Legal status by country
Is Nattokinase legal?
How Nattokinase is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
| Country | Status | Classification | Note | Detail |
|---|---|---|---|---|
| United StatesFDA | Supplement or cosmetic | Sold as a dietary supplement; not an approved drug | 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 legal in the United States? |
| United KingdomMHRA | Supplement or cosmetic | Sold as a food supplement | The nattokinase preparation is authorised in GB as the novel food 'fermented soybean extract', for food supplements aimed at adults and excluding pregnant and lactating women, at up to 100 mg/day (Commission Implementing Regulation (EU) 2017/2470, retained in GB law); the label must state that people on medication should use it only under medical supervision. | Is Nattokinase legal in the United Kingdom? |
| AustraliaTGA | Supplement or cosmetic | Listed complementary medicine (AUST L) | Sold over the counter as a listed medicine on the Australian Register of Therapeutic Goods; listed medicines are not independently evaluated for efficacy before sale and may not carry claims of treating or preventing serious conditions such as heart attack or stroke. | Is Nattokinase legal in Australia? |
| CanadaHealth Canada | Not approved | Sold as a natural health product; requires a Health Canada product licence and NPN | 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 legal in Canada? |
US 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.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or 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.