“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” whitepaper.html

Foods – the Critical Path A complementary approach Draft Working Title: “PROGRESS ON THE PATHWAY TO HEALTHIER CONSUMERS” “PROGRESS ON THE PATHWAY TO HEALTHIER CONSUMERS” IDENTIFYING AND FILLING CRITICAL FOOD AND NUTRITION RESEARCH, TECHNOLOGY AND INFORMATION GAPS

Premise: 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: 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:

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

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 NLEA was implemented by FDA regulations Modern biotech advanced Modern biotech advanced Obesity issue emerged as major public health threat Obesity issue emerged as major public health threat “Omics” – (linking genetics and nutritional influences) emerges “Omics” – (linking genetics and nutritional influences) emerges Food Technology advances (processes and packaging) Food Technology advances (processes and packaging) Dietary Supplements continue to be of interest Dietary Supplements continue to be of interest

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 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 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 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

Academic Research GAPS New safety questions Microbial, Nutritional, Toxicological, etc. Appropriate Validated Biomarkers Analytical Compliance Consumer understanding and behavior changes * * Includes development of effective scientific and social knowledge base as well as holistic analysis of risks and benefits. Healthier Consumers SOMETIMES A PICTURE IS WORTH A THOUSAND WORDS… Food Technology Food Safety Nutrition New products, e.g. biotech enhanced foods, dietary supplements, infant formulas, etc.

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.