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2
Background of the Study

Food labeling is a sharing of information between the food industry and consumers. One of the most important underlying rationales for this transfer of information is the assumption that it aids consumers in making dietary decisions conducive to health. The importance of this decisionmaking has been brought into stark relief in the past two decades by changes in the desire to protect and enhance the health of Americans. Among the most prominent of these changes is greater recognition of personal responsibility, which requires responsible and enlightened decisions by each individual, as a key to good health. Evidence of this perspective abounds in the growing interest in good nutrition practices and related health promotion behaviors.

Efforts to protect health and provide accurate information about foods being purchased led to the early local and subsequent State food laws in the United States. With technological advances and increased mobility of food products, Federal laws were enacted to protect consumers nationwide. First, the Pure Food and Drugs Act of 1906 (PFDA; P.L 59-384) and then the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA; P.L 75-717) provided the Food and Drug Administration (FDA) with the authority to regulate the information that appeared on food containers. Regulations promulgated under the provisions of these two statutes were designed to ensure that consumers received accurate information about the foods that they purchased. By 1990, however, the law and implementing regulations for the labeling of foods that had been created to address problems earlier in the century were out of date for assisting consumers to make informed dietary choices that would affect their health.

As a result, legislation was enacted to overhaul food labeling in general and nutrition labeling in particular. During the Congressional debate, food manufacturers voiced particular concern about the complex array of State



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Food Labeling: Toward National Uniformity 2 Background of the Study Food labeling is a sharing of information between the food industry and consumers. One of the most important underlying rationales for this transfer of information is the assumption that it aids consumers in making dietary decisions conducive to health. The importance of this decisionmaking has been brought into stark relief in the past two decades by changes in the desire to protect and enhance the health of Americans. Among the most prominent of these changes is greater recognition of personal responsibility, which requires responsible and enlightened decisions by each individual, as a key to good health. Evidence of this perspective abounds in the growing interest in good nutrition practices and related health promotion behaviors. Efforts to protect health and provide accurate information about foods being purchased led to the early local and subsequent State food laws in the United States. With technological advances and increased mobility of food products, Federal laws were enacted to protect consumers nationwide. First, the Pure Food and Drugs Act of 1906 (PFDA; P.L 59-384) and then the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA; P.L 75-717) provided the Food and Drug Administration (FDA) with the authority to regulate the information that appeared on food containers. Regulations promulgated under the provisions of these two statutes were designed to ensure that consumers received accurate information about the foods that they purchased. By 1990, however, the law and implementing regulations for the labeling of foods that had been created to address problems earlier in the century were out of date for assisting consumers to make informed dietary choices that would affect their health. As a result, legislation was enacted to overhaul food labeling in general and nutrition labeling in particular. During the Congressional debate, food manufacturers voiced particular concern about the complex array of State

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Food Labeling: Toward National Uniformity and local food laws and regulations that required their compliance. Industry maintained that national uniformity of both food safety and labeling requirements was a necessary component of reform to gain their support for passage of new labeling legislation. In the end, the legislation provided for national uniformity of food labeling, with an exemption for State food safety requirements. On November 8, 1990, President Bush signed the Nutrition Labeling and Education Act (NLEA). The new law was concerned specifically with FDA's food labeling authority, addressing issues similar to those already under review by the agency. The law required mandatory nutrition labeling on most packaged foods and voluntary nutrition information for produce and seafood; specified the nutrient content information that must appear on the label; provided for certain descriptive terms to be defined and claims to be allowed; established a petition mechanism for additional nutrient and health-related claims; required that consumer education be undertaken; provided for State enforcement of Federal requirements where the Federal government has not acted; revised certain requirements for ingredient listings and standards of identity; and specified the effective dates for implementation of various provisions of the Act. In addition, and of central significance to this study, enactment of NLEA established for the first time specific statutory provisions for achieving national uniformity of labeling requirements for foods subject to the provisions of FDCA. The purpose of Congress in this action is reflected in the title of NLEA Section 6, "national uniform nutrition labeling." The Act preempted State and local statutes and regulations whose coverage overlapped with and were different from certain FDCA provisions. State or local requirements identical to FDCA provisions are not preempted. Implementation dates for preemption varied. Some State and local misbranding statutes (e.g., standards of identity, imitation labeling) were preempted upon passage of the Act; a second group of statutes (e.g., net weight, ingredient labeling) were to be preempted in 12 months. For a third category, which included requirements for labeling "of the type" required by six provisions of FDCA Section 403, the Act delayed preemption of State and local requirements and mandated FDA to undertake a study to determine whether there was adequate implementation of the Federal law (Appendix A). The provisions to be studied included Sections 403(b) [food sold under the name of another food], 403(d) [misleading container], 403(f) [prominence of required information], 403(h) [standards of quality and fill], 403(i)(1) [common or usual name], and 403(k) [labeling of artificial flavorings, colorings, or chemical preservatives]. A fourth group of statutes (e.g., nutrition labeling, label claims) was to be preempted on completion of FDA's rulemaking process.

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Food Labeling: Toward National Uniformity The following list summarizes the schedule of preemption provisions under NLEA. Preemption on date of enactment (November 8, 1990) Standards of identity [Section 403(g)] Imitation foods [Section 403(c)] Preemption within 12 months of enactment (November 8, 1991) Manufacturer's name and address [Section 403(e)(1)] Net weight [Section 403(e)(2)] Ingredient labeling [Section 403(i)(2)] Preemption once mandated study is completed (November 8, 1992) Food sold under the name of another food [Section 403(b)] Misleading container [Section 403(d)] Prominence of required label information [Section 403(f)] Standards of quality and fill [Section 403(h)] Common or usual name [Section 403(i)(1)] Labeling of artificial flavorings, colorings, or chemical preservatives [Section 403(k)] Preemption once FDA has promulgated new regulations (May 8, 1993) Nutrition labeling [Section 403(q)] Nutrient content and health claims [Section 403(r)] NLEA also allowed States to petition for exemption from preemption of its food laws and regulations. When a State or locality submits a petition to the agency, the Secretary may exempt from preemption any State or local requirement that meets the following conditions: it would not cause any food to be in violation of any applicable requirement under Federal law; it would not unduly burden interstate commerce; and it is designed to address a particular need for information that is not met by the requirements of the sections that are otherwise preempted. States were also given authority to bring civil enforcement proceedings under certain provisions of FDCA Section 403 with prior notification to FDA, as long as the agency is not actively involved in or has not completed such an enforcement action. In accordance with the NLEA provisions, FDA contracted with the Institute of Medicine to conduct the mandated study of the six provisions of FDCA Section 403 in the third preemption category noted above. The study was to determine whether the Federal law was adequately implemented and examine those State and local laws and regulations slated for preemption in

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Food Labeling: Toward National Uniformity comparison to the Federal requirements. Based on the above review, the Committee's final report was to make recommendations to FDA on the six provisions of FDCA Section 403 under study that it determined were not adequately implemented by current or proposed regulations, and State or local regulations that should be considered for Federal adoption. COMMITTEE PROCEDURES Specifically, the Committee on State Food Labeling was charged to assemble a listing of all relevant State and local laws and regulations dealing with six misbranding sections of FDCA specified for study in NLEA; describe the provisions of each of the relevant State and local statutes that pertain to the sections under study and the basis on which those provisions were developed; and assess the extent to which each of the six sections of FDCA is being implemented under current and proposed regulations and evaluate existing data on the impact of such implementation on public health and nutrition. To meet its charge, the Committee held a public meeting on May 30, 1991 (FDA, 1991). At that meeting, eight individuals representing State and local governments, the food industry, and consumer groups presented testimony regarding the adequacy of Federal implementation (Appendix B); they also provided supporting information about State/local food labeling statutes and regulations concerned with the six provisions of the FDCA Section 403 under study following the meeting. To obtain further information on the six pertinent sections beyond that supplied through the public hearing process, the Committee convened several panels which included individuals knowledgeable about the Congressional intent underlying the NLEA provision for the study and the concerns of consumers, industry, and State and local regulators about the impact of Federal preemption. The developments that have occurred in food marketing, public health, and food regulation over the last century, but particularly since passage of FDCA, have been significant in terms of the changes currently sought in Federal regulatory policy. The contextual factors that have influenced this study are reviewed in Chapter 3. As further indication of whether Federal implementation of the six provisions of FDCA Section 403 has been adequate, the Committee requested that FDA provide all relevant materials about the issues under

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Food Labeling: Toward National Uniformity study. The Committees process for evaluating FDA materials required a determination about which types of available documents were pertinent to the question of adequate implementation. The Committee recognized that it would need to develop a set of criteria to evaluate the adequacy of Federal implementation and make recommendations concerning the status of State requirements. The process by which the Committee established its criteria and the steps taken in choosing which FDA materials to use are reviewed in Chapter 4. It was also necessary to review State activity in the areas under study to determine the full impact of preemption on State and local requirements, and the Committee soon discovered that there is no easy way to identify such activities. On several occasions, the Committee used electronic mail, letters, and fliers to request information from the States and selected local jurisdictions about those of their statutes and regulations that parallel the six provisions of FDCA Section 403 under study (Appendix E). At the request of the Committee, FDA twice sent communications through its electronic mail bulletin board, NRSTEN (National, Regional, and State Telecommunication Network), to elicit this information. The NRSTEN system reaches a wide audience of food and drug regulators and professional associations (Table 2-1). From an initial and follow-up request, all 50 States responded by providing the Committee with their basic food laws and regulations related to the misbranding provisions under study (Appendix F). The Committee also sent a letter containing a set of six questions (Appendix C) to all State governors and principal food regulatory officials, selected local jurisdictions, approximately 25 consumer groups, and several national associations of food regulatory officials/professionals. The letter requested information concerning the views of the addressee on the adequacy of Federal implementation in the areas under study and conflicting State or local requirements that might be preempted. Members of the Committee also made presentations about the study and distributed a flier (containing information identical to that in the letters) at the annual meetings of the Association of Food and Drug Officials (AFDO; approximately 250 contacts); the National Association of Consumer Affairs Administrators (NACAA; approximately 200 contacts); the National Association of State Departments of Agriculture (NASDA; 30 contacts); and the National Conference of Weights and Measures (NCWM; 300 contacts). The Committee received responses from 37 of 50 States providing additional information for its deliberations (Appendix D). The response from those other than State officials was very limited. The complete list of individuals who provided information to the Committee is contained in Appendix E. Virtually no information on the impact of implementation of State and local requirements on public health and nutrition was provided to the Committee.

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Food Labeling: Toward National Uniformity The Committee used legal data bases to search for State laws and regulations, primarily to cross-check information received from the States (Appendix F). It also searched legal data bases to find case law interpreting the Federal provisions under study and their State equivalents. These searches yielded only a small number of reported decisions involving Federal or State provisions in these areas (Chapter 5). The Committee thus depended on the voluntary assistance of States, consumer and industry groups in isolating those areas in which they believed the States had been taking regulatory action, or maintaining regulatory standards, that were different from Federal requirements and consequently subject to preemption after NLEA (Appendixes G and H). Most States did not identify any specific regulatory requirements related to the six provisions of FDCA Section 403 that they feared might be lost under NLEA preemption. Some States and consumer groups, however, expressed considerable concern about State enforcement authority and the petition process, issues that the Committee has considered (Chapter 6). TABLE 2-1 Central Contacts of the FDA NRSTEN (National, Regional, and State Telecommunications Network) System Staff Officials Attorneys General Directors of Agriculture Food Officials Health Officers State Co-op Program Managers (information only) Local Officials Major Metropolitan Health Departments Poison Control Centers Regional Federal Officials DHHS Regional Food and Drug Officials (information only) DHHS Regional Health Administrators Professional Organizations (information only) Association of State and Territorial Health Officials Association of Food and Drug Officials National Association of Attorneys General National Association of State Directors of Agriculture NOTE. DHHS = Department of Health and Human Services. SOURCE: Food and Drug Administration, Division of State-Federal Relations, 1991.

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Food Labeling: Toward National Uniformity Finally, the Committee sought information on the economic costs of nonuniformity. Given the lack of publicly available information, the Committee turned to informal communication with various manufacturers and trade associations. The cost information requested related to industry's monitoring of individual State legislative and regulatory activities; product negotiations with individual States having unique labeling requirements; legal confrontations over individual State requirements; and product retrieval, relabeling, and scrapping of product and labels. Although the Committee was uncomfortable with the lack of specific documentation, it felt compelled to explore this issue and present the available data at least as examples of costs. Chapter 6 also presents the Committee's findings on economic costs and provides the available information on State legislation related to misbranding that has been introduced in recent years, which serves as an additional indicator of nonuniformity. 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. This transfer of materials will allow FDA to promulgate the required proposed Federal regulation concerning adequate implementation of the six provisions of FDCA Section 403. In addition, it will allow access by all who wish to review the materials used in preparing this report and FDA's rulemaking. REFERENCE FDA (Food and Drug Administration). 1991. Food Labeling; Study of the State and Local Laws Relevant to Food Labeling; Public Meeting; National Academy of Sciences. Fed. Reg. 56:21388-21389; May 8.

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