special dietary use within the meaning of § 105.3(a)(1)(iii) of this section. (b) All nutrient quantities (including vitamins, minerals, calories, protein, carbohydrate, and fat) shall be declared in relation to the average or usual serving or, where the food is customarily not consumed directly, in relation to the average or usual portion. Another column of figures may be used to declare the nutrient quantities in relation to the average or usual amount consumed on a daily basis, in the same format required in paragraph (c) of this section for the serving (portion), where reliable data have established that the food is customarily consumed more than once during the day and the average or usual amount so consumed. (1) The term "serving" means that reasonable quantity of food suited for or practicable of consumption as part of a meal by an adult male engaged in light physical activity, or by an infant or child under 4 years of age when the article purports or is represented to be for consumption by an infant or child under 4 years of age. The term "portion" means the amount of a food customarily used only as an ingredient in the preparation of a meal component (e.g., 1⁄2 cup flour, 1⁄2 tablespoon cooking oil or 1⁄4 cup tomato paste). A label statement regarding a serving (portion) shall be in terms of a convenient unit of such food or a convenient unit of measure that can be easily identified as an average or usual serving (portion) and can be readily understood by purchasers of such food (e.g., a serving (portion) may be expressed in slices, cookies, or wafers; or in terms of ounces, fluid ounces, teaspoonfuls, tablespoonfuls, or cupfuls). (2) A teaspoonful shall be considered to mean 5 milliliters (approximately one-sixth fluid ounce) in volume; a tablespoon shall be considered to mean 15 milliliters (approximately one-half fluid ounce) in volume; and a cupful shall be considered to mean 240 milliliters (approximately 8 fluid ounces) in volume. The weight of the serving (portion) may also be expressed in grams. (3) The declaration of nutrient quantities shall be on the basis of the food as packaged. Another column of figures may be used to declare the nutrient quantities on the basis of the food as consumed after cooking or other preparation, in the same format required in paragraph (c) of this section for the food alone: Provided, That the specific method of cooking or other preparation shall be disclosed in a prominent statement immediately following the information required by paragraph (c) of this section. (c) The declaration of nutrition information on the label and in labeling shall contain the following information in the following order, using the headings specified, under the overall heading of "Nutrition Information Per Serving (Portion)." The terms "Per Serving (Portion)" are optional and may follow or be placed directly below the terms "Nutrition Information." (1) "Serving (portion) size": A statement of the serving (portion) size. (2) "Servings (portions) per container": The number of servings (portions) per container. (3) “Caloric content" or "Calories": A statement of the caloric content per serving (portion), expressed to the nearest 2-calorie increment up to and including 20 calories, 5-calorie increment above 20 calories and up to and including 50 calories, and 10-calorie increment above 50 calories. Caloric content shall be determined by the Atwater method as described in A. L. Merrill and B. K. Watt, "Energy Value of Foods-Basis and Derivation," USDA Handbook 74 (1955). Caloric content may be calculated on the basis of 4, 4, and 9 calories per gram for protein, carbohydrate, and fat respectively unless the use of these values gives a caloric value more than 20 percent greater than the caloric value obtained when using the more accurate values determined by use of the Atwater method as found in USDA Handbook 74 (1955).1 (4) "Protein content" or "Protein": A statement of the number of grams of protein in a serving (portion), expressed to the nearest gram except that if a serving (portion) contains less 'Copies may be obtained from: Division of Nutrition (HFF-260), Bureau of Foods, Food and Drug Administration, 200 C Street SW., Washington, D.C. 20204. than one gram, the statement "Contains less than one gram” or “less than one gram" may be used as an alternative. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis of the Association of Official Analytical Chemists, 12th edition, 1975, except when the official procedure for a specific food requires another factor. (5) "Carbohydrate content" or "Carbohydrate": A statement of the number of grams of carbohydrate in a serving (portion) expressed to the nearest gram except that if a serving (portion) contains less than one gram, the statement "Contains less than one gram" or "less than one gram” may be used as an alternative. (6) "Fat content" or "Fat": A statement of the number of grams of fat in a serving (portion) expressed to the nearest gram, except that if a serving (portion) contains less than one gram, the statement "Contains less than one gram” or “less than one gram” may be used as an alternative. Fatty acid composition, cholesterol content, and sodium content may also be declared in compliance with §§ 101.25 and 105.69 of this chapter. (i) When fatty acid composition is declared, the information on fatty acids required by § 101.25(c) shall be placed on the label immediately following the statement of fat content. The declaratory information statement required by § 101.25(d) shall be placed either immediately following the statement on fat and fatty acids or shall be appropriately referenced by symbol and placed immediately following the completed nutrition information statement. (ii) When cholesterol content is declared, the information on cholesterol required by § 101.25(b) shall immediately follow the statement on fat content (and fatty acids, if stated). The declaratory information statement required by § 101.25(d) shall be placed either immediately following the statement on cholesterol or shall be 'Copies may be obtained from: Association of Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, Washington, D.C. 20044. appropriately referenced by symbol and placed immediately following the completed nutrition information statement. (iii) When both fatty acid and cholesterol information are provided, the declaratory information statement may be combined as permitted by § 101.25(d). (iv) When sodium is declared, the information on sodium required by § 105.69 of this chapter shall be placed on the label immediately following the statement on fat content (and fatty acid and/or cholesterol, if stated). (7) "Percentage of U.S. Recommended Daily Allowances (U.S. RDA)": A statement of the amount per serving (portion) of the protein, vitamins, and minerals, as described in this paragraph (c)(7), expressed in percentage of the U.S. Recommended Daily Allowance (U.S. RDA). (i) The percentages shall be expressed in 2-percent increments up to and including the 10-percent level, 5percent increments above 10 percent and up to and including the 50-percent level, and 10-percent increments above the 50-percent level. Nutrients present in amounts less than 2 percent of the U.S. RDA may be indicated by a zero, or by an asterisk referring to another asterisk placed at the bottom of the table and followed by the statement “contains less than 2 percent of the U.S. RDA of this (these) nutrient (nutrients)." However, when a product contains less than 2 percent of the U.S. RDA for each of five or more of the eight nutrients specified in paragraph (c)(7)(iii) of this section, the manufacturer or distributor may choose to declare no more than three of those nutrients and none of the remainder listed in paragraph (c)(7)(iv) of this section. The statement "contains less than 2 percent of the U.S. RDA of -", listing whichever of the eight nutrients are present at less than 2 percent of the U.S. RDA and have not been declared, shall directly follow the declared nutrient in the same type size. Any nutrient declared shall always appear in the order established in paragraph (c)(7)(iv) of this section. (ii) The declaration of protein, which shall come first, shall be a statement of the amount per serving (portion) of protein, expressed as a percentage of the U.S. RDA. (a) The U.S. RDA of the protein in a food product is 45 grams if the protein efficiency ration (PER) of the total protein in the product is equal to or greater than that of casein, and 65 grams if the PER of the total protein in the product is less than that of casein. The percentage of the U.S. RDA shall be declared as described in paragraph (c)(7)(i) of this section. (b) Total protein with a PER less than 20 percent of the PER of casein may not be stated on the label in terms of percentage U.S. RDA, and the statement of protein content in grams per serving (portion) under paragraph (c)(4) of this section shall be modified by the statement "not a significant source of protein" immediately adjacent to the protein content statement regardless of the actual amount of protein present. (iii) The declaration of vitamins and minerals as a percent of the U.S. RDA which shall follow the protein declaration, shall include vitamin A, vitamin C, thiamine, riboflavin, niacin, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(7)(iv) of this section when they are added and may list any of the other vitamins and minerals listed in paragraph (c)(7)(iv) of this section when they are naturally occurring in the order listed therein. (iv) The following U.S. Recommended Daily Allowances (U.S. RDA) and nomenclature are established for these vitamins and minerals, essential in human nutrition: Iron, 18 milligrams. Vitamin D, 400 International Units. Pantothenic acid, 10 milligrams. These nutrients and levels have been derived by the Food and Drug Administration from the "Recommended Dietary Allowances," published by the Food and Nutrition Board, National Academy of Sciences-National Research Council, and are subject to amendment from time to time as more information on human nutrition becomes available. (v) No claim may be made that a food is a significant source of a nutrient unless that nutrient is present in the food at a level equal to or in excess of 10 percent of the U.S. RDA in a serving (portion). No claim may be made that a food is nutritionally superior to another food unless it contains at least 10 percent more of the U.S. RDA of the claimed nutrient per serving (portion). (d) Products with separately packaged ingredients or to which other ingredients are added by the user may be labeled as follows: (1) If a product is comprised of two or more separately packaged ingredients enclosed in an outer container, nutrition labeling of the total product shall be located on the outer container to provide information for the consumer at the point of purchase. However, when two or more food products are simply combined together in such a manner that no outer container is used, or no outer label is available, each product shall have its own nutrition information, e.g., two boxes taped together or two cans combined in a clear plastic overwrap. (2) If a food is commonly combined with another ingredient(s) before eating and directions for such combination are provided, another column of figures may be used to provide a list of the nutrient contents for the final combination in the same format required in paragraph (c) of this section for the food alone (e.g., a dry ready-toeat cereal may be described with one set of percentage U.S. RDA values for the cereal as sold (per ounce), and another set for the cereal and milk as suggested in the label (per ounce of cereal and one-half cup of vitamin D fortified whole milk); and a cake mix may be labeled with one set of percentage U.S. RDA values for the dry mix (per serving), and another set for a serving of the final cake when prepared). The type and quantity of the other ingredient(s) to be added by the user to the product shall be specified. (e) Compliance with this section shall be determined as follows: (1) A collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, or in the absence of any common container code or marking a day's production, constitutes a "lot." (2) The sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken one from each of 12 different randomly chosen shipping cases, to be representative of a lot. Composites shall be analyzed by Association of Official Analytical Chemists (AOAC) methods where available or, if no AOAC method is available, by reliable and appropriate analytical procedures. Alternative methods of analysis may be submitted to the Food and Drug Administration to determine their acceptability. (3) Two classes of nutrients are defined for purposes of compliance: Class I. Added nutrients in fortified or fabricated foods. Class II. Naturally occurring (indigenous) nutrients. If any ingredient which contains a naturally occurring (indigenous) nutrient is added to a food, the total amount of such nutrient in the final food product is subject to Class II requirements unless the same nutrient is also added. (4) A food with a label declaration of a vitamin, mineral, or protein shall be deemed to be misbranded under sec tion 403(a) of the act unless it meets the following requirements: (i) Class I vitamin, mineral, or protein. The nutrient content of the composite is at least equal to the value for that nutrient declared on the label. (ii) Class II vitamin, mineral, or protein. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value which falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved. (5) A food with a label declaration of calories, carbohydrates, or fat shall be deemed to be misbranded under section 403(a) of the act unless the nutrient content of the composite is no greater than 20 percent in excess of the value for that nutrient declared on the label. (6) Reasonable excesses of a vitamin, mineral, or labeled protein over amounts are acceptable within good manufacturing practices. Reasonable deficiencies of calories or fat under labeled amounts are acceptable within good manufacturing practices. (f) Nutrition information provided by a manufacturer or distributor directly to professionals (e.g., physicians, dietitians, educators) may vary from the requirements of this section but shall also contain or have attached to it the nutrition information exactly as required by this section. (g) The location of nutrition information on a label shall be in compliance with § 101.2. (h) The following foods are exempt from this section or are subject to special labeling requirements: (1)(i) Except where expressly covered by § 105.65 of this chapter, infant, baby, and junior-type food promoted for infants and children under 4 years of age shall include nutrition information on the label and in labeling in compliance with this section. (ii) Both the U.S. RDA levels for infants from birth to 12 months of age and the U.S. RDA values for children under 4 years of age may be declared (ii) The declaration of protein, which shall come first, shall be a statement of the amount per serving (portion) of protein, expressed as a percentage of the U.S. RDA. (a) The U.S. RDA of the protein in a food product is 45 grams if the protein efficiency ration (PER) of the total protein in the product is equal to or greater than that of casein, and 65 grams if the PER of the total protein in the product is less than that of casein. The percentage of the U.S. RDA shall be declared as described in paragraph (c)(7)(i) of this section. (b) Total protein with a PER less than 20 percent of the PER of casein may not be stated on the label in terms of percentage U.S. RDA, and the statement of protein content in grams per serving (portion) under paragraph (c)(4) of this section shall be modified by the statement "not a significant source of protein" immediately adjacent to the protein content statement regardless of the actual amount of protein present. (iii) The declaration of vitamins and minerals as a percent of the U.S. RDA which shall follow the protein declaration, shall include vitamin A, vitamin C, thiamine, riboflavin, niacin, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(7)(iv) of this section when they are added and may list any of the other vitamins and minerals listed in paragraph (c)(7)(iv) of this section when they are naturally occurring in the order listed therein. (iv) The following U.S. Recommended Daily Allowances (U.S. RDA) and nomenclature are established for these vitamins and minerals, essential in human nutrition: Vitamin A, 5,000 International Units. Thiamine, 1.5 milligrams. 3 Riboflavin, 1.7 milligrams. ' Iron, 18 milligrams. Pantothenic acid, 10 milligrams. These nutrients and levels have been derived by the Food and Drug Administration from the "Recommended Dietary Allowances,” published by the Food and Nutrition Board, National Academy of Sciences-National Research Council, and are subject to amendment from time to time as more information on human nutrition becomes available. (v) No claim may be made that a food is a significant source of a nutrient unless that nutrient is present in the food at a level equal to or in excess of 10 percent of the U.S. RDA in a serving (portion). No claim may be made that a food is nutritionally superior to another food unless it contains at least 10 percent more of the U.S. RDA of the claimed nutrient per serving (portion). (d) Products with separately packaged ingredients or to which other ingredients are added by the user may be labeled as follows: (1) If a product is comprised of two or more separately packaged ingredients enclosed in an outer container, nutrition labeling of the total product shall be located on the outer container to provide information for the consumer at the point of purchase. However, when two or more food products are simply combined together in such a manner that no outer container is used, or no outer label is available, each product shall have its own nutrition information, e.g., two boxes taped together or two cans combined in a clear plastic overwrap. (2) If a food is commonly combined with another ingredient(s) before eating and directions for such combination are provided, another column of figures may be used to provide a list of the nutrient contents for the final |