In 2016, Kappa Bioscience tested 96 finished products, purchased globally, to assess their vitamin K2 MK-7 label claims.
K2 is a fat-soluble vitamin and, like its peers, can be unstable in certain formulations when unprotected. Nearly 70 years ago, the Federal Security Agency identified that vitamin D combined with calcium can degrade “within a month or two.” It should come as no surprise that unprotected vitamin K2 can also degrade when formulated with calcium or magnesium.
Vitamin K2 products that contain minerals should use protected K2; if not, products may not meet their label claim, breaking a promise made to consumers.
So, what did Kappa find? As reported in a study released in 2017, half of the unprotected or natural-fermented K2-plus-calcium or K2-plus-magnesium products missed their label claim by 50% or more.
One in five contained less than 10% of the K2 claimed on the label, and four products had no measurable K2 content at all. In addition, a remarkable 50% of K2 products that did not contain minerals also performed poorly, with a third measuring zero K2 content.
Only about a quarter of these products delivered on their K2 label claim in formulations that should have posed no problem for K2 stability. Although stability solutions exist, such as microencapsulation or the physical separation of incompatible ingredients using dosage technology, some facets of the K2 market still fell short.
Dietary supplements as food products
The K2 market results may be symptomatic of a wider industry challenge. Dietary supplements are classified as food products. This classification requires less rigorous testing compared with the pharmaceutical industry, for example, in which products must undergo a strict approval procedure — including stability trials — and wherein each batch is fully tested and documented.
The lower testing requirements of food product classification opens the door to a wide range of quality issues and market outcomes.
At the top end of the dietary supplements market, suppliers to supermarkets and pharmacies are usually certified according to standards such as IFS (International Food Standard), BRC (British Retailer Consortium) and/or ISO 22000:2005, and have HACCP in place. However, in practice, any company can start manufacturing food supplements, even without the requirement of knowledge about certified standards.
Although HACCP is a legal requirement, it is only spot-tested by authorities. Because testing is typically focused on larger companies that supply mass markets, the door is left ajar to products that may demonstrate significant quality problems.
And although the dietary supplements industry certainly includes “black sheep” vendors who knowingly circumvent quality in pursuit of profit, the example of vitamin K2 demonstrates that even reputable manufacturers and brands may unknowingly fall behind on developments in science and formulation … and manufacture products that fall short.
As such, ingredient manufacturers should shoulder the responsibility of informing and educating customers about science-bound limitations for ingredients.
Ingredient manufacturers also have a responsibility to preserve and document manufacturing requirements throughout the product value chain, including spot-testing finished products and informing customers of any identified issues.
Accountability for a high-quality product does not end when ingredients are shipped from a warehouse. This event should represent the beginning of a product value chain that ultimately ends with the product in the hands of a consumer — our own families, friends and neighbours.
The complications of fast growing markets, wide access to customers via online channels or the animal spirits of free-market capitalism provide no excuse to overlook commercial and ethical industry challenges that currently fall outside any regulatory framework.
The K2 market is tiny within the dietary supplements industry as a whole, and the case of the K2 market might be isolated. Conversely, it might be multiplied a hundred fold for other ingredients, with the knowing or unknowing manufacture of products that may not meet stated label claims. An industry wide problem requires and industry wide solution.
Low quality: a high cost to the industry
The industry impact of substandard quality is far-reaching, with a cost that can be measured in dollar figures. Manufacturers that side-step quality can offer products at prices that undercut the companies that invest in quality products and good industry stewardship. Low quality products do a disservice to the entire supplements industry, forcing brands to invest in market education at the lowest common denominators (basic quality, value and safety).
Low quality also does a disservice to consumers. In an example from the K2 market, consumers were offered 600 µg products at fire-sale prices, only to receive products that contained zero ingredient. The wallets of these consumers certainly suffered as a result.
Likely worse, however, is that after taking positive action to learn about a new ingredient and make a purchase, these consumers were denied the health benefits contracted for in the product sale. This breach, in turn, may expose retailers to the costs of claims — legally, financially and in measures of brand reputation.
The domino effect of isolated quality cases can also have repercussions on the industry if and when quality problems are exposed publicly and prominently. The dietary industry as a whole takes a hit when claims of “consumer fraud” and “wasting money on supplements” hit news pages.
Industry associations can work to contain these situations, but the reputational and financial damage likely extends beyond the product category in question, damaging the credibility of the entire industry.
Product safety, and the ensuing regulatory response, may also be a concern. In 1989, 39 deaths were linked to the essential amino acid L-tryptophan. Although subsequent studies identified the trace impurity contamination of specific batches, the damage to the market was done.
Beginning in 1991, the US FDA banned the import and sale of L-tryptophan (with other countries following suit), and the ban was not fully lifted until 2005. Although the human costs of quality problems can be immeasurable, this case demonstrates that entire markets can be eradicated — even for essential vitamins or amino acids — based on the regulatory response to quality concerns.
Few, if any, niche ingredient companies could survive a 14-year regulatory ban stemming from the actions of an individual competitor.
These examples present extremes, and one could easily dismiss the case of K2 as irrelevant — based on the comparatively small size of this market. By contrast, can other conclusions be drawn from a study in which, despite known and scientifically verifiable stability issues (easily mitigated with planning), so many products missed label claim?
The industry has a responsibility to question whether there is an iceberg below a visible peak.
An industry commitment to an ethical label standard
Industry wide transparency and testing under one certified and audited standard, by a recognised regulatory authority, is the solution to substandard quality across supplement categories. The wait for this, unfortunately, may be long. Until then, individual players in a dietary supplement segment can foster accountability by embracing a commitment to only produce and offer products that
- deliver on all promises to consumers, including label claim
- comply with all legal and regulatory requirements
- have transparent documentation, including a commitment to third-party quality testing.
A voluntary commitment to a minimum standard of quality — one that permeates the value chain from ingredient manufacturing to final consumer — would provide the dietary supplements industry a means to communicate the importance of quality, while also serving and tangibly protecting consumers.
The Ethical Label Standard represents this commitment to quality. It is a voluntary promise to meet minimum label claims and all legal and regulatory requirements. But this standard is backed by fully transparent product documentation, and when possible, a commitment to independent third-party testing at all stages of the value chain.
In this regard, the K2 market provides a positive example, with some manufacturers offering free finished product testing for K2 products from any source, including at least one programme that includes independent third-party verification of results.
Although consumers would be the final beneficiaries of the wide adoption of this standard, all stakeholders in a product’s value chain benefit and have a role in preserving the integrity of the chain.
Ingredient and contract manufacturers, brands, technical solution providers and analytical labs all have a stake in producing, communicating and selling only well-documented, quality products. Conforming to an Ethical Label Standard provides a competitive advantage for companies.
The value created by the process-setting, documentation and data to support the standard can be leveraged in other areas, and adhering to the standard communicates a company’s commitment to quality to consumers and the industry as a whole.
Industry associations and consumer protection organisations benefit by supporting good corporate citizenship and social responsibility within the industry. Ultimately, however, the consumer who places their trust in the dietary supplements industry is the winner.