74TH CONGRESS 18T SESSION AN ACT To prevent the adulteration, misbranding, and false advertising of food, drugs, devices, and cosmetics in interstate, foreign, and other commerce subject to the jurisdiction of the United States, for the purposes of safeguarding the public health, preventing deceit upon the purchasing public, and for other purposes. 3 Passed Senate 5-28-35 S. 5 IN THE HOUSE OF REPRESENTATIVES Mar 31, 1935 Referred to the Committee on Interstate and Foreign Commerce Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, CHAPTER I SECTION 1. That this Act may be cited as the "Federal 1 5. Food, Drugs, and Cosmetic Act." 2 CHAPTER II DEFINITION OF TERMS SECTION 201. As used in this Act, unless the context 4 otherwise indicates 5 (a) The term "food" includes all substances and prep 6 arations used for, or entering into the composition of, food, 7 drink, confectionery, chewing gum, or condiment for man or other animals. 8 9 10 11 14 (b) The term "drug", for the purposes of this Act and not for the regulation of the legalized practice of the healing art, includes (1) all substances and preparations rec12 ognized in the United States Pharmacopoeia, Homœopathic 13 Pharmacopoeia of the United States, or National Formulary, or any supplement to any of them; and (2) all substances and preparations intended for use in the diagnosis, cure, 16 mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances, and preparations, 18 other than food and cosmetics, intended to affect the structure or any function of the body. 15 17 19 20 21 (c) The term device", for the purposes of this Act and not for the regulation of the legalized practice of the 22 healing art, includes all devices intended (1) for the use 23 in diagnosis, cure, mitigation, treatment, or prevention of 24 disease in man or other animals; and (2) to affect the 25 structure or any function of the body. 2 3 4 5 3 (d) The term "cosmetic includes all substances and preparations, except soaps or household cleansers for which no medicinal or curative qualities are claimed by the manufacturers or retailers in labels or advertisements, in tended for cleansing, or altering the appearance of, or 6 promoting the attractiveness of, the person. 7 (e) The term "Territory Territory" means any Territory or 8 possession of the United States, including the District of 9 Columbia and excluding the Canal Zone. 10 11 12 (f) The term "interstate commerce means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce or manufacture within the District of Columbia or within any other Territory not 14 organized with a legislative body. 13 15 (g) The term person "includes individual, part 16 nership, corporation, and association. 17 (h) The term "Secretary" means the Secretary of 18 Agriculture. 19 20 (i) The term "label" means the principal display or displays of written, printed, or graphic matter (1) upon any food, drug, device, or cosmetic, or the immediate 22 container thereof, and (2) upon the outside container or 21 23 wrapper, if any there be, of the retail package of any food, 24 drug, device, or cosmetic. 1 1 4 (j) The term " labeling" includes all labels and other 2 written, printed, and graphic matter, in any form what 3 4 soever, accompanying any food, drug, device, or cosmetic. (k) The term "advertisement" includes all representa 5 tions of fact or opinion disseminated to the public in any 6 7 manner or by any means other than by the labeling. (1) The term "medical profession" means the legal8 ized professions of the healing art; and the term "medical 9 opinion" means the opinion, within their respective fields, 10 11 of the practitioners of any branch of the medical profession, the practice of which is licensed by law in the State or Ter12 ritory where any drug or devise, to which such opinion relates, is held, sold, or distributed; and the term "scien 13 14 tific opinion" means the opinion, within their respective 15 fields, of competent pharmacologists, physiologists, or toxi 16 cologists. 17 18 66 (m) The termn official compendium" means the United States Pharmacopoeia, Homœopathic Pharmacopoeia 19 of the United States, National Formulary, or any supple20 ment to any of them, official at the time any drug to 21 22 23 24 which the provisions thereof relate is introduced into inter state commerce. (n) The term "Department" means the Department of Agriculture of the United States. 5 (0) The term "Administration" means the Food and Drug Administration of the Department. 2 3 4 CHAPTER III ADULTERATED FOOD 5 SECTION 301. A food shall be deemed to be 6 adulterated 7 8 9 10 11 12 (a) (1) If it bears or contains any poisonous or deleterious substance which may render it dangerous to health; or (2) if it bears or contains any added poisonous or added deleterious substance which may render it injurious to health, or which is prohibited by section 304, or in excess of the limits of tolerance prescribed by regulations as provided 13 by sections 304, 701, and 703; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its 14 15 16 17 18 19 20 21 22 23 24 container is composed of any poisonous or deleterious sub- |