Is Nattokinase legal in Australia?

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.

Registers or lists medicines and health products on the ARTG, its official register. It also sorts substances into schedules in the Poisons Standard. Many peptides are Schedule 4 (prescription only). So having them without a prescription, or importing them for yourself, is restricted. That is true even when no product is registered.

The legal category above is how The Longevity Archive reads Therapeutic Goods 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.

Check TGA directly

Whether Nattokinase is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in Australia. 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.