Kappa Bioscience gains regulatory approval for “newcomer” vitamin K2 in China and Mexico

12 Feb 2020 --- K2VITAL vitamin K2 MK-7 by Kappa Bioscience has received approval for use in children’s health and maternal milk powders in China, as well as being deemed safe for use in Mexico. Although K2 is an essential vitamin for the body, the commercial market for it is barely a decade old and is doubling each year, according to Kappa. These approvals indicate that K2 is becoming accepted as a mass-market ingredient that is set to expand its global footprint, notably in the early-life category. Now, questions are prompted over whether the new regulatory approval could lead to a strong trend toward K2 fortification.

“Commercial vitamin K2 MK-7 is still a relative newcomer to the dietary supplements market, and regulatory frameworks are being built one market at a time. The approvals for the Chinese and Mexican markets demonstrate how the expansion of the global regulatory framework is a driver of market growth,” Jim Beakey, Communication Lead at Kappa Bioscience, tells NutritionInsight.

K2’s growth has largely been driven by traditional capsule and tablet products. New growth, however, may be generated through innovative dosing forms and increasingly in food fortification.

The approval for synthetically produced K2 MK-7 in China is significant, not only due to its market potential but because it highlights an emerging K2 food fortification trend. However, the country is currently battling coronavirus, which has seen business active in the region struggle.

Nonetheless, the regulatory approvals mark the first Chinese approval of K2 MK-7 produced by organic synthesis. “Synthesis creates the purest K2 ingredient, and most vitamins offered in mass markets are produced like this,” Beakey maintains.

Purity is a key focus of Kappa, with independent research finding that less than one in five K2+ mineral products sold to consumers meet label claims. The approval for synthesis is expected to propel scalability, price reduction and a secure supply chain which can then make use of the vitamin in foods.  

K2 is an essential vitamin present in meat and some fermented cheeses, but studies show that many diets are K2-deficient.Powders are a frequent entry product and K2 in dairy products is increasingly common because of K2’s complementary benefits to calcium and vitamin D3. The K2 beverage market is also growing, notably in markets where deficiencies in milk consumption exist among children. “Vitamin K2 is an essential vitamin, and like all other nutrients, it is delivered to children through the breastmilk. Studies show that women have higher calcium utilization requirements during pregnancy and lactation to maintain proper bone health,” notes Beakey.

The approval for products for expecting and breast-feeding mothers is validated by multiple clinical studies, which demonstrate that both mother and child have enhanced calcium-mediation needs during this period.    

“Asia is perhaps ahead of world markets in recognizing K2 for children’s health. K2-fortified beverages for children are common in markets like Vietnam, where milk consumption is low. K2 plays an important role in bone growth in children, and powder and beverage formats increasingly used as a solution,” says Peter Wisler, Distributor Liaison for Kappa.

An essential vitamin throughout life
Vitamin K2 supports bone and heart health by activating proteins that mediate healthy and unhealthy calcium deposits. “K2 is the necessary co-factor for the activation of osteocalcin and matrix-Gla proteins (MGP). These proteins, along with vitamin D3, regulate calcium usage in the body. Activated osteocalcin integrates calcium into the bone matrix, while activated MGP binds excess calcium in the blood to prevent it from deposit in soft tissues, including arteries,” says Beakey.

The vitamin is required in all stages of life, affirms Beakey. However, the K2 market has historically skewed towards older consumers and K2 is frequently associated with health benefits related to osteoporosis and cardiovascular disease. One study found that low levels of circulating vitamin K in the body are linked to an increased risk of mobility limitations and disability in older adults

Building off of early-life nutrition, vitamin K2 provides synergistic benefits to calcium, magnesium, and omega 3, which may naturally play a role in healthy aging, joint & mobility, and sports nutrition categories for bone and heart health.

By Missy Green and Anni Schleicher