Legal status · United States
Is Vitamin K2 legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Vitamin K2 can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a supplement". 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. On the evidence, 2 human studies are cited on its profile.
- People given it
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Classification
Sold as a supplement
Incompatible with vitamin-K antagonist anticoagulation unless a clinician says otherwise.
Reviewed Sep 2026. This is a classification, not legal advice.
A research-use-only label on a vial does not make human use lawful.
Vitamin K2 in the United States at a glance
| Classification | Sold as a supplement |
|---|---|
| Note | Incompatible with vitamin-K antagonist anticoagulation unless a clinician says otherwise. |
| FDA approval status | Sold as a dietary supplement in the United States. Not approved to prevent heart disease or fractures. Warfarin remains a prescription anticoagulant that K2 can disturb. |
| Human studies cited | 2 of 2 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Vitamin K2 profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Vitamin K2 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 Vitamin K2 is
The K2 half of the owner's D3 plus K2 floor pairing. Observational menaquinone intake tracked with less coronary heart disease in Rotterdam. A three-year MK-7 trial reported less bone loss in healthy postmenopausal women. Warfarin is a hard stop.
Vitamin K2 is a family of menaquinones, most often sold as MK-7. The owner takes it beside vitamin D3.
Mechanism: Vitamin K is a cofactor for gamma-carboxylation of vitamin-K-dependent proteins, including clotting factors and osteocalcin. MK-7 is a long-chain menaquinone with a longer circulating half-life than MK-4.
Regulatory history: Sold as a dietary supplement in the United States. Not approved to prevent heart disease or fractures. Warfarin remains a prescription anticoagulant that K2 can disturb.
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 Vitamin K2 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.
Vitamin K2 in other countries
Frequently asked questions
Is Vitamin K2 legal in the United States?
Vitamin K2 can be sold in the United States as a supplement or cosmetic ingredient, classified as "Sold as a supplement". 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. On the evidence, 2 human studies are cited on its profile. Note: Incompatible with vitamin-K antagonist anticoagulation unless a clinician says otherwise.
Can I buy Vitamin K2 in the United States?
Yes, in supplement or cosmetic form. In the United States Vitamin K2 is classified as "Sold as a supplement", 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: Incompatible with vitamin-K antagonist anticoagulation unless a clinician says otherwise.
Is Vitamin K2 FDA approved?
No. FDA status: Sold as a dietary supplement in the United States. Not approved to prevent heart disease or fractures. Warfarin remains a prescription anticoagulant that K2 can disturb.. Current US classification: "Sold as a supplement". On the evidence, 2 human studies are cited on its profile.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Vitamin K2 live on its compound profile.
Vitamin K2 profileThis page is general information about the regulatory status of Vitamin K2 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 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. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.