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Food Labeling: Toward National Uniformity 4 Criteria for Determining Adequate Implementation of the Federal Statute The Nutrition Labeling and Education Act (NLEA) established for the first time specific statutory provisions for achieving national uniformity of labeling requirements for foods subject to the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the purposes of Congress in enacting this legislation is reflected in the title of NLEA Section 6, ''national uniform nutrition labeling.'' The approach taken in NLEA to achieve this uniformity, however, is neither uniform nor specific to nutrition labeling. For example, any State labeling requirement for a food that is the subject of a standard of identity established under FDCA Section 401 and not identical to that standard was preempted on the date of enactment of NLEA. Any State labeling requirement "of the type" required by FDCA Section 403(c) [limitation labeling] is preempted a year after enactment. State labeling requirements "of the type" required by FDCA Sections 403(b), 403(d), 403(f), 403(h), 403(i)(1), or 403(k) are preempted under a third set of conditions (see also Chapter 2). For these latter sections, NLEA required: (b) STUDY AND REGULATIONS – (1) For the purpose of implementing Section 403(a)(3), the Secretary of Health and Human Services shall enter into a contract with a public or nonprofit private entity to conduct a study of – (A) State and local laws which require the labeling of food that is of the type required by sections 403(b), 403(d), 403(f) 403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and Cosmetic Act, and (B) The sections of the Federal Food, Drug, and Cosmetic Act referred to in subparagraph (A) and the regulations issued by the Secretary to enforce such sections to determine whether such sections and regulations adequately implement the purposes of such sections.
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Food Labeling: Toward National Uniformity Under NLEA, the Secretary is bound by a strict timetable to disseminate the results of the study and propose changes in the Federal requirements, as appropriate. The focus of the Committee's work thus was outlined within the specific language of NLEA. One of the Committee's tasks was to establish a definition for adequate implementation as a basis for judging current Federal requirements. The Committee began with the NLEA statutory language and examined the Congressional Record on the subject. This inquiry revealed that the debate in both chambers primarily centered on sections other than the provision mandating this study. However, in summarizing the requirements of NLEA for the full House, Representative Henry A. Waxman (D-Calif.) made the following statements: Section 6(b)(1) requires the Secretary to enter into a contract for a study of State and local laws of the type that will be preempted by Section 403(a)(3), and of the relevant federal laws and regulations. The purpose of this study is to provide the Secretary information upon which to determine whether federal laws are adequate once the State laws are preempted [emphasis added]. It is anticipated that the study will identify an federal regulations that are applicable as well as State laws that will be preempted. The study should also survey local laws, but it is not anticipated that every local law will need to be identified (U.S. Congress, 1990). This language emphasized in particular that Congress expected the Committee to go beyond merely determining the existence of a Federal regulation. Rather, it was to decide, once State requirements were preempted, whether the remaining Federal statutes and regulations were adequate for the protection of the public. The Committee also sought guidance from persons who participated directly in the development of NLEA Section 6(b). William Schultz, Counsel to the House Subcommittee on Health and the Environment, and Peter Barton Hutt, Partner in the law firm of Covington and Burling, met with the Committee on separate occasions to share their recollections of the Congressional discussions of the definition of "adequate implementation" and the Committee's charge. As a result of these discussions, the Committee learned the following regarding the development of Section 6: There was no attempt on the part of Congress specifically to define adequate implementation; the final determination was left to those who would conduct the study as pan of their recommendations to the Secretary. The expectation of Congress was that the adequacy of the Food and Drug Administration's (FDA) implementation was to be determined by
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Food Labeling: Toward National Uniformity the specific language of statutes, regulations, and any other formal statements of policy issued by FDA. Congress understood that the actual level of effort exerted at any moment in time by FDA to enforce FDCA, its regulations, or policies was subject to factors beyond the scope of the study and therefore should not be a consideration of the Committee in its deliberations (Hutt, 1991; Schultz, 1991). THE HISTORICAL APPROACH OF FDA IN IMPLEMENTING FDCA The Committee then focused on formal statements and policies of FDA as indicators of implementation. FDCA and Court Enforcement Actions FDCA Section 701(a) authorizes, but does not require, FDA to promulgate regulations for the efficient enforcement of the Act. In contrast, NLEA requires FDA to promulgate certain implementing regulations. Similarly, other recent amendments to FDCA (e.g., Safe Medical Devices Act of 1990) have directed FDA to promulgate regulations to a prescribed end on an established schedule. Historically, however, except for specific requirements such as those mentioned above, FDA has maintained that regulations are not necessary for effective enforcement of a law such as FDCA but are thought to be fairer and more efficient. From 1938 to 1970, FDA relied primarily on case-by-case enforcement to establish principles and policies for food labeling and other requirements. From 1970 to the early 1980s, the agency emphasized regulations, particularly in the area of food labeling. This approach was typical for the period, although enforcement data reveal that such heavy reliance changed over time: FDA instituted 3,848 separate court actions in fiscal year 1945, as compared with only 943 in 1971 (Hutt, 1973). FDA continues to believe that successful civil and criminal actions establish valuable precedent for future conduct by the regulated industry. When appropriate, the agency has relied on the established body of case law in the area of food labeling, especially that created during the first two decades following passage of the 1938 Act (Hutt and Merrill, 1991). The steady decline in these types of enforcement activities beginning in the 1960s, however, reflects the increased use of the authority to promulgate regulations (Pfeifer, 1984).
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Food Labeling: Toward National Uniformity The Increasing Use of Regulations Although FDA issued some regulations prior to 1938, their legal status and enforceability were frequently challenged. The express rulemaking authority of the 1938 Act, however, began to alter industry's attitude toward and acceptance of the agency's regulations, although the substantive character of the regulations continued to be challenged from time to time (Pfeifer, 1984). Passage of the Administrative Procedure Act in 1946 established the basic framework of rulemaking for all government agencies, including FDA (Mintz and Miller, 1991). The agency, however, did not immediately turn to rulemaking as its principal means of setting implementation policy under FDCA. Thus, by the early 1970s, FDA and many other Federal agencies were subjected to criticism by the Administrative Conference of the United States for not establishing policies through rulemaking (Hamilton, 1972). In response to that criticism, agencies began to expand their use of regulations as a means of enunciating policy. During this same period, new and innovative approaches to regulate food labeling were being proposed. Many recommendations from the final report of the White House Conference on Food, Nutrition, and Health (WHC, 1969) formed the basis for FDA's proposing new regulations on nutrient content labeling and alternative regulatory approaches for other aspects of food labeling (i.e., the common or usual name regulation instead of the establishment of standards of identity; 21 CFR Part 102; FDA, 1972; FDA, 1973). The promulgation of rules has now become the principal means by which FDA implements its regulatory programs. During the past two decades, its regulations have become increasingly detailed in their requirements and the preambles to the regulations have become more extensive in their discussion of the agency's rationale and plans for enforcement. Regulations are now used to set standards for or otherwise define products, require specific labeling, establish procedures or define good manufacturing practices for the industry, or establish administrative processes for use by the public or the agency itself (Pfeifer, 1984). FDA's rationale in part is that by publicly establishing rules, responsible firms will comply, thus contributing to efficient enforcement of FDCA (Hutt and Merrill, 1991). Advisory Opinions as a Means of Implementation The process of promulgating regulations is burdensome and time-consuming. Therefore, regulations ordinarily speak to matters that are not transient or subject to frequent change. To address matters that are of
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Food Labeling: Toward National Uniformity importance to industry but specific to a class of product or reflective of current scientific procedure, FDA provides advisory opinions—statements of policy and interpretation of its position on such issues. FDA has formalized the procedure by regulation (21 CFR §10.85; FDA, 1979, FDA, 1981). The first advisory opinions were issued during the early 1940s as excerpts from trade correspondence, generally known as Ta. However, after passage of the Administrative Procedure Act in 1946, such policy statements were required to be published in the Federal Register, and the TC system was discontinued (Levinson, c. 1952), although a number of TCs remain in effect today as advisory opinions [21 CFR §10.85(d)(2)]. The TC system was followed by a system called "Statements of Policy and Interpretation," which were published in the Federal Register and codified. (The remnants of this system can be found in 21 CFR Part 1, Subpart B.) In recent years, FDA increasingly has used general statements of policy in the form of advisory opinions (in response to industry requests) or guidelines developed on its own initiative to indicate its position in instances in which regulations are not appropriate. For example, FDA developed guidelines to provide guidance on conducting safety studies of new food additive products requiring premarket approval; this guidance (known as the Red Book ) must be revised continuously to reflect contemporary scientific methods and thus is not amenable to issuance as regulations. Another example is The Fish List, which defines more than 100 species of fish for labeling purposes. Such guidelines provide a "safe harbor" for industry, because they are binding on FDA until revoked. They are not binding on industry; nevertheless, if followed by a company, they provide assurance that the conduct of the company is acceptable to FDA. The preambles to regulations and formal notices published by FDA in the Federal Register also carry advisory opinion status. The advisory opinion process is defined in 21 CFR §10.85. Speeches, Articles, and Other Statements by FDA Employees As part of their day-to-day activities, FDA officials frequently are asked to make speeches, write articles for publication, or informally discuss current agency activities at public meetings. Such statements are eagerly sought and provide valuable insights into emerging policies. Investigators and compliance officers also are often confronted with situations in which they must discuss their views on FDA policy. Such advice must be accepted for what it is: an informal communication that represents the best judgment of an employee at a given point in time but that does not constitute an official FDA advisory opinion. Except in cases in which the written advice is provided and issued under the provisions
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Food Labeling: Toward National Uniformity of Sections 21 CFR §10.85 or §10.90, it cannot be relied upon to represent the formal position of the agency and does not bind, otherwise obligate, or commit FDA to the views expressed [21 CFR §10.85(k)]. FDA Policy on Preemption FDA included in the preamble to its proposed rule, State Petitions Requesting Exemption from Federal Preemption, a discussion of preemption and the policies it will follow in granting exemptions. Regarding the intent of NLEA, FDA stated that: Moreover, section 6(c)(1) of the 1990 amendments clearly manifests Congress's intention that the 1990 amendments "shall not be construed to preempt any provision of State law, unless such provision is expressly preempted under section 403A of the Act." Section 403A of the act is only operative in matters where there is a Federal requirement applicable to the labeling addressed in the State requirement. If them is no applicable Federal requirement that has been given preemptive status by Congress, there is no competing claim of jurisdiction, and, therefore, no basis under the 1990 amendments for Federal preemption or grounds to justify the submission of a State petition for exemption. Therefore, FDA has no authority under the 1990 amendments to rule on State petitions for exemption where the 1990 amendments have not imposed such Federal requirements. Of course section 6(c)(3) of the 1990 amendments provides that the amendments shall not affect any preemption, expressed or implied, which arises under the Constitution or other provisions of Federal law or regulation. Several examples of the types of State requirements that would not be subject to the preemption provisions of the 1990 amendments were given in the Congressional Record of July 30, 1990 (H5842). The examples included State laws pertaining to issues for which there is no national framework, such as open date labeling, unit price labeling, container deposit labeling, religious dietary labeling, and previously frozen labeling (FDA, 1991, p. 60530). The agency continued its discussion by referencing Executive Order 12612 on federalism as its guiding policy regarding preemption. In construing the provision for exemption from preemption, the agency is guided by the policy in Executive Order 12612 (E.O. 12612) of October 26, 1987 on federalism (52 FR. 41685 at 41687, October 30, 1987) that preemption of State law shall be restricted to the minimum level necessary to achieve the objectives of the statute. A corollary of this policy is that exemption from preemption should be liberally granted to the extent that the statutory objectives am fulfilled. FDA will consider E.O. 12612 as part of its review of any petitions that it receives (FDA, 1991, p. 60530). During its closing deliberations and final review of its draft report, the Committee concluded that it was appropriate and necessary to recognize the publication of the proposal in its report (see also Chapter 6). The Commit
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Food Labeling: Toward National Uniformity tee has not, however, gone beyond this recognition, concluding further that the publication by the agency of the proposed regulation and its preamble should not affect its recommendations to FDA. SUMMARY OF STATE AND LOCAL COMMENTS As part of its process of collecting State laws and regulations that might be preempted by NLEA, the Committee specifically requested guidance from States and localities in defining adequate implementation for the purposes of this study. The responses to this request took a number of different forms but can be generally summarized as follows. The Association of Food and Drug Officials (AFDO) identified the factors that it believed influence adequacy: We firmly believe that a regulation becomes "adequate" only when it (1) is sufficient as an enforcement tool to prevent fraudulent or misleading claims; (2) addresses the subject to the extent necessary to provide for good, sound nutrition in all of the area it purports to encompass; (3) uses up-to-date terminology and science to define foods and food descriptors, and at the same time meets the criteria in (1) above; and (4) omits no meaningful information which is addressed by a state or local law or regulation (AFDO, 1991). AFDO also noted that even so-called industry protectionist requirements often provide valuable consumer protection, citing orange juice regulation by the State of Florida. AFDO believes that Florida officials have more experience than officials from other States in dealing with misbranding of fruit juices and, therefore the State requirements are beneficial both to consumers as well as industry (AFDO, 1991). The Attorneys General of seven States (California, Iowa, Minnesota, Missouri, New York, Texas, and Wisconsin) also provided a definition of adequacy for the Committee's consideration: The standard for making that determination [of adequate implementation] should be whether the federal regulations in the subject areas of the study are at least as protective of the public's well-being as existing state law or regulations. Where a state's laws are more protective, we urge the Committee to conclude that the federal regulations do not adequately implement those provisions of the FDCA and that protections at least as stringent as those provided by state laws or regulations should be adopted by the FDA through rulemaking. Any other result would be to strip consumers of their current level of protection and would run contrary to the intent of the legislators who drafted the NLEA (State Attorneys General, 1991).
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Food Labeling: Toward National Uniformity The Attorneys General suggested that States often serve as "laboratories of democracy," taking the lead in responding to the public's needs locally and well in advance of a Federal response. In this fashion, States ultimately stimulate the Federal government to act and provide a template for any national standard. They offered two examples of areas in which States are providing such leadership: the labeling of bottled water and the regulating of misleading containers. Special attention was drawn to the bottled water requirements of California and New York, which require labels to identify the source of the water, and the California requirement prohibiting the use of a false bottom, sidewalls, lid, or covering in a "fashion to facilitate the perpetration of deception or fraud" (State Attorneys General, 1991). Twenty-one of the States that responded to the Committee's request reported that their State food and drug laws included an automatic adoption provision (Table 4-1). Under these circumstances, FDA regulations are automatically adopted (or adopted under simplified, streamlined procedures) as State regulations. Some States pointed out, however, that certain local problems have required special additional action by States, even with the automatic adoption provisions. In these instances, the States urged the Committee to recommend that such State requirements be candidates for adoption as Federal requirements. The example most frequently cited was, again, the regulation of bottled water labeling (see Appendix I). Only a limited number of responses to the Committee's request were received from localities (city and county governments). The responses revealed no conflicts with Federal requirements. TABLE 4-1 Status of State Automatic Adoption Provisions for Federal Requirements of the Food, Drug, and Cosmetic Act of 1938, as Amended State With Auto Adoption Without Auto Adoption Alabama x Alaska x Arizona x Arkansas x California x Colorado x Connecticut x Delaware x Florida x Georgia x Hawaii x Idaho x Illinios x Indiana x Iowa x Kansas x
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Food Labeling: Toward National Uniformity State With Auto Adoption Without Auto Adoption Kentucky x Louisiana x Maine x Maryland x Massachusetts x Michigan x Minnesota x Mississippi x Missouri x Montana x Nebraska x Nevada x New Hampshire x New Jersey x New Mexico x New York x x North Carolina x x North Dakota x Ohio x Oklahoma x Oregon x Pennsylvania x Rhode Island x South Carolina x South Dakota x Tennessee x Texas x Utah x Vermont x Virginia x Washington x West Virginia x Wisconsin x Wyoming x SOURCE: FDA, 1990. SUMMARY OF INDUSTRY COMMENTS The comments provided by industry generally took the position that FDA has adequately implemented by setting requirements and monitoring compliance of the six provisions of FDCA Section 403 under study. In comments on behalf of Kraft General Foods, Inc., Merrill Thompson suggested that it should be presumed that the FDCA Sections under study
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Food Labeling: Toward National Uniformity and associated FDA regulations are adequate unless demonstrated otherwise (Thompson, 1991). The Grocery Manufacturers of America (GMA), Inc., made two specific points regarding adequate implementation: We have no objection to learning from the states, where they have clearly and significantly improved upon the Federal law and regulations. Where a state cannot demonstrate a unique local condition that requires a unique local solution, but rather has identified a local approach that is superior to the national approach, that approach should indeed be adopted for the entire country. Only in the very rare situation where a state has a unique local condition that requires a unique local solution that is in fact not applicable to the rest of the country should the exemption approach set forth in Section 403(A)(b) be invoked... (GMA, 1991). In its section-by-section evaluation, GMA concluded that current FDA implementation is adequate for all six provisions. SUMMARY OF CONSUMER INTEREST GROUP COMMENTS The Center for Science in the Public Interest (CSPI) and other consumer groups provided extensive written comments on the issue of adequate implementation. They concluded that while uniformity is an important goal of NLEA, it is also important that the standards imposed represent the "highest common denominator" of all existing legal requirements, whether Federal, State, or local (CSPI/CNI/CFA/NCL, 1991). This position was echoed by a panel of representatives of both consumer interest groups and government consumer affairs offices who appeared before the Committee. This panel strongly supported the position that the mere existence of a Federal regulation does not in itself constitute adequate implementation and urged that under any circumstance the strictest requirement be adopted as the Federal regulation (Karas, 1991; Rubin, 1991; and Silverglade, 1991). CSPI and other consumer groups also stressed the important leadership role that States play in responding rapidly to emerging regulatory needs. They provided the following example: Another area in which the federal government has not taken the initiative is the issue of "downsizing" or "package shorting," a practice where manufacturers reduce the amount of their product while maintaining the same size container. This area, which relates both to Section 403(d) (misleading containers) and to Section 403(h) (standards of fill), has been the subject of increased public concern as consumers continue to fall prey to this form of economic deception. Foods which have been downsized by manufacturers include canned tuna fish, coffee, tea, cereals, spaghetti sauce and soup mixes. New York is one state which has taken the initiative on this
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Food Labeling: Toward National Uniformity issue. Currently, a bill has been introduced in New York which would require notice of the package shorting to appear clearly and conspicuously on the principal display panel for at least six months from the date of the package shorting. In contrast, FDA has taken no public action on this issue (CSPI/CNI/CFA/NCL, 1991). COMMITTEE DELIBERATIONS Establishing a Foundation for Discussion The Committee began its deliberation on the issue of adequate implementation by establishing an agreed upon definition of the word adequate. The Committee selected Webster's Third New International Dictionary of the English Language (unabridged), which provides the following definitions: Adequate: 1) equal; 2) to make equal or sufficient. Adequate: 1) equal in size or scope, 2) equal to, proportionate to, or fully sufficient for a specified or implied requirement; narrowly or barely sufficient, no more than satisfactory; 3) legally sufficient, such as is lawfully and reasonably sufficient; 4) fully representative. Because of the element of subjectivity in the interpretation of several subparts of the definition, the Committee applied its best judgment in concluding that ''equal to, proportionate to, or fully sufficient for a specified or implied requirement'' best suited its initial needs. The Committee ruled out the remaining options, since they seemed to (1) define physical proportions ("size or scope"); (2) focus on a deficient level of parity ("narrowly or barely"); (3) focus solely on legal criteria; or (4) assume that an agreed upon standard was in place ("fully representative"), and not to embody a relationship that would provide for protection of consumers and public health. The Committee also concluded, however, that it could not apply its chosen definition to carry out its charge without further elaboration. Discussion of Recommendations to the Committee Having established a foundation for its discussion, the Committee considered several of the viewpoints summarized earlier in this chapter from Congress, States, the food industry, and consumer groups. The first such view was that it should be presumed that the existing FDCA Sections and any associated FDA regulations adequately implement the purpose of such
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Food Labeling: Toward National Uniformity Sections. After careful consideration of the NLEA language and the entire Congressional Record discussion of NLEA Section 6(b)(1), the Committee rejected this recommendation. It concluded that the existence of Section 6(b)(1) is evidence of the conclusion of Congress that it cannot be presumed that the six FDCA Sections to be studied are being adequately implemented. The Committee also concluded, however, that the absence of an implementing regulation should not lead to an automatic conclusion that implementation is inadequate, although it could raise suspicions. There are two reasons for this conclusion. First, from a legal standpoint, regulations ordinarily are not necessary to implement Federal law. Second, FDA implements policy in ways other than by regulation, and such policy statements deserved consideration by the Committee. However, lack of any formal policy could be troublesome. A second view, supported especially by States, was that a determination of adequate implementation could not be made without considering whether the statute, regulations, or other implementing policies were being actively and aggressively compiled with and enforced. Enforcement was defined as the application of dollar and personnel resources and the use of civil, criminal, or administrative sanctions against violators. States argued that they often established and enforced their own requirements because FDA failed to "enforce" its own statutes, regulations, or other policies. A number of States suggested that Federal implementation would be adequate if only it was well enforced (i.e., Crawford, 1991; Harden, 1991; McClellan, 1991; Niles, 1991). This second view was particularly troublesome to the Committee. The concerns expressed about the lack of FDA enforcement of policies that were otherwise viewed as adequate in implementing FDCA Section 403 were not without merit. The Committee considered this matter with cognizance of the NLEA provision for State enforcement of Federal law that, in effect, expands the total means available to enforce otherwise adequate provisions. From a pragmatic standpoint, however, the Committee could not ignore the realities of fiscal constraint at all levels of government. If any government agency, Federal, State, or local, has insufficient funding to carry out all of the activities that the agency, or its critics, believe are important to achieve, agency leadership must establish priorities. Historically, such priority setting for resource allocation has been the case, and the Committee is aware of the fact that for many years, FDA's broad enforcement priorities have included health hazards, and filth and related adulteration ahead of economic violations (DHHS, 1991). From the research it conducted, the Committee could not determine in any conclusive fashion whether or how the States' enforcement of their misbranding statutes differs from that of FDA. Many misbranding charges
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Food Labeling: Toward National Uniformity are settled informally, both at the Federal and State levels. For example, during or after an inspection, a regulator may inform a manufacturer (perhaps orally or in a Warning Letter) that a product appears to be misbranded. Industry may comply (or promise to comply when relabeling), and the matter may end. Alternatively, a formal legal complaint may be filed on behalf of a State or FDA in court, and the complaint then becomes a public document. However, only in instances in which written opinions by a court are collected in a data base system are these decisions easily identified for study. Generally, even these formal agency complaints produce a paper trail that is not easily studied by outside observers unless the matter is of sufficient significance to be reported in the literature and subject to indexing procedures. A reported decision is seldom the result of actions in State trial courts. The Committee concluded, therefore, that the extent to which FDA enforced the law was a function of national or partisan priorities as established by the elected officials of the executive and/or legislative branches of government. The Committee considered an evaluation of the adequacy of implementation, based on enforcement priority decisions, well beyond its charge, and the view was therefore rejected. The Committee's position was supported by those closely involved in the development of NLEA (Hutt, 1991; Schultz, 1991). The very strong arguments put forward by the proponents of the view (particularly States), that enforcement should be factored into an evaluation of adequacy, however, could not be completely dismissed. The Committee therefore has discussed the issue separately in Chapter 6. A third view expressed to the Committee was that where more than one implementing requirement existed, whether at the Federal, State, or local level, the strictest requirement should be adopted as the national standard. In considering this question, the Committee was confronted with the problem of defining strictness. In many cases, the differences between Federal and State requirements were small, and their relative significance was not readily apparent. For example, in the case of canned oysters, FDA and a number of States have set standards for fill of container that are different, with no readily apparent reason for the differences. In other instances, the Committee was concerned that unnecessarily strict requirements had been established to protect local industries rather than the public. In the final analysis, the Committee concluded that, absent specific justification, the strictest requirement was not always the best for national implementation and, therefore, rejected this view. An additional reason to reject this view was that it could mean that all FDA requirements were inadequate without more stringent standards.
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Food Labeling: Toward National Uniformity The Committee chose instead to base its conclusions on a consideration of its own criteria. Sources Other Than Regulations for Determining Adequacy of FDA Implementation Beyond regulations, a tremendous variety of written materials analyze, interpret, and discuss FDA's view of its statutory mandate. These documents include proposed regulations, preambles to proposed and final regulations, Compliance Policy Guides, guidelines, advisory opinions, letters to the regulated industry, Regulatory and Notice of Adverse Findings letters (both now called Warning Letters), records of court actions, speeches, press releases, and speeches given by FDA officials. At one time or another, FDA has used all of these materials as a way of implementing the law. The Committee concluded, however, that it would be impractical to examine all of them because (1) ensuring that all relevant documents had been discovered would be difficult, (2) all of these documents might not offer consistent advice, (3) no practical indexes or other means for retrieval exist except for hand searching, and (4) many of these mechanisms do not legally bind the agency. Accordingly, the Committee decided to examine only those mechanisms that FDA agrees bind it to a particular position. FDA has outlined the procedure that the public may use to seek a formal advisory opinion on the agency's view of the laws it administers (21 CFR §10.85). According to FDA, an advisory opinion represents the formal position of the agency on a matter; except in unusual situations that involve an immediate and significant danger to health, the agency is obligated to act in accordance with the opinion until it is amended or revoked [21 CFR §10.85(e)]. In addition to advisory opinions issued through the procedure outlined in 21 CFR §10.85, FDA has also identified in that section a number of other documents to which it accords the status of formal advisory opinions (unless they are subsequently repudiated by FDA or overruled by a court): Any portion of a Federal Register notice other than the text of a proposed or final regulation, for example, a notice to manufacturers or a preamble to a proposed or final regulation. Trade Correspondence (TC Nos. 1 through 431, and 1A through 8A) issued by FDA between 1938 and 1946. Compliance policy guides issued by FDA beginning in 1968 and codified in the Compliance Policy Guides manual.
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Food Labeling: Toward National Uniformity Other documents specifically identified as advisory opinions, for example, advisory opinions on the performance standard for diagnostic x-ray systems, issued before July 1, 1975, and filed in a permanent public file for prior advisory opinions maintained by the Freedom of Information staff. Guidelines issued by FDA under 21 CFR 10.90(b), which establishes the procedure for the issuance of guidelines [21 CFR 10.85 (d)]. Since FDA has publicly agreed to bind itself by these materials, it seems fair to view them as the agency's official implementation of the statute. The Committee judged that this approach provided ample material with which to work and perform its task. A second consideration for the Committee was the impact of the provisions of FDCA Sections 403(a)(1), 403(e), and 403(i)(2) on the adequacy of FDA implementation when coupled with the requirements of the six provisions that are the subject of this study. Because FDA can bring charges in cases of violation of FDCA under more than one section, the Committee concluded that this interrelationship could not be ignored. Indeed, when the Committee reviewed the enforcement history of regulatory actions taken by FDA, it invariably encountered charges under multiple sections of FDCA. For example, FDCA Section 403(a)(1) states that a food will be deemed to be misbranded if its labeling is false or misleading in any particular. A food in package form is considered misbranded under FDCA Section 403(e) unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of quantity of contents. FDCA Section 403(i)(2) raises another misbranding issue: in cases in which a food is fabricated from two or more ingredients, the label must bear the common or usual name of each such ingredient (with limited exceptions), or the product will be considered misbranded. These three sections affected the Committee's review of the adequacy of implementation of FDCA Sections 403(b) [food offered for sale under the name of another food], and 403(i)(1) [common or usual name]. The Committee, however, was careful not to attribute greater significance to the requirements of FDCA Sections 403(a)(1), 403(e), and 403(i)(2) than was appropriate for the study. On the other hand, these three sections were not ignored when the Committee considered the overall ability of FDA to implement an adequate food labeling regulatory program. Two other components of Federal regulations that could be considered in adequate implementation are compliance and enforcement. Compliance would address the issue of the extent to which manufacturers have met the provisions of the laws and regulations, i.e. the degree to which food labels
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Food Labeling: Toward National Uniformity in the marketplace comply with the 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 the 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 of FDCA. However, this issue was not mentioned as a criterion in either the provisions of NLEA, or the Congressional debate on the subject. In addition, the Committee received no information on compliance from its requests to FDA and the States. Anecdotal cases of violations were cited in discussions with State officials, but no comprehensive record of noncompliance 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 also 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 intent of Congress on whether enforcement was an issue for the Committee's consideration, it reviewed the provisions of NLEA and the Congressional record 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 which 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 (adequate manpower and funding) 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 considered to be an important issue for the future, the issue is addressed at considerable length later in the report. State Regulations as an Indicator of Adequacy of FDA Implementation The two most frequently cited justifications for State regulation were that (1) States provide an avenue by which new and innovative regulatory
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Food Labeling: Toward National Uniformity approaches can be developed and tested prior to adoption at the Federal level, and (2) States have often found it necessary to regulate in the absence of Federal leadership. Without passing judgment on the merits of these arguments, the Committee concluded that its review of State laws and regulations could provide one measure of the adequacy of Federal implementation. Therefore, in reviewing State laws and regulations, the Committee was sensitive to the following indicators: The frequency with which different States regulated a practice 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. The regulation by a State of a matter resulting in the economic protection of the industry, without consumer benefit. The basis for the review of State requirements was the tasks defined in the proposed plan of action presented by the Institute of Medicine (IOM). In broader terms, the Committee was required to carry out the following tasks: Identify existing State/local laws with provisions applicable to food labeling reform efforts currently being undertaken by FDA as related to FDCA Sections 403(b), 403(d), 403(f), 403(h), 403(i)(1), and 403(k). Summarize those State/local laws with relevant provisions and, if supporting data are provided by State/local regulators, consider the public health issues that prompted the development of the provisions. Assess the extent to which each of the six Sections of FDCA is being implemented; in addition, to the extent required by the six Sections of FDCA, evaluate existing data on the effect on public health and nutrition of preempting applicable State/local laws. Hold at least one open meeting to permit representatives of State/local governments and other interested persons to submit information relative to State/local laws and regulations for food labeling and comment on the adequacy of Federal implementation of the six relevant Sections of the FDCA. Identify, prioritize, and recommend those provisions that should be given consideration by FDA in its food labeling reform efforts. One definitional problem had a significant impact on the Committee's review of State requirements and preemption determinations. Under NLEA,
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Food Labeling: Toward National Uniformity State standards of identity that are different from Federal standards of identity were preempted on the date NLEA was enacted (November 8, 1990). However, a State statute or regulation setting forth a common or usual name for a food that is not identical to the requirements of FDCA Section 403(i)(1) is not immediately preempted but subject to review after the conclusion of this study. If preemption occurs, it will become effective November 8, 1992. However, regulatory areas of concern to the States cannot easily be categorized. Therefore, it is difficult to determine from a legal point of view whether State requirements are (1) "standards of identity" that are different from Federal standard, and thus already preempted by NLEA; (2) "standards of identity" in cases in which no Federal standards exist 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 for determination of the adequacy of Federal requirements. The Committee decided that it could not distinguish in any principled way among these three categories of misbranding and therefore it would view its own jurisdiction broadly. If it was reasonable to consider that the State regulation fell within the purview of the Committee's jurisdiction, it was treated as a matter for study. Because the conclusions of the Committee are only recommendations to FDA about which State requirements it should consider embracing, the Committee felt that it would be appropriate in its categorization of State requirements to take the broader rather than the narrower approach to the interpretation of NLEA. DEVELOPING THE COMMITTEE'S CRITERIA In carrying out its charge, the Committee evaluated the adequacy of FDA's implementation of the six provisions of FDCA Section 403 in the following manner. First, it applied the principles developed through its own 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 Sections 403(a)(1), 403(e), and 403(i)(2) when used in conjunction with the six provisions that are the subject of the Study.
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Food Labeling: Toward National Uniformity 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 automatically be recommended for adoption as the national standard. The Committee limited its study of the six FDCA sections to any implementing regulations for which rulemaking had been completed and published advisory opinions as defined in 21 CFR §10.85. In reviewing State and local requirements and their relationship to the six provisions of FDCA 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. Second, the Committee reviewed and evaluated all State requirements it had assembled against the tasks defined in the IOM Proposed Plan of Action described earlier in this chapter. Third, the Committee categorized the State requirements according to the following criteria: An adequate Federal requirement exists on the issue (the field is thus occupied). 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. As part of its consideration of adequacy, the Committee has suggested the adoption of State requirements by FDA that might otherwise be preempted if, in its judgment, those requirements clearly provide special benefit to the consumer. To the extent possible, it has also established priorities among the candidates under criteria 2 and 3 above. Under this approach, the Committee left to FDA the legal determination of whether certain State requirements (statutes and/or regulations) were "definitions and standards" or "common or usual names," and the steps necessary under NLEA regarding their preemption. The results of the review and evaluation
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Food Labeling: Toward National Uniformity process outlined above and the Committee's categorization of State requirements are discussed in the next chapter. REFERENCES AFDO (Association of Food and Drug Officials). 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 1. Crawford, B, Florida Department of Agriculture and Consumer Services. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. CSPI/CNI/CFA/NCL (Center for Science in the Public Interest, Community Nutrition Institute, Consumer Federation of America, and the National Consumers League). 1991. Statement of Sharon Lindan, Assistant Director for Legal Affairs, CSPI, on behalf of CSPI/CNI/CFA/NCL at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine , Washington, D.C. May 30. DHHS (Department of Health and Human Services). 1991. Final Report of the Advisory Committee on the Food and Drug Administration. Washington, D.C.: Government Printing Office. FDA (Food and Drug Administration). 1972. Nonstandardized Foods; Proposed Common or Usual Names. Fed. Reg. 37:12327; June 22. FDA (Food and Drug Administration). 1973. Common or Usual Names for Nonstandardized Foods. Final Rule. Fed. Reg. 38:6964–6967; March 14. FDA (Food and Drug Administration). 1979. Administrative Practice and Procedures. Final Rule. Fed. Reg. 44:22318–22370; April 13. FDA (Food and Drug Administration). 1981. Reorganizational/Location Changes. Final Rule. 46 Fed. Reg. 8454–8462; January 27. FDA (Food and Drug Administration). 1990. State Law Data: 1990. Rockville, Md.: FDA. FDA (Food and Drug Administration). 1991. State Petitions Requesting Exemption from Federal Preemption. Proposed Rule. Fed. Reg. 56:60528–60534; Nov. 27. GMA (Grocery Manufacturers of America). 1991. Statement of Sherwin Gardner, Vice President, Science and Technology, GMA, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Hamilton, R.W. 1972. Procedures for the adoption of rules of general application: The need for procedural innovation in administrative rulemaking. Calif. Law Rev. 60:1276–1337. Harden, B., Maryland Department of Health and Mental Hygiene. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. June 6. Hutt, P.B., 1973. Philosophy of regulation under the Federal Food, Drug, and Cosmetic Act. Food Drug Cosmetic Law J. 28:177–188. Hutt, P.B. 1991. Presentation by Peter Barton Hutt, Partner, Covington and Burling, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 29. Hutt, P.B., and R.A. Merrill. 1991. Food and Drug Law. Cases and Materials. 2nd ed. Westbury, N.Y.: The Foundation Press. Karas, A. 1991. Presentation by Amy Karas, New York Department of Consumer Affairs, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 29.
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Food Labeling: Toward National Uniformity Levinson, B.D. c. 1952. Regulations Under the Federal Food, Drug, and Cosmetic Act. Washington, D.C.: Federal Security Agency. McClellan, D., Utah Department of Agriculture. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine , Washington, D.C. July 8. Mintz, B.W., and N.G. Miller. 1991. A Guide to Federal Agency Rulemaking. Washington, D.C.: Administrative Conference of the United States. Niles, R., Georgia Department of Agriculture. 1991 Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. June 17. Pfeifer, E.M. 1984. 1984 Enforcement. Pp. 72–113 in Seventy-fifth Anniversary Commemorative Volume of Food and Drug Law. Washington, D.C.: Food and Drug Law Institute. Rubin, B. 1991. Presentation by Barry Rubin, General Counsel, The Advocacy Institute, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 29. Schultz, W. 1991. Presentation by William Schultz, Counsel, Subcommittee on Health and Environment, House Committee on Energy and Commerce, U.S. Congress, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 30. Silverglade, B. 1991 Presentation by Bruce Silverglade, Director of Legal Affairs, Center for Science in the Public Interest, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 29. State Attorneys General. 1991. Statement of Attorneys General of California, Iowa, Minnesota, Missouri, New York, Toms, and Wisconsin to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Thompson, M.S., Special Counsel, Arnold & Porter. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 14. U.S. Congress, House. 1990. Nutrition Labeling and Education Act of 1990. Move to suspend the rules and pass the bill (H.R. 3562). Congressional Record-House, H5836–H5845. WHC (White House Conference on Food, Nutrition, and Health). 1969. Final Report. Washington, D.C.: Government Printing Office.
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Representative terms from entire chapter: