Food Labeling1
F. Edward Scarbrough
1Abbreviations: CDCP, Centers for Disease Control and Prevention; Codex, Codex Alimentarius Commission; CSPI, Center for Science in the Public Interest; DRI, dietary reference intake; DRV, daily reference value; DSHEA, Dietary Supplement Health and Education Act; DV, daily value; EC, European Commission; EPA, Environmental Protection Agency; FAO, Food and Agriculture Organization; FDA, Food and Drug Administration; FDamp;C Act, Food, Drug and Cosmetic Act of 1938; FDAMA, Food and Drug Administration Modernization Act; FMIA, Federal Meat Inspection Act; FNB, Food and Nutrition Board; FPLA, Fair Packaging and Labeling Act; FSIS, Food Safety and Inspection Service; FTC, Federal Trade Commission; IOM, Institute of Medicine; NAS, National Academies of Science; NLEA, Nutrition Labeling and Education Act; NOAA, National Oceanic and Atmospheric Administration; OWG, Obesity Working Group; PDCAAS, Protein Digestibility-Corrected Amino Acid Score; PER, protein efficiency ratio; PPIA, Poultry Products Inspection Act; RACC, reference amount commonly consumed; RDA, recommended dietary allowance; RDI, reference daily intake; RNI, recommended nutrient intake; TTB, Alcohol and Tobacco Tax and Trade Bureau; USDA, United States Department of Agriculture; WHO, World Health Organization; WTO, World Trade Organization
In the United States, several federal agencies share responsibility for regulating foods. The Centers for Disease Control and Prevention (CDCP), the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), the National Oceanic and Atmospheric Administration (NOAA), and the Alcohol and Tobacco Tax and Trade Bureau (TTB) all have a role in regulating food. However, when discussing labeling related to health and nutrition, we need focus only on the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS). The FDA is responsible for the labeling of all foods except meat, poultry, and egg products, which is the responsibility of the FSIS.
THE LEGAL BASIS FOR FOOD LABELING IN THE UNITED STATES
In 1906, partially in response to the public uproar caused by the publication of The Jungle by Upton Sinclair (1), which graphically detailed the horrendous sanitary and working conditions in the meat-packing industry, Congress passed the Federal Food and Drugs Act (2) and the Federal Meat Inspection Act (3), authorizing the federal government to regulate the safety and quality of food. Both acts prohibited misbranded (i.e., mislabeled) foods from moving in interstate commerce.
In 1938, the Federal Food and Drugs Act was replaced by the Federal Food, Drug, and Cosmetic Act (FD&C Act), which is still the basic law in the United States (4). This law, and subsequent interpretations through regulations and court decisions, has proved to be a valuable tool for FDA control of food labeling.
The FD&C Act was strengthened in 1967 through passage of the Fair Packaging and Labeling Act (FPLA). Among other things, the FPLA requires that the labels of processed packaged foods bear the name of the food, the net contents, and the contact information for the manufacturer or distributor.
NUTRITION LABELING
History in the United States
In 1969, the White House Conference on Food, Nutrition, and Health was convened to address deficiencies in the US diet (5). The conference recommended that the FDA consider the development of a system for identifying the nutritional qualities of food (6).
Largely in response to the White House Conference’s recommendation, in 1971, the FDA proposed regulations on labeling of foods with information on cholesterol, fat, and fatty acid composition (7) and in 1972, proposed regulations on nutrition labeling (8). Final rules were published in 1973 (9) and went into effect in 1975. An essential feature of these regulations was that nutrition labeling
was required only when a nutrient was added to the food or a claim was made on the label or in advertising about the food’s nutritional properties. In 1984, the regulations were expanded when the FDA added sodium to the list of nutrients required on nutrition labeling. Potassium also was added as an optional nutrient (10).
was required only when a nutrient was added to the food or a claim was made on the label or in advertising about the food’s nutritional properties. In 1984, the regulations were expanded when the FDA added sodium to the list of nutrients required on nutrition labeling. Potassium also was added as an optional nutrient (10).
In the 1980s, with continuing interest in the role of diet in disease and health, several major studies were initiated. Notable among these was the 1988 release of The Surgeon General’s Report on Nutrition and Health (11). This report represents the federal government’s first formal recognition of the role of diet in certain chronic diseases. In 1989, the National Academy of Sciences (NAS) issued Diet and Health: Implications for Reducing Chronic Disease Risk (12), which presented additional evidence of the growing acceptance of diet as a factor in the development of chronic diseases, such as coronary heart disease and cancer. Also, the NAS’ Food and Nutrition Board, under contract to the FDA and the USDA’s FSIS, convened a committee to consider how food labels could be improved to help consumers adopt or adhere to healthy diets. The committee’s report, Nutrition Labeling: Issues and Directions for the 1990s (13), presented a number of recommendations to the government.
In response, Secretary of Health and Human Services Louis Sullivan announced that reform of the food label was a major priority for the FDA (14), and the FDA along with the FSIS held a series of public meetings around the country (15). In 1990, the FDA proposed extensive food labeling changes, including mandatory nutrition labeling for most foods (16). However, before the FDA could publish its final regulations, Congress, which had been discussing food labeling, passed the Nutrition Labeling and Education Act (NLEA) on November 8, 1990 (17). In many aspects, the requirements of the NLEA mirror those in the FDA’s proposed regulations of 1990. Perhaps the NLEA’s most important aspect is that the new law gave the FDA explicit authority to require nutrition labeling and control nutrient claims and health messages on food labeling. One notable section of the NLEA, the so-called hammer provision (18), required the FDA to publish proposed regulations within 1 year of the passage of the Act (or the law became the final regulations without regulatory interpretation) and to publish final regulations within 2 years (or the proposed regulations became the final regulations). In 1991, the FDA issued more than 20 proposals to implement the NLEA (19). In addition, the agency issued a final rule on voluntary point-of-purchase nutrition information for raw produce and fish. In 1992, the FDA issued final regulations, which became effective in 1993 (20). Even though the United States Department of Agriculture (USDA) was not subject to the NLEA, the FSIS, in coordination with the FDA, simultaneously issued proposals and final rules for mandatory nutrition labeling of processed meat and poultry, and voluntary point-of-purchase nutrition information for raw meat and poultry. In 2003, the FDA amended the nutrition labeling regulations to require that trans-fatty acids be declared on the nutrition label (21).
Requirements
The Food and Drug Administration
General. Nutrition labeling is required on all foods regulated by the FDA, with certain exceptions, as shown in Table 107.1.
When food is not in a packaged form, nutrition information may be given with a counter card, sign, tag, or in a loose-leaf binder.
Serving Size. FDA regulations require that nutrition information be given on the basis of a “serving size.” In many other countries, as discussed later, nutrition information is expressed on the basis of a specific weight or volume, such as 100 g or 100 mL. The FDA and many consumer advocates have argued, however, that 100 g, for example, is not relevant because many foods are consumed in quantities of more or less than 100 g or 100 mL. The counterargument is that not all consumers eat the same amount of a food in a serving, and the specific weight or volume allows much easier comparison among different foods.
Before 1990, the only requirement was that food manufacturers chose a “reasonable” serving size. In the years leading up to passage of the NLEA, many consumers were of the opinion that manufacturers were manipulating serving sizes, declaring smaller serving sizes to make
the content for nutrients that consumers were seeking to minimize appear more favorable, or larger serving sizes, to overemphasize more positive nutrients.
the content for nutrients that consumers were seeking to minimize appear more favorable, or larger serving sizes, to overemphasize more positive nutrients.
TABLE 107.1 FOODS EXEMPT FROM NUTRITION LABELING | ||||||||||||
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An important feature of the NLEA is that the FDA was required to “establish regulations defining serving size or other unit of measure.” This section of the law proved to be one of the more difficult to implement because of the vast number of food products, the facts that new foods were constantly being introduced and consumption patterns were changing, and that the amount of a particular food consumed varies significantly from person to person. The FDA approached this task by consulting nationwide food consumption surveys (primarily the 1977 to 1978 and 1987 to 1988 Nationwide Food Consumption Surveys conducted by the USDA) (22), and considered three statistical estimates, that is, the mean (average), the median (50th percentile), and the mode (most frequent value), for each product category. Using this procedure, the FDA established reference amounts commonly consumed (RACC), expressed in grams or milliliters, for approximately 150 different food categories, and provided a process for manufacturers to derive serving sizes from the RACC.
Given their complexity, there has been continued concern about serving sizes declared on food packages, particularly in what constitutes a single serving. For example, the Center for Science in the Public Interest (CSPI) filed a petition (23) with the FDA in 2004, requesting that the definition for a single serving be increased for three categories of food: soft drinks/beverages, muffins, and snack foods. The CSPI also suggested that the FDA should consider whether cutoff levels for other categories of oversized “single-serve” foods, such as candy bars, dried soups, frozen entrees, pizza crusts, and fruit cups, should be raised. For example, a serving of soft drink is defined as 8 oz, and 16-oz, 20-oz, and 24-oz bottles are labeled as containing multiple servings.
Another area of concern has been the increase in portion sizes typically consumed by Americans (24, 25, 26). Many nutritionists consider these increased portion sizes a major contributor to the critical obesity problem in the United States (27). In 2003, the FDA created an Obesity Working Group (OWG), charged with developing an action plan to help consumers lead healthier lives through better nutrition. A principal charge to the OWG was to “develop an approach for enhancing and improving the food label to assist consumers in preventing weight gain and reducing obesity.” In its final report, the OWG recommended that the FDA re-examine regulations on serving sizes, specifically, (a) whether to require that food packages that can reasonably be consumed at one eating occasion declare the whole package as a single serving; (b) which, if any, RACC of food categories need to be updated; and (c) whether to provide for comparative calorie claims for smaller portions of identical foods (28).
In 2005, to address the issues being raised about serving sizes, the FDA published an advance notice of proposed rulemaking, requesting comments on serving sizes (29).
Nutrients in the Nutrition Facts Panel. The following nutrients are either required to be on the Nutrition Facts panel or may be included voluntarily:
Calories (may also be expressed as total calories): The caloric content per serving is declared in 5-calorie increments up to 50 calories and 10-calorie increments above 50 calories. Energy content may also be expressed as kilojoules in parentheses. FDA regulations provide several methods for determining caloric content, including (a) Atwater factors (30); (b) general factors 4, 4, and 9, for protein, carbohydrate, and fat, respectively, or the same general factors but with insoluble fiber subtracted from total carbohydrate; (c) specific factors approved by the FDA; or (d) bomb calorimetry. The term “energy” may be added in parentheses following “Total Calories.”
Calories from fat: Calories from fat are declared in the same manner and increments as calories. If a serving contains less than 0.5 g of fat, calories from fat may be omitted and the statement, “Not a significant source of calories from fat” is placed at the bottom of the table of nutrient values.
Calories from saturated fat: Calories from saturated fat may be voluntarily declared.
Fat (total fat): Fat is defined as total lipid fatty acids. Amounts are rounded to the nearest 0.5-g increment below 5 g and to the nearest gram increment above 5 g, and can be stated as zero if the serving contains less than 0.5 g.
Saturated fat (or saturated): Saturated fat is required to be listed, with the same increments and rounding rules as fat.
Trans-fat (or trans): Trans-fat is defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in a trans-configuration and must be declared with the same increments and rounding rules as fat.
Polyunsaturated fat (or polyunsaturated): Polyunsaturated fat is defined as cis-, cis-methylene-interrupted polyunsaturated fatty acids, and may be declared voluntarily. The declaration is indented under the declaration for total fat.
Monounsaturated fat (or monounsaturated): Monounsaturated fat is defined as cis-monounsaturated fatty acids and may be declared voluntarily except when polyunsaturated fat is declared or a claim about fatty acids or cholesterol is made.
Cholesterol: Cholesterol is expressed in milligrams per serving to the nearest 5-mg increment, and may be declared as zero if a serving contains less than 2 mg and the product makes no claim about fat, fatty acids, or cholesterol content. If cholesterol is not required to be declared, the statement “Not a significant source of cholesterol” is placed at the bottom of the table of nutrient values.
Sodium: Sodium, in milligrams per serving, must be declared to the nearest 5-mg increment when the serving contains 5 to 140 mg of sodium, and to the nearest 10-mg increment when the serving contains greater than 140 mg. Sodium may be declared as zero for servings containing less than 5 mg.
Potassium: Potassium may be voluntarily declared, using the same units and criteria as for sodium.
Total carbohydrate: The Nutrition Facts panel must contain a statement of carbohydrate content, expressed in grams. If a serving contains less than 1 g carbohydrate, the label may contain a statement, “less than 1 gram.” Servings containing less than 0.5 g of carbohydrate may be declared as zero carbohydrate. Carbohydrate content is determined by difference, that is, the subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the food (31).
Dietary fiber: Dietary fiber content must be declared, using the same criteria as for total carbohydrate.
Soluble fiber and insoluble fiber: The content per serving of either or both soluble and insoluble fiber may be voluntarily declared, using the same criteria as for dietary fiber.
Sugars: Sugars, defined as the sum of all free monosaccharides and disaccharides (e.g., glucose, fructose, lactose, sucrose), are declared in gram units, again using the same criteria as for total carbohydrate.
Sugar alcohol: When sugar alcohols are present in a food, the sugar alcohol content of a serving must be declared in the Nutrition Facts panel, in gram units. Sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food has been approved by the FDA (e.g., mannitol, xylitol, sorbitol).
Other carbohydrate: Other carbohydrate is defined as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, and the content per serving may be declared voluntarily.
Protein: Protein is declared in gram units for servings containing more than 1 g of protein. Protein content is calculated by multiplying the nitrogen content of a serving by a factor of 6.25 (unless other factors are required for specific foods) (32). The FDA also includes a number of protein quality criteria. Protein quality is determined by the protein digestibility-corrected amino acid score (PDCAAS) (33). Except in the case of a food marketed to children less than 4 years old, the protein quality must be at least 20%; otherwise, the label must state that the food is not a significant source of protein. For foods marketed to children less than 4 years old, the PDCAAS must be at least 40% for the food to qualify as a significant source of protein. For foods marketed to infants, the older protein efficiency ratio (PER; which is a biologic assay of the quality of a particular protein, measured as the gain in weight of an animal per gram of the protein eaten) is still cited as the measure of protein quality, and the PER must be at least 40% of the reference standard, casein, for the food to be considered a source of protein.
Vitamins and minerals: Vitamins and minerals are expressed as a percentage of the daily value (DV). Vitamin A, vitamin C, calcium, and iron, in that order, are required to be listed. Any other vitamin or mineral listed in Table 107.2 may be declared, unless the nutrient is added to the food or a claim is made about the nutrient, in which case the percent DV must be declared. Exceptions are made for nutrients in standardized foods (e.g., thiamin, riboflavin, niacin in enriched flour) and when the standardized food is used as an ingredient in another food. Exemptions are also made for nutrients added to food strictly for technologic purposes (e.g., ascorbic acid added as an antioxidant). The percentages for vitamins and minerals are expressed to the nearest 2% increment, up to and including the 10% level, the nearest 5% increment above 10%, and up to the 50% level, and the nearest 10% increment above the 50% level. Amounts of vitamins and minerals present at less than 2% of the reference daily intake (RDI) may be declared as zero.
RDA, DRV, RDI, DV, RNI, and DRI. This veri table alphabet soup of acronyms has an interesting and ongoing history. The recommended dietary allowance (RDA) was developed during World War II by a committee of the NAS Food and Nutrition Board, at the request of the US military, to investigate nutritional issues that
might affect national defense. The committee created a set of recommendations for standard daily allowances for each nutrient, which would be used for nutrition recommendations for military personnel, civilians, and food relief overseas. The final set of guidelines, RDA, was accepted in 1941. The Food and Nutrition Board has periodically reviewed the RDAs and revised them as necessary. More recently, in a project jointly with the governments of Canada and the United States, the Food and Nutrition Board replaced the RDAs (United States) and the recommended nutrient intakes (RNIs) (Canada) with dietary reference intakes (DRIs) and is in the process of issuing a series of reports to establish RDI. For example, a report on energy and the macronutrients carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids was published in 2005 (34). Another report in this series, on calcium and vitamin D, was also released. A listing of the DRIs for various nutrients and population groups can be found on the NAS IOM website (35).
might affect national defense. The committee created a set of recommendations for standard daily allowances for each nutrient, which would be used for nutrition recommendations for military personnel, civilians, and food relief overseas. The final set of guidelines, RDA, was accepted in 1941. The Food and Nutrition Board has periodically reviewed the RDAs and revised them as necessary. More recently, in a project jointly with the governments of Canada and the United States, the Food and Nutrition Board replaced the RDAs (United States) and the recommended nutrient intakes (RNIs) (Canada) with dietary reference intakes (DRIs) and is in the process of issuing a series of reports to establish RDI. For example, a report on energy and the macronutrients carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids was published in 2005 (34). Another report in this series, on calcium and vitamin D, was also released. A listing of the DRIs for various nutrients and population groups can be found on the NAS IOM website (35).
TABLE 107.2 REFERENCE DAILY INTAKES | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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