The uptick in business for CROs is a positive indication that dietary supplement and functional food companies are doing more research on their products.
Going into more detail on some of the recent hurdles, Andrew Shao, PhD, senior vice president, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN), Washington, D.C., explained, “Some companies are beginning to get the message that ‘borrowed’ or ‘pirated’ science is not in their best interest. However, in most cases, the incentive is still not there for a commitment to invest in R&D.”
Dr. Shao also believes the narrow focus on price at the expense of quality and science continues to pervade in many circles, further undermining the long-term health of the industry.
However, the tricky part with clinical work, said Doug Kalman, RD, director of nutrition research, Miami Research Associates (MRA), Miami, FL, is making sure the objective doesn’t cross the line into disease. “When you do a clinical trial on a dietary supplement that is evaluating its effects on a disease or condition, it makes that study into a drug study. Therefore, you need to file an investigational new drug (IND) application with FDA,” he said, adding, “And lately, FDA has been saying that unless you are talking about quality of life or performance enhancement, you need to file an IND.”
These aren’t the only areas nutraceutical companies are coming up short. The R&D department, where research begins, is, by most accounts, understaffed and underfunded. Allocating the appropriate resources could alleviate many of the pressures companies face in today’s competitive, highly scrutinized business environment.
Despite the money needed for clinical trials, it is essential to get these studies done, said CRN’s Dr. Shao. “Too often these studies are cut back or cut out in favor of placing resources toward marketing efforts,” he said. “What some companies fail to realize is that these trials become the marketing.”