Quality control: Kappa Bioscience reveal vitamin K2 MK-7 testing program

The free service is available on all finished vitamin K2 products, regardless of origin. The testing will analyse the K2 content and verify that it matches the level specified on the label. The goals of the program are to promote market understanding of K2 stability and to highlight the issue of why unprotected K2 is unstable in mineral formulations.

Independent third-party laboratory verification is an important feature of the global program. The verification will be carried out by region and will ensure credibility of results.  Kappa Bioscience also believe such a program provides a role model for how the supplements industry can address issues such as low-quality ingredients, products that fail to meet label claims and the use of unvalidated data in marketing.

‘‘We view independently-validated testing programs as an innovative way to address quality issues in the K2 market, if not the supplements industry as a whole,’’​ said Egil Greve, CEO of Kappa Bioscience.

‘‘Even the purest unprotected K2 can degrade in certain formulations, particularly in mineral formulations. While the K2 industry debates the science of the problem, brands and consumers may bear the consequences by not receiving the promised K2. ​

“This program says, ‘don’t trust our data, or anyone else’s. Trust your own data for your own products.’ We hope to make this easier to do​,’’ Greve continued.

Kappa Bioscience is a leading global manufacturer of vitamin K2 menaquinone MK-7 which is marketed under the brand K2VITAL.

Scope of Program​

Kappa Bioscience initially proposed the free testing facility during a September webinar. With the formal launch, the company have also introduced website support to facilitate product submissions.

Kappa received their first participants to the program during CPhI India this week, where samples were submitted by brands, contract manufacturers and retailers looking to verify the quality of their products.

Kappa Bioscience is inviting stakeholders to submit samples for testing. The cost-free testing offer is open to K2 industry participants with a role in the supply chain for a K2 product or an interest in protecting consumers or other stakeholders.

Any product containing vitamin K2 will be eligible; however, the program will prioritise testing of products that contain vitamin K2 MK-7 and minerals, particularly calcium or magnesium.

K2 content validation will be conducted by globally recognized third-party laboratories in Europe, USA and Australia, while the program will be managed by independent group company Kappa Chemistry.

The tests are conducted using United States Pharmacopeia (USP) methods. Individual results are confidential and are reported solely to the test requestor. However, aggregated results that exclude brand identifiers will be included in Kappa’s annual K2 Market Study.​

Disturbingly, the 2016 report found that only 5% of unprotected K2-plus-minerals products met K2 label claim, and a third of K2-only products did not contain any K2 at all.

‘’K2 is a fast-growing category and this can draw in players that put profits ahead of quality. Unfortunately, we’ve seen that it can also pressure reputable players to push the limits of science-bound K2 performance – specifically regarding the inherent instability of unprotected K2 in mineral formulations.’’​ said Jörg Büttinghaus, VP of Kappa Sales.

Vitamin K2 MK-7​

The MK-7 form of vitamin K2 has been shown in research to be important in the transport and absorption of calcium. K2 MK-7 has also been shown to help prevent coronary artery calcification. The vitamin is therefore beneficial to both bone and cardiovascular health.

K2 MK-7 is typically found in fermented foods such as natto (fermented soy beans) and fermented cheeses.  Some epidemiological studies suggest that many people do not obtain enough vitamin K2 MK-7 from dietary sources.

However, the lack of awareness of the importance and function of this vitamin among medical practitioners may mean that the full implications of deficiency in certain populations are poorly recognised.