“REGULATIONS

"SEC. 13. The Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce shall make uniform rules and regulations, which shall be printed and published, for carrying out the provisions of this Act, including the collection and examination of specimens of food, drugs, or cosmetics manufactured or offered for sale in the District of Columbia, or in any Territory of the United States, or which shall be offered for sale in unbroken packages in any State other than that in which they shall have been respectively manufactured or produced, or which shall be received from any foreign country, or intended for shipment to any foreign country, or which may be submitted for examination by the chief health, food, or drug officer of any State, Territory, or the District of Columbia, or at any domestic or foreign port through which such product is offered for interstate commerce, or for export or import between the United States and any foreign port or country. provision of this Act imposing any liability shall apply to any act done or omitted in good faith in conformity with any rule or regulation, notwithstanding that such rule or regulation may, after such act or omission, be amended or rescinded or be determined by judicial or other authority to be invalid for any reason.

No

"SEC. 14. The examinations of specimens of foods, drugs, and cosmetics and the advertisements thereof shall be made in the Food and Drug Administration of the Department of Agriculture, or under the direction and supervision of such Administration, for the purpose of determining from such examinations whether such articles are adulterated, or misbranded, or falsely advertised within the meaning of this Act; and if it shall appear from any such examination that any of such specimens is adulterated, or misbranded, or falsely advertised within the meaning of this Act, the Secretary of Agriculture shall cause notice thereof to be given to the manufacturer or distributor thereof, if known, and if not known, then to the party from whom such sample was obtained, which said notice shall state such violation in sufficient detail to indicate specifically the nature of the offense charged. Any party so notified shall be given an opportunity to be heard, under such rules and regulations as may be prescribed as aforesaid, and if it appears that any of the provisions of this Act have been violated by such party, then the Secretary of Agriculture shall at once certify the facts to the proper United States district attorney, or, in the case of false advertisements, to the Federal Trade Commission, with a copy of the results of the analysis or the examination of such article duly authenticated by the analyst or officer making such examination, under the oath of such officer. After judgment of the court, or of the Federal Trade Commission, as the case may be, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid.

DUTY OF DISTRICT ATTORNEY

"SEC. 15. It shall be the duty of each district attorney to whom the Secretary of Agriculture shall report any violation of this Act, or to whom any health or food or drug officer or agent of any State, Territory, or the District of Columbia shall present satisfactory evidence of any such violation, to cause appropriate proceedings to be commenced and prosecuted in the proper courts of the United States, without delay, for the enforcement of the penalties as in such case herein provided.

26 EXEMPTION OF DEALERS

"SEC. 16. No dealer shall be prosecuted under the provisions of this Act for having received in interstate commerce an article, and in good faith, sold it as first received

(a) 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

"(b) When he can establish a guaranty signed by the wholesaler, jobber, manufacturer, or other party residing in the United States, from whom he

purchases such articles, to the effect that the same is not adulterated or misbranded within the meaning of this Act, designating it. Said guaranty, to afford protection, shall contain the name and address of the party or parties making the sale of such articles to such dealer, and in such case said party or parties shall be amenable to the prosecutions, fines, and other penalties which would attach, in due course, to the dealer under the provisions of this Act.

66 SEIZURE AND INJUNCTION

"SEC. 17. (a) Any article of food, drug, or cosmetic that is adulterated or misbranded within the meaning of this Act and is being transported from one State, Territory, District or insular possession to another for sale, or, having been transported, remains unloaded, unsold, or in original unbroken packages, or if it be sold or offered for sale in the District of Columbia, or the territories. or insular possessions of the United States, or if it be imported from a foreign country for sale, or if it is intended for export to a foreign country, shall be liable to be proceeded against in any District Court of the United States within the district where the same is found, and seized for confiscation by a process of libel for condemnation: Provided, however, That not more than one seizure action shall be instituted under this paragraph against any article of food, drug, or cosmetic if (1) the alleged violation is one of misbranding or labeling only; (2) all current shipments of the article alleged to be misbranded bear the same labeling; and (3) such misbranding has not been the basis of a prior judgment in favor of the United States in any criminal prosecution or libel for condemnation proceeding under this Act: And provided further, That said single seizure action shall be instituted in, or removed for trial to, a district of reasonable proximity to the residence of the manufacturer, distributor or claimant of the article seized.

"(b) Any article of food, drug, or cosmetic condemned as being adulterated or misbranded, within the meaning of this Act, shall be disposed of by destruction or sale, as the court may 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 goods shall not be sold in any jurisdiction contrary to the provisions of this Act or the laws of that jurisdiction: Provided, however, That upon the payment of the costs of such libel proceedings and the execution and delivery of a good and sufficient bond to the effect that such article shall not be sold or otherwise disposed of contrary to the provisions of this Act, or the laws of any State, Territory, District, or insular possession, the court may, by order, direct that such article be delivered to the owner thereof. The proceedings of such libel cases shall conform, as near 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, and all proceedings shall be at the suit of, and in the name of, the United States.

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

"(d) In the event any article of food, drug, or cosmetic, seized pursuant to the provisions of subsection (a) of this section, is condemned as being adulterated or misbranded within the meaning of this Act; or if no claimant appear for such article of food, drug, or cosmetic so seized; or if, having appeared, such claimant defaults, and default and judgment as of condemnation be thereupon entered, then, and in any such event, the District Courts of the United States and the Supreme Court of the District of Columbia are hereby vested with jurisdiction to restrain by injunction the shipment in interstate commerce of such article of food, drug, or cosmetic when so adulterated or misbranded. "(e) Upon a showing satisfactory to the court that the labeling of any article of food, drug, or cosmetic seized pursuant to the provisions of subsection (a) of this section is false or misleading in manner or degree to render such article imminently dangerous to public health, the District Courts of the United States and the Supreme Court of the District of Columbia are hereby vested with jurisdiction to restrain by temporary injunction, pending the final adjudication of the libel for condemnation, the shipment in interstate commerce of such article of food, drug, or cosmetic when so labeled; provided that no injunction shall be granted under this paragraph except on motion and after notice to the manufacturer, distributor, or claimant of such article.

"(f) Upon a showing satisfactory to the court that the labeling of any article of food, drug, or cosmetic seized pursuant to the provisions of sub

section (a) of this section is false or deceptive in manner or degree to render such article imminently dangerous to public health, the District Court of the United States and the Supreme Court of the District of Columbia are hereby vested with the further jurisdiction to order the seizure or impounding of such article when so labeled pending the final adjudication of the single seizure action authorized in subsection (a), when such article, having been transported from one State, Territory, District, or insular possession to another for sale, remains unloaded, unsold, or in original unbroken packages: Provided, That no order shall be granted under this paragraph except on motion and after notice to the manufacturer, distributor, or claimant of such article.

REPETITIOUS VIOLATIONS

"SEC. 18. The repetitious introduction into interstate commerce of any adulterated or misbranded food, drug, or cosmetic, or the repetitious dissemination of false advertisements, within the meaning and purposes of this Act, are hereby declared to be unfair methods of competition in commerce within the meaning 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.'

66 INSPECTION

"SEC. 19. (a) If it cannot be determined by an examination of a food, drug, or cosmetic, after it has entered commerce, whether it is adulterated or misbranded within the meaning of this Act; and if an officer or employee of the Department duly designated by the Secretary for the purpose, is refused permission to enter and inspect any factory or establishment where such article is manufactured, processed, or packed, and all equipment, finished and unfinished materials, containers and labels there used or stored, to the extent deemed necessary to determine whether it is adulterated or misbranded within the meaning of this Act; then the Secretary is authorized to apply to the District Courts of the United States or to the Supreme Court of the District of Columbia, in the district wherein such manufacture, processing, or packing is done, for an order effective to secure such inspection. Said courts are hereby vested with jurisdiction in the premises. Any order issued hereunder shall duly provide against disclosure of any secret method, process, or formula.

"(b) Any carrier transporting a food, drug, or cosmetic in commerce, and any person receiving a food, drug, or cosmetic in commerce or from shipment in commerce, which article is subject to investigation under this Act, shall inform the Secretary or his representative duly designated for the purpose, of the record of such transportation or receipt, upon his written request for such information. It shall be unlawful for any carrier or person to refuse or fail to give such information, upon such request therefor: Provided, That evidence obtained under this paragraph shall not be used in any criminal proceeding under this Act against the person from whom it was obtained. Any carrier or person willfully violating this paragraph shall be guilty of a misdemeanor and shall, upon conviction thereof, be subject to a fine of not more than $500 for each violation.

"(c) The Secretary of Agriculture, upon application of any packer of any sea food 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 applicants in the production of such food. If the food is found to conform to the requirements of this Act, the applicant shall be authorized, in accordance with regulations prescribed by the Secretary of Agriculture, to mark the food so as to indicate such conformity. Services to any applicant under this section shall be rendered only upon payment of fees to be fixed by regulations of the Secretary of Agriculture in such amount as to cover the cost of the supervisory inspection and examination, together with the reasonable costs of administration incurred by the Secretary of Agriculture in carrying out this section. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary of Agriculture for expenditures incurred in carrying out this section. 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 this section or regulations 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.

"(d) 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 this section concerning any secret method, process or formula, shall be guilty of a felony, and shall, on conviction thereof, be subject to imprisonment for not more than two years or a fine or not more than $5,000, or both such imprisonment and fine.

"SEC. 20. 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 into the United States or offered for import, giving notice thereof to the owner or consignee, who may appear before the Secretary of Agriculture, and have the right to introduce testimony, and if it appear from the examination of such samples that any article of food, drug, or cosmetic offered to be imported into the United States is adulterated or misbranded within the meaning of this Act, or its otherwise dangerous to the health of the people of the United States, or is of a kind forbidden entry into, or forbidden to be sold or restricted in sale in the country in which it is made or from which it is exported or is otherwise falsely labeled in any respect, the said article shall be refused admission, and the Secretary of the Treasury shall refuse delivery to the consignee and shall cause the destruction of any goods refused delivery which shall not be 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 such goods pending examination and decision in the matter on execution of a penal bond for the amount of the full invoice value of such goods, together with the duty thereon, and on refusal to return such goods, for any cause to the custody of the Secretary of the Treasury, when demanded, for the purpose of excluding them from the country, or for any other purpose, said consignee shall forfeit the full amount of the bond: And provided further, That all charges for storage, cartage, and labor on goods which are 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.

66 CONSTRUCTION

“SEC. 21. (a) When construing and enforcing the provisions of this Act, the act, omission, or failure of any officer, agent, or other person acting for, or employed by, any individual, corporation, company, society, or association, within the scope of his employment or office shall in every case be also deemed to be the act, omission, or failure of such corporation, company, society, or association as well as that of the person.

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

"(c) 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 inhibitory antiseptic for use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.

"(d) When construing and enforcing the provisions of this Act with respect to labeling and advertisements, any representation regarding the value or effect of a food, drug, or cosmetic shall be deemed to be false if such representation is not supported by demonstrable scientific facts or by substantial medical or scientific opinion.

"(e) When construing and enforcing the provisions of this Act reasonable allowances, consistent with the purpose of the Act, shall be made for (1) abnormal individual reactions to foods, drugs, and cosmetics, and (2) harmless trade claims recognized by and under the common law.

"(f) 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 wherever he believes the purposes of the Act can be accomplished by suitable notices or warnings.

66 SEPARABILITY CLAUSE

"SEC. 22. If any provision of this Act is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the Act, and the applicability thereof to other persons and circumstances, shall not be affected thereby.

66 EFFECTIVE DATE AND REPEALS

"SEC. 23. This Act shall take effect one year from date of approval. All provisions of the Federal Food and Drugs Act of June 30, 1906, as amended (U. S. C., title 21, secs. 1-15), not herein reenacted, are hereby repealed effective upon such date: Provided, That the Act of March 4, 1923 (U. S. C., title 21, sec. 6; 42 Stat. 1500, ch. 268), defining butter and providing a standard therefor; and the Act of July 24, 1919 (U. S. C., title 21, sec. 10; 41 Stat. 271, ch. 26), defining wrapped meats as in package form shall remain in force and effect and be applicable to the provisions of this Act. This Act shall not be held to modify or repeal any of the existing laws of the United States except as provided in this section."

[H. R. 8805, 74th Cong., 1st sess.]

A BILL To protect the consuming public of the United States of America, numbering one hundred and twenty-five million people, and the honest producers and distributors. numbering fifty thousand persons, of food, nonalcoholic or nonintoxicating beverages, drugs, and cosmetics, sold, or offered for sale, in containers or packages, and to prevent the manufacture, shipment, and sale of adulterated or misbranded foods, drugs, nonalcoholic and nonintoxicating beverages, and cosmetics, and to regulate traffic therein; to prevent the false or fraudulent advertisement of food, drugs, nonalcoholic and nonintoxicating beverages, and cosmetics, and for other purposes

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, (1) That nine months after the passage of this Act every bulk and separate container or package of food, nonalcoholic or nonintoxicating beverages, drugs, or cosmetics, produced or prepared or processed or packaged or distributed in the United States of America, its Territories, possessions, or in the District of Columbia, shall have affixed thereon and thereto a print or label which shall state: "Trade mark and label registered in the United States Patent Office. Formula registered in the Food and Drug Administration."

(2) When the formula, or formulas, of the product is filed for registration in the Food and Drug Administration by the producer, or preparer, or processor, of food, nonalcoholic or nonintoxicating beverages, drugs, or cosmetics, the formula, or formulas, shall fully describe the physiological action and properties and proportions, combination or composition of food, nonalcoholic or nonintoxicating beverage, drug, or cosmetic named in the formula, the names of all the active ingredients only being given in full. If the material, or materials, named in the formula or formulas be drugs, the therapeutic action, accepted by recognized authorities, shall be fully stated; if the material or materials be cosmetics or any preparation intended for use in improving the appearance of th user, the action, after external application, of the simple form or of the compound, composition, or combination of the material or materials shall be fully stated.

(3) On receipt of the information herein required, together with specimens or samples of sufficient quantity for all tests of the product of the food, nonalcoholic or nonintoxicating beverages, drugs, and cosmetics, and accurate copies of the prints, label, labels, and labeling purposed to be used by the applicant on or in the containers or packages of food, nonalcoholic or nonintoxicating beverages, drugs, or cosmetics, which prints, label, labels, and labeling shall truthfully state the authoritative accepted use and physiological action of the material or materials described in the formula or formulas, the Food and Drug Administration shall make chemical analysis, or other necessary examination, for which the applicant shall pay a minimum fee of $1 and a maximum fee of $10, of the specimen or sample material or materials submitted, and of similar material or materials purchased in the open market, if obtainable, and shall compare the material or materials submitted and purchased with the formula or formulas, submitted by the applicant to determine(1) if the material or materials described in the formula, or formulas, or n the prints, label, labels, or labeling and offered or purposed to be offered for lic or private sale, or sold, are not harmful to the average human system