Ingredients, Nutrition Science and Disease: A Messy Map

In some of our recent work in the curcumin/turmeric category and emerging prebiotic category we came up against that wall that often faces the dietary supplement industry: “Your scientific evidence does not show an impact on disease, therefore your research is insufficient to sway scientific opinion, let alone public opinion, therefore your benefit-risk ratio is negligible, therefore you are irrelevant to the conversation”.

While my summation above might be a bit over-dramatic, the line of thinking and outcome is not. Too often, ingredient and more broadly, dietary supplement research gets totally dismissed because it doesn’t report on disease state. We in the industry know that it’s most often because we can’t, either due to the regulatory climate, or to the complications that nutrition science and nutritional ingredients inherently provide. Trying to do a placebo-controlled, double blind nutritional product study, where the ingredient might itself be or is closely related to a confounding dietary ingredient complicates the research. Couple that complexity with arguments such as ‘entourage effect’ and ‘whole food ‘considerations, as well as the confusing landscape of bioavailability and you have an environment where strategizing, executing and communicating an ingredient research program becomes almost impossibly daunting.

The converse criticism is also true, as often, ingredient and supplement research gets over-stated and becomes hyperbole, and therefore meaningless or out of context.

Credibly presenting the science on dietary ingredients is therefore challenging and frustrating, especially for those actually investing in the science. Working with the academic community is an alternative strategy for scientific advancement, although if not planned and negotiated carefully, documentation regarding product quality and characterization can go awry, rendering the resulting findings meaningless. Then there’s the issue of objectivity. Many academic researchers demand objectivity and while looking to industry to support the research, want complete autonomy with process, design and results. In the worst case, this devalues or removes the intellectual property value of the results, creating a neutral or negative ROI for the ingredient underwriting company.

Against this backdrop, not surprisingly, we have heard it recently observed that there is an overall decline in industry funded research. This is understandable from a short-term standpoint but is disappointing and a mid- and long-term mistake. We know that the regulatory landscape will continue to evolve with increasing pressure to adopt a master file system, at least in the United States, that begins to recognize IP on the part of those submitting New Dietary Ingredient (NDI) notifications. While the details are a long way from materializing, this environment and a re-thinking of DSHEA could create a huge market opportunity for companies even now thinking strategically about their research agendas. We are also seeing new structures in academic/industry relationships where industry gets what it needs: proper characterization and description of research materials, worthwhile participation in IP and publication context, and a true strategic research partner. Lastly, emerging advances in mechanistic science where nutritional ingredients are concerned, in the microbiome and beyond, is opening up new frontiers (yet to be fully substantiated in some cases) in structure function claim language.

These developments (ingredient IP protection through a notification process, new relationships with academia and the incorporation of novel mechanistic science to support claims) bode well for the future of ingredient science. Smart companies are developing their strategies now.

One closing thought: In our single ingredient associations, we have explored the concept of category-based research. Are there research parameters that a group of companies could align behind? Toxicity perhaps? In fact, we even proposed that to a group of CBD executives – could there be a broader group that would work on CBD safety for the purposes of an NDI submission? And for synbiotics, in theory, a probiotic supplier and prebiotic supplier could band together to do research, couldn’t they? Or would it take a brand to get exclusive ROI by being the one to initiate that combination ingredient program? This has not happened yet, but one can’t help wondering whether these approaches do in fact a possible category growth strategies.

~Len

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