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FDA Obesity Work GroupKnowledge Base Subgroup

Richard Canady, Ph.D., DABT,

Corinna Sorenson, M.P.H., M.H.S.A.,

and Donna Robie Howard, Ph.D.

October 23, 2003

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Examples of Academic Research

Stanford – Prevention Research Center Modification of Social and Personal Factors

Tufts – School of Nutrition Science and Policy, Center on Nutrition Communication Dissemination of Nutrition Information Health and Nutrition Letter

University of Pennsylvania Research Related to Nutrition and Prevention of Obesity

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Example of Industry Activity

Kraft Foods

Worldwide Health & Wellness Advisory Council Guidelines for the Nutritional Characteristics of All

Products Limiting Portion Sizes on Single-Serving Packages A Planned Effort to Help Improve Existing Products and

Provide Alternative Choices, where Appropriate The Elimination of All In-School Marketing

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Examples of Restaurant Activity

Wendy’s Build a Meal Tray Liners – “Ask for a Nutrition Guide”

McDonald’s Healthy Lifestyle Initiative Menu Choices Physical Activity Education Bag a McMeal

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Foundations

International Food Information Council New Nutrition Conversation with Consumers Kidnetic.com Food Insight Newsletter

International Life Sciences Institute Physical Activity and Nutrition (PAN) Program Take 10TM!

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Grocery Manufacturers of America

Incorporate Physical Activity and Nutrition Education in our Nation’s Schools

Encourage People to Incorporate Physical Activity in their Daily Lives

Educate the Public on the Connection between Calories Consumed and Calories Burned

Raise Consumer Awareness of Standardized Serving Sizes Address the Needs of Different Population Subgroups

Opposition to School Marketing Restriction Legislation

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National Restaurant Association

“According to the National Restaurant Association, science clearly proves that food cannot be, and is not, the sole culprit of the increasing rate of obesity in the U.S. Experts agree that this problem is fundamentally about energy balance-how much we eat in relation to how many calories we burn off each day.”

National Restaurant Association Press Room, “Fitness is Key to a Healthy Lifestyle”, http://www.restaurant.org/pressroom/fitness.cfm

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Center for Science in the Public Interest

Have Historically Raised Issues Concerning “Unhealthy” Foods

Improving Your Diet and Health 9 Weeks to a Perfect Diet 10 Steps to a Healthy Diet 10 Foods You Should Eat 10 Foods You Should Never Eat

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Center for Science in the Public Interest

Policy Options CSPI Suggests Instructions to Take Action What Action is Appropriate

School Foods Tool Kit How to Improve School Foods and Beverages Model Materials and Policies Case Studies

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Center for Consumer Freedom

“Your Foods Under Attack”

Consequences of Litigation against Restaurants and Industry

Consequences of Classifying Obesity as a Disease

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States

California “Soda Ban” Signed into Law – September 2003 (Gov. Gray Davis)

DC Labeling Legislation (DC City Council Member Mendelson (D-At Large))

Florida Task Force (Gov. Jeb Bush (R)) NY Childhood Obesity Prevention Program –

Commercial Alert Assemblyman Felix Ortiz (D-Brooklyn)

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Legislation

"Personal Responsibility in Food Consumption Act (Representative Keller (R-FL))

"Commonsense Consumption Act" (Senator McConnell (R-KY))

“Restaurant Information Act of 2003” (Representative DeLauro (D-CT))

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Lawsuits

John F. Banzhaf – Seven Lawsuits Filed

Oreo Suit – Dropped

Barber Suit – Little Recent Activity

Pelman/Bradley Suit – Dismissed

Obesity Policy Report, Volume I, Number 8 (June 2003).

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Media - Periodicals

Time Magazine October 20, 2003 – “The Secrets of Eating Smarter” September 2, 2002 – “What Really Makes You Fat?”

U.S. News and World Report June 16, 2003 – “The Truth about Weight Loss” August 19, 2002 – “SuperSize America”

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Media - Books

Amazon Search for Books on “Diet” – 31,018 Matches

Amazon Search for Books on “Weight Loss” – 1913 Matches Atkins’ Diet Dr. Phil McGraw The South Beach Diet

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Media – Television

Food Network Cooking Thin

Kathleen Daelemans Lighten Up

Janette Barber and Christina Deyo

“A Katie Couric Special” – September 12, 2003 Two Hour Special – Dr Phil McGraw

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Weight WatchersFlex Points System

Every Food Assigned a Point Value Individuals Assessed and Given a Daily Point Value Participants Allowed 35 Free Points a Week Activity Points Maintenance Program Once Goal is Reached

Recipes Extensive Q&A on Website

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Government Agencies Involved in Addressing Obesity and Nutrition

Issues

Department of Health and Human Services (DHHS)

Centers for Disease Control and Prevention (CDC) National Institutes of Health (NIH) Food and Drug Administration (FDA)

U.S. Department of Agriculture (USDA)

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DHHS Initiatives: Fostering Disease Prevention and Health Promotion

Steps to a HealthierUS New Initiative to Advance the President’s HealthierUS goal Priority Areas Include Obesity, Poor Nutrition, and Physical Inactivity

Healthy People 2010 Comprehensive Set of Disease Prevention/Health Promotion

Objectives Developed to Improve the Health of All Americans Healthfinder®

Government’s Premier Gateway Web Site Linking Consumers and Professionals to Over 60,000 Health Information Resources from the Federal Government and its Many Partners

National Health Information Center (NHIC) National Health Information Infrastructure (NHII)

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CDC Initiatives: Focus on Improving Lifestyle Behaviors

“Regular Physical Activity is Such a Crucial Part of Good Health; Our Goal is to Help People Understand that even Modest Activity Such as Walking is a Step in the Right Direction.”

– J. Gerberding, MD, MPH, Director, CDC

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CDC Initiatives: Focus on Improving Lifestyle Behaviors

Trails for Health Program to Help Americans Achieve the Health Benefits of Physical

Activity by Increasing Opportunities for Physical Activity

Active Community Environments (ACES) Initiative to Promote Walking, Bicycling, and the Development of

Accessible Recreation Facilities

Personal Energy Plan (PEP) 12-Week Self-Directed, Worksite Program to Promote Healthy Eating

and Moderate Physical Activity

WISEWOMAN Provides 40 to 60 Year-Old Women with the Knowledge and Skills to

Improve Lifestyle Habits

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CDC Initiatives: Focus on Improving Lifestyle Behaviors

Programs that Target Youth KidsWalk-to-School

Community-Based Program that Encourages Individuals and Organizations to Work Together to Identify and Create Safe Walking Routes to School

VERB Integrated Awareness Campaign to Encourage Positive

Physical Activity among Youth Age 9-13 Media Partners Include Disney, Kids’ WB!,

Nickelodeon, and AOL Time Warner

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CDC Initiatives: Focus on Improving Lifestyle Behaviors

School Health Index Self-Assessment and Planning Tool that Enables Schools

to Identify the Strengths/Weaknesses of their Physical Activity and Nutrition Policies/Programs

Other CDC Efforts Health Program Funding Research Programs Surveillance Activities Provision of Consumer Information

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NIH Initiatives: Combating Obesity – a Precursor to Chronic Disease

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD)

NIH also Provides Relevant Information via MEDLINE and Supports Genetic Studies on Nutritional and Metabolic Diseases, Including Obesity

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NIH Initiatives: Combating Obesity – a Precursor to Chronic Disease

NHLBI

Obesity Education Initiative (OEI)

Decade Old Education Program to Encourage the Adoption of Heart Healthy Eating Patterns and Physical Activity Habits

Population-Based Strategy

Risk-Based Strategy

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NIH Initiatives: Combating Obesity – a Precursor to Chronic Disease

NIDDKD

National Task Force on Prevention and Treatment of Obesity Leading Obesity Researchers and Clinicians

Weight-Control Information Network (WIN) National Information Service for Health Professionals and Consumers

Sisters Together: Move More, Eating Better Designed to Encourage Black Women 18 and Over to Maintain a

Healthy Weight

Other Relevant Activities Include a Consumer Information Website and Grant Programs to Advance Obesity/Nutrition-Related Research

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NCI Initiatives: Ensuring 5 A DayNCI’s Well-Known Nutrition Programs Strive to

Increase the Intake of Fruits and Vegetables

5 to 9 A Day Program to Encourage Americans to Eat 5 or More Servings of Fruits

and Vegetables Every Day for Better Health In Collaboration with CDC and the Produce for Better Health

Foundation Men: Shoot for 9

Initiative to Encourage Men to Eat 9 or More Servings of Fruits and Vegetables Every Day for Better Health

Mechanisms for Physical Activity Behavior Change

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USDA Initiatives: Aiming to Encourage Good Nutrition

Interactive Healthy Eating Index (IHEI)

On-line Dietary Assessment Tool that Includes Nutrition Messages

Evaluates Dietary Intake as Compared to the Food Guide Pyramid

Website also Includes Recipes and Tips for Healthy Eating

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USDA Initiatives: Aiming to Encourage Good Nutrition

Food Guide Pyramid

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USDA Initiatives: Aiming to Encourage Good Nutrition

Nutrition and Your Health: Dietary Guidelines for Americans Provides Advice for Americans 2 Years and Older about

how Good Dietary Habits can Promote Health and Reduce Risk for Major Chronic Diseases

USDA Team Nutrition Designed to Ensure the Effective Implementation of

Healthy Breakfasts and Lunches in Schools

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USDA Initiatives: Aiming to Encourage Good Nutrition

Eat Smart. Play Hard. Education and Promotion Campaign to Combat

Childhood Obesity and Chronic Diseases

Food and Nutrition Information Center Website Includes Sections on Dietary Guidelines, Food

Guide Pyramid, Food Composition, Dietary Supplements, Food Safety, and Healthy School Meals

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USDA Initiatives: Aiming to Encourage Good Nutrition

USDA Programs Targeting Low-Income Children and Families Farmers’ Market Nutrition Program

Program Expands the Awareness and Use of Farmers’ Markets Provides Fresh, Unprepared, Locally Grown Fruits and

Vegetables to WIC Recipients

School Lunch Breakfast Program Federally-Assisted Meal Program to Help Ensure that Children

Engage in Healthy Eating Behaviors Meals must Meet the Applicable Recommendations of the

Dietary Guidelines for Americans

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FDA Knowledge Base

Conceptual Grouping

1. Education

2. Regulation/Guidance

3. Enforcement

4. Research

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1. Education

Know Your Label Web-based & video educational materials on how

to use nutrition labels to make informed food choices in the context of a healthy diet.

Power of Choice Guided activities and material to motivate and

empower kids to make healthy food choices in real-life settings, topics include portion control, emotional eating, and individual fitness. (Recently completed collaborative effort with USDA/FNS)

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1. Education

Food Label Content Relevant to WeightManagement Standard reference serving sizes in nutrition

facts panel Facilitates counting calories while choosing

nutritious foods, e.g., by comparing vitamins, minerals, and types of fats across products within a calorie range

Nutrient content claims Based on standard criteria, help consumers make

lower calorie choices when they see claims, like "reduced calories", "lite", "low calorie", "calorie free"

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 1. Education

Dietary Guidelines

2000 DG’s include attention to healthy BMI, activity,

eating sensibly, and portion size

Newly formed advisory committee is evaluating the need to update the DG's in 2005

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2. Regulation/Guidance

Labeling/Packaging Effort Research and development (stakeholder interaction, focus

groups, and modeling) to develop label modifications or new approaches to labeling conducive to weight management. (More under research heading below)

Task Force on Consumer Health Informationfor Better Nutrition Framework to enhance conveyance of scientifically

accurate information about the health consequences of foods.

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2. Regulation/Guidance

Guidance for Industry on Clinical Development of Weight Loss Drugs

Efficacy criteria for approval of drugs for the treatment of obesity Either, a statistically significant 5% or greater mean weight

loss from baseline with drug relative to placebo Or, a demonstration that the proportion of patients on

drug who reach and maintain a weight loss of at least 5% from baseline is statistically significantly greater than the proportion who achieve the same on placebo

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2. Regulation/Guidance

Guidance for Industry on Clinical Development of Weight Loss Drugs

Duration of trials

To establish durability of effect and to assess risks, FDA requires one year of placebo control with open-label extension through a second year

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Drug Approvals

Two products marketed for chronic use in obesity Orlistat (Xenical®) an inhibitor of intestinal fat

absorption Sibutramine (Meridia®) a

serotonergic/sympathomimetic anorexigen These are approved for patients with

BMI > 27 with co-morbid conditions and BMI > 30 with or without co-morbid conditions

2. Regulation/Guidance

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Devices Used for Obesity Treatment

Devices to restrict food intake or reduce hunger Lap-band and similar gastric pouch restriction devices

(only one approved specifically for obesity) Other devices in investigational stage

Surgical devices for use with lipoplasty, gastroplasty, and bypass/diversion

Monitoring and measuring devices related to body composition (body fat)

2. Regulation/Guidance

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Food Additive Approvals

Reduced or no-calorie sweeteners

Reduced or no-calorie fat substitutes

2. Regulation/Guidance

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3. Enforcement

Enforcement and Compliance Activities

Labeling errors Misleading claims Unsafe products

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a) Communication/Labeling/Packaging

b) Effectiveness of Treatment/Prevention

c) Describing the Causal Links

4. Research

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4. Researcha) Communication/Labeling/Packaging

Evaluation of restaurant and food labeling/packaging effects on weight management

November 20 options-generating and data-gathering workshop

Focus groups to probe new labeling/messaging 3rd party industry interviews to identify potential obstacles or

incentives to weight management messaging or products Development of a social science model for exploring

approaches to affecting weight management

Research on consumer use of calorie content labeling and calorie-related claims

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4. Research

b) Effectiveness of Treatment/Prevention

Pilot Cohort of dietary weight loss products used by women. Study pattern of use of herbal weight loss products by obese women; the potential for herbal/drug product interactions; and side effects

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c) Describing the Causal Links Genetic polymorphisms of obesity in conjunction

with susceptibility to breast cancer Role of exercise in weight gain and susceptibility to

mutation Effect of surgical intervention on metabolism and

biomarkers of reduced caloric intake Animal model of lower-level dietary restriction

10% dietary restriction increases lifespan and decreases cancer and other obesity-related diseases. What about 5%?

4. Research

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c) Describing the Causal Links Contribution of “methyl group” deficiency induced by

obesity to the development of cancer, heart disease and diabetes

Influence of developmental exposure to chemicals (e.g., tobacco smoke/nicotine) on childhood obesity

Rat model for nutritionally induced non-insulin dependent diabetes mellitus (link to morbidity)

4. Research