Legal status · United States
Is Nattokinase legal in the United States?
Nattokinase can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a dietary supplement; not an approved drug". That is not drug approval: FDA has not evaluated any health claim, and injectable or "research use only" versions fall outside supplement rules, so that label does not make human use lawful. Human evidence: Preliminary.
Nattokinase in the United States at a glance
| Classification | Sold as a dietary supplement; not an approved drug |
|---|---|
| Note | DSHEA permits structure/function claims with a disclaimer but not disease claims; FDA has enforced that line against nattokinase marketing specifically (2020 warning letter for plaque-reduction and heart attack/stroke prevention claims). |
| FDA approval status | 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 (research strength: Moderate) |
| Reviewed | Sep 2026 |
Classification and note come from the Nattokinase profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Nattokinase can be sold in the United States as a supplement, food or cosmetic ingredient under the classification above, without drug approval.
- 02
Supplement status means FDA has not evaluated any health claim; manufacturers are responsible for safety and labeling, and quality varies by product.
- 03
Injectable or "research use only" versions are not supplements. That label does not make human use lawful, and injectables fall under medicines rules.
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 FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration 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 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?Canada
Not approvedSold as a natural health product; requires a Health Canada product licence and NPN
Is Nattokinase legal in Canada?Frequently asked questions
Is Nattokinase legal in the United States?
Nattokinase can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a dietary supplement; not an approved drug". That is not drug approval: FDA has not evaluated any health claim, and injectable or "research use only" versions fall outside supplement rules, so that label does not make human use lawful. Human evidence: Preliminary. Note: DSHEA permits structure/function claims with a disclaimer but not disease claims; FDA has enforced that line against nattokinase marketing specifically (2020 warning letter for plaque-reduction and heart attack/stroke prevention claims).
Can I buy Nattokinase in the United States?
Yes, in supplement or cosmetic form. In the United States Nattokinase is classified as "Sold as a dietary supplement; not an approved drug", so oral, topical or cosmetic products can be sold under supplement rules. Injectable versions and products labeled "research use only" are not supplements and are not approved for human use. Note: DSHEA permits structure/function claims with a disclaimer but not disease claims; FDA has enforced that line against nattokinase marketing specifically (2020 warning letter for plaque-reduction and heart attack/stroke prevention claims).
Is Nattokinase FDA approved?
No. FDA status: 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.. Current US classification: "Sold as a dietary supplement; not an approved drug". Evidence level: Preliminary.
Related compounds in the United States
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 the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration 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.