The vitamin K2 supplement quality issue in the US: how to move forward

Published: 16-Aug-2024

Although a concerning number of K2 supplements on the market aren’t meeting label claims, there are ways that manufacturers can ensure they are selling high-quality and efficacious K2 products

Laboratory testing has revealed that that two thirds of vitamin K2 supplements sold in the US fail to meet basic label claims. 

This was discovered by an analysis of products purchased on a popular US e-commerce site, and brings into question the quality and safety of such products currently available on the market.

The research uncovered that a number of these supplements fail to meet label claims owing to their low quality or purity.

Products failing to meet their label claims can significantly impact the reputation of dietary supplement providers, while also potentially endangering consumer health.

It can also result in companies facing legal repercussions for making such false claims.

The study, run by Alkemist Labs, tested 38 vitamin K2 products in a range of formats.

In this study, 71% of the dietary supplements tested were not of isomeric purity, while they also fell short of the vitamin’s associated quality benchmarks.


Problems at an isomeric level

According to the results of the analysis, the reason that vitamin K2 products currently on the market are not meeting their label claims is due to excessive cis isomer content; these isomers are not as biologically effective as all-trans MK-7 vitamin K2.

Lindsay Cole, the North American Sales & Business Development Manager for Kappa Bioscience, a subsidiary of Balchem, commented: “When producing vitamin K2, production and stability issues make it extremely difficult to create an all-trans MK-7 molecule, and depending on the production method, one or more molecular bonds can have a cis configuration. These cis isomers are not linear, and therefore their shape differs substantially from that of the all-trans MK-7 form.”

“Like a lock and a key, trans isomers of vitamin K2 MK-7 fit into the binding sites of K2-dependent enzymes and proteins to activate them, whereas cis isomers may not be able to do this, making the cis form of vitamin K2 less biologically efficient.”

Some multivitamin and combination supplements with K2 present also use unprotected forms of the molecule, which can result in their rapid degradation in this type of formulation. 

Lindsay stresses that nutraceutical manufacturers producing vitamin K2 supplements must focus on maintaining high percentages of trans-K2 in their formulations: “The crucial factor when making efficacious vitamin K2 supplements is purity (all-trans), which is directly linked to bioavailability. The highest possible percentage of all-trans MK-7 is needed to achieve the desired effect of vitamin K2 MK-7.”


How businesses can ensure vitamin K2 supplement quality 

For companies to ensure their vitamin K2 products are living up to label claims and satisfying customers, they must:

  • Ensure their ingredients are from a reputable source: Only selecting ingredients which have come from companies with high-quality ingredients on offer can significantly improve the chances of your vitamin K2 supplement being efficacious and beneficial for the consumer base.

     
  • Test their supplements: This can be done through a third-party laboratory or internally, but testing for the isomeric purity and quality of your supplements ensures the products being released to the market are what they’re advertised as.

     
  • Account for stability issues: Lindsay explains that a common formulation challenge that manufacturers should be aware of with vitamin K2 is its stability. “While there are many synergies between vitamin K2 and other minerals, such as calcium, magnesium and vitamin D, unprotected vitamin K2 is highly susceptible to degradation and will break down rapidly when used in combination with certain minerals. Microencapsulation protects the vitamin’s stability and bioavailability, even in presence of other minerals. Without this protection, finished products may not deliver the desired health benefits, as the degradation of K2 results in decreased bioavailability."
     
  • Collaborate with other nutraceutical businesses: It would be useful for companies to work together to inform consumers on what high quality vitamin K2 supplements contain, allowing them to make the best choices for their health.

It goes without saying that quality control is paramount in the dietary supplement manufacturing process, and companies should continue to pursue high standards. 

Lindsay concludes: “Offering high-quality, efficacious all-trans K2 products ensures consumers get the full benefits of this vitamin, including bone and heart support. This in turn impacts consumer trust and affects whether or not they choose to repeat purchase.”

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