# Presentation: 106814

## FDA Obesity Work GroupKnowledge 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

## 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

## 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

## 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

## 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!

## 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

## 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

## 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

## 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

## Center for Consumer Freedom

- “Your Foods Under Attack”
- Consequences of Litigation against Restaurants and Industry
- Consequences of Classifying Obesity as a Disease

## 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)

## 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))

## 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).

## 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”

## 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

## 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

## Weight WatchersFlex 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

## 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)

## 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)

## 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**

## 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

## 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

## 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

## 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

## 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

## 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

## NCI Initiatives: Ensuring 5 A Day

- NCI’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

## 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

## USDA Initiatives: Aiming to Encourage Good NutritionFood Guide Pyramid

## 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

## 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

## 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

## FDA Knowledge Base

- Conceptual Grouping
- Education
- Regulation/Guidance
- Enforcement
- Research

## 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)

## 1. Education

**Food Label Content Relevant to Weight**
**Management**
- 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"

##  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

## 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 Information**
**for Better Nutrition**
- Framework to enhance conveyance of scientifically accurate information about the health consequences of foods.

## 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

## 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

## 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

- 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*

## 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)

- 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*

## Food Additive Approvals

Reduced or no-calorie sweeteners

Reduced or no-calorie fat substitutes 

- Reduced or no-calorie sweeteners
- Reduced or no-calorie fat substitutes

*2. Regulation/Guidance*

## 3. Enforcement

**Enforcement and Compliance Activities**
- Labeling errors
- Misleading claims
- Unsafe products

## a) Communication/Labeling/Packaging

b) Effectiveness of Treatment/Prevention

c) Describing the Causal Links

**b) Effectiveness of Treatment/Prevention**
**c) Describing the Causal Links**

- 4. Research

## 4. Research

**a) 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

## 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

## 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%? 

- 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*

## 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)

- 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*