June 3, 2004
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today's hearing on the government's role in combating the nation's obesity epidemic. I am Dr. Lester M. Crawford, Acting Commissioner, Food and Drug Administration (FDA or the Agency) and Chair of the Agency's Obesity Working Group. Today, I will cover a number of Department of Health and Human Services (HHS) initiatives and programs designed to combat the nation's obesity epidemic.
Overview of Obesity Epidemic in U.S.
In the United States, obesity has risen at an epidemic rate during the past 20 years. Nearly two-thirds of adults in the United States are overweight, and 31 percent are obese according to the Centers for Disease Control and Prevention (CDC) 1999-2000 National Health and Nutrition Examination Survey (NHANES). Particularly disturbing are the dramatic increases in the prevalence of overweight and obesity in children and adolescents of both sexes, with approximately 15.3 percent of children aged 6 to 11 years and 15.5. percent of adolescents aged 12 to 19 years considered overweight. The prevalence of overweight and obesity varies by gender, age, socioeconomic status, and race and ethnicity. In 2002, three states had obesity prevalence rates of 25 percent or more, and all but 15 states had obesity prevalence rates of 20 percent or greater.
Overweight and obesity are associated with increased morbidity and mortality. Approximately 400,000 adult deaths in the United States each year are attributable to unhealthy dietary habits coupled with physical inactivity. Overweight and obesity are considered risk factors for other chronic conditions such as diabetes and certain cancers, including cancers of the breast, colon, kidney, esophagus and endometrium.
As the prevalence of overweight and obesity has increased in the United States, so have direct and indirect related health care costs. The current total cost of overweight and obesity is $117 billion per year, which is greater than 5 percent of nation's total annual health care expenditures. Obesity represents a major long-term public health crisis. This well-documented trend toward overweight and obesity has accelerated during the past decade. If it is not reversed, the gains in life expectancy and quality of life resulting from modern medicine's advances on disease will erode, and more health-related costs will burden the nation.
Government's Role in Combating the Obesity Epidemic
Eating a healthy diet and increasing physical activity reduces weight which is shown to reduce the risk for many chronic diseases. Often small changes such as physical activity for 30 minutes a day or consuming 100 fewer calories a day can result in large health benefits. In order for individuals to take action, they must have the right information to empower their lifestyle choices. The government can support individual action by: providing leadership; establishing a framework for understanding issues related to overweight and obesity; coalescing and coordinating efforts to address the issues; developing clear, coherent and effective health messages to ensure that consumers have accurate and adequate information to make informed decisions about improving their health; identifying and addressing research gaps; bringing diverse stakeholders together to address the epidemic (e.g., food industry, consumer organizations and the medical community); coordinating private/public campaigns; providing training and education materials to address the epidemic; and working to improve the health-promoting nature of the environments in which individuals make their decisions.
HHS has made addressing the problems of overweight and obesity top priorities for the Department. In fact, HHS has a large number of current initiatives and programs underway to address these issues. They include programs in education, communication and outreach, intervention, diet and nutrition, physical activity and fitness, disease surveillance, research, clinical preventive services and therapeutics, and policy and web-based tools. These programs are targeted to a variety of populations including infants and breastfeeding mothers, children and adolescents, women, minorities, the elderly, the disabled, rural, and the general population.
Department of Health and Human Services Steps Initiative
In June 2002, President Bush launched the HealthierUS initiative designed to help Americans, especially children, live longer, better, and healthier lives. The President's HealthierUS initiative helps Americans take steps to improve personal health and fitness and encourages all Americans to: 1) be physically active every day; 2) eat a nutritious diet; 3) get preventive screenings; and 4) make healthy choices concerning alcohol, tobacco, drugs and safety.In 2003, Tommy Thompson, Secretary of the Department of Health and Human Services, further advanced the President's initiative by introducing Steps to a HealthierUS (Steps). At the heart of this program lies both personal responsibility for the choices Americans make and social responsibility to ensure that policy makers support programs that foster healthy behaviors and prevent disease. The Steps initiative envisions a healthy, strong, U.S. population supported by a health care system in which diseases are prevented when possible, controlled when necessary, and treated when appropriate.
The Steps Cooperative Agreement Program is one part of Secretary Thompson's larger Steps initiative. This program aims to help Americans live longer, better, and healthier lives by reducing the burden of diabetes, obesity, and asthma and addressing three related risk factors physical inactivity, poor nutrition, and tobacco use. In FY 2003, $15 million was provided to 23 communities to support innovative community-based programs that are proven effective in preventing and controlling chronic diseases. In FY 2004, $44 million will be used to increase funding to existing Steps communities, fund new communities, and fund one or two national organizations to enhance the capacity of Steps communities.
As part of the Steps initiative, HHS also recently released a report titled Prevention: A Blueprint for Action, which outlines simple steps that individuals and interested groups can take to promote healthy lifestyles and encourage healthy behavior. The Department's efforts to promote health and prevent disorders such as obesity rests, in large part, on developing effective messages that are appropriate for individuals and groups in ways that they can understand and act upon. An example of this is the CDC's youth media campaign demonstration, "VERB. It's what you do." VERB's goal has been to promote social norms that support physical activity and portray fitness as fun and healthy. HHS/CDC has enlisted partner organizations in the campaign, such as 4-H, Boys and Girls Clubs and the National Hockey League to brand the VERB message and make it appealing to its pre-teen audience. VERB also reaches out to parents and other adults influential to young people, encouraging them to support and participate in physical activity with pre-teens.
Working groups within the Department's agencies have recently evaluated current HHS programs and activities, made recommendations to better coordinate these efforts, and identified areas of opportunity for new initiatives. Two recent major initiatives tied to obesity are highlighted below: the Food and Drug Administration's (FDA) Obesity Working Group initiative and related recommendations, and the National Institute of Health's (NIH) development of an Obesity Research Task Force to develop a strategic plan for obesity research.
FDA Obesity Working Group
In August 2003, FDA established an Obesity Working Group (OWG) to advise the Agency on innovative ways to deal with the increase in obesity and to identify ways to help consumers lead healthier lives through better nutrition. Specifically, FDA looked at how the Agency could contribute to the solution of the obesity epidemic in the context of its mission and regulatory authority, which is to promote and protect the public health. The Agency seeks to accomplish its mission by enforcing the laws it is charged with administering and by conducting educational and public information programs relating to its responsibilities. The Federal Food, Drug, and Cosmetic Act (the Act) as amended by the Nutrition Labeling and Education Act of 1990 (NLEA, Public Law 101-535), together with FDA's implementing regulations, established mandatory nutrition labeling for most packaged foods to enable consumers to make more informed and healthier food product choices in the context of the total daily diet. The statute and the regulations were also intended to provide incentives to food manufacturers to improve the nutritional quality of their products. Under the NLEA, FDA also has authority over health claims and nutrient content claims for foods.
The OWG members represented a broad array of disciplines and perspectives from throughout the Agency and each brought unique strengths and expertise to the group. In addition, the OWG solicited input from experts in other parts of HHS, serving as adjunct members to the working group. To make the task of addressing the complex problem of obesity more manageable, the OWG organized a number of subgroups to address specific aspects of the issues. Each subgroup developed analyses and recommendations that were shared and vetted with the larger OWG, and integrated into the final report and recommendations. The resulting report and recommendations were vetted within the OWG, the agency, and at HHS, before being finalized and publicly released.
In addition, recognizing the high level of interest in obesity among FDA's many stakeholders, the OWG initiated a process to establish ongoing relationships with individuals and organizations from all sectors. A key aspect of this process included providing the public with multiple opportunities to become involved in a dialogue with the OWG on its activities and the issues associated with helping consumers address the problem of obesity. During its tenure, the OWG met eight times; received briefings from several invited experts from other government agencies; held one public meeting, one workshop, two roundtable discussions (one with health professionals/academicians, and one with representatives of consumer groups); and solicited comments on obesity-related issues, directing them to the Docket that DHHS established in July 2003 (Docket No. 2003N-0338). In addition, some members of the OWG met with representatives from various sectors of the packaged food and restaurant industries.
In March 2004, the FDA released its comprehensive report to combat obesity with a focus on the message, "Calories Count." The report closely follows the FDA Strategic Plan, in particular the FDA goal of providing consumers with better information to help them lead healthier lives through better nutrition. The group's long- and short-term proposals are based on the scientific fact that weight control is mainly a function of the balance between calories consumed and calories expended. That is, for weight maintenance, calories in must equal calories out. The report builds on these nutrition fundamentals through a comprehensive, science-based and consumer-friendly set of initiatives. Taken together, they represent a plan of action founded on science, FDA's public health mission and legal authorities, and the importance of considering consumer and other stakeholder views and needs in addressing obesity.
The OWG's major recommended action items include:
The OWG report recommends that FDA evaluate how the Nutrition Facts panel (NFP) may be revised to arm consumers with more of the information they need to make sound food choices in several areas:
Calories Recognizing the critical role calories play in consumers' diets, FDA will evaluate possible labeling changes to the Nutrition Facts panel that will further emphasize the focus on calories, such as: increasing type size for calories, eliminating the listing of calories from fat, and adding a column to list quantitative amounts of calories as a percent Daily Value for the entire package for certain package sizes. In response to the report's recommendations, FDA is working on an advance notice of proposed rulemaking to gain public input on approaches for revising food labels. FDA believes that such revisions may enable consumers to more easily determine what proportion of their day's allotment of calories they are consuming in a single food item
Serving Sizes The Agency will encourage food manufacturers to consider revising certain labels as single-servings if the food item can be reasonably consumed as one serving. For example, a 20 oz bottled soft drink would have the calorie content listed on the basis of the full 20 oz being a single serving. This is in contrast to having the calorie content listed as one serving on the basis of an 8 oz serving size and labeled as containing 2.5 servings. FDA's current regulations already allow this change to be implemented immediately on a voluntary basis. In response to the report's recommendations, FDA is also working on an advance notice of proposed rulemaking to address other aspects of the serving size issue.
Carbohydrates FDA has received petitions from manufacturers to provide for nutrient content claims for the carbohydrate content of foods. FDA is in the process of evaluating the petitions and plans to define terms such as "net," "low," and "impact" so that consumers are armed with better and more accurate information when making food choices.
Comparative Labeling Statements FDA is also encouraging the use of comparative labeling statements to make it easier for consumers to compare different types of foods and make healthier substitutions. In its final report, the OWG offered examples of comparative claims that are permissible under current regulations. For example, "One medium apple (80 calories) contains 47% fewer calories than a one ounce serving of potato chips (150 calories)."
As a part of this education campaign, the Department recently developed a series of public service announcements in collaboration with the Ad Council that will begin airing in the near future (service announcements are currently being pilot tested). In addition, the Department recently announced the signing of a Memorandum of Understanding (MOU) with the Girl Scouts of the USA, and is developing additional collaborative agreements with various private and public sector groups including NASULGC (National Association of State Universities and Land Grant Colleges) through its National 4-H program, and the Department of Education, to leverage efforts to educate young people about good nutrition and healthy eating and how to use the food label to make more informed healthy choices.
The third set of recommendations from FDA's Obesity Working Group focuses on encouraging restaurants to provide nutrition information. American consumers now spend approximately 46 percent of their total food budget on food consumed outside of the home, and these foods account for a significant portion of total calories consumed.
FDA is urging the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign for customers. FDA also encourages consumers routinely to request nutrition information when eating out. In addition, the final report calls for the development of options for providing voluntary, standardized, simple, and understandable nutrition information, including calorie information, at the point-of-sale in a restaurant setting. FDA plans to involve restaurants in a pilot program to study these options in a well-controlled setting.
In order to seek consensus and base decisions on the best available information for its education and restaurant nutrition information efforts, FDA is beginning work with a third-party facilitator to conduct a national policy dialogue on these issues.
The fourth set of recommendations involves various enforcement activities to ensure the accuracy of the information in the Nutrition Facts panel and to ensure that consumers can monitor their intake of calories and nutrients. The report also calls for stricter enforcement activities against those manufacturers that declare inaccurate serving sizes.
FDA has issued a general letter to food manufacturers encouraging them to review nutrition information to ensure that the serving size declared is appropriate for the commodity in question.
The fifth set of recommendations focus on revising and reissuing FDA's 1996 draft Guidance for the Clinical Evaluation of Weight-Control Drugs. This action item reflects the fact that some obese and extremely obese individuals are likely to need medical intervention to reduce weight and mitigate associated diseases and other adverse health effects. FDA would issue this revised guidance for public comment.
The final set of recommendations involves increased collaboration on obesity research on everything from the relationship between overweight/obesity and food consumption patterns to incentives for product reformulation. It calls for partnership with USDA's Agricultural Research Service on a USDA-sponsored obesity prevention conference to be held in October 2004.
Related FDA Actions
This past year also witnessed a major change in the nutrition label on foods to include a separate listing of trans fatty acids. This was the first significant change on the Nutrition Facts panel since it was established in 1993.
The Agency has also undertaken a broad effort to crack down on misleading information and/or unsafe dietary supplements, and proposed new regulations to establish good manufacturing practice requirements for dietary supplements.
The Agency took steps to remove dietary supplements containing ephedrine alkaloids from the market. These products were extensively promoted for aiding weight control and boosting sports performance and energy. The totality of the available data showed little evidence of benefit from dietary supplements containing ephedrine alkaloids except for modest, short-term weight loss insufficient to improve health, while confirming that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke. In March of this year, the Agency announced various efforts to crack down on products containing androstenedione, or "andro." This class of products poses substantial safety risks to all Americans, particularly our nation's youth and athletes.
One of the key messages of this effort is that there are no safe quick fixes when it comes to losing weight and improving athletic performance, and it is only through proper diet, nutrition and exercise that we can improve our physical performance and, more importantly, maintain and improve our health.
NIH's Obesity Research Task Force
Through its research mission, the NIH is seeking to capitalize on recent scientific discoveries to further understand the forces contributing to obesity and develop strategies for prevention and treatment. The increase in obesity over the past 30 years has been fueled by complex interplay of environmental, social, economic, and behavioral factors, acting on a background of genetic susceptibility. As a result, NIH supports a broad spectrum of obesity-related research, including molecular, genetic, behavioral, environmental, clinical, and epidemiologic studies.
As the problems of overweight and obesity have grown the need for new action and research has become more evident. In response, NIH assembled a Task Force to identify areas for new research across its many institutes. In March 2004, NIH released the draft of its Strategic Plan for NIH Obesity Research (www.obesityresearch.nih.gov). This report identifies key areas of research need, priorities among those areas, a road map and strategies for advancing these research priorities, and the establishment of a committee for monitoring progress in addressing the issues and problems relating to overweight and obesity.
The report highlights areas of research to better understand, prevent, and treat obesity. The strategic plan's goals, and strategies for achieving them, are organized into chapters organized around the following four themes:
Importantly, input from external experts through interactions among NIH staff at scientific meetings and workshops informed the planning process. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Clinical Obesity Research Panel (CORP) is an important advisory group that provides expert input on obesity to the NIH. This group is composed of leading external obesity researchers and clinicians. NIH National Advisory Council and NIH Obesity Research Task Force members reviewed and discussed strategies, in the form of initiatives, which were designed to achieve the goals of the Strategic Plan. Additionally, NIH held a public comment period on the report from February 12 April 2, 2004. The NIH expects to make the final, published Strategic Plan for NIH Obesity Research available shortly on the website noted above.
Other Key HHS Activities
The National Nutrition and Physical Activity Program to Prevent Obesity
With 2004 funding, the CDC will support obesity prevention programs in a total of 28 states. Of these, 23 states will be funded at the capacity-building level to hire staff with expertise in public health nutrition and physical activity, build broad based coalitions, develop state plans, identify community resources and gaps, implement small-scale interventions, and work to raise public health awareness of changes needed to help state residents achieve and maintain a healthy weight. The other five states are funded at the basic-implementation level to put their state plans into action, conduct and evaluate nutrition and physical activity interventions, train health care and public health professionals, provide grants to communities, make environmental changes, and strengthen obesity prevention programs in community settings. In addition, CDC provides funding to 23 states for the implementation of school-based policies and programs to help young people avoid behaviors that increase their risk for obesity specifically unhealthy eating and inadequate physical activity.
Additionally, the CDC is developing a mechanism to quickly deploy staff (rapid deployment teams) into communities, worksites and schools to facilitate evaluation of promising strategies aimed at improving nutrition, increasing physical activity, and preventing obesity. Each team would collect baseline data, and provide evaluation consultation and technical assistance, identify methodologic gaps, and provide recommendations to improve the quality of program evaluation.
WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation)
The WISEWOMAN Program, a sister program to the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), offers additional preventive health services to the same women targeted by the NBCCEDP. WISEWOMAN provides an opportunity to address health disparities of under-insured or uninsured low-income women, including minority populations, aged 40-64, with a primary focus on risk reduction for cardiovascular disease and other chronic diseases. Preventive health services provided through WISEWOMAN include screening for hypertension, cholesterol, and obesity along with culturally appropriate behavior or lifestyle interventions (including dietary, physical activity and tobacco cessation interventions) for the target population.
Children's Food Marketing Project
As directed by Congress, CDC will conduct a comprehensive review of the effects of advertising and marketing on children's behavior in general, and specifically on children's dietary patterns and health status. The project will include all aspects of marketing: product, promotion, placement, and pricing. Additionally, CDC will review policies and practices from other countries. Results from these efforts will inform the development of new social marketing strategies designed to promote more healthful nutrition behavior among youth.
National Dietary Guidelines
HHS is collaborating with the U.S. Department of Agriculture to review the Dietary Guidelines that were published in 2000 and to draft new 2005 Dietary Guidelines for Americans. In light of the growing number of overweight and obese Americans, a major focus of the new guidelines will be providing guidance to the public on maintaining a healthy weight and creating lifestyles that balance the number of calories eaten with the number of calories expended. These guidelines must: (1) contain nutritional and dietary information and guidelines for the general public, (2) be based on the preponderance of scientific and medical knowledge current at the time of publication, and (3) be promoted by each Federal Agency involved in a Federal food, nutrition, or health program.
A Day for Better Health
One of the most recognizable efforts to promote good nutrition and healthy eating habits has been the National Cancer Institute's 5 A Day for Better Health Program. This national nutrition program seeks to increase to 5 or more the number of daily servings Americans eat of fruits and vegetables. In addition to its widely known slogan, the 5 A Day program reaches many individuals through health care provider networks, the internet, and print media to provide information about the health benefits of eating more fruits and vegetables, as well as easy steps for adding more of them into daily eating patterns.
Administration on Aging Action
The Administration on Aging's (AoA) National Policy and Resource Center on Nutrition, Physical Activity and Aging was created for the purpose of increasing and improving food and nutrition services to older Americans through their caregivers at home, with community-based service providers, and in long-term care systems. The Center focuses on linking proper nutrition and physical activity as key themes in the healthy aging process. One strategy for making this link has been the development and publication of a community guide entitled, "You Can! Steps to Healthier Aging", that details a 12-week program to help older Americans "eat better" and "move more." The Center is awarding 10 mini-grants to local communities to implement the You Can! Program in 2004.
AoA provides funding to states to implement health promotion and disease prevention activities. Educational information is disseminated through Senior Centers, congregate meal sites, and home-delivered meal programs. Health screening and risk assessment activities including hypertension, glaucoma, hearing, nutrition screening, cholesterol, vision, diabetes, bone density, and others are also provided. Physical activity and fitness programs are provided along with education about the prevention and reduction of alcohol, substance abuse, and smoking. Further, this AoA program emphasizes the importance of appropriately managing medications.
Power of Choice
The Power of Choice is an after-school program jointly developed by FDA and USDA's Food and Nutrition Service. The materials guide pre-teens toward a healthier lifestyle by motivating and empowering them to make smarter food and physical activity choices in real-life settings. A Leader's Guide contains ten sequenced interactive sessions to engage adolescents in fun activities that develop skills and encourage personal development related to choosing foods wisely, preparing foods safety, and reducing sedentary behaviors.
Making It Happen School Nutrition Success Stories (MIH)
This material features the stories of 32 schools and school districts that have implemented innovative strategies to improve the nutritional quality of foods and beverages offered and sold on school campuses. MIH is a joint project of the Food and Nutrition Service of USDA and the Division of Adolescent and School Health of CDC/DHHS, undertaken as part of the Healthier Children and Youth Memorandum of Understanding between the two departments and the Department of Education.
An introductory section describes the importance of healthy eating for young people, how schools can support good nutrition, tips on implementing change, and information on school nutrition policies. The success stories are divided into six chapters based on the primary approach used to promote healthy eating. Each chapter features a description of the approach, its rationale, and relevant data. MIH contains additional information, including examples of actual policies, regulations, letters to parents, nutrition standards, and nutrition resources.
The President's Council on Physical Fitness and Sports (PCPFS)
Although it is an independent Agency, the PCPFS is headquartered at HHS. It promotes physical activity for all ages, backgrounds and abilities with information and publications (www.fitness.gov) and physical activity/fitness motivational awards programs (www.presidentschallenge.org). The Council advises the President and the Secretary of Health and Human Services about issues related to physical activity, fitness, and sports, and recommends programs to promote regular physical activity for the health of the nation.
Moving forward, HHS will continue to follow-up on current and future actions necessary to implement recent obesity related recommendations. Such actions are as follows:
To fully realize the benefit from scientific advances, to achieve further gains in the health of Americans, and to reduce the burden of chronic disease, government must provide leadership and guidance and work with a number of outside organizations to overcome obstacles and promote healthy habits. HHS and its agencies have engaged with business and community leaders, researchers, health and fitness providers, insurers and other interested parties to discuss health promotion and disease prevention issues and strategies. HHS's approach to combating obesity provides a comprehensive action plan for addressing the Nation's obesity epidemic and helping consumers lead longer, healthier lives through better nutrition and increased physical activity.
I thank you for your interest and the opportunity to share with you some of HHS's many activities related to promoting healthy lifestyles and reducing the burden of obesity in America.
Last Revised: November 1, 2004