Legal status · United States
Is Nattokinase legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
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.
- People given it
- 1,795
- Found nothing
- 3
Legal category
Sold as a dietary supplement; not an approved drug
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.
Reviewed Sep 2026. This is a legal category, not legal advice.
A "research use only" label on a vial does not make it legal to use on people.
Nattokinase in the United States at a glance
| Legal category | Sold as a dietary supplement; not an approved drug |
|---|---|
| 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. |
| FDA approval 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. |
| Studies in people | 13 of 22 sources on the profile |
| Reviewed | Sep 2026 |
The legal category and note come from the Nattokinase profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.
What this means
- 01
Nattokinase can be sold in the United States as a supplement, food or cosmetic ingredient, under the legal category above. It has no approval as a drug.
- 02
Being sold as a supplement means FDA has not checked any health claim. The makers are responsible for safety and labels, and quality varies from product to product.
- 03
Versions you inject, and "research use only" versions, are not supplements. That label does not make them legal to use in people, and anything you inject falls under the rules for medicines.
What Nattokinase is
Nattokinase is a clot-busting enzyme made when bacteria ferment soybeans into natto, a Japanese food. For a supplement, it has a big human trial record. That includes blood pressure trials against a dummy pill and a 3 year trial with one. There is no trial of heart attacks or strokes. And its famous plaque result did not use a dummy pill for comparison.
Nattokinase is a 275 building block enzyme. It is made when the bacterium Bacillus subtilis natto ferments boiled soybeans into natto, a food eaten in Japan for centuries.
How it works: Nattokinase works in several ways at once. It breaks down fibrin, the mesh that holds clots together, and fibrinogen, the protein fibrin is made from.
Approval history: 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.
How FDA treats this kind of product
Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.
The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Nattokinase on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.
Nattokinase 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 in the United States. 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.
Nattokinase in other countries
United Kingdom
Not approvedSold as a food supplement
Is Nattokinase legal in the United Kingdom?Australia
Not approvedListed complementary medicine (AUST L)
Is Nattokinase legal in Australia?Canada
Not approvedSold as a natural health product; needs a Health Canada product licence and a product number (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. 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. 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.
Can I buy Nattokinase in the United States?
Yes, as a supplement or cosmetic. In the United States, Nattokinase has the legal category "Sold as a dietary supplement; not an approved drug". So products you swallow, put on your skin or use as a cosmetic can be sold under supplement rules. Versions you inject, and products labeled "research use only", are not supplements. They are not approved for use in people. 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.
Is Nattokinase FDA approved?
No. 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.. Current US legal category: "Sold as a dietary supplement; not an approved drug". On the evidence, 9 completed human trials are cited on its profile.
Related compounds in the United States
Full research profile
How Nattokinase works, the studies we cite, FDA status and the full legal summary are all on its compound profile.
Nattokinase profileThis page is general information about the legal status of Nattokinase in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask 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.