FOOD, DRUGS, AND COSMETICS THURSDAY, DECEMBER 7, 1933 UNITED STATES SENATE, SUBCOMMITTEE OF THE COMMITTEE ON COMMERCE, The subcommittee met, pursuant to call, in room 335 Senate Office Building, at 10:30 a.m., Senator Royal S. Copeland, presiding. Present: Senators Copeland, McNary, and Caraway. Senator COPELAND. The hearing will come to order, please. We have a crowded room. I am sorry wo have not chairs enough for everybody. Perhaps we can secure enough after awhile to fill the room. We had to go from a room which we had arranged into this larger one, and even this seems to be crowded. So you will help us a lot if you will be as quiet as possible. This is a hearing of the subcommittee of the Committee on Commerce to consider Senate Bill 1944, and the record at this point will show a copy of the bill. (S. 1944 is as follows:) In the Senate of the United States, June 6 (calendar day, June 12), 1933. Mr. Copeland introduced the following bill; which was read twice and referred to the Committee on Commerce. A BILL to prevent the manufacture, shipment, nud sale of adulterated or misbranded food, drugs, and cosmetics, and to regulate traffic therein, to prevent the false advertisement of food, 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." DEFINITIONS SEC. 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" includes (1) all substances and preparations recognized in the United States Pharmacopoeia 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 of man or other animals. (e) The term "cosmetic includes all substances and preparations intended for cleansing, or altering the appearance of, or promoting the attractiveness of the person. Except as indicated in paragraph (b) (3) of this section, the definitions of food, drug, and cosinetic shall not be construed as mutually exclusive. (d) The term "territory' means any territory or possession of the United States. (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 and manufacture within the District of Columbia or the Canal Zone or within any territory not organized with a legislative body. 1 2 FOOD, DRUGS, AND COSMETICS (f) The term "person" includes individual, partnership, corporation, and association. (g) The term "Secretary" means the Secretary of Agriculture. (h) The term “label" incans the princijal label or inbeis (1) upon the í amediate 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. (4) The ferm "Tabeling" includes all labels and other written, printed, and graphie 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 in package form" includes wrapped meats enclosed in paper or other materials as prepared by the manufac'urers thereof for sale. ADULTERATION OF FOOD Sec. 3. A food shall be deemed to be ad iterated: (a) (1) If it is or inay be dangerous to !alth; 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 hereinafter provided; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or (4) if it has beeo prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth; or (5) if it is the produce of a disensed 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 contammation 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 mixed or parked therewith so as to increase its Imilk or weight, or reduce its quality or strength, or create a deceptive appearance, (If it is confectionery and bears or contains any alcohol, resinous glaze, or nennutritive substance except rojoring and flavoring. (c) If it contams a coal far color of her than one from a batch that has been certified by the Secretary in accordance with regulations as hereinafter provided ADULTERATION OF DRUGS Sce. 1. A drug shali Le deemed to be adulterated: (0) If it is or tony be dangerous to health under the conditions of use prescribed in the inbeling thereef. (b) If its urine is the same as or simulates a nume recognized in the United States Phomeopoeia or National Formulary or in any supplement thereto, cfemal the time the drug is introduced into the interstate commerce, or if it purports e such a drug, and it fails to meet the definition, fornoda, and description set forth therein, or differs from the standard of strengin, quality, or purity as as determined by the tests or methods of assay set forth therein; except that whenever feeds or methods of assay have not been prescribed therein or such festa or methods of a way as are prescribed are found by the Secretary to be insufficient, ho is hereby authorized to prescribe by reguintion, fests, or methods of assay for determindag whether or not such drug compii » with such standards. No drug shall be deemed to be adulterated under than pourmample if its inbel bears, in the mmer and form prescribed be regulations of the Secretary, a statement indienting wherein its strenrih, quality, and purity differ from the standard of strength, quality, and purity set forth in the United States Pharmacopoem or National Formulary or in any supplement thereto, official at the time the drug is introduced into interstate commerce, as determined by the tests or methods of assay applicable under this porngraph. If it is not sidhjeet to the provisions of paragraph (b) of this section and its alentity or strength differs from or its purity or quality falls below, that which ports or is represented to possess. Chichi If any sulestance Ing been mixed or packed therewith so as to reduen da qonaty on streppih; or (2) of any substance has been substituted wholly or in FOOD, DRUGS, AND COSMETICS 3 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 proscribed 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 hereinafter provided. MISHRANDING-GENERAL SEC. 6. A food, drug, or cosmetic shall be deemed to be misbranded: (a) If its labeling is in any particular false, or by ambiguity or inference creates a misleading impression regarding any food, drug, or cosmetic. (b) If in package form it fails to bear a label containing: (1) the name and place of business of the manufacturer, packer, seller, or distributor; and (2) an acenrato statement of the quantity of the contents in such torms of weight, measure, or numerical count as may be prescribed by regulations of the Secretary: Provided, That under subdivision (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages of foods and 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 hearing, 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 exempted by regulations from the requirements of this paragraph during transportation from the establishment where processed or packed to an establishment for labeling, if such articles are labeled in conformity with the provisions, of this Act prior to removal from such labeling establishment. (c) If any word, statement, or other information required on the label to avoid adulteration or misbranding under any provisions of this Act is not prominently placed thereon in such a manner as to be easily seen and in such terins as to be readily intelligible to the purchasers and users of such articles under customary conditions of purchase and use. 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 provided. (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 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 prominent as the naine of the food imitated. " (d) If it purports to be or is represented as a food for which a definition of identity has been prescribed by regulations as hereinafter provided, and the fab to bear on its label the name of the food defined in such terms as the regulations specify, or (2) fails to conform to the definition. (e) If it purports to be or is represented as a food for which standards of quali have been prescribed by regulations as hereinafter provided, and (1) fails to stor on its label, if so required by the regulations, a standard of quality in such terma as the regulations specify, or (2) falls below the standard stated on the label. (f) If it purports to be or is represented as a food for which no definition or identity has been prescribed by regulations as hereinafter provided, and its label fails to bear (1) the common or usual name of the food, if any there be and o the common or usual name of each ingredient thereof in order of på dob by weight; except that spices, flavors, and artificial colors may be de ignated us such without naming each spice, flavor, or artificial color. The S hereby authorized to prescribe by regulations requirements for orel formation on the label thereof as he may deem necessary to protect the publ from deception. 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 no & specific cure but is a palliative, and fails to bear in juxtaposition and in letters of the same size and promience a statement that the 4 FOOD, DRUGS, AND COSMETICS cure for such disease; or (2) if its labeling bears any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion. (b) If it is for internal use by man and contains any quantity of any of the following narcotic or hypnotic substances: Alpha cucaine, barbital, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, morphine, opium, paraldehyde, peyote, sulphonmethane, or any narcotic or hypnotic derivative therefrom by actual or theoretical chemical reaction, and its label fails to bear the name and a statement, in the manner and form preseribed by regulations promulgated by the Secretary, of the quantity or proportion of such substance or derivative in juxtaposition with the statement "Warning-May be habit forming." The Secretary is hereby authorized, by regulations prescribed after notice and hearing, to designate as narcotics or hypnotics within the meaning of this pargaraph such other substances as he may find to possess narcotic or hypnotic properties. (c) If it contains any quantity of ethyl alcol ol, ethyl ether, or chloroform, and its label fails to bear a statement, in the manner and form prescribed by regulations of the Secretary, of the quantity or proportion of such substance. (d) If it is not subject to the provisions of paragraph (i) of this section, and its labeling fails to bear complete and explicit directions for use: Provided, That the Secretary may by regulation exempt any drug from any requirement of this paragraph if he deems such requirement unnecessary for the protection of public health. (c) If it is not subject to the provisions of paragraph (b) of section 4 and its label fails to bear (1) the common name of the drug, if any there be, and (2) the name and quantity or proportion of each medicinal or physiologically active ingredient thereof. The Secretary is hereby authorized to prescribe by reguintions requirements for such further information on the label of such drug as he may deem necessary to protect the public health. (f) If its name is the same as, or simulates, a name recognized in the United States Pharmacopoein or National Formulary or any supplement thereto official at the time such drug is introduced into interstate commerce, and it is not packaged and labeled as prescribed therein. (g) If it is a drug liable to deterioration, and is not packaged in such form or manner, or if its label fails to bear a statement of such precautions, as the Secre tary may prescribe by regulations, after notice and hearing, for the protection of public health. The Secretary is hereby authorized to designate by regulations, prescribed after notice and hearing, as drugs liable to deterioration within the meaning of this paragraph, such drugs as he may find to be liable to deterioration. (h) (1) If its container is so made, formed, or filled as to mislead the purchaser; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug. (i) If it purports to be or is represented as a germicide, bactericide, disinfectant, or antiseptic for any use on or within the human or animal body and its labeling fails to hear a statement of each such use and, plainly and conspicuously and in juxtaposition therewith, the method and duration of application necessary to kill all micro-organisms in the vegetative or other active forin with which it comes in contact when so used; except that no drug shall be deemed to be misbranded under this paragraph if its label bears a statement that it is a germicide, bacteri cide, disinfectant, or antiseptic for specific kinds of micro-organisms only, and its labeling bears a statement of each purported or represented use and, plainly and conspicuously and in juxtaposition therewith, the conditions, including duration of application, under which the drug kills all such specific kinds of micro-organisins in the vegetative or other active form with which it comes in contact when so used. FALSE ADVERTISEMENT SEC. 9. (a) An advertisement of a food, drug, or cosmetic shall be deemed to be false if in any particular it is untrue, or by ambiguity or inference creates a misleading impression regarding such food, drug, or cosmetic. (b) An advertisement of a drug shall also be deemed to be false if it includes (1) the name of any disease for which the drug is not a specific cure but is a palliative, and fails to state with equal prominence and in immediate connection with such name that the drug is not a cure for such disease; or (2) any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion. FOOD, DRUGS, AND COSMETICS 5 (c) To discourage the public advertisement for sale in interstate commerce of drugs for diseases wherein self-medication may be especially dangerous, or patently contrary to the interests of public health, any advertisement of a drug representing it directly or by ambiguity or inference to have any effect in the treatment of any of the following disenses shall be deemed to be false: Albuminuria, appendicitis, arteriosclerosis, bloed poison, bone diseases, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis, prostate gland disorders, pyolitis, scarlet fever, sexual impotence, sinus infections, smallpox, tuberculosis, tumors, typhoid, uremia, veneral diseases, whooping cough; except that no advertisement shall be deemed to be false under this paragraph if it is disseminated to members of the medical and pharmacological professions only or appears in scientific periodicals: Provided, That whenever the Secretary, after notice and hearing, determines that an advance in medical science luns inado any type of self-medication safe as to any of the diseases enumerated above, he may by regulation authorize the advertisement of drugs having curativo or therapeutic effect for such disease, subject to such conditions and restrictions as he may deem necessary in the interests of public health: Provided further, That whenever the Secretary, after notice and hearing, determines that self-medication for disenses other than those herein named may be especially dangerous, or patently contrary to the interests of public health, he is hereby authorized to promulgato regulations designating such other diseases as diseases within the meaning of this paragraph: Provided further, That this paragraph shall not be construed as indicating that self-medication for diseases other than those named herein or desig nated by regulations of the Secretary under the authority hereof is safe or efficacious. TOLERANCE SEC. 10. (a) If the Secretary finds that the presence of an added poisonous or added deleterious substance in or on food or cosmetics is or may be injurious to the health taking into account other ways in which the consumer or user may partake of or be exposed to the same or other poisonous or deleterious substances, then the Secretary shall by regulations promulgated after notice and hearing prohibit such added substatices in or on food or cosmetics, or establish tolerancos limiting the amount therein or thereon, to such extent as he may deem necessary to prevent such injury to health. (b) The Secretary is hereby authorized to make regulations, after notice and hearing, for the certification of coal-tar colors which he finds to be harmless for use in food. DEFINITIONS AND STANDARDS FOR FOOD SEC. 11. The Secretary is hereby authorized to fix, establish, and promulgate definitions of identity and standards of quality and fill of container for any food. Whenever the Secretary deems that for the purposes of this Act any such definition or standard should be established for any food, he shall give notice of a proposed definition or standard and of the time and place of a public hearing to be held thereon not less than thirty days after the date of such notice. After such public hearing the Secretary may fix, establish, and promulgate definition or standard for such food. The definition or standard so promulgated shall become effective on a date fixed by the Secretary, which date shall not be prior to ninety days after its promulgation. Any such definition or standard may be amended or repealed after notice and hearing as hereinbefore provided, and if amended or repealed the amendment or repeal shall become effective in the manner and at the time hereinbefore provided." PERMIT FACTORIES SEC. 12. (n) Whenever the Secretary Jinds that the distribution in interstate commerce of any class of food, drugs, or cosinetics may, by reason of conditions surrounding the manufacture, processing, or packing thereof, be injurious tɔ health, and such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he is authorized, after notice and hearing, to make such regulations governing the conditions of manufacture, processing, or packing as lie deems necessary to protect the public health, and |