Evolution of Nutrition Labeling of Foods

FDA's nutrition labeling regulations have undergone relatively few changes since 1973. These regulations derive their authority from the FD&C Act, which states nothing about nutrition. The Act requires that every food label must contain the name of the food, a statement of net quantity of contents, and the name and address of the manufacturer or distributor. In addition, most FDA-regulated foods must also list ingredients in descending order by weight. The Act also prohibits label statements that are false or misleading. A unique provision of the Act (section 201(n)) specifies that, in determining whether the labeling of a food is misleading, consideration should be given to whether it fails to reveal material facts about the consequences of using the product. This provision, and FDA's general power to adopt regulations to enforce the Act, formed the basis for the agency's 1973 nutrition labeling rules on packaged food labels.

It was the 1969 White House Conference on Food, Nutrition, and Health, convened to respond to reports of widespread malnutrition in America, that motivated FDA's initiative. The final report of the conference addressed the regulation of food composition and labeling, criticizing FDA's approaches to standards of identity, marketing of substitute foods, and label statements relating to nutrition and long-term health. The report stressed the need to help consumers make wise food choices by providing more nutrition information on food labels.

In response to the report, FDA initiated the adoption of regulations governing voluntary nutrition labeling for packaged foods. The regulations specified how nutrition information was to be provided if manufacturers chose to include it, and prescribed that nutrition labeling was required when a nutrient was added or a nutrition claim was made. In 1973, the goal was to enable consumers to select a diet adequate in vitamins, minerals, and protein. Thus, labels were required to provide information on the food's contribution to the desired daily consumption of these nutrients. To convey this information FDA created the U.S. Recommended Daily Allowances (U.S. RDA), which were based on the Recommended Dietary Allowances (RDA) established by FNB but reduced them to a single set of numbers applicable to healthy adults.

FDA's 1973 regulations prescribed a uniform sequence and format for disclosure of nutrition information in terms of serving size; servings per container; number of calories; amount of protein, carbohydrate, and fat (in grams per serving); and percentage of the U.S. RDA for protein, vitamin A, vitamin C, thiamin, riboflavin, niacin, calcium, and iron. A manufacturer also could list a number of other vitamins and minerals. A separate regulation allowed, but did not require, disclosure of fatty acid composition and cholesterol information, but only with an accompanying statement that such information was provided to assist individuals who were under the care of a physician. Information on the label about sodium content was required in 1984.

To convey nutrition information, FDA chose a numeric format over other alternatives. This choice seems to have been based more on informed intuition than on extensive testing of utility. FDA's scheme effectively limited the coverage of nutrition labeling. It did not have authority to require labeling on most meat and poultry products. Foods sold in restaurants and other food service operations were excluded. The agency's original plan to require nutrition labeling for fruits and vegetables, albeit with modified conditions, was withdrawn in 1975.

Although USDA has never adopted formal regulations governing nutrition labeling of meat and poultry products, it has evolved policies for such labeling that paralleled those of FDA. They are found in the FSIS Standards and Labeling Policy Book and policy memoranda. Policy Memorandum 039 allows a product's label to state that the food can help reduce or maintain body weight or to make a claim regarding caloric content as long as it provides nutrition information. Policy Memorandum 086, which sets forth USDA's required format for declaring nutrition information, allows either an abbreviated listing (calories, protein, carbohydrate, and fat [in grams] per serving) or the longer FDA version. USDA has also allowed provision of information about cholesterol and fatty acid content as part of either format.

The more significant differences between the two agencies concern the philosophy and manner of implementation. FDA has typically encouraged manufacturers to provide information even when it is not required, whereas USDA has been chiefly concerned with ensuring the accuracy of whatever information appears on meat and poultry products.

Deficiencies in Current Federal Requirements for Nutrition Labeling

Critics of current nutrition labeling cite its limited coverage, the failure to keep pace with current knowledge of the relationship between nutrition and long-term health, the amassing of information about fats and fiber, incomplete information about ingredients, misleading or undefined statements about the levels of nutrients, lack of uniformity, and inadequate consumer education efforts.

Currently, only over half of packaged foods carry nutrition information. Other foods omitted from nutrition labeling include meat, poultry, and seafood; eggs; fruits and vegetables; and foods sold in restaurants, institutional food services, vending machines, and grocery store carryout food bars. In addition, some foods subject to FDA's standards of identity (official recipes used to define the composition of standard products) still fail to list all their ingredients.

The content of current nutrition labels is incomplete given current knowledge of the relationship between diet and chronic disease. Labels are not now required to list cholesterol, saturated, monounsaturated, or polyunsaturated fatty acids, complex or simple carbohydrates, dietary fiber, and potassium, for whose inclusion there is some support. Many observers believe that labels list too many vitamins and minerals.

It is not only the nutrition information on food labels that has been criticized. Listing of ingredients by percentage has been urged. Current provision for "and/or" ingredient labeling allows manufacturers to declare a number of ingredients without specifying which ones are actually present in foods. In the case of fats and oils, it is difficult for consumers to determine the level of saturated fat in specific foods. Sugars are not currently required to be aggregated in the ingredient listing.

Confusion is reported about the meaning of both serving size and the U.S. RDAs. Nutrition information is provided as the amount per serving, but manufacturers determine the serving size, which has allowed manipulation. Serving sizes are not uniform within or between product categories. In addition, serving sizes are frequently expressed in units that consumers do not understand. The U.S. RDAs, which serve as the reference point for describing micronutrient content, have not been updated since 1972.

Finally, FDA's original choice of a numeric display rather than narrative, graphic, or symbolic presentation of nutrient information remains controversial. Some groups suggest that current dietary recommendations should also be included on labels so that consumers can compare these standards with a food's nutrient composition. There is debate, as well, over how the caloric contribution of fat can best be shown, either by calories from fat or the percentage of calories from fat.

Current Dietary Patterns of Americans

Since the turn of the century Americans have made extensive changes in their eating habits. More food is consumed away from home. Snacking is more common. A wider variety of foods is available year-round. Changes have occurred in the composition of foods due to improved production methods, new varieties of foods, and advances in food processing. Records maintained and surveys conducted by USDA and DHHS confirm these changes.

The primary changes in food energy sources in the past 70 years have been an increase in the percentage of energy contributed by fats, oils, sugars, and sweeteners, along with a decrease in the percentage of energy contributed by grain products. There has been no change in the amount of protein consumed, but the amount obtained from animal sources has risen. The consumption of fat and its components (certain fatty acids and cholesterol) has increased. Consumption of whole milk products and eggs has declined, whereas consumption of fats and oils, primarily salad and cooking oils, has risen. Current fat intakes are about 36 percent of total calories, compared with the frequent dietary recommendation of 30 percent of total calories from fat. Dietary fats are considered to be a current public health issue due to their association with coronary heart disease (CHD) and certain cancers. There has been a significant decrease in the proportion of carbohydrates obtained from grain products, with an increase in the consumption of sugars and sweeteners to 50 percent of total carbohydrate calories. No historical data exist on the amount of fiber available in the food supply, but current intakes are generally considerably less than the recommended minimum of 20 g/day. Americans generally consume an adequate amount of most vitamins and minerals due to new plant varieties, food fortification, and supplement use. However, there is concern about general low consumption of several micronutrients, primarily calcium and iron, and in certain population groups, vitamins A and C, folate, and zinc.

Food Marketing in the United States

A 1990 U.S. Department of Commerce document, U.S. Industrial Outlook, suggests that consumers demand foods with convenience, quality, variety, and healthful attributes. By 1990, an average of 12,000 new food products were being introduced annually in supermarkets, more than double the number a decade earlier. Many of these products are targeted directly at a health-conscious public and feature health and nutrition claims on their labels, and more advertising dollars are being allotted to their promotion. Sales of foods in limited-menu restaurants and foods for home use purchased in supermarkets have risen sharply, whereas those from limited-line grocery stores have fallen.

The increasing integration of the food distribution system with trade throughout the world will continue to affect the U.S. food supply. Current Codex Alimentarius rules and the scheduled 1992 adoption of food labeling rules by the 12 member nations of the European Community are all likely to have an impact on trade in the future, as well as the United States-Canada Free Trade Agreement. In the area of food processing, growing internationalization has occurred in food company ownership, and the pace of leveraged buyouts and takeovers has reduced funds for product research and development.

From a general marketing standpoint, it is readily apparent that nutrition "sells" food to today's consumer, and it has become an integral part of product development and marketing strategies. Manufacturers view the principal display panel of food packages as "real estate," to be reserved for sales promotion and competition with rivals, and will not willingly surrender it to government labeling requirements. Although industry can be expected to generally support labeling changes that will create a more informed consumer choice process, it will resist changes perceived to disturb consumer perception of product value, erode consumer ability to evaluate products in the context of total diet, or risk the disclosure of proprietary formulations.

Consumer Understanding of Nutrition and Use of Food Labels

No single study has adequately described how dietary patterns are developed, maintained, and changed; food choices are influenced by social, cultural, economic, psychological, and physiological factors. Familiarity is a particularly important factor in choosing foods. Education and income levels have a significant influence on food choices.

Results of the 1990 Food Marketing Institute (FMI) survey of consumer attitudes and shopping behavior indicate that over 70 percent of shoppers identified taste, nutrition, and product safety as very important factors. Those on medically restricted diets were more likely to rank nutrition first. Numerous studies have confirmed that Americans are increasingly interested in nutrition, including increasing concerns about the health risks associated with sodium, fat, and cholesterol intakes. They report eating less salt, red meat, butter, whole milk, and eggs.

Motivation is a key factor in how receptive any target audience will be to new information. Curiosity about a new claim may lead to a specific food purchase. Medical advice to limit certain food components often leads to closer attention to nutrition information. However, increased knowledge about nutrition does not guarantee dietary change by consumers. Moreover, increased concern expressed by consumers about the relationship between diet and long-term health was matched by increased food and nutrition knowledge related to dietary fats and cholesterol, except in those who are trying to avoid cholesterol. Several surveys have suggested that confusion exists over the relationship between grams and ounces; percent reductions of a food component; and the differences between fat and cholesterol, saturated and unsaturated fats, and dietary and serum cholesterol.

Although consumers may think of nutrition in terms of the positive attributes of a food, they increasingly pay attention to "negative nutrients" (e.g., calories, cholesterol, sodium, sugar, and certain chemical additives) by avoiding certain foods. Trends identified by the 1990 FMI survey indicate that consumers report that of the six food concerns listed, five related to food components that recent reports have stated need to be reduced in Americans' diets. Although consumers' stated predispositions about food components may eventually translate into food choices, no dramatic shift in dietary behavior has been observed.

Studies reveal that although consumers report that they want more nutrition information on food labels, many do not actually comprehend this information and use it in making food purchases. Research has shown that older adults are more likely to use labels to compare products or examine ingredients. The 1990 FMI survey revealed that almost one-half of respondents indicated that they read nutrition and ingredient information sometimes, whereas those on medically restricted diets are twice as likely to read labels for this information. In the 1989 FMI survey, consumers reported that labels should be easier to understand and should include more information on calories, salt and sodium, fat and saturated fats, chemicals, colorings, and dyes. Although consumers report that they understand food labels, some studies suggest that consumers often do not actually comprehend the terms and definitions used on nutrition labels, and therefore, they cannot make optimum use of them in making food purchases.

A few studies have suggested that consumers are motivated to buy foods with nutrition profiles that are more consistent with current dietary recommendations. The 1990 National Food Processors Association study reported that 51 percent of consumers were influenced "a great deal" by nutrition information at the point-of-purchase. The cooperative Giant Food, Inc. (Washington, D.C.), and FDA supermarket point-of-purchase program, which tracked food purchases, revealed that sales of products that were labeled with nutrition information on shelf price tags increased over sales of products that were not labeled. Several programs for meat, such as the Minnesota Heart Health and the Meat Nutri-Facts programs, have shown an increase in purchases of leaner cuts of meat, and consumers reported that nutrition information was useful in making meat selections. Other studies have suggested, however, that information programs may be more successful in improving nutrition knowledge than in changing purchasing behaviors.

Analytical Considerations Affecting Food Labeling Reform

Providing information about the nutrient content of foods on labels requires an analysis of food composition. Both FDA and USDA currently have requirements for label accuracy that reflect the current capacity of analytical chemistry. USDA permits manufacturers to provide nutrition information derived either by calculation from analyses based on official methods of the Association of Official Analytical Chemists (AOAC) or accepted references. USDA has implemented the Nutrition Label Verification (NLV) program, which includes procedures to verify labels for accuracy, although the degree of accuracy that is required imposes analytical problems on food manufacturers. FDA regulations mandate that all the required and any optional information on the nutrition information panel must be determined by direct laboratory analysis. A ± 20 percent tolerance from label values is allowed. FDA generally requires that analysis be done by AOAC-approved methods or by reliable and appropriate analytical procedures set by the Secretary of DHHS.

Acquisition of reliable food composition data is not easy. Difficulties include complexities of analytical methods and food composition, differences in the analytical capabilities of different laboratories, and the need for improved analytical methods and training of technicians. Current methods vary with respect to their applicability, convenience, expense, and the degree of analytical expertise required to perform them. Considerable improvement is needed in the validation and standardization of methods of food analysis for use in labeling as well as food composition data bases.

Soluble fiber cannot easily be measured, since it is usually calculated by determining the difference between total dietary fiber and insoluble dietary fiber, which is subject to considerable imprecision compared to a direct measurement. Thus, the method remains controversial. Measurement of total carbohydrate per serving for food labeling purposes is generally performed indirectly by determining the amount remaining after protein, ash, moisture, and fat are subtracted, resulting in potential inaccuracy and imprecision. Recent advances in the methods used to measure complex carbohydrates will allow for potentially more accurate measurement of various carbohydrate components. Total fat is currently measured routinely, and methods exist for the accurate measurement of cholesterol. Suitable methods exist for the measurement of most minerals in foods, although standardization and validation are needed. Considerable development is required to obtain reliable analytical methods for many vitamins in foods, because of natural variability, especially in plant sources.

The application of direct analytical analyses to nonpackaged foods, including meat, poultry, seafood, fruits, and vegetables, and foods sold in restaurants, is impractical. The need to expand public access to information about the nutrient content of foods suggests the desirability of using appropriate data base information as an alternative to direct analyses for these foods. The USDA National Nutrient Data Bank contains reasonably complete data on the composition of foods, although data are less complete on nutrients for which sound analytical methods are lacking. Other sources of food composition data complement USDA data, but these need to be certified by FDA and USDA to be used for nutrition labeling purposes. At best, however, data bases can indicate representative information on the composition of foods, which means that there may be large differences between data base values and the actual amounts of certain nutrients in a single sample of food.

The Committee recommends that:

• Label verification by analysis of composite samples should be made at least twice each year to ensure reasonable accuracy of nutrition labels without imposing the burden of a complete quarterly analysis.
• FDA and USDA should certify data from the National Nutrient Data Bank or other appropriate sources regarding the nutrient content of fresh foods and foods sold in restaurants.
• FDA and USDA should allow considerable flexibility in the selection of analytical methods for label verification of nutrient content.
• In proposing an alternative (nonofficial) analytical method, suitable verification must be required (e.g., recovery of samples and analysis of reference materials). In addition, appropriate quality control procedures should be used in each analysis.
• Development of additional standard reference materials for use in food analysis should be encouraged.
• Funding should be provided for the development of improved analytical methods, establishment of programs for the testing of methods through interlaboratory studies, and development of additional standard reference materials.
• Completion and expansion of the USDA National Nutrient Data Bank should be continued.

Mandatory Nutrition Labeling

Although nutrition knowledge will continue to evolve, there is now sufficient consensus on diet and long-term health to serve as a basis for changes in food labeling. The Surgeon General's report and the NRC Diet and Health report indicate that consumers must make changes in both the dietary components and the food groups they eat, if they are to reduce their risk of chronic disease. In order to achieve the recommended dietary adjustments, consumers must be able to make informed choices in their daily selection of foods. The current lack of relevant, consistent information across the full spectrum of food products is a significant deterrent to consumers who wish to make informed choices. However, certain foods need to be either exempted from these requirements or, in the case of foods for children under age 2 with special dietary requirements, have alternative labeling requirements more suitable to that group of foods.

The Committee recommends that:

• FDA and USDA should promptly adopt regulations to institute mandatory and uniform nutrition labeling requirements for all packaged foods within their respective jurisdictions, with limited exemptions.
• Exemptions from the general requirement should only be granted in those situations in which alternatives to nutrition labeling have been fully explored and determined to be unreasonable, impractical, or too costly.
• Food designed for children under age 2 should be exempted from the general requirements; nutrition labeling of macronutrients in baby foods should be required, with the optional listing of all micronutrients, except for calcium and iron declaration.
• Nutrition labeling should be required on institutional-size packages and commodity foods or on product specification sheets.

Produce, Seafood, and Meat and Poultry

Recent dietary recommendations emphasize that Americans should reduce their consumption of fat and cholesterol by eating more fruits, vegetables, seafood, poultry, and lean meat. Nutrition information on fresh foods would aid consumers in making appropriate food choices. However, providing nutrition information about fresh foods presents some special challenges. Fresh foods are more heterogeneous than formulated foods, which are more uniform in composition and are batch tested. The variability of the nutrient content of fresh foods is due to factors such as biological variability, climate, seasonal variations, agricultural practices, and animal husbandry. The effects of storage and cooking on fresh foods further affects their nutrient composition. None of these factors are reflected in nutrient composition information provided in data bases.

For fresh foods, the use of food composition data may provide a practical alternative to laboratory analysis. Although the USDA National Nutrient Data Bank is not totally complete, the data base provides an adequate basis for use of nutrient content information in point-of-purchase labeling of most fresh foods. An alternative data bank has been developed by the Produce Marketing Association for about 30 different produce commodities. FDA and USDA currently require that nutrient information be based on analytical data of foods as actually purchased, which effectively precludes the use on the food composition data bases.

The Committee recommends that:

• Retailers should be required to provide point-of-purchase nutrition labeling information for produce, and for fresh and frozen meat, poultry, and seafood (e.g., 20 to 30 top items in each category using data base information, rather than lot-by-lot analysis). After the first 3 years, the program should be evaluated for consumer reaction, use, and understanding and modified accordingly.
• FDA and USDA should allow flexibility in the format and the nutrition information required for labeling of fresh foods.
• FDA and USDA should establish a joint committee to certify the data bases and acceptable methodologies for providing nutrient composition data for fresh foods.
• FDA and USDA should continue to improve the USDA's National Nutrient Data Bank, particularly in the area of fresh foods, in harmony with the above recommendations.

Foods Sold by Restaurants

Americans currently spend about 43 percent of their food dollar on meals eaten away from home, which is expected to total $156.4 billion in 1990. The National Restaurant Association estimates that 45.8 million Americans (about 20 percent of the population) eat in refreshment places each day. According to a 1989 National Restaurant Association survey, an increasing number of consumers are concerned about the types of foods available in restaurants.

Restaurants are paying more attention to providing foods that are consistent with current dietary recommendations. In the past 5 years, the number of restaurants reporting that they have nutrition information on their menu items available for those consumers who request it has doubled. Many restaurants have menus coded for items that are low in fat, cholesterol, salt, and calories.

Some groups have urged that restaurants provide more information on the ingredients and nutrient contents of foods served to aid consumers who are concerned about their intake of salt, fat, and sugar. Although primary attention has focused on the limited-menu segment of the restaurant industry, there is no evidence to suggest that meals served in other restaurants are necessarily more nutritious or likely to meet the recent dietary recommendations.

The nutrient composition of menu items can be computed either by the use of readily available computer software or by subscribing to programs that perform the evaluation. Nutrient content information should be based on the standardized serving sizes for foods in limited-menu restaurants. For other restaurants, normative serving sizes will need to be identified by the agencies.

Because Americans are consuming a growing number of their meals in restaurant settings where nutrition information is not routinely available, the Committee recommends that:

• All restaurants should be required to have standard menu items evaluated for their nutritional profiles and provide this information to patrons upon request.
• Restaurant menus should be required to state that ''nutrient evaluation is available upon request,'' so that consumers can, if they desire, obtain such information.
• FDA and USDA should, through regulations, allow the use of nutrient data bases to provide nutrient evaluation of menu items.
• Food service establishments above a specified size and/or volume (limited-menu and regional/national restaurant chains) should be required to provide nutrition analysis of food items at the point of purchase. This requirement can be met by placing the information either on package wrappers and containers or at some other point-of-purchase location that allows consumers easy access and use.
• Restaurants should be encouraged to participate in programs and/or otherwise provide for appropriate symbols or descriptors on menu items that identify foods that meet criteria for low-calorie, low-fat, low-cholesterol, and/or low-sodium. Comparable definitions for symbols and descriptors should be established by FDA and USDA.
• FDA and USDA should define the categories and size of restaurant operations for which regulations based on the above recommendations are applicable.

Foods Sold by Noncommercial Food Services

In recent years, institutional food service operations have grown substantially as an increasing number of meals are being prepared, served, and consumed outside the home. Members of all age groups are eating away from home in institutional or congregate settings. Children may eat up to two meals per day at school. Long- and short-term health care facilities are feeding a growing population of elderly people. Military installations, correctional facilities, and institutions of higher education feed millions of people daily. None of these noncommercial services have strict rules on serving meals that meet current dietary recommendations. Many of their customers, however, are health-conscious and/or are open to nutrition education programs.

The Committee recommends that:

• The agencies at the federal, state, and local levels that oversee or support noncommercial food services encourage voluntary nutrition labeling of meals at the point-of-purchase or point of selection as part of overall nutrition education efforts.

Health Relevance of Nutrient Recommendations

Serving Size

The concept of serving is currently used as a reference unit for information about the nutrient content of foods. FDA regulations define serving to be the actual amount of a food likely to be consumed at a single selling or the portion of the food likely to be used as an ingredient. Nutrient information is declared in relation to the average or usual serving. Serving is also used as a tool for food and nutrient composition data bases and in dietary guidance systems that advise consumers about the number of daily servings of foods from each food group they should consume.

A number of studies have shown that a large proportion of respondents cannot accurately judge the amounts of foods and beverages they consume. There is a tendency to overestimate serving sizes, with the magnitude of the error varying with the specific food item and experience in food preparation.

There is currently wide variation in the size of servings declared on food labels, both between categories of foods and among foods in the same product category. It is frequently possible for two products with similar nutrient content to have different serving sizes. The ability of manufacturers to set serving sizes allows them to portray foods in the most favorable light to attract consumers. FDA has frequently voiced concern about the confusion in the marketplace caused by the practice of manufacturers to set serving sizes to enhance the attractiveness of a product's nutritional value. This problem is further compounded by the use of nutrient descriptors.

Several alternatives to serving size as the reference unit for nutrition information have been suggested, such as per 100 grams, and entire package. Although no reference unit is ideal, expressing nutrition information by serving seems to be preferred by consumers, health professionals, and food manufacturers.

The Committee recommends that:

• Given the alternatives available (serving size, nutrient values per package or container, 100-g portions), serving should continue to be the reference unit for presenting nutrition information on foods.
• Serving sizes should be expressed in common household measures, followed by the weight in grams (in parentheses) to facilitate comparisons across product categories. Serving sizes should be standardized across food categories on the basis of volume or weight measures. All serving sizes should be rounded down to the nearest whole number.
• The number of servings per package or container should continue to be specified. For a single-serving container, 50 to 150 percent of the commonly consumed unit would be acceptable. The number of servings per container should be rounded down to the nearest in whole number.
• Consistent with the recommendation that serving sizes should be standardized, quantities specified by dietary guidance recommendations should serve as the main criteria for selecting the amount of food to be described as a serving. This preference for recommended amount, rather than consumed amount, has the advantage that it can be more readily applied in educational programs and will ensure consistency among serving sizes as presented in dietary guidance materials and on the food label.
• FDA and USDA should, jointly, establish serving sizes for a limited number of different food categories, (i.e., fruit juices, breads, cereals, fruits, vegetables, spreads, and salad dressings) since serving size information will be more valuable to consumers if it applies to broad categories of food. The Committee favors fewer, rather than more, categories so that nutrition information can readily be used by consumers for product comparisons and reference purposes.
• If a food manufacturer desires a serving size different from that set by the agencies, it should be permitted to petition the responsible agency to allow a deviation or to create a new subclass of foods with its own serving size.
• FDA and USDA should establish uniformity in serving size specifications within product categories and between agencies to facilitate comparisons among products, labels, point-of-purchase information, and federal and private data bases.
• Research should be conducted to determine how consumers comprehend food label information and how they interpret serving sizes declared on the food package.

U.S. Recommended Daily Allowances

The U.S. RDA reference standards were set in 1972 based on the 1968 RDA (which have since been updated several times), generally at the highest level of RDA recommended for any age or sex group in the population. The amounts of protein, vitamins A and C, thiamin, riboflavin, niacin, calcium, and iron per serving as a percentage of the U.S. RDA are currently required to be declared on the nutrition information panel. Amounts are expressed in 2 percent increments up to the 10 percent level, 5 percent increments up to the 50 percent level, and 10 percent increments above 50 percent. Nutrients present in amounts of less than the 2 percent are indicated by a zero or an asterisk, which refers to a statement at the bottom of the table indicating that the product "contains less than 2 percent of the U.S. RDA of these nutrients." When a vitamin or mineral is added to a food or a claim is made about any nutrients, the percentage of the U.S. RDA must be declared for all seven vitamins and minerals. No claim can be made that the food is a significant source of a nutrient unless a serving of the food contains 10 percent or more of the U.S. RDA of the nutrient per serving.

The Committee recommends that:

• The U.S. RDAs (or different reference term) should be updated, even if they are to play a more limited role in nutrition labeling in the future.
• FDA and USDA should require the use of the descriptors very good source of, good source of, or contains to characterize the content of required or optional micronutrients in foods.
• Use of the descriptive terms on the nutrition information panel would require that micronutrient meet the following or similar criteria: use of very good source of must provide, in a serving, more than 20 percent of the dietary standard for a given vitamin or mineral; use of good source of must provide, in a serving, 11 to 20 percent of the dietary standard for a given nutrient; use of contains must provide between 2 and 10 percent of the dietary standard for any nutrient; and a manufacturer would not be required or allowed to declare any nutrient present at less than 2 percent of the dietary standard.

Ingredient Labeling

The ingredient listing can be an important source of information about the nutrient composition of packaged foods. FDA and USDA require that ingredients be listed by their common names in their order of decreasing predominance by weight. The most significant exception to the general requirement that ingredients be disclosed is for foods covered by an FDA standard of identity for which only optional ingredients may be required to be labeled. Although FDA lacks the authority to require the labeling of mandatory ingredients, it has taken steps to amend existing standards to recharacterize most ingredients as optional. USDA requires ingredient labeling on standardized foods. The exemption of any standardized foods from mandatory ingredient labeling can no longer be justified. The Committee did not take a position on percentage ingredient labeling because it viewed the issue as having no nutritional significance, although it may have merit for other reasons.

The current format for the ingredient listing has been criticized. Ingredients typically appear as running text and often are printed entirely in capital letters separated only by commas, with no breaks or classifications and some use of parenthetical phrases to describe functions. Several useful proposals have been suggested to make this portion of the label easier to read, including required use of capital and lowercase letters, separation of major from the minor ingredients, and the use of contrasting colors. Efforts should be made to improve the readability of the ingredient listing to aid consumer understanding of the nutritional characteristics of different foods.

The Committee recommends that:

• Congress should amend the FD&C, FMI, and PPI Acts to make clear that the general requirement of full ingredient listing applies to standardized as well as nonstandardized foods.
• FDA and USDA should take steps to amend their regulations for ingredient labeling to require that the ingredients of standardized foods that are incorporated into other processed foods are declared by name on the label of the final product.
• When FDA and USDA test different basic formats for nutrition labeling, they should also seek information about consumer reactions to and use of different formats for depicting the ingredients in foods.

Food Standards of Identity

FDA has established standards of identity for nearly 300 foods, most which have existed since the 1940s and 1950s. These standards define the composition of products entitled to use the official product name. Some of these standards of identity have been criticized for impeding manufacturers' ability to offer more nutritious foods. The legal process for establishing and amending food standards of identity is extremely cumbersome, which discourages changes that would facilitate marketing of more healthful versions of products traditionally high in fat.

In theory, standards of identity need not impede the marketing of reduced-fat or low-fat substitutes for foods traditionally high in fat but critics have claimed that FDA compliance policy discourages such innovations by precluding the use of standardized names on products that contain reduced levels of fat. Although the Committee could not fully assess the criticisms of standards of identity, standards of identity certainly justify reexamination of the impact on efforts to develop more healthful versions of well-known foods.

The Committee recommends that:

• FDA's food standards should be carefully examined for their effects on the marketing of low-, lower-, and no-fat substitutes for high-fat foods.
• Congress should amend the FD&C Act to eliminate the requirement that standards be adopted and amended through formal rulemaking procedures.
• Congress should eliminate the exemption from full ingredient labeling for standardized foods.

Descriptors

Product labels have long been used for promotional as well as informational purposes, and food marketers give careful consideration to every facet of label design. Although many facets of food labels are regulated, manufacturers nonetheless have considerable choice in the information that they include and the manner in which it is displayed within the constraints of label and package size. Growing consumer interest in nutrition and specific nutritional components has led many manufacturers to feature the desirable characteristics of products. Common examples in this practice are so-called nutrient content descriptors, such as low-calorie, fat-free, no cholesterol, fiber-rich, and lite.

The proliferation of these descriptors and the growth in their usage have drawn attention from regulatory bodies, health professionals, and competitors. On the one hand, their popularity signals an encouraging interest among consumers about the links between nutrition and long-term health. On the other hand, the potential for confusion, exaggeration, and outright deception has prompted some to argue that nutrient content claims should be forbidden altogether.

The problem stems in part from failure of the current system to regulate such claims in a systematic way. Users of many content descriptors have no official definition against which to basis their claims. USDA reviews all labels individually and does not approve a label that carries an unapproved claim. FDA lacks standard definitions for most of the descriptors in common use, and at times is hampered in its efforts to prevent the use of terms in the absence of formal definitions. FDA has often relied on compliance with informal advice which depends on manufacturers' knowledge and their willingness to adhere to informal policy. Compliance with FDA's criteria is as likely to be related to the practices of competitors as to the views of agency officials. The problem is compounded when one agency has defined a descriptive term in official guidelines, but the other has not, or in the case where there are descriptors whose meanings the two agencies dispute. Without official, uniform definitions of common descriptors, food manufacturers are able to exploit consumer interest in foods that appear to be healthful. For example, the term lite or light has been used to imply fewer calories, reduced fat, lower sodium, improved texture, flavor, or color, and even the amount of breading, depending on the product. There are other practices that border on the deceptive. Although it is common to highlight desirable components of foods, rarely is there any effort to provide balanced information about other undesirable characteristics. For example, it may be literally truthful to label a food as containing no cholesterol, but even so, this may mislead consumers if it also contains substantial amounts of total fat and saturated fatty acids, particularly for unsophisticated consumers who equate cholesterol with fat. The responsible, restrained use of content descriptors may provide benefits to consumers who use them to hastily compare the main nutritional features of various foods. To promote the proper use and to aid consumer understanding of such descriptors, it is important that appropriate word definitions and criteria for their use be established. It is also important that the definitions established be the same for both agencies. Such quantitative descriptors are widely used and thus are of particular concern.

The Committee readily agreed on these elementary propositions. It found the challenge of formulating definitions for the growing variety of content descriptors in common use considerably more difficult. Each example that it undertook to evaluate seemed to present distinctive issues, and the judgments reflected in existing agency regulations and guidelines governing the use of specific terms seemed heavily influenced by precedents that cannot readily be appreciated. It quickly became clear that the Committee's work schedule would not allow the sort of in-depth study of agency policy and commercial practice that would be necessary to formulate recommendations for defining individual terms.

The Committee was also persuaded that the agencies themselves probably cannot expect to establish formal definitions for all of the terms that inventive marketers are likely to adapt or invent to describe the nutrient content of foods. The goal should be to define a core set of the terms used to describe the most important food components—fat, cholesterol, carbohydrates, fiber, and sodium. The agencies have made progress toward this goal.

The Committee was concerned that further progress would be slowed if the agencies had to treat each component—and associated set of descriptors—as presenting a unique problem. Accordingly, the Committee attempted to develop, and suggest for the agencies' consideration, a possible general framework for assigning nutrient values to such terms as low, very low, and reduced.

The Committee's suggested framework would allow the use of quantitative descriptors limited to two categories—high, low, very high, very low—with demarcations established for each descriptor. A scheme of benchmark ranges would be established for all quantitative descriptors for each nutrient based on the RDAs and other recognized dietary recommendation standards, and benchmark limits would be kept conceptually consistent for all nutrients in order to simplify the message. The use of comparative descriptors should be strictly regulated, with clear identification of the products being compared. In addition, the extent of nutrient modification should be specified and based on a modification of at least 20 percent, and descriptors should not be allowed for nutrients unless they are normally present in physiologically significant amounts (when physiologically significant amount is defined, such as 1 percent of the maximum allowance used to define the limits for very low). Synonyms of approved descriptors should not be allowed except by petitioning FDA and USDA; and descriptors that characterize other features that are not directly nutritional in nature (e.g., organic, fresh, and natural) should be controlled by narrowing the conditions for their use. Finally, the Committee believes that descriptors that imply mitigation or cure of disease or health condition should be controlled under the regulations being developed for health claims.

Comparative descriptors, such as reduced fat, are also widely used on many foods. Often, the compared food is not identified, and just as often the difference between the products is not described quantitatively. Use of such comparative terms should require clear identification of the product being compared and specification of the extent of modification. Descriptors that proclaim the absence of an undesired component, such as cholesterol free, should not be allowed on foods that do not normally contain cholesterol. And when used on foods that contain significant amounts of fat, or another undesired component, such as sodium, such claims should be accompanied by a disclosure of that fact.

Label Format Options

In 1972, when the voluntary nutrition labeling program was being developed, FDA investigated the various options that might be used to convey the nutrition information on the package and decided to use a numeric presentation. In 1982, FDA commissioned a study to develop alternative label formats, but systematic consumer testing was not undertaken. Some research has been done on the effectiveness of the current label format and various alternatives to convey nutrition information to consumers. Alternative presentations have included descriptors, graphics nutrient density with and without graphics, food equivalents calorie-based, and symbols. When any of these alternatives have been evaluated against the current format, consumers generally say they prefer the graphic format, yet they also seem to prefer nutrition information stated in absolute numbers and percentages over the alternatives.

Research on nutrition information provided at the point-of-purchase suggests that the form of presentation has an impact on the format judged to be most useful. Control over the individual's information input rate and ability to process data at a comfortable pace seem to reduce confusion.

In addition to the recommendations listed earlier on the mandatory and voluntary disclosure of nutrient content information, the Committee recommends that:

• Serving size should be prominently displayed on the nutrition information panel and should appear in household units.
• The amount of the serving should appear in grams or milliliters in parentheses following household units.
• Nutrient information should appear for the food as it is packaged, with the option of providing information relevant to the manner in which the food is prepared.
• Macronutrients should be listed in grams or milligrams.
• Macronutrients should be listed first, and then other food components, electrolytes, and micronutrients, or similar food components should be grouped together, except fiber and cholesterol should not appear in groupings.
• Various issues related to placement and prominence of food components on the nutrition label (e.g., increased prominence of fat components, ordering of macro- and micronutrients) should be subjected to consumer testing.
• Comparison with dietary recommendations should be optional.

Consumer Testing

Alternative label formats should be subjected to both qualitative and quantitative consumer testing prior to issuance of any final nutrition labeling requirements. However, this testing must be carefully structured to produce measurable results and, given the level of expectation for this process, carried out within a reasonable period of time. It is also assumed that before any testing procedures begin, the agencies will have determined through the comment and rulemaking process the nutrient content information to be conveyed on the label as this will affect the required nutrition information to be presented in any format tested.

The Committee recommends that:

• A brief test panel education program reviewing the current dietary recommendations and explaining the basics of the new label formats should precede label format testing.
• A formal testing procedure should include: an advisory panel to help determine the formats to be tested; an initial testing phase to include a comprehensive, qualitative review by consumers; an in-depth evaluation of the most preferred choices to assess consumer ability to use label information; and finally, large-scale surveys to determine consumer acceptance and comprehension of label information.

Educating Consumers to Use Nutrition Information on Food Labels

Two general strategies have been described for promoting dietary change. Environmental or structural interventions are strategies that encourage positive behaviors by creating opportunities for action and removing barriers so that consumers can follow health-promoting behaviors. In terms of dietary change, modification of some aspect of the food supply or improvement of consumer access to food would represent such a change. Personal or direct influence strategies are based on providing information or directing educational efforts, persuasion, and behavior modification techniques toward individuals or small groups. Techniques in these areas evolve from simple information transmission (based on the premise that knowledge of the facts will change behavior) to a variety of direct behavior modification techniques that are designed to lead directly to the development of health-promoting skills and practices.

The nutrient composition information provided on food labels should enable the public to make informed food choices. The provision of nutrition information on food labels is an amalgam of these two strategies: it is an environmental strategy because the federal government adopted an information provision policy by allowing not only nutrition information to appear, but also by setting the rules governing format, content, and placement, a personal-influence strategy for consumers to have the information to use.

Various public information campaigns aimed at promoting healthy behavior (including those for heart disease, high blood pressure, and cancer) have focused on enhancing knowledge, changing attitudes, and improving skills. Unfortunately, research suggests that improving consumer knowledge and consumer attitudes alone will not result in adoption of health-promoting practices. Consumers need information to make long-term dietary changes, but they need more than just information to achieve this goal. Educational resources will be required to effect behavioral change.

Obstacles to effecting dietary change in consumers include factors that are both cultural and psychological in nature. Most diet-related health problems develop gradually, without immediate or dramatic symptoms. Risk factor reduction and disease prevention through dietary means require an individual to make long-term and often arduous changes in food habits. However, many Americans consider themselves reasonably healthy and question whether major alterations in their dietary habits will be worthwhile in the long run.

A comprehensive national nutrition policy would ensure the availability of adequate supplies of safe and nutritious foods as well as provide consumers with the educational means for making informed food choices. A well-designed nutrition labeling program is an important component of an education program, but the provision of information is only the first stage in the behavioral change process. It cannot substitute for a comprehensive nutrition education program.

The Committee recommends that:

• Public- and private-sector initiatives should be established to help consumers understand and apply the information on the nutrition label.
• Comprehensive nutrition education programs should be developed in order to help consumers to understand the information on food labels to enable them to plan diets and make appropriate food choices.

Costs of Labeling Reform

Any reform of food labeling to provide more complete nutrition information and any expansion of the coverage of current nutrition labeling requirements will impose costs on producers, manufacturers, retailers, and ultimately, consumers regardless of who is recommending reform. It is the Committee's judgment that its recommendations for the content of nutrition labeling would require very little information that producers do not already possess. The timing of the imposition of such requirements could affect the cost of compliance. For foods that do not now bear nutrition labeling of any sort, additional costs will be incurred. The costs of analysis of these foods may not be trivial, though adequate methods and laboratory resources are available to analyze, at a reasonable cost, virtually all packaged foods for all of the nutrition components that the Committee recommends. Providing point-of-purchase nutrition information on produce and fresh meat, poultry, and seafood will impose significant new costs on retailers and consumers. The Committee is recommending that limited-menu restaurants be required to display point-of-purchase nutrient content information on their foods and that all other restaurants be required to have such information available to consumers on request. This recommendation is not likely to entail substantial additional costs, either for the limited-menu restaurant or consumers. The cost to require all other restaurants to have their menus evaluated and to offer nutrient information on request to consumers are considerably less certain. However, evaluation of the nutrition profile of menus is widely available and inexpensive, but even modest expense may prove high for small operators.

Desirability of New Legislative Authority for Nutrition Labeling

The foregoing discussion suggests why new legislation is, in principle, desirable. The Committee does recommend that Congress amend the FD&C, FMI, and PPI Acts to enlarge and clarify the authority of FDA and USDA, but it acknowledges that this has costs as well as advantages.

Design of Food Labeling Legislation

New legislation should clarify the authority of FDA and USDA to mandate nutrition labeling on all packaged foods and coverage of fruits and vegetables, fresh and frozen meats and poultry, fresh and frozen seafood, and foods sold in restaurants.

The next issue concerns what new legislation should provide regarding the content of labeling. A distinction should be drawn between those components of nutrition labeling that should be required by FDA and USDA regulations and those that should be mandated by statute. Legislation should limit itself to prescribing calories per serving, complex carbohydrates, sugars, and those components whose consumption should be restricted or curtailed (fat, saturated fat, cholesterol, and sodium). All other components to be included in nutrition labeling should be left to FDA and USDA. The Committee expects that, in addition, the agencies would agree to requiring protein, fiber, calcium, and iron.

New legislation should direct the two agencies to agree on the same reference unit for listing nutrition information, presumably a serving of food. It should also direct the agencies to adopt a uniform serving size for purposes of nutrition labeling.

The Committee believes that current legislation gives FDA and USDA adequate legal authority to adopt standard and uniform definitions of the most commonly used descriptors. However, if new legislation is enacted to resolve other questions, confirmation of the agencies' power to define commonly used nutrient descriptors would be desirable. FDA and USDA should also have the power to prohibit the use of any undefined descriptors on a food that do not conform to the definition or that are not defined by the agencies.

The Committee is reluctant to endorse any outright ban on the truthful, even if incomplete, description of nutrition components without evidence that this is the only means of preventing consumer confusion. But the agencies should have the authority to restrict the official nutrition label to designated components and relegate other components to the ingredient listing or other portions of the label. Current law appears to provide the agencies with adequate authority.

Legislation should direct FDA and USDA to identify and test different label formats and then to specify in regulations the uniform format that must be followed by all food sellers. FDA and USDA should be empowered to approve modifications of the basic format in appropriate cases, such as for foods with few mandatory components, those with very small packages, fresh foods, and foods sold in restaurants. Either agency may wish to consider other modifications for specific products, but the burden of justifying departures from the uniform format should rest on those manufacturers seeking them. Explicit confirmation of the agencies' authority to exempt certain foods from nutrition labeling would be desirable, but final decisions about which foods to exempt should remain with FDA and USDA.

A national food labeling advisory committee could periodically review the need for revision of both the format and the content of nutrition labels and labeling. Legislation should direct that regular reviews of nutrition labeling be done, prescribe deadlines for completion of these reviews, and mandate consideration of the views of the public as well as other sectors.

Allowing different formats for conveying nutrition information on food labels diminishes the utility of labels to consumers. It is essential that one format be established. A nutrition label should be prescribed by federal law, and legislation should presumptively preclude modifications or additions by state authorities or legislation to allow states to petition FDA or USDA for approval to require additional information needed by their citizens, but would disapprove of any state addition that would prevent use of the same label throughout the country.

A formal mechanism, such as a national food labeling advisory committee, including representatives from the states, should be established to provide FDA and USDA with advice on the design of nutrition labeling requirements. This could increase the willingness of the states to collaborate in enforcement efforts and would perhaps induce federal authorities to fashion their requirements to reflect the interests of the states. Establishment of such a food labeling committee would not require new legislation, but a congressional mandate would ensure creation of such a mechanism.

Finally, Congress should establish deadlines for adoption of new food labeling regulations by the agencies.