|
CFSAN/Office of Nutrition, Labeling, and Dietary Supplements
April 2008
Where should the Nutrition Facts label be placed on food packages?
Answer: The Nutrition Facts label may be placed together with the ingredient list and the name and address (name and address of the manufacturer, packer, or distributor) on the PDP. These three label statements also may be placed on the information panel (the label panel adjacent and to the right of the PDP, or, if there is insufficient space on the adjacent panel, on the next adjacent panel to the right). On packages with insufficient area on the PDP and information panel, the Nutrition Facts label may be placed on any alternate panel that can be seen by the consumer.
Answer: Yes. Even when using the tabular display, the nutrition information must be set off in a box.
Answer: No. The name may be placed above the box that encloses the nutrition information.
Answer: Yes. There is no requirement that any information, other than the net quantity of contents and statement of identity, be printed parallel to the base of the package. However, FDA urges manufacturers to strive for consistency of presentation of nutrition information in the market and to place the Nutrition Facts label so that it is readily observable and legible to the consumer at the point of purchase.
Answer: Yes. The vertical format may be broken in either of the following ways: (1) placement of the footnote to the right of the panel as shown in 21 CFR 101.9(d)(11) or (2) all vitamins and minerals that are listed voluntarily (i.e., after iron) may be moved to the top right of the panel along with the footnote.
Answer: The Nutrition Facts label (an example is illustrated in VII L2) is required on most food packages labeled. The illustration indicates FDA's typeface and style to help assure readibility and conspicuousness. Not all of these type specifications are required. The mandatory type specifications are listed in 21 CFR 101.9(d). Unlike the illustrative examples in this guidance, (1) Any legible type style may be used, not just Helvetica, (2) The heading Nutrition Facts must be the largest type size in the nutrition label (i.e., it must be larger than 8-point, but does not need to be 13-point), and (3) There is no specific thickness required for the three bars that separate the central sections of the nutrition label. 21 CFR 101.9(a) and 21 CFR 101.9(a)(1)
Below are listed categories providing exemptions or special provisions for nutrition labeling. A food package loses those exemptions, which are asterisked, if a nutrition claim is made or nutrition information is provided:
| Summary of Exemption | Regulation # |
|---|---|
| *Manufactured by small businesses | 21 CFR 101.9(j)(1) and 101.9(j)(18) |
| *Food served in restaurants, etc. or delivered to homes ready for immediate consumption | 21 CFR 101.9(j)(2) |
| *Delicatessen-type food, bakery products and confections that are sold directly to consumers from the location where prepared | 21 CFR 101.9(j)(3) |
| *Foods that provide no significant nutrition such as instant coffee (plain, unsweetened) and most spices | 21 CFR 101.9(j)(4) |
| Infant formula, and infant and junior foods for children up to 4 years of age (modified label provisions for these categories) | 21 CFR 101.9(j)(5) and 101.9(j)(7) |
| Dietary supplements (must comply with 21 CFR 101.36) | 21 CFR 101.9(j)(6) |
| Medical foods | 21 CFR 101.9(j)(8) |
| Bulk foods shipped for further processing or packaging before retail sale | 21 CFR 101.9(j)(9) |
| *Fresh produce and seafood (a voluntary nutrition labeling program covers these foods through the use of the appropriate means such as shelf labels, signs, and posters) | 21 CFR 101.9(j)(10) and 101.45 |
| Packaged single-ingredient fish or game meat may be labeled on basis of 3-ounce cooked portion (as prepared). Custom-processed fish and game are exempt from nutrition labeling. | 21 CFR 101.9(j)(11) |
| Certain egg cartons (nutrition information inside lid or on insert in carton) | 21 CFR 101.9(j)(14) |
| Packages labeled "This unit not labeled for retail sale" within multiunit package, and outer wrapper bears all required label statements | 21 CFR 101.9(j)(15) |
| Self-service bulk foods--nutrition labeling by placard, or on original container displayed clearly in view | 21 CFR 101.9(a)(2) and 101.9(j)(16) |
| Donated food that is given free (not sold) to the consumer. | You are not required to put Nutrition Facts labels on donated food unless the donated food is later placed on sale (the law applies only to food that is "offered for sale") -- 21 CFR 101.9(a) |
| Game meats may provide required nutrition information or labeling in accordance with 21 CFR 101.9(a)(2). | 21 CFR 101.9(j)(12) |
Answer: FDA considers information that is required or permitted in the Nutrition Facts label on the front label or elsewhere on the package to be a Nutrient Content Claim (NCC). In such cases, the package label must comply with the regulations for nutrient content claims. See the NCC section and Appendices A and B of this document for more information. 21 CFR 101.13(c)
Answer: In addition to the nutrients shown on the label in VII L2 manufacturers may add calories from saturated fat, polyunsaturated fat, monounsaturated fat, potassium, soluble and insoluble fiber, sugar alcohol, other carbohydrate, vitamins and minerals for which Reference Daily Intake (RDI's) have been established, or the percent of vitamin A that is present as beta-carotene. 21 CFR 101.9(c)
Answer: Only those nutrients listed in FDA's nutrition regulations, as mandatory or voluntary components of the nutrition label, may be included in the Nutrition Facts label. 21 CFR 101.9(c)
Answer: In addition to the nutrients shown on the sample labels in this guidance, other nutrients (listed in FDA's regulations, e.g., thiamin) must be included in a food's Nutrition Facts label if the nutrients are added as a nutrient supplement to the food, if the label makes a nutrition claim (such as a NCC) about them, or if advertising or product literature provides information connecting the nutrients to the food. 21 CFR 101.9(a), 21 CFR 101.9(c), 21 CFR 101.9(c)(8)(ii)
Answer: Generally, FDA only requires that the label declare the vitamins A and C, and the minerals calcium and iron. The other enrichment vitamins and minerals must be declared when they are added directly to the packaged food (e.g., enriched bread), but not when the enriched product is added as an ingredient to another food. NOTE: It is necessary to declare the other vitamins and minerals in the ingredient list. However, if unenriched flour is used, and the enrichment nutrients are added separately, those nutrients (i.e., thiamin, riboflavin, niacin, and folic acid) would have to be declared on the Nutrition Facts label. 21 CFR 101.9(c)(8)(ii)(A)-(B) and 21 CFR 101.9(c)(8)(iv)
Answer: The caloric value of a product containing less than 5 calories may be expressed as zero or to the nearest 5 calorie increment (i.e., zero or 5 depending on the level). Foods with less than 5 calories meet the definition of "calorie free" and any differences are dietarily insignificant.
Answer: Calories must be shown as follows:
21 CFR 101.9(c)(1)
Also see Appendix H for rounding guidelines.
Answer: Calories from alcohol may be calculated using specific Atwater factors as provided for in 21 CFR 101.9(c)(1)(i)(A). USDA Handbook No. 74 provides a specific food factor of 7.07 calories per gram of alcohol.
Answer: To determine the total fat content of a food, add the weight in grams of all lipid fatty acids in the food (e.g., lauric, palmitic, stearic fatty acids) and express as triglycerides. Total fat = Weight of all individual fatty acids + weight of one unit of glycerol for each three fatty acids. 21 CFR 101.9(c)(2)
Answer: No.
Answer: Because it is present at a level below 0.5 g, the level of fat is expressed as 0 g. Calories from fat would also be expressed as zero.
Answer: Below 0.5 grams total fat per serving: Use the declaration 0 grams for total fat. 0.5 grams to 5 grams total fat: Use ½ gram increments rounded to the nearest ½ gram.
Examples: 0.5 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, 3.5 g, 4 g, 4.5 g, 5 g
Above 5 grams: Use 1 gram increments rounded to the nearest 1 gram (do not use fractions above 5 grams).
Examples: 5 g, 6 g, 7 g, etc.
21 CFR 101.9(c)(2)
Also see Appendix H for rounding guidelines.
Answer: See Appendix F: Calculate the percent daily value (DV) for the appropriate nutrients and Appendix G: Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant and Lactating Women
Answer: Yes. Section 101.9(d)(7)(ii) permits the percent Daily Value to be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the Daily Reference Value (DRV) for that nutrient except that the percent for protein must be calculated as specified in 21 CFR 101.9(c)(7)(ii). As a result of this change, whenever a declared quantitative amount is zero, the declared percent Daily Value will also be zero.
Answer: Total carbohydrate is calculated by subtracting the weight of crude protein, total fat, moisture, and ash from the total weight ("wet weight") of the sample of food. 21 CFR 101.9(c)(6)
Answer: Yes. Dietary fiber must be listed as a subcomponent under total carbohydrate.
Answer: To calculate sugars for the Nutrition Facts label, determine the weight in grams of all free monosaccharides and disaccharides in the sample of food. The other nutrients declared on the nutrition label are defined in 21 CFR 101.9(c). 21 CFR 101.9(c)(6)(ii)
Answer: Since this serving contains less than 1 gram of dietary fiber per serving, fiber is to be expressed as "Less than 1 gram" or "Contains less than 1 gram," or the manufacturer has the option to not list dietary fiber and include the following statement at the bottom of the table of nutrients: "Not a significant source of dietary fiber." Protein can be expressed to the nearest whole gram (i.e., 1 g); or the label can state "less than 1 gram" or "Contains less than 1 gram." The "<" symbol may be used in place of the words "less than" (21 CFR 101.9(d)(7)(i)).
Answer: When a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the food 21 CFR 101.9(c)(6)(iii).
Answer: The DRV for protein for adults and children 4 or more years of age is 50 grams. The RDIs for protein for children less than 4 years of age, infants, pregnant women, and lactating women are established at 16 grams, 14 grams, 60 grams, and 65 grams respectively. 21 CFR 101.9(c)(7)(iii)
Answer: The percent of the DRV is required if a protein claim is made for the product or if the product is represented or purported to be for use by infants or children under 4 years of age. Based on current scientific evidence that protein intake is not a public health concern for adults and children over 4 years of age, and because of the costs associated with a determination of the Protein Digestibility Corrected Amino Acid Score (PDCAAS), FDA has determined that declaration of the percent of the DRV for protein need not be provided when a claim is not made.
Answer: When protein is listed as a percent of the 50 gram DRV and expressed as % DV, the % DV is calculated by correcting the actual amount of protein in grams per serving by multiplying the amount by its amino acid score corrected for protein digestibility, dividing by 50 grams, and converting to percent.
Answer: Protein should be listed in the footnote under dietary fiber with the DRV inserted on the same line in the numeric columns. The DRV for protein is based on 10 percent of calories as protein, which equates to 50 grams for a 2,000 calorie diet and 65 grams (62.5 rounded up to 65) for a 2,500 calorie diet. Similarly, potassium would be listed in the footnote under sodium. The DRV for potassium is 3,500 milligrams for both the 2,000 and 2,500 calorie diets.
Answer: The nutrient values declared on the Nutrition Facts label are based on the nutrient profile of the product, as packaged, rounded as required by regulation. Rounding rules are provided in 21 CFR 101.9(c) and summarized in Appendix H.
Answer: Please refer to 21 CFR 101.9(c)(8)(iv).
Answer: If potassium is listed, it should be listed in bold type directly under sodium. Voluntary vitamins and minerals (i.e., those other than vitamin A, Vitamin C, Calcium, and Iron), should be declared horizontally or vertically following the required vitamins and minerals. 21 CFR 101.9(c)(5) and 21 CFR 101.9(d)(8)
Answer: Yes. The percent Daily Value is based on the amount of the nutrient present in the product.
Answer: Yes, provided that the information is truthful and not misleading and is provided outside the Nutrition Facts label. Such information is limited to statements of amount and may not characterize the level of the nutrient (e.g., can not state "High in Omega-3").
Answer: Only the nutritional properties of the product as packaged is required. However, nutritional information may be voluntarily presented "as prepared" as provided for in 21 CFR 101.9(h)(4).
Answer: FDA has not stated how a company should determine the nutrient content of their product for labeling purposes. Therefore, there is no prohibition from using "average" values for its product derived from data bases if a manufacturer is confident that the values obtained meet FDA's compliance criteria. Regardless of its source, a company is responsible for the accuracy and the compliance of the information presented on the label. Use of a data base that has been accepted by FDA affords a firm some measure of security in that the agency has stated that it will work with industry to resolve any compliance problems that might arise for food labeled on the basis of a data base that the agency has accepted. A manual entitled "FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases" is available online.
Answer: FDA has not defined the number of samples that must be analyzed. It is the responsibility of the manufacturer/packer/distributor to determine the variability of their product(s) and the number of samples needed to provide accurate nutrient data. The "FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases," available from FDA, may be of assistance in this area. FDA will use a composite of 12 units when performing enforcement analyses.
Answer: Firms are responsible for the accuracy of the Nutrition Facts label and there is no assurance that the data from a competitor's product is valid for another product. Products of a similar nature are not necessarily equivalent in ingredients and nutrient value. If FDA found a product to be out of compliance because a firm merely copied its competitor's label, the firm would be hard pressed to prove that they labeled the product "in good faith."
Answer: No. FDA does not have the resources to analyze products upon request. However, FDA will collect surveillance samples to monitor the accuracy of nutrition information. The manufacturer, packer or distributor would be advised of any analytical results that are not in compliance. Additionally, depending on circumstances, FDA may initiate regulatory action.
Answer: No. FDA will review and accept industry data bases which remain the property of the organization that developed and submitted the data.
Answer: FDA does not approve, and is not in a position to endorse or recommend, specific laboratories. Assistance may be available through the following sources: trade and professional associations, trade publications, colleges and universities, and by looking in local phone books under testing or analytical laboratories. For compliance purposes FDA uses appropriate methods published by the Association of Analytical Chemists (AOAC) in Official Methods of Analysis of the AOAC International, 18th edition (2005) 
or other methods as needed. You may wish to ascertain if the laboratory is familiar with these methodologies when selecting a laboratory.
Answer: The number of samples to analyze for each nutrient is determined by the variability of each nutrient in a food. Fewer analytical samples are generally required for nutrients that are less variable. The variables that affect nutrient levels should be determined, and a sampling plan should be developed to encompass these variables.
Answer: If manufacturers choose to use ingredient data bases, they should be assured of the accuracy of the databases and validate the resulting calculations by comparing them with values for the same foods obtained from laboratory analyses. Manufacturers are responsible for the accuracy of the nutrition labeling values on their products. Although FDA specifies the laboratory methods that will be used to evaluate the accuracy of the labeled products, FDA does not specify acceptable sources for the labeled values.
Answer: Section 101.9(h)(1) provides the option of listing nutrition information per serving for each component or as a composite value. The decision is up to the manufacturer. A column of total values is not required.
Answer: Section 101.9(h)(1) of the final regulations pertaining to nutrition labeling of foods allows the nutrition information for assortments of the same type of food (e.g., mixed nuts or mixed fruits) that are intended to be consumed at the same time to be specified for each component or as a composite value. Therefore, if it is reasonable to assume that a consumer would eat an assortment of the nuts or fruits offered, a single composite analysis may be used to determine the nutrient composition.
Answer: Nutrition labeling of gift food packages is addressed in 21 CFR 101.9(h)(3) which:
The required nutrition information for different foods may be put on a brochure or package insert using the aggregate display illustrated in 21 CFR 101.9(d)(13)(ii). Listing the servings per container as "varied" allows use of the same nutrition label on packages of varied sizes.
If some individually wrapped food items in the gift pack bear nutrition labeling, that information need not be repeated with the nutrition information provided for the unlabeled foods (e.g., on the outside of the gift pack or on a package insert). Further, the labeling of all malt beverages, regardless of alcohol content, and of liquors and wines containing 7 percent or more by volume of alcohol is regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). TTB does not require that the products it regulates bear nutrition labeling.
Answer: Gift packages are required to bear nutrition labeling in accordance with current labeling regulations. The following rules apply to the above categories:
Answer: The full format must be used because the space available is not limited by the size of the label.
Answer: Nutrition labeling is not required when the entire package is made up of fresh fruits (which fall under the voluntary nutrition labeling program) or when the fruit is packed with other processed foods that are intended to be eaten separately. However, if the fruit is included as one part of a kit with more than one ingredient, and some of the other ingredients are not subject to the voluntary labeling exemption, nutrition labeling is required (e.g., apples and caramel sauce).
Answer: Claims subject the food to nutrition labeling in accordance with 21 CFR 101.45, which means that nutrition information will have to be available at point of purchase although not necessarily on the package.
Answer: Nutrition labeling must be made available for all foods in a gift pack unless the packer, as well as the manufacturer, qualifies for a small business exemption. Section 101.9(h)(3)(i) allows for the added nutrition information to be placed on an insert in the gift pack rather than on each package label.
