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such body shall have failed within a reasonable time to prescribe such requirements.

(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 body and its labeling fails to bear a plain and conspicuous statement of such use, including the strength or dilution, manner, and duration of application, and when tested by methods simulating as nearly as practicable the conditions of such use, or in the absence of such methods, when tested by a standard method, it does not have the germicidal effect within the duration so prescribed of a 1 to 80 dilution of phenol used by a standard testing method for 10 minutes at 37 degrees centigrade. All testing methods for the purposes of this paragraph shall be prescribed by regulations as provided by section 22: Provided, That no drug shall be deemed to be misbranded under this paragraph by reason of failure of its labeling to bear a statement of any advertised use if such advertising is disseminated to members of the medical and pharmaceutical professions only, or appears in scientific publications of these professions.

(j) If it purports to be or is represented as an inhibitory antiseptic for any use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body and its labeling fails to bear a plain and conspicuous statement of such use, including strength or dilution and manner of application, and when tested by methods simulating as nearly as practicable the duration of application and other conditions of such use, or in the absence of such methods when tested by a standard method, it fails to prevent the growth of micro-organisms within the entire time of such duration. All testing methods for the purposes of this paragraph shall be prescribed by regulations as provided by section 22: Provided, That no drug shall be deemed to be misbranded under this paragraph by reason of failure of its labeling to bear a statement of any advertised use if such advertising is disseminated to members of the medical and pharmaceutical professions only, or appears in scientific publications of these professions.

FALSE ADVERTISEMENT

Sec. 9. (a) An advertisement of a food, drug, or cosmetic shall be deemed to be false if it is false or misleading in any particular relevant to the purposes of this act regarding such food, drug, or cosmetic. 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) An advertisement of a drug shall also be deemed to be false if it contains the name of any disease for which the drug is not a specific cure but is a palliative and fails to contain 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.

(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 to have any effect in the treatment of any of the following diseases shall be deemed to be false : Albuminuria, appendicitis, arteriosclerosis, blood poison, bone diseases, cancer, carbuncle, cataract, cholecystitis, dental caries or erosion, diabetes, diphtheria, dropsy, encephalitis, epilepsy, erysipelas, gallstones, goiter, heart diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, periodontal diseases, pneumonia, poliomyelitis, prostate-gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infections, smallpox, tuberculosis, tumors, typhoid, uremia, venereal diseases, and whooping cough ; except that no advertisement not in violation of paragraph (a) or (b) of this section shall be deemed to be false under this paragraph if it is disseminated to members of the medical and pharmaceutical professions only or appears in the scientific periodicals of these professions, or if it is disseminated for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs: Provided, That whenever the Secretary determines that an advance in medical science has made any type of self-medication safe as to any of the diseases enumerated above, he shall promulgate regulations, as provided by section 22, exempting the advertisement of drugs having curative or therapeutic effect for such disease from the operation of this paragraph, subject to such conditions and restrictions as may be necessary in the interests of public health.

TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND COSMETICS AND CERTIFICATION

OF COAL-TAR COLORS FOR FOOD

SEC. 10 (a). If an added poisonous or added deleterious substance in or on food or cosmetics is or may be injurious to health, the Secretary is hereby authorized to promulgate regulations, as provided by section 22, prohibiting such added substance in or on any food or cosmetic, or establishing tolerances limiting the amount therein or thereon, for the protection of public health, taking into account the extent to which the use of such substance is required in the production of such food or cosmetic 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, as provided by section 22, for the certification of coal-tar colors which are harmless and suitable for use in food.

DEFINITIONS AND STANDARDS FOR FOOD

SEC. 11. For the effectuation of the purposes of this Act the Secretary is hereby authorized to promulgate regulations, as provided by section 22, fixing and establishing for any food (1) a definition and standard of identity, and (2) one objectively determinable minimum standard of quality and fill of container.

PERMIT FACTORIES

Sec. 12. (a) Whenever the Secretary finds that the distribution in interstate commerce of any class of food, drugs, or cosmetics may, by reason of conditions surrounding the manufacture, processing, or packing thereof, be injurious to health, and such injurious nature cannot be adequately determined after such articles have entered interstate commerce, and in such case only, he is authorized to promulgate regulations, as provided by section 22, governing the conditions of manufacture, processing, or packing necessary to protect the public health, and requiring manufacturers, processors, and packers of such class of articles to hold permits conditioned on compliance with such regulations.

(b) The Secretary is authorized to issue such permits for such periods of time as he may by regulations prescribe and to make regulations governing the issuance and renewal thereof. 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 Secretary shall reinstate the permit whenever, after hearing and an inspection of the establishment, it is found that adequate measures have been taken to comply with and maintain the conditions of the original permit.

(c) Any officer 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.

FACTORY INSPECTION

SEC. 13. (a) In order adequately to regulate interstate commerce in food, drugs, and cosmetics, and enforce the provisions of this Act, officers or employees duly designated by the Secretary, after first making reasonable request and obtaining permission of the owner, operator, or custodian thereof, are authorized (1) to enter any factory, warehouse, or establishment in which food, drugs, 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, or cosmetics, in interstate commerce ; and (2) to inspect such factory, warehouse, establishment, or vehicle and all equipment, finished and unfinished materials, containers, and labels there used or stored.

(b) The several district courts of the United States are hereby vested with jurisdiction to restrain by injunction, temporary or permanent, the shipment in interstate commerce or delivery after receipt in interstate commerce of any food, drug, or cosmetic from or by any factory, warehouse, establishment, or vehicle, designated in paragraph (a) of this section if the owner, operator, or custodian thereof has denied to officers or employees duly designated by the Secretary, permission, after reasonable request, so to enter and inspect such factory, warehouse, establishment, or vehicle and equipment, finished and unfinished materials, containers, and labels there used or stored. Whenever such permission is granted, the injunction issued pursuant to this paragraph shall be dissolved, or may be continued in force subject to such conditions governing the inspection as the court may order. Violation of any injunction issued pursuant to this paragraph may be summarily tried and punished by the court as a contempt. Such contempt proceedings may be instituted by order of the court or by the filing of an information by the United States attorney.

RECORDS OF INTERSTATE SHIPMENT

SEC. 14. For the purpose of enforcing the provisions of this Act, carriers subject to the Interstate Commerce Act, as amended (U.S.C., title 49), and other carriers engaged in interstate commerce, and persons receiving food, drugs, or cosmetics in interstate commerce, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee to have access to and to copy all records showing the movement in interstate commerce of any food, drug, 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 definite statement in writing specifying the nature or kind of food, drug, 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 hereinbefore designated shall not be subject to the provisions of this Act by reason of their receipt, carriage, or delivery of food, drugs, cosmetics, or advertising matter in the usual course of business as carriers.

INVESTIGATIONS AND INSTITUTION OF PROCEEDINGS

SEC. 15. (a) The Secretary is authorized to conduct examinations and investigations for the purposes of this Act through officers and employees of the Department of Agriculture or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary. To aid in securing compliance with the requirements of this Act, the Secretary is further authorized to accept plans for such selfregulation of advertising and commercial practices as tend to effectuate the purposes of this Act, when presented by associations or groups representative of their industries: Provided, That such plans shall not restrict the responsibilities and powers conferred upon the Secretary by this Act and shall not be designed to promote monopolies or eliminate or oppress legitimate enterprise.

(b) It shall be the duty of each United States attorney to whom satisfactory evidence has been presented by the Secretary of any violation for institution of criminal, libel for condemnation, or other proceedings under this Act, or to whom any health, food, or drug officer of any State or Territory, or political subdivision thereof, presents evidence satisfactory to the United States attorney of any such violation, to cause appropriate proceedings to be instituted in the proper courts of the United States without delay. All suits instituted under this Act shall be by and in the name of the United States.

(c) The Secretary shall, before reporting any violation of this Act to the United States attorney for institution of criminal proceedings thereunder, afford due notice and opportunity for hearing to interested persons in accordance with such regulations as the Secretary shall prescribe. The report of the Secretary to the United States attorney for the institution of criminal proceedings under this Act shall be accompanied by findings of the appropriate (.fficers and employees, duly authenticated under their oaths. Nothing in this Act shall be construed as requiring the Secretary to report for prosecution or for the institution of libel or injunction proceedings minor violations of this Act whenever he believes that the purposes of the Act can best be accomplished by a suitable notice or warning.

SEIZURE

SEC. 16. (a) Any article of food, drug, or cosmetic in interstate commerce that is adulterated or misbranded or that has been manufactured, processed, or packed in a factory or establishment, the operator of which did not, at the time of manufacture, processing, or packing, hold a valid permit, if so required by regulations under section 12, shall be liable to be proceeded against while in interstate commerce or at any time thereafter on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found. The article shall be liable to seizure (1) by process pursuant to the libel, or (2) if a chief of station or other officer of the Food and Drug Administration, duly designated by the Secretary, has probable cause to believe that the article is so adulterated as to be imminently dangerous to health, then, and in such case only, by order of such officer, issued under his oath of office, particularly describing the article to be seized, the place where located, and the officer or employee to make the seizure. In case of seizure pursuant to any such order, the jurisdiction of the court shall attach upon such seizure. Any article seized pursuant to any such order shall thereupon be promptly placed in the custody of the court and a libel of information shall be promptly filed for condemnation thereof.

(b) When, upon the trial of any cause instituted pursuant to paragraph (a), subdivision (2), of this section, judgment is rendered for the claimant, but it appears to the court that there was reasonable cause for the seizure, the court shall cause a proper certificate thereof to be entered and no officer or employee of the United States shall be liable to suit or judgment by reason of the seizure of the goods or the institution of such proceedings.

(c) The court may, by order at any time before trial, allow any party to a condemnation proceeding to obtain representative sample of the article seized.

(d) Any article of food, drug, or cosmetic condemned under this section shall, after entry of the decree, be disposed of by destruction or sale as the court may, in accordance with the provisions of this section, direct and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treasury of the United States; but such article shall not be sold under such decree contrary to the provisions of this Act or the laws of the jurisdiction in which sold: Provided, That after entry of the decree and upon the payment of the costs of such proceedings and the execution of a good and sufficient bond conditioned that such article of food, drug, or cosmetic shall not be sold or disposed of contrary to the provisions of this Act or the laws of any State or Territory, the court may by order direct that such article be delivered to the owner thereof to be destroyed or brought into compliance with the provisions of this Act under the supervision of an officer or employee duly designated by the Secretary, and the expenses of such supervision shall be paid by the party obtaining release of the article under bond. Any article condemned by reason of the manufacturer, processor, or packer not holding a valid permit when so required by regulations under section 12 shall be disposed of by destruction.

(e) The proceedings in cases under this section shall conform, as nearly as may be, to the proceedings in admiralty; except that either party may demand trial by jury of any issue of fact joined in any such case.

(f) When a decree of condemnation is entered against the article, court costs and fees, and storage and other proper expenses, shall be awarded against the person, if any, intervening as claimant of the article.

PENALTIES

SEC. 17. (a) The following acts are hereby prohibited :

(1) The introduction into interstate commerce of any food, drug, or cosmetic that is adulterated or misbranded.

(2) The adulteration or misbranding of any food, drug, or cosmetic in interstate commerce.

(3) The receipt in interstate commerce of any food, drug, 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 radio broadcast, United States mails, or in interstate commerce for the purpose of inducing, directly or indirectly, the purchase of food, drugs, or cosmetics.

(5) The dissemination of a false advertisement by any means for the purpose of inducing, directly or indirectly, the purchase of food, drugs, or cosmetics in interstate commerce.

(6) The introduction into interstate commerce of any food, drug, or cosmetic if the manufacturer, processor, or packer does not hold a valid permit when so required by regulations under section 12.

(7) The refusal to permit access to or copying of any record as required by section 14.

(b) Any person who violates or causes to be violated any of the provisions of paragraph (a) of this section shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not less than $100 nor more than $1,000, or both such imprisonment and fine; and for a second or subsequent offense imprisonment for not more than two years, or a fine of not less than $100 nor more than $3,000, or both such įmprisonment and fine.

(c) Notwithstanding the provisions of paragraph (b) of this section, in case. of a willful offense the penalty shall be imprisonment for not more than three years, or a fine of not less than $1,000 nor more than $10,000, or both such imprisonment and fine.

(d) No person acting in the capacity of publisher, advertising agency, or radio broadcast licensee shall be deemed in violation of paragraphs (b) or (c) of this section by reason of the dissemination of any false advertisement. Any such person who, on reasonable request of an officer or employee duly designated by the Secretary, willfully refuses to furnish the name and post-office address of the person who caused him to disseminate such advertisement shall be guilty of a misdemeanor and shall on conviction thereof be subject to the penalties prescribe in paragrapin (b) of this section.

(e) No dealer shall be prosecuted under paragraph (b) of this section (1) because of commerce in any article he has purchased or received in good faith if he furnishes on request of an officer or employee duly designated by the Secretary the name and address of the person from whom he purchased or received such article, or (2) if he establishes a guaranty or undertaking signed by the person residing in the United States from whom he received in good faith the article of food, drug, or cosmetic, or the advertising copy therefor, to the effect that such person assumes full responsibility for any violation of this Act, designating it, which may be incurred by the introduction of such article into interstate commerce or by the dissemination of such advertising. To afford protection, such guaranty or undertaking shall contain the name and address of the person furnishing such guaranty or undertaking, and such person shall be amenable to the prosecution and penalties which would attach in due course to the dealer under the provisions of this Act. No retail dealer shall be prosecuted under this section for the dissemination, other than by radio broadcast, of any advertisement offering for sale at his place of business any product which is not dis buted or sold in interstate commerce.

(f) Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other idenfication device required by regulations promulgated for the enforcement of the provisions of section 12 shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.

(g) Any person who uses to his own advantage or reveals, other than to the Secretary or his officers or employees, or to the courts when relevant in the trial of any case under this Act, any information acquired under authority of sections 12 or 13 concerning any method or process which is entitled to protection in equity as a trade secret, shall be guilty of a felony, and shall on conviction thereof be subject to imprisonment for not more than two years or a fine of not more than $5,000 or both such imprisonment and fine.

LIABILITY OF CORPORATIONS AND THEIR OFFICERS

SEC. 18. (a) When construing and enforcing the provisions of this Act, the act, omission, or failure of any officer, employee, or agent acting for or employed by any person, within the scope of his employment or office, shall in every case be deemed to be the act, omission, or failure of such person, as well ils that of the officer, employee, or agent.

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