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4 Contextual Factors Affecting Food Labeling Reform A number of external factors have an influence on food labeling reform. Although an exhaustive discussion of all these factors is not possible in this report, a brief review is necessary in order to convey the milieu in which proposals for changes in food labeling will be evaluated. The factors that are considered in this chapter include current dietary patterns, food marketing in the United States, consumer understanding of nutrition and use of food labels, and analytical considerations that affect food labeling information. CURRENT DIETARY PATTERNS OF AMERICANS Since me turn of the century, Americans have made extensive changes in their eating habits. More food is purchased for consumption away from home. Snacking is more common. A wider variety of foods is available year-round. Changes in the composition of foods have occurred due to improved methods of cultivation and animal husbandry, the introduction of new varieties of plants and animals bred for either nutritional or other features, and advances in food processing that permit the formulation of foods with desirable characteristics. The data on which a discussion of these changes is based come primarily from records maintained and surveys conducted by the U.S. Department of Agriculture (USDA) and the U.S. Deponent of Health and Human Services (DHHS). Most of the trend data discussed here are based on the U.S. Food Supply Series and the Nationwide Food Consumption Survey (NFCS) conducted by USDA and the National Health and Nutrition Examination Survey (NHANES) conducted by DHHS. 74

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CONTEX7VAL FA=ORS AFFECTING FOOD LABELING REFORM Sources of Data and Issues of Interpretation 75 Major changes have occurred in what and where Americans eat; however, care needs to be taken in the interpretation of the available data The data that are collected represent four different levels: national food supply, use of food in households, individual food intakes, and nutritional and health outcomes that are influenced by diet. A variety of methods is used to collect the data, and the collective evaluation of such data needs to be sensitive to these different methods. Systematic collection of data on the U.S. food supply began in 1909, when USDA initiated tracking the availability of foods in the U.S. marketplace. USDA has been able to calculate annually the approximate amount of food available per individual by dividing the total amount of foodstuffs available by the civilian population of the United States at a given time. The total amount of foodstuffs is calculated as [(food produced + beginning inventories + food import - (food exported + food purchased by the military + year-end inventories + food having nonfood uses)~. Through the use of food composition tables, a rough estimate can then be made of the nutritive value of foods available for consumption by Americans. Refinements of these types of calculations have led to the development of estimates of the per capita availability of 25 nutrients in approximately 350 foods as they "disappear" into the U.S. food distribution system. Data on food availability represent quantities that are larger than those actually eaten, because the amounts do not account for the losses that occur during processing, marketing, and home use. Calculations of the nutritive value of the food supply overlook some sources of nutrients such as alcoholic beverages (which provide calories, but few nutrients) and vitamin and mineral supplements (which provide micronutrients, but essentially no calories). Because the per capita availability of food and nutrients is based on the total U.S. population in any given year, comparisons over time do not take into account the changing demographic structure of the U.S. population. With these caveats in mind, and recognizing that food supply data do not provide information on the actual foods that are eaten, they are still useful for reflecting changes in the overall patterns of the foods and nutrients available over time. At He second and third levels, data are collected by using household- based surveys (i.e., use of food in households and individual food intakes). At approximately l~year intervals since 1936, USDA has conducted its NFCS. The first four surveys collected data only on the use of foods in households. In 1965, data on the consumption of food by individuals were added to the information collected. Surveys were conducted in 1965-1966, 1977-1978, and 1987-1988. Beginning in 1985, USDA began the Continuing Survey of Food Intakes of Individuals (CSFII), which is performed annually except in years when the more comprehensive NFGS is conducted.

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76 Nlm~lTION LABELfiNG DHHS conducts a variety of surveys and surveillance activities that provide information on food intakes and the nutritional and health status of the U.S. population and subgroups of the population. The Total Diet Study, which has been conducted annually since 1961 by the Food and Drug Administration (ADA), estimates intakes of certain essential minerals as well as the extent of contamination of foodstuffs by industrial chemicals and pesticides. The Ten-State Nutrition Survey was conducted from 1968 to 1970 to examine the diets and nutritional status of the poor. The first National Health and Nutrition Examination Survey, NHANES I, which was conducted between 1971 and 1974, collects an ambitious set of data, including not only He dietary intakes of individuals but also health and medical histories, physical examinations, and Laboratory data Particular attention is paid to nutrition-related diseases. NHANES II was conducted from 1976 to 1980, the Hispanic HANES (HHANES) was carried out from 1982 to 1984, and NHANES III began in 1988. In 1977, the U.S. Congress directed that a comprehensive, coordinated nutrition monitoring system be created. The National Nutrition Monitoring System (NNMS) was begun as a collaborative program between USDA and DHHS. NNMS is meant to coordinate the survey activities of these two federal departments and to issue joint survey reports through the Interagency Committee on Nutrition Monitoring. Reports issued in 1986 and 1989; these reports compared data from the 1977-1978 NFCS, 198~1986 CS~I, NHANES II, HHANES, and USDA's historical data series (DHHS/USDA, 1986; LSRO, EASED, 1989). Data from the surveys mentioned above and historical data series can be useful in assessing major shifts in eating habits and the resulting nutritional status of Americans; however, the nature of the information requires that these conclusions must be reached with consideration of the limitations of the sources. All of the information, whether derived from food supply data or dietary surveys, is dependent on the quality of estimates and assumptions that permit the calculation of nutrient intakes. Dietary intake surveys of individuals often use a technique called the 24-hour dietary recall, relying on the respondent to accurately recall and describe the foods consumed during the pawing day or in the past 24 hours. Much of the data concerning the per capita disappearance of food consists of gross estimates of the amount of food produced; no adjustments are made for discar - , wasted, and spoiled foods. In addition, the data represent the average amount of food and nutrients available to the population, regardless of differences in age, sex, race, and economic status. However, major shifts in eating habits and the resulting nutritional status of Americans can be discerned from the available data. More detail on changes in food consumption over the years than is offered here are provided in the National Research Council ARCS report, Diet and Health: Implications for Reducing Chronic Disease Risk MARC, 1989) and the

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CONTEXTUAL Fx~rORS AFFECTING FOOD LA~EuNG REFORM 77 Expert Panel on National Nutrition Monitoring report, Nutrition Mon~tonng in the United States (LSRO, FASEB, 1989~. Food Energy The daily food energy content (or calories, as it is expressed on food labels) of the food supply is substantially higher (3,500 calories in 1985) than intakes recorded in surveys. The primary changes in food sources of energy in the past 70 years have been from an increase in the percentage of energy contributed by fats, oils, sugars, and sweeteners, along with a decrease in the percentage contributed by grain products. Of the percentage of calories obtained from macronutrients from 1909 to 1985, protein contributed about 11 percent, fats increased from 32 to 43 percent, and carbohy~es fell from 57 to 46 percent (NRC, 1989~. In 1985, the major sources of food energy in the food supply were fats and oils (20 percent); grains (19.9 percent); meat, poultry, and fish (19 percent); and sugars and sweeteners (17.8 percent) (LSRO, FASEB, 1989~. Data from the 1985-1986 CSPII indicate that children aged 1 to 5 have mean energy intakes that fall within the range for their age groups, with little difference observed between blacks and whites or among those from families with different income levels. The reported mean intakes by women, however, fall below the recommended range. In addition, intakes are lower in older (40 to 49 years) than in younger (20 to 29 years) women, lower in blacks than In whites, and lower in women below the poverty level than in those above the poverty level (LSRO, FASEB, 1989~. Despite the low caloric intakes report, more than a quarter of American adults are overweight. Data from NHANES I, NHANES II, and HHANES reveal that women are more likely than men to be overweight (LSRO, FASEB, 1989~. A comparison of NHANES I and health survey data from 1960 to 1962 reveals that the average weight gain was a 3-pound increase for women and a 6-pound increase for men (NRC, 1989~. Data from national surveys reveal that reported caloric intakes have de- creased over time, while the prevalence of overweight individuals has remained the same or increased slightly. Whether an individual's weight changes or is maintained depends on He balance between caloric intake and physical activity, body size, body composition, and metabolic efficiency. The paradox of He re- ported low caloric intakes in conjunction with the high prevalence of overweight individuals in the United States has yet to be fully explained. A number of reasons have been suggested, including underreporting of caloric intake, hered- ity, decreased physical activity, and metabolic mechanisms. However, JNMEC considered it probable that low levels of physical activity have a significant relationship to the high prevalence of overweight individuals observed in He United States (DHHS/US DA, 1986~. Concern exists that recommendations to

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78 NUTRITION LABELING reduce caloric intake further without a concomitant increase in nutrient density may compromise nutritional status. Food energy is considered a current public health issue due to the rela- tionship of total caloric intake to both its association with body weight and the implications for overall nutrient intakes and chronic diseases (LSRO, FASEB, 1989~. Fats and Cholesterol The per capita amount of fat available in the food supply, the food sources, and the types of fat have changed considerably during the twentieth century. The amount of fat available per capita has increased to the current level of 169 g/day. The types of fat have also changed. Since 1909, the per capita amount of samraled fatty acids has remained constant at approximately 60 g/day, but the amount of monounsaturated fatty acids has gradually increased to Me current level of 68 g/day, and since the mid-1960s the amount of polyunsaturated fatty acids has doubled to 33 g/day (LSRO, FASEB, 1989~. Cholesterol in the food supply increased from 500 mg/day in 1909 to a peak of 570 mg/day in 1947. It subsequently fell to 480 mg/day in 1977, where it has remained. The decline in the availability of cholesterol is primarily due to the reduced use of eggs, from a peak of 49 pounds per person per year in 1951 to 32 pounds per person per year in 1985 ARC, 1989). Sources of dietary fats in the food supply have also changed. The proportion of total fats from meat, poultry, and fish has changed little, amounting to about 31.4 percent in 1985. Fat from whole mink has declined steadily, from 10.4 percent in the late 1940s to 3 percent in 1985, while a significant increase has occurred in the amount from fats and oils, increasing from 38 to 47 percent during the same period. The proportion of saturated fatty acids from meat, poultry, and fish has changed little since 1909, although there has been an increase in poultry consumption (LSRO, FASEB, 1989~. Since the mid-1960s, a shift in daily product consumption has occurred, with about a 50 percent decrease in whole mink consumption, a doubling of low-fat mink consumption, and a 173 percent increase in the consumption of cheeses (NRC, 1989~. Within the fats and oils group, the proportion of saturated fatty acids obtained from animal sources has declined, while the amount obtained from vegetable sources has increased, due to the use of salad and cooking oils, which has increased from 2 to 25 pounds per capita since 1909 (NRC, 1989~. In 1985, meat, poultry, and fish, fats and oils, and dairy products contributed almost all of the saturated fatty acids to the food supply. The proportion of polyunsaturated fatty acids from meat, poultry, and fish has decreased, while the amount from fats and oils has more than doubled in the past 70 years. ~ 1985, the food groups contributing

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CONTEXTUAL FA=ORS AFFECI7NG FOOD lung REFORM 79 most of the cholesterol were meat, poultry, and fish (43 percent), caky products (13 percent), and eggs (39 percent) (LSRO, FASEB, 1989). The most recent data on dietary fat intakes are derived from the Away dietary intakes from the 1985-1986 CSFII. Women aged 20 to 49 and children aged 1 to 5 consumed 37 percent and 35 percent of total calories from fat, respectively. Only about 10 percent of women surveyed had fat intakes below 30 percent of total calories. Fat intakes by women in this survey were higher among whites than among blacks and were higher for those in higher socioeconomic groups. However, race and economic status have been shown to have little to do with the percentage of calories from fat. Samurai fatty acids comprised an estimated 13 percent and 14 percent of calories in the diets of women and children, respectively. Monounsa~ed fatty acids accounted for 13 percent of calories in both groups. Polyunsaturated fatty acids provided 6 percent of calories for children and 7 percent for women. Mean cholesterol intakes were 277 mg/day and 228 mg/day by women and children, respectively. More Ran 25 percent of women had mean cholesterol intakes in excess of 300 mg/day. Estimated intakes by men have remained high, at 423 to 466 mg/day (LSRO, FASEB, 1989~. Comparison of 1-day data from the 1985-1986 CSFII and the 1977-1978 NFGS reveals similar intakes of total fat by children and adult males, whereas for females aged 20 to 49 there appeared to be a decrease of about 10 percent between the surveys. The data can be considered to suggest that only women's fat intakes have actually changed. However, from 1977 to 1985 the percentage of tote calories from fat has declined for children (37 to 35 percent) and adult males and females (42 to 37 percent). This change may be the result of an increase in carbohydrate consumption (LSRO, FASEB, 1989~. Data on mean serum cholesterol levels from national surveys have been compared (NRC, 1989~. For adult men and women aged 20 to 74, the mean serum cholesterol levels have decreased 3 to 4 percent since the early 1960s, and the declines are statistically significant for both men and women, for all whites, but not for blacks (LSRO, FASEB, 1989~. According to the definition of the National Cholesterol Education Program, 36 percent of all adults aged 20 to 74 are candidates for medical advice and intervention for high blood cholesterol levels (Sempos et al., 1989~. In view of the continuing indications of the high per capita availability and higher than recommended intakes of dietary fats and cholesterol, dietary fats are considered to be a current public health issue due to their association with heart disease, certain cancers, and obesity. As a result, the high consumption of total fat, saturated fate acids, and cholesterol has a high priority in public health monitoring NERO, FASEB, 1989~.

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80 Carbokydr~es Nl~lNTION LABELING The per capita amount of carbohydrates in the food supply declined from the turn of the century until Me mid-1960s. In the past 70 years there has been a significant decrease in the proportion of carbohy~es obtained from grain products and an increase in We proportion obtained from sugars and sweeteners; in particular, high-fructose corn syrup has replaced sucrose in many products since the 1960s. In 1909, Me proportion of carbohy~s in Me food supply was about ~vo-thirds from complex carbohydrates and one-third from sugar. In 1985, sugars and sweeteners contributed 39.6 percent of the carbohydrates in the food supply, while gIain products, fruits, and vegetables provided most of the remainder (35.8 percent, 6.6 percent, and 9.2 percent, respectively) (LSRO, FASEB, 1989~. Four-day data from the 1985-1986 CSFII showed Mat Me carbohydrate intake for women aged 20 to 49 was 175 g/day, providing 46 percent of calories; and the intake for children aged 1 to 5 was 184 g/day, providing 52 percent of calories (LSRO, FASEB, 1989). The 1977-1978 NFCS found that carbohydrate intake averaged 47 percent of calories for children aged 1 to 8 and 46 percent of calories for females and 45 percent of calories for males aged 9 to 18. Based on 1-day estimates, the general trend during the past two decades seems to indicate an increase in the mean percentage of calories obtained from carbohydrates in most age groups (NRC, 1989~. Dietary Fiber Data on the amount of fiber in the food supply are not available. Dietary fiber sources include whole gins, fruits, and vegetables. Oat bran, beans, and dried fruits provide soluble fiber, while wheat bran is a source of insoluble fiber. Four-day estimated mean intakes of dietary fiber from the 1985-1986 CSFII were 11 g/day for women aged 20 to 49 and 10 g/day for children aged 1 to 5. Only 5 percent of the women surveyed had dietary fiber intakes of 20 g or more per day, as currently recommended by the National Cancer Institute (NCI). One analysis indicated that vegetables, grains, and fruits supplied 50 percent, 30 percent, and 12 percent, respectively, of the dietary fiber consumed by women. finely intake data from the 1985-1986 CSFII indicate Am, on average, the dietary fiber intake by men aged 19 to 50 was 17 g/day, a level higher Man Be dietary fiber intake by women (LSRO, FASEB, 1989~. DietaIy fiber is considered a potential public health issue worthy of further study due to its possible role in reducing the risk of certain chronic diseases (LSRO, FASEB, 1989~.

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CONTEXTUAL FACTORS AFFECTING FOOD LABEl]NG RE;FORAl Protein i] 81 Since early in the twentieth century, the food supply has provided approx- mately 11 percent of calories as protein, or the equivalent of about 100 g of protein per person per day ARC, 1989~. Over the years the source of protein has changed from plant sources to increased levels from animal sources. Dunng the period from 1909 to 1913, approximately 52 percent of protein came from animal sources; by 1982, the amount had increased to 68 percent as a result of the increased use of meat, poultry, ash, and daily products, with a concomitant decrease in the use of eggs, flour, cereal products, and potatoes (NRC, 1989~. The amount of protein available per capita is considerably higher Man the 1980 Recommended Dietary Allowances (RDA) for protein, which is 56 g/day for men over age 15 who weigh 70 kg and 44 g/day for women in the same age group who weigh 55 kg (LSRO, FASEB, 1989~. According to We 1977- 1978 NFCS, the average protein intake was 74.3 g/day for all respondents' with race, economic status, region, urbanization, and season having little influence on dietary protein levels (NRC, 1989~. Protein contributed an average of 17 percent of total calories in the diets of males and females. 1h 1985, meat, poultry, and fish supplied 43.4 percent, daily products supplied 20.6 percent, and grain products supplied 19 percent from the food supply (LSRO, FASEB, 1989~. Sodium aru! Potassium Data on the amount of sodium in the food supply are not available. The daily per capita amount of potassium has been declining since 1909, to a level of 3,460 mg in 1985. Dietary sources of sodium include meat, dairy products, some vegetables, and sodium-containing compounds added to foods during processing, preparation, or at the table. The major sources of potassium in the food supply are vegetables; daily products; meat, poultry, and fish; and fruits. Four-day data from the 1985-1986 CSFII provide estimates of individual sodium intakes. The mean intake by women aged 20 to 49 was 2,372 mg/day (excluding salt added at the tablet, with many exceeding the upper limit of estimated safe and adequate intakes. Intakes were slightly higher in whites, those above the poverty level, and those with higher education levels. The mean sodium intake by children aged 1 to 5 was 2,036 mg/day. Estimates from NHANES II and 1985-1986 CSFII data (l-day) reported mean intakes in excess of 3,300 mg/day by males aged 12 to 49. Sodium intake is considered a public health issue due to its relationship to hypertension. Thursday data from the 1985-1986 CSFII indicated that the mean potassium intake by women aged 20 to 49 was 2,073 mg/day, with at least 25 percent of women having intakes below the lower limit of the safe and adequate range. Intakes were higher by white women, those above the poverty level, and those with higher education levels. For children aged 1 to 5, mean intakes were almost

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82 NU=TION LABELING all above the lower limit of safe and adequate intakes, and some intakes exceeded the upper limit. In 1980, only 4.5 percent of the adult U.S. population obtained potassium in the form of supplements, and only a few exceeded the upper limit of the safe and adequate level. Vitamins Vitamin A and Carotenes From 1909 to 1985 there was an increase in the daily per capita amount of vitamin A available in the U.S. food supply, and since 1965 there has been an increase in carotenes. Both nutrients reached a peak in 1985, at 1,610 retinal equivalents (RE) for vitamin A and 660 RE for carotene. The increases in availability were primarily the result of the development of new varieties of deep yellow vegetaWes with higher carotene contents and the fortification of margarine and other daily products. Vegetables have accounted for three-fourths of carotenes in the U.S. food supply, particularly dark green and yellow varieties. Vitamin A is also supplied by meat, poultry, and fish, as well as daily products (LSRO, FASEB, 1989~. Individual dietary intake data from the 1985-1986 CSFII indicate that He mean intake of vitamin A by women is 832 RE, although considerable individual variation was observed. Data from HHANES suggest that poor young children may be at risk for low serum vitamin A levels (LSRO, FASEB, 1989~. A survey of dietary supplement use found that 25 percent of the U.S. adult population obtained vitamin A from supplementary sources (LSRO, FASEB, 1989). Although the availability and intakes of vitamin A are generally adequate, it is considered a potential public health issue due to the low serum levels found in certain groups (LSRO, FASEB, 1989~. Thiamin Key sources of thiamin in the food supply include grain products (42.3 percent); meat, poultry, and fish (25.7 percent); vegetables (10.9 percent); and daily products (8 percent). About 2.2 mg of thiamin per capita per day is available in the U.S food supply, which is 40 percent higher than that in the pre-World War II era, when the level was 1.6 mg per capita per day. The introduction of enrichment of flour with thiamin is primarily responsible for the increase (LSRO, FASEB, 1989). Women aged 20 to 49 in the 1985-1986 CSI;II (delay) had a mean intake level slightly above the 1980 RDA. Only 5 percent of women had intakes that were below 50 percent of the RDA. Mean thiamin intakes by children aged 1 to 5 were above the RDA among all races and were highest among black children. Data from the 1977-1978 NFCS and the 1985-1986 CSFII (l~ay) indicate that mean intake levels increased 9.3 percent for children aged 1 to 5, 18 percent for

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CONTEXTUAL FACTORS AFFECTING FOOD LABELING REFORM 83 men aged 20 to 49, and 10.8 percent for women aged 20 to 49 (LSRO, FASEB, 1989). In 1980, supplements containing thiamin were ingested by 30 percent of the population, with the median intake being about five times the 1980 RDA (LSRO, FASEB, 1989~. Riboflc*vir' Riboflavin is currently available in the food supply at about 2.3 to 2.4 mg per capita per day, which is about 30 percent higher Ran that prior to World War II, when the level was 1.8 mg per capita per day. The amount available has remained unchanged since World War II, when enrichment of flour with riboflavin was implemented (LSRO, FASEB, 1989~. Primary sources of riboflavin in the food supply include dairy products (34.7 percent); grain products (24 percent); and meat, poultry, and fish (24.3 percent). The mean intake of riboflavin by women aged 20 to 49 in Me 1985-1986 CSFII (4-day) was 12.5 percent above the 1980 RDA, with only 5 percent having intakes below 50 percent of the 1980 RDA. Mean riboflavin intakes by children aged 1 to 5 were at least 60 percent above the 1980 RDA, with 95 percent of children having intakes of at least 0.9 mg/day. Companson of intakes from the 1977-1978 NFCS and 1985-1986 CSFII shows that the mean intake levels of riboflavin increased by 4.3 percent for children aged 1 to 5, 8.1 percent for men aged 20 to 49, and 8.3 percent for women aged 20 to 49 (LSRO, PASEB, 1989~. In 1980, supplements with riboflavin were taken by 30 percent of the adult population, with the median intake being about four times the 1980 RDA (LSRO, FASEB, 1989~. Niacin The daily per capita amount of preformed niacin available in the food supply was 26 mg in 1985, which has increased since the 1940s, when enrichment of flour with niacin was instituted. Major sources of niacin in the food supply include meat, poultry, and fish (46 percent) and grain products (30 percent) (LSRO, FASEB, 1989). Four-day data from the 1985-1986 CSFII reveal Rat mean intakes of preformed niacin in all age groups of women and in children aged 1 to 5 are well above the 1980 RDA. Tryptophan conversion to niacin is not included in these values but would undoubtedly contribute to even higher niacin intake levels. There does not seem to be any real difference in niacin intake by age, race, or degree of urbanization. Comparison of data on niacin intakes from 1971 to 1986 showed a slight increase over time (LSRO, FASEB, 1989~. Supplements containing niacin are used by 30 percent of the adult popula- tion, and the median intake of niacin from these products is 190 times Be 1980 RDA (LSRO, FASEB, 1989~. Vitamin B6 The daily per capita amount of vit~nin B6 available in the food supply has changed little since early in the twentieth century, but the

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84 NtJTHTION LABELING food sources have changed. The contributions from meat, poultry, and fish have increased dramatically, whereas the amounts from potatoes and grains have decreased. In 1985, the daily per capita amount in the food supply was 2.1 ma; the mayor sources were meat, poultry, and fish (41.1 percent); vegetables (21.9 percent); dairy products (10.7 percent); and fruits (10.6 percent). Stakes by children aged 1 to 5 exceeded Me 1980 RDA, as desk in We 198541986 CSFII. The mean intake by women was well below the 1980 RDA (approximately half) and varied by age. Thirty percent of the adult U.S. population consumed supplements contain- ing vitamin B6, at a median level of 1.4 times the 1980 RDA (LSRO, EASES, 1989~. Due to Me low intakes by a substantial numba of individuals, vitamin B6 is considered a potential public health issue (LSRO, FASEB, 1989~. Vitamin C The daily per capita amount of vitamin C in the food supply has fluctuated since the turn of the century, but it has not changed consistency. In 1985, 115 mg of vitamin C per capita per day was available, an amount well in excess of the 1980 RDA. Major food sources of vitamin C have changed; contributions from citrus fruits have increased whereas those from potatoes and vegetables other than dark green and deep yellow types have decreased. In 198S, the food groups that contributed the major shares of vitamin C to the food supply were vegetables (47.9 percent) and fruits (42.7 percent), especially citrus fruits (27.7 percent). Four-day data from the 198~1986 CS~I revealed that mean intakes of dietary vitamin C in women aged 20 to 49 and children aged 1 to 5 were well above the 1980 RDA. A comparison of intakes of vitamin C ding the period from 1971 to 1986 showed an increase, although results are not consistent over all surveys. Greater changes may be observed in the future with the introduction of higher levels of vitamin C fortification in a variety of foods and beverages (LSRO, FASEB, 1989~. In 1980, 35 percent of the adult U.S. population consumed vitamin C in supplements, and the median amount consumed was three times the 1980 RDA. Vitamin C is considered to be a potential public health issue due to low intakes in groups with low socioeconomic status; however, recent vitamin C fortification may have affected intakes by this group (LSRO, FASEB, 1989~. Folate The daily per capita amount of folate has not changed substantially since the early l900s which was nearly 300 fig in 1985. The contributions from meat, poultry, and fish, and fruit have increased, whereas the contribution from grain products has decreased. In 1985, the major sources of folate in Be food supply were Tom vegetables (24.8 percent), legumes, nuts, and soybeans (19.5 percent), grain products (12.7 percent), meat, poultry, and fish (12.6 percent), and fruits (12.4 percent) (LSRO, FASEB, 1989~.

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118 Nu~rRITIoN LABELING Recent improvements in methods for folate analysis have been made, although questions regarding the factors that affect the responses of the various types of assays (i.e., chromatographic, microbiological, or ligand binding) have not been fully resolved (Gregory, 1989~. The Surgeon General's report (DHHS, 1988) indicated that research should be directed toward the development of improved methods for the measurement of folate in foods. The AOAC methods for analyzing folate (AOAC, 1989, methods 43.183~3.190) are designed such that they cannot be applied to the measurement of total folate in foods. The organism used in AOAC assays for folate analysis, Streptococcusfaecalis, does not respond to methyl folates, the major form of the vitamin found in foods. The method also does not provide for the deconjugation of food folates, and thus would grossly underestimate the amount of the vitamin in foods. In Nutrition Monitoring in the United States (LSRO, EASER, 1989), caro- tenes were proposed as a class of nutrients having potential public health signif- icance. Currently, there appears to be little justification for the inclusion of data regarding total carotenes in nutrition labeling on analytical grounds. The AOAC method for carotene analysis is based on cumbersome open-column chromatog- raphy, and its validity is questionable for samples containing complex mixtures of carotenes, as present in most foods (Simpson et al., 1985~. Recent advances have been made in high-performance liquid chromatographic methodology, but individual quantitation of the many naturally occurring carotenes requires con- siderable effort to adapt the procedures to each different type of food sample analyzed (Khachik et al., 1989~. The existence of cis and bans isomers of carotenes further complicates the analysis. Ability of Analytical Laboratories To Accommodate Expanded Nutrition Labeling There is some question among industry representatives concerning the ability of analytical laboratories to manage the increased analytical demand imposed by expanded nutrition labeling requirements. This burden may be as serious for small companies with limited laboratory capabilities as it is for larger manufacturers with diverse product lines. The services of private analytical laboratories are commonly used by all segments of the food industry, particularly with respect to analyses involving nutrition labeling which are frequently not performed in-house on a routine basis, as is the case for quality control analyses used to monitor the formulation and processing of food products. Private analytical laboratories appear to be able to expand to the analytical demands of the marketplace (as influenced, in this case, by nutrition labeling requirements). For laboratories Hat already provide the analyses required for nutrition labeling, accommodating a greater volume of samples would be feasible but would require the addition of equipment and technical personnel. Regulatory agencies would

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CONTEmIAL FACTORS AFFECTING FOOD LABEUNG REFORM 119 also require additional resources (personnel, equipment, and laboratory space) to monitor compliance. Nutrition Labeling of Non packaged Foods: Application of Food Composition Data Bases The application of current labeling procedures based principally on direct analytical data appears to be impractical for fresh foods, including meat, poultry, seafood, and produce and foods sold in restaurants. In view of the need for expansion of public access to food composition information; however, the use of information from appropriate data bases may be a useful alternative. However, the validity, analytical basis, and completeness of existing data must be examined. The most complete food composition data base for unprocessed foods is the National Nutrient Data Bank, which is maintained by the Hwnan Nutrition Information Service, USDA. This system contains reasonably complete data concerning the proximate composition of foods, although the data are less complete and potentially less reliable for nutrients for which sound analytical methods are lacking, especially dietary fiber and folate (Hepburn, 1987~. This data base needs to be completed and up some values are woefully out of date. Table 4-1 illustrates the comparatively incomplete state of the USDA data base as of 1987. Since then, progress has been made with respect to the inclusion of additional foods and modest increases in the percentage of foods for which actual analytical data are available for each nutrient (Ruth Matthews, Human Nutrition Information Service, USDA, personal communication, 1990~. The accuracy of information in the USDA data base has not been examined systematically. This is very important, especially for the micronutrients that are subject to considerable natural variation, inadequate sampling, analytical uncertainty, or to which obsolete methods are applied (e.g., cholesterol and iron). With respect to the USDA data base concerning folates in foods, Subar et al. (1989) recently reported on a preliminary comparative study of the content of folate in foods. It was concluded that, despite potential underestimation and overestimation of the actual folate content in foods, overall assessments of dietary folate may be reasonably accurate when the USDA data base is used. As discussed previously, the composition of food is subject to a high degree of variability. This is particularly true of vitamins and minerals. In addition, the amounts of certain major constituents, including dietary fiber, total fat, and the pattern of individual fatty acids, vary across different samples of the same food. To generate information for use in data bases, appropriate sampling protocols would involve selection of samples from venous sources to compensate for geographic and seasonal variation. Data bases currently in use may be biased if values are based on inappropriate sampling procedures or have been imputed without consideration of these variables.

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120 Nl~RlTION LABELING TABLE 4-! Percentage of Analytical Data for a Given Nutrient in USDA Primary Data Set Nutrient Percentage All Best Foods Sources Calcium 97 Protein 97 Pat 96 Thiamin 91 Riboflavin 91 Niacin 91 Sodium 90 Potassium 90 Phosphorus 90 Iron 90 Vitamin C 83 92 Vitamin A (IU) 80 89 Cholesterol 80 Magnesium 75 72 Zinc 73 79 Copper 67 71 Vitamin B6 64 72 Vitamin B12 64 79 Vitamin A (RE) 61 73 Folate 56 69 Carotene 54 88 Dietary fiber 29 40 a-Tocopherol 28 39 NOTE: The USDA Primary Data Set contains data on basic foods, including ingredients of foods such as flour. SOURCE: Adapted from Hepburn, F. 1987. Food con- sumptiontfood composition inte~relabonships. Pp. 68 74 in Re- search on Survey Methodology, HNIS Report No. Adm-382. Hu- man Nutrition Information Service, U.S. Department of Agricul- ture, Hyattsville, Md. The information in a data base may indicate representative food composi- tion, but there may be large differences between data base values and the actual concentrations of certain nutrients in a single specimen of that food. It has been suggested that information from appropriate data bases (e.g., USDA) could be used as the basis for nutrition labeling of certain foods that cannot be read- ily analyzed during distribution (e.g., fresh meat, poultry, seafood, fmits, and vegetables). If this data base is to be used to provide nutrient composition data

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CONTEXTUAL FACTORS AFFECTING FOOD LABEl]NG REFORM 121 for nonpackaged foods, this potential for substantial variability with respect to micronutrient content must be recognized. In addition to the USDA data base, other sources of food composition data are available for use in nutrition labeling of foods. Although not actually formal data bases, analytical data provided by various trade associations clearly complement other sources of information for nutrition labeling. Some of these data bases are reviewed by FDA, although no formal certification procedure currently exists. Data bases may serve as a mechanism for providing reasonably represen- tative nutrient content data for foods sold in restaurants, particularly those pro- viding packaged products in a highly standardized format (i.e., for foods sold in limited-menu restaurants). At present, there appears to be no means of analytical verification of the nutrient content of foods sold in other resultants and non- commercial food service settings, although the nutrient composition of recipe menus could be calculated by using food composition data from nutrient data bases. Committee Recommendations All nutrition labeling is predicated on acceptable accuracy and precision of the information provided, whether obtained by direct analysis or indirectly from a food composition data base. Thus, the validity of nutrition labeling ultimately depends on the adequacy of analytical methods used in food analysis and their appropriate application. Because of the key role of food analysis in nutrition labeling and in view of the analytical limitations described in this section, He 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. Although Mere are clear meets of the USDA system of label verification in terms of ensuring accuracy, management of the FDA system seems much less costly. FDA and USDA should certify data from the National Nutrient Data Bank or over 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. The limitations of certain official methods hinder the analytical process, given the volume of analyses performed. In proposing an alternative (nonofficial) analytical method, suitable verifi- cation must be required (e.g., recovery of samples and analysis of refer- ence materials), and appropriate quality control procedures should be used in each analysis. A mechanism should be developed to verify the quality

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122 NUTRITION LABELING control measures that are used whenever analytical data are submitted to a regulatory agency. 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 Trough interl~ratory studies, and development of additional standard reference materials. Completion and expansion of the USDA National Nutrient Data Bank should be continued. It is recommended that the relative merits of the various alternative food composition data bases be examined and that efforts toward He consolidation of data bases be support REFERENCES Achterberg, C. 1990. Information presented at the Workshop on Consumer Understanding and Use of Food Labels, Committee on the Nutrition Components of Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington D.C. March 13. Achterberg, C., G. Auld, V. Getty, and J. Durrwachter. 1990. Misconceptions about fat and cholesterol in a sample of Pennsylvania men and women. Unpublished draft paper. Pennsylvania State University, University Park. ADA (American Dietetic Association). 1990. Position of the American Dietetic Associ- ation: Nutrition education for the public. J. Am. Diet. Assoc. 90:107-110. Alvarez, R. 1984. NBS standard reference materials for food analysis. Pp. 81-99 in Modern Methods of Food Analysis, K.K. Stewart and J.R. Whitaker, eds. AVI Publishing Co., Westport, Conn. AOAC (Association of Official Analytical Chemists). 1989. Official Methods of Analysis, 15th ed. AOAC, Washington, D.C. 1298 pp. Asam, E.H., and L.P. Bucklin. 1973. Nutrition labeling for canned goods: A study of consumer response. J. Marketing 37:32-37. Babcock MJ., and M.M. Murphy. 1973. Two nutrition labeling systems. J. Am. Diet. Assoc. 62:155-161. Beecher, G.R., and J.T. Vanderslice. 1984. Determination of nutrients in foods: Factors that must be considered. Pp. 29-56 in Modern Methods of Food Analysis, K.K. Stewart and J.R. Whitaker, eds. AVI Publishing Co., Westport, Conn. Bettman, J.R. 1979. An Information Processing Theory of Consumer Choice. Addison- Wesley, Reading, Mass. 402 pp. CNI (Community Nutrition Institute). 1988. FDA, private surveys disagree on diet trends. Nutr. Week. June 23. 18~23~:1 Daly, P. 1976. The response of consumers to nutrition labeling. J. Consumer Affairs 10:170-178. DHEW/USDA/FIC (U.S. Department of Health, Education, and Welfare; U.S. Depart- ment of Agriculture; and Federal Trade Commission). 1979. Food Labeling Back- ground Papers. Govemment Printing Office, Washington, D.C. 124 pp. DHHS (U.S. Department of Health and Human Services). 1988. The Surgeon General's

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