1 fda obesity work group knowledge base subgroup richard canady, ph.d., dabt, corinna sorenson,...
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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
Slide 2
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
Slide 3
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
Slide 4
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
Slide 5
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!
Slide 6
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
Slide 7
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
Slide 8
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
Slide 9
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
Slide 10
Center for Consumer Freedom
“Your Foods Under Attack”
Consequences of Litigation against Restaurants and Industry
Consequences of Classifying Obesity as a Disease
Slide 11
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)
Slide 12
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))
Slide 13
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).
Slide 14
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”
Slide 15
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
Slide 16
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
Slide 17
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
Slide 18
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)
Slide 19
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)
Slide 20
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
Slide 21
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
Slide 22
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
Slide 23
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
Slide 24
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
Slide 25
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
Slide 26
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
Slide 27
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
Slide 28
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
Slide 29
USDA Initiatives: Aiming to Encourage Good Nutrition
Food Guide Pyramid
Slide 30
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
Slide 31
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
Slide 32
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
Slide 33
FDA Knowledge Base
Conceptual Grouping
1. Education
2. Regulation/Guidance
3. Enforcement
4. Research
Slide 34
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)
Slide 35
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"
Slide 36
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
Slide 37
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.
Slide 38
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
Slide 39
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
Slide 40
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
Slide 41
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
Slide 42
Food Additive Approvals
Reduced or no-calorie sweeteners
Reduced or no-calorie fat substitutes
2. Regulation/Guidance
Slide 43
3. Enforcement
Enforcement and Compliance Activities
Labeling errors Misleading claims Unsafe products
Slide 44
a) Communication/Labeling/Packaging
b) Effectiveness of Treatment/Prevention
c) Describing the Causal Links
4. Research
Slide 45
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
Slide 46
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
Slide 47
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
Slide 48
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
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