Joanna Cosgrove11.11.10
Solid research is always a good thing, especially in the nutritional supplement industry. The last few years has seen an increasing number of supplement companies investing in their own futures by opening dedicated clinical investigation centers that put their own products to task in an effort to ultimately forge greater understanding and consumer confidence.
While Nestle, Danone, M&M Mars and Hershey’s are a few of the larger companies already embracing and promoting ingredient and condition-specific research, other companies are devoting precious capital too. One such company is Naturalpha. Based in Loos, France, Naturalpha announced last month that it had created a new Clinical Investigation Center for Nutrition that will be exclusively dedicated to clinical trials with functional foods, ingredients and dietary supplements.
Christophe Ripoll, the company’s executive vice president of R&D, said there were three primary reasons behind the development. The first revolved around the introduction of the new Health Claims Regulation (1924/2006/EC) in Europe, which subsequently changed the regulatory environment for the agro-food industry in the European Union. “The pre-approval of the European Food Safety Authority is necessary for the use of health claims, which makes it impossible for food companies to make health claims without scientifically proven health benefits,” he said. “This new regulation coincides with the increased consumer awareness of products that are beneficial for health. Therefore agro-food industrials and functional ingredient producers have growing needs for the development of their products, especially regarding the proof of benefit in humans.”
Mr. Ripoll went on to add that the Center will enable Naturalpha the distinction of providing “an international offer of clinical trials corresponding to EFSA standards with high focus on the methodology, the targeted population, the biomarkers as well as the characterization of food products.”
As importantly, Naturalpha also looks forward to supporting its industrial partners in building the proof of "health effect" of their products by proposing scientific and regulatory intelligence, consulting, health claim dossier audit, preclinical and clinical studies.
Located within the Hospital Saint Vincent de Paul, a major hospital in the center of Lille, the Center is also uniquely flush with a pool of volunteers from a regional population ripe with specific nutritional needs. “The Nord-Pas de Calais region has the highest prevalence of weight problems, obesity, diabetes and broader cardiometabolic disorders in France,” said Mr. Ripoll. “In the center we will be able to perform studies with a wide variety of finished foods (cranberry, green tea, dairy products fortified with omega 3, Bifidus, etc.), functional ingredients (prebiotics, probiotics, fiber, flavonoids, phytosterols, etc.) or food supplements (vitamins, minerals, fatty acids, etc.) and in various areas of expertise such as cardiovascular and metabolic diseases, atherosclerosis, diabetes, inflammation disorders, mental health and many more.”
Naturalpha is currently conducting various clinical studies on behalf of local and international clients—ingredients manufacturers, dietary supplements makers and food industries. The company expects its first set of results to be ready in late spring 2011.
Making a Case for Research
Opening a research center the scale of Naturalpha’s might not be in the cards for most businesses, however Doug Kalman, PhD, MS, RD, director of nutrition, Miami Research, South Miami, FL, asserted that investing in one’s own research is a wise business move, both for its potential for return on investment as well as its potential to instill greater consumer confidence in a company’s product.
Most companies would be stymied by the assumption that since they don’t have Nestle or Danone-type capital, conducting their own research is out of the question. Not so, according to Dr. Kalman. “On some level there’s an over estimation about the cost of research in the dietary supplement industry,” he said. “For example, the rule of thumb in pharmaceutical research is that 10-15% of marketing budget is put into R&D. Lily puts about $19.7 billion into R&D.
“I realize the supplement market doesn’t have that kind of cash. People think dietary supplement companies make so much money but some reports list the total market value at $20-25 billion. As a comparison, Merck bought Wyeth for $58 billion—that’s one purchase worth more than what the dietary supplement industry is worth in its entirety.”
Although the supplement market size is less in comparison to big pharma, Dr. Kalman said industry can take many research cues to make the most of more modest budgets.
“When it comes to research for dietary supplement companies, as long as the ingredient is DSHEA-compliant, and it’s not a new dietary ingredient that requires a company to invest in expensive toxicology and safety testing, there really aren’t high costs for finished products or finished ingredient research,” he said. “I would argue that probably for the cost of two or three national advertisements, supplement companies could probably get two or three clinical trials with hard outcomes that will probably allow them to be in better compliance with FTC and FDA because now you have finished ingredient or finished product data that can be used in your marketing, rather than borrowed science. Even $10,000 can fund a research project in a setting that would produce legitimate and publishable results, while at the same time increasing your potential for patentable Intellectual Property (IP), should you discover something novel.”
Dr. Kalman went on to explain how the low barrier for entry into the supplement market can also be easily overlooked. “Overall, there isn’t a good understanding of regulatory or the U.S. patent and trademark system, and few companies understand how to obtain state and federal tax credits for research and development,” he said. “Obviously it becomes harder to patent something that occurs in nature but you can couple what’s called a use patent with a clinical trial that has hard data, which can become something that has real teeth. That becomes what’s part of somebody’s intellectual property portfolio, meaning that it increases the valuation of both the product and the company as a business. It’s not really that costly and you can actually get some tax credit back for innovation up to about 75% of the dollars spent.”
He added that the bonus of being first to market with a new product typically returns a 60-70% market share, even after other companies follow up with “me too” products.
Petitioning the U.S. government for financial assistance is also an option. “The NIH is currently funding five academic research center studies regarding botanicals,” said Dr. Kalman. “There is definitely an uptick in our government’s interest in research thanks to the the popularity of certain supplements and conditions. They’re currently funding at about $5-7 million per center and that’s a lot of money for research.”
Overall, a few noteworthy supplement and nutrition companies that have made the most of their research investments include Gatorade, Metagenics, Life Extension Foundation and Herbalife.
Another area to explore is partnering with medical centers, though there is a misperception that when a company pursues this route they might be paying for their results, so to speak, rendering the research less valid. “Thought the same scenario is not used against big pharma, it’s unfortunately used against the supplement industry,” Dr. Kalman said. “Those kind of knocks have no legitimacy, especially if the study undergoes peer review and obtains proper approval. To make claims on your product, you need two randomized, double-blind, placebo-controlled trials done by different institutions or researchers. The idea is to promote research and innovation. The difference is only in the quality of study design.”