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Summary

On November 8, 1990, President Bush signed into law the Nutrition Labeling and Education Act (NLEA), which mandated nutrition labeling information on most foods marketed to American consumers. The Act also provided for a nationally uniform food labeling regulatory system, which was to be achieved by preempting State and local labeling requirements whose coverage overlapped with certain provisions of the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA). In passing the legislation, Congress concluded that to achieve the goal of national uniform food labeling, certain State and local requirements should be preempted. Based on this consideration, all State and local requirements of the type contained in FDCA Section 403 were preempted on a schedule that varied over a 24-month period. For six provisions of FDCA Section 403, however, Congress concluded that further study was needed to determine whether those provisions had been adequately implemented by the Food and Drug Administration (FDA) and whether any State or local requirements should be considered for Federal adoption. Preemption of State and local requirements related to those six provisions of FDCA Section 403 was to occur only after a study had been conducted. This report is the culmination of that study, the purpose of which was to review and determine whether current Federal requirements were adequately implementing the intent of the six provisions of FDCA Section 403.

NLEA directed the Secretary of the U.S. Department of Health and Human Services (DHHS), through FDA, to implement such a study. FDA thus contracted with the Institute of Medicine (IOM) to study the adequacy of implementation of the following provisions: FDCA 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],



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Food Labeling: Toward National Uniformity 1 Summary On November 8, 1990, President Bush signed into law the Nutrition Labeling and Education Act (NLEA), which mandated nutrition labeling information on most foods marketed to American consumers. The Act also provided for a nationally uniform food labeling regulatory system, which was to be achieved by preempting State and local labeling requirements whose coverage overlapped with certain provisions of the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA). In passing the legislation, Congress concluded that to achieve the goal of national uniform food labeling, certain State and local requirements should be preempted. Based on this consideration, all State and local requirements of the type contained in FDCA Section 403 were preempted on a schedule that varied over a 24-month period. For six provisions of FDCA Section 403, however, Congress concluded that further study was needed to determine whether those provisions had been adequately implemented by the Food and Drug Administration (FDA) and whether any State or local requirements should be considered for Federal adoption. Preemption of State and local requirements related to those six provisions of FDCA Section 403 was to occur only after a study had been conducted. This report is the culmination of that study, the purpose of which was to review and determine whether current Federal requirements were adequately implementing the intent of the six provisions of FDCA Section 403. NLEA directed the Secretary of the U.S. Department of Health and Human Services (DHHS), through FDA, to implement such a study. FDA thus contracted with the Institute of Medicine (IOM) to study the adequacy of implementation of the following provisions: FDCA 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],

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Food Labeling: Toward National Uniformity 403(i)(1) (common or usual name], and 403(k) [labeling of artificial flavorings, colorings, or chemical preservatives). The IOM established the Committee on State Food Labeling under the auspices of the Food and Nutrition Board to advise the agency on whether those six provisions of the law were being adequately implemented and recommend any State requirements that should be considered for Federal adoption. The charge to the Committee was 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. This report is the product of the Committee's research, analysis, and deliberations; the findings and conclusions presented are based on materials received from FDA. State and local food officials, industry trade associations and companies, and consumer groups; presentations to the Committee; correspondence; and searches of legal data bases. The Committee's assignment turned out to be a good deal more complex than it initially appeared and entailed the deciphering of Federal requirements, discovery and classification of State requirements, translation of Congress's somewhat delphic language about adequacy and implementation, and determined pursuit of an understanding of the purpose and impact of State requirements. The Committee developed well-defined working principles and criteria for analysis and viewed its jurisdiction rather broadly in its efforts to untangle many of these complexities. As a consequence of the lack of clear lines separating some of the six study provisions, the Committee had to classify and review State food labeling requirements based upon the exercise of its best judgment. Based on the legislative history and text of the NLEA, the Committee excluded from its deliberations issues related to food safety, grading, kosher, organic, natural, origin, and open date labeling; which were not preempted under the Act. The Committee also excluded an analysis of emerging State and local regulatory issues such as environmental ''green'' labeling, although it believes these issues deserve consideration by FDA in the future.

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Food Labeling: Toward National Uniformity CONTEXTUAL FACTORS AFFECTING THE REGULATION OF MISBRANDED FOOD From the beginning of the twentieth century, and certainly since passage of FDCA, there has been a tremendous change in the types of food products available to the American consumer. A brief review of the progress made in the past 50 years provides a sense of the significant differences that exist in today's food products and the marketplace compared with those of 1938. Indeed, the complex national and international systems for food manufacturing and merchandising have been a significant factor behind the impetus for national control of food regulation. The evolution of food products cannot be considered separately from the significant changes that have occurred in food packaging. A related factor is the importance of package design and graphics, which in today's market are fundamental to product differentiation on the shelf. Manufacturers see "burdensome" labeling requirements as a potential obstacle to the marketability of their products—not only domestically but in international food trade, an area of substantial marketing opportunity. Proper labeling to provide the consumer with useful, factual information was the rationale for the original FDCA misbranding provisions, and that motivation has not changed in more than half a century. Early misbranding provisions were related to "food sold under the name of another food"; they were designed to give consumers accurate information about the food they were purchasing. Current labeling concerns about nutrient content and health claims focus on the content and composition of food products as these components relate to contemporary public health issues. Early in the twentieth century, Congress enacted the first Federal statute to deal with food regulation, the Pure Food and Drugs Act of 1906. This early law defined those products that were to be considered foods and contained provisions on the adulteration and misbranding of food products. The passage of FDCA in 1938 addressed a host of practices that were new or had not been controlled under the earlier statute. The Act described in much more specific terms the circumstances under which a food was to be considered adulterated or misbranded under the law and provided FDA with new authority to combat violations. Following enactment of FDCA, the agency developed "standards of identity" for several hundred foods and sought to implement the other provisions through various means. In the early 1970s, following recommendations of the White House Conference on Food, Nutrition and Health, the Federal government developed the current system of nutrition labeling in the United States. Late in the decade, FDA, the U.S. Department of Agriculture, and the Federal Trade Commission reviewed existing U.S. food labeling requirements to

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Food Labeling: Toward National Uniformity determine whether those provisions were still appropriate. Although the agencies prepared detailed recommendations for implementing changes in many aspects of food labeling, a lack of scientific consensus and the prevailing deregulatory environment would not support comprehensive reform at that time. Criticism of the type of information on food labels escalated in the 1980s as scientific investigations convincingly demonstrated the relationship between dietary habits and the prevalence of chronic diseases. American consumers became increasingly attentive to choices among foods and sought improved information on the products that they were selecting. In addition, the proliferation of health claims being made for foods created a demand for more consistent and scientifically sound messages on labels. By 1990, efforts to reform the current policy on food labeling, especially in regard to nutrition information, were being pursued by the Federal agencies and Congress. The food industry was particularly concerned about national uniformity in food regulation. All of these efforts culminated in the passage of NLEA. CRITERIA FOR DETERMINING ADEQUATE IMPLEMENTATION OF THE FEDERAL STATUTE In carrying out its charge, the Committee evaluated the adequacy of FDA's implementation of the six provisions of FDCA Section 403 by first applying principles developed during its deliberative process. The definition of adequate as "equal to, proportionate to, or fully sufficient for a specified or implied requirement" was used as a foundation for decisions. The intent of any section and any regulation, as interpreted by the Committee, was a consideration, including, as appropriate, a consideration of the impact of FDCA Sections 403(a)(1), 403(e), and 403(i)(2) when used in conjunction with the six provisions that were the subject of the study. The absence of an FDA implementing regulation would not lead to an automatic conclusion that implementation was inadequate. The level of enforcement would not be a consideration in determining adequacy of implementation. The strictest requirement, whether Federal, State, or local, would not always be recommended for adoption as the national standard.

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Food Labeling: Toward National Uniformity The Committee limited its study of the six FDCA Sections to any implementing regulations for which rulemaking had been completed and advisory opinions had been published, as defined in 21 CFR §10.85. In reviewing State and local requirements and their relationship to the six provisions of FDCA Section 403 under study, the Committee viewed its own jurisdiction broadly to ensure a fair, balanced review of the materials provided by State and local officials and other interested persons. Once the principles for evaluating adequacy were established, the Committee interpreted adequacy of implementation in the following manner. In some circumstances where only a law existed, the law alone could be judged to adequately implement the provision. In other circumstances, the existence of implementing regulations for a given section of the law could be judged to represent adequate implementation of the statute. In other situations, consideration could be given to other types of evidence to assist in judging adequate implementation of a provision of the law; i.e., an FDA advisory opinion. Two additional concepts that could be used to define adequate implementation are compliance and enforcement. Compliance would address the extent to which manufacturers have met the provisions of laws and regulations; i.e., the degree to which food labels in the marketplace comply with Federal labeling requirements. An evaluation of enforcement would address the extent to which FDA has pursued manufacturers that market products with labels that do not meet Federal requirements. With regard to compliance as a measure of adequate implementation, this criterion was considered to be important because it represents the effectiveness of existing requirements to fulfill the Congressional mandate on the six FDCA misbranding provisions under study. However, the Committee received no information on compliance from its requests to FDA and the States. Anecdotal cases of noncompliance were cited in discussions with State officials, but no comprehensive record of noncompliance problems was available for the Committee's use. Although the Committee recognized the critical importance of compliance to an evaluation of adequate implementation, the absence of compliance data required the Committee to omit inclusion of compliance as a criteria for determining adequacy of implementation of the six provisions of FDCA Section 403 under study. The Committee considered the question of whether FDA's enforcement of existing laws and regulations should be a criterion for evaluating the adequacy of implementation of the six provisions of FDCA Section 403. To determine the intention of Congress on whether enforcement was an issue for the Committee's consideration, it reviewed the provisions of NLEA and

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Food Labeling: Toward National Uniformity the Congressional debate on the issue and discussed the question with a number of individuals familiar with the course of the Act's development. No evidence was presented to the Committee that would indicate that enforcement was an anticipated criterion for determining adequacy of implementation. While the Committee believed that the issue of enforcement was important in terms of evaluating the agency's implementation record, it also recognized that FDA's enforcement record is significantly influenced by resources available and the political will at given points in time. Therefore, the Committee chose not to include enforcement as a criterion for adequate implementation. However, because enforcement was clearly a concern to States and consumer groups, and was considered to be an important issue for the future, the issue is addressed at considerable length later in the report. Second, the Committee reviewed all of the State requirements it had assembled and evaluated them in terms of the tasks defined in the IOM's Proposed Plan of Action for the study. Third, the Committee categorized the State requirements according to the following criteria: An adequate Federal requirement exists on the issue. The agency has not adequately implemented the Act in the area of concern represented by the State requirement. Such a conclusion would be based on the requirement's national importance, its national prominence as indicated by the frequency of attention to the issue by the States, and/or the lack of an existing Federal regulation. The State requirement meets a demonstrated local need. The State requirement provides only economic protection to the industry, is without consumer benefit, and/or has no other redeeming virtue. Beyond Federal laws and regulations, there is a tremendous variety of less formal written materials that analyze, interpret, and discuss FDA's view on its statutory mandate. These documents include preambles of proposed and final regulations, compliance policy guides, guidelines, advisory opinions, letters to the food industry, Regulatory Letters and Notice of Adverse Findings letters (now both called Warning Letters), speeches, press releases, and talk papers. The Committee concluded that although many informal mechanisms are used to implement the law, it would not be possible or appropriate to examine all such materials in determining the adequacy of implementation. However, the Committee did view advisory opinions (as defined in 21 CFR §10.85) as representing the formal position of FDA on a matter and, except in unusual situations, as obligating the agency to follow that position until it was amended or revoked. Therefore, the Committee

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Food Labeling: Toward National Uniformity decided to rely on the following FDA materials in evaluating the adequacy of implementation of the six provisions of FDCA Section 403 under study: preambles of proposed and final regulations, regulations, compliance policy guides, trade correspondence, guidelines, and other formally established advisory opinions. State regulation is frequently justified on two counts: (1) State requirements provide an avenue for new and innovative regulatory approaches to labeling to be developed and tested prior to Federal adoption, and (2) in the absence of Federal leadership, States have often found it necessary to regulate to ensure that consumers are protected. Without judging the merit of these arguments, the Committee relied on the following indicators during its analysis of State and local requirements: the frequency with which different States regulated a matter regardless of any FDA regulation; the regulation by one or more States of a matter considered by the Committee to be of national importance and/or prominence; the regulation by a State of a matter of strictly local significance to both consumers and industry, and the regulation by a State of a matter resulting in the economic protection of the industry, without consumer benefit. One definitional problem had an impact on the Committee's review of State requirements and preemption determinations. Often, regulatory areas of concern to the States could not be easily categorized as relating to (1) standards of identity that are different from Federal standards and already preempted by NLEA; (2) standards of identity in cases in which no Federal standard exists and therefore may not be preempted; or (3) common or usual names that are different from Federal standards, not yet preempted, and thus subject to the Committee's review to determine the adequacy of implementation of Federal requirements. The Committee decided that it could not distinguish in any principled way among these categories of misbranding relative to State regulations. Therefore, it decided to view its jurisdiction broadly: if it was reasonable to consider that the State regulation fell within the Committee's purview, it was treated as a matter for study. COMPARISON AND ANALYSIS OF FEDERAL AND STATE FOOD LABELING REQUIREMENTS The following sections briefly discuss the Committee's findings and conclusions regarding the six provisions of FDCA Section 403 mandated for

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Food Labeling: Toward National Uniformity study. The discussion covers current Federal legal authority and regulations, the relationship of the six provisions to other FDCA misbranding sections and related Federal laws, a review of State and available local statutes and regulations, and a summary of State, industry, and consumer perspectives. The Committee's analysis of each of the study provisions is built on this information, as well as the Committee's working principles and criteria, and other information and materials submitted by States, industry, consumer groups, and other interested parties. Virtually no information on the rationale for establishing or impact of implementing State and local requirements on public health and nutrition was provided to the Committee. The Committee found that many State labeling laws were generally consistent with the Federal statute (i.e., 45 States utilize the Uniform State Food, Drug, and Cosmetic Bill and 21 States have autoadoption provisions to incorporate Federal regulations by reference). The instances in which there were apparent discrepancies were reviewed and recommendations were made. Table 1-1 summarizes the conclusions of the Committee's comparison and analysis of the Federal and State requirements. In general, most State requirements that differed from Federal provisions involved only a few commodities. Where State requirements were established in response to an absence of Federal regulations to ensure consumer protection, the Committee suggested actions to be taken by FDA and State requirements be exempted from preemption until FDA acts. Where State requirements regulate commodities important to a State economically but do not provide consumer protection, the Committee suggested that States petition FDA either for exemption from preemption or to establish a unifying Federal requirement. Where State requirements regulate a particular local need, the Committee suggested that the States petition FDA for exemption from preemption through the petition process. Where an adequate Federal regulation is in place, the Committee suggested that State requirements are candidates for preemption. In some cases, State requirements were either already preempted by other NLEA provisions (i.e., standards of identity), or not subject to the study (i.e., grading under USDA jurisdiction) and therefore not addressed. A more extensive discussion of the rationale for the Committee's conclusions is found in Chapter 5. The Committee reached its conclusions through consensus in most cases. In several instances very strongly held views among members kept the Committee from reaching complete agreement. In these cases, both views are expressed in the report.

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Food Labeling: Toward National Uniformity TABLE 1-1 Summary of Conclusions of the Report of the Committee on State Food Labeling FDCA section Determination of Implementation Conclusion Suggestions to FDA 403(b)-Food Under the Name of Author Food Adequate • Related State requirements are candidates for preemption • Aggressively pursue regulatory options for naming non-standardized foods       • Consolidate FDCA Section 403(b) with 403(i)(1) 403(d)-Container Fill and Deceptive Packaging Not adequate • Exempt related requirements from preemption until adequate FDA policy in place • Consider using FPLA definition of nonfunctional slack fill for Federal requirements 403(f)-Placement of Required Information Adequate • Related State requirements are candidates for preemption   403(h)-Standards of Quality and Fill Adequate • Related State requirements are candidates for preemption   403(i)(1)-Common or Usual Name Adequate • Related State requirements are candidates for preemption       For commodities and food categories examined:       Bottled water       • Exempt State requirements until adequate FDA policy is in place • Establish common or usual name or standards of identity for names (sources) of bottled water       • Consider AFDO model bottled water bill     Cider, cider vinegar, and other vinegar products       • Related State requirements are candidates for preemption  

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Food Labeling: Toward National Uniformity FDCA section Determination of Implementation Conclusion Suggestions to FDA 403(i)(1)-Continued   Citrus       • Preempted under other NLEA provision not part of this study • States should petition FDA to amend citrus standards of identity     Honey       • Exempt State requirements until FDA considers need for Federal requirement       Milk, milk products, and other dairy products       • Preempted under other NLEA provision not part of this study       Seafood       • Continue use of Fish List advisory opinion as Federal policy       • Consider origin definitions for catfish and other aquaculture seafood products       • Preempt State surimi requirements       maple syrup       • Preempted under other NLEA provision not part of this study       Olive and vegetable oils       • Related State requirements are candidates for preemption       Oriental noodles       • Related State requirements are candidates for preemption  

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Food Labeling: Toward National Uniformity FDCA section Determination of Implementation Conclusion Suggestions to FDA 403(i)(1)-Continued   Pine nuts       • States should petition FDA for exemption from preemption or creation of a Federal requirement       Poi       • Candidate for exemption from preemption       Vidalia onion       • States should petition FDA for exemption from preemption or creation of a Federal requirement       Wild rice       • Exempt State requirements until FDA considers need for Federal requirement • Issue advisory opinion or common or usual name based on botanical names 403(k)-Artificial Colors, Adequate Flavors, and Chemical Preservatives   • Related State requirements are candidates for preemption   NOTE: AFDO = Association of Food and Drug Officials; FDA = Food and Drug Administration; FDCA = Food, Drug, and Cosmetic Act; FPLA = Fair Packaging and Labeling Act; NLEA = Nutrition Labeling and Education Act. FDCA Section 403(b) FDCA Section 403(b) provides that a food is misbranded "if it is offered for sale under the name of another food." The intent of Section 403(b) is to prohibit the use of misleading names on a food when there are no common or usual names or definitions and standards of identity for the food. The Committee found considerable overlap between the provisions of FDCA Section 403(b) and FDCA Section 403(i)(1), which requires foods to be sold under established common or usual names. The views of States, industry, and consumer groups on the adequacy of implementation of FDCA Section 403(b) all coincided, reflecting the opinion that although Federal requirements under Section 403(b) may be

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Food Labeling: Toward National Uniformity are not "of the type" and therefore not subject to study by the Committee. Nevertheless, the Committee decided to view its jurisdiction broadly and reviewed all State requirements regarding the labeling of products for which State standards of quality and fill of container have been established. A number of States have regulations regarding standards of fill of container, but most do not establish labeling requirements for foods that do not meet those standards apart from the provisions of FDCA Section 403(h). Industry groups did not speak directly to the adequacy of FDA implementation of Section 403(h); instead, they emphatically stated that no State should be allowed to establish different requirements for standards of quality and fill of container. Consumer groups neither cited specific examples of discrepancies between Federal and State requirements related to Section 403(h) nor commented on the adequacy of FDA implementation. Conclusions Based on its analysis and criteria, the Committee concludes that FDCA Section 403(h) is adequately implemented. The Committee further concludes that State requirements related to FDCA Section 403(h) are candidates for preemption. The Committee also suggested that because of the ambiguities of NLEA regarding preemption of State requirements for quality and fill of container "of the ripe" related to FDCA, FDA should consult with Congress to clarify the status of these standards and requirements for the States and industry. FDCA Section 403(i)(1) FDCA Section 403(i)(1) states that a food is misbranded "if it is not subject to the provisions of paragraph (g) of this section [which concerns standards of identity] unless its label bears (1) the common or usual name, if any there be." A similar requirement is found in FPLA Section 4(a)(1), which specifies that each consumer commodity—packaged food in this context—must "bear a label specifying the identity" of the product. The Committee grappled with problems associated with differentiating between State requirements that were common or usual names, or definitions and standards of identity. Viewing its jurisdiction broadly, the Committee embraced for analysis a set of State requirements that included provisions for establishing common or usual names and many requirements related to the naming of specific foods that could be subject to either FDCA Section 403(i)(1) or Section 401 (standards of identity).

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Food Labeling: Toward National Uniformity The Committee found many State requirements that differed from Federal requirements for common or usual names. The State provisions established specific requirements for food commodities (e.g., names for fish), or groups of foods (eg., dairy products, bottled water). States are highly protective of their historical involvement in the naming of foods, either through the common or usual name mechanisms, or definitions and standards of identity. A number of States expressed concern about FDA's slow response to petitions establishing names and standards for foods and, in general, with the level of Federal enforcement of FDCA Section 403(i)(1)—which has been virtually nonexistent since the mid-1970s. In comparison, industry groups agreed that the Federal system for establishing a common or usual name under FDCA Section 403(i)(1) is adequately implemented and all differing State requirements should be preempted. Consumer groups, on the other hand, commented that Federal implementation is sporadic and insufficient to protect consumers adequately. Conclusions Based on its analysis and criteria, the Committee concludes that an adequate procedure currently exists in 21 CFR Part 102 for the development and application of common or usual names for foods under FDCA Section 403(i) (1). The Committee further concludes that State requirements for the process of establishing and defining a common or usual name are candidates for preemption. However, to promote the development and introduction of new foods, the Committee suggests that FDA more aggressively pursue regulatory options that will allow the development of names for new, nonstandardized foods. Common Names for Specific Foods Having reached a conclusion regarding the adequacy of the Federal procedure for establishing common or usual names, the Committee discussed its responsibility to review further the States' specific food requirements. After considerable debate, the Committee concluded that because its report to FDA is advisory, it would view its responsibility broadly and review all of the materials provided by the States. The Committee selected food categories for review on the basis of their economic or public health importance, prominence by virtue of the number of State requirements that address them, regional significance, or fulfillment in some other fashion of the criteria established by the Committee. All of

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Food Labeling: Toward National Uniformity the State requirements were then reviewed based on comments received from States, industry, and consumer groups, and application of the Committee's criteria for adequacy. Based on its review, the Committee judged whether the State requirements were (1) candidates for preemption, (2) candidates for consideration by FDA as Federal requirements, (3) candidates for exemption, (4) already preempted by NLEA, or (5) excluded from consideration under NLEA. The results of the Committee's review are summarized below. Bottled Water FDA's original decision not to define the various kinds of bottled waters may have been correct when it was adopted in 1973, but the market for, and the public perception of, bottled water have changed substantially since then. 'Me proliferation of products in the marketplace and the increasingly aggressive claims made for those products have magnified the opportunity for public confusion, indicating that the existing policy is not adequate. Therefore, the Committee suggests that FDA establish common or usual names or standards of identity for bottled water and concludes that State laws and regulations that define and/or standardize the names of the various kinds of bottled water should be considered candidates for preemption after a Federal requirement is established. The Committee suggests that the Association of Food and Drug Officials' model bill be examined as a unifying basis for Federal regulation of bottled water. Cider, Cider Vinegar, and Other Vinegar Products In applying its criteria, the Committee concluded that none of the State requirements it had identified met the threshold for consideration for adoption as a Federal requirement, nor did there appear to be a compelling reason for additional Federal regulation of cider products. Therefore, the Committee concludes that State requirements for cider products am candidates for preemption. Citrus After reviewing Florida's analysis and its current requirements and the provisions of the remaining three citrus-producing States, the Committee concluded that the issues raised during this review fall outside its charge and

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Food Labeling: Toward National Uniformity the requirements either are already preempted (juice standards of identity) or would not be affected by preemption (grading). The Committee, however, found merit in Florida's position that its standards of identity may provide additional consumer protection (i.e., through specific production criteria beyond FDA's standard of good manufacturing practice). Therefore, the Committee suggests that Florida and/or other citrus-producing States consider petitioning FDA to amend the Federal standards of identity for citrus products, and existing State requirements be exempt from preemption until the petition process is complete. Honey That 22 States needed to specifically regulate this food suggested to the Committee the potential benefit of some Federal unifying regulatory requirement. The promulgation of a Federal standard of identity and quality under FDCA Section 401 would establish national uniformity through clear preemptive action. If appropriate, concerns over the possible microbiological contamination of honey, especially with Botulinum spores, might be addressed in the standard of quality established not only under the misbranding provisions but also under the adulteration provisions of FDCA. Such an initiative, however, is not viewed as a high priority among the overall activities associated with implementation of NLEA. In addition, State requirements that establish grades or define adulteration are not subjects of this study. Therefore, the Committee suggests that FDA consider the need for a single unifying Federal requirement for honey. The Committee further suggests that State requirements for honey remain in effect until a Federal requirement is established. Maple Syrup The Committee concludes that the State maple syrup requirements reviewed are either standards of identity and preempted under NLEA Section 6, or grade standards and not subject to NLEA preemption, and are not subject to study. Milk, Milk Products, and Other Dairy Products This category of products represented by far the largest number of State requirements. A careful review and evaluation of these requirements,

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Food Labeling: Toward National Uniformity however, led the Committee to the conclusion that all were standards of identity and thus regulated by FDA under FDCA Section 401. The Committee concludes that these State dairy requirements were preempted upon the date of enactment of NLEA and are not subject to study. Olive and Vegetable Oils Federal regulations concerning ingredient labeling and nomenclature of blended oils appear adequate. Therefore, the Committee concludes that State requirements related to olive oil and oil mixtures are candidates for preemption. Oriental Noodles Because of national marketing and acceptance of oriental-type noodles, the Committee suggests that the existing FDA compliance policy guide serve as the national standard for oriental-type noodles and concludes that individual State requirements are candidates for preemption. Pine Nuts The Committee concludes that although this unique State provision meets a local need, it appears to serve only the economic interest of a limited commodity industry. Therefore, the Committee suggests that New Mexico petition FDA to exempt its pine nut provision from preemption or create a national common or usual name for pinon (pine) nuts. Poi In view of the highly localized and culturally specific nature of poi, the Committee suggests that Hawaii petition FDA to exempt its poi provision. Seafood Nomenclature of seafood is an issue of both public health and economic concern. Identification of species is essential in cases of certain forms of

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Food Labeling: Toward National Uniformity food allergy. In addition, a well-regulated system of common or usual names is vital to prevent economic deception of consumers. Therefore, the Committee suggests that: The Fish List should be continued as a formal FDA advisory opinion to industry. the designations of origin (farm, river, lake) for catfish, which provide potentially useful information to consumers, should be considered by FDA as candidate for an advisory opinion or incorporated into Federal regulations. because FDA policies for labeling surimi-based products appear to provide adequate regulation, State requirements are candidates for preemption. Vidalia Onions This State requirement appears to be predominantly protectionist in that no specific justification is provided for limiting the source to the defined producing locality. However, because of the widespread recognition of the Vidalia onion name, the Committee suggests that Georgia (or any other group or industry) consider submitting a petition to FDA to establish a common or usual name for the Vidalia onion based on measurable geographical, botanical, and/or quality criteria that justifiably differentiate it from other varieties or species of onion. Wild Rice The high cost of wild rice makes this product prone to consumer deception through substitution and blending, regardless of its relative market position as compared with other rice products. Therefore, the Committee suggests that FDA issue a formal advisory opinion or establish a common or usual name regulation defining wild rice in terms of its botanical name(s). Current State requirements should not be candidates for exemption from preemption until a formal FDA requirement is in place.

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Food Labeling: Toward National Uniformity FDCA Section 403(k) FDCA Section 403(k) provides that a food is misbranded if it bean or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulation promulgated by the Secretary. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream. The provisions of this paragraph with respect to chemical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil. States have many specific requirements related to artificial colors, flavors, and chemical preservatives. However, many State provisions relate to the safety of these food additives and/or prescribe health-related warnings on food labels, apart from general label disclosure requirements. These types of requirements are exempt from NLEA preemption provisions. More than one-third of the States reported requirements identical to FDA requirements for food additive labeling related to FDCA Section 403(k). Half of the States reported differences between some specific Federal and State requirements in this area. In addition, FDA is currently in the process of promulgating requirements regarding label disclosures for certified color additives, as part of NLEA. Nonetheless, States made few comments on the adequacy of FDA implementation of Section 403(k). Industry groups concurred that FDCA requirements under Section 403(k) are adequately implemented, noting that a lack of perceived problems over the years provides the rationale for preemption of State requirements for food labeling ''of the type'' provided by this provision. Consumer groups, however, stated that Federal implementation has been inadequate, citing State requirements as offering a significantly higher level of consumer protection than that afforded by FDA requirements. They did not comment directly on the adequacy of the requirements themselves except in instances in which safety issues were involved. Conclusions For many State labeling requirements for food additives, colors, and chemical preservatives, there are not clear delineations among economic adulteration, health and safety issues, and misbranding requirements. It is clear however, that State requirements that specifically address issues of adulteration, in contrast to misbranding, are not preempted under NLEA. Many issues addressed by specific State requirements will either be covered

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Food Labeling: Toward National Uniformity by the proposed implementing rules or not be subject to preemption under NLEA. Based on its analysis, criteria, and current FDA regulatory activity, the Committee concludes that FDCA Section 403(k) is adequately implemented. The Committee further concludes that State requirements related to FDCA Section 403(k) are candidates for preemption. ISSUES RAISED BY STATES, CONSUMERS, AND INDUSTRY In the process of obtaining information from States, localities, food and drug officials, industry, and consumer groups, the Committee received comments on a number of issues that were not directly related to its specific charge. The Committee felt, however, that these issues were germane to uniform food labeling regulation and devoted considerable discussion to their significance in relation to the central topics of the study. When the groups named above were asked if there were issues other than the six provisions under study that the Committee should consider as it deliberated on recommendations for preemption of State/local requirements, the following concerns were raised: The adequacy of the fiscal and personnel resources applied by FDA in enforcing its food labeling requirements as a dimension of implementation. The importance of the enforcement activities of the States to ensure consumer protection in the area of food labeling. The value of existing cooperative relationships between FDA and the States, which have been developed and strengthened over many years. The concerns of States about FDA's implementation of the petition process of NLEA for exemption of a State requirement from preemption and State enforcement of Federal requirements, so that these processes will be uncomplicated and well managed. The economic cost of nonuniformity and the potential savings to be realized through increased national uniform food labeling (a particular concern of the food industry). State officials and consumer groups commented on the importance of enforcement and the States' future role in food labeling regulation under the provisions of NLEA. Concern focused on the need for an equal partnership between States and FDA to implement and enforce Federal food labeling laws and regulations. Virtually all such comments by these groups linked adequacy of implementation with enforcement and the availability of fiscal

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Food Labeling: Toward National Uniformity resources and shared the concern that without a clear and important State role, many legislatures might cease to fund food regulatory programs at the State and local levels. State officials also raised the issue of their continued role in enforcement of the Federal statute, which allows them to bring civil enforcement proceedings within their jurisdictions. FDA's proposed regulations on State enforcement under NLEA outlined the procedures that States should follow in taking enforcement action beginning in November 1992. The Committee believes that FDA will need to follow implementation of these requirements closely to allow the States to play an effective role in enforcement. It also seems reasonable that some mechanism should be established for States to apprise FDA and other State agencies of actions taken in State courts in the interest of the goals of national uniformity. Cooperative working relationships between FDA and the States need to be further enhanced or expanded to address emerging issues on a regular basis. Active dialogue was viewed by States as necessary to handle such issues before they are either addressed (1) by one jurisdiction or (2) through the petition process, and would allow for early input from State regulators in the development of Federal responses. State officials and consumer groups generally agreed that Federal preemption of State requirements under NLEA is unlikely to be accompanied or followed by major new FDA funding to increase its regulatory efforts to make up for a perceived decrease in State regulatory efforts for preempted requirements. It is not yet possible to predict whether there will be a loss of State resources, participation, and involvement in food regulation as a result of preemption. On November 27, 1991, FDA published a proposed regulation for the petition process concerned with exemption from preemption of State requirements. The petition process will serve as a mechanism by which States can request FDA to exempt a specific State provision from preemption. The proposed regulation outlined specific criteria for exemption and the information that must be submitted to the agency, which then has 90 days to respond on the merits of the petition. Although exemptions would only be granted to the petitioner State, the Committee believes that if an issue is national in scope, the agency should consider amending the Federal requirement. The petition process affords the States a mechanism to deal with their particular needs and the opportunity to suggest to FDA those instances in which some informational requirements may be considered candidates for Federal adoption. The Committee believes that the petition process must take into account genuine local concerns basing judgments on evidence to justify exemption of State requirements from preemption. The Committee further believes that FDA must ensure that its requirements for information

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Food Labeling: Toward National Uniformity supporting petitions be clear to the States and the agency must adhere to its own time schedule for action on petitions. FDA can use the petition process as a way to evaluate its own activities in regard to adequate implementation of the various misbranding sections of FDCA. Finally, significant concern about the economic impact of nonuniformity was voiced by industry representatives. The Committee requested information from a number of food companies and trade associations on the costs to industry of monitoring individual State legislative and regulatory activities; product negotiations with individual States having unique requirements; legal confrontations over individual State requirements; and retrieval, relabeling, and scrapping of products and labels. The Committee was advised that industry considered the economic impact of nonuniformity between State and Federal requirements for food labeling to be significant, although the cost figures it provided were principally anecdotal. While many manufacturers indicated that they viewed the economic impact of nonuniformity as part of the cost of food manufacturing in the United States, these costs are passed on regardless of consumer benefits. No information was available to the Committee to evaluate the costs and benefits of nonuniform label requirements in relation to consumers. ******* This study on the adequacy of FDA implementation of six provisions of FDCA Section 403 was undertaken as a result of the requirement mandated by NLEA. The Committee overcame the ambiguities of NLEA and established a set of criteria that it believed were reasonable for judging the adequacy of Federal implementation of FDCA requirements and making recommendations to FDA regarding the future of related State requirements slated for preemption. The associated issues of the States' role in future food labeling regulation, enforcement, and petitions were also discussed, and the Committee has provided its position on these issues in the report for the agency. The Committee believes that its conclusions, recommendations, and suggestions meet the expectations of both Congress and FDA. It further believes that the report will be a valuable, useful document to form the basis for FDA's development of the required Federal Register notices to complete implementation of the NLEA provisions for national uniform nutrition labeling.

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