FDA Obesity Work Group Knowledge Base Subgroup

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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

• Wendys
• Build a Meal
• Tray Liners Ask for a Nutrition Guide
• McDonalds 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 Nations 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 QA 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 Presidents
  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
• Governments 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 DiseaseNHLBI

• 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 DiseaseNIDDKD

• 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 Day

• NCIs 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
NutritionFood 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
• Education
• Regulation/Guidance
• Enforcement
• 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 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"

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 1. Education

• Dietary Guidelines
• 2000 DGs 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 Information
• for 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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2. Regulation/Guidance

• Drug Approvals
• Two products marketed for chronic use in obesity
• Orlistat (Xenical) an inhibitor of intestinal
  fat absorption
• Sibutramine (Meridia) a serotonergic/sympathomime
  tic anorexigen
• These are approved for patients with
• BMI 27 with co-morbid conditions
• and BMI 30 with or without co-morbid conditions

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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)

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2. Regulation/Guidance

• Food Additive Approvals
• Reduced or no-calorie sweeteners
• Reduced or no-calorie fat substitutes

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3. Enforcement

• Enforcement and Compliance Activities
• Labeling errors
• Misleading claims
• Unsafe products

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4. Research

• a) Communication/Labeling/Packaging
• b) Effectiveness of Treatment/Prevention
• c) Describing the Causal Links

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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

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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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4. Research

• 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?

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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)