5 ADULTERATION OF DRUGS 1 2 3 SEC. 4. A drug shall be deemed to be adulterated- 4 conditions of use prescribed in the labeling thereof. .5 (b) If its name is the same as or simulates a name 6 recognized in the United States Pharmacopoeia or National 7 Formulary or in any supplement thereto, official at the 8 time the drug is introduced into the interstate commerce, 9 or if it purports to be such a drug, and it fails to meet 10 the definition, formula, and description set forth therein, or 11 differs from the standard of strength, quality, or purity 12 as determined by the tests or methods of assay set forth 13 therein; except that whenever tests or methods of assay 14 have not been prescribed therein or such tests or methods. 15 of assay as are prescribed are found by the Secretary to 16 be insufficient, he is hereby authorized to prescribe by regu 17 lations, tests, or methods of assay for determining whether 18 19 or not such drug complies with such standards. No drug shall be deemed to be adulterated under this paragraph if 20 its label bears, in the manner and form prescribed by regu21 lations of the Secretary, a statement indicating wherein 22 its strength, quality, and purity differ from the standard 23 of strength, quality, and purity set forth in the United States 24 Pharmacopoeia or National Formulary or in any supple 6 1 ment thereto, official at the time the drug is introduced into 2 interstate commerce, as determined by the tests or methods 3 of assay applicable under this paragraph. 4 5 6 7 8 (c) If it is not subject to the provisions of paragraph (b) of this section and its identity or strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. (d) (1) If any substance has been mixed or packed 9 therewith so as to reduce its quality or strength; or (2) 10 if any substance has been substituted wholly or in part 11 therefor. 12 13 14 15 16 17 ADULTERATION OF COSMETICS SEC. 5. A cosmetic shall be deemed to be adulterated (a) If it is or may be injurious to the user under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. (b) If it bears or contains any poisonous or deleterious 18 ingredient prohibited, or in excess of the limits of tolerance 19 prescribed, by regulations as hereinafter provided. 20 21 MISBRANDING GENERAL SEC. 6. A food, drug, or cosmetic shall be deemed to 22 be misbranded 23 (a) If its labeling is in any particular false, or by 24 ambiguity or inference creates a misleading impression re25 garding any food, drug, or cosmetic. 1 2 7 (b) If in package form it fails to bear a label contain ing: (1) the name and place of business of the manufacturer, 3 packer, seller, or distributor; and (2) an accurate statement 4 of the quantity of the contents in such terms of weight, 5 measure, or numerical count as may be prescribed by regu6 lations of the Secretary: Provided, That under subdivision 7 10 11 13 (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages of foods and 9 cosmetics shall be established, by regulations prescribed by the Secretary: And provided further, That such classes of canned foods as the Secretary finds, after notice and hear12 ing, are, in accordance with the practice of the trade, labeled in substantial quantities at establishments other than the establishments where processed or packed, shall be ex15 empted by regulations from the requirements of this para16 graph during transportation from the establishment where 17 processed or packed to an establishment for labeling, if such 18 articles are labeled in conformity with the provisions of this Act prior to removal from such labeling establishment. 14 19 20 (c) If any word, statement, or other information re21 quired on the label to avoid adulteration or misbranding 22 under any provisions of this Act is not prominently placed 23 thereon in such a manner as to be easily seen and in such 24 terms as to be readily intelligible to the purchasers and users of such articles under customary conditions of purchase 26 and use. 25 1 2 3 4 5 8 MISBRANDING OF FOOD SEC. 7. A food shall be deemed to be misbranded (a) If (1) its container is so made, formed, or filled as to mislead the purchaser, or (2) its contents fall below the standard of fill prescribed by regulations as hereinafter 6 provided. 7 8 food. 9 10 (b) If it is offered for sale under the name of another (c) If it is an imitation of another food, except that no imitation shall be deemed to be misbranded under this 11 paragraph if its label bears the word "imitation" in juxta12 position with and in type of the same size and prominence as the name of the food imitated. 13 14 15 16 (d) If it purports to be or is represented as a food for which a definition of identity has been prescribed by regula tions as hereinafter provided, and (1) fails to bear on its 17 label the name of the food defined in such terms as the 18 regulations specify, or (2) fails to conform to the definition. (e) If it purports to be or is represented as a food for 20 which standards of quality have been prescribed by regula 19 21 tions as hereinafter provided, and (1) fails to state on its 22 label, if so required by the regulations, a standard of quality 23 in such terms as the regulations specify, or (2) falls below 21 the standard stated on the label. 1 2 9 (f) If it purports to be or is represented as a food for which no definition of identity has been prescribed by regu 3 lations as hereinafter provided, and its label fails to bear 4 (1) the common or usual name of the food, if any there 5 be, and (2) the common or usual name of each ingredient 6 thereof in order of predominance by weight; except that -7 spices, flavors, and artificial colors may be designated as 8 such without naming each spice, flavor, or artificial color. 9 The Secretary is hereby authorized to prescribe by regu10 lations requirements for such further information on the label 11 thereof as he may deem necessary to protect the public 14 15 16 17 18 MISBRANDING OF DRUGS SEC. 8. A drug shall be deemed to be misbranded (a) (1) If its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, and fails to bear in juxtaposition with such name and in letters of the same size and prominence a statement that the 19 drug is not a cure for such disease; or (2) if its labeling 20 bears any representation, directly or by ambiguity or infer21 cnce, concerning the effect of such drug which is contrary to the general agreement of medical opinion. 22 23 (b) If it is for internal use by man and contains any 24 quantity of any of the following narcotic or hypnotic sub |