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Food Labeling: Toward National Uniformity FOOD LABELING Toward National Uniformity Donna V. Porter and Robert O. Earl, Editors Committee on State Food Labeling FOOD AND NUTRITION BOARD INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1992
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Food Labeling: Toward National Uniformity 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 competences 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. 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 Catalog Card No. 92-60416 International Standard Book Number 0-309-04737-4 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, N.W. Washington, DC 20418 S585 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.
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Food Labeling: Toward National Uniformity COMMITTEE ON STATE FOOD LABELING J. PAUL HILE (Chair), Phoenix Regulatory Associates, Ltd., Sterling, Virginia MARY M. HESLIN (Vice Chair), Consultant, Hartford, Connecticut SANDRA O. ARCHIBALD, Food Research Institute, Stanford University, Stanford, California MARSHA N. COHEN, Hastings College of the Law, University of California, San Francisco, California JOHN W. ERDMAN, Jr., Department of Food Science and Division of Nutritional Sciences, College of Agriculture, University of Illinois, Urbana, Illinois JESSE F. GREGORY III, Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, Florida TIMOTHY M. HAMMONDS, Research and Education, Food Marketing Institute, Washington, D.C. ALVIN J. LORMAN, Akin, Gump, Hauer & Feld, Washington, D.C. WALTER H. MEYER, Consultant, Cincinnati, Ohio PATRICIA M. MORRIS, Public Voice for Food and Health Policy, Washington, D.C. LAURA S. SIMS, College of Human Ecology, University of Maryland, College Park, Maryland BAILUS WALKER, Jr., College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma NANCY S. WELLMAN, Department of Dietetics and Nutrition, Florida International University, Miami, Florida Staff DONNA V. PORTER, Project Director ROBERT O. EARL, Staff Officer BARBARA L. MATOS, Project Assistant
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Food Labeling: Toward National Uniformity FOOD AND NUTRITION BOARD M.R.C. GREENWOOD (Chair), Office of Graduate Studies, University of California, Davis, California DONALD B. McCORMICK (Vice Chair), Department of Biochemistry, Emory University School of Medicine, Atlanta, Georgia DeWITT S. GOODMAN (Vice Chair) (deceased),** Institute of Human Nutrition, Columbia University, New York, New York PERRY L. ADKISSON,* Department of Entomology, Texas A&M University, College Station, Texas LINDSAY ALLEN, Department of Nutritional Sciences, University of Connecticut, Storrs, Connecticut DENNIS M. BIER, Pediatric Clinical Research Center, Washington University School of Medicine, St. Louis, Missouri EDWIN L. BIERMAN,** Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, Washington MICHAEL P. DOYLE, Department of Food Science and Technology, Georgia Experiment Station, University of Georgia, Griffin, Georgia JOHANNA T. DWYER, Frances Stern Nutrition Center, New England Medical Center Hospital, Boston, Massachusetts JOHN W. ERDMAN, Jr., Department of Food Science and Division of Nutritional Sciences, College of Agriculture, University of Illinois, Urbana, Illinois NANCY FOGG-JOHNSON, Consumer Healthcare Division, Miles, Inc., Elkhart, Indiana CUTBERTO GARZA, Division of Nutritional Sciences, Cornell University, Ithaca, New York K. MICHAEL HAMBIDGE, Department of Pediatrics, University of Colorado Medical Center, Denver, Colorado JANET C. KING, Department of Nutritional Sciences, University of California, Berkeley, California JOHN E. KINSELLA, School of Agriculture and Environmental Sciences, University of California, Davis, California LAURENCE N. KOLONEL, Cancer Center of Hawaii, University of Hawaii, Honolulu, Hawaii SANFORD A. MILLER, Graduate Studies and Biological Sciences, University of Texas Health Science Center, San Antonio, Texas MALDEN C. NESHEIM, Office of the Provost, Cornell University, Ithaca, New York
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Food Labeling: Toward National Uniformity ROY M. PITKIN (Ex Officio),** Department of Obstetrics and Gynecology, School of Medicine, University of California, Los Angeles, California STEVE L. TAYLOR (Ex Officio), Department of Food Science and Technology, University of Nebraska, Lincoln, Nebraska * Member, National Academy of Sciences ** Member, Institute of Medicine Staff CATHERINE E. WOTEKI, Director MARCIA S. LEWIS, Administrative Assistant SUSAN M. WYATT, Financial Associate
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Food Labeling: Toward National Uniformity Preface The Committee on State Food Labeling was assembled in the spring of 1991 by the Food and Nutrition Board (FNB) of the Institute of Medicine (IOM) to conduct a study of selected Federal and State food labeling requirements. The study was initiated in response to the Nutrition Labeling and Education Act of 1990 (NLEA; P.L. 101–535). NLEA preempted all State and local misbranding laws and regulations on a fixed schedule in order to achieve national uniformity. One provision of Section 6 of NLEA required the Secretary of Health and Human Services to enter into a contract with a public or nonprofit private entity to conduct a study of State and local laws that require food labeling of the type mandated by certain misbranding provisions of the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA)—that is, Sections 403(b), 403 (d), 403(f), 403(h), 403(i)(1), and 403(k). The study was also to consider whether the Food and Drug Administration (FDA) has been adequately implementing those sections prior to the effective date of preemption of related State and local requirements. FDA, the study's sponsoring agency, contracted with IOM based on the Institute's expertise in food labeling issues, which was demonstrated by the 1990 report Nutrition Labeling: Issues and Directions for the 1990s. The 13 members of the Committee of State Food Labeling were selected for their expertise in consumer affairs, dietetics, Federal and State food regulatory policy, food law, food production and marketing, food science, human nutrition, and public health. From the first meeting of the Committee, its members realized that there was a broad array of issues to be explored, some of which were outside their areas of experience. Consequently, the Committee gathered additional needed information through a public meeting, panel discussions at
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Food Labeling: Toward National Uniformity Committee meetings, requests to the States, and communications with public interest groups, trade associations, and organizations representing food and drug officials. The Committee welcomed information from all outside sources. Further, the Committee recognized that the study was not typical of those regularly conducted by the Institute of Medicine. Beyond an understanding of the food, nutrition, and public health sciences important to the study, there was a need to consider Federal administrative procedures, the policy relationships of different levels of government, the Federal regulatory process, economic issues and consumer concerns. The composition of the Committee established by the Academy was multidisciplinary in nature to meet these diverse needs. The Committee aggressively pursued collection of the information it identified as necessary to accomplish the requirements of the study outlined in NLEA. The Committee requested the 50 States, selected larger municipalities, and FDA to provide copies of applicable laws, regulations, and other policy statements promulgated in implementing those statutes. The data received from these requests were voluminous; both the amount of individual effort expended and the number of documents exceeded all expectations. The Committee found, however, that there was no single comprehensive data source available for the compilation of relevant Federal, State, and local labeling and related regulatory requirements. As a consequence, the Committee cannot be certain that all relevant materials that might exist were reviewed. With these caveats, the data the Committee collected are perhaps the most extensive available, and have been categorized and analyzed thoroughly. Following completion of the study, the Committee has planned for all the materials collected from States, localities, and other interested parties to be provided to FDA to allow access by all who wish to review them. The Committee went beyond the strict limits of its charge for several reasons. First, from a practical standpoint, it was difficult and sometimes impossible to separate the existing State and local requirements into six discrete packages to parallel exactly the six FDCA Sections that are the subject of this report. The Committee, therefore, felt it was necessary to review and comment on all State requirements, except those that were obviously not part of the charge—for example, State requirements that were clearly preempted by other provisions of NLEA (e.g., the definition of ice cream). Second, the NLEA language was ambiguous, leaving unanswered questions regarding the scope of the Committee's inquiry and the status of some current State requirements under its automatic preemption requirements. This ambiguity was particularly true for FDCA Section 403(h),
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Food Labeling: Toward National Uniformity dealing with standards of quality and fill. Section 403(h) as enacted, presumes the existence of standards established under FDCA Section 401. Standards of identity established under Section 401, however, are clearly preempted by NLEA. The Committee decided early in its deliberations that such questions of statutory interpretation were beyond its charge. Finally, a wide variety of views emerged from the information provided to the Committee on the adequacy of FDA's implementation of the six FDCA Sections. In this regard, the Committee decided to review all materials and comments that were submitted and, in turn, believed it had a responsibility to provide FDA with the results of that review. Therefore, the report speaks to the future, suggesting that if FDA implementation of the six FDCA sections under study is to continue to be viewed as adequate by its State counterparts and critics, the agency must manage the petition process in an efficient, timely manner and commit Federal resources to food labeling enforcement. The Committee views its observations regarding both the petition process and enforcement as important outcomes of this study, together with its conclusions regarding the adequacy of FDA implementation and the status of existing State requirements. ACKNOWLEDGMENTS It is difficult to find an appropriate way to acknowledge the many persons who contributed to the development and completion of this report. Data on existing labeling statutes and related regulations were received from the 50 States, and one local jurisdiction. The Committee also drew heavily on FDA and others knowledgeable in the field of food labeling. It is not unreasonable to conclude that literally hundreds of people were somehow involved in the effort. The gratitude of the Committee extends well beyond those few who receive special recognition in the following paragraphs. First, the Committee thanks those individuals who made presentations at its public meeting on behalf of State, national, and public interest organizations, and food companies: Richard Frank, Sherwin Gardner, Dennis Johnson, Sharon Lindan, Allen Matthys, Dan Sowards, Merrill Thompson, and Francis Williams (see also Appendix B). Their presentations provided a solid base of information for the Committee's work Second, the Committee recognizes the critical contribution of all those at the State and local levels of government who provided data. These individuals are not all known to the Committee, but their contributions are no less appreciated. Third, the Committee thanks the staff of FDA, especially those in the Division of Nutrition and the Regulations and Industry Activities Branch of the Center for Food Safety and Applied Nutrition, as well as the Division of Federal-
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Food Labeling: Toward National Uniformity State Relations of the Office of Regulatory Affairs. These offices all provided materials and other assistance to help the Committee understand the agency's policies and procedures. At several of its meetings, the Committee held panel discussions focused on specific issues. We therefore wish to thank the following individuals for their participation in discussing: NLEA background and Federal implications—Heinz Wilms, Director, Division of Federal-State Relations, FDA; Peter Barton Hutt, Partner, Covington and Burling; and William Schultz, Counsel, Subcommittee on Health, Committee on Health and the Environment, U.S. House of Representatives; perspectives of State regulators—Leroy Corbin, National Association of State Departments of Agriculture; Jim Sevchik, New York State Department of Agriculture and Markets; Dan Sowards, Association of Food and Drug Officials; and Betsy Woodward, Florida Department of Agriculture and Consumer Services; industry concerns—Sherwin Gardner, Grocery Manufacturers of America; and Allen Matthys, National Food Processors Association; and consumer views—Bruce Silverglade and Sharon Lindan, Center for Science in the Public Interest; Amy Karas, New York City Office of Consumer Affairs; and Barry Rubin, the Advocacy Institute. Special thanks go to Richard L. Frank and Christina M. Markus of Olsson, Frank, and Weeda, P.C., and Sharon Lindan of the Center for Science in the Public Interest for their assistance in the identification of additional State and local food labeling activities, laws, and regulations relevant to the Committee's charge. The Committee also is indebted to Tom Mullen and Shirley Murphy, students at Hastings College of the Law, University of California, for performing legal data base searches to double-check the Committee's work, and Chambers Bryson, former chief of the Food and Drug Branch, California Department of Health Services, for drafting a background paper on State enforcement and the process of petitioning FDA for exemptions/exceptions from food labeling statutes. Ten food companies and trade associations must be thanked for providing information on the economic costs/savings of uniform food laws and regulations: Borden Foods, General Mills, Grocery Manufacturers of America, Kellogg Company, Kraft General Foods, Land O'Lakes, National Food Processors Association, Pepsico-Frito Lay, Procter & Gamble, and the Quaker Oats Company. The Committee also wishes to thank the Institute of Medicines project staff who were critical to the completion of this report. Donna V. Porter,
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Food Labeling: Toward National Uniformity Project Director, Robert O. Earl, Staff Officer, and Barbara L. Matos, Project Assistant, were thoughtful, insightful, and untiring in their support. Others within the IOM who were supportive of the project and understanding of its unique character were Catherine E. Woteki, FNB Director, and Enriqueta C. Bond, IOM Executive Director. IOM computer analyst Sabrina Montesa ensured proper manuscript and report preparation. Finally, I wish to thank my 12 colleagues on the Committee on State Food Labeling. They were a most able team who accepted the challenge of reviewing, categorizing, and evaluating the plethora of gathered materials with the professional skills and good humor necessary to provide Congress with the study it requested and ensure the development of a thoughtful, useful report for FDA. It was a pleasure to be associated with them and serve as chairman of the Committee.
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Food Labeling: Toward National Uniformity Contents PREFACE vii 1 SUMMARY 1 2 BACKGROUND OF THE STUDY 27 Committee Procedures 30 3 CONTEXTUAL FACTORS AFFECTING THE REGULATION OF MISBRANDED FOOD 35 Developments Before 1900 36 Developments Between 1900 and 1940 40 Developments Between 1940 and 1970 44 Developments Between 1970 and 1990 48 Current Federal and State Roles in Food Regulation 54 Implications for FDCA Section 403 58 4 CRITERIA FOR DETERMINING ADEQUATE IMPLEMENTATION OF THE FEDERAL STATUTE 63 The Historical Approach of FDA in Implementing FDCA 65 Summary of State and Local Comments 69 Summary of Industry Comments 71 Summary of Consumer Interest Group Comments 72 Committee Deliberations 73 Developing the Committee's Criteria 80
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Food Labeling: Toward National Uniformity 5 COMPARISON AND ANALYSIS OF FEDERAL AND STATE FOOD LABELING REQUIREMENTS 85 Complexity of the Analysis and Coverage 85 Food Under the Name of Another Food—Section 403(b) 87 Container Fill and Deceptive Packaging—Section 403(d) 90 Placement of Required Information—Section 403(f) 97 Standards of Quality and of Fill of Container—Section 403(h) 103 Common or Usual Name—Section 403(i)(1) 107 Labeling of Artificial Colorings, Flavorings, and Chemical Preservatives—Section 403(k) 126 6 ISSUES RAISED BY STATES, CONSUMERS, AND INDUSTRY 141 Enforcement as a Dimension of Implementation 142 State Action Under NLEA 144 Cooperative Relationships Between FDA and the States 147 Preemption and the Petition Process 149 Economic Impact of Nonuniformity 153 Committee Observations 159 APPENDIXES 163 A Provision for the State Food Labeling Study Contained in the Nutrition Labeling and Education Act of 1990 165 B Participants at the Public Meeting Held by the Committee on State Food Labeling, May 30, 1991 167 C Letter of Request Sent to State and Local Regulators and Consumer Groups by the Committee on State Food Labeling 169 D States Providing Written Response to the Six Questions from the Committee on State Food Labeling 173 E Individuals from States That Provided Information to the Committee on State Food Labeling 175
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Food Labeling: Toward National Uniformity F State and Local Laws, Regulations, and Other Materials Submitted to the Committee on State Food Labeling 183 G Areas of Discrepancy Between Federal and State Food Labeling Requirements Identified by States and Consumer and Industry Groups 195 H State Food Labeling Requirements and Relationship to the Misbranding Provisions of Section 403 of the Federal Food, Drug, and Cosmetic Act 203 I Case Study: Requirements for Labeling Bottled Water 209 J Biographical Sketches of Committee Members and Staff 219 INDEX 225
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