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(i) The term "labeling" includes all labels and other

2 written, printed, and graphie matter, in any form what

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soever, accompanying any food, drug, device, or cosmetic.

(k) The term "advertisement" includes all representations of fact or opinion disseminated to the publie in any

manner or by any means other than by the labeling.

The term "medical profession" means the legal

ized professions of the healing art; and the term "medical 9 opinion" means the opinion, within their respective fields, of the practitioners of any branch of the medical profession, the practice of which is licensed by law in the State of Ter12 ritory where any drug or devise, to which such opinion relates, is held, sold, or distributed; and the term "scientifie opinion" means the opinion, within their respective 15 fields, of competent pharmacologists, physiologists, or toxi16 eologists.

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(m) The term "official compendium" means the United States Pharmacoperia, Homeopathie Pharmacopeia of the United States, National Formulary, or any supplement to any of them, official at the time any drug to which 21 the provisions thereof relate is introduced into interstate

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22 commerce,

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(n) The term "Department" means the Department

24 of Agriculture of the United States.

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(e) The term "Administration" means the Food

26 and Drug Administration of the Department.

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(a) (1) If it bears or contains any poisonous or dele

6 terious substance which may render it dangerous to health;

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or (2) if it bears or contains any added poisonous or added

8 deleterious substance which may render it injurious to health,

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or which is prohibited by section 304, or in excess of the 10 limits of tolerance prescribed by regulations as provided, 11 by sections 304, 701, and 703; or (3) if it consists in 12 whole or in part of any filthy, putrid, or decomposed sub13 stance, or if it is otherwise unfit for food; or (4) if it has 14 been prepared, packed, or held under insanitary conditions 15 whereby it may have become contaminated with filth, or 16 whereby it may have been rendered injurious to health; or 17 (5) if it is the product of a diseased animal or of an animal 18 which has died otherwise than by slaughter; or (6) if its 19 container is composed of any poisonous or deleterious sub20 stance which may render the contents injurious to health. (b) (1) If any valuable constituent has been in whole

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or in part abstracted therefrom; or (2) if any substance has 23 been substituted wholly or in part therefor; or (3) if

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damage or inferiority has been concealed in any manner;

or (4) if any substance has been added thereto or mixed or

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packed therewith so as to increase its bulk or weight, or

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reduce its quality or strength, or create a deceptive appear

anee.

(e) If it contains a coal tar color other than one from

a batch that has been certified in accordance with regula

6 tions as provided by sections 304, 701, and 703.

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(d) If it is confectionery or ice cream, it shall also

be deemed to be adulterated if it bears or contains any 9 alcohol, resinous glaze, or nonnutritive substance except 10 harmless coloring, harmless flavoring, natural gum, and 11 peetin: Provided, That this paragraph shall not apply to any 12 confectionery or ice cream by reason of its containing less 13 than one-half of 1 per centum by volume of alcohol derived 14 solely from the use of flavoring extracts, or to any chewing 15 gum by reason of its containing harmless nonnutritive masti 16 eatory substances.

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SEO 302. A food shall be deemed to be misbranded (a) If its labeling is false or misleading in any 20 particular.

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22 food.

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(b) If it is offered for sale under the name of another

(e) If it is an imitation of another food, and its label 24 fails to bear, in type of uniform size and prominence, the

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word "imitation" and, immediately thereafter, the name of

the food imitated.

(d) If its container is so made, formed, or filled as

to mislead the purchaser.

fe) If in package form it fails to bear a label contain

6 ing (1) the name and place of business of the manufae

7 turer, packer, seller, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight,

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measure, or numerical count: Provided, That under sub10 division (2) of this paragraph reasonable variations shall be 11 permitted, and exemptions as to small packages shall be 12 established, by regulations prescribed by the Secretary.

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(f) If any word, statement, or other information re14 quired on the label under any provision of this Act is not 15 prominently placed thereon in such a manner as to be 16 easily seen and in such terms as to be readily understood 17 by purchasers and users of such articles under customary 18 conditions of purchase and use, due consideration being 19 given to the size of the package.

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(g) If it purports to be or is represented as a food for which a definition and standard of identity has been pre22 seribed by regulations as provided by sections 303, 701, and 23 703, and it fails to conform to such definition and 24 standard, or (2) its label fails to bear the name of the food

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1 prescribed in the definition and standard, and if so required 2 by such regulations when such definition and standard permits 3 optional ingredients other than spices, flavors, and coloring, 4 the common names of such optional ingredients as are 5 present in such food.

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(b) If it purports to be or is represented as a food 7 for which a standard of quality or fill of container has 8 been prescribed by regulations as provided by sections 303, 9 701, and 703, and its quality or fill falls below such stand10 ard of quality or fill of container and its label fails to bear a statement, in such manner as the regulations specify, show12 ing that it falls below such standard of quality or fill of

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13 container.

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(i) If it is not subject to the provisions of para15 graph (g) of this section and its label fails to bear (1) the common or usual name of the food, if any there be, and 17 (2) in ease it is fabricated from two or more ingredients

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the common or usual name of each such ingredient; except 19 that spices, flavors, and colorings, other than those sold

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as such, may be designated as spices, flavors, and colorings 21 without naming each: Provided, That, to the extent that

22 compliance with the requirements of subdivision (2) of

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this paragraph is impracticable, exemptions shall be 24 established by regulations promulgated by the Secretary.