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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. (June 30, 1906, sec. 3, 34 Stat. 768; Mar. 4. 1913, 37 Stat. 736; 21 Ư. S. C., sec. 3.)
1347. Definitions; “Territory ", "person ", liability of principal for acts of agent.—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. (June 30, 1906, sec. 12, 34 Stat. 772; 21 U.S. C., secs. 4, 5.)
1348. Standard of butter under Food and Drugs Act.—That for the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) [21 U. S. C., secs. 1-15]," butter” shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for. (Mar. 4, 1923, 42 Stat. 1500; 21 U. S. C., sec. 6.)
1349. Definition of terms “ drug” and “food.”—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. (June 30, 1906, sec. 6, 34 Stat. 769; 7 U.S. C., sec. 7.)
1350. Articles deemed adulterated.—That for the purposes of this Act an article shall be deemed to be adulterated.
Drugs.-In case of drugs:
DIFFERENCE FROM RECOGNIZED STANDARD ; STATEMENT ON BOTTLE, BOX, ETC., AS TO
First. If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopoeia 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 Pharmacopoeia or National Formulary.
BELOW PROFESSED STANDARD Second. If its strength or purity fall below the professed standard or quality under which it is sold.
Confectionery.—In the case of confectionery: MINERAL SUBSTANCES, POISONOUS COLOR OR FLAVORS, OTHER DELETERIOUS, ETC.,
INGREDIENTS, LIQUORS, ETO., OR NARCOTIC DRUGS 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.
Food. In the case of food:
INJURIOUS MIXTURES First. If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength.
SUBSTITUTES Second. If any substance has been substituted wholly or in part for the article.
VALUABLE CONSTITUENTS ABSTRACTED
Third. If any valuable constituent of the article has been wholly or in part abstracted.
DAMAGE OR INFERIORITY CONCEALED Fourth. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed. POISONOUS OR OTHER DELETERIOUS INGREDIENTS ADDED; PRESERVATIVES OF FOOD
PRODUCTS FOR SHIPMENT, NECESSARILY REMOVED WHEN PRODUCTS READY FOR CONSUMPTION
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 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. FILTHY, ETC., SUBSTANCES, PORTIONS OF ANIMALS UNFIT FOR FOOD, AND PRODUCTS
OF ANIMALS DISEASED OR HAVING DIED OTHERWISE THAN BY SLAUGHTER 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. (June 30, 1906, sec. 7, 34 Stat. 769; 21 U. S. C., sec. 8.)
1351. Definition of term "misbranded." That the term “misbranded ”, as used herein, shall apply to all drugs, 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 product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced.
Articles deemed misbranded.That for the purposes of this Act an article shall also be deemed to be misbranded:
Drugs. In case of drugs:
IMITATION OR USE OF NAME OF OTHER ARTICLE
First: If it be an imitation of or offered for sale under the name of another article.
REMOVAL AND SUBSTITUTION OF CONTENTS OF PACKAGE, OR FAILURE TO STATE ON LABEL
QUANTITY OR PROPORTION OF ALCOHOL, MORPHINE, ETC., OR OTHER NARCOTICS CONTAINED THEREIN
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 indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein. FALSE AND FRAUDULENT STATEMENT, ETC., AS TO CURATIVE OR THERAPEUTIO EFFECT
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.
Food.-In case of food :
IMITATION OR USE OF NAME OF OTHER ARTICLE
First. If it be an imitation of or offered for sale under the distinctive name of another article.
FALSE LABEL OR BRAND, ETC., REMOVAL AND SUBSTITUTION OF CONTENTS OF PACKAGE,
OR FAILURE TO STATE ON LABEL QUANTITY OR PROPORTION OF MORPHINE OR OTHER NARCOTICS, ETC., CONTAINED THEREIN
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 indica, chloral hydrate, or acetanilide, or any derivative or preparation of any of such substances contained therein.
PACKAGES NOT MARKED WITH WEIGHT, MEASURE, OR NUMERIOAL COUNT; VARIATIONS
AND EXEMPTIONS PERMITTED
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 [21 U.S. C., sec. 3].
That the word “package" (as used in this paragraph) shall include and shall be construed to include wrapped meats inclosed in papers or other materials as prepared by the manufacturers thereof for sale.
Fourth. If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or the 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:
MIXTURES OR COMPOUNDS UNDER DISTINCTIVE NAMES 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. ARTICLES LABELED, BRANDED, ETC., AS COMPOUNDS, IMITATIONS, OR BLENDS; CON
STRUCTION OF TERM BLEND"; EXEMPTION FROM DISCLOSURE OF TRADE FORMULAS OF PROPRIETARY FOODS
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 “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 “hlend” 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 (Thirty-fourth Statutes, page 1260), as amended [21 U. S. C., secs. 71-93], 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. (June 30, 1906, sec. 8, 34 Stat. 771; Aug. 23, 1912, 37 Stat. 416; Mar. 3, 1913, 31 Stat. 732; July 24, 1919, 41 Stat. 271; July 8, 1930, 46 Stat. 1019; 21 U. S. C., secs. 9, 10.)
1352. Examinations of specimens; notice of adulteration or misbranding; certification of violations to district attorneys; notice of judgment.—That the examinations of specimens of foods and drugs shall be made in the Food, Drug, and Insecticide Administration or in such other branches of the Department of Agriculture as the Secretary of Agriculture may direct, 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. 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, 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. (June 30, 1906, sec. 4, 34 Stat. 769; Jan. 18, 1927, 44 Stat. 1003; 21 U.S. C., sec. 11.)