Calories Count: Report of the Working Group on Obesity - Table of Contents

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March 12, 2004

Memorandum of Transmittal

Executive Summary

OWG Principal Recommended Action Items

Report of the Working Group on Obesity

  1. Introduction
    1. Public Health Impetus
    2. FDA Obesity Working Group
  2. Foundations of this Report
    1. Scientific Principles
    2. FDA's Public Health Mission and Legal Authorities
    3. Stakeholder Participation
    4. The OWG's Work
  3. Messages
    1. Obesity Knowledge Base
    2. Obesity Messages
    3. OWG Message Recommendations
  4. Education Program to Deliver the Message
    1. Need for Education Programs
    2. OWG Education Recommendations
  5. Supporting the Message
    1. Food Labels
      1. The Food Label
      2. FDA Focus Groups on Food Labels
      3. OWG Food Label Recommendations
    2. Restaurants/Industry
      1. FDA Focus Groups on Restaurants
      2. OWG Restaurant Recommendations
      3. OWG Diet Plan Recommendations
    3. Therapeutics
      1. Background
      2. FDA's Draft Guidance
      3. Existing Therapies
      4. OWG Therapeutics Recommendations
    4. Research
      1. Joint Research with USDA/ARS
      2. Survey of Research
  6. Stakeholder Investment to Help Ensure Results
    1. Background
    2. OWG Stakeholder Investment Recommendations
  7. Overall Conclusions
  8. References

List of Appendices

Appendix A - List of Acronyms and Abbreviations

Appendix B - TEXT BOXES on Body Mass Index (BMI), Energy (Calorie) Balance, and Carbohydrates and Other Macronutrient Contributions to Caloric Value

Appendix C - Notice Concerning July 30, 2003, Secretary's Roundtable on Obesity/Nutrition

Appendix D - August 11, 2003, Charge Memorandum

Appendix E - FDA Obesity Working Group Membership

Appendix F - FDA Obesity Working Group - Subgroup Members

Appendix G - Report from the Division of Market Studies Office of Scientific Analysis and Support, FDA CFSAN - Helping Consumers Lead Healthier Lives through Better Nutrition: A Social Sciences Approach to Consumer Information, Food Choices and Weight Management

Appendix H - Developing Effective Consumer Messages

Appendix I - Power of Choice

Memorandum of Transmittal 


February 11, 2004

From: Chair and Vice Chair, Obesity Working Group

Subject: Working Group Report and Recommendations

To: Mark B. McClellan, M.D., Ph.D. Commissioner of Food and Drugs

We are pleased to transmit the final report and recommendations of the Food and Drug Administration's (FDA) Obesity Working Group (OWG). You established the OWG on August 11, 2003. The OWG met eight times from August 28, 2003, to January 22, 2004. In addition, the OWG 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. The public meeting examined FDA's role and responsibilities in addressing the major health problem of obesity, focused on issues related to promoting better consumer dietary and lifestyle choices that have the potential to significantly improve the health and well-being of Americans, and obtained stakeholder views on how best to build a framework for messages to consumers about reducing obesity and achieving better nutrition. The science-based public workshop, which was co-sponsored and funded by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, collected data relevant to FDA efforts to help consumer make better-informed weight management decisions. In addition, some members of the OWG met with representatives from various sectors of the packaged food and restaurant industries.

To accomplish its work, the OWG organized several subgroups (i.e., messages, education, food label, restaurants/industry, therapeutics, research, and stakeholder investment), each designed to focus on a particular aspect of the original charge to prepare a report that outlines an action plan to cover critical dimensions of the obesity problem from FDA's perspective and authorities. In addition, in order to inform its work, the OWG created a knowledge base subgroup. All the subgroups, in turn, met separately and developed respective analyses and recommendations, which serve as the basis for this report.

The report that follows provides, for your consideration, a range of short- and long-term recommendations that are responsive to the charge. The OWG believes that, if the report's recommendations are implemented, they will make a worthy contribution to confronting our Nation's obesity epidemic and helping consumers lead healthier lives through better nutrition. The report also contains a number of appendices, including your original charge memo, the list of OWG members and subgroups, and other supporting material.

We appreciate the opportunity to have served FDA as leaders of the OWG, and we stand ready to facilitate the implementation of the OWG's recommendations.

Lester M. Crawford, D.V.M., Ph.D.
Chair Deputy Commissioner of Food and Drugs

Robert E. Brackett, Ph.D.
Vice Chair Director Center for Food Safety and Applied Nutrition

Executive Summary

Obesity is a pervasive public health problem in the United States. Since the late 1980s, adult obesity has steadily and substantially increased in the United States. Today, 64 percent of all Americans are overweight and over 30 percent are obese; in 1988 through 1992, fewer than 56 percent were overweight and fewer than 23 percent of American adults were obese. The trends for children are even more worrisome. Recent research by the U.S. Centers for Disease Control and Prevention(1) (CDC) shows that 15 percent of children and adolescents aged 6 to 19 are overweight -double the rate of two decades ago (CDC, 2003). As Americans get heavier, their health suffers. Overweight and obesity increase the risk for coronary heart disease, type 2 diabetes, and certain cancers. According to some estimates, at least 400,000 deaths each year may be attributed to obesity (Mokdad, et al., 2004).

To help confront the problem of obesity in the United States and to help consumers lead healthier lives through better nutrition, on August 11, 2003, Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs, created the Food and Drug Administration's (FDA) Obesity Working Group (OWG). He charged the OWG to prepare a report that outlines an action plan to cover critical dimensions of the obesity problem from FDA's perspective and authorities.

This report reflects the work of the OWG to meet the Commissioner's charge and is organized largely around the specific elements of the August 11, 2003, charge.

The problem of obesity has no single cause. Rather, it is the result of numerous factors acting together over time. Similarly, there will be no single solution; obesity will be brought under control only as a result of numerous coordinated, complementary efforts from a variety of sectors of society. Nor can this problem be solved quickly. Any long-lasting reversal of this phenomenon will itself be a long-term process.

The OWG's recommendations are centered on the scientific fact that weight control is primarily a function of balance of the calories eaten and calories expended on physical and metabolic activity (see Appendix B Text Boxes in the report for a fuller discussion). The recommendations contained in this report therefore focus on a "calories count" emphasis for FDA actions. The box on the next page contains the OWG's principal recommendations. The body of this report details the underlying rationale for each of these principal recommendations and additional recommendations. 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.

OWG Principal Recommended Action Items 

Food Labeling

  • Calories: Issue an advance notice of proposed rulemaking (ANPRM) to solicit public comment on how to give more prominence to calories on the food label. As examples, increasing the font size for calories, including a percent Daily Value (%DV) column for total calories, and eliminating the listing for calories from fat.
  • Serving Sizes: Encourage manufacturers immediately to take advantage of the flexibility in current regulations on serving sizes and label as a single-serving those food packages where the entire content of the package can reasonably be consumed at a single-eating occasion. For example, a 20 oz bottle of soda that currently states 110 calories per serving and 2.5 servings per bottle could be labeled as containing 275 calories per bottle.
  • Carbohydrates: File petitions and publish a proposed rule during summer 2004 to provide for nutrient content claims related to carbohydrate content of foods, including guidance for use of the term "net" in relation to the carbohydrate content of foods.
  • Comparative Labeling Statements: Encourage manufacturers to use appropriate comparative labeling statements that make it easier for consumers to make healthy substitutions, including calories (e.g., "instead of cherry pie, try our delicious low fat cherry yogurt - 29 percent fewer calories and 86 percent less fat").

Enforcement Activities

  • Together with the Federal Trade Commission (FTC), increase enforcement against weight loss products having false or misleading claims.
  • Consider enforcement action against products that declare inaccurate serving sizes.

Educational Partnerships

  • As part of a larger DHHS effort, establish relationships with, among others, youth-oriented organizations such as the Girl Scouts of the USA, the National Association of State Universities and Land Grant Colleges (4-H program), to educate Americans about obesity and leading healthier lives through better nutrition.


  • Urge the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign for consumers.


  • Convene a meeting of a standing FDA advisory committee meeting to address challenges, as well as gaps in knowledge, about existing drug therapies for the treatment of obesity.
  • Revise 1996 draft guidance on developing obesity drugs and re-issue for comment.


  • Support and collaborate, as appropriate, on obesity-related research with others, including NIH.
  • Pursue research on obesity prevention with U.S.Department of Agriculture/Agricultural Research Service (USDA/ARS).

(1) See Appendix A for a list of acronyms and abbreviations used throughout this report.

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