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NUTRITION lABEIIN' Issues and Directions for the 199Os Committee on the Nutrition Components of Food Labeling Food and Nutrition Board Institute of Medicine National Academy of Sciences Donna V. Porter and Robert 0. Earl, Editors NATIONAL ACADEMY PRESS Washington, D.C. 1990

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National Academy Press ~ 2101 Constitution Avenue, N.W. ~ Washington, D.C. 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. the Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Samuel O. Thier is President of the Institute of Medicine. This study was supported by project no. 282-89-0022 from the Public Health Service, U.S. Department of Health and Human Services. Library of Congress Cataloging-in-Publication Dam Institute of medicine (U.S.). Committee on the Nutrition Components of Food Labeling. Nutrition labeling: issues and directions for the 1990s: report of a study / by the Committee on the Nutrition Components of Food Labeling, Food and Nutrition Board, Institute of Medicine, National Academy of Sciences; Donna V. Porter and Robert O. Earl, editors. p. cm. Includes bibliographical references and index. ISBN 0-309 0432~3 1. Food-Labeling-United States-Standards. 2. Nutrition. L Porter, Donna Viola. IL Earl, Robert O. m. Title. [DNLM: 1. Food Labeling-standards-United States. 2. Food Labeling-United States-legislation. WA 33AA1 LSn] IXSSl.I56 1990 363.19'~cd20 DNLbVDLC 90-133 16 for Library of Congress CIP Copyright ~)1990 by the National Academy of Sciences No part of this boolc may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purposes of official use by the U.S. Govemment. Printed in the United States of America

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COMMITTEE ON NUTRITION COMPONENTS OF FOOD LABELING RICHARD A. MERRILL (Chair), School of Law, University of Virginia, Charlottesville, Virginia HENRY C. McGILL, Jr. (vice Chair), Depar~nent of Pathology, University of Texas Health Science Center, San Antonio, Texas W. VIRGIL BROWN, Medlantic Research Foundation, Washington, D.C. T. COLIN CAMPBELL, Division of Nutritional Science, Cornell University, Ithaca, New York JOHN W. ERDMAN, Jr., Deponent of Food Science and Division of Nu- tritiona1 Sciences, College of Agriculture, University of Illinois, Urbana, minois JESSE F. GREGORY III, Food Science and Human Nutrition Deparunent, Insti- tute of Mod and Agricultural Sciences, University of Florida, Gainesville. Plonda RICHARD L. HALL, Consultant, Baltimore, Maryland TIMOTHY M. HAMMONDS, Research and Education, Food Marketing Insti- ~te, Washington, D.C. ELISABET HELSING, Regional Office for Europe, World Heals Or~anizadon Copenhagen, Denmark _ _ _ O _ _ _ _ , ALEXANDER M. SCHMIDT, Technology Advancement Center, Oakbrook, minois LAURA S. SIMS, College of Human Ecology, University of Maryland, College Park, Maryland JUDITH S. STERN, Department of Nutrition and Division of Clinical Nutrition, University of California, Davis, California NANCY S. WELLMAN, Department of Dietetics and Nutrition, Flonda In~r- national University, Miami, Florida JOAN D. GUSSOW (Food and Nutntion Board Liaison), Department of Nu- ~ition Education, Teachers College, Columbia University, New York, New York Staff DONNA V. PORTER, Project Director ROBERT O. EARL, Staff Officer JANIE B. MARSHALL, Senior Secretary 111

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FOOD AND NUTRITION BOARD RICHARD J. HAVEL (Chair), Cardiovascular Research Institute, School of Medicine, University of California' San Hancisco, California DONALD B. McCORMICK (vice Chair), Department of Biochemistry, Emory University School of Medicine, Atlanta, Georgia EDWIN L. BERMAN, Division of Metabolism, Endocrinology, and Nutrition, School of Medicine, University of Washington, Seattle, Washington EDWARD J. CALABRESE, Environmental Health Program, Division of Public Health, University of Massachusetts, Amherst, Massachusetts DORIS H. GALLOWAY, Department of Nutritional Sciences, University of California, Berkeley, California DeWll~l S. GOODMAN, Institute of Human Nutrition, Columbia University, New York, New York MR.C. GREENWOOD, Graduate Division, University of Califomia, Davis, California JOAN D. GUSSOW, Department of Nutrition Education, Teachers College, Columbia University, New York, New York JOHN E. KINSELLA, College of Agriculture and Environmental Sciences, University of California, Davis LAURENCE N. KOLONEL, Cancer Center of Hawaii University of Hawaii, Honolulu, Hawaii REYNALDO MARTORELL, Food Research Institute, Stanford University, Stanford, California WALTER MERES, Human Nutrition Research Center, Agricultural Research Service, U.S. Department of Agriculture, Beltsville, Maryland MALDEN C. NESHEIM, Office of the Provost, Cornell University, Ithaca, New York JOHN LISTON (Ex Officios, Division of Food Science, School of Fisheries, College of Ocean and Fishery Sciences, University of Washington, Seattle, Washington ARNO G. MOTULSKY (Ex Officio), Center for Inherited Diseases, University of Washington, Seattle, Washington ROY M. PITKIN (Ex Officio), Deparanent of Obstetrics and Gynecology, School of Medicine, University of California, Los Angeles, California Stay CATHERINE E. WOTEKI, Director SHIRLEY ASH, Financial Specialist UTE S. HAYMAN, Administrative Assistant 1V

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Preface The Committee on the Nutrition Components of Food Inhaling was assem- bled in the fall of 1989 by the Food and Nutrition Board (FNB) of the Institute of Medicine (IOM) to consider how food labels could be improved to help con- sumers adopt or adhere to healthy diets. The sponsors of the study the Mod and Drug Administration (ADA) of the U.S. Deparanent of Health and Human Services (DHHS) and the Food Safety and Inspection Service APSIS) of the U.S. Department of Agriculture (USDA), were influenced by the rapidly accumulat- ing evidence that an individual's dietary choices can significantly affect chronic disease risk. Their support for this study reflects a shared judgment that changes in eating habits can improve the health of Americans and that food labeling, broadly defined, can materially aid wise dietary choices. The Committee agrees with bow of these premises. This Preface describes the Committee's operations and work schedule, identifies and Woks the large number of individuals and organizations that aided in He Committee's deliberations, and notes some of the limitations under which the Committee operated. FORMATION OF THE COMMITTEE The Committee's 14 members were convened under the auspices of the FNB and included research scientists and health professionals with experience in nutrition and health promotion as well as individuals who have experience in food formulation and food marketing and others who are familiar with the v

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V1 PREFACE workings of He two federal agencies chiefly involved in regulating food labels, FDA and USDA. Although there were gaps in the Committee's collective expe- nence, the members were generally aware of these limitations and took steps to augment their expertise through public hearings, workshops, and commissioned papers. Some issues are treated more cursorily than their complexity and im- portance warrant, but these deficiencies are, to a large extent, a consequence of the constraints, particularly of time, under which the Committee worked. COMMITTEE PROCEDURES From the beginning, members of the Committee appreciated that the sum ject of food labeling and nutrition is of intense interest to a wide range of organizations and individuals. Furthermore, it recognized that many of these or- ganizations and individuals had information, experience, and in some instances, concrete proposals that could aid in its deliberations. Accordingly, the Commit- tee set out to elicit a wide range of views, both through a general invitation to communicate with the Committee and by specific requests to address particular topics. The full Committee met for 2 or more days on five different occasions, commencing in October 1989 and concluding in June 1990. In December 1989, at the second meeting, a full day was set aside to hear from organizational representatives. An announcement of the meeting was published in the Federal Register with a general invitation to appear, submit statements, or testify. Indi- vidual invitations were extended to 150 organizations. On December 4, 1989, 13 witnesses from 12 organizations testified at an open forum at the National Academy of Sciences (NAS) in Washington, D.C., and several other organiza- tions and individuals submitted material to the Committee. The witnesses from these 12 organizations contributed significantly to the Committee's understand- ing of the issues, and the Committee wishes to identify and thank them: Sandra Bartholomey, Susan Braverman, J.B. Cordaro, Sherwin Gardner, Hilarie Holing, Michael Jacobson, James Marsden, Allen Matthys, Elaine McLaughlin, Monica Olsen, Claire Regan, Sarah Setton, and Ann Winslow (see Appendix A). Early in the Committee's discussions, members also realized that additional information on specific topics would be required, including issues surrounding the legal authority of EDA and USDA to adopt the type of recommendations the Committee might make, the importance of including information about specific nutrients on food labels, the utilibr of different types of label formats, consumer understanding and use of nutrition information, and the forces at work in the marketing of foods. The devices used to enhance understanding of these topics were through "workshops": informal conversations among Committee members and invited participants who were selected because of their experience, affiliation, or expertise. The focus of each workshop and the invited participants, to whom we

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PREFACE . V11 are indebted, are as follows. The workshop on label content included David Kritchevsky, Judy Marlett, Donald McCormick, Walter Mertz, Leon Prosky, and Janet Tenney. The workshop on legal issues included Edward Dunl~le- b~ger, Richard Hank, Thomas Scarlett, William Schultz, Bruce Silverglade, and Michael Taylor. The workshop on consumer understanding and use of food labels included Cheryl Achterberg, Robert Gould, James Heimbach, James Heisler, Alan Levy, and Vickie Peters. The workshop on label formats in- cluded Michael Audette, John Blair, Michael Golderman, Michael Jacobson, Pat Kuntze, Gluten Moliter, Ray Schucker, and Carole Sugannan. The wo*- shop on food marketing, label design, and promotion included Marguerite Copel, Maurice Cox, Robbi Dietrich, Harold Handley, Arthur Harckham, Doris Lennon- Thompson, Kelly Lewis, Charles Martin III, Craig Shulstad, and Robert Wher- mann. More detailed information about these individuals can be found in AD pendix B. The Committee appreciates the in-depth presentation on the history of food labeling regulation made by Taylor Quinn at its first meeting. It is also indebted to Robert Conley, Diane Heiman, Alvin Lorman, and Ronald Tenpas, each of whom prepared papers on relevant legal issues. Mr. Lorman's paper on the nutrition implications of FDA food standards of identity is reproduced in Appendix D. This study is part of a larger undertaking coordinated by Michael McGinnis, deputy assistant secretary for health, and director, Office of Disease Prevention and Health Promotion (ODPHP), DHHS, that involved FDA, as well as other units of DHHS, and USDA. This effort has gone forward under the oversight of an interagency steering committee, which includes eight individuals who have provided valuable assistance to the Committee. Notable among these are Linda Meyers of ODPHP, John Vandeneen of FDA, and Ashland Clemons of FSIS. Even before the Committee began its work, FDA and USDA had taken the first steps to prepare themselves to reform the existing requirements for food labels. The most important effort was a series of public hearings held in four cities around the United States, at which agency representatives heard from hundreds of witnesses on a series of issues, including the needed or desired changes in He nutrition contents provided in food labels. At the same time, ADA solicited public comment by publishing an announcement in the Federal Register (54 Fed. Reg. 32,61~32,615, Aug. 8, 1989). The regional hearings and request for public comments produced a large volume of useful information on consumer desires and food marketing practices. FDA has been generous in allowing He Committee access to all this material, and the Committee extends special thanks to agency personnel who provided assistance. The Committee also had Be benefit of a study of current PDA and USDA labeling requirements prepared by Gary Kushner, under contract with ODPHP.

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~ V111 PRERACE TIME CONSTRAINTS Readers should be aware of an important constraint under which this report was completed. The Committee was appointed in September 1989 and met for the first time a month later; its full membership was not complete until November 1989. However, the contract between the sponsoring agencies and IOM provided for a study period of just 1 year, with a final report due by September 1990. To allow time for the National Research Council ARCS internal review and publication processes, the Committee was required to complete its deliberations and submit a final manuscript in July 1990. By any measure this was a short period for so complex an undertaking. The schedule was dicing, understandably, by the wishes of the sponsoring agencies rather than the complexity of the subject. This account is not intend as an excuse for the work the Committee has done or failed to do, but as background for assessing the anal product. The Committee did not attempt to produce definitive discussions of the role, content, format, and implementation of a new system of nutrition labeling for foods sold in the United States. Instead, this report attempts to advance the ongoing debate about the information that food labels should provide about nutrient content, the type of foods that should be accompanied by nutrition information, and the form in which this information should be conveyed. Many organizations and hundreds of individuals have been thinking about these subjects for many years. FDA and USDA have devoted considerable effort to studying the issues and planning for reform. In addition, many members of the U.S. Congress have displayed interest in the subject by holding hearings, drafting legislation, and pressing for its enactment. Against this background, the Committee's report is an attempt to synthesize the scientific evidence and formulate practical proposals for improving food labels and enhancing other forms of point-of-purchase information about the nutrient content of foods. Our comparative advantage lies in the procedures and work environment of the Institute of Medicine. No member's personal well- being is dependent on the resolution of any issue discussed in the report This is not to say that individual members lacked strong personal views or relationships that could be thought to affect their views, but members were apprised of their colleagues' affiliations and possible sources of bias, and were thus placed in a position to assess them. In addition, the Committee solicited the views of a wide range of individuals and groups with interests in the subject. THE POLITICS OF FOOD LABELING Although it is not appropriate in the body of this report, no serious account of the origins and progress of this study can fail to mention two developments that gained momentum in the spring and summer of 1990, some 6 months

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PREFACE LO after the Committee's work had begun. Each reflected an official effort to do something about food labels promptly, and each threatened to obviate He Committee's effort. The first development began with the announcement by DHHS Secretary Louis Sullivan in March 1990 that FDA was developing, and by mid-l99O proposed for adoption, the first in a series of revised regulations governing food labels, including information on the nutrition panel of food labels. The Committee was assured that this initiative reflected no diminution of interest in the report it had been assembled to produce and was promised that both FDA and the participants in the contemplated rulemaking would have ample opportunity to take account of the Committee's recommendations before publication of anal regulations. The second, more disconcerting development, from the perspective of the 14 individuals who volunteered their time to produce this report, has been the rapid movement of legislation that would mandate new nutrition labels on foods and that would prescribe to a substantial degree the content of those labels. No citizen who believes that more informative food labels will facilitate wiser dietary choices by Americans can be disappointed when government takes steps to accomplish this goal, and no member of the Committee believes that new legislation is, in principle, unwise. Indeed, as Chapter 8 of this report reveals, the Committee believes that legislation is desirable to confirm the authority of FDA and USDA to mandate the types of nutrition labeling that are endorsed by this report. The Committee's concern about the legislative process has been twofold. First, investment of enormous effort and a certain pride have kindled a wish that the Committee had been able to complete work on this study before mem- bers of Congress completed theirs, desirably with an interval during which the Committee's collective recommendations could be weighed in the legislative de- liberations. Second, and more important, the likelihood of legislation, combined with uncertainty about what the final product might provide, has cast a shadow over the Committee's deliberations. The Committee had no desire to disagree for disagreement's sake with the proposals pending in the Congress, but neither did it think it appropriate to express what would inevitably be seen as political positions for or against specific proposals. The Committee's response to these external events was to ignore both of them to the extent we could. We produced the best report possible in the time available with the hope that it might be published in time to be helpful to those (IDA, USDA, and the Congress) who must make the anal decisions about food labels. With respect to FDA's rulemaking initiative, the Committee assumed that the process would continue long enough to allow discussion of the recommendations before any final regulations were adopted. FDA's proposed regulations to reform food labeling were published after the Committee had completed its deliberations, and therefore, to a large extent are not addressed in

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x PREFACE this report. The same assumption could not be made about the legislative process, which appeared to be on a faster track. Even so, the Committee resisted the temptation to compare the conclusions of the study with the terms of particular legislation, none of which, until enacted, could be said to represent He judgments of Congress. COVERAGE OF THE REPORT As noted above, the short time frame for completing this report was He most important limitation under which the Committee functioned, and it affected the scope of the deliberations. In addition, adherence to the terms of the charge led the Committee to put aside some food labeling issues that continue to merit attention. At its first meeting, the Committee agreed that it would not attempt to reassess, or second-guess, the conclusions about diet, nutrition, and disease that comprise the core findings of The Surgeon General's Report on Nutrition and Health (1988) and the NBC report, Diet awl Health: Implications for Reducing Chronic Disease Risk (1989~. The conclusions of these reports enjoy strong support within the scientific and public health communities not only in the United States but also in other countries. Moreover, the Committee's charge clearly implied that the conclusions of these reports should be taken as given and that it should focus on their implications for food labels. The Committee reached a second self-limiting decision at the outset that was also encouraged by the sponsoring agencies. The report generally does not attempt to grapple with the phenomenon of health claims for foods. Health claims are those sorts of representations and depictions typically featured in ad- vertising (and, thus, are beyond the jurisdiction of FDA and USDA) and on food packages, by which sellers of food have attempted to exploit the new knowledge of the relationships between diet and risk of disease. This is an area of consider- able concern to the two sponsoring agencies and the Federal Trade Commission, and the commercial practices at issue have, understandably, attracted consider- able interest among members of Congress. The Committee could not pretend that the subject of health claims was unrelated to its assignment- the nutrition content of food labels and other point-of-purchase labeling. The information that is allowed or required in food labels has a bearing on the types of promotional claims that should be considered legitimate. Yet, the regulatory issues presented in the latter context are more difficult, the problems of agency jurisdiction and coordination are more complex, and First Amendment limits on governmental regulation are, arguably, more potent than in the Labeling context. To have grap- pled with the broad subject of health claims would have dramatically enlarged the Committee's work load and delayed completion of this report well beyond the established deadline. In agreeing to exclude health claims, however, the Committee recognized

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PRERACE MU that the boundary it was attempting to draw was, in some sense, an artificial one; much of the information provided in a food label can be considered a claim of some sort for that food. Thus, factual information about the level or presence of nutrients that have long-term health significance, such as fat or fiber, can be considered a type of health claim, no matter how it is presented. Moreover, the Committee was faced with the growing practice among food sellers of providing more than the basic information about the presence or levels of nutrients, a practice exemplified by labels that attempt to state or imply something about the special value of the food. Examples include such descriptors as fat free, f her rich, and low calone. The Committee felt obliged to examine these practices and at least attempt to suggest how FDA and USDA might deal with ~em. To this extent, the report crosses the boundary that the Committee initially established for itself. It should be emphasized, however, that the Committee did not delve far into the area of health claims, nor did it attempt to identify, much less suggest definitions for, all the descriptors that have come into use to highlight the nutritional value of specific foods. Their number and variety made such an exercise imprudent. This also means that the Committee did not deal at all with terms used to describe or highlight components or features of foods that carry no obvious nutritional connotation. Many criticisms of current food labels likewise have no nutritional implica- tions, whatever their merits may be. For example, some critics have advocated that ingredients should be listed by percentage, others have urged that all food colors be identified by name, and still others have argued that warnings should appear on all foods that contain ingredients to which any significant number of consumers might be allergic. While sound nutrition contributes to good health, and in this sense can be considered a matter of safety, the Committee generally did not deal with criticisms of current food labels or proposals for reform that do not have an obvious bearing on the nutritional quality of foods. This report does not, however, entirely ignore the listing of ingredients on the food label. It addresses both the manner of listing and the categories of food for which the listing of ingredients is incomplete, but the discussion is confined to issues that relate to the consumer's ability to make informed choices about and among foods on the basis of their nutritional characteristics. ACKNOWLEDGMENTS Any undertaking of this sort accumulates debts to individuals who were not Committee members. The attempt to thank all of those who have helped the Committee complete its report would risk omitting some whose contributions were important. Therefore, expressions of appreciation are confined to the small number of individuals within IOM whose support was instrumental. Leading this list are Donna V. Porter, Project Director, and Robert O. Earl, Staff Officer.

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e X11 PREFACE It is no exaggeration to say that without them the report would not have been completed. We are grateful, also, to Janie B. Marshall, secretary to He project, who ~ volumes, arranged travel, and assisted at meetings. Others within IOM who were very helpful in seeing this project to fruition were Catherine E. Woteki, Director of FNB; Enriqueta C. Bond, Executive Director of IOM; and Samuel O. Thier, President of IOM. Betsy S. Tunrene, Michael K. Hayes, and Julie P. Phillips are to be commended for orchestrating and conducting the final manuscript editing and report preparation on a very tight schedule. Finally, I wish to thank my 13 colleagues who comprised He Committee on He Nutrition Components of Food Labeling. They responded willingly to an unrealistic schedule' which was established after Heir own plans for He year were firmly fixed; Hey conscientiously fulfilled requests for research and writing; and Hey debated potentially contentious issues with tolerance and good will. Id addition to producing what all Committee members hope will be an important and useful report, they made service as Chapman a pleasure. RICHARD A. MERRILY Chair Committee on the Nutrition Components of Food ~ sheling

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Contents PREFACE 1 SUMMARY 2 OVERVIEW - PART I CURRENT STATE OF NUTRITION LABELING Formation of the Committee on the Nutrition Components of Food Labeling, 41 Relevant Studies on Nu~idon, Dielary Consumption, and Health, 42 Role of Food Labels in Implementing Dietary Changes, 44 Purpose, Characteristics, and Audiences of Nutrition Labeling, 46 Food Labels, Labeling, and Advertising, 47 Summary of Report, 49 3 CURRENT FOOD LABELING Overview of He U.S. System for Regulating Mod T ~heling, 51 Evolution of Nutrition Labeling for Foods, 55 Deficiencies in Current Requirements for Food Labels, 63 . . X111 v 39 51

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XIV 4 CONTEXTUAL FACTORS AFFECTING FOOD LABELING REFORM Current Dietary Patterns of Americans, 74 Food Marketing in the United States, 88 Consumer Understanding of Nutrition and Use of Food Labels, 93 Analytical Considerations Affecting Food Labeling Reform, 109 PART II REFORMING FOOD LABELS 5 LABELING COVERAGE Mandatory Nutrition Labeling, 131 Produce, Seafood, and Meat and Poultry, 135 Foods Sold by Restaurants, 143 Is Sold by Noncommercial Food Services, 151 6 NUTRITION LABEL CONTENT Calories, 159 Fat and Cholesterol, 160 Carbohydrates, 172 Dietary Fiber, 176 Protein, 179 Sodium, 181 Potassium, 185 Vitamins and Minerals, 187 7 PRESENTATION OF NUTRITION INFORMATION ON FOOD LABELS Criteria for Presenting Label Information, 203 Reference Units for Declaring Nutrient Content (Serving Size), 203 U.S. Recommended Daily Allowances, 216 Ingredient Labeling, 224 Standards of Identity, 228 Principal Display Panel Descriptors, 231 whet Format Options, 254 Testing of Label Formals, 260 Educating Consumers To Use Nutrition Information on Food Labels, 264 CONTEND 74 131 158 203

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CONT~VTS 8 LEGISLATION AND REGULATION Current Legal Authority To Expand Nutrition Labeling, 280 Desirability of Seeking New Legislative Authority for Nutrition T busheling, 289 Design of Food Labeling Legislation, 292 APPENDIXES A Participants at He Public Meeting Held by the Committee on the Nutrition Components of Food Labeling, 309 B Participants at Workshops Conducted by the Committee on the Nutrition Components of Food Labeling, 310 C International Food Labeling, 313 D Food Standards and the Quest for Healthier Foods, Alvin J. Lorman, 320 INDEX xv 279 343

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