branding.

1.102 Drugs and devices; labeling require

ments.

PUBLIC NOTICE OF REGULATIONS

1.715 Public notice of regulations.

SOURCE: §§ 1.1 to 1.715 appear at 20 F. R. 9526, Dec. 20, 1955, except as otherwise noted. GENERAL

§ 1.1 General regulation.

(a) The provisions of regulations promulgated under the act with respect to the doing of any act shall be applicable also to the causing of such act to be done.

(b) The definitions and interpretations of terms contained in section 201 of the act shall be applicable also to such terms when used in regulations promulgated under the act.

(Sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371)

DEFINITIONS

AUTHORITY: §§ 1.2 and 1.3 issued under sec. 701, 52 Stat. 1055, as amended, 21 U. S. C. 371. Statutory provisions interpreted or applied are cited to text in parentheses.

The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation. (Sec. 201, 52 Stat. 1041, as amended; 21 U. S. C. 321)

PROHIBITED ACTS AND PENALTIES

AUTHORITY: §§ 1.4 to 1.6 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371. Statutory provisions interpreted or applied are cited to text in parentheses.

§ 1.4 Guaranty.

In case of the giving of a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. (Sec. 301, 52 Stat. 1042, as amended; 21 U. S. C. 331)

$ 1.5 Guaranty; definition, and suggested forms.

(a) A guaranty or undertaking referred to in section 303 (c) (2) of the act may be:

(1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or

(2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking.

(b) The following are suggested forms of guaranty or undertaking under section 303 (c) (2) of the act:

(1) Limited form for use on invoice or bill of sale.

(Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty or undertaking)

(2) General and continuing form.

The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or on the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty of undertaking)

(c) The application of a guaranty or undertaking referred to in section 303 (c) (2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes adulterated or misbranded within the meaning of the act, or becomes an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce.

(d) A guaranty or undertaking referred to in section 303 (c) (3) of the act shall state that the shipment or other delivery of coal-tar color covered thereby was manufactured by a signer thereof. It may be a part of or attached to the invoice or bill of sale covering such color. If such shipment or delivery is from a foreign manufacturer, such guaranty or undertaking shall be signed by such manufacturer and by an agent of such manufacturer who resides in the United States.

(e) The following are suggested forms of guaranty or undertaking under section 303 (c) (3) of the act:

(1) For domestic manufacturers.

(Name of manufacturer) hereby guarantees that all coal-tar colors listed herein were manufactured by him, and are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.

(Signature and post-office address of manufacturer)

(2) For foreign manufacturers.

(Name of manufacturer and agent) hereby severally guarantee that all coal-tar colors listed herein were manufactured by (name of manufacturer), and are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.

(Signature and post-office address of manufacturer)

(Signature and post-office address of agent)

(f) For the purpose of a guaranty or undertaking under section 303 (c) (3) of the act the manufacturer of a shipment or other delivery of a coal-tar color is the person who packaged such color.

(g) A guaranty or undertaking, if signed by two or more persons, shall state that such persons severally guarantee the article to which it applies.

(h) No representation or suggestion that an article is guaranteed under the act shall be made in labeling.

(Sec. 303, 52 Stat. 1043; 21 U. S. C. 333)

§ 1.6 Presentation of views under section 305 of the act.

(a) Presentation of views under section 305 of the act shall be private and informal. The views presented shall be confined to matters relevant to the contemplated proceeding. Such views may be presented by letter or in person by the person to whom the notice was given, or by his representative. In case such person holds a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views.

(b) Upon request, seasonably made, by the person to whom a notice appointing a time and place for the presentation of views under section 305 of the act has been given, or by his representative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall be addressed to the office of the Food and Drug Administration which issued the notice.

(Sec. 305, 52 Stat. 1045, as amended; 21 U. S. C. 335)

FOOD

AUTHORITY: $ 1.7 to 1.14 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371. Statutory provisions interpreted or applied are cited to text in parentheses.

§ 1.7 Food; labeling; misbranding.

(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.

(Sec. 403, 52 Stat. 1047, as amended; 21 U. S. C. 343)

§ 1.8 Food; labeling; required statements; when exempt.

(a) Where a food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase which reveals the connection such person has with such food, such as "Manufactured for and Packed by "Distributed by," or other similar phrase which expresses the facts.

(b) The statement of the place of business shall include the street address, if any, of such place, unless such street address is shown in a current city directory or telephone directory.

(c) 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 each package of such food was manufactured or packed or is to be distributed, if such statement is not misleading in any particular.

(d) The requirement that the label shall contain the name and place of business of the manufacturer, packer, or distributor shall not be considered to relieve any food from the requirement that its label shall not be misleading in any particular.

(e) (1) The statement of the quantity of the contents shall reveal the quantity of food in the package, exclusive of wrappers and other material packed with such food.

(2) The statement shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure, which are generally used by consumers to express quantity of such food and which give accurate information as to