(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.

(Secs. 201, 403, 701(a), 52 Stat. 1040-1042, 1047, 1055; 21 U.S.C. 321, 323, 343(a), 371(a)) [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]

§ 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.

(Secs. 201, 403, 701(a), 52 Stat. 1040-1042 as amended, 1047-1048 as amended, 1055 (21 U.S.C. 321, 343, 371(a)))

§ 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:

90-061 0-82--3

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 requirements:

(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.

(Secs. 201(s), 403(p), 409, and 701(a), Pub. L. 717, 52 Stat. 1055 as amended, 72 Stat. 17841788 as amended, 91 Stat. 1453 (21 U.S.C. 321(s), 343(p), 348, 371(a)) and Pub. L. 95203, 91 Stat. 1451-1454 (21 U.S.C. 301 note)) [43 FR 8795, Mar. 3, 1978]

§ 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.

as

(b) No exemption depending on insufficiency of label space, 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 au

thority 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 on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.

(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language: Provided, however, That individual serving-size packages of foods containing no more than 11⁄2 avoirdupois ounces or no more than 1% fluid! ounces served with meals in restaurants, institutions, and passenger carriers and not intended for sale at retail are exempt from the requirements of this paragraph (c)(2), if the only representation in the foreign language(s) is the name of the food.

(3) If any article of labeling (other than a label) contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on such article of labeling.

§ 101.17 Food labeling warning statements.

(a) Self-pressurized containers. (1) The label of a food packaged in a selfpressurized container and intended to be expelled from the package under pressure shall bear the following warning:

WARNING-Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at tem

perature above 120° F. Keep out of reach of children.

(2) In the case of products intended for use by children, the phrase "except under adult supervision" may be added at the end of the last sentence in the warning required by paragraph (a)(1) of this section.

(3) In the case of products packaged in glass containers, the word "break" may be substituted for the word "puncture" in the warning required by paragraph (a)(1) of this section.

(4) The words "Avoid spraying in eyes" may be deleted from the warning required by paragraph (a)(1) of this section in the case of a product not expelled as a spray.

(b) Self-pressurized containers with halocarbon or hydrocarbon propellants. (1) In addition to the warning required by paragraph (a) of this section, the label of a food packaged in a self-pressurized container in which the propellant consists in whole or in part of a halocarbon or a hydrocarbon shall bear the following warning:

WARNING-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

(2) The warning required by paragraph (b)(1) of this section is not required for the following products:

(i) Products expelled in the form of a foam or cream, which contain less than 10 percent propellant in the container.

(ii) Products in a container with a physical barrier that prevents escape of the propellant at the time of use.

(iii) Products of a net quantity of contents of less than 2 ounces that are designed to release a measured amount of product with each valve actuation.

(iv) Products of a net quantity of contents of less than one-half ounce.

(c) Self-pressurized containers with a chlorofluorocarbon propellant. (1) In addition to the warning required by paragraphs (a) and (b) of this section, the label on each package of a food in a self-pressurized container in which the propellant consists in whole or in part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon) shall bear the following warning:

WARNING-Contains a chlorofluorocarbon that may harm the public health and environment by reducing ozone in the upper atmosphere.

(2) The warning required by paragraph (c)(1) of this section shall appear on an appropriate panel with such prominence and conspicuousness as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase. The warning may appear on a firmly affixed tag, tape, card, or sticker or similar overlabeling attached to the package. The warning shall comply in all other respects with § 101.2, e.g., type-size requirements.

(3) The warning required by paragraph (c)(1) of this section is applicable only to self-pressurized containers that use chlorofluorocarbons in whole or in part as a propellant to expel from the container liquid or solid material different from the propellant, but the warning is not applicable to the use of chlorofluorocarbon as a stabilizer in food toppings and spreads.

(Secs. 201(n), 301, 402, 403, 501, 502, 505, 507, 512, 601, 602, 701(a), 52 Stat. 1041-1043 as amended, 1046-1048 as amended, 1049, 1051-1053 as amended, 1054-1055, 57 Stat. 463 as amended, 82 Stat. 348-351 (21 U.S.C. 321(n), 331, 342, 343, 351, 352, 355, 357, 360b, 361, 362, and 371(a)); sec. 101(2), 83 Stat. 853 (42 U.S.C. 4332))

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977]

§ 101.18 Misbranding of food.

(a) Among representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic.

(b) The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.

(c) Among representations in the labeling of a food which render such food misbranded is any representation