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2 Overview In the early 1970s the federal government took the first steps to establish the current framework for the nutrition labeling of foods used in the United States. In a series of regulations the Food and Drug Administration (ADA) expanded the information that manufacturers were required to include about the composition of foods and standardized the format in which this information was to appear. The most significant of these regulations dealt with nutrition labeling. For most packaged food products under its jurisdiction, FDA allowed information about the nutrient content of a food to be provided voluntarily. When it was provided, however, this information had to appear in a standard format. Nutrition labeling was mandatory for any food to which a nutrient was added or for which a nutrition claim was made. FDA officials encouraged manufacturers to provide nutrition information even when it was not required. At the same time, the U.S. Department of Agriculture (USDA) proposed nutrition labeling regulations for meat and poultry products in a form very close to those of FDA. Although these regulations were not adopted, USDA issued policy guidance on nutrition labeling and encouraged manufacturers to use nutrition information on Heir products. By 1990 over 60 percent of the sales of FDA-regulated packaged foods sold in the United States bore nutrition labeling. Over 35 percent of the packaged foods regulated by the Food Safety and Inspection Service (FSIS) of USDA provided nutrition labeling. The labeling reforms adopted in the early 1970s, of which nutrition labeling was a - , represented a fundamental shift in regulatory philosophy. Until that time Me federal government had sought to regulate food quality chiefly through restrictions on He composition of foods, many of which were exempted from 39

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40 N~WTION DIG full ingredient labeling. Under the new regimen, EDA and USDA began to rely on consumer choice by allowing manufacturers to provide information on the composition and nutritional quality of the foods they purchased Considered from the perspective of 1990, however, the changes adopted over 15 years ago seem modest. Mods subject to ADA food standards remain exempt from full ingredient labeling. Nutrition labeling was mandatory only on relatively few foods. In addition, the information that was required did not cover many important components. Thus, it is no surprise that 17 years later the food labeling regimen established in 1973 seems both incomplete and outlaw. Appreciation of the deficiencies of current labeling of the nutrient content of foods began to emerge in the 1980s. Two related developments demonstrated that food labels should be reformed. The most important development was the expanding knowledge of the relationship among diet, nutrition, and long-term health. By the 1980s the results of scientific investigation had convincingly demonstrated important linkages between the dietary habits of Americans and the prevalence of chronic diseases, most notably, cardiovascular disease, cancer, stroke, diabetes, and obesity. The central message of these findings was that, in broad terms, Americans' diets were not deficient in essential nutrients but, rather, provided excessive amounts of calories, fat, cholesterol, and sodium. Confronted with an abundant and varied food supply Americans have found it easy to make unwise choices. The second development can be viewed as a logical response to reports of scientific research on the relationship between nutrition and chronic disease. With the accumulating knowledge about these relationships, many Americans became increasingly attentive to choices among foods. Predictably, food pro- ducers responded to this interest by reformulating foods, creating new products, and aggressively promoting those products whose composition could be said to reflect this new learning about nutrition and health. No examples need to be cited to support the conclusion that good nutrition and disease avoidance had become central themes of food marketing in the United States by 1990. In this environment, the current rules governing food labeling are seriously out of date. The labels of many packaged foods provide no nutrition information. No form of nutrition labeling is required for major segments of the food supply, including produce, meats, poultry, seafood, and foods served in restaurants. Advertising and label claims of nutritional value or the ability of foods to prevent disease have proliferated with seemingly little control. Moreover, the information required on those foods that do bear nutrition labeling is incomplete and misfocused. Under the current system the presence and levels of micronutrients are emphasized; disclosure of cholesterol and fiber content is not required; and information about levels, sources, and types of fat is incomplete. It is not difficult to understand why some critics charge that the federal government has ignored major segments of the food supply, been concerned with the wrong nutrients, and tolerated nutrition claims in advertising and labeling of pacl~ged foods that

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OVERVIEW 41 are, at best, confusing and, at worst, deceptive economically and potentially harmful. In He 15 years since FDA's regulations were adopted, concerns have been raised repeatedly about whether those requirements were too modest and should be updated in light of both the increasing use of nutrition labeling by manufacturers and growing consumer interest in the nutritional quality of their foods. Most notably, in 1978 and 1979, the U.S. DeparUnent of Heals, Education, and Welfare, USDA, and the Federal Made Commission (E;TC) held hearings and examined possible changes in many areas of food labeling regulation. Dunng He same period, bills have been introduced in He U.S. Congress to overhaul both USDA's and FDA's food labeling regulations; despite vigorous efforts to achieve consensus on needed reform, none had been enacted by the end of the 1980s. In addidon, many private organizations, including heals, consumer, and some producer groups, put forward improved labeling approaches. FORMATION OF THE COMMITTEE ON THE NUTRITION COMPONENTS OF FOOD LABELING The 1980s witnessed both the expanded use of He current nutrition labeling system and a growing consensus on the relationship between diet and chronic disease. This was exemplified by the release of two landmark reports on nutrition and health: one by the Public Health Service, The Surgeon General's Report on Nutrition and Health (DHHS, 1988), and the other by the National Research Council ARCS, Diet and Health: implications for Reducing Chronic Disease Risk ARC, 1989a). According to these two reports, diet plays a role in 5 of 10 leading causes of death among Americans. Health conditions that are affected by diet include heart disease (the leading cause of death), cancers (second leading caused, strokes (third leading caused, diabetes (seventh leading caused, and atherosclerosis (tenth leading cause). The release of those two reports and He growing recognition of the need for food label reform prompted the Public Health Service (PHS) of the U.S. De~ranent of Health and Human Services and USDA's FSIS to request, in 1989, that the Food and Nutrition Board of the Institute of Medicine conduct a study of nutrition labeling. The Board assembled the Committee on the Nutrition Components of Food Labeling, which consisted of 14 members representing the fields of analytical chemistry, dietetics, food marketing, food science, nutrition and biomedical sciences, nutrition education, and regulatory law. The Committee was charged to: assess the implications for nutrition labeling of current lmowledge on nutrition and health, determine He most appropriate content and format for food labels by

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42 NEGATION LABELING taking into account the scientific data base as well as the best means to communicate the information to the public, examine the implications of the labeling proposals for current legisla- tion and regulatory statutes governing ingredient and nutrition labeling, and propose policy options for modifying current legislative and regulatory directives (PHS contract 282-89-0022). In responding to this charge, the Committee first reviewed the recommen- dations of recent reports concerned with nutrition, dietary consumption, and health as the scientific basis for reform. After examining the implications of the recommendations for nutrition labeling, it then evaluated the current information on food labels, the nutrition information that needed to be added and deleted, and the availability of valid and reliable analytical methods for use in providing information for nutrition labeling. The Committee also discussed how nutrient information should be displayed in terms of serving size, the listing of required core and optional nutrients and ingredient information, and label format. Finally, the Committee evaluated the use and appropriate definitions for quantitative and other descriptors of nutrient content. While addressing the tasks in their charge, the Committee tried to weigh the various factors in addition to the scientific consensus that influence labeling re- form, including current legal authority, existing label coverage, criticism leveled against existing food labels, current dietary consumption patterns, marketing forces, consumer understanding and use of food labels, the forces operating in the world market, the need for consumer testing of formats, the knowledge base of some consumers about the current system, and consumer education that would be needed if labels are to be changed significantly. Following the development of recommendations for food label reform, the Committee examined these options in light of the existing regulatory authority of FDA and USDA and considered the benefits and liabilities of specific legislation mandating nutrition labeling. In the process of its deliberations and final recommendations, the Committee gleaned valuable information and insights from a variety of sources, including agency officials, witnesses at a public meeting held on December 4, 1989, and invited participants at workshops on the following subjects: label content, le- gal authority, consumer understanding and use of labels, label formats, and the marketing aspects of label information. RELEVANT STUDIES ON NUTRITION, DIETARY CONSUMPTION, AND HEALTH Several studies that have examined the scientific evidence on the relation- ship between diet and disease formed the basis for the Committee's assessment of the kinds of information about nutrient content that food labels should pro-

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OVERVIEW 43 vice. The Committee accepted the central findings from these reports without independently assessing their correctness. This approach was dictated by the lim- ited time available for completing the report, but it was independently justified by the broad acceptance of these findings within the scientific community. The Committee also recognized the evolving character of the scientific understanding of the relationship between diet and chronic disease and, therefore, sought to make its recommendations in light of the changes in scientific knowledge likely to occur in the next decade. The Surgeon General's report made a number of recommendations for change in the eating habits of Americans, including: reduced consumption of fat (especially saturated fat) and cholesterol; achievement and maintenance of a desirable body weight; increased consumption of complex carbohydrates and fiber, reduced intake of sodium; increased intake of calcium by women of childbearing age; adequate iron consumption by children, adolescents, and women of childbearing age; reduced amount and frequency of consumption of sugar by children; and addition of optimal levels of fluoride to community water systems to prevent tooth decay (DHHS, 1988~. The NRC Diet and Health report made more specific recommendations for the quantities of venous dietary constituents that Americans should consume. The report recommended that U.S. consumers should: reduce total fat to 30 percent or less of calories, reduce saturated fatty acid intake to less than 10 percent of calories, and reduce intake of cholesterol to less than 300 mg daily; limit total daily intake of salt (sodium chlorides to 6 g or less; maintain protein intake at moderate levels; balance food intake and physical activity to maintain appropriate body weight; maintain adequate calcium intake; and maintain an optimal intake of fluoride (NRC, 1989a). The report also described the types and amounts of foods to be consumed to achieve these recommendations. In the fall of 1989 the tenth edition of Recommended Dietary Allowances (RDA) was released by the Food and Nutrition Board ARC, 1989b). As with previous editions, the 1989 RDA updated the standards by which dietary consumption patterns were to be judged for adequacy. Sevem1 other reports on dietary intake, disease prevention, and the food supply complete the core of the scientific data base on which the Committee

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44 NOTATION LABELING relied. The earliest one was Diet, Nutrition, and Cancer MARC, 1982), which offered interim dietary recommendations based on the knowledge at that time. The recommendation most relevant to the Committee's task was the suggestion that the consumption of both saturate and unsaid fats should be reduced in the average diet of Americans. The report suggested that an approIxiate and practical target was to reduce intake of total fat to 30 percent of total calories. Designing Foods: Animal Product Options in the Marketplace was con- cerned with changing the food products available to consumers. The report made a number of dietary recommendations, including: caloric intake to match individual needs; no more that 30 percent of calories from fat, 10 percent from sa~a~ fatty acids, 10 percent from polyunsa~a=1 fatty acids, and 10 percent from monounsatura~ fatty acids; no more than 300 mg of cholesterol per day; and calcium and iron in keeping with the RDAs for age and sex (NRC, 1988). The second report on U.S. dietary consumption and nutrition status, Nu- trition Monitoring in the United States (LSRO, EASES, 1989), confirmed the findings of its predecessor concerning the nutritional problems and health impli- cations for U.S. consumers. The Expert Panel on Nutrition Monitoring reported evidence of changes in eating patterns consistent with recommendations for the avoidance of too much fat, saturated fat, and cholesterol, and for the consump- tion of adequate amounts of starch and dietary fiber. Available data on dietary and nutritional status with respect to individual food components, however, did not indicate that there had been substantial dietary changes since the first re- port in 1986. According to the 1989 report, the principal nutrition-related health problems experienced by many Americans continue to be related to the over- consumption of some nutrients and food components, particularly food energy (calories), fat, saturated fatty acids, cholesterol, sodium, and alcohol. Further- more, although the supply of nutrients is generally adequate, there is evidence of inadequate individual dietary intake or imp nutritional status in some subgroups of the population with respect to iron; calcium; folate; zinc; and vitamins A, C, and B6. ROLE OF FOOD LABELS IN IMPLEMENTING DIETARY CHANGES The Committee believes that the reports of the Surgeon General and the NRC send a clear message Hat dietary changes can materially reduce the prevalence of major diseases. The Committee further believes that consumers can improve their own health and reduce their long-term risk of disease by being more careful in the food choices Hat they make. Better food labels can play a

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OVERVIEW 45 central role in facilitating such choices. These reports indicate that consumers need to alter their current dietary consumption patterns. The similarity and complementary nature of the recommendations of the two reports provide a strong basis on which government and the private sector can design dietary guidance, programs, and services. A host of activities can be envisioned to promote dietary change; however, food labels are only one part of the larger effort The Surgeon General's report outlined the activities that could lead to consumer implementation of its recommendations. The report urged that the general public be educated about dietary choices and adequate physical activity conducive to prevention and control of certain chronic diseases. The report stated that food manufacturers can improve the quality of Americans' diets by increasing the availability of padatable, easily prepared food products that will help consumers follow the dietary principles it set forth. The specific recommendations relevant to food labeling included - More information should be provided by manufacturers to consumers on the composition of food products, including total fat, saturated and unsaturated fatty acids, cholesterol, calories, carbohy~es, added sugars, fiber, sodium, iron, folate, and complete, explicit ingredient contents. Information should be straightforward, efficient, and effective. Health claims, if allowed' should be informative, scientific, and non- misleading. Health warnings on alcoholic beverage containers should warn about the hazards associated with alcohol consumption during pregnancy (DHHS, 1988~. The NRC Diet and Health report concluded that several sectors of society need to collaborate in the effort to implement dietary changes. Although the report did not provide specific recommendations for food labeling, it reviewed a number of issues that have implications for Label reform, including serving size, macronutrient quantification, label format, food safety information, product development, and educational aspects of dietary change. In 1973, when FDA established the current food labeling system, the seventh edition of the RDA (NRC, 1968) was the basis for establishing guidelines for the nutrition labeling of foods in the form of the U.S. Recommended Daily Allowances ~J.S. RDA). The U.S. RDAs were, in general, set by taking the highest value of an RDA for a given nutrient, regardless of the age and sex group, and making it the standard for that nutrient. The tend edition of the RDA provides a basis for changing the U.S. RDAs if they are to remain the standard for nutrition labeling, even if some other choice of name is to be used. Designing Foods ARC, 1988) made a number of specific recommendations for food labeling. The report recommended Hat regulations should not restrict

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46 NUTS DIG truthful information at the point of purchase or on food product packaging. USDA should restrict use of the descriptors light, lite, or lean to products in the form that would be presented to the retail consumer, so that use of descriptive terminology on foods sold at the retail level should require some objective standard for the food itself. It recommended that point-of-purchase programs be developed to supplement and support information provided on the label. Finally, the report recommended that shards be set to govern serving size. PURPOSES, CHARACTERISTICS, AND AUDIENCES OF NUTRITION LABELING Any effort to improve the nutrition content information on food labels must begin with a set of assumptions about the purpose labels should serve and the audiences that they should be designed to inform and assist food selection. According to the agencies, the purpose of food labeling is to enable consumers to select and use products that meet their individual needs and preferences. To achieve this purpose, labeling must provide sufficient information to enable the public to identify foods and their characteristics, including ingredients and nutritional value. Effective labeling must present the information so that consumers can understand and use it in deciding what foods to buy. The agencies' guiding principles in recommending specific changes have been public health importance, the consumer's right to know, and economic protection (44 Fed. Reg. 75,992-76,020, Dec. 21, 1979~. These goals for labeling by no means exhaust the purposes of food labels. The relevant laws administered by FDA and USDA impose additional, explicit requirements for the content of food labels, which manufacturers are not free to ignore. These requirements include the name of the food, the disclosure of the quantity of contents, and the name and place of business of the manufacturer or distributor. In addition, most foods must bear a list of their ingredients. These requirements, together with demands for nutrition information, may compete with the manufacturer's own objectives for the label, which can be summarized as the desire to make the product appealing to consumers by depiction and description. Even if there were no tension among these objectives, space limitations on many food labels would necessitate compromise. The Committee's focus was on label information about nutrient content, and it developed its own list of the purposes of nutrition labeling which formed one premise for this report. The Committee believes that nutrition Labeling should: provide consumers with nutrition information about the food product, enable consumers to compare the nutritional quality of products from the same food group, enable consumers to choose among products from different food groups on the basis of nutritional quality,

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OVERVIEW 47 prevent or reduce consumer deception by providing information about the nutrient composition of the product, and provide incentives to improve food products by requiring manufacturers to describe fully the ingredients and nutrient value of their products. Other characteristics of food labels can affect the extent to which any of these varied and sometimes competing informational objectives are achieved. These features include legibility, which is a function not only of type size but also of typography, background, and color; understandability of terms and illustrations; consistency among products and between agencies; and uniformity over time and across political boundaries. The Committee discussed the audiences for which nutrition labeling is important. One very important group that nutrition labels should serve is the large number of consumers with special dietary requirements as the result of diagnosed health conditions. Members of this group have been instructed to moderate or change their diets in some way, such as to avoid salt, reduce calories, or change fat and cholesterol intake. These consumers realize that they have a health problem that can be helped by making dietary changes. A second audience that is large, but perhaps less critical, consists of those consumers whose interest in nutrition and improved diets is largely self- generated These consumers are already aware of dietary factors that have an impact on long-term health and wish to be provided with more useful information on the nutritional quality of food products. This group wants more and better information on food labels to enable them to select their foods wisely. For this group improved labels will serve an educative function; in truth, they are already educated and simply want better information so that they can put their knowledge to use. A third, even larger, group consists of consumers who do not now pay attention to nutrition labels. This potentially vast audience could make use of better labels if they were educated to know why it was important to make dietary changes and how food labels can be useful in making these changes. Major educational efforts, in addition to changes in food labels, will be required to reach this new audience. FOOD LABELS, LABELING, AND ADVERTISING From the outset, the Committee faced a need to define its jurisdiction. Manufacturers and sellers provide information about their food products to consumers by several different means, including, but not limited to, what is thought of as the labelthe printed material that is affixed to or that is part of the package. They use a wide variety of off-package textual and graphic materials displayed at the point of purchase or, more accurately, at the point of selection. In the merchandising trade these materials have a variety of titles, such as "shelf

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48 NUTRITION DIG talkers" and "coupon pads." Manufacturers and sellers also rely heavily on media advertising which consumers usually encounter away from the locations at which food is sold, such as on television and in newspapers and magazines. All these potential sources of information about the nutritional content and quality of foods are, in theory, subject to federal regulation. Manufacturers and sellers use them to describe and promote the nutritional characteristics of their products. In addition, consumers have access to several other sources of information about diet and foods, including books and articles, a growing number of health- focused newsletters, special media reports, regular health segments on television and radio, and formal and informal classes. These sources are to be distinguished, however, from information that originates with manufacturers or sellers of foods, which has special legal status, because their designers have an obvious interest in influencing consumer decisions about which foods to buy. Federal law divides commercially inspired information into three categories for regulatory purposes. Food labels comprise the first category, and it is this category with which the Committee was chiefly concerned. Many foods are sold without conventional labels, however; and most foods that do bear labels are displayed in conjunction with additional graphic or textual material, which falls within the category of labeling as similarly defined by the laws administered by FDA and USDA. In technical terms, labeling is the broader category, for it also comprehends labels, as the Federal Food Drug and Cosmetic Act definition reveals: "The term 'labeling' means all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" (21 USC 1.3~. The courts have interpreted accompanying expansively, which means that FDA and USDA are, in theory, empowered to regulate the contents of off-package material that describe and promote foods. While the Committee has focused primarily on the nutritional content and format of food labels, it has also been concerned with food labeling for several reasons. The sponsoring agencies have jurisdiction over labeling, not just labels, and as the Committee's title indicates, they asked for advice regarding the nutrition components of food labeling. More, the Committee was interested in the quality of nutrition information provided in conjunction with the sale of foods that do not bear conventional labels produce, meats and poultry, and foods provided by food service establishments, such as restaurants. Some of the Committee's recommendations contemplate action by FDA and USDA to regulate the content of labeling for such foods. Neither FDA nor USDA has jurisdiction over manufacturer- or seller- initiated advertising, which is the province of FIC at the federal level. However, the Committee is aware Hat much of the public interest in nutrition and messages about foods is focused on and stimulated by advertising. The proliferation of so-called health claims for food products is, in part, a response to, as well as an effort to exploit, the scientific findings about diet and health Hat led to the

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OVEWIEW 49 Committee's creation and precipitated the current congressional interest in food labeling. The Committee has not, however, studied either the content of food advertising or the manner of its regulation, and because of time constraints, there is relatively little discussion in this report about heals claims. Furthermore, the study's sponsors made clear that they did not expect the Committee to address the issues surrounding health claims. Although the Committee was content to accept this narrowed charge, it was not possible to ignore the area of health claims entirely. The growing use of so-called descriptors, which are verbal attempts to capture and highlight the distinctive nutritional value of a food, such as fat-free or low in sodium, on food labels and in labeling proved to be closely rented to what is customarily regarded as nutrition labeling. Thus, the Committee's effort to formulate advice on the nutrition compo- nents of food labeling has taken it beyond the boundaries of the food label and, in one instance, into the promotional, as distinct from the informational, facets of food labeling. This should not, however, obscure the central focus of this report: to assess the content, format, and coverage of the current FDA and USDA rules for nutrition labeling. SUMMARY OF REPORT The report is in two principal parts, in addition to the Summary. The remainder of Part I provides a comprehensive introduction to the work of the Committee and the nutrition labeling of food in the United Sties. Chapter 3 recounts the history of nutrition labeling, discusses its key features, and identifies the central themes in the growing number of proposals for reform and expansion of the system. Finally, Chapter 4 explores in considerable detail the context in which reform proposals must be evaluated, including current dietary habits of Americans, the behavior and incentives of food manufacturers and sellers, and the increasing internationalization of the food market. It concludes with a discussion of the important topic of chemical analysis of the nutrient contents of foods, bow the source of He information to improve food labels and an important constraint on issues of coverage and content. Part II sets forth the key findings and recommendations of the Committee. Chapter 5 discusses the foods to be accompanied by some form of nutrition labeling, focusing first on packaged foods and then on the important segments of the food supply that do not now bear conventional labels produce, seafood, meat and poultry, and foods served in food service settings. Chapter 6 deals with the desired content of nutrition labeling: the nutrients that should be declared and the information about them that should be provided in a comprehensive discussion. Chapter 7 treats the important, but still poorly studied, subject of label formats: how important nutrition information should be depicted and conveyed. While the Committee offers several suggestions for the final formags)

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so NUTRITION MUNG that should be chosen by FDA and USDA, the recommendations are guarded Chapter 7 also considers the issues of serving size, U.S. RDA, descriptors, and consumer education. Finally, Chapter 8 deals broadly win the implementation of nutrition labeling and specifically with issues of legal authority. Although it is not common for the Institute of Medicine to be asked to provide legal advice, in this instance the Committee's charge included He explicit request to consider whether FDA and/or USDA could implement the Committee's recommended reforms using their current statutory authority. And, if the Committee concluded that there might be advantages in the enactment of new legislation directing and empowering the agencies to act, the Committee was encouraged to comment on what such legislation should include. Both of these large issues are addressed. REFERENCES DHHS (U.S. Deparunent of Health and Human Services). 1988. The Surgeon General's Report on Nutrition and Health. Government Printing Office, Washington, D.C. 727 PP LSRO, FASEB (Life Sciences Research Office, Federation of American Societies for Experimental Biology). 1989. Nutrition Monitoring in the United States: An Update Report on Nutrition Monitoring. Prepared for the U.S. Department of Agriculture and the U.S. Department of Health and Human Services. Government Printing Office, Washington, D.C. 408 pp. 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, Commission on Life Sciences. National Academy of Sciences, Washington, D.C. 101 pp. NRC (National Research Council). 1982. Diet, Nutrition, and Cancer. Report of the Committee on Diet, Nutrition, and Cancer, Assembly of Life Sciences. National Academy Press, Washington, D.C. 478 pp. NRC (National Research Council). 1988. Designing Foods: Animal Product Options in the Marketplace. Report of the Committee on Technological Options to Improve the Nutritional Attributes of Animal Products, Board on Agriculture. National Academy Press, Washington, D.C. 367 pp. NRC (National Research Council). 1989a. Diet and Health: Implications for Reducing Chronic Disease Risk. Report of the Committee on Diet and Health, Food and Nu- ~ition Board, Commission on Life Sciences. National Academy Press, Washington, D.C. 749 pp. NRC (National Research Council). 1989b. Recommended Dietary Allowances, 10th ed. Report of the Subcommittee on the Tend Edition of the RDAs, Pood and Nutrition Board, Commission on Life Sciences. National Academy Press, Washington, D.C. 284 pp.