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year's imprisonment, or both such fine and imprisonment, in the discretion of the court, and for each subsequent offense and conviction thereof shall be fined not less than $1,000 or sentenced to one year's imprisonment or both such fine and imprisonment, in the discretion of the court.
8718. SEC. 2. That the introduction into any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or from any foreign country, or shipment to any foreign country of any article of food, drug, or cosmetic which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited; and any person who shall ship or deliver for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, or to a foreign country, or who shall receive in any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or foreign country, and having so received, shall deliver, in the original unbroken packages, for pay or otherwise, or offer to deliver to any other person, any such articles so adulterated or misbranded within the meaning of this act, or any person who shall sell or offer for sale in the District of Columbia or the Territories of the United States any such adulterated or misbranded foods (or] drugs or cosmetics, or export or offer to export the same to any foreign country, shall be guilty of a misdemeanor, and for such offense be fined not exceeding $200 for the first offense, and upon conviction for each subsequent offense not exceeding $300 or be imprisoned not exceeding one year, or both, in the discretion of the court: Provided, That no article shall be deemed misbranded or adulterated within the provisions of this Act when intended for export to any foreign country and prepared or packed according to the specifications or directions of the foreign purchaser when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption, then this proviso shall not exempt said article from the operation of any of the other provisions of this Act.
8719. SEC. 3. That [the Secretary of the Treasury,) the Secretary of Agriculture [, and the Secretary of Commerce and Labor) shall make uniform rules and regulations for carrying out the provisions of this Act, including the collection and examination of specimens of foods, [and] drugs and 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 products are offered for interstate commerce, or for export or import between the United States and any foreign port or country.
8720. Sec. 4. That the examinations of specimens of foods, [and] drugs and cosmetics shall be made in (the Bureau of Chemistry of the Department of Agriculture) such existing bureau or bureaus in the Department of Agriculture as may be directed by the Secretary of Agriculture, or under the direction and supervision of such bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this Act; and if it shall appear from any such examination that any of such specimens is adulterated or misbranded within the meaning of this Act, the Secretary of Agriculture shall cause notice thereof to be given to the party from whom such sample was obtained] manufacturer of such article if known or if unknown to the party who caused said article to be introduced into interstate commerce. 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) manufacturer or such person who introduced the article in interstate commerce, then the Secretary of Agriculture shall at once certify the facts to the proper United States district attorney, 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, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid.
8721. SEC. 5. That 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.
8722. [SEC. 6. That the term "drug”, as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals. The term “food”, as used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound.]
SEC. 6. The term "food" includes all substances and preparations used for, or entering into the composition of food, drink, confectionery, or condiment for man or other animals. The term drug" includes (1) all substances and preparations recognized in the United States Pharmacopæia or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food, and all devices, intended to affect the structure or any function of the body of man or other animals. The term “cosmetic" includes all substances and preparations intended for cleansing, or altering the appearance of, or promoting the attractiveness of, the person.
8723. Sec. 7. That for the purposes of this Act an article shall be deemed to be adulterated:
In case of drugs:
First. If, when a drug is sold under or by a name recognized in the United States Pharmacopeia or National Formulary, or supplements thereto, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopeia or National Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof, although the standard may differ from that determined by the test laid down in the United States Pharmacopæia or National Formulary, and provided further, that no drug defined in the United States Pharmacopæia or National Formulary or supplements thereto, shall be deemed to be adulterated under this provision if it complies with the standard of strength, quality, and purity as determined by the test laid down in the United States Pharmacopeia or National Formulary or supplements thereto, notwithstanding that it may have been made by a modification of the official formula or directions made necessary to meet manufacturing requirements.
Second. If its strength or purity fall below the professed standard or quality under which it is sold.
In the case of confectionery:
If it contain terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt, or spirituous liquor or compound or narcotic drug.
In the case of food:
First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength.
Second. If any substance has been substituted wholly or in part for the article.
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 contain 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 macreation 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 consist 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 or 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.
8724. 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, [or] drug or cosmetic (product] 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 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 (alcohol] morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis, chloral hydrate, (or) 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 labeled, branded, or tagged so as to plainly indicate that they are compounds, imitations, or blends, and the word "compo "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.
8725. SEC. 9. That no dealer shall be prosecuted under the provisions of this act when he can establish a guarantee 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 amendable to the prosecutions, fines, and other penalties which would attach, in due course, to the dealer under the provisions of this Act.
8726. 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 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 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 be in violation of said paragraph third, and a day to be fixed upon which said person may be heard. No criminal proceedings 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 false and 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 of 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 directions of 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 bear or contain 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 or 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 (Judiciary Code No. 129).
106. 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 matters 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 proceedings, 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 appears 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