Market Updates

CRN Updates Clinical Safety Guidance on Vitamin K2   

The full evaluation, relying on over 40 human clinical trials, presents a strong safety profile and establishes a new highest observed limit (HOI) for supplemental vitamin K2 as MK-7.

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By: Mike Montemarano

Associate Editor, Nutraceuticals World

Photo: Kongkairt | Adobe Stock

The Council for Responsible Nutrition (CRN)’s CRN Foundation announced the release of an updated vitamin K2 (menaquinone-7, or MK-7) chapter as part of its Vitamin & Mineral Safety, 4th Edition (VMS4).

The safety evaluation establishes a Highest Observed Intake level of 375 µg/day for adults, offering new scientific guidance for manufacturers, regulators, and health practitioners.

Previous editions of CRN’s VMS derived a single upper limit value for all vitamin K, including K1 and K2 ingredients. In response to growing consumer interest in and use of vitamin K2, CRN conducted a new assessment, specifically for vitamin K2 as MK-7, which is widely recognized for its role in supporting bone and cardiovascular health.

The new chapter reviews more than 40 human clinical trials conducted over the last decade, evaluating doses ranging from 59 to 462 µg/day for periods of up to two years.

Across these trials, no serious adverse events were reported, and research consistently demonstrated no clinically meaningful impact on coagulation parameters in individuals not taking vitamin K antagonist medications such as warfarin.

CRN identified 375 µg/day as the HOI for supplemental MK-7 in adults. This HOI doesn’t apply to people using vitamin K antagonist anticoagulants, who are advised to consult their healthcare providers before using vitamin K-containing supplements.

“CRN’s updated MK-7 chapter reflects our commitment to providing rigorous, transparent safety evaluations grounded in the totality of evidence,” said Andrea Wong, senior vice president, scientific and regulatory affairs at CRN. “Establishing a HOI for vitamin K2  represents a major step forward for scientific understanding and responsible product development across the dietary supplement category.”

The MK-7 update is part of a broader rollout of updated nutrient safety assessments in VMS4, which incorporates modern methodology, new human clinical evidence, and new global regulatory perspectives. VMS4 is funded through a grant from the CRN Foundation, which supports information and education about the beneficial, safe, and responsible use of dietary supplements and their ingredients.

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