““Critical Path” for Food Critical Path” for Food and Nutritionand Nutrition

Science BoardScience Board

November 5, 2004November 5, 2004

Alan M. RulisAlan M. Rulis

FDA recently released aFDA recently released a“Critical Path” paper: “Critical Path” paper:

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

http://www.fda.gov/oc/initiatives/http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.htmlcriticalpath/whitepaper.html

Foods – the Critical PathFoods – the Critical Path

A complementary approachA complementary approach

Draft Working Title:Draft Working Title:

“ “PROGRESS ON THE PATHWAY TO PROGRESS ON THE PATHWAY TO HEALTHIER CONSUMERS”HEALTHIER CONSUMERS”

IDENTIFYING AND FILLING CRITICAL FOOD AND NUTRITION IDENTIFYING AND FILLING CRITICAL FOOD AND NUTRITION RESEARCH, TECHNOLOGY AND INFORMATION GAPSRESEARCH, TECHNOLOGY AND INFORMATION GAPS

Premise:Premise:

Targeted research efforts in specific areas Targeted research efforts in specific areas of nutrition and food science have the of nutrition and food science have the ability to accelerate progress in using ability to accelerate progress in using nutrition to achieve public health goals.nutrition to achieve public health goals.

A decade ago, the National Academy of A decade ago, the National Academy of Sciences foresaw potential advances in Sciences foresaw potential advances in nutrition and food sciences as among the nutrition and food sciences as among the most important determinants in advancing most important determinants in advancing public health and recommended five public health and recommended five areas/themes in which research should be areas/themes in which research should be focused:focused:

Nutrients and biologically active food Nutrients and biologically active food constituents in development, cell constituents in development, cell differentiation, growth, maturation, and differentiation, growth, maturation, and aging;aging;

Genes, food, and chronic diseases;Genes, food, and chronic diseases;

Determinants of food intake;Determinants of food intake;

Improving food and nutrition policies; andImproving food and nutrition policies; and

Enhancing the food supplyEnhancing the food supply

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

NAS Research Recommendations:NAS Research Recommendations:

What’s happened since 1994?What’s happened since 1994?

Nutrition is still a prime determinant in public Nutrition is still a prime determinant in public healthhealthMany changes (some good/ some less good)Many changes (some good/ some less good) NLEA was implemented by FDA regulationsNLEA was implemented by FDA regulations Modern biotech advancedModern biotech advanced Obesity issue emerged as major public health threatObesity issue emerged as major public health threat ““Omics” – (linking genetics and nutritional influences) Omics” – (linking genetics and nutritional influences)

emergesemerges Food Technology advances (processes and packaging) Food Technology advances (processes and packaging) Dietary Supplements continue to be of interestDietary Supplements continue to be of interest

What’s the approach for the What’s the approach for the Foods paper?Foods paper?

We are making progress in advancing nutrition We are making progress in advancing nutrition knowledge that holds the promise of improved knowledge that holds the promise of improved health and longevity for millions of our citizens.health and longevity for millions of our citizens.

Along the pathway to future improved health Along the pathway to future improved health status are unanswered research questions and status are unanswered research questions and information gaps.information gaps.

The paper will identify what we believe are critical The paper will identify what we believe are critical food and nutrition research, technology and food and nutrition research, technology and information gaps and encourage applied research information gaps and encourage applied research and the development of evaluative tools in and the development of evaluative tools in several areas.several areas.

Underpinning these endeavors is the need for Underpinning these endeavors is the need for FDA to be positioned with the proper knowledge, FDA to be positioned with the proper knowledge, skills, and tools that will enable us to endorse and skills, and tools that will enable us to endorse and promote the science behind advances in nutrition, promote the science behind advances in nutrition, and assure that the benefits are real and that and assure that the benefits are real and that products based on these advances are safe.products based on these advances are safe.

Research Needs/Knowledge GapsResearch Needs/Knowledge Gaps

General Nutrition Research:General Nutrition Research: Advancing the Advancing the foundations of general nutrition knowledge, foundations of general nutrition knowledge, including the role of proper nutrition for adults including the role of proper nutrition for adults and the elderly, and making use of research in and the elderly, and making use of research in animal modelsanimal models

Infants, children and adolescents:Infants, children and adolescents: Improving Improving the scientific foundation for the scientific foundation for establishing/assessing the benefits and safety of establishing/assessing the benefits and safety of new/novel infant formula ingredients, for new/novel infant formula ingredients, for example, and addressing nutrition issues example, and addressing nutrition issues relevant to children and adolescents. relevant to children and adolescents.

Research Needs/Knowledge GapsResearch Needs/Knowledge Gaps

Biotechnology:Biotechnology: Validating new techniques for Validating new techniques for safely using biotechnology to create foods with safely using biotechnology to create foods with enhanced levels of constituents important to enhanced levels of constituents important to good healthgood health

““Omics:”Omics:” Research into the application of Research into the application of modern “omics” techniques to better facilitate modern “omics” techniques to better facilitate the tailoring of nutrition advice to individual the tailoring of nutrition advice to individual consumers. consumers.

Research Needs/Knowledge GapsResearch Needs/Knowledge Gaps

Food Technology: Food Technology: Research directed at advancing Research directed at advancing modern food technology by developing new means to modern food technology by developing new means to produce, preserve, package and distribute food;produce, preserve, package and distribute food;

Behavioral research:Behavioral research: Advancing our knowledge and Advancing our knowledge and developing a better understanding of behavioral factors developing a better understanding of behavioral factors influencing consumer food choice decisionsinfluencing consumer food choice decisions

Dietary Supplements:Dietary Supplements: Developing the capacity and the Developing the capacity and the knowledge base required for assuring the safety of new knowledge base required for assuring the safety of new dietary supplements ingredients dietary supplements ingredients

Academic Research

GAPSGAPSNew safety questionsMicrobial, Nutritional, Toxicological, etc.

Appropriate Validated Biomarkers

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