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CHAPTER FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION

AND WELFARE

SUBCHAPTER A-GENERAL

Part 1

3 4 8 9

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

Act.
Statements of general policy or interpretation.
Official records and information.
Color additives.
Color certification.

SUBCHAPTER B-FOOD AND FOOD PRODUCTS

10 14 15 16 17 18 19

20 22 25 27

Definitions and standards for food.
Cacao products; definitions and standards of identity.
Cereal flours and related products; definitions and standards of identity.
Macaroni and noodle products; definitions and standards of identity.
Bakery products; 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.
Frozen desserts; definitions and standards of identity.
Food flavorings; definitions and standards of identity.
Dressings for food.
Canned fruits and canned fruit juices; definitions and standards of identity;

quality; and fill of container.
Fruit butters, fruit jellies, fruit preserves, and related products; definitions

and standards of identity.
Shellfish.
Fish; definitions and standards of identity; standards of fill of container.
Eggs and egg products; definitions and standards of identity.
Oleomargarine, margarine; definitions and standard of identity.
Nut products; definitions and standards of identity.
Canned vegetables; definitions and standards of identity; quality; and fill

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

29

36 37 42 45 46 51

53

Part

85 120

Seafood inspection.
Tolerances and exemptions from tolerances for pesticide chemicals in or

on raw agricultural commodities.
Food additives.
Label statements concerning dietary properties of food purporting to be

or represented for special dietary uses.

121 125

SUBCHAPTER C-DRUGS 130 New drugs. 131 Interpretative statements re warnings on drugs and devices for over-the

counter sale. 132 Registration of producers of drugs. 133 Drugs; current good manufacturing practice in manufacture, processing,

packing or holding. 141 Tests and methods of assay of antibiotic and antibiotic-containing drugs. 141a Penicillin and penicillin-containing drugs; tests and methods of assay. 141b Streptomycin (or dihydrostreptomycin) and streptomycin- (or dihydro

streptomycin-) containing drugs; tests and methods of assay. 141c Chlortetracycline (or tetracycline) and chlortetracycline- (or tetracycline-)

containing drugs; tests and methods of assay. 141d Chloramphenicol and chloramphenicol-containing drugs; tests and methods

of assay.

141e Bacitracin and bacitracin-containing drugs; tests and methods of assay. 146 General regulations for the certification of antibiotic and antibiotic-con

taining drugs. 146a Certification of penicillin and penicillin-containing drugs. 146b Certification of streptomycin (or dihydrostreptomycin) and streptomycin

(or dihydrostreptomycin-) containing drugs. 146c Certification of chlortetracycline (or tetracycline) and chlortetracycline

(or tetracycline-) containing drugs. 146d Certification of chloramphenicol and chloramphenicol-containing drugs. 146e Certification of bacitracin and bacitracin-containing drugs. 147 Antibiotics intended for use in the laboratory diagnosis of disease. 164 Certification of batches of drugs composed wholly or partly of insulin. 165 Habit-forming drugs.

SUBCHAPTER D-HAZARDOUS SUBSTANCES

191

Hazardous substances: definitions and procedural and interpretive regu

lations.

SUBCHAPTER E-REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS

OTHER THAN THE FOOD, DRUG, AND COSMETIC ACT

281 285 290

Enforcement of the Tea Importation Act.
Regulations under the Federal Caustic Poison Act.
Regulations for the enforcement of the Federal Import Milk Act.

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FOOD 1.7 Food; labeling; misbranding. 1.8 Food; labeling; required statements;

when exempt. 1,9 Food; labeling; prominence of re

quired statements. 1.10 Food: labeling; designation of ingredi

ents. 1.11 Special dietary uses. 1.12 Food; labeling; artificial flavoring of

coloring, chemical preservatives. 1.13 Food: exemptions from labeling re

quirements. 1.14 Food; labeling; exemption from dec

laration of markers.

DRUGS AND DEVICES

1.705 Appearances. 1.706 Order of procedure. 1.707 Submission and receipt of evidence 1.708 Transcript of the testimony. 1.709 Oral and written arguments. 1.710 Filing the record of the hearing. 1.711 Copies of the record of the hearing.

cracin-containing drugs; tests and methods of assay. for the certification of antibiotic and antibiotic-con

ISSUANCE OF ORDER

1.712 Proposed order. 1.713 Exceptions. 1.714 Final order.

illin and penicillin-containing drugs. comycin (or dihydrostreptomycin) and streptomycinmycin-) containing drugs. tetracycline (or tetracycline) and chlortetracycline-ntaining drugs. mphenicol and chloramphenicol-containing drugs. acin and bacitracin-containing drugs. r use in the laboratory diagnosis of disease. es of drugs composed wholly or partly of insulin.

§ 1.1

1.100 Drugs; name. 1.101 Drugs and devices; labeling, mis

branding. 1.102 Drugs and devices; labeling require

ments, 1.103 Drugs and devices; forms of making

required statements. 1.104 Drugs; statement of ingredients. 1.105 Prescription-drug advertisements. 1.106 Drugs and devices; directions for use. 1.107 Drugs and devices; exemptions. 1.108 Drugs and devices; statement of pol

icy re Spanish-language versions of

required labeling statements. 1.115 Definition of term "Insulin."

COSMETICS 1.201 Cosmetic; labeling; misbranding. 1 202 Cosmetic; labeling; required state

ments; exemptions. 1203 Cosmetic: labeling requirements, form

of stating. 1204 Cosmetic; labeling requirements; ex

RD-HAZARDOUS SUBSTANCES

PUBLIC NOTICE OF REGULATIONS 1.715 Public notice of regulations.

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

GENERAL General regulation. (a) The provisions of regulation promulgated under the act with respec to the doing of any act shall be ap plicable also to the causing of such act to be done.

(b) The definitions and interpreta tions of terms contained in section 20 of the act shall be applicable also to suc terms when used in regulations promul gated under the act. (Sec. 701, 52 Stat. 1055, as amended; 2 U. S. C. 371)

DEFINITIONS AUTHORITY: $$ 1.2 and 1.3 1ssued unde sec. 701, 52 Stat. 1055, as amended, 2 U. 8. C. 371. Statutory provisions inte

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definitions and procedural and interpretive regu

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emptions.

IMPORTS AND EXPORTS

1.316 Definitions. 1.316 Notice of sampling. 1.317 Payment for samples. 1318 Hearing.

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preted or applied are cited to text in parenthoses. § 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 commerce. (Sec. 201, 52 Stat. 1041, as amended; 21 U. 8. C. 821) 8 1.3 Difference of opinion among ex

perts. 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, 62 Stat. 1041, as amended; 21 U. 8. C. 821)

PROHIBITED ACTS AND PENALTIES AUTHORITY: $$ 1.4 to 1.6 issued under SEC. 701, 62 Stat. 1065, as amended; 21 U. 8. 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, 62 Stat. 1042, as amended; 21 U. 8. C. 881) 8 1.5 Guaranty; definition, and sug.

gested 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 ar. ticle listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or 18 an article which may not, under the provisions of section 404 or 506 of the act, be introduced into Interstate commerce.

(Signature and post-ofice 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 neaning 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-omce 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 the color additive 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 color additives listed herein were manufactured by him, and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under

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the Federal Food, Drug, and Cosmetic Act.

(Signature and post-office address of manwacturer.)

(2) For foreign manufacturers:

(Name of manufacturer and agent) hereby severally guarantee that all color additives Usted herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.

(Signature and post-ofice 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 color additive 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)

[20 FR. 9526, Dec. 20, 1955, as amended at 28 FR. 6398, June 21, 1963) & 1.6 Presentation of views under sec

tion 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. 1046, as amended; 21 U. S. C. 836)

FOOD AUTHORITY: $$ 1.7 to 1.14 Issued under sec. 701, 52 Stat. 1066, as amended; 21 U. 8. C. 871. Statutory provisions interpreted or applied are cited to text in parentheses. 8 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 state

ments; 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.

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