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CHAPTER I-FOOD AND DRUG ADMINISTRATION

FEDERAL SECURITY AGENCY

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Regulations for the enforcement of the Federal Food, Drug, and Cosmetic
Act.

Statements of general policy or interpretation.

General regulations relating to definitions and standards for food.
Cacao products; definitions and standards of identity.

Cereal flours and related products; definitions and standards of identity.
Alimentary pastes; definitions and standards of identity.

Milk and cream; definitions and standards of identity.

Cheeses; processed cheeses; cheese foods; cheese spreads, and related foods; definitions and standards of identity.

Canned fruits; definitions and standards of identity; quality; and fill of container.

Fruit preserves and jellies; definitions and standards of identity.

30 Fruit butters; definitions and standards of identity.

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Shellfish; definitions and standards of identity; quality; and fill of container.
Eggs and egg products; definitions and standards of identity.
Oleomargarine; definition and standards of identity.

51 Canned vegetables; definitions and standards of identity; quality; and fill of container.

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Canned vegetables other than those specifically regulated; definitions and standards of identity.

Tomato products; definitions and standards of identity; quality; and fill of container.

Tolerances for poisons in food.

Label statements concerning dietary properties of food purporting to be or represented for special dietary uses.

135 Color certification.

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Tests and methods of assay for antibiotic drugs.

Certification of batches of drugs composed wholly or partly of insulin.
Certain chemical derivatives of substances named in section 502 (d) of the
Federal Food, Drug, and Cosmetic Act designated as habit forming.
Certification of batches of penicillin- or streptomycin-containing drugs.

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Regulations for the enforcement of the Federal Import Milk Act.

General regulations.

NOTE: Other regulations issued by the Federal Security Agency appear in Title 20, Chapters I, III, IV, and V, Title 42 and Title 45.

CROSS REFERENCES: Bureau of Animal Industry, Department of Agriculture: See Animals and Animal Products, 9 CFR Chapter I.

Bureau of Customs, Department of the Treasury, regulations on examination, classification, and disposition of special classes of merchandise: See Customs Duties, 19 CFR Part 12. National Bureau of Standards, Department of Commerce: See Commerce and Foreign Trade, 15 CFR Chapter II.

Production and Marketing Administration (Standards, Inspections, Marketing Practices): See 7 CFR Chapter I.

Public Health Service, Department of the Treasury, regulation of biological products: See Public Health, 42 CFR Part 73.

ABBREVIATIONS: The following abbreviations are used in this chapter:

cc. cubic centimeter. C. Centigrade. Cat.=Catalogue. F. Fahrenheit. FDC= Food, Drug and Cosmetic docket. gm.=gram. kg.=kilogram. L. C.-Letter Circular. meg. microgram. mg.=milligram. ml. milliliter. mm. millimeter. N. F.-National Formulary. SRA, CP=Service and regulatory announcements, caustic poison, Secretary of Agriculture. SRA, IM=Service and regulatory announcements, import milk, Secretary of Agriculture. SRA, T-Service and regulatory announcements, tea, Secretary of Agriculture. T. D. Treasury Decision. T. I. S.=Tea inspection service. U. S. P. United States Pharmacopoeia.

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(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 (a), 52 Stat. 1055; 21 U.S. C. 371 (a)) [3 F. R. 3161, redesignated at 13 F. R. 6969] DEFINITIONS

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

SOURCE: 1.2 and 1.3 appear at 3 F. R. 3161, redesignated at 13 F. R. 6969.

§ 1.2 Labeling; definition. Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate com

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AUTHORITY:

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

SOURCE: §§ 1.4 to 1.6 appear at 3 F. R. 3161, redesignated at 13 F. R. 6969.

§ 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 (h), 52 Stat. 1042; 21 U. S. C. 331 (h))

§ 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 manufacturer)

(Signature and post-office agent)

address of

address of

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

§ 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

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