1 4) If it purports to be or is represented for special 2 dietary uses, such as by infants or invalids or for other 3 special nutritional requirements, and its label fails to bear, 4 if so required by regulations as provided by sections 701 5 and 703, statements concerning its vitamin, mineral, and 6 other dietary properties which fully inform the purchaser as to its nutritional value. 7 8 9 (k) If it bears or contains any artificial flavor, artificial color, or chemical preservative, which is not prohibited by 10 section 301, and it fails to bear a label stating that fact. 11 The Secretary is hereby authorized to promulgate 12 regulations exempting from any labeling requirement of this 13 Aet small open containers of fresh fruits and fresh vegetables 14 and also food which is, in accordance with the practice of 15 the trade, processed, labeled, or repacked in substantial 16 quantities at establishments other than those where origi17 nally processed or packed, on condition that such food is in 18 conformity with the provisions of this Act upon removal from such processing, labeling, or repacking establishment. 19 20 21 DEFINITIONS AND STANDARDS FOR FOOD SEO. 303. For the effectuation of the purposes of this 22 Aet the Secretary is hereby authorized to promulgate regulations, as provided by sections 701 and 703, fixing and 24 establishing for any food a definition and standard of iden 23 25 tity, and a reasonable standard of quality and/or fill of 10 1 container: Provided, That no standard of quality shall be 2 established for fresh fruits and fresh vegetables and no 3 standard of identity for fresh apples and fresh pears: And 4 provided further, That in any regulation pertaining to fill 5 of container the Secretary shall give due consideration to 6 the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and 8 protective material. 7 9 TOLERANCES FOR POISONOUS IN DIENTS IN FOOD AND 10 11 13 CERTIFICATION OF COAL-TAR COLORS FOR FOOD Sue. 304. (a) To safeguard the public health, no 12 poisonous or deleterious substance shall be added to any food except where such substance is required in the production 14 thereof or cannot be avoided by good manufacturing prae15 tice; but when such substance is so required or cannot be so 16 avoided, the Secretary is authorized, for the protection of 17 public health, to promulgate regulations, as provided by 18 sections 704 and 703, limiting the quantity therein or thereon. In determining the quantity of such added substance to be tolerated in or on different articles of food the 21 Secretary shall take into account the extent to which the 19 20 22 use of such substance is required or cannot be avoided in the 23 production of each such article, and the other ways in which 24 the consumer may be affected by the same or other poisonous 11 1 (b) The Secretary is hereby authorized to promulgate 2 regulations, as provided by sections 701 and 708, for the 3 certification of coal tar colors which are harmless and suit 4 able for use in food. 5 6 EMERGENCY PERMIT CONTROL SEO. 305. (a) Whenever the Secretary finds after 7 investigation that the distribution in interstate commerce of 8 any class of food may, by reason of contamination with 9 miero organisms during the manufacture, processing, or packing thereof in any locality, he injurious to health, and such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he is then, 10 11 12 13 14 and in such ease only, authorized to promulgate regulations, as provided by sections 701 and 703, governing the condi 15 tions of manufacture, processing, or packing for such tempo16 rary periods of time as may be necessary to protect the pub17 lie health, and thereafter no manufacturer, processor, or 18 packer of such class of articles shall introduce into interstate 19 commerce any such food unless he holds an unsuspended, valid permit issued by the Secretary as provided by the 21 regulations. 20 22 23 (b) The Secretary is authorized to issue such permits for such periods of time as he may by regulations prescribe 24 and to make regulations governing the issuance and renewal 25 thereof. The Secretary is authorized to suspend immedi 12 1 ately upon notice any permit issued under authority of this 2 section if it is found that any of the conditions of the permit 3 have been violated. The holder of a permit so suspended 4 shall be privileged at any time to apply for the reinstatement 5 of such permit, and the Secretary shall immediately after 6 prompt hearing and an inspection of the establishment, rein 7 state such permit if it is found that adequate measures have 8 been taken to comply with and maintain the conditions of 9 the permit, as originally issued or as amended. 10 11 fe) Any officer or employee duly designated by the Seeretary shall have access to any factory or establishment, 12 the operator of which holds a permit from the Secretary, for 13 the purpose of ascertaining whether or not the conditions of 14 the permit are being complied with, and denial of access for 15 such inspection shall be ground for suspension of the permit 16 until such access is freely given by the operator. 17 18 19 CHAPTER IV ADULTERATED DRUGS SECTION 401. A drug shall be deemed to be adul 20 terated 22220 21 (a) (1) If it consists in whole or in part of any filthy, 22 putrid, or decomposed substance; or (2) if it has been 23 prepared, packed, or held under insanitary conditions 24 whereby it may have been contaminated with filth, or 25 whereby it may have been rendered injurious to health, or 13 1 (3) if its container is composed of any poisonous or dele 2 3 4 terious substance which may render it injurious to health; or (4) if it contains, for purposes of coloring only, a coal tar color other than one from a batch that has been certified in 5 accordance with regulations as provided by sections 408, 6 701, and 703. 7 (b) If its name is recognized in an official com 8 pendium, or if it purports to be a drug the name of which is 9 so recognized, and it differs from the standard of strength, 10 quality, or purity as determined by the tests or methods of assay set forth therein; except that whenever tests or metheds of assay have not been prescribed therein, or such tests 11 12 13 or methods of assay as are prescribed are insufficient, for 14 determining whether or not such drug complies with such 15 standard, the Secretary is hereby authorized to bring such fact to the attention of the appropriate body charged with the revision of such compendium and if such body fails within 16 17 18 19 21 a reasonable time to prescribe tests or methods of assay which are sufficient, then the Secretary may prescribe for the pur20 poses of this Act such tests or methods of assay by regulations as provided by sections 701 and 708. No drug shall be 22 deemed to be adulterated under this paragraph because it 23 differs from the standards of strength, quality, or purity 24 therefor set forth in an official compendium, if its standard 25 of strength, quality, or purity be plainly stated on its |