1. Obesity Research Science Board Advisory Committee Meeting April 22, 2004 David W K Acheson Chief Medical Officer, Director Food Safety and Security Staff, Center for Food Safety and Applied Nutrition

2. Research – OWG approach One of the mandates of the OWG was to identify applied and basic research needs that include the development of healthier foods as well as a better understanding of consumer behavior and motivation.

3. Overall Approach 1.Principle was to determine the main research topics that are mission relevant to FDA 2.Document current and relevant research related to the mission relevant topics 3.Identify knowledge gaps

4. Three Main Areas Examined 1.Labeling a.Restaurants b.Nutrition Facts Panel 2.Translational Research a.Neonatal imprinting b.Genomics, Proteomics, Metabolomics c.Impact of caloric restriction 3.Other areas a.Drugs and devices b.Food additives c.Dietary supplements

5. Labeling Research Focus groups a.Restaurant label – determine consumer reaction to menus that include caloric information. b.Food label – determine consumer reaction to Nutrition Facts Panel Calories %DV, eliminating calories from fat, Adding more information on multi-serving packages to show actual calories and %DV in package c. Messages: Determine what is most effective for conveying sound nutritional message.

6. Labeling Research Development of a social sciences model to help determine factors that influence dietary and weight management. Review of literature to: –identify factors affecting food behavior –catalogue existing data Develop quantitative model –individual decisions affecting weight –physical activity, food choice –attitudinal, behavioral, environmental factors Useful in cost benefit analyses –food labeling regulation –policy development

7. Consumers Perceptions and Attitudes Overweight vs. Obesity –Some indication that the former is of little consequence to consumers Perception of weight status –Adults and teenagers misperceive –Men underestimate –Healthy/underweight women over estimate –Parents misjudge the weight of their children Consumers perception of their diet –Tendency to think you are eating a more healthy diet than you actually are Recent focus group studies on obesity –Parents & children –Perception of obesity, access to information, perceived barriers, motivators –Conclusions: Emphasize incremental change, beware of over-saturation with health information, focus on child education

8. Knowledge Gaps 1.Information used to facilitate consumers’ weight management decisions. Need for qualitative and quantitative research: –Consumer reaction to the food label (e.g. highlighting calories, listing the quantitative amounts of nutrients in multi-size packages) –Consumer reaction to and effectiveness of restaurant nutrition information (e.g. listing information about calories, fat and sodium) –Consumer dietary behavior and attitudes toward weight management

9. Knowledge Gaps 2. Relationship between obesity and food consumption patterns: Relationship between obesity and the frequency of foods consumed in different locations (e.g. home, fast food, restaurants) –Impact of socioeconomic status and ethnic background Factors that contribute to overeating (e.g. supersize portions)

10. Forumulation Research Qualitative investigation to understand what determines food product reformulation Do current regulations offer either a barrier or incentive for the production of healthy foods? Discussions with key industry personnel through third party contractor Reformulation by manufacturers –food labeling, label claims –changes in regulations –incentives

11. Knowledge Gaps 3. Incentives to product reformulation Explore the barriers and incentive to the development of healthier foods –Do incentives (e.g. label prominence) impact industry on development of healthier foods –Do barriers (e.g. regulatory hurdles) have an impact on development of healthier foods. –If so to what degree and how can these be addressed?

12. Other Areas to Consider Drugs and devices Food additives Dietary supplements

13. Knowledge Gaps 4. Potential for FDA-regulated products to be unintentionally contributing to obesity Weight gain may be an unintended and under recognized complication of certain medications This has not been consistently measured, evaluated and considered as an adverse effect –Need to determine if this is a problem –Potentially develop an animal model to study long term effects on weight with medications

14. Basic Science 1.Neonatal imprinting Impact of “developmental programming” during early development when metabolic pathways are being established in the fetus and neonate. 2. ‘Omics to identify susceptibilities Linking genetics with subsequent obesity through genomics proteomics and metabolomics. 3.Effects of caloric restriction or sudden weight loss on metabolism Over the last 10 years research at NCTR has examined metabolic and disease outcome effects (e.g., free radical formation, malignant tumor rates) of “less than ad lib” feeding and rapid weight reduction.

15. Knowledge Gaps 5. Translational Research Essential for FDA to use basic research in developing regulatory policies, especially NIH. –Developmental imprinting to determine the impact of fetal or neonatal exposure on future weight –Use of “omics” to identify how FDA-regulated products modify risk factors for weight gain –Development of animal models for effects of diet, drugs therapy, long-term weight maintenance.

16. Conclusions Calories are a critical element Understanding consumers –Food label –Eating habits –Weight management Develop healthier foods Input from basic research in development of regulatory policy