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Current Food Labeling OVERVIEW OF THE U.S. SYSTEM FOR REGULATING FOOD LABELING The United States has no single system for regulating food labels. The federal government operates two major food labeling programs that differ in their requirements and in their modes of operation. In addition, the states may, in some circumstances, impose labeling requirements that go beyond those established by the federal government. To complicate the picture further, the authority to regulate food promotion practices that extend beyond the label, such as media advertising, lies with a third federal agency. Finally, many foods in grocery stores and supermarkets, and foods sewed in restaurants and institutional settings are sold without any nutrition information at all. This complex picture can be explained in historical and political terms, and many of its features are not irrational. It may be appropriate to rely chiefly on state and local authorities to oversee restaurants and educational, medical, social, and penal institution food senice operations. Similarly, consumers and producers alike might come to resent the cost and complications of a regimen that requires all produce, meat, poultry, and seafood to be packaged and sold in a form that would require conventional labeling. Other features of the splintered U.S. system for regulating food labels, however, are certainly subject to question. That, however, is not the focus of this report. The purpose of this chapter is to describe how food labels are currently regulated so that readers can better understand how food labels came to be the way they are and better assess the recommendations for reform that are made in Part II of this report. 51

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52 NUTRITION LABEllNG The two federal agencies whose activities are of central interest are the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Although FDA regulates a larger share of the retail food market, it is easier to define the two agencies' responsibilities by first describing the jurisdiction of USDA. Through its Food Safety and Inspection Service (FSIS), USDA regulates the labeling of meat and poultry products pursuant to the Federal Meat Inspection Act SEMI Act, 21 USC 601, et seq.) and the Poultry Products Inspection Act (PPI Act, 21 USC 451, et seq.~. ~JSDA's jurisdiction does not extend to the packaging of fresh meat and poultry at the retail level.) Operating under the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 USC 321), FDA is responsible for regulating the labeling of virtually all other foods. It could be said that FDA has jurisdiction over the center aisles of the supermarket, while USDA regulates the side counters. This summary, however, overlooks the daily section, the large (and growing) produce section, whose products rarely bear conventional labels, and the increasingly important seafood counter, both of which theoretically fall under FDA jurisdiction, as do the growing number of foods prepared on the supermarket premises, such as bakery products and salad bars. The laws under which FDA and USDA operate differ in their histories, provisions, and modes of implementation. Some, but not all, of these differences have importance for this study and for the implementation of the Committee's recommendations; these are discussed in greater detail below. For the purposes of the present discussion, it suffices to note that all three laws~the EMI Act, the PPI Act, and the FD&C Actsay virtually nothing about nutrition and provide little guidance as to the information about nutrient content that USDA or FDA may require on food labels. In both systems, decisions about the information to prescribe on food labels have to a large extent reflected administrative judgments. The laws administered by FDA and USDA disguise a more fundamental difference in their modes of operation, a difference that influences enforcement capacity and may also explain some of the reported variations in substantive policy. Although specific requirements are not obvious in the language of the FIJI and PPI Acts (e.g., 21 USC 607(d), (e)), USDA has always taken the position Hat a manufacturer must obtain approval in advance for any label it wishes to use on a meat or poultry product, as well as for any change it wishes to make in an approved label (Kushner et al., 1990~. Research has not disclosed any challenge to this position. Indeed, many producers of USDA-regulated products probably favor the current system of prior label approval, which at least ensures certainty. In practical terms, under the USDA system no meat or poultry product bears a label that fails to meet the agency's requirements. This label review system is a relatively small part of USDA's extensive program for regulating meat and poultry products. The ESIS work force exceeds 9,000 employees, most of whom are engaged in on-site inspection of production activities. Fewer than two dozen employees are engaged in the review and

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CUMENT FOOD LABELING 53 approval of labels. They process a caseload of about 130,000 requests for label approval each year (Crawford, 1990~. The USDA system displays another notable feature. Because each manu- facturer must secure approval for its label, USDA has had less reason than FDA to issue formal regulations detailing its requirements. Although the agency has evolved clear policies regarding such matters as nutrition labeling, they typically cannot be found in the Code of Federal Regulations (CFR). Most are spelled out in the FSIS Standards and Labeling Policy Book and policy memoranda (USDA, 1989), which are available publicly and, therefore, are sources of guid- ance to applicants. Reliance on these forms of guidance has meant that USDA can, in theory, be more adaptable than FDA because it generally does not need to revise existing regulations before requiring or allowing new information on the labels of the foods it regulates. On the other hand, the failure to incorpo- rate key policies in regulations may limit awareness of them and surely inhibits public discussion of their merits. By contrast, FDA has never operated a system of prior approval for food labels, and any assertion of such authority now would surely be considered beyond the agency's powers. Instead, FDA has relied on publication of its labeling requirements, typically in the form of regulations, coupled with informal advice giving and periodic threats of enforcement against products whose labels fail to comply with those requirements. This mode of operation means that industry compliance with federal requirements depends on close monitoring by the agency and the ability to initiate enforcement against violative products. Because FDA does not approve food labels, its system allows issues of labeling policy to remain unresolved, sometimes for many years. A manufacturer of meat or poultry products can always discover USDA's position on a new labeling initiativefor example, the use of a new descriptor because it must seek approval, and the agency must provide a response. A "no" response may, in fact, mean only that USDA has not yet formulated a policy but operationally, the answer is clear. In the FDA context, however, a manufacturer that wishes to use a new label, even one that appears to challenge the spirit of the agency's regulations, can use it and hope that the agency will not challenge its product as being mislabeled. FDA's lack of formal policy on an issue does not necessarily deter a practice unless the agency is prepared to take enforcement action. The system therefore allows FDA to ignore practices that it finds objectionable but is not prepared to challenge. It also ensures that the agency may not be aware of label changes until after they are adopted, because manufacturers are not obliged to submit copies of their labels on a regular basis. These contrasting systems for regulating the contents of food labels might only be a curiosity if the jurisdictions of the two agencies did not overlap. The boundary between them, however, can sometimes be elusive. USDA shares jurisdiction with FDA over food labels for products containing meat and poultry, because the FD&C Act ostensibly applies to all food. The FMI and PPI Acts

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54 Nl~RITION LABELING authorize USDA to exempt from their requirements food products that contain meat or poultry only in a relatively small proportion, and accordingly the agency has determined that products containing less than 3 percent raw meat, 2 percent cooked meat, or 2 percent cooked poultry are subject only to PDA regulations. In addition, FDA exercises limited jurisdiction over products that remain subject to USDA's primary control. For example, no USDA-regulated product may contain a food or color additive that has not been approved by PDA (Kushner et al., 1990~. The potential overlap in jurisdictions can exaggerate the consequences of policy differences between the two agencies. A modest change in composition may cause a product to cross the jurisdictional boundary. For example, a pizza product containing cheese but little meat will fall under FDA's control, and thus escape USDA's requirement of advance label approval (GAO, 1988~. For manufacturers whose product lines are under the jurisdiction of both agencies, labels for similar products may be subject to different substantive requirements as well as different approvalprocedures (Kushneret al., 1990~. It should be stated, however, that suggestions of serious conflict between FDA and USDA in substantive labeling requirements often appear to be un- supported on close review. The Committee found few instances in which FDA expected different information on food labels than USDA required or allowed. USDA's rules for nutrition labeling of meat and poultry products have generally tracked, although sometimes not immediately, FDA's regulations. In the Com- mittee's judgment, the more important difference between the two systems lies in their contrasting modes for establishing and enforcing labeling requirements. It is important to reemphasize that both FDA and USDA have jurisdiction over more than the printed label attached to a product. Under the FD&C Act, FDA's authority extends to all "labeling" for foods, a term that includes labels and other wntten, printed, or graphic matter on or accompanying a food. Thus, the agency presumably has the power to regulate most of the in-store point- of-purchase information that is provided about foods. The test is whether the material "accompanies" the product; virtually any material supplied by the manufacturer or displayed by the retailer near the food would qualify. USDA's authority is comparably broad, but it does not customarily require prior approval of point-of-purchase labeling for meat and poultry products. Thus, food "labeling" encompasses a broader range of communicative devices than the printed labels affixed to products. Current FDA and USDA nutrition information requirements, however, are chiefly directed at product labels, and it is these requirements on which this report focuses. It is important, however, to understand that both agencies have the authority to challenge labels and labeling that make claims that conflict with or go beyond the content of current regulations or policies. Both agencies use statements made on off- package labeling to determine whether nutrition information is required on a product's label. In many of the contexts discussed in this report, the distinction

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CUMENT FOOD lABELING 55 between labels and Labeling is not important. The legal outdone of the two agencies to regulate labeling may prove decisive when foods are sold without conventional labels (for example, produce) or in packaging Hat no federal agency currently attempts to regulate (for example, foods sold by some limited- menu restaurants). EVOLUTION OF NUTRITION LABELING FOR FOODS FDA Nutrition Labeling Requirements Labels on over half of all packaged foods sold in the United States currently provide some Me of nutrition information. The information allowed or required on FDA-regulated foods is prescribed by regulations that the agency first adopted in 1973 (38 Fed. Reg. 2125-2132, Jan. 19, 1973~. These regulations have undergone relatively few changes since they went into effect in 1975, which helps to explain the present interest in reform. Any assessment of proposed reforms, therefore, requires some understanding of FDA's original regulations and the judgments that they reflect. It is appropriate to begin this examination of current nutrition labeling policy with FDA, because its requirements antedated and influenced USDA (Kushner et al., 1990~. FDA derives its authority to regulate food labels from the FD&C Act. That law was enacted in 1938, when knowledge about nutrition was rudimentary and most links between diet and chronic disease were unsuspected. Although the FD&C Act has been amended many times, the provisions governing the labeling of conventional foods have undergone no significant change since their enactment. These provisions are written such that their broad language, coupled with the agency's explicit authority to prescribe regulations for the efficient enforcement of the Act, has allowed FDA to update the Act's requirements as processed foods have proliferated and expectations for the types of information that should appear on food labels have changed (21 USC 371 Gail. Under section 403 of the PD&C Act (21 USC 343), every food label must contain the name of the food, a statement of the net quantity of contents (typically net weight), and the name and address of the manufacturer or distributor. Even today, some foods are lawfully marketed with labels that bear only these three items of information, although most labels contain more. Most notably, all but a few FDA-regulated foods must also bear a list of ingredients in descending order of predominance. The exception, however, is an important one: Foods for which EDA has established a standard of identity need not list ingredients that the standard makes mandatory. In addition to requiring these affirmative statements on food labels, the FD&C Act prohibits other statements; most significantly, it prohibits statements that are false or misleading in any particular. A related provision, section 201(n) (21 USC 321(n)), specifies Hat in determining whether He labeling of a food

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56 Nl~RITION LABEllNG is misleading, "there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling . . . fails to reveal facts material in light of such representations...." This was the U.S. Congress's way of recognizing that half-truths can often be as misleading as outright misrepresentations. Section 201(n) was originally treated as guidance for courts that adjudicated FDA charges of misbranding, but since the 1960s the agency has, on occasion, invoked this provision and its general rulemaking power to prescribe affirmative disclosures on food labels. These provisions provided the authority on which FDA relied in adopting its current requirements for nutrient information on the labels of packaged foods (38 Few Reg. 2125- 2132, Jan. 19, 1973). Before the 1973 regulations are discussed, FDA's early attitude toward health claims for foods and its protracted efforts to control foods offered for their vitamin and mineral contents should be mentioned. Through the late 1960s, FDA relied primarily on the FD&C Act's prohibition against misleading labeling to curb what it considered irrational fortification of foods and the sale of products that offered ingredients of no proven nutritional value. Moreover, the agency consistently objected to specific claims that a food or any component could treat or prevent disease. Agency officials took the position that any product with a label that explicitly or implicitly claimed utility in preventing or treating disease, other than nutritional deficiency, was, under the law, a "drug" and, thus, a product whose safety and effectiveness had to be proved before it could lawfully be marketed Mutt, 1986~. Sometimes, the accumulation of knowledge about nutrition and disease seemed to challenge FDA's uniform opposition to health claims. Following the publication in 1957 of a major report by the American Heart Association recommending a reduction in dietary cholesterol and saturated fats, marketers of many foods began referring to this advice in their labeling. FDA officials viewed any reference to cholesterol or saturated fat with suspicion and they threatened to seize products whose labeling featured such references. As the evidence linking these food constituents to coronary heart disease grew stronger, however, the agency came under increasing pressure to change its position and by 1970 was no longer attempting to enforce it (Huts, 1984~. The I;D&C Act does not, in so many words, require that a label for any food provide information about nutrient content. However, Congress recognized as early as 1938 that some nutrient information might be important for certain products. In section 403a) Of the Act (21 USC 343a)), it authorized FDA to issue regulations prescribing the information about vitamin, mineral, and other dietary properties that must appear in the labeling of foods represented for what the law termed "special dietary use." FDA inaugurated section 4030) in 1941 by adopting regulations governing the labeling of fortified foods, vitamin and mineral supplements, and other special dietary foods such as infant foods, hypoallergenic foods, and foods for use in weight control. The 1941 regulations

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CURRENT FOOD LABELING 57 specified how food components should be described if the manufacturer chose to feature them, but they did not purport to restrict the type or quantity of nutrients that could be included or limit other claims that could be made. Over the next two decades, the types of special dietary products marketed and the claims made for them grew in number and variety. By the early 1960s, FDA officials had concluded that the 1941 regulations needed updating, and in 1966 the agency proposed a far-reaching set of changes. In addition to proposing to limit the foods that could be fortified and to restrict the nutrients that could be used in fortification, FDA proposed to curtail the number of allowable formulations of dietary supplements of vitamins and minerals. It alto proposed to ban statements on vitamin and mineral supplements Hat Americans' diets were nutrient deficient, that common foods did not supply adequate amounts of nutrients, or that routine vitamin or mineral supplementation was prudent. The agency's most provocative proposal was to treat all products that supplied significantly more than the Recommended Dietary Allowance (RDA) of any nutrient as "drugs." The administrative hearings on these proposals lasted from 1967 to 1969, and decisions about the content of final regulations were still pending at the close of the decade. Space does not allow, nor does the context warrant, a full account of the ensuing 5 years of litigation over the substance and legality of FDA's proposals for vitamin-mineral supplements. The final chapter of the story, however, is noteworthy. In 1976, for the first time since its passage, Congress amended the 1938 FD&C Act to withdraw authority from FDA, forbidding it to restrict as unneeded or uselessthe kind or amounts of vitamins and minerals that can be added to foods or sold as supplements (Merrill and Hutt, 19803. While any summary of FDA's early food labeling policies involves over- simplification, it is nonetheless fair to describe the agency as being concerned chiefly with protecting the consumer's pocketbook by maintaining the compo- sition of basic foods and discouraging the sale of processed substitutes. The agency started with the assumption that traditionally formulated foods and meals prepared in the home would ensure headthy diets. Furthermore, it displayed lit- tle confidence in the ability of consumers to make wise dietary choices. These policies, however, began to undergo significant change. In 1969, President Richard Nixon convened the White House Conference on Food, Nutrition, and Health, largely in response to reports of widespread malnutrition among Americans. While this topic was the focus of the conference, the final report also addressed the regulation of food composition and labeling (WHC, 1970~. The report criticized FDA's approaches to food standards of identity, the marketing of substitute foods, and label statements relating to nutrition and long-term health. While the report stressed the importance of sound nutrition, it emphasized He need to help consumers make sound nutritional choices by requiring more information on food labels. Among the conference participants were several individuals who soon after became officials of ADA,

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58 NUTRITION L4BELING and its recommendations had an immediate impact on the agency's policies (Wodicka, 1990~. By 1973, FDA had adopted several amendments to its regulations that reflected a new emphasis on providing consumers with information needy to make informed dietary choices. Under the FD&C Act (21 USC 343(i)) the label of a standardized food does not need to contain a list of any marKlatory ingredients but must contain a list only of those optional ingredients specified by FDA. The agency urged manufacturers to list all ingredients voluntarily (21 CFR 101.6~. Then, it began (although it has not yet completed the task) to amend existing standards of identity to classify most previously mandatory ingredients as optional and to require that they be listed on the label (Huts, 1984~. FDA's most important initiative was its adoption of regulations governing nutrition labeling for pacl~ged foods. These regulations, He coverage and current adequacy of which are the focus of this report, did not (and still do not) require nutrition labeling of all foods within the agency's jurisdiction. Among other considerations, uncertainty about its legal authority to mandate across-the-board nutrition information led the agency to set more modest goals. The regulations specified how nutrition information was to be provided if a manufacturer chose to do so. The regulations also required that certain foods have nutrition labeling. If a nutrient were added to, or any nutrition claim was made for a food, its label had to provide nutrition information in a prescribed format. Because these regulations established the framework for most of the nutn- tion information that currently appears on the labels of packaged foods, whether regulated by FDA or USDA, their examination in furler detail is useful. It is important to emphasize that FDA's 1973 regulations had a different focus from those of current proposals to reform food labels. In the early 1970s, fed- eral health officials were preoccupied about reports of undernourishment in the United States, and FDA officials wanted to ensure that consumers were provided with sufficient information to enable them to select a diet that was adequate in vitamins, minerals, and protein. At the same time they remained eager to curb excessive consumption of these nutrients. These complementary views produced agreement on a label that focused on a food's contribution to the desired daily intake of vitamins, minerals, and protein. Thus, the prescribed nutrition infor- mation panel featured those nutrients, among others, and most of them were de- scribed in terms of the percentage of the U.S. Recommended Daily Allowances GAS. RDA) provided in a serving. The U.S. RDAs were a creation of FDA, based on the 1968 RDA established by the Food and Nutntion Board of the National Research Council (NRC, 1968) but simplified to facilitate label disclo- sure. EDA's regulations prescribed a uniform sequence and format for nutrition information. The label was to set forth the following, in the indicated order: (1) serving size for the food; (2) the number of servings in the container, and per

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CURRENT FOOD LABELING 59 serving (3) the number of calories; (4) the amount of protein (in grams); (5) the amount of carbohydrate (in grams); (6) the amount of fat (in grams); (7) the amount of protein (expressed as a percentage of the U.S. RDA); and (8) the percentage of the U.S. RDA of each of seven micronutrients (vitamin A, vitamin C, thiamin, riboflavin, niacin, calcium, and iron). The regulations also allowed a manufacturer to list any of a dozen other vitamins and minerals, in terms of the percentage of the U.S. RDA in a serving (21 CF~ lOl.9(c)). The explanation accompanying the regulations did not always spell out the agency's reasons for the choices it had made. Contemporary statements by I;DA officials indicated little more than that the list of required nutrients was consistent with the opinions of professional nutritionists consulted by the agency (Stakes, 1972~. Among the major constituents, only protein was to be described in terms of recommended intake, and it seems clear that EDA officials were not concerned about excessive protein consumption but, rather, about deceptive claims for protein content. The agency required that protein be listed, by percentage of the U.S. RDA, "unless the product contained no substantial amount of protein." In that case, protein could be omitted (21 CFR lOl.9(c)C7~(ii)~. FDA's regulations required the disclosure of total fat content but not fatty acid composition. A separate regulation that addressed this subject allowed manufacturers to include information about fatty acid composition, with certain conditions (21 CPH 101.25). If the fatty acid composition was listed, the regulations specified that it was to be described in terms of polyunsaturated, saturated, and percent calories from fat. Furthermore, reflecting FDA's long- standing opposition to label claims about saturated fats and coronary heart disease, the regulations provided that if fatty acid composition was listed, the label also had to include the following statement: '`Information on fatty acid content is provided for individuals who, on the advice of a physician, wish to modify their total dietary intake of fatty acids" (Dunning, 1973~. The agency adopted the same position regarding cholesterol. Stating cholesterol content was optional, but if it were included the manufacturer had to add a similar statement that the purpose was to assist individuals who were under a physician's care (21 CF1( 101.25). Sodium was treated somewhat differently. Under the 1973 regulations, listing of sodium (in milligrams per seeing) was optional, but it could also be listed in the absence of full nubidon labeling (21 CF~ lOl.9(c)~8)(i)). The objective was to encourage the provision of sodium information without subjecting manufacturers to the expense of determining the amounts of other nutrients in a food. However, rules adopted in 1984 required sodium to be declared when nutrition information was provided. FDA's 1973 regulations reflected important decisions regarding the format of nutrition labels. First, the agency specified that nutrition information, when provided, was to appear on the information panel or principal display panel of the package (21 CF~ 101.2~. Another regulation had previously fixed the

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60 NUrRlTION LABEIJNG location of these label components (21 CF1{ 101.1~. The goal was to make sure that nutrition information appeared in the same location on similar foods and in roughly the same position on all foods, so that it would be "more easily found and read by consumers under normal conditions of purchase and use" (37 Fed. Reg. 6493 6497, Mar. 30, 1972~. Second, for the presentation of nutrition information, FDA chose a numeric format over verbal and pictorial alternatives. This choice was based in large part on studies the agency had commissioned by the Consumer Research Institute (CRI) Johnson, 1973; Wells, 1972~. The agency apparently had already decided that the U.S. RDAs should provide the framework for describing nutrient content; it asked CRI to test three approaches for communicating this information. One format, the one Rat was chosen, presented the information numerically as a percentage of the U.S. RDA. One of the two rejected, the so-called verbal format, described the content of individual nutrients as fair, good, and excellent. In the other, We pictorial format, the proportion of the U.S. RDA provided by a serving was expressed by small circles, stars, or smiling faces. According to an FDA official, all three formats were understood by uneducated, low-income consumers as well as by educated consumers, although the former group had greater difficulties with He verbal design. Consumers found me pictorial format least desirable; many thought it condescending (Johnson, 1973~. See Figure 3-1 for an example of a nutrition information panel based on current FDA regulations. FDA's original nutrition labeling regulations embodied several decisions that ensured that its system would not be comprehensive. Because of its under- standing with USDA, FDA could not make its regulations applicable to meat and poultry products. Foods sold by restaurants and other food service institutions 2% LOWFAT MILK Nutrition Information Per Serving SERVI NG SIZE ONE CUP SERVINGS PER CONTAINER 8 CALORIES 120 PROTEIN .............. CARBOHYDRATE...................... FAT SODI UM 8 GRAMS 1 1 GRAMS 5 GRAMS 130 mg Percentage of U.S. Recommended Daily Allowances (U.S. RDA) PROTEIN 20 RIBOFLAVIN 25 VITAMIN A 10 NIACIN * VITAMIN C 4 CALCIUM 30 THIAMINE 6 IRON ~ 'CONTAINS LESS THAN 2% OF THE U.S. RDA FOR THESE NUTRIENTS FIGURE 3-1 Sample nutrition information panel for 2% low-fat mild (Y2 gallon) under current FDA regulations (minimum requirements).

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CURREVT FOOD LAsELlNG 61 were also excluded, chiefly, but not solely, because of problems of enforcement (DHEWtUSDAIE1C, 19793. The agency originally contemplated labeling for fresh fruits and vegetables, albeit with modifications, but it eventually exempted them from the regulations, ostensibly on the grounds of infeasibility (38 Bed. Reg. 32,78~32,787, Nov. 28, 1973~. FDA never finalize a later proposal to extend nutrition labeling to produce (40 Fed. Reg. 8214-8217, Feb. 26, 1975~. In sum, FDA's 1973 nutrition labeling regulations applied only to retail packaged foods other than meat and poultry products. Even for these retail packaged foods, the agency's requirements were not universally binding. By their terms, the regulations required nutrition labeling on a packaged food only if the manufacturer of a food added a nutrient or made a nutrition claim for the product. The decision to make nutrition labeling essentially voluntary was carefully considered. Although it was not spelled out in the preamble, almost surely one of FDA's reasons for this was uncertainty about its legal authority to require affirmative disclosure of nutrient information on foods for which no nutritional claim, implicit or express, was made (Wodicka, 1990~. The agency's chief source of power in the FD&C Act, in addition to its general power to adopt regulations for the efficient enforcement of the Act, was the section 403(a) prohibition against misleading labeling, coupled with section 201(n), which, arguably, is activated by what manufacturers chose to say about their products. FDA had other reservations as well, however, as its preamble in the Federal Register explained: The Commissioner has concluded that insufficient information is known about the nutrient content and variability of some foods, and that the analytical methodology and capacity of some food manufacturers, processors, and distributors is inadequate to permit adoption of a requirement at this time that all foods bear nutrition labeling. Experience under this new regulation is required before expansion to all foods on a mandatory basis can be considered (38 Fed. Reg. 212~2132, Jan. 19, 1973). Although changed in some details, FDA's current nutrition labeling regula- lions still make nutrition labeling mandatory only for foods to which a nutrient has been added or for which a nutrition claim has been made. USDA Nutrition Labeling Requirements Soon after FDA issued its final nutrition labeling regulations, USDA proposed a similar set of requirements for meat and poultry products (Mussman, 1974~. However, the department never completed this nllemaking. Its system of prior label approval allows it to effect compliance with deparanental policies without issuing regulations, and apparently, USDA officials concluded that it was preferable to set forth its policies in a less formal fashion. USDA's current

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CURRENT FOOD lABELING 63 and both say relatively little about the lope of information USDA may require on labels, the universal acceptance of USDA's prior approval system, coupled with the broad language of these statutes, would appear to put any such doubts to rest. DEFICIENCIES IN CURRENT REQUIREMENTS FOR FOOD LABELS For 15 years, nutrition labeling has been used to provide consumers win information to make more informed food choices, primarily to avoid certain nutrient inadequacies. Critics of the current system stress the need to provide information to help consumers manage their total dietary pattern in line with current dietary recommendations (ADA, 1990; AIN/ASCN, 1990; CNCFL, 1989; CSPI, 1989; DHEW/USDA/FI C, 1979; DHHS, 1988; FDA, 1978, 1989a,b; FNLG, 1989; GAO, 1988; ORC, 1990; U.S. Congress, 1989a,b). Their criticisms of current food labels fall into several categories: Nutrition labeling should be mandatory; currently, it is not required on all packaged foods and is not used in conjunction with the sale of other important classes of foods. Nutrition panel information is not uniform across all food products. Current nutrition labeling as well as efforts to make labeling changes should be accompanied by a consumer education program. Nutrition panel information includes some nutrients that should not or do not need to be listed, while other information is omitted. Ingredient labeling is incomplete and misleading. Current format is too confusing and complex. Label disclosures of nutrient contents are misleading and are not based on established standard definitions. Foods Not Currently Covered or Exempted from Nutrition Labeling Regulations Recent estimates are that about 60 percent of packaged products regulated by FDA have nutrition labeling; for USDA, more than 35 percent of regulated packaged products carry nutrition labeling. This means that almost half of all packaged foods do not bear nutrition labeling. Moreover, nutrition information is not required on or in conjunction with the sale of fresh and frozen meats, poultry, eggs, and seafood; fruits and vegetables; foods prepared and sold for immediate consumption by restaurants, carryout food bars, and many supermarkets; and most foods sewed in institutional settings. Many consumer and health and nutrition organizations have called for mandatory nutrition labeling of all foods under FDA and USDA jurisdiction,

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64 NUT]UTION LABELING either based on current law or mandated by new legislation. These groups also argue that FDA and USDA requirements for such labeling should be uniform. Industry groups have expressed concern over the potential for a multiplicity of food labeling rules by the states and have argued that food labels throughout the United States should bear uniform information that is subject to supervision and enforcement by FDA and USDA. However, many proponents of nutrition labeling changes have opposed preemption of state labeling laws and expressed concern that efforts to achieve uniformity could extend beyond nutrition and ingredient information on food labels into areas such as food safety. Virtually all groups urge that legislative or regulatory reforms of food Labels should include a comprehensive consumer education component developed and funded jointly by the public and private sectors. Deficiencies in Information About Nutrient Content There is considerable public health interest in several food components that are currently not required on the standard nutrition information panel, including cholesterol; saturated, monounsa~a~, and polyunsaturated fatty acids; complex carbohydrates; fiber; and potassium. Although current rules allow voluntary declaration of some of these food components, none of this information is now mandatory. Fat and Cholesterol Current FDA and USDA regulations permit the voluntary inclusion of fatty acid and cholesterol contents, in addition to total fat content, as part of nutrition labeling (21 CER 101.25; USDA, 1985~. The rules allow a food label to include information on fatty acid content if the food contains 10 percent or more fat on a dry weight basis and not less than 2 percent of fat in an average serving. If any claim about fatty acid and/or cholesterol content is made for a product, full nutrition information becomes mandatory. ~ addition, current regulations on fat content require an accompanying statement, for example, "Information on fat [and/or cholesterol, where applicable content is provided for individuals who, on the advice of a physician, are modifying their dietary intake of fat [and/or cholesterol, where applicable]." However, FDA has not enforced He requirement for several years and the disclosure now rarely appears on food labels. Health professional and consumer groups have called for more compre- hensive information about fat and cholesterol to be included on food labels. Suggestions for expanded fat information include mandatory disclosure of satu- rated, monounsaturated, and polyunsaturated fatter acids, and cholesterol. Some also urge that each fat component be disclosed by weight (in grams), number of calories, and/or percentage of total calories.

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CURRENT FOOD lABE:LING Carbohydrates 65 Both FDA and USDA require the disclosure of total carbohy~es when nutrition information is provided (21 CF-R 101.9(c)~5~; USDA, 1985~. Various consumer groups have called for more complete information on complex and simple carbohydrates (starches and sugars, respectively). These groups are con- cerned that high levels of sugar consumption contribute to dental caries, nutrient dilution, and, potentially, excess calories. Quantitative declaration of carbo hydrate components has been urged as consumers have become increasingly concerned about the quantity of sugars they are consuming. Numerous critics have argued that the amount of sugar and other sweeteners should be declared by weight, or by both percentage and weight' either on the nutrition panel or ingredient listing. Many industry groups, however, have ques- tioned whether current analytical techniques are adequate to support mandatory disclosure of total carbohy~es, simple carbohydrates (sugars), and complex carbohydrates. Fiber Over the past several years, breakfast cereal manufacturers and other segments of the food industry have included fiber content declarations on their food labels as a result of consumer interest. Although not required, FDA policy currently states that if fiber content is report, it must be expressed as dietary fiber and declared in grams. Consumer and health advocates support the mandatory declaration of fiber content on the nutrition information panel. Sodium and Potassium Sodium content (in milligrams) is a required component of the nutrition information panel when it is used voluntarily or a claim is made on the label. However, sodium content can be declared on a food label without providing full nutrition information labeling (21 CPR 101.9(c)~8~(i)~. In the absence of a claim, listing of the sodium content remains voluntary under USDA Policy Memorandum 049C (USDA, 1984~. FDA applies similar rules to potassium; however, declaration is voluntary (21 CFE 101.9(c)~8~(ii)~. For more than a decade, consumer, professional, and industry groups, as well as legislators, have supported mandatory labeling of the sodium and, sometimes, potassium contents on all foods. Recommendations from these groups vary as to whether the total and/or added sodium or salt should be declared on the nutrition information panel and whether it should be declared by weight or percent.

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66 Other Nutrients NllTl~lTION LABELING Micronutrients of current public health concern (e.g., folate, zinc, and vitamin B6) have been proposed by venous groups to be required components of the nutrition information panel. Most groups seem to agree, however, that federal agencies should have regulatory discretion to add or subtract nutrients from the required label information as knowledge of dietary patterns and the relationship of nutrition to long-term health change. Incomplete Ingredient Information When the 1938 ED&C Act first mandated the listing of ingredients on most packaged foods, the requirement was viewed primarily as a means of providing consumers with basic information about the value of foods. While the listing of ingredients does not provide direct information about a product's nutrient composition, it does provide information about the components used to make the food and about ingredients that consumers may wish to avoid, such as certain fats. Current interest in the ingredient listing has focused on the health implications of specific ingredients and consumers' ability to identify and avoid certain food constituents. Current FDA and USDA regulations generally require that, except for for standardized foods, if a food is formulated from two or more ingredients, the ingredients must be listed on the label in descending order of predominance by weight (21 CFR 101.4; 9 CER 317.2). Each ingredient is to be listed by its common or usual name, except for spices, flavors, and colors, which generally may be listed in categorical groupings (21 CF~ 101.22). Percent Ingredient Labeling Many groups have proposed Hat the ingredient panel disclose the percent- age of each ingredient in a food product. Current FDA and USDA regulations do not require percent ingredient labeling. The possibilities for listing percentages of ingredients range from listing the major ingredients to listing all of them. Manufacturers have resisted this proposal, arguing that it would reveal propri- eta~y formulations. "AndlOr" Ingredient Labeling Current EDA regulations allow the use of "and/or" ingredient labeling for the declaration of leavening agents, yeast nutrients, dough conditioners, firming agents, and fats and oils (21 CFR 101.4(b)~14~. "Andfor" labeling allows the manufacturer the flexibility to switch among interchangeable ingredients without revising food labels, when price, availability, or both vary. Particular attention

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CURRENT FOOD IABE1]NG 67 has focused on the implications of this practice regarding the fat composition of foods. Continued use of "and/or" labeling for fats and oils is opposed by groups which believe Rat consumers should be able to avoid certain fats and oils with high levels of satiated fatty acids. Many groups argue ~at"and/or" labeling could continue to be allowed for fats and oils only if nutrition information labeling is mandatory for total fat and saturate and unsaturate fatty acids. Some consumer groups have proposed extension of the use of "and/of labeling to nutritive carbohydrate sweeteners, which would have We effect of aggregating all sugars under a single entry in the ingredient list. These groups have expressed concern about the quantity of sugars in Americans' diets and claim Cat many ingredients being used in foods would not be identified as sweeteners by consumers. By grouping these ingredients together on the label, they argue, consumers would realize that, in addition to sugar, over ingredients (e.g., corn syrup, honey, or molasses) are being used to sweeten a given product. Confusing and Complex Disclosures Several critics argue that a number of items currently required or allowed on food labels create confusion and are difficult for the average consumer to grasp, including the concept and sizes of servings and the U.S. RDA. Serving size A critical element of the nutrition information panel is the serving size of the food, for "serving" provides the reference unit for declaring nutrient content. While both agencies require that serving size be declared when nutrition information is provided, neither FDA nor USDA has established serving sizes for any class of foods; they allow manufacturers to set the serving size. FDA regulations define seeing size as Cat reasonable quantity of food consumed as part of a meal (21 CFR lOl.9(b)~1~. There are notable disparities in serving sizes among foods. Some manu- facturers have clearly manipulated serving sizes to promote perceived or real benefits from the nutrition information panel (e.g., calories per serving). Some seeing sizes appear to be altogether unrealistic. For example, a 12-fluid-ounce (355-ml) can of a carbonated beverage lists two settings per container at 6 fluid ounces (177 ml) each when most individuals would consume the entire contents at one time. Critics also point to Be lack of unifo~.'ity within product categories. Different seeing sizes within product categories make comparisons between similar foods difficult. Concerned about these practices, FDA proposed a procedure for standardizing seeing sizes in 1974 (39 Fed. Reg. 20,887-20,888, June 14, 1974), but it never finalized the rule. Professional and consumer orga- nizations have recommended that FDA and USDA standardize Be serving sizes

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68 NUIRlTION L4BEl~NG used in nutrition labeling to make comparisons among products easier and to prevent misleading manipulation. Consumer groups and some food manufacturers believe that many con- sumers are unfamiliar with serving sizes expressed in grams and milligrams; they are more familiar win food measurements in household units, such as teaspoons and cups. It has also been argued that all foods that require additional ingredients for the usual forms of preparation should be required to provide seeing size and nutrition information for the food in the form that is consumed, not just in the form that is packaged. For example, since mink is routinely added to breakfast cereal, the nutrition information panel should be required to provide nutrient information for both He dry cereal and the cereal as consumed. U.S. Recommended Daily Allowances Amounts of protein, vitamins, and minerals per seeing are currently required to be expressed as a percentage of the U.S. RDA. FDA developed the U.S. RDAs in the early 1970s for use in nutrition labeling by taking the highest level of the NRC 1968 RDAs (NRC, 1968) for each nutrient and malting it the standard for expressing nutrient levels (21 CF~ 101.9(c)~7~. RDAs were updated in 1974, 1980, and 1989, the current 10th edition (NRC, 1974, 1980, 1989~. The U.S. RDAs, however, have not been unaged since 1972. Most professional and consumer groups have recommend that the U.S. RDA system at least be updated to reflect the 1989 RDAs. Some have also urged adoption of the quantitative nutrient intake recommendations from recent reports as standards for expressing amounts of macronutrients. Many groups have also expressed concern about consumers' understanding of the U.S. RDA. Some evidence suggests that consumers have difficulty understanding and using percentages. It appears that many consumers do not understand that the U.S. RDA percentages for different nutrients on food labels cannot collectively be added up to reach a total of 100 percent for their U.S. RDA for the day. Other critics question whether the concept of the U.S. RDA is sound in principle. They suggest that there should be a different system for presenting nutrition infonnation to consumers and, at the very least, some beer way to educate consumers about the nutrition information on food packages. Nutrition Label Format Although there seems to be widespread support for changing the content of nutrition labeling, opinions diverge on the best format for depicting nutrition information on food labels. Current research provides little guidance about the best nutrition label format for consumers. Advocates of label change, however, have proposed a variety of untested new label formats. Other label expression

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CURRENT FOOD lABELING 69 issues include weight versus percentages, "and/or" labeling, and the listing of the ingredients discussed above. Critics of the current numeric labeling system have urged federal agencies to use market research techniques, including focus groups, to demmim consumers' ability to use different presentations of nutrition information on food labels. They argue that education, media, and marketing experts should be included in the development and analysis of new potential label formats. A variety of groups have also supported the need for strong efforts to educate consumers about the use of a new label once a new label format is developed and approved for implementation. Nutrition Information Pane! The expression of fat content by weight (grams or household measures), as calories from fat, or as a percentage of total calories has been widely discussed. Although many supporters of additional fat information do not support use of the percentage of calories from fat, they acknowledge that it may be useful when comparing similar foods. Numeric Displays The current label format presents nutrition information as numbers in col- umns. Many critics believe that the current format is confusing, complicated, and difficult for consumers to understand. When FDA established nutrition labeling regulations in 1973, it prescribed text and numbers rather than text alone or text with graphics because results of the limited amount of consumer research available suggested that consumers preferred numbers to indicate the amounts of nutrients in a food. The nutrient content of a food can be expressed as absolute amounts, such as grams and milligrams, or as a percentage of a daily intake standard. Currently, only protein, vitamins, and minerals are expressed in terms of a daily intake standard. Some have suggested that other food components such as fat, carbohydrates, and fiber should be expressed in a similar fashion. Descriptive (Adjectival) Display Descriptors are already widely used to describe He nutrient content of foods on the principal display panel, and some argue that their use should be expanded to describe nutrient content on Be nutrition panel. It is argued, for example, that terms such as excellent, good, and fair, or high, medium, and low are more easily understood by most consumers than are the metric weights (grams and milligrams) currently used. Others note, however, the difficulty of defining

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70 NUTRITION LABELING such terms and point to the lack of consistency in their use among agencies. Some also argue that descriptive terms alone may not provide sufficiently precise information on the nutrient content of a food, and numeric ranges would need to be defined for the use of each term. Graphic Display There have been several innovative suggestions for the use of visual representations to convey nutritional value. Pie charts have been proposed to present information on the protein, fat, and carbohydrate contents of a food, with the information being presented either on a weight basis or as a percentage of calories. Critics of such approaches note that vitamins and minerals cannot be presented in this manner since they make no caloric contribution to the food. The bar graph is another graphic option that }has been proposed to express nutritional values as a percentage of a daily intake standard. It has been noted, however, that bar graphs confront problems in expressing nutrient values that exceed 100 percent of the standard (e.g., over 100 percent of the U.S. RDA), and some worry that consumers would perceive that only long bars are good. Symbolic Display Another approach to providing consumers with nutrient information is the use of symbols. Various types of symbols (colors) have been suggested, including the use of stoplight colors (e.g., red is bad or high, yellow is caution or moderate, and green is good or low) and icons for low-fat, low-cholesterol, low-sodium, high-fiber, and low-sugar. Symbols of this type currently appear on some restaurant menus. Groupings and Sequences Some commentors have suggested the grouping of nutrients in positive and negative clusters. Protein, fiber, vitamins, and minerals would appear in a group, possibly at the top of the label, whereas fat, cholesterol, sugar, and sodium would be clustered, perhaps, at the bottom of the label. Another variation would be to provide groupings according to nutrient type; that is, all carbohydrates, all fats, and all micronutrients would appear in separate blocks on the nutrition panel. Typography and Color The type sizes of words on labels are frequently criticized as being too small and, therefore, illegible to many consumers. Individuals with sight problems,

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CURRENT FOOD L4BE~NG 71 especially Me elderly, are thought to find labels difficult to use. Better use of color has also been recommended to make information more Wily distinguishable. Some industry representatives argue, however, that Be use of multiple colors on labels may add significant costs and present additional comprehension problems. Nutrient Content Claims The growing practice of labeling packaged foods win descriptors that characterize a food's nutrient content has led FDA and USDA to establish or propose definitions for certain descriptive teens, such as low catone (21 Can 105.66), sodium free, low sodium (21 CAR 101.13), no cholesterol, and low cholesterol (55 Fed. Reg. 29,45~29,473, July 19, 1990~. Other widely used terms, however, such as natwal, organic, and fresh, have never been defined by either agency or have been defined by only one. As a result, some descriptors are used to refer to several different product characteristics, creating confusion among consumers. For example, the term lite has been used by various manufacturers to describe color, ~caste, texture, fat, sugar, calories, salt or sodium, weight, and even breading. Furthermore, other descriptors are used in different ways to describe Be same nutrient. Most groups urge Rat regulations be established to define terms such as high, reduced, low, no, lite, and others as they are nee - . Most groups have requested formal definitions of descriptors for all nutrients that appear on Be nutrition information label. There is disagreement whether certain claims should be allowed only when a food meets over charactenstics (e.g., not allowing a n~cholestero1 claim when a food is high in saturated fat). REFERENCES ADA (American Dietetic Association). 1990. Position of The American Dietetic As- sociation: Nutrition and health information on food labels. J. Am. Diet. Assoc. 90:58~585. AIN/ASCN (American Institute of Nutrition and the American Society for Clinical Nutrition). 1990. Position Statement on Food Labeling. Nutrition Notes January:7- 9. CNCFL (Committee on the Nutrition Components of Food Labeling). 1989. Information presented at a public meeting of the Committee on the Nutrition Components of Food Labeling, Food and Nutrition Board, Institute of Medicine, December 4, 1989. Unpublished. Crawford, L.M. 1990. Testimony before die Subcommittee on Rural Development, Agriculture, and Related Agencies, Committee on Appropriations, U.S. House of Representatives, Washington, D.C., March 5, 1990. CSPI (Center for Science in the Public Interest). 1989. Food Labeling Chaos: The Case for Reform. CPSI, Washington, D.C. 37 pp.

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72 NUTRITION LABELING DHEW/USDA/FIC (U.S. Department of Health, Education, and Welfare; U.S. Depart- ment of Agriculture; and Federal Trade Commission). 1979. Food Labeling Back- ground Papers. Government Printing Office, Washington, D.C. 124 pp. DHHS (U.S. Department of Health and Human Services). 1988. The Surgeon General's Report on Nutrition and Health. Government Printing Office, Washington, D.C. 727 PP Dunning, H.N. 1973. Integration with other labeling concerns. Food, Drug, Cosmetic Law J. 28:118-122. FDA (U.S. Food and Drug Administration). 1978. FDA Food Labeling Consumer Survey. Government Printing Office, Washington, D.C. 188 pp. FDA (U.S. Food and Drug Administration). 1989a. Summary of regional hearings on food labeling (Chicago, San Antonio, Seattle, Atlanta). Unpublished FDA staff document. FDA (U.S. Food and Drug Administration). 1989b. Comments received from the FDA Advanced Notice of Proposed Rulemaking on Food Labeling, Docket No. 89N- 0226. Dockets Management Branch, FDA, Washington, D.C. FNLG (Food and Nutrition Labeling Group). 1989. Joint Statement on Nutrition La- beling. FNLG Coordinating Committee (American Association of Retired Persons, American Cancer Society, The American Dietetic Association, American Heart As- sociation, Center for Science in the Public Interest, and Public Voice for Food and Health Policy) and 18 other professional nutrition and health organizations. FNLG, Washington, D.C. 2 pp. GAO (U.S. GeneralAccounting Office). 1988. Food Marketing: Frozen Pizza Cheese Representative of Broader Food Labeling Issues. Report to the Chairman, Subcom- mittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. Government Printing Office, Washington, D.C. 47 pp. Hutt, PA. 1989. Regulating die misbranding of food. Food Technol. 43~9~:228. Hutt, P.B. 1986. Government regulation of health claims in food labeling and advertising. Food, Drug, Cosmetic Law J. 41:3-73. Johnson, O.C. 1973. Nutrition labelinga foremost concern. Food, Drug, Cosmetic Law J. 28:10~117. Kushner, GJ., R.S. Silverman, S.B. Steinbom, and RA. Johnson. 1990. A Guide to Federal Food Labeling Requirements. Draft prepared for the U.S. Department of Agriculture and the U.S. Department of Health and Human Services. Government Printing Office, Washington, D.C. 37 pp. Merrill, R.A., and P.B. Hutt. 1980. Food and Drug Law: Cases and Materials. The Foundation Press, Mineola, N.Y. 959 pp. Mussman, H.C. 1974. USDA nutrition labeling regulations and the growth of voluntary nutrition labeling on meat. Food, Drug, Cosmetic Law J. 29:425~28. NRC (National Research Council). 1968. Recommended Dietary Allowances, 7th ed. Report of the Subcommittee on the Seventh Edition of the RDAs, Food and Nutrition Board, Assembly of Life Sciences. National Academy of Sciences, Washington, D.C. 101 pp. NRC (National Research Council). 1974. Recommended Dietary Allowances, 8th ed. Report of He Committee on Dietary Allowances, Committee on the Interpretation

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CURRENT FOOD L4BEl]NG 73 of the Recommended Dietary Allowances, Food and Nutrition Board, Assembly of Life Sciences. National Academy of Sciences, Washington, D.C. 128 pp. NRC (National Research Council). 1980. Recommended Dietary Allowances, 9th ed. Report of the Committee on Dietary Allowances, Food and Nutrition Board, Assembly of Life Sciences. National Academy of Sciences, Washington, D.C. 185 PP NRC (National Research Council). 1989. Recommended Dietary Allowances, 10th ed. Report of the Subcommittee on the Tenth Edition of the RDAs, Food and Nutrition Board, Commission on Life Sciences. National Academy Press, Washington, D.C. 284 pp. ORC (Opinion Research Corporation). 1990. Food Labeling and Nutrition: What Amer- icans Want. Survey conducted for the National Food Processors Association. ORC, Washington, D.C. 178 pp. Stokes, R.C. 1972. The Consumer Research Institute's Nutrition Labeling Research Program. Food, Drug, Cosmetic Law J. 27:249-262. U.S. Congress. 1989a. Hearing before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, Washington, D.C., Aug. 3, 1989. 261 pp. U.S. Congress. 1989b. Hearing before the Committee on Labor and Human Resources, U.S. Senate, Washington, D.C., Nov. 13, 1989. Unpublished. USDA (U.S. Department of Agriculture). 1982. FSIS Policy Memorandum 039. Food Safety and Inspection Service, Washington, D.C. USDA (U.S. Department of Agriculture). 1984. FSIS Policy Memorandum 049C. Food Safety and Inspection Service, Washington, D.C. USDA (U.S. Department of Agriculture). 1985. FSIS Policy Memorandum 086. Food Safety and Inspection Service, Washington, D.C. USDA (U.S. Department of Agriculture). 1989. FSIS Standards and Labeling Policy Book. Food Safety and Inspection Service, Washington, D.C. Wells, B.H. 1972. The Consumer Research Institute's nutrient labeling research. Food, Drug, Cosmetic Law J. 27:4~44. WHC (White House Conference on Food, Nutrition, and Health). 1970. Final Report. Government Printing Office, Washington, D.C. 341 pp. Wodicka, V.O. 1990. The 1970s: The decade of regulations. Food, letup, Cosmetic Law J. 45:59~7.