Regulation. [1.2] 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. For the purposes of this Act-]

(n) If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.

Regulation. [§ 1.3] 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.

CHAPTER III-PROHIBITED ACTS AND

PENALTIES

PROHIBITED ACTS

SEC. 301. The following acts and the causing thereof are hereby prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate com

merce.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404 or 505.

(g) The manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.

(h) The giving of a guaranty or undertaking referred to in section 303 (c) (2), which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, or cosmetic; or the giving of a guaranty or undertaking referred to in section 303 (c) (3), which guaranty or undertaking is false.

Regulation. [1.4] 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. The following acts and the causing thereof are hereby prohibited:]

(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.

PENALTIES

SEC. 303. (a) Any person who violates any of the provisions of section 301 shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine; but if the violation is committed after a conviction of such person under this section has become final such person shall be subject to imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine.

(b) Notwithstanding the provisions of subsection (a) of this section, in case of a violation of any of the provisions of section 301, with intent to defraud or mislead, the penalty shall be imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine.

(c) No person shall be subject to the penalties of subsection (a) of this section, (1) for having received in interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, unless he refuses to furnish on request of an officer or employee duly designated by the Administrator the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; or (2) for having violated section 301 (a) or (d), if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the effect, in case of an alleged violation of section 301 (a), that such article is not adulterated or misbranded, within the meaning of this Act, designating this Act, or to the effect, in case of an alleged violation of section 301 (d), that such article is not an article which may not, under the provisions of section 404 or 505, be introduced into interstate commerce; or (3) for having violated section 301 (a), where the violation exists because the article is adulterated by reason of containing a coal-tar color not from a batch certified in accordance with regulations promulgated by the Administrator under this Act, if such person establishes a guaranty or undertaking signed by, and containing the name and address of, the manufacturer

Public Law 717-75th Congress, Ch. 675-3rd Session, Supp. 5, [21 U. S. C. 301-392; 52 Stat. 10401059] Federal Food, Drug, and Cosmetic Act” -Continued.

of the coal-tar color, to the effect that such color was from a batch certified in accordance with the applicable regulations promulgated by the Administrator under this Act.

Regulation. [§ 1.5] (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 adul
terated or misbranded within the meaning of the Fed-
eral 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 under-
taking is given) is hereby guaranteed, as of the date of
such shipment or delivery, to be, on such date, not adul-
terated 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 or 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 ap-
plicable 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 guar-
antee that all coal-tar colors listed herein were manu-
factured by (name of manufacturer), and are from
batches certified in accordance with the applicable regu-
lations promulgated under the Federal Food, Drug, and
Cosmetic Act.

(Signature and post-office address of manufa (Signature and post-office address of agent.) (f) For the purpose of a guaranty or under section 303 (c) (3) of the Act the manufacturer or other delivery of a coal-tar color is the person such color.

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

(h) No representation or suggestion that an a anteed under the Act shall be made in labeling

SEIZURE

SEC. 304. (a) Any article of food, drug, cosmetic that is adulterated or misbrande troduced into or while in interstate cor while held for sale (whether or not the after shipment in interstate commerce, may not, under the provisions of section 4 be introduced into interstate commerce liable to be proceeded against while in commerce, or anytime thereafter, on libe mation and condemned in any district co United States within the jurisdiction of article is found: Provided, however, Tha for condemnation shall be instituted unde for any alleged misbranding if there is p any court a libel for condemnation proceed this Act based upon the same alleged mis and not more than one such proceeding sh stituted if no such proceeding is so pendi that such limitations shall not apply (1) v misbranding has been the basis of a prior in favor of the United States, in a crimina tion, or libel for condemnation proceedi this Act, or (2) when the Administrator able cause to believe from facts found with ing, by him or any officer or employee of th that the misbranded article is dangerous t or that the labeling of the misbranded fraudulent, or would be in a material res leading to the injury or damage of the pur consumer. In any case where the number o condemnation proceedings is limited as al vided the proceeding pending or instituted application of the claimant, seasonably ma moved for trial to any district agreed upon lation between the parties, or, in case of fail stipulate within a reasonable time, the clain apply to the court of the district in which th has been made, and such court (after gi United States attorney for such district re notice and opportunity to be heard) shall unless good cause to the contrary is shown, district of reasonable proximity to the cl principal place of business to which the c be removed for trial.

REPORT OF MINOR VIOLATIONS

SEC. 306. Nothing in this Act shall be c as requiring the Administrator to report f cution, or for the institution of libel or in proceedings, minor violations of this Act w

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CHAPTER IV-FOOD

DEFINITIONS AND STANDARDS FOR FOOD

SEC. 401. Whenever in the judgment of the Administrator such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations1 fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or ❝ reasonable standards of fill of container: Provided, That no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and melons. In prescribing any standard of fill of container, the Administrator shall give due consideration to the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and protective material. In the prescribing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and due allowance made for the differing characteristics of the several varieties of such fruit or vegetable. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Administrator shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. Any definition and standard of identity prescribed by the Administrator for avocadoes, cantaloupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing.

1 Service and Regulatory Announcements, Food, Drug, and Cosmetic No. 2, Rev. 1.

MISBRANDED FOOD

SEC. 403. A food shall be deemed to be misbranded

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

Regulation. [$ 1.7] (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. A food shall be deemed to be misbranded-]

(d) If its container is so made, formed, or filled as to be misleading.

888243-51-3

(e) 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. [§ 1.8] (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 similar phrase which expresses the facts.

or other

(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 threequarters 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 food 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

Public Law 717-75th Congress, Ch. 675-3rd Session, Supp. 5, [21 U. S. C. 301-392; 52 Stat. 10401059] "Federal Food, Drug, and Cosmetic Act" -Continued.

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 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 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, 14 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, instead of "1 quart 16 fluid ounces" the statement shall be “11⁄2 quarts" or "1 quart 1 pint"; instead of “24 ounces" the statement shall be “11⁄2 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 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 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 permitted 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.

(m) A food shall be exempt from compliance with the requirements of clause (2) of section 403 (e) of the Act if: (1) The quantity of the contents, as expressed in terms applicable to such food under the provisions of paragraph (e) (2) of this section, is less than one-half ounce avoirdupois, or less than one-half fluid ounce, or (in case the units of the food can be easily counted without opening the package) less than six units; or (2) The statement of the quantity of the contents of the package, together with all other words, statements, and information required by or under authority of the Act to appear on the label, cannot, because of insufficient label space, be so placed on the label as to comply with the requirements of section 403 (f) of the Act and regulations promulgated thereunder. [SEC. 403. A food shall be deemed to be misbranded-]

(f) 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. [§ 1.9] (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 403 (f) 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;

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; or

(6) Smallness or style of type in which such word, statement, 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 403 (e) or (i) 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 conspicuous-
ness to any word, statement, or other information than
is required by section 403 (f) 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 required 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 foreign language. (3) If the labeling 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 or labeling shall appear on the labeling in the foreign language.

[SEC. 403. A food shall be deemed misbranded—] (h) If it purports to be or is represented as

(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 401, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard.

REGULATIONS MAKING EXEMPTIONS

SEC. 405. The Administrator shall promulgate regulations exempting from any labeling requirements of this Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.

Regulation. [ 1.13] (a) (1) An open container is a container of rigid or semi-rigid construction, which is not closed by lid, wrapper, or otherwise.

(2) An open container of a fresh fruit or fresh vegetable, the quantity of contents of which is not more than one dry quart, shall be exempt from the labeling requirements of paragraphs (e), (g) (2) (with respect to the name of the food specified in the definition and standard), and (i) (1) of section 403 of the Act; but such exemption shall be on the condition that if two or more such containers are enclosed in a crate or other shipping package, such crate or package shall bear labeling showing the number of such containers enclosed therein and the quantity of the contents of each.

CHAPTER V-DRUGS AND DEVICES
MISBRANDED DRUGS AND DEVICES

SEC. 502. A drug or device shall be deemed to be misbranded

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

Regulation. [§ 1.101] (a) Among representations in the labeling of a drug or device which render such drug or device misbranded is a false or misleading representation with respect to another drug or device or a food or cosmetic.

(b) The labeling of a drug which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such drug 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. 502. A drug or device shall be deemed to be misbranded-]

(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. [§ 1.102] (a) If a drug or device 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 drug or device, such as "Manu factured 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 drug or device 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 drug or device 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 drug or device from the requirement that its label shall not be misleading in any particular.

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

(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 and users of such drug to express quantity thereof and which give accurate information as to such quantity. But if no general usage in expressing accurate information as to the quantity of such drug exists among consumers and users thereof, the statement of the quantity of a drug which is not in tablet, capsule, ampul, or other unit form shall be in terms of weight if the drug is solid, semisolid, or viscous, or in terms of measure if the drug is liquid; the statement of the quantity of a drug which is in such unit form shall be in terms of the numerical count of such units, supplemented, when necessary to give accurate information as to the quantity of such drug in the package, by such statement (in such terms, manner, and form as are not misleading) of the weight or measure of such units, or of the quantity of each active ingredient in each such unit, as will give such information.

(3) The statement of the quantity of a device shall be ex pressed in terms of numerical count.

(f) A statement of weight shall be in terms of the avoirdupois pound, ounce, and grain, or of the kilogram, gram, and milligram. A statement of liquid measure shall be in terms of the United States gallon of 231 cubic inches and quart, pint, fluid ounce, and fluid dram subdivisions thereof, or of the liter, milliliter, or cubic centimeter, and shall express the volume at 68° Fahrenheit (20° Centigrade).