Legal status by country
Is Nicotinamide legal?
Written by Aaron CuhaReviewed Sep 2026
How Nicotinamide 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 niacinamide. Not approved as a drug for skin-cancer chemoprevention despite the phase 3 result. | Sold as a supplement and used as a cosmetic ingredient. No licensed chemoprevention indication. | Widely used off-label for skin-cancer chemoprevention following ONTRAC, which was run in Australia. Not a registered indication. | Sold as a supplement under a Natural Product Number. No approved chemoprevention indication. |
US FDA status: Not an approved drug for skin cancer prevention in the United States. It is a recognised form of the vitamin niacin, sold over the counter, and included in multivitamins and topical cosmetics. The ONTRAC dose is an over-the-counter dose used off-label.. 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.