In 2016, Kappa Bioscience tested 96 finished products, purchased globally, for vitamin K2 stability. K2 is a fat-soluble vitamin, and like others, can be unstable in certain formulations if unprotected. In 1948, the US Federal Security Agency identified vitamin D can degrade ‘within a month or two’ when combined with calcium. It should come as no surprise then, that unprotected vitamin K2 can also degrade with calcium or magnesium. Vitamin K2 products that contain minerals should only use protected K2—if not, products may misclaim on their labels, breaking promises made to consumers.
Kappa found that half of unprotected or natural-fermented K2 products missed label claim by 50 percent or more in those containing calcium or magnesium. One in five products contained less than 10 percent of the K2 claimed on the label, and four products had no measurable K2 content. Additionally, a remarkable 50 percent of K2 products that did not contain any minerals also performed poorly. One third of this sample demonstrated no K2 content at all. In formulations that should have posed no problem for K2 stability, only a quarter of products delivered on their K2 label claim.
These results demonstrate a much bigger problem. The K2 market is tiny within the dietary supplements industry and dietary supplements are classified as food products. As quality standards can vary among contract manufacturers and marketers, and this classification has less rigorous testing standards, this opens the door to questionable consumer products. The K2 market may be an isolated example, but conversely, this may also be multiplied several hundred-fold for other ingredients, with the manufacture of products that do not meet stated label claims, whether knowingly or otherwise.
Lack of batch testing, minimal testing by authorities, and the generally unregulated market of online trade open dietary supplements markets to products that do not comply with regulatory standards and do not meet the label claim expectations of consumers. Products that side-step quality are often offered at a low price, undercutting the companies that invest in a quality product. This does a disservice to the entire industry, and forces brands to invest in market education at the lowest common denominator—basic quality. Product safety is also a concern here.
Transparency and testing under one certified and audited standard is the solution. Until that happens, the industry must rally around a promise to produce and offer products that comply with promises to consumers, including label claim, and comply with all legal and regulatory requirements. This minimum voluntary commitment to a standard of an Ethical Label, including transparent product documentation and third party testing, is a positive first step. Ingredient and contract manufacturers, brands, technical solution providers and analytical labs all have a stake in producing only well-documented, quality products.
Jim Beakey is Marketing Director at Kappa Bioscience AS.