gredients shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:", e.g., "vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)". No fat or oil ingredient shall be listed unless actually present if the fats and/or oils constitute the predominant ingredient of the product, as defined in this paragraph (b)(14).

(15) When all the ingredients of a wheat flour are declared in an ingredient statement, the principal ingredient of the flour shall be declared by the name(s) specified in §§ 137.105, 137.200, 137.220 and 137.225 of this chapter, i.e., the first ingredient designated in the ingredient list of flour, or bromated flour, or enriched flour, or self-rising flour is "flour", "white flour", "wheat flour", or "plain flour"; the first ingredient designated in the ingredient list of durum flour is "durum flour"; the first ingredient designated in the ingredient list of whole wheat flour, or bromated whole wheat flour is "whole wheat flour", "graham flour", or "entire wheat flour"; and the first ingredient designated in the ingredient list of whole durum wheat flour is "whole durum wheat flour”.

(16) Ingredients that act as leavening agents in food may be declared in the ingredient statement by stating the specific common or usual name of each individual leavening agent in parentheses following the collective name "leavening", e.g., "leavening (baking soda, monocalcium phosphate, and calcium carbonate)". The listing of the common or usual name of each individual leavening agent in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of leavening agents in the product, the listing of individual leavening agents need not be in descending order of predominance. Leavening agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:".

(17) Ingredients that act as yeast nutrients in foods may be declared in the ingredient statement by stating the specific common or usual name of each individual yeast nutrient in parentheses following the collective name "yeast nutrients", e.g., "yeast nutrients (calcium sulfate and ammonium phosphate)". The listing of the common or usual name of each individual yeast nutrient in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of yeast nutrients in the product, the listing of the common or usual names of individual yeast nutrients need not be in descending order of predominance. Yeast nutrients not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", “and/or”, or "contains one or more of the following:".

(18) Ingredients that act as dough conditioners may be declared in the ingredient statement by stating the specific common or usual name of each individual dough conditioner in parentheses following the collective name "dough conditioner", e.g., "dough conditioners (L-cysteine, ammonium sulfate)". The listing of the common or usual name of each dough conditioner in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of dough conditioners in the product, the listing of the common or usual names of individual dough conditioners need not be in descending order of predominance. Dough conditioners not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", or "contains one or more of the following:".

(c) When water is added to reconstitute, completely or partially, an ingredient permitted by paragraph (b) of this section to be declared by a class name, the position of the ingredient class name in the ingredient statement shall be determined by the weight of

the unreconstituted ingredient plus the weight of the quantity of water added to reconstitute that ingredient, up to the amount of water needed to reconstitute the ingredient to single strength. Any water added in excess of the amount of water needed to reconstitute the ingredient to single strength shall be declared as "water" in the ingredient statement.

(Secs. 201(n), 403, 701(a), 52 Stat. 1041 as amended, 1047-1048 as amended, 1055 (21 U.S.C. 321(n), 343, 371(a)))

[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978; 43 FR 24519, June 6, 1978]

§ 101.5 Food; name and place of business of manufacturer, packer, or distributor.

(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as

"Manufactured "Distributed

for

by

or any other wording that expresses the facts.

(d) The statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP code shall appear either on the label or the labeling (including invoice).

(e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading.

§ 101.6 Label designation of ingredients for standardized foods.

(a) There is significant consumer interest that the labels of standardized foods bear complete information on the ingredients contained in the food. In the absence of legal authority to require that the label bear such information, the Food and Drug Administration encourages all manufacturers, packers, and distributors to voluntarily make such disclosure.

(b) The Food and Drug Administration intends to amend the definitions and standards of identity of food by setting into motion as rapidly as possible the provisions of section 401 of the act to require label declaration of all optional ingredients with the exception of optional spices, flavorings, and colorings which may continue to be designated as such without specific ingredient declaration.

(c) Statutory authority does not exist to require the declaration of mandatory ingredients on the label of standardized foods.

(d) The requirement (set forth in some of the definitions and standards of identity for food) that designated optional ingredients such as spices, flavorings, colorings, emulsifiers, flavor enhancers, stabilizers, preservatives, and sweeteners be declared in a specified manner on the label wherever the name of the standardized food appears on the label so conspicuously as to be easily seen under customary conditions of purchase shall not apply to any manufacturer, packer, or distributor of a standardized food who voluntarily labels such food in the manner indicated by section 403(i) of the act (21 U.S.C. 343(i)), and the regulations promulgated thereunder, and who otherwise complies with such definition and standard. Words and statements that significantly differentiate between several foods complying with the same standard by describing the

optional forms or varieties, the packing medium, and significant characterizing ingredients present in the food, shall continue to be declared in the manner as required by the particular standard.

§ 101.8 Labeling of food with number of servings.

(a) The label of any package of a food which bears a representation as to the number of servings contained in such package shall bear in immediate conjunction with such statement, and in the same size type as is used for such statement, a statement of the net quantity (in terms of weight, measure, or numerical count) of each such serving; however, such statement may be expressed in terms that differ from the terms used in the required statement of net quantity of contents (for example, cupfuls, tablespoonfuls, etc.) when such differing term is common to cookery and describes a constant quantity. Such statement may not be misleading in any particular. A statement of the number of units in a package is not in itself a statement of the number of servings.

(b) If there exists a voluntary product standard promulgated pursuant to the procedures found in 15 CFR Part 10 by the Department of Commerce, quantitatively defining the meaning of the term "serving" with respect to a particular food, then any label representation as to the number of servings in such packaged food shall correspond with such quantitative definition. (Copies of published standards are available upon request from the National Bureau of Standards, Department of Commerce, Washington, DC 20234.)

§ 101.9 Nutrition labeling of food.

(a) Nutrition information relating to food may be included on the label and in the labeling of a product: Provided, That it conforms to the requirements of this section. Except as provided in paragraph (h) of this section, inclusion of any added vitamin, mineral, or protein in a product or of any nutrition claim or information, other than sodium content, on a label or in advertising for a food subjects the label to the requirements of this section, and

in labeling for a food subjects the label and that labeling to the requirements of this section.

(1) Solicitation of requests for nutrition information by a statement "For nutrition information write to

on the label or in the labeling or advertising for a food, or providing such information in a direct written reply to a solicited or unsolicited request, does not subject the label or the labeling to the requirements of this section if no other nutrition claim is made on the label or in other labeling or advertising, if the reply to the request conforms to the requirements of this section, and if no vitamin, mineral, or protein is added to the food.

(2) If any vitamin and/or mineral is added to a food so that a single serving provides 50 percent or more of the U.S. Recommended Daily Allowance (U.S. RDA) for adults and children 4 years or more of age, as specified in paragraph (c)(7)(iv) of this section, of any one of the added vitamins and/or minerals, unless such addition is permitted or required in other regulations, e.g., a standard of identity or nutritional quality guideline, or is otherwise exempted by the Commissioner the food shall be considered a food for 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).1 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 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, 2 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

'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.

'Copies may be obtained from: Association of Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, Washington, D.C. 20044.

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 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