States. But doctors mostly stopped using it after two large studies, AIM-HIGH and HPS2-THRIVE. Lower-dose nicotinic acid is also sold over the counter as a supplement. The mix of slow-release niacin and laropiprant tested in HPS2-THRIVE was pulled from sale worldwide after that study reported.. Reviewed Sep 2026.
Country by country
Is Niacin legal in the United States?
Yes. Niacin is an approved medicine in the United States. Its legal category is "FDA-approved prescription cholesterol drug, also sold over the counter as a supplement". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full United States answerIs Niacin legal in the United Kingdom?
Niacin can be sold in the United Kingdom as a supplement or cosmetic ingredient. Its legal category is "Available as a supplement; the slow-release niacin plus laropiprant product was withdrawn". That is not approval as a drug. MHRA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full United Kingdom answerIs Niacin legal in Australia?
Niacin can be sold in Australia as a supplement or cosmetic ingredient. Its legal category is "Available as a supplement; prescription cholesterol use largely abandoned". That is not approval as a drug. TGA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full Australia answerIs Niacin legal in Canada?
No. Niacin is not an approved medicine in Canada. Its legal category is "Prescription slow-release product was once available; also sold as a supplement". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full Canada answerNiacin in sport and the military
Whether Niacin is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up Niacin by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.