Many ingredients don’t clear that hurdle, or at least they don’t do it under the original ownership. Part of the problem often seems to be a disconnect within the original ranks of company executives. Scientists—biologists, botanists, pharamcognosits—are usually the ones who come up with the original research ideas and design the first studies. But they are not always the most appropriate personnel to have sole responsibility for making business planning decisions. It has happened again and again in the dietary supplement industry where an ingredient comes to light with a significant suite of research behind it, but those studies don’t come together in such a way as to support a marketing plan.
This difficulty—matching research aspirations with achievable business goals—is one reason for the proliferation of branded ingredient suppliers such as PLT Health Solutions, XSTO Solutions, Maypro and others—who can help development stage ingredients and companies successfully take the next step.
Going it alone
But a number of companies have gone it alone with success. Marketing manager Eric Anderson works at one such company, Norwegian firm NattoPharma, which supplies a form of vitamin K2. Anderson spoke with NutraIngredients-USA at the recent Expo East trade show in Baltimore, MD on the process of bringing this ingredient, branded as MenaQ7, to market. The ingredient has been studied for both bone health and cardiovascular benefits.
“There’s a saying in the natural products business: An overnight success takes about 10 years. First you look at epidemiological studies. For example, it was observed in Japan the portion of the population that who consumed the fermented soy food called natto had stronger bones. From that recognition in food, one has to identify what the nutrient in the food is that is potentially responsible for that and that’s where the work begins,” Anderson said.
Then come regulatory hurdles, such as GRAS filings and/or NDI notifications if those are called for, Anderson said. Then come the studies that build on that first epidemiological evidence. It may requires up to several double blind, placebo controlled trials to fully demonstrate an ingredient’s benefit, Anderson said. It requires investors who are on board with the entire scope of the program.
“To go into double-blind, placebo controlled trials where you are looking for a therapeutic outcome is a significant undertaking. To get to the point to able to say that a specific ingredient has a specific benefit may take six, seven or eight years,” he said.