Is Nicotinamide legal?
Written by Aaron CuhaReviewed Sep 2026
- US: Sold as a supplement
- UK: Sold as a supplement
- AU: Available as a supplement / complementary medicine
- CA: 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 | Not approved | Not approved | Not approved | Not approved |
| Legal category | Sold as a supplement | Sold as a supplement | Available as a supplement / complementary medicine | Sold as a supplement |
| Note | Sold over the counter as niacinamide. Not approved as a drug to prevent skin cancer, despite the result of the final-stage study. | Sold as a supplement and used as a cosmetic ingredient. Not licensed to prevent cancer. | Widely used off label to help prevent skin cancer since ONTRAC, which was run in Australia. That is not a registered use. | Sold as a supplement with a Natural Product Number. Not approved to prevent cancer. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Not an approved drug for preventing skin cancer in the United States. It is a standard form of the vitamin niacin. It is sold over the counter and found in multivitamins and skin care products. The dose used in the ONTRAC study is an over-the-counter dose, used off label, meaning outside any approved use.. Reviewed Sep 2026.
Country by country
Is Nicotinamide legal in the United States?
Nicotinamide can be sold in the United States as a supplement or cosmetic ingredient. Its legal category is "Sold as a supplement". That is not approval as a drug. FDA 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, 4 completed human trials are cited on its profile.
The full United States answerIs Nicotinamide legal in the United Kingdom?
Nicotinamide can be sold in the United Kingdom as a supplement or cosmetic ingredient. Its legal category is "Sold as a supplement". 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, 4 completed human trials are cited on its profile.
The full United Kingdom answerIs Nicotinamide legal in Australia?
Nicotinamide can be sold in Australia as a supplement or cosmetic ingredient. Its legal category is "Available as a supplement / complementary medicine". 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, 4 completed human trials are cited on its profile.
The full Australia answerIs Nicotinamide legal in Canada?
Nicotinamide can be sold in Canada as a supplement or cosmetic ingredient. Its legal category is "Sold as a supplement". That is not approval as a drug. Health Canada 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, 4 completed human trials are cited on its profile.
The full Canada answerNicotinamide in sport and the military
Whether Nicotinamide 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 Nicotinamide 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.