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The Council for Responsible Nutrition establishes first-ever standalone safety guidance for vitamin K2 (MK-7) supplements, responding to rapidly expanding consumer demand for bone and cardiovascular health support.
The Council for Responsible Nutrition establishes first-ever standalone safety guidance for vitamin K2 (MK-7) supplements, responding to rapidly expanding consumer demand for bone and cardiovascular health support.
CRN Publishes Dedicated Safety Assessment for Vitamin K2 MK-7
The Council for Responsible Nutrition Foundation (CRN) has released updated safety guidance establishing a Highest Observed Intake (HOI) level of 375 µg/day for vitamin K2 in the form of menaquinone-7 (MK-7) for adults. This marks a significant shift from previous editions of CRN’s Vitamin & Mineral Safety guidelines, which combined vitamin K1 and vitamin K2 into a single Upper Limit value.
The decision to provide separate assessment reflects the rapidly expanding global consumer interest in vitamin K2 supplements, driven by scientific evidence supporting MK-7’s role in bone and cardiovascular health. “CRN’s updated MK-7 chapter reflects our commitment to providing rigorous, transparent safety evaluations grounded in the totality of evidence,” explains Andrea Wong, senior vice president of scientific and regulatory affairs at CRN. “Establishing a HOI for vitamin K2 (MK-7) represents a major step forward for scientific understanding and responsible product development across the dietary supplement category.”
The updated vitamin K2 guidance appears in the 4th edition of CRN’s Vitamin & Mineral Safety (VMS4), incorporating modern methodology, expanded human clinical evidence, and new global regulatory perspectives.
What Does “No Adverse Effects Observed” Mean for Supplement Manufacturers?
There is no established Tolerable Upper Intake Level (UL) for vitamin K (K1 or K2) by major bodies like EFSA (European Food Safety Authority) or the US NIH (National Institutes of Health) because no adverse effects or toxicity have been reported from high intakes in humans from food or supplements. Therefore, when a UL cannot be identified, the Highest Observed Intake (HOI) may be used as an alternative risk-assessment method.
The new guidance summarizes reviews of more than 40 human clinical trials conducted over the past decade, evaluating a wide range of vitamin K2 doses for periods up to two years. Among these trials, researchers observed no serious adverse effects related to MK-7 supplementation. Studies also consistently demonstrated no clinically meaningful impact on coagulation parameters in individuals not taking vitamin K-antagonist medications, commonly known as blood thinners such as warfarin.
Based on these findings, CRN established 375 µg/day as the HOI for supplemental MK-7 in adults. This guidance does not apply to individuals using VKA anticoagulants, who should consult their healthcare providers before using vitamin K-containing supplements.
Beyond Bone and Heart: Emerging Research Areas for Vitamin K2
While vitamin K2 is recognized for supporting bone density and cardiovascular wellness, scientific studies are highlighting additional potential benefitsResearch indicates that vitamin K2 may support metabolic health, help mitigate complications associated with impaired kidney function, and help address women’s health concerns during menopause, with emerging evidence also pointing to a role in brain health.
For manufacturers working with clinically studied vitamin K2 ingredients such as MenaQ7®, this comprehensive safety data provides evidence-based support for product development decisions. Dr. Katarzyna Maresz, coordinator of the Gnosis Vitamin K2 Scientific Advisory Committee, has noted that nearly two decades of clinical research support the safety of MenaQ7® in children and adults, including both healthy populations and individuals with underlying health conditions. She added that ongoing research—such as the VIKIPEDIA study, which is evaluating intakes up to 1,000 µg/day—may justify future upward revisions of the HOI as additional data become available.
The CRN’s dedicated assessment of vitamin K2 MK-7 offers the supplement industry transparent, science-backed guidance for formulating products that meet consumer demand while maintaining the highest safety standards.
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The scientific conference “Application of MenaQ7 in Height Development for Children and Global Vitamin K2 Trends”, organized by Midu MenaQ7 Joint Stock Company with sponsorship from Gnosis by Lesaffre, took place on October 19, 2025, at Hanoi Medical University. The event brought together leading Vietnamese and international experts in medicine, pediatrics, and nutrition to discuss the latest findings on Vitamin K2—particularly MenaQ7® (MK-7)—and its role in supporting children’s height and bone development.
Interest in Vitamin K2 and Magnesium is not a marketing trend. It reflects a significant shift in the scientific understanding of calcium metabolism and its implications for cardiovascular and bone health. For decades, supplementation strategies focused on Vitamin D3 and calcium. Today, clinical evidence shows that the real issue is not calcium deficiency, but rather calcium mismanagement within the body, which affects both arterial and skeletal integrity. This is where the D3 + Magnesium + K2 combination becomes essential.
The Real Challenge Is Not Calcium Intake
The dietary supplement and functional nutrition industry widely associates Vitamin D3 and calcium with bone health. However, D3 alone increases calcium absorption without ensuring correct biological routing. The central concern is vascular calcification: when calcium does not reach the bone, it can accumulate in the arterial walls. This mechanism is now recognized as a major contributor to arterial stiffness and age-related cardiovascular decline.
The triad is designed to solve this:
– D3 increases calcium absorption,
– Magnesium activates Vitamin D3, and
– Vitamin K2 directs calcium away from soft tissues and toward the bone.
This model is supported by metabolic and cardiovascular research, which validates the synergy between these nutrients.
Three Interdependent Mechanisms
Vitamin D3: Increasing the Calcium Pool
Vitamin D3 boosts calcium availability through intestinal absorption. This is necessary, but insufficient for optimal mineral utilization.
Magnesium: Activating Vitamin D3
Magnesium is an essential cofactor for converting Vitamin D3 into calcitriol. Without adequate Magnesium, Vitamin D3 remains inactive mainly, which can reduce its biological impact and compromise long-term supplementation outcomes.
Vitamin K2: Directing Calcium
Vitamin K2 activates two key proteins:
– Matrix Gla Protein (MGP), which inhibits arterial calcification,
– Osteocalcin, which binds calcium to the bone matrix.
Together, these mechanisms support a more efficient calcium metabolism, including absorption, activation, and direction.
A Safer and More Rational Formulation Approach
This scientific evolution is reshaping formulation strategies for supplement manufacturers, premium brands, and private label developers. The market is shifting away from traditional D3 + calcium formulas and towards intelligently designed combinations that deliver more apparent clinical benefits in cardiovascular protection and bone health.
The D3 + Magnesium + K2 complex delivers on those expectations with a more evidence-based and safety-oriented approach.
Why MK-7 Is Becoming Central
Not all forms of Vitamin K2 are equal. MK-7 is the most clinically validated form, with superior bioavailability and a longer half-life, enabling sustained activity in extra-hepatic tissues, particularly the vascular system.
Within the MK-7 category, MenaQ7® stands out for its clinical validation, stability, and traceability. It is widely recognized in the industry as a reliable and safe MK-7 source, making it a preferred choice for premium formulations and brands looking to differentiate through scientifically supported ingredients.
More Than a Supplement Strategy
The value of the triad extends beyond the combination of three ingredients. It represents a new approach to calcium metabolism: activate, direct, and protect. This enables the development of products that are safer, more closely aligned with clinical research, and more relevant to real-world consumer needs.
The convergence of scientific evidence, product development trends, and consumer expectations is transforming the D3 + Magnesium + K2 triad into a new category standard. For supplement brands and manufacturers, it represents an opportunity for innovation, premium positioning, and clinically meaningful differentiation.
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Professor Leon Schurgers, PhD, a globally renowned vitamin K expert and Chair of the Department of Biochemistry at CARIM, Maastricht University, shared preliminary findings from the VitaK-CAC Trial at the esteemed Linus Pauling Institute Diet and Optimum Health Conference.
Professor Leon Schurgers, PhD, a globally renowned vitamin K expert and Chair of the Department of Biochemistry at CARIM, Maastricht University, shared preliminary findings from the VitaK-CAC Trial at the esteemed Linus Pauling Institute Diet and Optimum Health Conference.
Gnosis by Lesaffre was proud to sponsor the Linus Pauling Institute “Diet and Optimum Health” conference, where new results from the VitaK-CAC study were presented.
Prof. Leon Schurgers (Maastricht University) shared compelling data showing that two years of MenaQ7® (vitamin K2 as MK-7) supplementation significantly slowed the progression of coronary artery calcification (CAC) compared to placebo — marking the first time a vitamin has demonstrated this effect in individuals with coronary artery disease.
These findings reinforce the important role of vitamin K2 in cardiovascular health and ageng. As the developer of MenaQ7®, Gnosis continues to invest in clinical research and scientific partnerships to advance evidence-based solutions for better vascular health.
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At the recent IUNS International Congress of Nutrition, discussions on the future of Vitamin K2 research featured Prof. Leon Schurgers, a respected expert, long-standing collaborator, and chairman of the Gnosis K2 Scientific Advisory Committee. His leadership within the ILSI Europe Task Force reinforces Gnosis by Lesaffre’s commitment to supporting innovation and scientific progress for this essential nutrient.
At the recent IUNS International Congress of Nutrition, discussions on the future of Vitamin K2 research featured Prof. Leon Schurgers, a respected expert, long-standing collaborator, and chairman of the Gnosis K2 Scientific Advisory Committee. His leadership within the ILSI Europe Task Force reinforces Gnosis by Lesaffre’s commitment to supporting innovation and scientific progress for this essential nutrient.
About ILSI Europe
ILSI Europe is the European branch of the International LifeSciences Institute (ILSI), a global, non-profit organization that brings together scientists from academia, public institutions, and industry to address key issues in nutrition, food safety, and health. Through collaborative task forces, ILSI creates a neutral platform to review science, identify research priorities, and build consensus on emerging health topics.
Vitamin K2: From Known Benefits to New Horizons
Vitamin K2 is well recognized for its established roles in blood coagulation, cardiovascular, and bone health. Science has demonstrated that the MK-7 form of K2 shows the best bioavailability and longest half-life among all K vitamins. Research is now expanding beyond bone and cardiovascular health, including blood glucose control, cognitive health, and even nerve and muscle health.
The ILSI Roadmap for Vitamin K2
Since its 2013 review of menaquinones, ILSI Europe has highlighted the need to explore the broader health implications of Vitamin K2. To address this, the group launched a new Task Force on Vitamin K2. The outcomes of this Task Force’s activities are expected to provide updated assessments of the health benefits of different forms of Vitamin K2 to the scientific, industrial, and public communities. Furthermore, the estimation of healthcare cost savings resulting from adequate Vitamin K2 intakes will offer valuable guidance to clinicians and public health organizations.
Our Commitment
As one of the industry leaders in Vitamin K2, Gnosis by Lesaffre is proud to be actively involved in this initiative. By engaging with ILSI’s extraordinary expert group, we reaffirm our commitment to advancing science, building credibility for K2, and shaping the future of nutrition on a global scale.
Do you need more information about Vitamin K2 or have any outstanding questions? Please do not hesitate to contact us; our expert team will happily answer!