The subcommittee met at 10 a. m., Hon. Virgil Chapman (chair- Mr. CHAPMAN. The committee will please be in order. The pur- pose of this meeting is to conduct hearings on the subject of food and drugs legislation. The committee has before it S. 5, generally known as the "Copeland bill ", which already has passed the Sen- ate; also before this committee are H. R. 6906, introduced by Mr. Mead, New York; H. R. 8805, introduced by Dr. Sirovich, a Rep- resentative from New York; and H. R. 8941, introduced by Mrs. (The bills referred to are as follows:) [H. R. 6906, 74th Cong., 1st sess.] A BILL To revise and amend the Food and Drugs Act of June 30, 1906, as amended Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled That the Act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or mis- branded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes", approved June 30, 1906, as amended, is hereby amended in title to read "An Act to prevent the manufacture, shipment, and sale of adulterated or misbranded food, drugs and cosmetics; to prevent the false advertising of food, drugs, and cosmetics; and to regulate traffic therein "; and in the several sections thereof to read as "SECTION 1. This Act may be cited as the "Federal Food, Drug, and "SEC. 2. As used in this Act, unless the context otherwise indicates- "(b) The term 'drug' includes (1) all substances and preparations recog- nized in the United States Pharmacopoeia, National Formulary, or any supple- ment thereto official at the time of investigation, and intended for use as or in medicine for man or other animals; (2) all substances and preparations in- tended to be used for the cure, mitigation, treatment, or prevention of disease of either man or other animals; (3) all substances and preparations, other than food, intended to affect the structure or any function of the body; and (4) all devices intended to be used for the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of either man or other 1 "(c) The term 'cosmetic' includes all substances and preparations intended for external or orificial application in cleansing or altering the appearance of, or promoting the attractiveness of the person. "(d) 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. "(e) The term 'labeling' includes all labels and other written, printed, and graphic matter, in any form whatsoever, accompanying any food, drug, or cosmetic. "(f) The term advertisement' includes all advertisements and all representations of fact or opinion therein or commercially disseminated in any manner or by any means other than by the labeling. "(g) The terms interstate commerce' or commerce' mean (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 organized with a legislative body. "(h) The term 'territory' means any territory or possession of the United States, including the District of Columbia, but excluding the Canal Zone. "(i) The term 'person' shall be construed to import both the plural and the singular, as the case demands, and shall include individuals, corporations, companies, societies, and associations. “(j) The term 'Secretary', unless otherwise indicated, means the Secretary of Agriculture. 66 MANUFACTURE WITHIN TERRITORIES OR DISTRICT OF COLUMBIA "SEC. 3. It shall be unlawful for any person to manufacture within any Territory or the District of Columbia any article of food, drug, or cosmetic, which is adulterated or misbranded within the meaning of this Act; and any person who shall violate any of the provisions of this section shall be guilty of a misdemeanor and for each offense shall, upon conviction thereof, be fined not to exceed $500, or shall be sentenced to not more than one year's imprisonment, or both such fine and imprisonment, in the discretion of the court; and for each subsequent offense and conviction thereof shall be fined not to exceed $1,000, or sentenced to not more than two years' imprisonment, or both such fine and imprisonment, in the discretion of the court. 66 66 SHIPMENT IN INTERSTATE COMMERCE 'SEC. 4. The introduction into any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or from any foreign country, or shipment to any foreign country of any article of food, drug, or cosmetic, which is adulterated or misbranded, within the meaning of this act, is hereby prohibited; and any person who shall ship or deliver for shipment from any State or Territory or the District of Columbia, to any other State or Territory or the District of Columbia, or to a foreign country; or who shall receive in any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or foreign country, and having so received, shall deliver, in original unbroken packages, for pay or otherwise, or offer to deliver to any other person, any such article so adulterated or misbranded, within the meaning of this act; or any person who shall sell or offer for sale in the District of Columbia, or the territories of the United States any such adulterated or misbranded food, drug, or cosmetic, or export or offer to export the same to any foreign country, shall be guilty of a misdemeanor and for such offense be fined not exceeding $500 for the first offense, and upon conviction for each subsequent offense not exceeding $1.000, or by imprisonment not exceeding 2 years, or both, in the discretion of the court: Provided, That no article shall be deemed misbranded or adulterated within the provisions of this act when intended for export to any foreign country and prepared or packed according to the specifications or directions of the foreign purchaser when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption, then this proviso shall not exempt said article from the operation of any of the other provisions of this act. DISSEMINATION OF FALSE ADVERTISING "SEC. 5. False advertisements of food, drugs, and cosmetics within the meaning, and for the purposes, of this act are hereby declared unlawful. "(a) The Federal Trade Commission is hereby empowered and directed to prevent such advertisements in the same manner as that whereby it is empowered and directed to prevent unfair methods of competition in commerce by an act of Congress approved September 26, 1914, entitled 'An act to create a Federal Trade Commission, to define its powers and duties, and for other purposes, and amendments thereto; "(b) The Secretary shall report to the Federal Trade Commission all violations of this section, and shall furnish the said Commission, upon its request, scientific information as to the properties, qualities, and effects of any food, drug, or cosmetic; "(c) Upon a showing by the Federal Trade Commission satisfactory to the court that any advertisement is false or deceptive in manner or degree to render said advertisement, or the article of food, drug, or cosmetic in the sale of which said advertisement is disseminated, imminently dangerous to public health, the District Courts of the United States and the Supreme Court of the District of Columbia are hereby vested with jurisdiction to restrain the dissemination of said advertisement pending the final determination of the proceedings in the Federal Trade Commission. 66 "ADULTERATED FOOD SEC. 6. A food shall be deemed to be adulterated"(a) If it is dangerous to public health; 66 '(b) (1) If it bears or contains any added poisonous or other added deleterious substances which may render such food injurious to health; or (2) if its container bears or is composed of any poisonous or deleterious substance which may by contamination render such food injurious to health; or (3) in the case of an ingredient, if its use in the composition of a food, as defined in section 2 (a) (1) and (2) of this Act, would render such food injurious to health; “(c) (1) If it consists, in whole or in part, of a filthy, decomposed or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not; or (2) if it is the product of a diseased animal, or one that has died otherwise than by slaughter; or (3) if it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth; or (4) in the case of an ingredient, if its use in the composition of a food, as defined in section 2 (a) (1) and (2) of this Act, would render such food unfit for consumption; 66 ' (d) (1) If any valuable constituent of the article has been, wholly or in part, abstracted; or (2) if any substance has been substituted, wholly or in part, for the article; or (3) if any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength; or (4) if any substance has been added to it or mixed or packed with it so as to increase its bulk or weight, whereby such food is deceptive; or (5) if any substance has been added to it or mixed or packed with it in any way so as to create a deceptive appearance, or (6) if damage or inferiority has been concealed in any manner; "(e) If it contains a coal-tar color other than one from a batch certified by the Secretary under this Act. The Secretary is hereby authorized to promulgate, after a duly advertised public hearing, regulations for the certification of coal-tar colors which are harmless and suitable for use in food; "(f) If it is confectionery or ice cream and bears or contains any alcohol, harmful resinous glaze, or nonnutritive substance except masticatory substances in chewing gum, coloring, flavoring, natural gums, gelatin, and pectin. "ADULTERATED DRUGS “SEC. 7. A drug shall be deemed to be adulterated 66 (a) If, when sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, or supplements thereto, it differs from the standard of strength, identity, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopoeia or National Formulary, or supplements thereto, shall be deemed to be adulterated under this provision if the standard of strength, identity, or purity be plainly stated upon the bottle, box, or other container thereof, although the standard may differ from that laid down in the United States Pharmacopoeia or National Formulary; (b) If its strength, identity, or purity differs from the professed standard or quality under which it is sold.. "ADULTERATED COSMETICS "SEC. 8. A cosmetic shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substances 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. 66 MISBRANDED FOOD "SEC. 9. A food shall be deemed to be misbranded "(a) (1) If its labeling is false or misleading in any particular; "(b) If its container is so made, formed, or filled, as to mislead the purchaser. In construing and applying this paragraph, as to the fill of a container, reasonable variations and tolerances shall be permitted, which allow for subsequent shrinkage or expansion of the food and for discrepancies due to a natural or other cause beyond reasonable control in good commercial practice; "(c) If it is offered for sale under the name of another food; "(d) If it bear a copy, counterfeit, or colorable imitation of the trade mark, label, or identifying name or device of another person; "(e) 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; "(f) If in package form, and it fails to bear a label plainly and correctly stating (1) the name and address of the manufacturer, packer, distributor, or seller; and (2) the quantity of the contents in terms of weight, measure, or numerical count. In construing and applying subdivision (2) of this paragraph reasonable variations and tolerances shall be permitted, which allow for discrepancies due to a natural or other cause beyond reasonable control in good -commercial practice; and reasonable exemption of small packages shall be made; “(g) (1) If it is a food for which the Secretary has prescribed a minimum standard of identity, quality, and/or fill, under this subdivision, and it falls below such standard, unless its label plainly indicates that fact. The Secretary is hereby authorized to prescribe one minimum standard of identity, quality. and/or fill for each generic class of food, which is reasonable in character and necessary for the purposes of this Act, as and to the extent hereinafter defined: Provided, That nothing in this subdivision shall be construed or applied to prevent or restrict commerce in any proprietary food sold in compliance with the other provisions of this Act: Provided further, That in prescribing such standard the Secretary shall follow good commercial practice, if and to the extent he can do so consistently with the public interest; "(2) Whenever the Secretary shall determine upon such a minimum standard he shall first submit it to a public hearing, held not less than thirty days after the date of published notice thereof. If, after such hearing, the Secretary shall conclude that the standard should be prescribed by him under this subdivision he shall promulgate the standard accordingly. The standard so promulgated shall become effective on a date fixed by the Secretary, which date shall not be prior to ninety days after the date of promulgation. Any such promulgated standard may be amended or repealed, by the same procedure; "(h) If it is for a special dietary or nutritional use and its label does not contain a plain and correct informative statement which is adequate in the circumstances; "(i) If it is dangerous to health under the conditions of use prescribed in the labeling or advertisement thereof; "(j) A food put up at one establishment and labeled at another shall be exempt from the labeling requirements of this Act while in transit from the former to the latter establishment. 66 GENERAL-MISBRANDED DRUGS AND COSMETICS “SEO. 10. A drug or cosmetic shall be deemed to be misbranded 66 (a) If it fails to bear a label containing a statement of the name and address of the manufacturer, packer, seller, or distributor; 66 (b) If it bear a copy, counterfit, or colorable imitation of the trade-mark, label, or identifying name or device of another person; 66 (c) If the contents of the package as originally put up shall have been removed, in whole or in part, and other contents shall have been placed in such package; "d) If it is dangerous to health under the conditions of use prescribed in the labeling or advertisement thereof; "(e) If its labeling is false or misleading in any particular; “(f) A drug or cosmetic put up at one establishment and labeled at another shall be exempt from the labeling requirements of this Act while in transit from the former to the latter establishment. 66 MISBRANDED DRUGS 66 66 SEC. 11. A drug shall be deemed to be misbranded— (a) If it is offered for sale under the name of another drug; (b) If it is an imitation of another drug; "(c) If its labeling fails to state plainly and conspicuously complete and explicit directions for use, except, however, in the case of a drug advertised only to physicians, veterinarians, dentists, and pharmacists when such statement would involve danger to health; "(d) If it is for internal use by man and contains any quantity of any of the following narcotic or hypnotic substances: Alpha eucaine, barbituric acid compounds, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, sulphonmethane, or any habit forming narcotic or hypnotic substance chemically derived therefrom, 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'; 66 (e) If it contains any quantity of (1) any of the stimulant-depressant substances, ethyl alcohol, ethyl ether, or chloroform; or (2) any of the sedative substances, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, or hyoscyamine; or (3) any of the cumulative substances: arsenic, digitalis glucosides, mercury, ouabain, strophanthin, or strychnine; or (4) 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; "(f) If it is a drug liable to deterioration and its label fails to bear an appropriate precautionary statement; "(g) If its labeling shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein which is false or misleading. 66 FALSE ADVERTISEMENTS—FOODS, DRUGS, AND COSMETICS "SEC. 12. (a) An advertisement of a food, drug, or cosmetic shall be deemed to be false if it is false or misleading in any particular relative to the purposes of this Act regarding such food, drug, or cosmetic. An advertisement shall also be deemed to be false if such commodity is dangerous to health when used as prescribed or under customary conditions unless a warning of such danger is included in the advertisement. "(b) For the purpose of this Act, the advertisement of a drug for sale in interstate commerce representing it to have any therapeutic effect in the treatment of Bright's disease, cancer, tuberculosis, venereal disease, heart or vascular disease, poliomyelitis (infantile paralysis) shall be deemed to be false; except that no advertisement not in violation of subsection (a) of this section shall be deemed to be false under this paragraph if it is disseminated only to members of the medical or pharmaceutical professions or appears only in scientific periodicals of these professions, or if it is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs. |