Innovation fuels our industry. The number one question at tradeshows? “What’s new?”
In the U.S. we have a gift that many other countries don’t enjoy, the structure-function claims provision under DSHEA, the 1994 Dietary Supplements Health and Education Act. However, this carries a stipulation that the claims must be validated.
Leading innovative companies sponsor research to validate their ingredients, including documenting historical use, in vitro, in vivo and human research. The Federal Trade Commission (FTC) would like to see the gold standard double-blind, placebo-controlled studies—powered appropriately and published in peer-reviewed journals. And more than one!
The costs of validating safety, regulatory, and human research is in the hundreds of thousands and even millions of dollars. These studies are specific to the company providing the ingredients and the onus rests on these companies to provide safe and efficacious commercial products backed by this validation. This rests on the production of the active markers (we are discussing natural products) and, importantly, on the delivery of the final commercial product. This responsibility must be earned and demonstrated over time.
This intellectual property validates the ingredient and allows the finished product brands to incorporate structure-function claims on their products. In the case of MenaQ7, the vitamin K2 industry relies on the 22 published studies validating MenaQ7 benefits for children, bone, heart and kidney health, with other studies pending.
Let’s coin a new term: “Valuedation”—the value created in the ingredient rests in its evidence.
The challenge for our industry is the companies that invest nothing, and claim to have the same product, and for less! Clearly outsourcing the R&D requirement to the pioneer reduces the cost of entry.
At the end of the day this stifles innovation. At what point do companies stop investing in innovation because copycats simply steal it? We encourage the brands to embrace the pioneers and reward the basis of growth in our industry by purchasing the validated ingredients. This, in the long run, benefits everyone.
Thus, we encourage other suppliers to take on the task of validation. If their ingredients are “the same” then the risks of conducting a study should be quite small. So why not do it?
Let’s expand the body of knowledge around our natural products. Let’s build our industry on Valuedation. Most importantly, let’s make sure we provide safe and efficacious ingredients delivering on the consumer promise of benefits. That is Valuedation.
Eric Anderson is senior vice president of new business development at NattoPharma, supplier of the MenaQ7 vitamin K2 ingredient.