Legal status · Canada
Is Nattokinase legal in Canada?
No. Nattokinase is not an approved medicine in Canada; its classification is "Sold as a natural health product; requires a Health Canada product licence and NPN". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. Human evidence: Preliminary.
Nattokinase in Canada at a glance
| Classification | Sold as a natural health product; requires a Health Canada product licence and NPN |
|---|---|
| Note | Classified as a Schedule 1 isolate under the Natural Health Products Regulations; licensed labels carry a mandatory caution against use by anyone taking health products that affect blood coagulation or with a bleeding disorder, against use in pregnancy or breastfeeding, and an instruction to stop the product 7 days before any scheduled surgery. |
| Health Canada approval status | Not approved by Health Canada |
| Evidence level | Preliminary (research strength: Moderate) |
| Reviewed | Sep 2026 |
Classification and note come from the Nattokinase profile, checked against Health Canada, Health Products and Food Branch (Health Canada) listings at the reviewed date.
What this means
- 01
No product containing Nattokinase is approved by Health Canada for any use in Canada, so nothing on the market is authorized for people.
- 02
"Research use only" is a vendor label, not a legal category that permits human use. It does not exempt a product from medicines law.
- 03
Importing, supplying or promoting it for human use can fall under medicines legislation in Canada. This page is general information, not legal advice.
What Nattokinase is
A fibrinolytic enzyme from Bacillus subtilis natto fermentation with a genuinely large human trial record for a supplement, including randomized blood pressure trials and a 3 year placebo-controlled outcome study, but no hard cardiovascular endpoint trial and a carotid-plaque result that is widely cited despite not being placebo-controlled.
Nattokinase is a 275 amino acid serine protease of the subtilisin family, produced when the bacterium Bacillus subtilis var. natto ferments boiled soybeans into natto, a food eaten in Japan for centuries.
Mechanism: Nattokinase acts through several routes rather than one. It directly hydrolyzes fibrin and fibrinogen; it converts endogenous prourokinase to active urokinase; it degrades plasminogen activator inhibitor-1 (PAI-1), the protein that normally restrains the body's own clot-dissolving system; and cell-culture work found that heat-inactivated Bacillus subtilis natto culture and marketed nattokinase both stimulate tissue plasminogen activator (tPA) release from human vascular endothelial cells and HeLa cells, raising tPA activity several-fold over control.
Regulatory history: Sold as a dietary supplement under DSHEA; not an approved drug and never evaluated by FDA for safety or effectiveness. A label may carry a structure/function claim, such as supporting healthy circulation, if it carries the required disclaimer that FDA has not evaluated the statement, but it may not claim to treat, prevent, or reduce the risk of a disease. In August 2020, FDA sent a warning letter to a supplement seller for marketing a nattokinase-containing product as able to decrease arterial plaque buildup and help prevent a heart attack or stroke, concluding those were illegal disease claims regardless of the underlying data.
How Health Canada treats this kind of product
Authorises drugs for sale through a Notice of Compliance and Drug Identification Number. A compound that is not authorised for sale cannot lawfully be sold for human use, and personal importation of prescription drugs is limited.
The classification above is the The Longevity Archive reading of Health Canada, Health Products and Food Branch listings for Nattokinase at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
Nattokinase in other countries
United States
Supplement or cosmeticSold as a dietary supplement; not an approved drug
Is Nattokinase legal in the United States?United Kingdom
Supplement or cosmeticSold as a food supplement
Is Nattokinase legal in the United Kingdom?Australia
Supplement or cosmeticListed complementary medicine (AUST L)
Is Nattokinase legal in Australia?Frequently asked questions
Is Nattokinase legal in Canada?
No. Nattokinase is not an approved medicine in Canada; its classification is "Sold as a natural health product; requires a Health Canada product licence and NPN". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. Human evidence: Preliminary. Note: Classified as a Schedule 1 isolate under the Natural Health Products Regulations; licensed labels carry a mandatory caution against use by anyone taking health products that affect blood coagulation or with a bleeding disorder, against use in pregnancy or breastfeeding, and an instruction to stop the product 7 days before any scheduled surgery.
Can I buy Nattokinase in Canada?
No approved product exists to buy. In Canada Nattokinase is classified as "Sold as a natural health product; requires a Health Canada product licence and NPN", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors. Note: Classified as a Schedule 1 isolate under the Natural Health Products Regulations; licensed labels carry a mandatory caution against use by anyone taking health products that affect blood coagulation or with a bleeding disorder, against use in pregnancy or breastfeeding, and an instruction to stop the product 7 days before any scheduled surgery.
Is Nattokinase Health Canada approved?
No. In Canada Nattokinase is classified as "Sold as a natural health product; requires a Health Canada product licence and NPN", which is not a Health Canada marketing approval. For comparison, the US FDA status is: Sold as a dietary supplement under DSHEA; not an approved drug and never evaluated by FDA for safety or effectiveness. A label may carry a structure/function claim, such as supporting healthy circulation, if it carries the required disclaimer that FDA has not evaluated the statement, but it may not claim to treat, prevent, or reduce the risk of a disease. In August 2020, FDA sent a warning letter to a supplement seller for marketing a nattokinase-containing product as able to decrease arterial plaque buildup and help prevent a heart attack or stroke, concluding those were illegal disease claims regardless of the underlying data.. Evidence level: Preliminary.
Related compounds in Canada
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Nattokinase live on its compound profile.
Nattokinase profileThis page is general information about the regulatory status of Nattokinase in Canada, current as of Sep 2026. It is not legal advice, and classifications change; check Health Canada, Health Products and Food Branch directly or consult 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 and does not recommend where to buy anything.