final score is used to characterize the quality of the study (the eight items are inclusion or exclusion criteria, group allocation, blinding, attrition, exposure or intervention, health effect, statistical analysis, and potential confounders).

DuPont also has its own internal tools for rating evidence, including one developed by Craig that rates each study as A (excellent), B (good), C (weak), or F (does not support) and then rates the overall body of evidence based on the cumulative study ratings. For example, a high-quality study that reported a significant effect but only in the elderly and at a high dose might be rated B because it provides only limited support for a claim that a lower dose is effective in the general adult population. Craig noted that opinions sometimes differ on whether a study should be rated an A, B, or C or even on the overall assessment of the evidence, but at least the tool provides a framework for having a discussion.

Craig remarked that while DuPont is conscientious about scientific substantiation of claims and will provide its clients with analyses of their claims, final responsibility for scientific substantiation lies with the food manufacturer. Because there is no global system for scientific substantiation, with every region operating according to its own rules, what is needed in one country may differ from what is needed in another country. Navigating these complex regulatory differences across the globe is challenging, especially as the global regulatory environment moves toward a higher scientific standard for safety and efficacy, but “we have to rise to that challenge,” Craig said. He encouraged more discussion among government, industry, and academia.

THE REGULATORY ENVIRONMENT: A SYNTHESIS16

Some of the regulatory challenges addressed by previous workshop speakers stem from the fact that “we are struggling to fit” an emerging science into “an outdated paradigm” for conceptualizing the relationship between food and health, Sarah Roller said. The paradigm recognizes that by virtue of essential nutrients it contributes to the body, food is capable of supporting nutritional needs, promoting normal growth and development, and otherwise affecting the structures and functions of the body. However, the paradigm fails to adequately account for contributions food makes to health through components that are not currently classified as essential nutrients, such as probiotics. The outdated scientific paradigm was codified in the “drug” definition that is part of the FD&C Act adopted in 1938. The drug definition in the FD&C Act continues to play a key role in the regulatory and enforcement policies of FDA and functions to limit the opportuni-

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16 This section summarizes the presentation of Sarah Roller.



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