FOODS, DRUGS, AND COSMETICS TUESDAY, FEBRUARY 27, 1934 UNITED STATES SENATE, The committee met at 10 a.m., pursuant to call, in the caucus room, Senate Office Building, Senator Hubert D. Stephens, presiding. Present: Senators Stephens (chairman), Copeland, Caraway, Clark, Murphy, Overton, McNary, Nye, Vandenberg, Patterson, Hebert, Brown, and Gibson. (The committee had under consideration S. 2800, which is here printed in full, as follows:) A BILL To prevent the manufacture, shipment, and sale of adulterated or misbranded food, drink, drugs, and cosmetics, and to regulate traffic therein; to prevent the false advertisement of food, drink, drugs, and cosmetics; and for other purposes Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Federal Food and Drugs Act." ADULTERATED DRUGS SEO. 2. As used in this Act, unless the context otherwise indicates (a) The term "food" includes all substances and preparations used for, or entering into the composition of, food, drink, confectionery, or condiment for man or other animals. (b) The term "drug", for the purposes of this Act and not to regulate the practice of medicine, includes (1) all substances and preparations recognized in the United States Pharmacopoeia, Homœopathic Pharmacopoeia of the United States, or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food, and all devices intended to affect the structure or any function of the body. (c) The term "cosmetic" includes all substances and preparations intended for cleansing, or altering the appearance of, or promoting the attractiveness of, the person. (d) The term "territory" means any territory or possession of the United States, including the District of Columbia. (e) The term "interstate commerce means (1) commerce between any State or Territory and any place outside thereof, or between points within the same State or Territory but through any place outside thereof, and (2) commerce or manufacture within the District of Columbia or within any other territory not organized with a legislative body. (f) The term " person" includes individual, partnership, corporation, and association. (g) The term "Secretary" means the Secretary of Agriculture. (h) The term "label" means the principal label or labels (1) upon the immediate container of any food, drug, or cosmetic, and (2) upon the outside container or wrapper, if any there be, of the retail package of any food, drug, or cosmetic. 1 (i) The term “labeling” includes all labels and other written, printed, and graphic matter, in any form whatsoever, accompanying any food, drug, or cosmetic. (j) The term "advertisement" includes all representations of fact or opinion disseminated in any manner or by any means other than by the labeling. (k) The term "medical profession means the professions of physicians, pharmacologists, dentists, and veterinarians; and the term "medical opinion means the opinion of physicians, pharmacologists, dentists, or veterinarians relating to the fields of their respective professions. (1) The term "official compendium means the United States Pharmacopoeia, Homœopathic Pharmacopoeia of the United States, National Formulary, or any supplement thereto, official at the time any drug to which the provisions thereof relate, is introduced into interstate commerce. ADULTERATED FOOD SEC. 3. A food shall be deemed to be adulterated (a) (1) If it bears on 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 prohibited, or in excess of the limits of tolerance prescribed, by regulations as provided by sections 10 and 22; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth; 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 container is composed of any poisonous or deleterious substance which may by contamination render the contents injurious to health. (b) (1) If any valuable constituent has been in whole or in part abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight in a deceptive manner, or reduce its quality or strength, or create a deceptive appearance. (c) If it is confectionery and bears or contains any alcohol, resinous glaze, or nonnutritive substance except masticatory substances in chewing gum, coloring, and flavoring. (d) If it contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by sections 10 and 22. ADULTERATED DRUGS SEC. 4. A drug shall be deemed to be adulterated (a) If it is dangerous to health under the conditions of use prescribed in the labeling thereof. (b) If its name is the same as or simulates a name recognized in an official compendium, or if it purports to be a drug the name of which is so recognized, and it (1) fails to meet the definition, formula, and description set forth therein, or (2) differs from the standard of strength, quality, or purity as determined by the tests or methods of assay set forth therein; except that whenever tests or methods of assay have not been prescribed therein, or such tests or methods of assay as are prescribed are insufficient, for determining whether or not such drug complies with such 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 a reasonable time to prescribe tests or methods of assay which are sufficient, then the Secretary may prescribe such tests or methods of assay by regulations as provided by section 22. No drug shall be deemed to be adulterated under subdivision (2) of this paragraph if its label bears, in juxtaposition with the name of the drug, a statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in he appropriate official compendium, as determined by the tests or methods of assay applicable under this paragraph. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homœopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homœopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia. (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) If any substance has been (1) mixed or packed therewith so as to reduce its quality or strength in a deceptive manner, or (2) substituted wholly or in part therefor. ADULTERATED COSMETICS SEC. 5. A cosmetic shall be deemed to be adulterated (a) If it bears or contains any poisonous or deleterious substance in such quantity as may render it 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 ingredient prohibited, or in excess of the limits of tolerance prescribed, by regulations as provided by sections 10 and 22. MISBRANDED FOOD, DRUGS, AND COSMETICS-GENERAL SEC. 6. A food, drug, or cosmetic shall be deemed to be misbranded (a) If its labeling is false or misleading in any particular. Any representation concerning any effect of a drug shall be deemed to be false under this paragraph if that representation is not supported by substantial medical opinion or by demonstrable scientific facts. (b) If in package form it fails to bear a label containing: (1) The name and place of business of the manufacturer, packer, sell, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under subdivision (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. (c) The Secretary is hereby authorized to promulgate regulations exempting from any labeling or packaging requirement of this Act food, drugs, and cosmetics which are, in accordance with the practice of the trade, processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such articles are in conformity with the provisions of this Act upon removal from such processing, labeling, or repacking establishment. (d) If any word, statement, or other information required on the label to avoid adulteration or misbranding under any provision of this Act is not prominently placed thereon in such a manner as to be easily seen and in such terms as to be readily intelligible to the purchasers and users of such articles under customary conditions of purchase and use. MISBRANDED FOOD SEC. 7. A food shall be deemed to be misbranded― (a) (1) If its container is so made, formed, or filled as to mislead the purchaser, or (2) if its contents fall below the minimum standard of fill prescribed by regulations as provided by sections 11 and 22. (b) If it is offered for sale under the name of another food. (c) If it is an imitation of another food, except that no imitation shall be deemed to be misbranded under this paragraph if its label bears the word “imitation" in juxtaposition with and in type of the same size and prominence as the name of the food imitated. (d) If it purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by sections 11 and 22, and (1) its label fails to bear the name of the food prescribed in the definition and minimum standard, or (2) it fails to conform to such definition and minimum standard. (e) If it purports to be or is represented as a food for which a minimum standard of quality has been prescribed by regulations as provided by sections 11 and 22, and (1) its label fails to bear, if so required by the regulations, a statement of a standard of quality in such terms as the regulations specify, or (2) it falls below such standard. (f) If it is not subject to paragraph (d) of this section and its label fails to bear (1) the common or usual name of the food, if any there be, and (2) the common or usual name of each ingredient such food bears or contains in order of predominance by weight; except that spices, flavors, and colorings, other than those sold as such, may be designated as spices, flavors, and colorings without naming each: Provided, That to the extent that compliance with the requirements of subdivision (2) of this paragraph is impracticable because of normal variations in ingredients or their quantities, usual to good manufacturing or packing practice, reasonable variations from the stated order of such ingredients shall be permitted, and exemptions as to packages of assorted food shall be established, by regulations promulgated by the Secretary. (g) If it is for special dietary uses, such as by infants or invalids or for other special nutritional requirements, and its label fails to bear, if so required by regulations as provided by section 22, statements concerning its vitamin, mineral, and other dietary properties which fully inform the purchaser as to its nutritional value. MISBRANDED DRUGS SEC. 8. A drug shall be deemed to be misbranded (a) 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 a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected. (b) If it is for internal use by man and contains any quantity of any of the following narcotic or hypnotic substances: Alpha eucaine, barbital, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, sulphon-methane or any narcotic or hypnotic substance chemically derived therefrom, or any other narcotic or hypnotic substance which is habit forming, and its label fails to bear the name and quantity or proportion of such substance or derivative in juxtaposition with the statement "Warning-May be habit forming." (c) If it contains any quantity of (1) any of the stimulant-depressant substances ethyl alcohol, ethyl ether, chloroform, or isopropyl alcohol; or (2) any of the sedative substances, acetanilid, actephenetidin, amidophyrine, antipyrine, atropine, bromides, hyoscine, or hyoscyamine; or (3) any of the cumulative substances arsenic, digitalis glucosides, mercury, ouabain, strophanthin, or strychnine; or (4) any crude plant material or preparation thereof in which any substance named in subdivision (2) or (3) above is present; or (5) any chemical compound of any substance named above possessing stimulantdepressant, sedative, or cumulative properties; and its label fails to bear a statement of the name and quantity or proportion of such substance, or crude plant material or preparation thereof, or chemical compound, as the case may be. (d) If it is not designated solely by a name recognized in an official compendium and its label fails to bear a common or usual name of the drug, if such there be. (e) If its labeling fails to bear plainly and conspicuously (1) complete and explicit directions for use, and (2) such warnings in such manner and form as may be prescribed by regulations, as provided by section 22, against use in such pathological conditions or by children where its use contraindicated and may be dangerous to health, or against unsafe dosage or methods of administration or application: Provided, That where any requirement of subdivision (1) of this paragraph, as applied to any drug, is not necessary for the protection of the public health, the Secretary shall promulgate regulations, as provided by section 22, exempting such drug from such requirement. (f) If its name is the same as, or simulates, a name recognized in an official compendium and it is not packaged and labeled as prescribed therein. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homœopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homœopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopœia. (g) If it has been designated by regulations, as provided by section 22, as a drug liable to deterioration, and is not packaged in such form or manner, or its label fails to bear a statement of such precautions, as such regulations require for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the Secretary shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and |