(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 diseases shall be deemed to be false: Albuminuria, appendicitis, arteriosclerosis, blood 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 has made any type of self-medication safe as to any of the diseases enumerated above, he may by regulation authorize the advertisement of drugs having curative 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 diseases other than those herein named may be especially dangerous, or patently contrary to the interests of public health, he is hereby authorized to promulgate regulations designating such other diseases as diseases within the meaning of this paragraph: Provided further, That this paragraph shall not be construed as indiating that self-medication for diseases other than those named herein or desigated by regulations of the Secretary under the authority hereof is safe or efficacious.

TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND COSMETICS AND

CERTIFICATION OF COAL-TAR COLORS FOR FOOD

SE 10. (a) If the Secretary finds that the presence of an added poisonous or add 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 substances in or on food or cosmetics, or establish tolerances 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 a 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. (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, he is authorized, after notice and hearing, to make such regulations governing the conditions of manufacture, processing, or packing as he deems necessary to protect the public health, and

requiring manufacturers, processors, and packers of such class of articles to hold a permit conditioned on compliance with such regulations.

(b) The Secretary is authorized to issue such permits for such periods of time as he may be 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 may reinstate the permit whenever, after hearing and an inspection of the establishment, it is found that adequate measures have been taken to comply with 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 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, methods, processes, finished and unfinished materials, containers, and labels there used or stored.

(b) (1) 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, if the owner, operator, or custodian thereof has denied to officers or employees duly designated by the Secretary permission so to enter and inspect such factory, warehouse, establishment, or vehicle and equipment, methods, processes, 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; and (2) violation of any such injunction 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 nature, kind, 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 record so requested: Provided, That evidence obtained under this section shall not be used in a criminal prosecution of the person from whom obtained.

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.

(b) It shall be the duty of each United States attorney to whom the Secretary reports 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 parties 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 officers and employees duly authenticated under their oaths.

SEIZURE

SEC. 16. (a) Any article of food, drug, or cosmetic in interest 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 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) If recovery is had in any suit or proceeding against any officer or employee by reason of a seizure pursuant to any such order, and the court certifies that there is probable cause for the acts done by such officer or employee, or that he acted under the direction of the Secretary or a duly designated officer of the Food and Drug Administration, no execution shall issue against such officer or employee, but the amount so recovered shall, upon final judgment, be provided for and paid out of appropriations for the administration of this Act.

(c) The court may, by order at any time before trial, allow any party to a condemnation proceeding to obtain a 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 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.

(3) 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.

(4) The dissemination of a fasle advertisement by any means for the purpose of inducing, directly or indirectly, the sale of food, drugs, or cosmetics in interstate

commerce.

(5) 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.

(6) 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 $500 nor more than $3,000, or both such imprisonment 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 less than six months nor 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 radiobroadcast licensee shall be prosecuted under paragraphs (b) or (c) of this section for disseminating a false advertisement if, on request of an officer or employee duly designated by the Secretary, he furnishes the name and post-office address of the person who contracted for or caused him to disseminate such advertisement. (e) No dealer shall be prosecuted under paragraph (b) of this section if he establishes a guaranty or undertaking signed by the person residing in the United States from whom he received 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.

(f) Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized by the provisions of sections 12 and 22 of this Act or regulation thereunder, 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.

LIABILITY OF CORPORATE 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 as that of the officer, employee, or agent.

(b) Whenever a corporation or association violates any of the provisions of this Act, such violation shall also be deemed to be a violation of the individual directors, officers, or agents of such corporation or association who authorized, ordered, or did any of the acts constituting, in whole or in part, such violation.

INJUNCTION PROCEEDINGS

SEC. 19. (a) The repetitious introduction into interstate commerce of any adulterated or misbranded food, drug, or cosmetic, or the repetitious dissemination by radio broadcast or United States mail or in interstate commerce of false advertising of any food, drug, or cosmetic, by any person, is hereby declared to be a public nuisance. In order to avoid multiplicity of criminal proceedings with respect to such person or libel for condemnation proceedings with respect to the

food, drug, or cosmetic, the district courts of the United States are hereby vested with jurisdiction to restrain by injunction, temporary or permanent, any person from continuing any such nuisance. In such injunction proceedings it shall not be necessary to show on the part of such person an intent to continue such nuisance.

(b) Violation of any such injunction 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; and process of the court for the arrest of the violator may be served at any place in the United States or subject to its jurisdiction.

IMPORTS

SEC. 20 (a) The Secretary of the Treasury shall deliver to the Secretary of Agriculture upon his request, from time to time, samples of food, drugs, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee who may appear before the Secretary of Agriculture and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) any false advertisement of such food, drug, or cosmetic has been disseminated in the United States within three months prior to the date such article is offered for import, or (2) such article has been manufactured, processed, or packed under unsanitary conditions, or (3) such article is adulterated or misbranded within the meaning of this act, then such article shall be refused admission.

(b) The Secretary of the Treasury shall refuse delivery to the consignee and shall cause the destruction of any such article refused admission, unless such article is exported by the consignee within three months from the date of notice of such refusal, under such regulations as the Secretary of the Treasury may prescribe: Provided, That the Secretary of the Treasury may deliver to the consignee any such article pending examination and decision in the matter on execution of a bond as liquidated damages for the amount of the full invoice value thereof together with the duty thereon, and on refusal to return such article or any part thereof for any cause to the custody of the Secretary of the Treasury when demanded for the purpose of excluding it from the country or for any other purpose said consignee shall forfeit the full amount of the bond as liquidated damages. (c) All charges for storage, cartage, and labor on any article which is refused admission or delivery shall be paid by the owner or consignee and in default of such payment shall constitute a lien against any future importations made by such owner or consignee.

PUBLICITY

SEC. 21. The Secretary shall cause to be published periodically a report summarizing all judgments, decrees, and orders which have been rendered, and all proceedings instituted and seizures made, including the nature of the charge and the disposition thereof. The Secretary shall cause to be disseminated such information regarding any food, drug, or cosmetic as he deems necessary in the interests of public health and for the protection of the consumer against fraud.

VOLUNTARY INSPECTION SERVICE

SEC. 22. The Secretary, upon application of any manufacturer or packer of any food, drug, or cosmetic sold in interstate commerce, may at his discretion, designate supervisory inspectors to examine and inspect all premises, equipment, methods, materials, containers, and labels used by such applicant in the production of food, drugs, or cosmetics. If upon such examination the food, drug, or cosmetic is found to conform to the requirements of this Act, the applicant may be authorized, in accordance with regulations prescribed by the Secretary, to mark the food, drug, or cosmetic so as to indicate such conformity and such other facts relating to the identity or quality of the food, drug, or cosmetic as the regulations may provide. Services to any applicant under this section shall be rendered only upon the payment of fees to be fixed by regulations of the Secretary in such amount as to cover the cost of the supervisory inspection and examination, together with the reasonable costs of administration (including costs of establishing under section 11 additional definitions and standards for the purposes of this section) incurred by the Secretary in carrying out this section Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out this section.