July 9, 2003: For updated examples of nutrition labels
see Examples of Revised Nutrition Facts Panel Listing Trans Fat.
Grocery store aisles are avenues to greater nutritional knowledge.
Under regulations from the Food and Drug Administration of the Department of Health and Human Services and the Food Safety and Inspection Service of the U.S. Department of Agriculture, the food label offers more complete, useful and accurate nutrition information than ever before.
With today's food labels, consumers get:
Select any part of the food label graphic to find the relevant sections of this document.
These and other changes are part of final rules published in the Federal Register in 1992 and 1993. FDA's rules implement the provisions of the Nutrition Labeling and Education Act of 1990 (NLEA), which, among other things, requires nutrition labeling for most foods (except meat and poultry) and authorizes the use of nutrient content claims and appropriate FDA-approved health claims.
Meat and poultry products regulated by USDA are not covered by NLEA. However, USDA's regulations closely parallel FDA's rules, summarized here.
Under these rules, nutrition labeling is required for most foods. In addition, voluntary nutrition information is available for many raw foods: the 20 most frequently eaten raw fruits, vegetables and fish each, under FDA's voluntary point-of-purchase nutrition information program, and the 45 best-selling cuts of meat, under USDA's program.
Although voluntary, FDA's program for raw produce and fish carries a strong incentive for retailers to participate. The program will remain voluntary only if at least 60 percent of a nationwide sample of retailers continue to provide the necessary information. (In a 1996 survey, FDA found that more than 70 percent of U.S. food stores were complying.)
Also nutrition information is required for some restaurant foods. FDA requires nutrition information for foods about which health or nutrient-content claims are made on restaurant menus, signs or placards. Restaurants have to provide a "reasonable basis" for making claims, although they are given some flexibility in demonstrating that reasonable basis. For example, they could rely on recipes endorsed by medical or dietary groups.
Under NLEA, some foods are exempt from nutrition labeling. These include:
Food produced by small businesses also may be exempt, under 1993 amendments to the NLEA. Businesses with fewer than 100 full-time equivalent employees may claim an exemption for food products that have U.S. sales of fewer than 100,000 units annually. Companies claiming this exemption must notify FDA that they meet the criteria before they begin marketing their products. U.S. companies, other than importers, with fewer than 10 full-time equivalent employees and selling fewer than 10,000 units of a food in a year also are exempt but do not need to notify FDA. Also exempt are retailers with annual gross sales in the United States of less than $500,000 or with annual gross sales of food to consumers in the United States of less than $50,000.
Although certain foods may be exempt, they are free to carry nutrition information, when appropriate--as long as it complies with regulations. Also, these foods will lose their exemption if their labels carry a nutrient content or health claim or any other nutrition information.
Nutrition information about game meats--such as deer, bison, rabbit, quail, wild turkey, and ostrich--is not required on individual packages. Instead, it can be given on counter cards, signs, or other point-of-purchase materials. Because few nutrient data exist for these foods, FDA believes that allowing this option will enable game meat producers to give first priority to collecting appropriate data and make it easier for them to update the information as it becomes available.
Under the label's "Nutrition Facts" panel, manufacturers are required to provide information on certain nutrients. The mandatory (underlined) and voluntary components and the order in which they must appear are:
If a claim is made about any of the optional components, or if a food is fortified or enriched with any of them, nutrition information for these components becomes mandatory.
These mandatory and voluntary components are the only ones allowed on the Nutrition Facts panel. The listing of single amino acids, maltodextrin, calories from polyunsaturated fat, and calories from carbohydrates, for example, may not appear as part of the Nutrition Facts on the label.
The required nutrients were selected because they address today's health concerns. The order in which they must appear reflects the priority of current dietary recommendations.
All nutrients must be declared as percentages of the Daily Values which are label reference values. The amount, in grams or milligrams, of macronutrients (such as fat, cholesterol, sodium, carbohydrates, and protein) are still listed to the immediate right of these nutrients. But, for the first time, a column headed "% Daily Value" appears on the far right side.
Declaring nutrients as a percentage of the Daily Values is intended to prevent misinterpretations that arise with quantitative values. For example, a food with 140 milligrams (mg) of sodium could be mistaken for a high-sodium food because 140 is a relatively large number. In actuality, however, that amount represents less than 6 percent of the Daily Value for sodium, which is 2,400 mg.
On the other hand, a food with 5 g of saturated fat could be construed as being low in that nutrient. In fact, that food would provide one-fourth the total Daily Value because 20 g is the Daily Value for saturated fat.
The % Daily Value listing carries a footnote saying that the percentages are based on a 2,000-calorie diet. Some nutrition labels--at least those on larger packages--have these additional footnotes:
An optional footnote for packages of any size is the number of calories per gram of fat (9), and carbohydrate and protein (4).
In some circumstances, variations in the format of the nutrition panel are allowed. Some are mandatory. For example, the labels of foods for children under 2 (except infant formula, which has special labeling rules under the Infant Formula Act of 1980) may not carry information about saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, calories from fat, or calories from saturated fat.
The reason is to prevent parents from wrongly assuming that infants and toddlers should restrict their fat intake, when, in fact, they should not. Fat is important during these years to ensure adequate growth and development.
The labels of foods for children under 4 may not include the % Daily Values for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber. They may carry % Daily Values for protein, vitamins and minerals, however. These nutrients are the only ones for which FDA has set Daily Values for this age group.
Thus, the top portion of the "Nutrition Facts" panels of foods for children under 4 will consist of two columns. The nutrients' names will be listed on the left and their quantitative amounts will be on the right. The bottom portion will provide the % Daily Values for protein, vitamins and minerals. Only the calorie conversion information may be given as a footnote.
Some foods qualify for a simplified label format. This format is allowed when the food contains insignificant amounts of seven or more of the mandatory nutrients and total calories. "Insignificant" means that a declaration of zero could be made in nutrition labeling, or, for total carbohydrate, dietary fiber, and protein, the declaration states "less than 1 g."
For foods for children under 2, the simplified format may be used if the product contains insignificant amounts of six or more of the following: calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins A and C, calcium, and iron.
If the simplified format is used, information on total calories, total fat, total carbohydrate, protein, and sodium--even if they are present in insignificant amounts--must be listed. Other nutrients, along with calories from fat, must be shown if they are present in more than insignificant amounts. Nutrients added to the food must be listed, too.
Some format exceptions exist for small and medium-size packages. Packages with less than 12 square inches of available labeling space (about the size of a package of chewing gum) do not have to carry nutrition information unless a nutrient content or health claim is made for the product. However, they must provide an address or telephone number for consumers to obtain the required nutrition information.
If manufacturers wish to provide nutrition information on these packages voluntarily, they have several options: (1) present the information in a smaller type size than that required for larger packages, or (2) present the information in a tabular or linear (string) format.
The tabular and linear formats also may be used on packages that have less than 40 square inches available for labeling and insufficient space for the full vertical format.
Other options for packages with less than 40 square inches of label space are:
A select group of packages with more than 40 square inches of labeling space is allowed a format exception, too. These are packages with insufficient vertical space (about 3 inches) to accommodate the required information. Some examples are bread bags, pie boxes, and bags of frozen vegetables. On these packages, the "Nutrition Facts" panel may appear, in tabular format, with the footnote information appearing to the far right.
For larger packages in which there is not sufficient space on the principal display panel or the information panel (the panel to the right of the principal display), FDA allows nutrition information to appear on any label panel that is readily seen by consumers. This lessens the chances of overcrowding of information and encourages manufacturers to provide the greatest amount of nutrition information possible.
For products that require additional preparation before eating, such as dry cake mixes and dry pasta dinners, or that are usually eaten with one or more additional foods, such as breakfast cereals with milk, FDA encourages manufacturers to provide voluntarily a second column of nutrition information. This is known as dual declaration.
With this variation, the first column, which is mandatory, contains nutrition information for the food as purchased. The second gives information about the food as prepared and eaten.
Still another variation is the aggregate display. This is allowed on labels of variety-pack food items, such as ready-to-eat cereals and assorted flavors of individual ice cream cups. With this display, the quantitative amount and % Daily Value for each nutrient are listed in separate columns under the name of each food.
The serving size remains the basis for reporting each food's nutrient content. However, unlike in the past, when the serving size was up to the discretion of the food manufacturer, serving sizes now are more uniform and reflect the amounts people actually eat. They also must be expressed in both common household and metric measures.
FDA allows as common household measures: the cup, tablespoon, teaspoon, piece, slice, fraction (such as "1/4 pizza"), and common household containers used to package food products (such as a jar or tray). Ounces may be used, but only if a common household unit is not applicable and an appropriate visual unit is given--for example, 1 oz (28g/about 1/2 pickle).
Grams (g) and milliliters (mL) are the metric units that are used in serving size statements.
NLEA defines serving size as the amount of food customarily eaten at one time. The serving sizes that appear on food labels are based on FDA-established lists of "Reference Amounts Customarily Consumed Per Eating Occasion."
These reference amounts, which are part of the regulations, are broken down into 139 FDA-regulated food product categories, including 11 groups of foods specially formulated or processed for infants or children under 4. They list the amounts of food customarily consumed per eating occasion for each category, based primarily on national food consumption surveys. FDA's list also gives the suggested label statement for serving size declaration. For example, the category "breads (excluding sweet quick type), rolls" has a reference amount of 50 g, and the appropriate label statement for sliced bread or roll is "___ piece(s) ( _ g)" or, for unsliced bread, "2 oz (56 g/_ inch slice)."
The serving size of products that come in discrete units, such as cookies, candy bars, and sliced products, is the number of whole units that most closely approximates the reference amount. Cookies are an example. Under the "bakery products" category, cookies have a reference amount of 30 g. The household measure closest to that amount is the number of cookies that comes closest to weighing 30 g. Thus, the serving size on the label of a package of cookies in which each cookie weighs 13 g would read "2 cookies (26 g)."
If one unit weighs more than 50 percent but less than 200 percent of the reference amount, the serving size is one unit. For example, the reference amount for bread is 50 g; therefore, the label of a loaf of bread in which each slice weighs more than 25 g would state a serving size of one slice.
Certain rules apply to food products that are packaged and sold individually. If such an individual package is less than 200 percent of the applicable reference amount, the item qualifies as one serving. Thus, a 360-mL (12-fluid-ounce) can of soda is one serving, since the reference amount for carbonated beverages is 240 mL (8 ounces).
However, if the product has a reference amount of 100 g or 100 mL or more and the package contains more than 150 percent but less than 200 percent of the reference amount, manufacturers have the option of deciding whether the product can be one or two servings.
An example is a 15-ounce (420 g) can of soup. The serving size reference amount for soup is 245 g. Therefore, the manufacturer has the option to declare the can of soup as one or two servings.
The new label reference value, Daily Value, comprises two sets of dietary standards: Daily Reference Values (DRVs) and Reference Daily Intakes (RDIs). Only the Daily Value term appears on the label, though, to make label reading less confusing.
DRVs have been established for macronutrients that are sources of energy: fat, saturated fat, total carbohydrate (including fiber), and protein; and for cholesterol, sodium and potassium, which do not contribute calories.
DRVs for the energy-producing nutrients are based on the number of calories consumed per day. A daily intake of 2,000 calories has been established as the reference. This level was chosen, in part, because it approximates the caloric requirements for postmenopausal women. This group has the highest risk for excessive intake of calories and fat.
DRVs for the energy-producing nutrients are calculated as follows:
Because of current public health recommendations, DRVs for some nutrients represent the uppermost limit that is considered desirable.The DRVs for total fat, saturated fat, cholesterol, and sodium are:
"Reference Daily Intake" replaces the term "U.S. RDA," which was introduced in 1973 as a label reference value for vitamins, minerals and protein in voluntary nutrition labeling. The name change was sought because of confusion that existed over "U.S. RDAs," the values determined by FDA and used on food labels, and "RDAs" (Recommended Dietary Allowances), the values determined by the National Academy of Sciences for various population groups and used by FDA to figure the U.S. RDAs.
However, the values for the new RDIs remain the same as the old U.S. RDAs for the time being.
The regulations also spell out what terms may be used to describe the level of a nutrient in a food and how they can be used. These are the core terms:
Synonyms for low include "little," "few," "low source of," and "contains a small amount of."
The term "light" still can be used to describe such properties as texture and color, as long as the label explains the intent--for example, "light brown sugar" and "light and fluffy."
Alternative spelling of these descriptive terms and their synonyms is allowed--for example, "hi" and "lo"--as long as the alternatives are not misleading.
Healthy. A "healthy" food must be low in fat and saturated fat and contain limited amounts of cholesterol and sodium. In addition, if it' s a single-item food, it must provide at least 10 percent of one or more of vitamins A or C, iron, calcium, protein, or fiber. Exempt from this "10-percent" rule are certain raw, canned and frozen fruits and vegetables and certain cereal-grain products. These foods can be labeled "healthy," if they do not contain ingredients that change the nutritional profile, and, in the case of enriched grain products, conform to standards of identity, which call for certain required ingredients. If it's a meal-type product, such as frozen entrees and multi-course frozen dinners, it must provide 10 percent of two or three of these vitamins or minerals or of protein or fiber, in addition to meeting the other criteria. The sodium content cannot exceed 360 mg per serving for individual foods and 480 mg per serving for meal-type products.
The regulations also address other claims. Among them:
Although not mandated by NLEA, FDA has issued a regulation for the term "fresh." The agency took this step because of concern over the term's possible misuse on some food labels.
The regulation defines the term "fresh" when it is used to suggest that a food is raw or unprocessed. In this context, "fresh" can be used only on a food that is raw, has never been frozen or heated, and contains no preservatives. (Irradiation at low levels is allowed.) "Fresh frozen," "frozen fresh," and "freshly frozen" can be used for foods that are quickly frozen while still fresh. Blanching (brief scalding before freezing to prevent nutrient breakdown) is allowed.
Other uses of the term "fresh," such as in "fresh milk" or "freshly baked bread," are not affected.
FDA is not allowing broad use of nutrient claims on infant and toddler foods. However, the agency may propose claims specifically for these foods at a later date. The terms "unsweetened" and "unsalted" are allowed on these foods, however, because they relate to taste and not nutrient content.
Claims for 10 relationships between a nutrient or a food and the risk of a disease or health-related condition are now allowed. They can be made in several ways: through third-party references (such as the National Cancer Institute), statements, symbols (such as a heart), and vignettes or descriptions. Whatever the case, the claim must meet the requirements for authorized health claims--for example, they cannot state the degree of risk reduction and can only use "may" or "might" in discussing the nutrient or food-disease relationship. And they must state that other factors play a role in that disease.
The claims also must be phrased so that consumers can understand the relationship between the nutrient and the disease and the nutrient's importance in relationship to a daily diet.
An example of an appropriate claim is: "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease."
The allowed nutrient-disease relationship claims and rules for their use are:
(See updated information on additional health claims below.)
Ingredient declaration is required on all foods that have more than one ingredient.
Because people may be allergic to certain additives and to help them better avoid them, the ingredient list must include, when appropriate:
As required by NLEA, beverages that claim to contain juice must declare the total percentage of juice on the information panel. In addition, FDA's regulation establishes criteria for naming juice beverages. For example, when the label of a multi-juice beverage states one or more--but not all--of the juices present, and the predominantly named juice is present in minor amounts, the product' s name must state that the beverage is flavored with that juice or declare the amount of the juice in a 5 percent range--for example, "raspberry-flavored juice blend" or "juice blend, 2 to 7 percent raspberry juice."
For more information, contact:
General Inquiries: Call toll-free 1-888-INFO-FDA (1-888-463-6332).
Food Safety Hotline: 1-800-332-4010
FDA's food label information on the Web: www.cfsan.fda.gov/label.html.
Food Safety Education and Communication Office
1400 Independence Ave., S.W., Room 1180
Washington, DC 20250
Meat and Poultry Hotline: 1-800-535-4555.
(Replaces BG 95-14)
Updated Information - October 20, 1999: FDA Approves New Health Claim for Soy Protein and Coronary Heart Disease
Updated Information - September 5, 2000: FDA Authorizes New Coronary Heart Disease Health Claim For Plant Sterol And Plant Stanol Esters
Updated Information - March 20, 2001: Claims That Can Be Made for Conventional Foods and Dietary Supplements