DIETARY REFERENCE INTAKES

Guiding Principles for Nutrition Labeling and Fortification

Committee on Use of Dietary Reference Intakes in Nutrition Labeling

Food and Nutrition Board

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification DIETARY REFERENCE INTAKES Guiding Principles for Nutrition Labeling and Fortification Committee on Use of Dietary Reference Intakes in Nutrition Labeling Food and Nutrition Board INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 competences and with regard for appropriate balance. Support for this project was provided by the Food and Drug Administration of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service of the U.S. Department of Agriculture under Contract No. 223-01-2460, Task Orders 5 and 8, and by Health Canada under Contract No. H1021-020552/001/SS. The views presented in this report are those of the Institute of Medicine Committee on Use of Dietary Reference Intakes in Nutrition Labeling and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on Use of Dietary Reference Intakes in Nutrition Labeling. Dietary reference intakes : guiding principles for nutrition labeling and fortification / Committee on Use of Dietary Reference Intakes in Nutrition Labeling, Food and Nutrition Board. p. cm. Includes bibliographical references and index. ISBN 0-309-09132-2 (hardcover) — ISBN 0-309-09143-8 (pbk.) — ISBN 0-309-52962-X (pdf) 1. Food—Labeling. 2. Nutrition. I. Title. TX551.I58 2004 363.19’2—dc22 2004002799 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification COMMITTEE ON USE OF DIETARY REFERENCE INTAKES IN NUTRITION LABELING IRWIN H. ROSENBERG (chair), Jean Mayer USDA Human Nutrition Research Center on Aging and Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts STEVEN A. ABRAMS, Department of Pediatrics, USDA/ARS Children’s Nutrition Research Center, Baylor College of Medicine, Houston, Texas GARY R. BEECHER, Lothian, Maryland CATHERINE M. CHAMPAGNE, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge FERGUS M. CLYDESDALE, Department of Food Science and Nutrition, University of Massachusetts, Amherst JEANNE P. GOLDBERG, Center on Nutrition Communication and Graduate Program in Nutrition Communication, Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts PENNY M. KRIS-ETHERTON, Department of Nutritional Sciences, The Pennsylvania State University, University Park JEROLD R. MANDE, Yale Cancer Center, Yale University School of Medicine, New Haven, Connecticut GEORGE P. MCCABE, Department of Statistics, Purdue University, West Lafayette, Indiana FRANCES H. SELIGSON, Hershey, Pennsylvania VALERIE TARASUK, Department of Nutrition Sciences, University of Toronto, Ontario SUSAN WHITING, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon Consultant BERNADETTE M. MARRIOTT, Chapel Hill, North Carolina

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification Staff LINDA D. MEYERS, Study Director ROMY GUNTER-NATHAN, Co-Study Director1 GAIL SPEARS, Staff Editor TAZIMA DAVIS, Research Assistant2 HARLEEN SETHI, Senior Project Assistant3 SHANNON RUDDY, Senior Project Assistant4 1   Until December 2002. 2   From June 2003. 3   Until September 2003. 4   From September 2003.

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification FOOD AND NUTRITION BOARD CATHERINE E. WOTEKI (chair), College of Agriculture, Iowa State University, Ames ROBERT M. RUSSELL (vice chair), Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts LARRY R. BEUCHAT, Center for Food Safety, University of Georgia, Griffin BENJAMIN CABALLERO, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland SUSAN FERENC, SAF*Risk, LC, Madison, Wisconsin NANCY F. KREBS, Department of Pediatrics, University of Colorado Health Sciences Center, Denver SHIRIKI KUMANYIKA, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia LYNN PARKER, Child Nutrition Programs and Nutrition Policy, Food Research and Action Center, Washington, D.C. PER PINSTRUP-ANDERSEN, Division of Nutritional Sciences, Cornell University, Ithaca, New York A. CATHERINE ROSS, Department of Nutritional Sciences, The Pennsylvania State University, University Park BARBARA O. SCHNEEMAN, Department of Nutrition, University of California, Davis NICHOLAS J. SCHORK, Polymorphism Research Laboratory, University of California, San Diego JOHN W. SUTTIE, Department of Biochemistry, University of Wisconsin, Madison STEVE L. TAYLOR, Department of Food Science and Technology and Food Processing Center, University of Nebraska, Lincoln BARRY L. ZOUMAS, Department of Agricultural Economics and Rural Sociology, The Pennsylvania State University, University Park

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification Staff ALLISON A. YATES, Director5 LINDA D. MEYERS, Deputy Director GAIL SPEARS, Staff Editor GERALDINE KENNEDO, Administrative Assistant GARY WALKER, Financial Associate 5   Until October 2003.

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Richard Black, International Life Sciences Institute, North America; Susan Borra, International Food and Information Council; Robert O. Earl, National Food Processors Association; John W. Erdman, University of Illinois; Nancy D. Ernst, Ernst Nutrition Consulting; Kenneth Fisher, KD Consultants; Cutberto Garza, Cornell University; Katherine Gray-Donald, McGill University; Peter Barton Hutt, Covington & Burling; Gilbert Leveille, Cargill, Inc.; Ian C. Munro, Cantox Health Sciences International; Suzanne P. Murphy, University of Hawaii; Lynn Parker, Food Research and Action Center; Donna Porter, Congressional Research Service; George F. Sheldon, The University of North Carolina at Chapel Hill; John Vanderveen, San Antonio, Texas; and Kathryn L. Wiemer, General Mills.

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Maldon C. Nesheim, Cornell University, and Enriqueta Bond, Burroughs Wellcome Fund. Appointed by the Institute of Medicine and the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification Preface The task for the Committee on Use of Dietary Reference Intakes in Nutrition Labeling, which I was privileged to chair, was to provide guidance to the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA), the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), and Health Canada on how to use the Dietary Reference Intakes (DRIs) to update the nutrient reference values used in nutrition labeling. The committee was also asked to produce guidance on how to use the DRIs when making decisions about the discretionary fortification of food. The evolution of the current seven plus DRI volumes from a single-volume book of Recommended Dietary Allowances (RDAs) in the United States and from Recommended Nutrient Intakes (RNIs) in Canada reflects the tremendous surge in the scientific understanding of basic nutrition and the relationships between diet and health in the 8 years between the publication of the last RDA and RNI books and the first volume of the DRIs. The DRIs are definitely not your mother’s RDAs or RNIs! They include four reference values: the RDA, the Estimated Average Requirement (EAR), the Adequate Intake (AI), and the Tolerable Upper Intake Level (UL). (An overview of the DRIs and their derivation is provided in Chapter 4.) The report before you represents the result of six meetings, numerous phone conferences, and much writing by the scientists on this committee who volunteered their time to work with the complexity of these issues. First and foremost, I want to acknowledge them for their dedication and perseverance in working through the

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification diversity of issues and bringing to the discussion their depth of expertise in the diverse areas necessary for a report such as this. Second, I want to thank Linda Meyers, study director, for her leadership in helping all of us stay focused on the task at hand and for providing support to our endeavor in so many ways. I especially thank our expert consultant, Bernadette Marriott, for her vital contributions that were essential and critical to the completion of the report. The committee appreciates the assistance of the Food and Nutrition Board (FNB) staff in developing this report, particularly that of Romy Gunther-Nathan for her contributions as the original co-study director, Harleen Sethi for making our meetings and conference calls run so smoothly, Tazima Davis for her research assistance, Shannon Ruddy for assisting in the completion of the report, and Gail Spears for her technical editing. We wish to thank Allison Yates, former FNB Director, for her thoughtful interactions and discussions with the committee on some of the more difficult issues. The committee also benefited greatly from the statistical and computer skills of Craig Johnson. The committee held two workshops to broaden its knowledge of the issues and to hear from interested groups. The committee acknowledges the following individuals for their insightful comments at these workshops: Susan Borra, Margaret Cheney, Brenda Derby, Annette Dickinson, Robert Earl, Constance Geiger, Nancy Green, Suzie Harris, Regina Hildwine, Clifford L. Johnson, Allison Kretser, Bonnie Liebman, Alanna Moshfegh, Ian Munro, Robert Post, Leila Saldanha, Christine Taylor, and Kathryn Wiemer. In particular, the committee thanks Margaret Cheney, Robert Post, and Virginia Wilkening and their colleagues for assisting its research into the history and status of food labeling and fortification. This report is a derivative of the DRI reports and as such reflects the work of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its panels and subcommittees. The multipart committee-panel structure that comprises the DRI process has led to a series of reports involving over 100 expert scientists who have rigorously maintained a consistent approach and understanding of the basic DRI definitions and derivations. While this report is outside of the framework of review for the DRI reports, its essence has benefited from the diligent work of those scientists. In this report the Committee on Use of Dietary Reference Intakes in Nutrition Labeling presents its recommendations as a series of guiding principles to assist the regulatory agencies that oversee food labeling and fortification in the United States and Canada. Although the committee members have varying levels of past experience with food regulations in our respective countries, over the course of this

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification study we have gained a deeper appreciation for the difficulty and complexity of the steps necessary to develop a nutrition label and the policies of discretionary fortification that are truly helpful for the broad population of consumers in our two countries. We provide this guidance to FDA, FSIS, and Health Canada with the hope that it will assist them in moving the process forward so that the significant science base in the DRIs can rapidly be used to benefit the health of our nations. Irwin H. Rosenberg, Chair Committee on Use of Dietary Reference Intakes in Nutrition Labeling

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   13      Committee Charge and Study Process,   15      Report Organization,   17 2   OVERVIEW OF NUTRITION LABELING IN THE UNITED STATES AND CANADA   18      Reference Values and Nutrition Labeling in the United States,   18      Reference Values and Nutrition Labeling in Canada,   35      Consumer Understanding and Use of Nutrition Labeling,   40 3   OVERVIEW OF FOOD FORTIFICATION IN THE UNITED STATES AND CANADA   45      History and Current Status of U.S. Food Fortification Policy,   45      History and Current Status of Canadian Food Fortification Policy,   52      Summay,   55 4   A BRIEF REVIEW OF THE HISTORY AND CONCEPTS OF THE DIETARY REFERENCE INTAKES   56      Origin,   56      Rationale for the Framework,   58

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification      What Are Dietary Reference Intakes?,   60      Categories of Dietary Reference Intakes,   61      Dietary Reference Intake Issues Especially Relevant to Nutrition Labeling and Discretionary Fortification,   74      General Issues for Nutrition Labeling and Discretionary Fortification,   78 5   GUIDING PRINCIPLES FOR SELECTING REFERENCE VALUES FOR NUTRITION LABELING   79      Guidance on Developing Reference Values,   80      Use of Tolerable Upper Intake Levels,   109      Additional Issues,   110 6   GUIDING PRINCIPLES FOR THE DISCRETIONARY ADDITION OF NUTRIENTS TO FOOD   124      Scientific Justification and Criteria,   126      A Conceptual Model,   131      Issues in Implementing a Level of Discretionary Fortification,   138 7   DATA SUPPORT AND RESEARCH RECOMMENDATIONS   145      Research in Support of Determining Nutrient Requirements,   146      Biological Endpoints Underlying the Tolerable Upper Intake Levels and Information on Adverse Effects,   146      Empirical Research to Ascertain the Impact of Discretionary Fortification,   147      Food Composition and Dietary Supplement Databases,   148      Changes in Nutrition Labeling and Consumer Research on Its Use,   149 8   REFERENCES   153     APPENDIXES     A   Biographical Sketches of the Committee,   165 B   Selected Illustrative Calculations Using a Population-Weighted Approach,   172 C   Reference Tables,   179 D   Workshop Programs,   194     INDEX   197

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification DIETARY REFERENCE INTAKES Guiding Principles for Nutrition Labeling and Fortification

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