10230 Parsons Pearson CONGRESSIONAL RECORD-HOUSE Peterson, Ga. Romjue Pierce Seger Powers Shannon Wallgren Warren West Whelchel Wigglesworth Wolfenden Quinn Sauthon Schneider, Wis. Schuetz Scrugham Sears Secrest Stewart Bullivan Sumners, Tex. Taylor, Colo. Tinkham Tolan Weaver Wilson, La. Wilson, Pa. Wood Zioncheck So, two-thirds not having voted in favor thereof, the motion was rejected. The Clerk announced the following pairs: On this vote: Mr. Hobbs and Mr. Knute Hill (for) with Mr. Ditter (against). Mr. Corning with Mr. Martin of Massachusetts. Mr. Taylor of Colorado with Mr. Bacon. Mr. Lanham with Mr. Eaton. Mr. Rayburn with Mr. Bolton. Mr. O'Connor with Mr. Higgins of Connecticut. Mr. Bulwinkle with Mr. Reed of New York Mr. Darden with Mr. Tinkham. Mr. Montague with Mr. Andrews. Mr. Fernandez with Mr. Collins. Mr. McFarlane with Mr. Bacharach. Mr. Dingell with Mr. Robsion of Kentucky. Mr. O'Connell with Mr. Quinn. Mr. Dies with Mr. Schuetz. Mr. Imhoff with Mr. O'Neal. Mr. Hamlin with Mr. Crosby. Mr. Lee of Oklahoma with Mr. Brooks. Mr. McCormack with Mr. Harter. Mr. Claiborne with Mr. Keller. Mr. Scrugham with Mr. Tolan. Mr. Nelson with Mr. Ford of California. Mr. Maverick with Mr. Deen. Mr. Kee with Mr. Cannon of Missouri. Mr. Celler with Mr. DeRouen. Mr. McGroarty with Mr. Peterson of Florida. Mr. May with Mr. Gassaway. Mr. Buckley of New York with Mr. Green. Mr. Cross of Texas with Mr. Cannon of Wisconsin. Mr. Cary with Mr. Ayers. Mr. Oliver with Mr. Berlin. Mr. Parks with Mr. Samuel B. Hull. Mr. Sadowski with Mr. Brennan. Mr. Duffey of Ohio with Mr. Sanders of Louisiana. Mr. Flesinger with Mr. Eagle. Mr. Moritz with Mr. Wilson of Louisiana. Mr. Cummings with Mr. Dunn of Mississippi. Mr. WEARIN and Mr. GAVAGAN changed their vote from "nay" to "yea." Mr. McCORMACK. Mr. Speaker, I was unavoidably absent on account of official business. Had I been present, I would have voted "yea." The result of the vote was announced as above recorded. JUNE 19 FEDERAL FOOD, DRUG, AND COSMETIC ACT Mr. CHAPMAN. Mr. Speaker, I move to suspend the rules and pass the bill (S. 5) 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 purpose of safeguarding the public health, preventing decett upon the purchasing public, and for other purposes, with an amendment. The SPEAKER. The gentleman from Kentucky moves to suspend the rules and pass the bill S. 5, the Federal Food, Drug, and Cosmetic Act, with an amendment, which the Clerk will report. The Clerk read as follows: Be it enacted, etc. CHAPTER I SECTION 1. That this act may be cited as the "Pederal Food, Drug, and Cosmetic Act." CHAPTER I DEFINITION OF TERMS SECTION 201. 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, canfectionery, chewing gum, or condiment for man or other animals. (b) The term "drug", for the purposes of this act, includes (1) all substances and preparations recognized in the official United States Pharmacopola, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) all substances and preparations intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food and cosmetics, intended to affect the structure or any function of the body. (c) The term "device", for the purposes of this act, includes all devices intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (2) to affect the structure or any function of the body. (d) The term "cosmetic" includes all substances and preparations intended for cleansing, or altering the appearance of, or promoting the attractiveness of, the person; except that such term shall include soaps only when medicinal or curative qualities are claimed therefor. (e) The term "Territory" means any Territory or possession of the United States, including the District of Columbia and excluding the Canal Zone. (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 organized with a legislative body. (g) The term "person" includes individual, partnership, corporation, and association. (h) The term "Secretary" means the Secretary of Agriculture. (1) 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 container thereof, and (2) upon the outside container or wrapper, if any there be, of the retail package of any food, drug, device, or cosmetic. (1) The term "labeling" includes all labels and other written, printed, and graphic matter, in any form whatsoever, accompanying any food, drug, device, or cosmetic. (k) The term "advertisement" includes all representations of fact or opinion disseminated to the public in any manner or by any means, other than by the labeling, for the purpose of inducing, directly or indirectly, the purchase of food, drugs, devices, or cosmetics. (1) The term "medical profession" means the legalized professions of the healing art; and the term "medical opinion" means the opinion, within their respective fields, of the practitioners of any branch of the medical profession, the practice of which is licensed by law in the State or Territory where any drug or device, to which such opinion relates, is held, sold, or distributed; and the term "scientific opinion" means the opinion, within their respective fields, of competent pharmacologists, physiologists, or toxicologists. (m) The term "official compendium" means the United States Pharmacopoeia, Homeopathic Pharmacopala of the United States, National Formulary, or any supplement to any of them, oficial at the time any drug to which the provisions thereof relate is introduced into interstate commerce. (n) The term "Department" means the Department of Agriculture of the United States. (0) The term "Administration" means the Food and Drug Administration of the Department. CHAPTER III ADULTERATED FOOD SECTION 301. A food shall be deemed to be adulterated(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 unsafe within the meaning of section 305, or in excess of the limits of 1936 CONGRESSIONAL RECORD-HOUSE tolerance prescribed by regulations as provided by section 305; or (3) if it consists in whole or in part of any althy, putrid, or decomposed substance, or if it is otherwise unnt for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with alth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may 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, or reduce its quality or strength, or create a deceptive appearance. (c) If it contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 305. (d) If it is confectionery or ice cream, it shall also be deemed to be adulterated if it bears or contains any alcohol, harmful resinous glaze, or nonnutritive substance except harmless coloring. harm'ess flavoring. natural gum, and pectin: Provided, That this paragraph shall not apply to any confectionery or ice cream by reason of its containing less than one-half of 1 percent by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless nonnutriLive masticatory substances. MISBRANDED FOOD Szc. 302. A food shall be deemed to be misbranded (a) If its labeling is false or misleading in any particular. (b) If it is offered for sale under the name of another food. (c) If it is an imitation of another food, and its label falls to bear, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated. (d) If its container is so made, formed, or filled as to mislead the purchaser. (e) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, seller, 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. (1) If any word, statement, or other information required on the label 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 understood by purchasers and users of such articles under customary conditions of purchase and use, due consideration being given to the size of the package. (g) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 304, and (1) it fails to conform to such definition and standard, or (2) its label fails to bear the name of the food prescribed in the definition and standard, or if so required by such regulations when such definition and standard permits optional ingredients other than spices, flavors, and coloring, the common names of such optional ingredients as are present in such food. (h) If it purports to be or is represented as a food for which standards of quality or fill of container have been prescribed by regulations as provided by section 304, and (1) its label fails to bear a statement of its standard of quality in such terms as the regulations specify, or (2) if its fill falls below such standard of fill of container and its label fails to bear a statement, in such manner as the regulations specify, showing that it falls below such standard of fill of container. (1) If it is not subject to the provisions of paragraph (g) of this section and its label falls to bear (1) the common or usual name of the food, if any there be, or (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavors, and colorings, other than those sold as such, may be designated as spices, flavors, and colcrings without naming each: Provided, That, to the extent that compliance with the requirements of subdivision (2) of this paragraph is impracticable because of variations in ingredients usual to good manufacturing or packing practice, or is impracticable for any other reason, exemptions shall be established by regulations promulgated by the Secretary. Such subdivision (2) shall not apply to any proprietary food the ingredients of which have been fully and correctly disclosed to the Secretary if compliance with such subdivision would give to competitors information they could not otherwise obtain. (1) If it purports to be or is represented for special dietary uses. such as by infants or invalids or for other special nutritional requirements, and its label falls to bear, if so required by such regulations as may be prescribed by the Secretary as necessary for the protection of the public health, statements concerning its vitamin. mineral, and other dietary properties which fully inform the purchaser as to its nutritional value. (k) If it bears or contains any artificial flavor, artificial color, or chemical preservative, and it fails to bear a label stating that fact: Provided, That to the extent that compliance with the re 10231 quirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (1) If it is a distilled liquor, or if it is a beverage (other than fortified wine) containing any distilled liquor, unless its label states (1) the percentage by volume of alcohol therein; (2) in case it contains two or more whiskies or other alcoholic beverages, the percentage by volume of each distilled liquor present and the source or sources from which each is derived; (3) in of any kind of whisky stored in wood, or any mixture of whiskies of which one or more has been stored in wood, the length of time, if any, each such whisky has been so stored; and (4) in the case of any mixture of any kind of whisky or whiskies with neutral spirits, the length of time, if any, each such whisky has been stored in wood: Provided, That the provisions of this paragraph shall not apply insofar as they impose any requirement imposed by or under authority of the Federal Alcobol Administration Act. (m) If it purports to be or is represented as any kind of whisky, and it contains alcohol derived from any source other than grain. REGULATIONS MAKING EXEMPTIONS SEC. 303. The Secretary is hereby directed to promulgate regulations exempting from any labeling requirement of this act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this act upon removal from such processing, labeling, or repacking establishment. DEFINITIONS AND STANDARDS FOR FOOD SEC. 304. For the effectuation of the purposes of this act the Secretary is hereby authorized to promulgate regulations fixing and establishing for any food definitions and standards of identity, and reasonable standards of quality and fill of container: Provided, That no standard of quality shall be established for fresh fruits (except fresh citrus fruits) or fresh vegetables and no standard of identity for fresh fruits or fresh vegetables. In the fixing and establishing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and dus allowance made for the differing characteristics of the several varieties of such fruit or vegetable. TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND CERTIFICATION OF COAL-TAR COLORS FOR FOOD SEC. 305. (a) Any poisonous or deleterious substance added to any food, except where such substance is required in the produotion thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of section 301 (a); but when such substance is so required or cannot be so avoided, the Secretary is authorized to promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. (b) The Secretary is hereby authorized to promulgate regulations for the certification of coal-tar colors which are harmless and suitable for use in food. EMERGENCY PERMIT CONTROL SEC. 306. (a) Whenever the Secretary ands after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he is then, and in such case only, authorized to promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health, and after the effective date of such regulations, and during such temporary period, no person shall introduce into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations. (b) The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The bolder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended. (c) Any ofcer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator. 10232 CONGRESSIONAL RECORD-HOUSE CHAPTER IV. ADULTERATED BRUOS SECTION 401. A drug shall be deemed to be adulterated(a) (1) If it consists in whole or in part of any Althy, patrid, or decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with Alth, or whereby it may have been rendered Injurious to health; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious 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 certißed in accordance with regulations as provided by section 404. (b) If its name is recognized in an official compendium, or if It purports to be a drug the name of which is so recognized, and it diders 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 insuficient, 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 falls within a reasonable time to prescribe tests or methods of assay which are suficient, then the Secretary may by regulations prescribe for the purposes of this act such tests or methods of assay. No drug shall be deemed to be adulterated under this paragraph because it differs from the standard of strength therefor set forth in an official compendium, if its standard of strength be plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic Pharmacopeis 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 Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopeia. (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 or (2) substituted wholly or in part therefor. MUSBRANDED DRUGS AND DEVICES SDC. 402. A drug or device 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 or device shall be deemed to be false under this paragraph if such representations not supported by scientific facts or substantial and reliable medical or scientific opinion. (b) If it is dangerous to health when used in the dosage, or with the frequency or duration, prescribed or recommended in the labeling or advertisement thereof. (c) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, seller, 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. (d) If any word, statement, or other information required on the label 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 understood by purchasers and users of such articles under customary conditions of purchase and use, due consideration being given to the size of the package. (e) If it is for use by man and contains any quantity of any of the following narcotic or hypnotic substances: Alpha eucaine, barbituric acid, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine. opium. paraldehyde, peyote, sulphonmethane, or any substance chemically derived therefrom or any other narcotic or hypnotic substance, which derivative or other narcotic or hypnotic substance has been designated as habit forming by regulations prescribed by the Secretary, and, except when dispensed on the written order of a member of the medical profession, its label fails to bear the name and quantity or proportion of such sustance or derivative and in juxtaposition therewith the statement "Warning-May be habit forming." (f) If it is a drug and is not designated solely by a name recognized in an official compendium and its label fails to bear (1) a common or usual name of the drug. If such there be; or (2). in case it is fabricated from two or more ingredients, the name of each active ingredient, including the quantity, kind, and proportion of any alcohol: Provided, That, to the extent that compliance with the requirements of subdivision (2) of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. Such subdivision (2) shall not (except the requirements as to alcohol) apply to any drug the ingredients of which are fully and correctly disclosed to the Secretary. (g) If its labeling fails to bear plainly and conspicuously (1) adequate directions for use, or (2) such warnings, in such manner and form, as are required by regulations prescribed by the Secretary, against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application: JUNE 19 Provided, That where any requirement of subdivision (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. (h) If its name is recognized in an official compendium, or if It purports to be a drug the name of which is so recognized, and It is not packaged and labeled as prescribed therein. Whenever a drug is recognised in both the United States Pharmacopoeia and the Homeopathic Pharmacopeia of the United States, it shall be subject to the requirements of the United States Pharmacoperia 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 Homeopathic Pharmacopoeia of the United States, and not to those of the United States Pharmacoparia. (1) If it has been designated by regulations prescribed by the Secretary as a drug liable to deterioration, and is not packaged in such form and 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 recognised 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 such body shall have failed within a reasonable time to prescribe such requirements. (1) (1) If it is a drug and 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 MEANING OF "ANTISEPTIC"; REGULATIONS MAKING EXEMPTIONS Src. 403. (a) When construing and enforcing the provisions of this act with respect to labeling and advertisements, the term "antiseptic" shall be deemed to have the same meaning as the word "germicide", except, however, in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body. (b) The Secretary is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this act drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this act upon removal from such processing, labeling, or repacking establishment. CERTIFICATION OF COAL-TAR COLORS FOR DRUGS SEC. 404. The Secretary is hereby authorized to promulgate regulations for the certification of coal-tar colors which are harmless and suitable for use in drugs for purposes of coloring only. CHAPTER V ADULTERATED COSMETICS SECTION 501. A cosmetic shall be deemed to be adulterated(a) If it bears or contains any poisonous or deleterious substance which renders or will render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual. (b) If it consists in whole or in part of any filthy, putrid, or decomposed substance. (c) 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. (d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which renders or will render it injurious to health. (e) If it contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 50%. MISERANDED COSMETICS Szc. 502. A cosmetic shall be deemed to be misbranded (a) If its labeling is false or misleading in any particular. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, seller, 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) If any word, statement, or other information required on the label 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 understood by the purchasers and users of such articles under customary conditions of purchase and use, due consideration being given to the size of the package. REGULATIONS MAKING EXEMPTIONS Spc. 503. The Secretary is hereby directed to promulgate regulations exempting from any labeling requirement of this act cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this act upon removal from such processing, labeling, or repacking establishment. 1936 CONGRESSIONAL RECORD-HOUSE CERTIFICATION OF COAL-TAR COLORS FOR COSMETICS Szc. 504. The Secretary is hereby authorized to promulgate regulations for the certification of coal-tar colors which are harmless and suitable for use in cosmetics. CHAPTER VI. FALSE ADVERTISEMENT DEFINITION OF FALSE ADVERTISEMENT SECTION 601. (a) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular regarding such food, drug. device, or cosmetic. Any representation concerning any effect of a drug or device shall be deemed to be false under this paragraph if such representation is not supported by scientific facts or substantial and reliable medical or scientific opinion. (b) The advertisement of a drug or device representing it to have any therapeutic effect in the treatment of Bright's disease, cancer. tuberculosis, poliomyelitis (infantile paralysis), venereal diseases. heart or vascular diseases shall be deemed to be false: Provided, That the Secretary shall establish exemptions from the provisions of this subsection in the case of drugs and devices with respect to which such a representation as to therapeutic effect would not, in his opinion, be a violation of subsection (a). (c) Nothwithstanding any provision of this section, no advertisement of a drug shall be deemed to be false or misleading under this section if it is disseminated only to members of the medical profession and/or appears only in the scientific periodicals of that profession. POWERS AND DUTIES OF THE FEDERAL TRADE COMMISSION SEC. 632. (a) The Federal Trade Commission is hereby empowered and directed to prevent (1) the dissemination, or the causing of the dissemination, of any false advertisement by United States mails, or in interstate commerce by radio broadcast or otherwise, for the purpose of inducing, directly or indirectly, the purchase of food, drugs, devices, or cosmetics; (2) the dissemination, or the causing of the dissemination, of any false advertisement by any means for the purpose of inducing, directly or indirectly, the purchase of food. drugs, devices, or cosmetics in interstate commerce. (b) Whenever the Commission shall have reason to believe that any person has disseminated, or is disseminating, or has caused or is causing the dissemination of, any false advertisement by any of the means and for the purpose specified in subdivision (a) of this section, and it shall appear to the Commission that a proceeding by it in respect thereof would be to the interest of the public. it shall proceed to prevent the same in the same manner and by the same procedure as provided by section 5 of 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", as amended. The provisions of said section 5 and of sections 6, 9, and 10 of said act, as amended, shall apply, for purposes of enforcement of the provisions of this section, insofar as they may be applicable. The circuit court of appeals shall have the same jurisdiction to review the orders of the Commission and to enforce the same, and shall review and enforce the same, as provided by said section 5. (c) The Secretary shall report to the Federal Trade Commission on all cases of false advertising, to which subsection (a) may apply, that may come to his knowledge and submit therewith any evidence he may have together with any reports and scientific opinions of his Department relative thereto. CHAPTER VII. GENERAL ADMINISTRATIVE PROVISIONS PROVISIONS AS TO REGULATIONS SECTION 701. (a) The authority to promulgate regulations for the eficient enforcement of this act, except as otherwise provided in this section and except those provisions which are to be enforced by the Federal Trade Commission, is hereby vested in the Secretary. (b) The Secretary of the Treasury and the Secretary of Agriculture shall jointly prescribe regulations for the emcient enforcement of the provisions of section 712, except as otherwise proTided therein. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Secretary of Agriculture shall determine. (c) Hearings authorized or required by this act, except those provisions which are to be enforced by the Federal Trade Commission, shall be conducted by the Secretary or such officer or employee as he may designate for the purpose. (d) The definitions and standards of identity promulgated by or in accordance with the provisions of this act shall be effective for the purposes of the enforcement of this act, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder. PROCEDURE IN CASE OF CERTAIN REGULATIONS Szc. 702. Whenever the Secretary deems that there should be established any regulation contemplated by section 301, paragraph (a) or (c); section 302, paragraph (g). (h), or (j); section 304; section 305. paragraph (a) or (b); section 306, paragraph (a); section 401, paragraph (a) or (b); section 402, paragraph (e), (g), or (1): section 404; section 501, paragraph (e); or section 504, he shall give appropriate notice of the proposal and of the time and place for a public hearing to be held thereon not less than 30 days after the date of such notice. After such hearing the Secretary is authorized to formulate and promulgate such regulation as he chall find to be necessary to effectuate the purposes of such provialou. The regulation so promulgated shall become effective on a date Axed by the Becretary, which date shall not be prior to 90 10233 days after its promulgation, and may be amended or repealed in the same manner as is provided for its adoption; except that (1) regulations setting up exemptions pursuant to section 402, paragraph (g). may be promulgated without notice or hearing and shall become effective at such time as the Secretary determines; and (2) public hearing on regulations under section 306 (a) may be held within a reasonable time after notice thereof, and the Secretary may fix the effective date of such regulations at any reasonable time after promulgation thereof. EXAMINATIONS AND INVESTIGATIONS SEC. 703. (a) The Secretary is authorized to conduct examinations and investigations for the purposes of this act through omoers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department. In the case of food packed in a Territory or possession of the United States the Secretary shall attempt to make inspection of such food at the first point of entry within the territorial limits of the United States when, in his opinion and with due regard to the enforcement of all the provisions of this act, the facilities at his disposal will permit of such inspection. (b) Where a sample of a food, drug, or cosmetic is collected for analysis under this act, the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such terms and conditions relating to, the operation of this sentence as he deems necessary for the effectuation of the purposes of this act. (c) For purposes of enforcement of this act, records kept by the Treasury Department in accordance with laws, and regulations thereunder, relating to alcoholic beverages and medicinal liquors shall be open to inspection by any official of the Department of Agriculture duly authorized by the Secretary of Agriculture to make such inspection. RECORDS OF INTERSTATE SHIPMENT SEC. 704. For the purpose of enforcing the provisions of this act, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, or cosmetics in interstate commerce, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, or cosmetic, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, or cosmetic to which such request relates: Provided, That evidence obtained under this section shall not be used in a criminal prosecution of the person from whom obtained: Provided further, That carriers shall not be subject to the other provisions of this act by reason of their receipt, carriage, or delivery of food, drugs, devices, cosmetics, or advertising matter in the usual course of business as carriers. FACTORY INSPECTION SEC. 705. For purposes of enforcement of this act, officers or employees duly designated by the Secretary, after first making request and obtaining permission of the owner, operator, or custodian thereof, are authorized (1) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held for shipment in interstate commerce or are held after such shipment, or to enter any vehicle being used to transport such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, at reasonable times, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. Any such owner, operator, or custodian who refuses such request shall be guilty of a misdemeanor and shall on conviction thereof, be subject to the penalties prescribed by section 706 (b) of this act. PROHIBITED ACTS AND PENALTIES SEC. 706. (a) The following acts and the causing thereof are hereby prohibited: (1) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded. (2) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce. (3) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof in the original unbroken package for pay or otherwise. (4) The dissemination of any false advertisement by United States mails, or in interstate commerce by radio-bioadcast or otherwise, for the purpose of inducing, directly or indirectly, the purchase of food, drugs, devices, or cosmetics. (5) The dissemination of a false advertisement by any means for the purpose of inducing, airectly or indirectly, the purchase of food, drugs, devices, or cosmetics, in interstate commerce. (6) The introduction into interstate commerce of any food in violation of section 306. (7) The refusal to permit access to or copying of any record as required by section 704. (8) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using, any mark, stamp, tag, label, |