diseases, heart and vascular diseases, shall be deemed to be false; except that no advertisement not in violation of paragraph (a) of this section shall be deemed to be false under this paragraph if it is disseminated only to members of the medical and pharmaceutical professions or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public-health education by persons not commercially interested, directly or indirectly, in the sale of such drugs or devices.

CHAPTER VII

GENERAL ADMINISTRATIVE PROVISIONS

PROVISIONS AS TO REGULATIONS

SECTION 701. (a) The authority to promulgate regulations for the efficient enforcement of this Act, except as otherwise provided in this section, is hereby vested in the Secretary.

(b) The Secretary of the Treasury and the Secretary of Agriculture shall jointly prescribe regulations for the efficient enforcement of the provisions of section 714, except as otherwise provided 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 shall be conducted by the Secretary or such officer or employee as he may designate for the purpose.

COURT REVIEW OF REGULATIONS AND ADMINISTRATIVE ACTIONS

SEC. 702. The district courts of the United States are hereby vested with jurisdiction, on pettion by any interested person, (1) to restrain by injunction, temporary or permanent, the enforcement by any oflicer, representative, or employee of the Department of any regulation promulgated as provided in sections 701 and 703 if it is shown that the regulation is unreasonable, arbitrary, or capricious, or not in accordance with the facts or law, and that the petitioner may suffer substantial damage by reason of its enforcement; and (2) to grant appropriate injunctive relief from any act or omission of any officer, representative, or employee of the Department in the administration of this Act, if it has been shown that such act or omission is unreasonable, arbitrary, or capricious, or not in accordance with the facts or law, and that the petitioner may suffer substantial damage thereby: Provided, That nothing in this section shall be deemed to abridge the right of any person against whom a criminal prosecution or suit for injunction shall have been brought under this Act. or who shall intervene as claimant in any proceeding of libel for condemnation, to plead that the regulation, the violation of which is alleged as the ground for such prosecution, suit, or libel, is invalid on any of the grounds set forth above.

PUBLIC HEALTH AND FOOD STANDARDS COMMITTEE

SEC. 703. (a) To aid and advise the Secretary in promulgating regulations for the protection of public health, as contemplated by section 301, paragraphs (a) and (c); section 302, paragraph (j); section 304, paragraphs (a) and (b); section 305, paragraph (a); section 401, paragraphs (a) and (b); section 402, paragraphs (e), (g), and (i); section 403; section 501, paragraph (e); and section 503, a Committee on Public Health is hereby provided which shall consist of five members designated by the President with a view to their distinguished scientific attainment and interest in public health with respect to food, drugs, and/or cosmetics and without regard to their political affiliation.

(b) To aid and advise the Secretary in the promulgation of regulations with respect to food, as contemplated by section 302, paragraphs (g) and (h); and section 303, a Committee on Food Standards is hereby provided which shall consist of seven members, three of whom shall be selected from the public, two from the food producing processing, manufacturing, and distributing industry, and two from the Administration. The members selected from the public and the food industry shall be appointed by the President without regard to political affiliation, and the members from the Administration shall be designated by the Secretary.

(c) Whenever the Secretary deems that any regulation contemplated by any provision of this Act enumerated in paragraphs (a) and (b) of this section

should be established, he shall so advise the appropriate committee. With the approval of a majority of its members, the committee shall recommend to the Secretary a proposed regulation, and the Secretary shall give notice of the proposal 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 hearing the Secretary is authorized to formulate and promulgate such regulation as he shall find to be necessary to effectuate the purposes of such provision, but no such regulation shall be promulgated without the approval of a majority of the members of the committee. The regulation so promulgated shall become effective on a date fixed by the Secretary, which date shall not be prior to ninety days after its promulgation, and may be amended or repealed in the same manner as is provided for its adoption: Provided, That 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.

(d) The term of office of members of the committee provided by paragraphs (a) and (b) of this section, other than members from the Administration, shall be five years; except that an appointment to fill a vacancy occurring before the expiration of a term shall be for the remainder of that term, and of the appointments first made to each committee after approval of this Act, one shall be for one year, one for two years, one for three years, and one for four years, as shall be designated by the President in their respective appointments. The President shall fix the compensation of members and shall designate the chairmen of the committees. No person who is a member of the Department or who has or acquires a financial interest in the manufacture, advertising, or sale of any food, drug, device, or cosmetic shall be eligible to serve on the Committee on Public Health, or as a member from the public on the Committee on Food Standards.

(e) Each committee shall convene at the call of its chairman at such time and place as he may designate, but action by either committee under this section may be taken by the members thereof acting individually without convening in meeting. In each case in which approval by either committee of a regulation is required under this section, the Secretary shall transmit to each member of such committee a transcript of the record of the public hearing held by him. Members of the committees shall be given due notice of, and may sit with the Secretary or his representatives at, all such public hearings relating to the functions of their respective committee. Having received from an interested industry or from representatives of the public, a request for a new regulation or a change in an existing regulation, either committee, on its own motion, may advise the Secretary of its recommendations for action in accordance with the procedure set up by this section.

ADVISORY COMMITTEES FROM INDUSTRIES AND PUBLIC

SEC. 704. For the purposes of consultation in formulating general administrative policies for the enforcement of this Act, the Secretary is authorized to appoint an advisory committee from each of the following groups: The food industry, the drug industry, the cosmetic industry, creators and/or disseminators of advertising, the public. The Secretary is further authorized to accept plans for such self-regulation of advertising and/or trade practices as will aid in securing compliance with the requirements of this Act, when presented by associations or groups representative of their industries: Provided, That nothing in this paragraph shall be construed as restricting the responsibilities and powers conferred upon the Secretary by this Act.

EXAMINATIONS AND INVESTIGATIONS

SEC. 705. The Secretary is authorized to conduct examinations and investigations for the purposes of this Act through officers 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.

RECORDS OF INTERSTATE SHIPMENT

SEC. 706. 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 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 definite 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: Provided further, That whenever in the opinion of the Secretary it is practical, he shall attempt to make the objective inspection of food packed in a Territory or possession of the United States at the first point of entry within the territorial limits of the United States.

FACTORY INSPECTION

SEC. 707. In order to prevent interstate commerce in adulterated or misbranded food, drugs, devices, or cosmetics for the purposes of safeguarding the public health and preventing deceit upon the purchasing public, 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, 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 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 reasonable request shall be guilty of a misdemeanor and shall on conviction thereof, be subject to the penalties prescribed by section 708 (b) of this Act.

PROHIBITED ACTS AND PENALTIES

SEC. 708. (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-broadcast 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, directly or indirectly, the purchase of food, drugs, devices, or cosmetics, in interstate commerce.

(6) The introduction into interstate commerce of any food if the manufacturer, processor, or packer does not hold an unsuspended valid permit when so required by regulations under section 305.

(7) The refusal to permit access to or copying of any record as required by section 706.

(8) The forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of section 305.

(9) The using by any person to his own advantage, or revealing, 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 305 or 707 concerning any method or process which as a trade secret is entitled to protection.

(b) Any person who violates any of the provisions of subdivision (1) to (7), inclusive, 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 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 more than $3,000, or both such imprisonment and fine: Provided, however, That any person who violates any of the provisions of subdivisions (4) or (5) of paragraph (a) of this section shall only be liable for and forfeit and pay a civil penalty of not more than $1,000, to be recovered by civil action in the district court within the district where the person resides or carries on business if (1) the violation does not involve imminent danger to health or gross deception, and (2) the violation is established by opinion evidence only.

(c) Notwithstanding the provision of paragraph (b) of this section, in case of a willful violation of any of the provisions of subdivisions (1) to (7), inclusive, of paragraph (a) of this section the penalty shall be imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine.

(d) No publisher, radio-broadcast licensee, advertising agency, or other agency or medium for the dissemination of advertising shall be deemed to have violated the provisions of subdivision (4) or (5) of paragraph (a) of this section by reason of the dissemination of any false advertisement when such dissemination is caused by the manufacturer, packer, distributor, or seller residing in the United States of the article so advertised; but such manufacturer, packer, distributor, or seller shall be amenable to the prosecution and penalties provided for violation of such subdivisions. It shall be unlawful for any publisher, radiobroadcast licensee, advertising agency, or other agency or medium for the dissemination of advertising willfully to refuse, on reasonable request of an officer or employee duly designated by the Secretary, to furnish to such officer or employee the name and post-office address of the manufacturer, packer, distributor, or seller residing in the United States who caused him to disseminate any such advertisement; and any publisher, radio-broadcast licensee, advertising agency, or other agency or medium for the dissemination of advertising who so refuses shall be guilty of a misdemeanor and shall on conviction thereof be subject to the penalties prescribed by paragraph (b) of this section.

(e) No dealer shall be subject to the penalties of paragraph (b) of this section (1) for having received in interstate commerce any article of food, drug, device, or cosmetic and in good faith sold it as received unless he refuses to furnish 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 and all documents pertaining to the delivery of the article to him, 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, device, or cosmetic, or the advertising copy therefor, to the effect that such article is not adulterated or misbranded, and such copy is not false, within the meaning of this Act, designating it. 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, in good faith, of any advertisement offering for sale at his place of business any article which he does not distribute or sell in interstate commerce.

(f) Any person who violates any of the provisions of subdivision (8) 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 more than $5,000, or both such imprisonment and fine.

(g) Any person who violates any of the provisions of subdivision (9) of paragraph (a) of this section 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. 709. (a) When construing and enforcing the provisions of this Act, unless otherwise provided, the act, omission, or failure of any officer, employee, or agent acting for or employed by any person, within the scope of his employ

ment 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, unless otherwise provided, such violation shall also be deemed to be a violation by the individual directors, officers, or agents of such corporation or association who personally ordered, or did any of the acts constituting, in whole or in part, such violation.

INSTITUTION OF CRIMINAL AND CIVIL PENALTY PROCEEDINGS

SEC. 710. Before reporting any violation of this Act to any United States attorney for institution of criminal proceedings thereunder, or for the institution of civil penalty action under Section 708 (b), the Secretary shall, in accordance with regulations prescribed by him, afford appropriate notice and opportunity for hearing to interested persons (1) for hearing upon the question of such violation; and (2) for hearing to review his tentative decision to make such report, upon cause shown satisfactory to the Secretary. The report shall be accompanied by findings of the appropriate officers 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, injunction proceedings, or civil penalty action, minor violations of this Act whenever he believes that the purposes of the Act can best be accomplished by a suitable written notice or warning.

SEIZURE

SEC. 711. (a) Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, 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 an unsuspended valid permit, if so required by regulations under section 305, 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: Provided, however, That not more than one seizure shall be instituted in cases of alleged misbranding, except when the Secretary has probable cause to believe from facts found by him that such article is so misbranded as to render it imminently dangerous to health, or when such alleged misbranding has been the basis of a prior judgment in favor of the United States in a criminal prosecution or libel for condemnation proceeding under this Act respecting such article: And provided further, That said single seizure action shall, on motion, be removed for trial to the jurisdiction of the claimant's residence.

(b) The article shall be liable to seizure by process pursuant to the libel and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty; except that either party may demand trial by jury or any issue of fact joined in any such case. In cases of articles of food, drugs, devices or cosmetics seized under the provisions of this section when the same issues of adulteration or misbranding under the provisions of this act, raised by the same claimant, are pending in various jurisdictions, the United States District Court for any district where one of such seizures is pending, or for the district of the claimant's residence, is hereby vested with jurisdiction to consolidate and try such cases; and on application of the claimant, seasonably made, such cases may be tried in any such jurisdiction of the claimant's choice.

(c) The court at any time after seizure up to a reasonable time before trial shall by order allow any party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized, and as regards fresh apples and fresh pears, a true copy of the analysis on which the proceeding is based.

(d) Any food, drug, device, 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 shall not be sold or disposed of contrary to the provisions of this act or