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Public Law 717—75th Congress, Ch. 675—3rd Ses

sion, Supp. 5, [21 U. S. C. 301-392; 52 Stat. 1040 1059]—"Federal Food, Drug, and Cosmetic Act” -Continued.

(g) Statements of the quantity of a drug shall contain only such fractions as are generally used in expressing the quantity of such drug. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than three places, except in the case of a statement of the quantity of an active ingredient in a unit of a drug. (h) (1) Unless made in accordance with the provisions of

subparagraph (2) of this paragraph, a statement of
the quantity of a drug, in the terms of weight or
measure applicable to such drug under the provisions
of paragraph (e) (2) of this section, shall express
the number of the largest unit specified in paragraph
(f) of this section which is contained in the package
(for example, the statement of the label of a package
which contains one pint of a drug shall be “1 pint,”
and not "16 fluid ounces"). Where such number is a
whole number and a fraction, there may be substi-
tuted for the fraction its equivalent in smaller units,
if any smaller is specified in such paragraph (f) (for
example, 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 para-
graph (f)) contained in the package shall not equal
or exceed the number of such smaller units in the
next larger unit so specified (for example, instead of
"1 quart 16 fluid ounces" the statement shall be "142

quarts" or "l quart 1 pint").
(2) In the case of a drug with respect to which there exists

an established custom of stating the quantity of the contents 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 of the quantity of a drug or device 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, except in the case of ampuls, shall be considered to express the average quantity. The state. ment of the quantity of a drug in ampuls shall be considered to express the minimum quantity.

(j) Where the statement expresses the minimum quantity, no variation below the stated minimum shall be permitted except variations below the stated weight or measure of a drug caused by ordinary and customary exposure, after such drug 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. In the case of a liquid drug in ampuls the variation above the stated measure shall comply with the excess volume prescribed by the National Formulary for filling of ampuls. (k) Where the statement does not express the minimum

quantity: (1) Variations from the stated weight or measure of a

drug shall be permitted when caused by ordinary and customary exposure, after such drug 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 nu.

merical count of a drug or device shall be permitted
when caused by unavoidable deviations in weighing,
measuring, or counting the contents of individual
packages which occur in good packing practice.
But under subparagraph (2) of this paragraph varia-
tions shall not be permitted to such extent that the
average of the quantities in the packages comprising a
shipment or other delivery of the drug or device 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 (i) and (k) of this regulation in the case of each shipment or other delivery shall be determined by the facts in such case.

(m) A drug or device shall be exempt from compliance with the requirements of clause (2) of section 502 (b) of the Act if: (1) The statement of the quantity of the contents, as ex

pressed in terms applicable to such drug or device under the provisions of paragraph (e) (2) of this sec. tion, together with all other words, statements, and information required by or under authority of the Act to appear on the label of such drug or device, cannot, because of insufficient label space, be so placed on the label as to comply with the requirements of section 502 (c) of the Act and regulations promulgated there

under, or (2) The quantity of the contents of the package, as ex

pressed in terms of numerical count in compliance with paragraph (e) (2) or (3) of this section, is less than six units, and such units can be easily counted

without opening the package. (SEC. 502. A drug or device shall be deemed to be misbranded-1

(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Regulation. [$ 1.103] (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 502 (c) 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 promi

nent placing of such word, statement, or information; (4) Insufficiency of label space (for the prominent plac

ing of such word, statement, or information) result. ing 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 in

formation, or to any design or device; or (6) Smallness or style of type in which such word, state

ment, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding

with other written, printed, or graphic matter. (b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502 (b) or (e) 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

authority 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 502 (c) 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 re

quired by or under authority of the Act to appear on the label or labeling shall appear thereon in the

English language. (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 for

eign language. (3) If the labeling contains any representation in a for

eign 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 the labeling in the foreign language.

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the actual place where each package of such cosmetic 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 cosmetic from the requirement that its label shall not be misleading in any par. ticular. (e) (1) The statement of the quantity of the contents

shall reveal the quantity of cosmetic in the package, exclusive of wrappers and other material packed with

such cosmetic. (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 cosmetic and which give accurate information as to the quantity thereof. But if no general consumer usage in expressing accurate information as to the quality of such cosmetic exists, the statement shall be in terms of liquid measure if the cosmetic is liquid, or in terms of weight if the cosmetic is solid, semisolid, or viscous, or in such terms of numerical count, or numerical count and weight or measure, as will give accurate information as to the quantity of the

cosmetic in the package. (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 shall express the volume at 68° Fahrenheit (20° Centigrade). 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 ex

ported. (2) A statement of weight or measure in the terms speci.

fied 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 cosmetic in the package, it shall be supplemented by such statement of weight, measure, or size of the individual

units of the cosmetic as will give such information. (g) Statements shall contain only such fractions as generally used in expressing the quantity of the cosmetic. 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 cosmetic 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 cosmetic under the provisions of paragraph (e) (2) of this 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 pint of cosmetic shall be “1 pint" and not “16 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 example, 13/4 quarts may be expressed as "1 quart 11/2 pints” or “1 quart 1 pint 8 fluid ounces”; 114 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, in. stead of "I quart 16 fluid ounces" the statement shall be “11/2 quarts" or "l quart 1 pint”; instead of "24 ounces" the statement shall be “11/2 pounds" or "I pound 8 ounces").

(i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading;

CHAPTER VI-COSMETICS

MISBRANDED COSMETICS SEC. 602. A cosmetic shall be deemed to be misbranded

(a) If its label is false or misleading in any particular.

Regulation. [$ 1.201] (a) Among representations in the labeling of a cosmetic which render such cosmetic misbranded is a false or misleading representation with respect to another cosmetic or a food, drug, or device.

(b) The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic 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. 602. A cosmetic shall be deemed to be misbranded-1

(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted and exemptions as to small packages shall be established, by regulations prescribed by the Administrator.

Regulation. [$ 1.202] (a) If a cosmetic 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 cosmetic 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) Where a person manufactures, packs, or distributes a cosmetic at a place other than his principal place of business, the label may state the principal place of business in lieu of

are

Public Law 717—75th Congress, Ch. 675—3rd Ses

sion, Supp. 5, [21 U. S. C. 301-392; 52 Stat. 1040– 1059]— "Federal Food, Drug, and Cosmetic Act" -Continued. (2) In the case of a cosmetic with respect to which there

exists an established custom of stating the quantity of the contents as a fraction of a unit, which unit is larger than the quantity contained in a 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 quan. tity 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 permitted except variations below the stated weight or measure caused by ordinary and customary exposure, after the cosmetic 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 cosmetic is introduced into inter-
state commerce, to conditions which normally occur
in good distribution practice and which unavoidably
result in change of weight or measure.
Variations from the stated weight, measure, or numeri.
cal count shall be permitted when caused by unavoid.
able deviations in weighing, measuring, or counting
individual packages which occur in good packing
practice. But under subparagraph (2) of this para-
graph variations shall not be permitted to such ex-
tent that the average of the quantities in the pack-
ages comprising a shipment or other delivery of the
cosmetic is below the quantity stated, and no un.
reasonable 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.

(m) A cosmetic shall be exempt from compliance with the requirements of clause (2) of section 602 (b) of the Act if the quantity of the contents of the package, as expressed in terms applicable to such cosmetic under the provisions of paragraph (e) (2) of this section, is less than one-fourth ounce avoirdupois, or less than one-eighth fluid ounce, or (in case the units of the cosmetic can be easily counted without opening the package) less than six units.

[SEC. 602. A cosmetic shall be deemed to be misbranded— ]

(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Regulation. [$ 1.203] (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 602 (c) 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 in.

formation, or to any design or device; (6) Smallness or style of type in which such word, state.

ment, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding

with other written, printed, or graphic matter. (b) (1) All words, statements, and other information re

quired by or under authority of the Act to appear on the label or labeling shall appear thereon in the Eng.

lish language. (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. SEC. 602. A cosmetic shall be deemed to be misbranded-1

(d) If its container is so made, formed, or filled as to be misleading. CHAPTER VII—GENERAL ADMINISTRATIVE

PROVISIONS

EXAMINATIONS AND INVESTIGATIONS SEC. 702. (a) The Administrator is authorized to conduct examinations and investigations for the purposes of this Act through officers and employees of the Agency or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Administrator as an officer of the Agency. In the case of food packed in a Territory the Administrator shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all provisions of this Act, the facilities at his disposal will permit of such inspection. For the purposes of this subsection the term “United States” means the States and the District of Columbia.

CHAPTER IX_MISCELLANEOUS Sec. 902. (a)

the Act of March 4, 1923 12 (U. S.C., 1934 ed., title 21, sec. 6; 42 Stat. 1500, ch. 268), defining butter and providing a standard therefor;. the Act of July 24, 1919 13 (U. S. C., 1934 ed., title 21, sec. 10; 41 Stat. 271, ch. 26), defin. ing wrapped meats as in package form shall remain in force and effect and be applicable to the provisions of this Act.

(b) Meats and meat food products shall be exempt from the provisions of this Act to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended (U. S. C., 1934 ed., title 21, secs. 71-91; 34 Stat. 1260 et seq.).

shall issue and cause to be served on such person, partnership, or corporation an order requiring such person, partnership, or corporation to cease and desist from using such method of competition or such actor practice.

[1914; last amended 1938.] U. S. Code, 1946 Ed., Title 7, Ch. 6—"Federal Iosec

ticide, Fungicide and Rodenticide Act.” Sec. 135. Definitions.

For the purposes of sections 135-135k

a. The term "economic poison” means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any

insects, rodents, fungi, weeds, and other forms of plant or animal life or viruses, except viruses on or in living man or other animals, which the Secretary shall declare to be a pest.

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p. The term "Secretary" means the Secretary of Agriculture.

r. The term “label” means the written, printed, or graphic matter on, or attached to, the economic poison or device or the immediate container thereof, and the outside container or wrapper of the retail package, if any there be, of the economic poison or device.

(Approved June 25, 1938.) 12 That for the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768), “butter" shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without ad. ditional coloring matter, and containing not less than 80 per. centum by weight of milk fat, all tolerances having been allowed for

13 That the word “package” where it occurs the second and last time in the Act entitled "An act to amend section 8 of an act entitled, 'An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved March 3, 1913, shall include and shall be construed to include wrapped meats inclosed in papers or other materials as prepared by the manufacturers thereof for sale. U. S. Code, 1946 Ed., Title 15, Ch. 24"Federal Trade

Commission Act.” Sec. 45. Unfair methods of competition unlawful; prevention; proceeding by commission.

(a) Unfair methods of competition in commerce, and unfair or deceptive acts or practices in commerce, are hereby declared unlawful.

The Commission is empowered and directed to prevent persons, partnerships, or corporations, except banks, common carriers subject to the Acts to regulate commerce, air carriers and foreign air carriers subject to chapter 9 of Title 49, and persons, partnerships, or corporations subject to sections 181-203, 205-228 and 229 of Title 7, except as provided in section 227 of Title 7, from using unfair methods of competition in commerce and unfair or deceptive acts or practices in commerce.

(b) Whenever the Commission shall have reason to believe that any such person, partnership, or corporation has been or is using any unfair method of competition or unfair or deceptive act or practice in commerce, and if it shall appear to the Commission that a proceeding by it in respect thereof would be to the interest of the public, it shall issue and serve upon such person, partnership, or corporation a complaint stating its charges in that respect and containing a notice of a hearing such hearing the Commission shall be of the opinion that the method of competition or the act or practice in question is prohibited by sections 41-46 and 47–58 of this title, it shall make a report in writing in which it shall state its findings as to the facts and

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(a) It shall be unlawful for any person to distribute, sell, or offer for sale in any Territory or in the District of Columbia, or to ship or deliver for shipment from any State, Territory, or the District of Columbia to any other State, Territory, or the District of Columbia, or to any foreign country, or to receive in any State, Territory, or the District of Columbia from any other State, Territory, or the District of Columbia, or foreign country, and having so received, deliver or offer to deliver in the original U.S. Code, 1946 Ed., Title 7, Ch. 6—"Federal Insecti

cide, Fungicide and Rodenticide Act”—Continued. unbroken package to any other person, any of the following:

whenever he believes that the public interest will be adequately served by a suitable written notice of warning. [1947)

(2) Any economic poison unless it is in the registrant's or the manufacturer's unbroken immediate container, and there is affixed to such container, and to the outside container or wrapper of the retail package, if there be one through which the required information on the immediate container cannot be clearly read, a label bearing

(c) the net weight or measure of the content: Provided, That the Secretary may permit reasonable variations.

Sec. 135e. Exemptions from penalties.

a. The penalties provided for a violation of section 135a (a)

shall not apply to (1) any person who establishes a guaranty signed by, and containing the name and address of the registrant or person residing in the United States from whom he purchased and received in good faith the article in the same unbroken package, to the effect that the article was lawfully registered at the time of sale and delivery to him, and that it complies with the other requirements of sections 135-135k

*, designating said sections. In such case the guarantor shall be subject to the penalties which would otherwise attach to the person holding the guaranty under the provisions of said sections;

(2) any carrier while lawfully engaged in transporting an economic poison or device if such carrier upon request by a person duly designated by the Secretary shall permit such person to copy all records showing the transactions in and movement of the articles;

(3) to public officials while engaged in the performance of their official duties;

(4) to the manufacturer or shipper of an economic poison for experimental use only by or under the supervision of any Federal or State agency authorized by law to conduct research in the field of economic poisons; or by others if a permit has been obtained before shipment in accordance with regu. lations promulgated by the Secretary. [1947]

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Sec. 135f. Penalties for violations.

(3) for any person to give a guaranty or undertaking provided for in section 135e

* which is false in any particular, except that a person who receives and relies upon a guaranty authorized under section 135e

may give a guaranty to the same effect, which guaranty shall contain in addition to his own name and address the name and ad. dress of the person residing in the United States from whom he received the guaranty or undertaking;

[1947] Sec. 135d. Rules and regulations; examinations; notification to violators.

a. The Secretary (except as otherwise provided in this section) is authorized to make rules and regulations for carrying out the provisions of sections 135– 135k

c. The examination of economic poisons or devices shall be made in the United States Department of Agriculture or elsewhere as the Secretary may designate for the purpose of determining from such examination whether they comply with the requirements of sections 135-135k

*, and if it shall appear from any such examination that they fail to comply with the requirements of said sections, the Secretary shall cause notice to be given to the person against whom criminal proceedings are contemplated.

Provided, That nothing in said sections shall be construed as requiring the Secretary to report for prosecution or for the institution of libel proceedings, minor violations of said sections

b. Any person violating any provision other than section 135a (a) (1)

shall be guilty of a misdemeanor and shall upon conviction be fined not more than $500 for the first offense, and on conviction for each subsequent offense be fined not more than $1,000 or imprisoned for not more than one year, or both such fine and imprisonment: Provided, That an offense committed more than five years after the last previous conviction shall be considered a first offense:

[1947]

Sec. 135g. Seizures.

a. Any economic poison or device that is being transported from one State, Territory, or District to another, or, having been transported, remains unsold or in original unbroken packages, or that is sold or offered for sale in the District of Columbia or any Territory, or that is imported from a foreign country, shall be liable to be proceeded against in any district court of the United States in the district where it is found and seized for confiscation by a process of libel for condemnation

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