ࡱ> [ >bjbj ΐΐ6 Tc+f"" "6+8+8+8+8+8+8+$-/J\+"""""\+q+%%%"6+%"6+%%:&*,f*P$<R* "++0+\* 0% 0f*f* 0+ ""%"""""\+\+%"""+"""" 0""""""""" :   HYPERLINK "http://www.hhs.gov/" U. S. Department of Health and Human Services  HYPERLINK "http://www.fda.gov/" U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition A Food Labeling Guide September, 1994 (Editorial revisions June, 1999)  July 9, 2003: For updated examples of nutrition labels see  HYPERLINK "http://www.cfsan.fda.gov/~dms/labtr.html" Examples of Revised Nutrition Facts Panel Listing Trans Fat. A Food Labeling Guide  HYPERLINK "http://www.cfsan.fda.gov/~dms/flg-cfr.html" Food Labeling CFR References Chapter V--Nutrition Labeling Questions 1 - 15 QuestionsAnswers1. Are "Nutrition Facts" labels required on all foods?The new nutrition label (an  HYPERLINK "http://www.cfsan.fda.gov/~dms/flg-5-1.html" \l "example" example is illustrated in #4 below) is required on most food packages labeled on or after May 8, 1994. The illustration indicates suggested typeface and style to help assure readibility and conspicuousness. Not all of these type specifications are required. The mandatory type specifications are listed in 101.9(d). Unlike the illustrative examples in this booklet, (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 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 to 4 years (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) 2. Are nutrition designations permitted on food package labels?FDA considers information that is required or permitted in the "Nutrition Facts" panel on the front label or elsewhere on the package to be a nutrient content claim. In such cases, the package label must comply with the regulations for nutrient content claims. 21 CFR 101.13(c)3. Where should the "Nutrition Facts" label be placed on food packages?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 principal display panel (PDP). These three label statements also may be placed on the "information panel" (the label panel adjacent and to the right of the principal display panel, 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 principal display panel and information panel, the "Nutrition Facts" label may be placed on any alternate panel that can be seen by the consumer. 21 CFR 101.2(b), 101.2(d)(1), and 101.9(j)(17)4. What are the minimum type sizes and other format requirements for the "Nutrition Facts" panel? The illustration below (Nutrition Label Format) indicates the suggested typesetting specifications for a "Nutrition Facts" label to be considered conspicuous and adequately formatted. Format requirements are specified in 21 CFR 101.9(d)  A. Overall Nutrition Facts Label is boxed with all black or one color type printed on a white or neutral background. B. Typeface and Size The "Nutrition Facts" label uses 6 point or larger Helvetica Black and/or Helvetica Regular type. In order to fit some formats the typography may be kerned as much as -4 (tighter kerning reduces legibility). Key nutrients & their % Daily Value are set in 8 point Helvetica Black (but "%" is set in Helvetica Regular). "Nutrition Facts" is set in either Franklin Gothic Heavy or Helvetica Black to fit the width of the label flush left and flush right. "Serving Size" and "Servings per container" are set in 8 point Helvetica Regular with 1 point of leading. The table labels ( for example, "Amount per Serving") are set in 6 point Helvetica Black. Absolute measures of nutrient content ( for example, "1g") and nutrient subgroups are set in 8 point Helvetica Regular with 4 points of leading. Vitamins and minerals are set in 8 point Helvetica Regular, with 4 points of leading, separated by 10 point bullets. All type that appears under vitamins and minerals is set in 6 point Helvetica Regular with 1 point of leading. C. Rules A 7 point rule separates large groupings as shown in the example. A 3 point rule separates calorie information from the nutrient information. A hairline rule or 1/4 point rule separates individual nutrients, as shown in the example. Descenders do not touch rule. The top half of the label (nutrient information) has 2 points of leading between the type and the rules, the bottom half of the label (footnotes) has 1 point of leading between the type and the rules. D. Box All labels are enclosed by 1/2 point box rule within 3 points of text measure. 5. What can be done if the regular "Nutrition Facts" label (i.e., the vertical format) does not fit the package? On packages with more than 40 square inches available to bear labeling, the "side-by-side" format may be used if the regular "Nutrition Facts" label does not fit. In this format, the bottom part of the "Nutrition Facts" label (following the vitamin and mineral information) is placed immediately to the right and separated with a line. If additional vitamins and minerals are listed after iron and the space under iron is inadequate, they may also be listed to the right with a line that sets them apart from the footnotes. Also, if the package has insufficient continuous vertical space (ie., about 3 inches) to accomodate the above format, the nutrition label may be presented in a tabular (i.e., horizontal) display.  21 CFR 101.9(d)(11)(iii)6. Is it necessary to include a calorie conversion footnote which states that fat, carbohydrate, and protein furnish 9, 4, and 4 calories per gram, respectively?No, the use of that footnote is optional. 21 CFR 101.9(d)(10)7. How should variety packs (e.g., breakfast cereals) display the nutrition information? When a package contains two or more packaged foods that are intended to be eaten individually, such as a variety pack of breakfast cereals or when packages may be used interchangably for the same type of food, such as round ice cream containers, the manufacturer may choose to include separate "Nutrition Facts" panels for each food product, or may use an aggregate "Nutrition Facts" panel.  21 CFR 101.9(d)(13)(i) & (ii)8. What are the special labeling provisions for small and intermediate-sized packages?Food packages with a surface area of 40 sq. in. or less available for labeling may place the "Nutrition Facts" label on any label panel (not limited to the information panel), may omit the footnotes to the "Nutrition Facts" label if another asterisk is placed at the bottom of the label with the statement "Percent Daily Values are based on a 2,000 calorie diet," and, may also use the tabular display label format.  21 CFR 101.9(j)(13)(ii)(A), (C), and (D)9. Is there another exemption if the tabular display label does not fit on small and intermediate-sized packages?A linear (string) format may be used on food packages with 40 sq. in. or less total surface area available for labeling if the package shape or size cannot accomodate the nutrition information placed in columns on any label panel.  21 CFR 101.9(j)(13)(ii)(A)10. Are abbreviations permitted on "Nutrition Facts" labels for small and intermediate-sized packages?Food packages with a surface area of 40 sq. in. or less available for labeling may use the following abbreviations in the "Nutrition Facts" label:  Label Term  Abbreviation  Label Term  Abbreviation Serving size Serv size Cholesterol Cholest Servings per container Servings Total carbohydrate Total carb Calories from fat Fat cal Dietary fiber Fiber Calories from saturated fat Sat fat cal Soluble fiber Sol fiber Saturated fat Sat fat Insoluble fiber Insol fiber Monounsaturated fat Monounsat fat Sugar alcohol Sugar alc Polyunsaturated fat Polyunsat fat Other carbohydrates Other carb 21 CFR 101.9(j)(13)(ii)(B)11. What is the "telephone number exemption" for small food packages?Small packages (less than 12 sq. in. total surface area available to bear labeling) may be printed with a telephone number or an address to obtain nutrition information. This exemption (using a telephone number or address in place of the "Nutrition Facts" label) is permitted only if there are no nutrient content claims or other nutrition information on the product label. 21 CFR 101.9(j)(13)(i)12. What is the minimum type size for "Nutrition Facts" label on small packages?Small packages (less than 12 sq. in. total surface area available to bear labeling) may use type sizes no smaller than 6 point or all uppercase type of not less than 1/16 inch for all required nutrition information. 21 CFR 101.9(j)(13)(i)(B)13. What are the exemptions for single-serving containers?Single serving containers may omit the "servings per container" declaration. In addition, most single serving containers may omit the metric equivalent portion of the serving size declaration. However, if it is voluntarily included, it must be consistent with the net quantity of contents value. The serving size for single-serving containers must be a description of the container such as: "Serving Size: 1 package" for food in bags, "Serving Size: 1 container" for foods in plastic containers, or "Serving Size: 1 can" as appropriate. Only those few foods that are required to declare drained weights must include the metric equivalent as part of the serving size declaration, e.g., "Serving size: 1 can drained (__g)." 21 CFR 101.9(b)(5)(iv), 101.9(b)(7) & 101.9(d)(3)(ii)14. If a manufacturer chooses to do so, how may a food be labeled if the labeled food is commonly combined with another food before eating?The "Nutrition Facts" panel must state the nutrients in the food "as packaged" (i.e., before consumer preparation). However, manufacturers are encouraged to add a second column of nutrition information showing calories, calories from fat and the % Daily Value for the combination of foods eaten. Quantitative amounts (i.e., g/mg) need only be given for the packaged food. However, as shown in this example, a footnote can be added to indicate the amount of nutrients in the added food. Alternatively, the quantitative amounts of the prepared food may be included immediately adjacent to those for the packaged food (e.g., "Sodium 200 mg, 265 mg"). 21 CFR 101.9(e)15. If a manufacturer chooses to do so, what is an example of the "Nutrition Facts" label for a food requiring further preparation by the consumer? When the nutrient values in the column for the product prepared according to package directions would be identical to the column for the product as packaged (e.g., the only ingredients added during preparation are ingredients such as water), manufacturers may omit the second column and include the amount made as part of the serving size declaration. For example, a dry beverage mix could declare: "Serving Size: 1 tsp dry powder (4 g)(makes 1 cup prepared)." 21 CFR 101.9(b)(7)(v), 101.9(e), 101.9(e)(5)  HYPERLINK "http://www.cfsan.fda.gov/~dms/flg-5-2.html" Chapter V: Questions 16 - 41   HYPERLINK "http://www.cfsan.fda.gov/~dms/flg-toc.html" Food Labeling Guide |  HYPERLINK "http://www.cfsan.fda.gov/label.html" Additional Information on Food Labeling   HYPERLINK "http://www.cfsan.fda.gov/list.html" Foods Home |  HYPERLINK "http://www.fda.gov/" FDA Home |  HYPERLINK "http://www.hhs.gov/" HHS Home |  HYPERLINK "http://www.cfsan.fda.gov/~dms/wsearch.html" Search/SubjectIndex |  HYPERLINK "http://www.cfsan.fda.gov/required.html" Disclaimers&Privacy Policy |  HYPERLINK "http://www.cfsan.fda.gov/~dms/help.html" Accessibility/Help Hypertext updated by dms/ear/kwg 2003-JUL-09 $%RSTUvw   N O 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