Just in time for the deadline for comments, the Council for Responsible Nutrition (CRN), Washington, D.C., responded in late March to the Office of Dietary Supplements’ (ODS) 2010-2014 strategic plan. Overall, the trade association’s comments both acknowledged ODS for its research achievements and criticized its shortcomings.

With regard to the former, CRN said, “Fifteen years ago, many scientists at major universities would have shied away from research dealing with herbs and other botanicals, while today there are half a dozen ODS-funded Botanical Research Centers at leading universities. Fifteen years ago, serious discussions of dietary supplement usage patterns and potential health benefits were rare at scientific meetings, while today such discussions are a routine component of research conferences.”

CRN went on to say that ODS has excelled in the area of dietary supplement research largely because of its focus on partnering with various NIH institutes and other research institutions, including Federal entities such as USDA, CDC and National Institutes of Standards and Technology (NIST), as well as numerous universities in every region of the country. “ODS is congratulated for skillfully multiplying its limited resources…Such efforts must definitely continue and even be expanded if resources permit,” CRN suggested.

One area of expansion that CRN believes ODS should consider addressing is healthcare savings. “It is important to assess whether, and to what extent the use of dietary supplements leads to reductions in healthcare spending, presumably by reducing the risk of chronic disease,” it said. “Ultimately, public health recommendations involving dietary supplements will be tied to healthcare and associated costs.”

CRN also discussed the inadequacy of randomized controlled trials (RCTs) in assessing nutrient effects, and emphasized that future research involving dietary supplements be less reductionist in nature and more holistic and integrative. “ODS has been active in sponsoring evidence-based reviews through the Agency for Healthcare Research and Quality (AHRQ). As currently defined, evidence-based reviews focus on evidence from RCTs and give little credence to other scientific evidence, including well-conducted observational studies,” the organization commented.

“While RCTs are needed to establish causality between intake of a substance and an outcome(s) of interest, many of the large, highly publicized RCTs published in recent years may not have been adequately designed to assess nutrient effects. In contrast, most have assessed nutrients using a drug-like model. Although experts in the field of nutrition science have been openly critical of this approach, and justifiably so, none have as yet offered an alternative approach with comparable rigor to that established for the classic RCT.”

In its comments, CRN also lauded the efforts of ODS in the areas of analytical methods, dietary supplement databases, biomarkers and outreach efforts. The organization also offered its assistance in helping ODS fulfill its goals in these areas.

While the comments were mostly positive, CRN did harshly criticize some ODS staff for their negative perception of dietary supplements and use of outdated statistics with regard to dietary supplement usage. Further, it urged ODS to fulfill its mission as an advocate of dietary supplements and provide more balance in public statements regarding their use. CRN concluded its comments by suggesting that ODS serve as an advisor to FDA on dietary supplement matters and more actively engage industry trade associations in collaborating and implementing its initiatives in the years ahead.