Third. If any valuable constituent of the article has been wholly or in part : abstracted.

Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed.

Fifth. If it contains any added poisonous or other added deleterious ingredient which may render such article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this Act shall be construed as applying only when said products are ready for consumption.

Sixth. If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter.

In the case of cosmetics :

If it contains poisonous of deleterious ingredients in such quantities as likely to be imminently dangerous to the user under the conditions of use prescribed in the labeling thereof, or when used under such conditions of use as are .customary or usual.

SEC. 8. That the term "misbranded", as used herein, shall apply to all drugs, or cosmetics, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, and to any food, drug, or cosmetic which is falsely branded as to the State, Territory, or country in which it is manufactured or produced.

The term "package" or "original unbroken package" as used herein means the immediate container of the article which is intended to be delivered for consumption by the public. The term "label" includes all written, printed, and graphic matter in any form whatsoever accompanying any food, drug, or cosmetic.

That for the purposes of this Act an article shall also be deemed to be misbranded

In the case of drugs:

First. If it be an imitation of or offered for sale under the name of another -article.

Second. If the contents of the package as originally put up shall have been removed, in whole or in part, and other contents shall have been placed in such package, or if the package fail to bear a statement on the label of the quantity or proportion of any morphine, opium, cocaine, heroin, alpha or beta eucaine. chloroform, cannabis, chloral hydrate, acetanilid, or barbituric acid, or any derivative or preparation of any such substances contained therein.

Third. If its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent. Fourth. If it fail to bear the true name and address of the manufacturer, packer, seller, or distributor thereof.

In the case of food:

First. If it be an imitation of or offered for sale under the distinctive name of another article.

Second. If it be labeled or branded so as to deceive or mislead the purchaser, or purport to be a foreign product when not so, or if the contents of the package as originally put up shall have been removed in whole or in part and other contents shall have been placed in such package, or if it fail to bear a statement on the label of the quantity or proportion of any morphine, opium. cocaine, heroin, alpha or beta eucaine, chloroform, cannabis, chloral hydrate, or barbituric acid or any derivative or preparation of any such substances contained therein.

Third. If in package form, the quantity of the contents be not plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count: Provided, however, That reasonable variations shall be permitted, and tolerances and also exemptions as to small packages shall be established by rules and regulations made in accordance with the provisions of section three of this Act.

Fourth. If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or substances contained therein, which statement, design, or device shall be false or misleading in any particular: Provided, That an article of food which does not contain any added poisonous or deleterious ingredients shall not be deemed to be adulterated or misbranded in the following cases:

First. In the case of mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with a statement of the place where said article has been manufactured or produced. Second. In the case of articles labled, branded, or tagged so as to plainly indicate that they are compounds, imitations, or blends, and the word “ compound","imitation ", or "blend", as the case may be, is plainly stated on the package in which it is offered for sale: Provided, That the term "blend " as used herein shall be construed to mean a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only: And provided further, That nothing in this Act shall be construed as requiring or compelling proprietors or manufacturers of proprietary foods which contain no unwholesome added ingredient to disclose their trade formulas, except insofar as the provisions of this Act may require to secure freedom from adulteration or misbranding.

Fifth. If it be canned food and falls below the standard of quality, condition, and/or fill of container, promulgated by the Secretary of Agriculture for such canned food and its package or label does not bear a plain and conspicuous statement prescribed by the Secretary of Agriculture indicating that such canned food falls below such standard. For the purposes of this paragraph the words "canned food" mean all food which is in hermetically sealed containers and is sterilized by heat, except meat and meat food products: which are subject to the provisions of the Meat Inspection Act of March 4, 1907, as amended, and except canned milk; the word "class" means and is limited to a generic product for which a standard is to be established and does: not mean a grade, variety, or species of a generic product. The Secretary of Agriculture is authorized to determine, establish, and promulgate from time. to time, a reasonable standard of quality, condition, and/or fill of container for each class of canned food as will, in his judgment, promote honesty and fair dealing in the interest of the consumer; and he is authorized to alter or modify such standard from time to time as, in his judgment, honesty and fair dealing in the interest of the consumer may require. The Secretary of Agriculture is further authorized to prescribe and promulgate from time to time the form of statement which must appear in a plain and conspicuous manner on each package or label of canned food which falls below the standard promulgated by him, and which will indicate that such canned food falls below such standard, and he is authorized to alter or modify such form of statement from time to time, as in his judgment may be necessary. In promulgating such standards and forms of statements and any alteration or modification thereof, the Secretary of Agriculture shall specify the date or dates when such standards shall become effective, or after which such statements shall be used, and shall give public notice not less than ninety days in advance of the date or dates: on which such standards shall become effective or such statements shall be used. Nothing in this paragraph shall be construed to authorize the manufacture, sale, shipment, or transportation of adulterated or misbranded foods.

SEC. 9. That no dealer shall be prosecuted under the provisions of this Act 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, or who caused said articles to be introduced in interstate commerce, 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.

SEC. 10. That any article of food, drug, cosmetic, or liquor 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. And if such article is condemned as being adulterated or misbranded, or of a poisonous or deleterious character, within the meaning of this act, the same shall be disposed of by destruction or sale, as the said 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 articles 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 articles be delivered to the owner thereof. The pro-` ceedings 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 such proceedings shall be at the suit of and in the name of the United States.

SEC. 10a. Notwithstanding the provisions of section 4 the Secretary of Agriculture shall, before certifying any violation of paragraph third, “In the case of drugs", in section 8 of this Act, to any United States district attorney to cause criminal proceedings to be commenced and prosecuted or to cause any seizure for confiscation by process of libel for condemnation, cause notice to be given to the person primarily responsible for the representations alleged to be in violation of said paragraph “third”, and a day to be fixed upon which said person may be heard. No criminal proceeding shall be commenced nor shall any article of drug be proceeded against or seized for condemnation on the grounds that the label or package of said article of drug bears or contains any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein which is falseand fraudulent, unless and until the Secretary of Agriculture shall have given the notice and afforded the opportunity for hearing as provided in this section. At such hearing the party or parties interested may furnish evidence, either by himself or his representative, to justify the representations of therapeutic or curative value made in or upon such label or package.

In the event such person shall refuse or is unable to justify such representations to the satisfaction of the person designated by the Secretary of Agriculture to hold such hearing, the Secretary shall fix a reasonable time for such party to discontinue such representations or to make changes in or upon the label or package in the manner indicated by the Secretary. After such hearing the Secretary shall furnish such person a statement of his ruling and set forth his reasons therefor.

If such person at such hearing shall by proper evidence justify such representations or shall make changes indicated by the Secretary, the Secretary shall then furnish such person with a certificate that his rulings have been complied with.

In the event of the refusal or failure of such person to conform to directionsof the Secretary or his designate within the time so fixed to discontinue representations or make changes in the package or label, the Secretary shall at once certify the facts as provided in section 4 of this Act.

Not more than one action based upon alleged false and fraudulent representations of therapeutic value shall be pending in the courts of the United States at one time until after there has been an adjudication that said article is misbranded within the meaning of said paragraph "third" herein mentioned. After notice and upon good cause being shown by the District Attorney that an emergency exists, the judge of the court in which said action has been commenced may enjoin the repetitious introduction in interstate commerce of articles similar to the article seized, until such time as the pending cause may be tried.

In the event, after the trial of said single action, there shall have been a final decree or judgment entered in favor of the Government, then further proceedings in libel for confiscation may be commenced against the article of drugs.

complained of and the label or package of which bears or contains similar statements, designs, or devices, and which have been shipped in interstate

commerce.

The District Attorney may apply to the District Court in any jurisdiction where an article of drugs may be found, the label and package of which bears or contains any statement, design, or device, concerning the therapeutic value of such article or of the ingredients contained therein which is false and fraudulent, upon a showing that an emergency exists and drastic action in the interests of public health is necessary, and obtain an order directing the United States marshal to impound such article pending further order of the court. Appeals and other proceedings under this section may be had in accordance with title 12c, section 1121 (Judicial Code, Numbered 129).

10b. The term advertisement" as used herein includes all representations of fact disseminated by the manufacturer, producer, owner, or distributor of an article of food, drug, or cosmetic, or by his authorized agent or representative in any manner by other than label, and excludes statements which involve mat'ters of opinion where there is no exact standard of absolute truth. Any advertisement of food, drug, or cosmetic will be deemed false if in any particular representations of fact are untrue. The Secretary shall, before reporting any violation of this Act by reason of any advertisement of foods, drugs. or cosmetics for institution of criminal procedings, afford due notice and opportunity for a hearing to interested parties.

The examination of advertising shall be made in a bureau of the Department of Agriculture as may be directed by the Secretary of Agriculture, and if it appear that such advertisement is false within the meaning of this section the Secretary of Agriculture shall cause notice to be given to the person primarily responsible for the representations appearing in such advertisement alleged to be in violation of this section, and the day fixed upon which said person may be heard. No criminal proceedings shall be commenced on the grounds that said advertisement is false, as defined in this section, until the notice and hearing provided for have been given and afforded. If it appears to the Secretary after such hearing that such advertisement is false as provided herein, then the Secretary shall direct that such party shall cease and desist from making the representations complained of, and in making such order the Secretary shall furnish to such person a statement of his ruling and set forth his reasons therefor. In the event such person shall fail to cease and desist from continuing the representations in such advertising complained of, the Secretary shall at once certify the facts as provided in section 4 of this Act.

10c. The dissemination of any false advertisement as defined in the next preceding section by any means for the purpose of inducing directly or indirectly the sale of foods, drugs, or cosmetics in interstate commerce is prohibited, and any person who violates or causes to be violated any of the provisions of paragraph A of this section, and who shall fail or refuse to comply with the cease and desist order as provided for herein, shall be guilty of a misdemeanor and shall, on conviction thereof be subject to a fine of not less than $100 nor more than $1,000, or imprisonment for not more than one year. or both such fine and imprisonment, in the discretion of the court.

SEC. 11. The Secretary of the Treasury shall deliver to the Secretary of Agriculture, upon his request from time to time, samples of foods, 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 is otherwise dangerous to the health of the people of the United States, or if 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 importation made by such owner or consignee.

SEC. 12. That the term "Territory as used in this Act shall include the insular possessions of the United States. The word "person" as used in this Act shall be construed to import both the plural and the singular, as the case demands, and shall include corporations, companies, societies, and associations. 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 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.

[S. 2858]

A BILL To prevent the adulteration, misbranding, and false advertising of food, drugs, and cosmetics, in the commerce affected, for the following purposes, namely, to safeguard the public health and to protect the purchasing public from injurious deception

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Federal Food, Drug, and Cosmetic Act."

GENERAL DEFINITIONS

SEC. 2. As used in this Act, unless the context otherwise indicates(a) The term "President" means the President of the United States. (b) The term "Secretary" means the Secretary of Agriculture of the United States.

(c) The term “Department" means the Department of Agriculture of the United States.

66

(d) The term commerce" means (1) commerce between any State or Territory and any place outside thereof, or between points within the same State or Territory but through any place outside thereof; and (2) manufacture or commerce within the District of Columbia or within any Territory not organized with a legislative body.

(e) The term "Territory" means any Territory or possession of the United States and includes the District of Columbia.

(f) The term " person" includes individual, partnership, corporation, and association.

(g) The term "label" means all labels and includes all statements, designs, and representations of any kind upon or attached to a food, drug, or cosmetic, or upon or attached to any container, wrapper, or covering thereof.

(h) The term "principal label" means the principal label or labels upon the package of a food, drug, or cosmetic.

66

(i) The term package means the retail package or the immediate container of a food, drug, or cosmetic.

(j) The term "advertisement" means any advertisement, made through any medium or by any means, and includes all written, printed, and graphic matter accompanying a food, drug, or cosmetic, in its sale, or separately distributed in furtherance of its sale.

(k) The term "particular" means any material particular relative to the purposes of this Act.

(1) The term "animal" means any domestic animal, bird, or fish.

(m) The term "medical opinion" means the opinion of physicians, dentists, veterinarians, or pharmacologists, relating to the field of their respective professions.