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Perspectives on Biomarker and Surrogate Endpoint Evaluation Discussion Forum Summary (2011) / Chapter Skim
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6 Public Health, Consumer, and Consulting Organization Perspectives
Pages 69-74

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From page 69...
... • How does the recommended biomarker evaluation framework relate to biomarker evaluation processes currently in use with your industry or stakeholder? • Will a prospective biomarker evaluation process add clarity to product development and consumer understanding?
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From page 70...
... Johnson emphasized that biomarkers offer an important means to communicate useful information to companies and other organizations and to inform research. He expressed hope that the report can be used to "provide some structure around how that information can be communicated." Such communication could happen during the utilization step, by distinguishing between predictive biomarkers, for which there is evidence of an association with a clinical endpoint (for example, C-reactive protein [CRP]
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From page 71...
... The abundance of calories in the current American diet does not guarantee nutrient sufficiency, let alone the optimal or ideal intake of particular nutrients, she said. "Biomarkers of nutritional status as they relate to health are very important, and understanding the interplay between the nutrient intake and the development and progression of these chronic diseases is very important for individuals and consumers at large," Dr.
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From page 72...
... Ms. Heller described three categories of health-related claims: autho rized health claims, which require significant scientific agreement; qualified health claims, which are based on credible evidence; and structure– function claims, which merely associate a nutrient contained in the food with a health benefit.
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From page 73...
... However, the City of San Francisco successfully challenged a false immunity claim displayed on Cocoa Krispies boxes, as did the Federal Trade Commission, while the FDA did not. Recently, the FDA sent a warning letter to the makers of Juicy Juice regarding its structure–function claim linking docosahexaenoic acid (DHA, an omega-3 fatty acid)
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From page 74...
... "There are well-established claims, like ‘calcium builds strong bones,' that could form a category of claims to be included in a safe harbor or a positive list, as it is known in the European Union." In addition, health claims could be rephrased as structure–function claims, provided structure–function claims meet the minimum and maximum nutrient levels currently demanded by health claims. The FDA could also consider the structure–function claims approved by the European Food Safety Authority, she added.
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Key Terms

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  • surrogate endpoint

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  • food labels
  • nutrient levels
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  • drinking green

  • food safety
  • american dietetic
  • maximum nutrient
  • dietetic association
  • tea reduces

  • nutrition solutions
  • credible evidence
  • fda sent
  • stringent standards
  • nearly half

  • prosecute breaches
  • staff attorney
  • inform research
  • government accountability
  • current american

  • nutrient contained
  • originally applied
  • prior approval
  • lacks resources
  • purported benefit


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