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CHAPTER #FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION

AND WELFARE

(Parts 1 to 119)

SUBCHAPTER A-GENERAL

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

Act.
Administrative functions, practices, and procedures.
Statements of general policy or interpretation.
Official records and information.
Food; exemptions from labeling requirements.
Color additives.
Color certification.

SUBCHAPTER B-FOOD AND FOOD PRODUCTS

10 Definitions and standards for food. 14 Cacao products. 15 Cereal flours and related products. 16 Macaroni and noodle products. 17 Bakery products. 18 Milk and cream. 19 Cheeses, processed cheeses, cheese foods, cheese spreads, and related foods. 20 Frozen desserts. 22 Food flavorings. 25 Dressings for food. 27 Canned fruits and fruit juices. 29 Fruit butters, fruit jellies, fruit preserves, and related products. 31 Nonalcoholic beverages. 36 Shellfish. 37 Fish. 42 Eggs and egg products. 45 Oleomargarine, margarine. 46 Nut products. 51 Canned vegetables. 53 Tomato products. 85 Seafood inspection. 86—119 [Reserved]

SUBCHAPTER A-GENERAL

PART 1-REGULATIONS FOR THE EN

FORCEMENT OF THE FEDERAL
FOOD, DRUG, AND COSMETIC ACT

GENERAL
Sec.
1.1 General regulation.

DEFINITIONS 1.2 Labeling; definition. 1.3 Difference of opinion among experts.

PROHIBITED ACTS AND PENALTIES 1.4 Guaranty. 1.5 Guaranty; definition, and suggested

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

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 or

coloring, chemical preservatives.

DRUGS AND DEVICES 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. 1.203 Cosmetic; labeling requirements, form

of stating. 1.204 Cosmetic; labeling requirements; ex

emptions.

IMPORTS AND EXPORTS 1.315 Definitions. 1.316 Notice of sampling. 1.317 Payment for samples. 1.318 Hearing. 1.319 Application for authorization. 1.320 Granting of authorization. 1.321 Bonds.

Sec. 1.822 Costs chargeable in connection with

relabeling and reconditioning Inadmissible imports.

ADMINISTRATIVE 1.700 Examinations and investigations;

samples. SOURCE: The provisions of this Part 1 appear at 20 F.R. 9526, Dec. 20, 1955, unless otherwise noted.

GENERAL 8 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, 62 Stat. 1065, as amended; 21 U. S. C. 871)

DEFINITIONS AUTHORITY: 88 1.2 and 1.3 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted. § 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, 52 Stat. 1041, as amended; 21 U. 8. C. 821)

PROHIBITED ACTS AND PENALTIES AUTHORITY: 88 1.4 to 1.6 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted.

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8 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. S. C. 381) 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 18 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-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 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-ofice 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 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 color additives listed 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-office address of manufacturer.)

(Signature and post-ofice 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 F.R. 6398, June 21, 1968]

& 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 ofice 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 1.12 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted. $ 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.

(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 the quantity thereof. But if no general consumer usage in expressing accurate information as to the quantity of such food exists, the statement shall be in terms of liquid measure if the food is liquid, or in terms of weight if the food is solid, semisolid, viscous, or a mixture of solid and liquid; except that such statement may be in terms of dry measure if the food is a fresh fruit, fresh vegetable, or other dry commodity.

(f) (1) A statement of weight shall be in terms of the avoirdupois pound and ounce. A statement of liquid measure shall be in terms of the United States gallon of 231 cubic inches and quart, pint, and fluid Ounce subdivisions thereof, and, except in case of frozen food which is so consumed, shall express the volume at 68° Fahrenheit (20° Centigrade). A statement of dry measure shall be in terms of the United States bushel of 2150.42 cubic inches and peck, dry quart, and dry pint subdivisions thereof; or in terms of the United States standard barrel and its subdivisions of third, half, and three-quarters barrel. However, in the case of an export shipment, the statement may be in terms of a system of weight or measure in common use in the country to which such shipment is exported.

(2) A statement of weight or measure in the terms specified in subparagraph (1) of this paragraph may be supplemented by a statement in terms of the metric system of weight or measure.

(3) Unless an unqualified statement of numerical count gives accurate information as to the quantity of food in the package, it shall be supplemented by such statement of weight, measure, or size of the individual units of the foods as will give such information.

(g) Statements shall contain only such fractions as are generally used in expressing the quantity of the food. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places.

(h) (1) If the quantity of food in the package equals or exceeds the smallest unit of weight or measure which is specified in paragraph (f) of this section, and which is applicable to such food under the provisions of paragraph (e) (2) of the section, the statement shall express the number of the largest of such units contained in the package (for example, the statement on the label of a package which contains one quart of food shall be “1 quart”, and not “2 pints" or “32 fluid ounces”), unless the statement is made in accordance with the provisions of subparagraph (2) of this paragraph. Where such number is a whole number and a fraction, there may be substituted for the fraction its equivalent in smaller units, if any smaller is specified in such paragraph (f) (for examples, 134 quarts may be expressed as "1 quart 112 pints" or "1 quart 1 pint 8 fluid ounces”; 11/4 pounds may be expressed as “1 pound 4 ounces"). The stated number of any unit which is smaller than the largest unit (specified in such paragraph (f)) contained in the package shall not equal or exceed the number of such smaller units in the next larger unit so specified (for examples, instead of "1 quart 16 fluid ounces” the statement shall be "112 quarts" or "1 quart 1 pint”; instead of “24 ounces" the statement shall be “142 pounds” or “1 pound 8 ounces").

(2) In the case of a food with respect to which there exists an established custom of stating the quantity of the con

tents as a fraction of a unit, which unit is larger than the quantity contained in the package, or as units smaller than the largest unit contained therein, the statement may be made in accordance with such custom if it is informative to consumers.

(i) The statement shall express the minimum quantity, or the average quantity, of the contents of the packages. If the statement is not so qualified as to show definitely that the quantity expressed is the minimum quantity, the statement shall be considered to express the average quantity.

(j) Where the statement expresses the minimum quantity, no variation below the stated minimum shall be per mitted except variations below the stated weight or measure caused by ordinary and customary exposure, after the food is introduced into interstate commerce, to conditions which normally occur in good distribution practice and which unavoidably result in decreased weight or measure. Variations above the stated minimum shall not be unreasonably large.

(k) Where the statement does not express the minimum quantity:

(1) Variations from the stated weight or measure shall be permitted when caused by ordinary and customary exposure, after the food is introduced into interstate commerce, to conditions which normally occur in good distribution practice and which unavoidably result in change of weight or measure;

(2) Variations from the stated weight, measure, or numerical count shall be permitted when caused by unavoidable deviations in weighing, measuring, or counting individual packages which occur in good packing practice. But under subparagraph (2) of this paragraph variations shall not be permitted to such extent that the average of the quantities in the packages comprising a shipment or other delivery of the food is below the quantity stated, and no unreasonable shortage in any package shall be permitted, even though overages in other packages in the same shipment or delivery compensate for such shortage.

(1) The extent of variations from the stated quantity of the contents permissible under paragraphs (j) and (k) of this section in the case of each shipment or other delivery shall be determined by the facts in such case.

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