under 4 years of age may be declared for foods represented or intended for use by both infants and children under 4 years of age. If such dual declaration is used on any label, it shall also be included in all labeling, and equal prominence shall be given to both values in all promotional material.

(iii) For the purposes of labeling these foods with a percent of the U.S. RDA for protein for infants, a value of 18 grams of protein shall be the U.S. RDA value for protein with a protein efficiency ratio (PER) equal to or greater than casein, and 25 grams if the PER of the protein is less than the PER of casein but greater than 40 percent of casein. For purposes of labeling foods for children under 4 years of age with a percent of the U.S. RDA for protein, a value of 20 grams of protein shall be the U.S. RDA value for protein with a PER equal to or greater than casein, and 28 grams if the PER of the protein is less than the PER of casein but greater than 20 percent of casein.

(iv) Total protein with a PER less than 40 percent of the PER of casein may not be stated on the label in terms of percentage U.S. RDA for infants, and the statement of protein content in grams per serving under paragraph (c)(4) of this section shall be modified by the statement "not a significant source of protein for infants" immediately adjacent to the protein content statement regardless of the actual amount of protein present.

(2) Dietary supplements are exempted, except that the labeling of a dietary supplement in food form, e.g., a breakfast cereal, shall conform to the labeling established in paragraph (c) of this section, including the order for listing vitamins and minerals established in paragraph (c)(7)(iv) of this section.

(3) Any food represented for use as the sole item of the diet shall be labeled in compliance with Part 105 of this chapter.

(4) Foods represented for use solely under medical supervision to meet nutritional requirements in specific medical conditions shall be labeled in compliance with Part 105 of this chapter.

(5) Iodized salt shall be labeled in compliance with § 100.155 of this chapter and when used in a food does not subject that food to labeling under this section if it is declared in the ingredient statement by its name (iodized salt) and neither iodine nor iodized salt is otherwise referred to on the label or in labeling or advertising.

(6) A nutrient(s) included in food solely for technological purposes may be declared solely in the ingredient statement, without complying with this section, if the nutrient(s) is otherwise not referred to on the label or in labeling or in advertising.

(7) A standardized food containing an added nutrient(s), e.g., enriched flour, and included in another food as a component may be declared in the ingredient statement by its standardized name, without compliance with this section, if neither the nutrient(s) nor the component is otherwise referred to on the label or in labeling or in advertising.

(8) Food products shipped in bulk form for use solely in the manufacture of other foods and not for distribution to consumers in such bulk form or container.

(9) Food products containing an added vitamin, mineral, or protein, or for which a nutritional claim is made on the label or in labeling or in advertising, which are supplied for institutional food service use only: Provided, That the manufacturer or distributor provides the nutrition information required by this section directly to those institutions on a current basis.

(10) Fresh fruits and fresh vegetables, pending promulgation of specific labeling requirements for these products.

(11) A percentage declaration of the fat (milkfat, butterfat) content appearing only in the ingredient statement on the label of a food listed in § 1.24(a)(7)(i) of this chapter does not constitute a "nutrition claim or information" within the meaning of paragraph (a) of this section if:

(i) The declaration appears on the information panel (for requirements for information panels, see § 101.2) with no greater prominence than any other printed matter appearing on the panel, and in a type size no larger

93-060 0-87--2

than the minimum type size required by § 101.105(i) for the declaration of net quantity of contents, and

(ii) The declaration is not required by other regulations in this chapter.

(i) A food labeled under the provisions of this section shall be deemed to be misbranded under sections 201(n) and 403(a) of the act if its labeling represents, suggests, or implies:

(1) That the food because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom.

(2) That a balanced diet of ordinary foods cannot supply adequate amounts of nutrients.

(3) That the lack of optimum nutritive quality of a food, by reason of the soil on which that food was grown, is or may be responsible for an inadequacy or deficiency in the quality of the daily diet.

(4) That the storage, transportation, processing or cooking of a food is or may be responsible for an inadequacy or deficiency in the quality of the daily diet.

(5) That the food has dietary properties when such properties are of no significant value or need in human nutrition. Ingredients or products such as rutin, other bioflavonoids, paraamino-benzoic acid, inositol, and similar substances which have in the past been represented as having nutritional properties but which have not been shown to be essential in human nutrition may not be combined with vitamins and/or minerals, added to food labeled in accordance with this section, or otherwise used or represented in any way which states or implies nutritional benefit. Ingredients or products of this type may be marketed as individual products or mixtures thereof: Provided, That the possibility of nutritional, dietary, or therapeutic value is not stated or implied, e.g., their labeling does not state that their usefulness in human nutrition has not

been established and does not otherwise disclaim nutritional, dietary, or therapeutic value.

(6) That a natural vitamin in a food is superior to an added or synthetic vitamin, or to differentiate in any way between vitamins naturally present from those added.

(Collection of information requirements were approved by the Office of Management and Budget under OMB control number 0910-0198)

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 27226, May 27, 1977; 44 FR 16006, Mar, 16, 1979; 45 FR 37422, June 3, 1980; 47 FR 11820, Mar. 19, 1982; 49 FR 5609, Feb. 14, 1984; 49 FR 15533, Apr. 18, 1984; 49 FR 26572, June 28, 1984]

§ 101.10 Nutrition labeling of restaurant foods.

A nutrition claim or nutrition information concerning a combination of restaurant foods, e.g., the total nutritional value of a meal consisting of a hamburger, french fries, and milk shake, may be included in advertising and/or in labeling (other than labels), without causing nutrition information to be required on the label(s) of each article of food: Provided, That complete nutrition information for the combination of foods (the combination as an entity without the nutritional value of each article being specified) in the format established by § 101.9(c) is effectively displayed to the customer both when he orders the food and when he consumes the food. This statement of policy does not apply to food dispensed in automatic vending machines.

§ 101.11 Saccharin and its salts; retail establishment notice.

Each retail establishment (except restaurants) that sells food that contains saccharin shall display the following notice in the locations set forth in paragraph (b) of this section:

feet of floor space shall display at least two notices. The first notice shall be located near the entrance to the retail establishment and arranged so that consumers are likely to see the notice upon entering. The second notice shall be centrally located in the area of the retail establishment in which soft drinks containing saccharin are displayed. If there is more than one such place, then in the area where the greatest quantity of diet soft drinks are displayed. If diet soft drinks are not sold, then in the area of the establishment in which the largest quantity of saccharin-containing foods (including saccharin sold in package form as a sugar substitute) are displayed.

(3) A large retail establishment, e.g., department store, whose primary business consists of selling nonfood items (i.e., the proportion of food sold is extremely small compared to other items) shall display at least one notice. The notice shall be located in the area of the establishment in which foods containing saccharin are displayed. If there is more than one such area, then a notice shall be displayed in each area.

(d) Each manufacturer of saccharincontaining food who customarily delivers his products directly to retail establishments shall make available at least three notices to each retail establishment in which his products are sold. Each manufacturer shall also arrange to supply additional notices to a retail establishment that asks for them.

(e) Manufacturers who do not customarily deliver their saccharin-containing food products directly to retail establishments may fulfill their obligation to provide notices either in the manner set forth in paragraph (d) of this section or by participating in, and performing the actions required by, a trade association coordinated program that meets the following ments:

require

(1) The coordinating association shall have filed notice of the program with the Food and Drug Administration, including the association's name, mailing address, telephone number, and contact person.

(2) Each manufacturer participating in the program shall file notice of its

participation with the coordinating association, including its name, mailing address, telephone number, and contact person.

(3) The association shall ensure that retail establishment notices, in the form specified in this section, are readily available to participating manufacturers.

(4) The association shall take affirmative steps to coordinate with retail establishments, their trade associations, and the trade press to disseminate information about the applicable requirements of the Saccharin Study and Labeling Act and these regulations, the existence of the association coordinated program, and the availability of notices through the program.

(5) Each manufacturer shall, in consultation with the association, communicate with its contacts in the distributional chain to inform them of the applicable requirements of the Saccharin Study and Labeling Act and these regulations, and the continued availability of notices.

(6) Each manufacturer shall ensure that notices are promptly provided on request to any retail establishment carrying its products.

(7) The association shall consult with participating manufacturers concerning the implementation and progress of the program and shall disseminate information to facilitate the conduct of the program based on such consultations or consultation with the Food and Drug Administration.

(8) The association shall, on request, permit the Food and Drug Administration to have access to the participation notices filed by manufacturers, samples showing the form of retail establishment notices made available, and typical communication materials used by the association in the course of the program.

[43 FR 8795, Mar. 3, 1978]

§ 101.13 Sodium labeling.

(a) Certain descriptive terms about the quantitative sodium content of foods may be used on the label and in labeling provided such statements comply with the following rules:

(1) The term "sodium free" may be used on the label and in labeling of foods that contain less than 5 milligrams of sodium per serving.

(2) The term "very low sodium" may be used on the label and labeling of foods that contain 35 milligrams or less of sodium per serving.

(3) The term "low sodium" may be used on the label and in the labeling of foods that contain 140 milligrams or less of sodium per serving.

(4) The term "reduced sodium" may be used on the label and in the labeling of foods that have been formulated to serve as and are represented as direct replacements for foods containing at least four times the sodium content (75 percent reduction). The label of such a food shall provide information comparing the sodium content per serving with that of the food it replaces.

(5) When any of the definitions set forth in paragraph (a) (1), (2), (3), or (4) of this section are used in labeling or when any other truthful statement about sodium content is used in labeling, quantitative information shall be provided on the label in conformity with § 105.69 or § 101.9 of this chapter.

(b) The term "salt" is not synonymous with "sodium." Salt refers to sodium chloride. References to salt content such as "unsalted," "no salt added," or "without added salt" or an equivalent term may be used on the label and in labeling of food only if:

(1) No salt is added during processing;

(2) The food that it resembles and for which it substitutes is normally processed with salt; and

(3) Sodium content information is provided in conformity with § 105.69 or § 101.9 of this chapter.

[49 FR 15534, Apr. 18, 1984]

§ 101.15 Food; prominence of required statements.

(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f) of the act by reason (among other reasons) of:

(1) The failure of such word, statement, or information to appear on the

part or panel of the label which is presented or displayed under customary conditions of purchase;

(2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;

(3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;

(4) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(5) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or

(6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.

(b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 403 (e) or (i) of the act, shall apply if such insufficiency is caused by:

(1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(2) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by section 403(f) of the act;

or

(3) The use of label space for any representation in a foreign language.

(c)(1) All words, statements, and other information required by or under authority of the act to appear