Dietary supplements are classified as food products, with less stringent standards than for pharmaceuticals. Smaller players aren’t required to have knowledge of standards like IFS, BRC, ISO 22000:2005 to start manufacturing. While HACCP is a legal requirement, it is only spot-tested by authorities and this is typically focused on companies that supply mass markets. This leaves the door open for low quality products, and low quality has a high cost for the responsible players in an industry. Low quality undercuts price, forces good manufacturers to invest in basic market education, and breeds uncertainty among the customer base. Low quality inhibits market growth, and is enabled by a 24/7, internet-enabled global marketplace of countless regulatory and legal judications. How can a small category, or just one company, foster change?
The case of vitamin K2 MK-7 may provide a model. Unprotected K2 MK-7 is not stable when combined with calcium or magnesium—a frequent pairing for this bone and heart health vitamin. High levels of biologically inactive cis MK-7 are also common in mono-K2 products made with low-quality MK-7. This means a lot of K2 products offered to consumers probably can’t meet label claim in an otherwise thriving market. Solutions exist, and high-quality is the norm at the top end of the market. The question is how to address low quality without stalling category growth, avoiding confidence-damaging mud-slinging, and leaving the lawyers out of it? In a word … transparency.
Six years ago, Kappa Bioscience discovered its own products were under-performing in some formulations and launched a testing program to discover why. The result was the development of a protected, microencapsulated MK-7. Kappa decided, however, to continue the testing program to monitor market development and to publish the results each year. In 2017, Kappa tested 119 K2 products for label claim in an independently verified study. The study released in 2018 shines a light on K2 quality and measures year-over-year trends. The annual study encourages the healthy development of the K2 market by promoting open discussion, market education, independent testing, and transparency-of-documentation throughout the supply chain.
What did the 2017 study find? Unfortunately, the results were not good. Only 8 of 94 (9 percent) unprotected K2-plus-minerals products met label claim. Two-thirds missed label claim by over 50 percent and one-in-three products contained zero K2. In comparison, protected/encapsulated K2 products in formulation with minerals performed well and delivered on label claim.
The 2016 study produced an unexpected result—over half of K2-alone or K2 in non-mineral formulations (i.e. K2 + D3) performed poorly, with 33 percent containing zero K2. Non-mineral formulations should not pose a problem for K2 stability; the explanation is likely poorly manufactured K2 ingredient. The 2017 results demonstrated improvement, but a new problem was identified. Isometric purity testing revealed high levels of non-bioactive cis MK-7 in some the mineral and non-mineral products. These products technically met USP requirements for MK-7 label claim, but with high percentages of biologically inactive MK-7.
Why would Kappa continue invest in a study that highlights such poor results for their industry? In a word … transparency. By addressing quality in an open forum with readily replicable data, progress has been made. One big shift has been greater recognition of the need for independent, third-party testing using USP methods to cut through marketing claims and cherry-picked data. Brands are increasingly building finished product testing into ingredient purchase agreements. A push to include isometric testing in the standard USP monograph for K2 is another positive outcome.
Another 2017 development included the announcement of encapsulated K2 products by two additional K2 manufacturers. This wider category acknowledgement of K2 stability begins to form a consensus that will pushes others to innovate and protect more consumers. The year 2018 also saw the launch of a K2 trade association which can provide a uniform, science-based voice for K2, and will launch an independent quality testing program. Finally, industry influencers have joined the call for transparency for dietary supplements. Vitafoods Insights hosted a panel discussion on transparency at Vitafoods Europe this year. Market-shapers such as Capsugel, Eurofins and others have weighed in on the concept of the Ethical Label for finished products. The Ethical Label is a voluntary commitment meeting all promises communicated on the label (including label claim), transparent documentation and third-party testing. By shining a light on quality, vitamin K2 may provide a model for other ingredients.
To download a copy of the 2017 K2 Market Study click here.