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“Critical Path” for Food and Nutrition. Science Board November 5, 2004 Alan M. Rulis. FDA recently released a “Critical Path” paper: . “Challenge and Opportunity on the Critical Path to New Medical Products”

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critical path for food and nutrition

“Critical Path” for Food and Nutrition

Science Board

November 5, 2004

Alan M. Rulis

fda recently released a critical path paper
FDA recently released a“Critical Path” paper:

“Challenge and Opportunity on the Critical Path to New Medical Products”

foods the critical path
Foods – the Critical Path
  • A complementary approach
  • Draft Working Title:



  • Targeted research efforts in specific areas of nutrition and food science have the ability to accelerate progress in using nutrition to achieve public health goals.
A decade ago, the National Academy of Sciences foresaw potential advances in nutrition and food sciences as among the most important determinants in advancing public health and recommended five areas/themes in which research should be focused:

NAS Research Recommendations:

  • Nutrients and biologically active food constituents in development, cell differentiation, growth, maturation, and aging;
  • Genes, food, and chronic diseases;
  • Determinants of food intake;
  • Improving food and nutrition policies; and
  • Enhancing the food supply

(“Opportunities in the Nutrition and Food Sciences: Research Challenges and the Next Generation of Investigators,” National Academy Press (1994))

what s happened since 1994
What’s happened since 1994?
  • Nutrition is still a prime determinant in public health
  • Many changes (some good/ some less good)
    • NLEA was implemented by FDA regulations
    • Modern biotech advanced
    • Obesity issue emerged as major public health threat
    • “Omics” – (linking genetics and nutritional influences) emerges
    • Food Technology advances (processes and packaging)
    • Dietary Supplements continue to be of interest
what s the approach for the foods paper
What’s the approach for the Foods paper?
  • We are making progress in advancing nutrition knowledge that holds the promise of improved health and longevity for millions of our citizens.
  • Along the pathway to future improved health status are unanswered research questions and information gaps.
The paper will identify what we believe are critical food and nutrition research, technology and information gaps and encourage applied research and the development of evaluative tools in several areas.
  • Underpinning these endeavors is the need for FDA to be positioned with the proper knowledge, skills, and tools that will enable us to endorse and promote the science behind advances in nutrition, and assure that the benefits are real and that products based on these advances are safe.
research needs knowledge gaps
Research Needs/Knowledge Gaps
  • General Nutrition Research: Advancing the foundations of general nutrition knowledge, including the role of proper nutrition for adults and the elderly, and making use of research in animal models
  • Infants, children and adolescents:Improving the scientific foundation for establishing/assessing the benefits and safety of new/novel infant formula ingredients, for example, and addressing nutrition issues relevant to children and adolescents.
research needs knowledge gaps11
Research Needs/Knowledge Gaps
  • Biotechnology: Validating new techniques for safely using biotechnology to create foods with enhanced levels of constituents important to good health
  • “Omics:” Research into the application of modern “omics” techniques to better facilitate the tailoring of nutrition advice to individual consumers.
research needs knowledge gaps12
Research Needs/Knowledge Gaps
  • Food Technology: Research directed at advancing modern food technology by developing new means to produce, preserve, package and distribute food;
  • Behavioral research: Advancing our knowledge and developing a better understanding of behavioral factors influencing consumer food choice decisions
  • Dietary Supplements: Developing the capacity and the knowledge base required for assuring the safety of new dietary supplements ingredients


Healthier Consumers




New products, e.g. biotech enhanced foods, dietary supplements, infant formulas, etc.

New safety questions

Microbial, Nutritional, Toxicological, etc.

Consumer understanding and behavior changes

Appropriate Validated Biomarkers

Analytical Compliance

Translational Research



Includes development of effective scientific and social knowledge base as well as holistic analysis of risks and benefits.


Food Safety

Academic Research

when all is said and done
When all is said and done…
  • A major focus of the initiative will be to enhance the long-term health and well-being of the American consumer by identifying ways to develop a more effective scientific and social knowledge base, within the framework of a holistic approach to analyzing risks and benefits, which integrates both nutrition and food safety, and to apply that knowledge to foster innovation that helps establish healthy nutrition and dietary patterns throughout life.