Is Nattokinase legal?
Written by Aaron CuhaReviewed Sep 2026
- US: Sold as a dietary supplement; not an approved drug
- UK: Sold as a food supplement
- AU: Listed complementary medicine (AUST L)
- CA: Sold as a natural health product; needs a Health Canada product licence and a product number (NPN)
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 dietary supplement; not an approved drug | Sold as a food supplement | Listed complementary medicine (AUST L) | Sold as a natural health product; needs a Health Canada product licence and a product number (NPN) |
| Note | The US supplement law allows claims about how a product supports the body, with a disclaimer, but not claims about disease. The FDA has enforced that line against nattokinase sellers directly: a 2020 warning letter over claims that it cuts plaque and helps prevent heart attack and stroke. | In Great Britain, nattokinase is allowed as the 'novel food' called 'fermented soybean extract'. It can go in supplements for adults, but not for women who are pregnant or breastfeeding, at up to 100 mg a day (Commission Implementing Regulation (EU) 2017/2470, kept in GB law). The label must say that people on medicines should use it only under a doctor's supervision. | Sold over the counter as a listed medicine on the Australian Register of Therapeutic Goods. Nobody independently checks whether listed medicines work before they go on sale. They may not claim to treat or prevent serious conditions such as heart attack or stroke. | Listed as a Schedule 1 isolate under the Natural Health Products Regulations. Licensed labels must warn people not to use it if they take products that affect blood clotting, have a bleeding disorder, or are pregnant or breastfeeding. Labels must also tell people to stop it 7 days before any planned surgery. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Sold as a dietary supplement under the US supplement law. It is not an approved drug, and the FDA has never checked it for safety or whether it works. A label may say how it supports the body, such as supporting healthy blood flow, if it carries the required disclaimer that the FDA has not checked the statement. It may not claim to treat, prevent, or lower the risk of a disease. In August 2020, the FDA sent a warning letter to a supplement seller. The seller had marketed a product with nattokinase in it as able to cut plaque build-up in the arteries and help prevent a heart attack or stroke. The FDA said those were illegal disease claims, no matter what the research showed.. Reviewed Sep 2026.
Country by country
Is Nattokinase legal in the United States?
Nattokinase can be sold in the United States as a supplement or cosmetic ingredient. Its legal category is "Sold as a dietary supplement; not an approved drug". 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, 9 completed human trials are cited on its profile.
The full United States answerIs Nattokinase legal in the United Kingdom?
Nattokinase can be sold in the United Kingdom as a supplement or cosmetic ingredient. Its legal category is "Sold as a food 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, 9 completed human trials are cited on its profile.
The full United Kingdom answerIs Nattokinase legal in Australia?
Nattokinase can be sold in Australia as a supplement or cosmetic ingredient. Its legal category is "Listed complementary medicine (AUST L)". 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, 9 completed human trials are cited on its profile.
The full Australia answerIs Nattokinase legal in Canada?
No. Nattokinase is not an approved medicine in Canada. Its legal category is "Sold as a natural health product; needs a Health Canada product licence and a product number (NPN)". 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, 9 completed human trials are cited on its profile.
The full Canada answerNattokinase in sport and the military
Whether Nattokinase 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 Nattokinase 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.