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RULES AND REGULATIONS FOR THE ENFORCEMENT OF THE

FOOD AND DRUGS ACT OF JUNE 30, 1906, AS AMENDED.

Regulation 1.-Short Title of the Act.

The act, "For preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved June 30, 1906 (34 Stat. 768), as amended by the act approved August 23, 1912 (87 Stat. 416), by the act approved March 3, 1913 (37 Stat. 732), by the act approved July 24, 1919 (41 Stat. 271), and as it may be amended hereafter, shall be known and referred to as the Federal food and drugs act.

Regulation 2.-Scope of the Act.

The provisions of the act apply to foods and to drugs which have been shipped or delivered for shipment in interstate commerce, or which are exported or offered for export to foreign countries, or which are being transported in interstate commerce for sale or have been transported in interstate commerce, or which have been received from a foreign country, or which are manufactured, sold, or offered for sale in the District of Columbia, Territories of the United States, or insular possessions.

Regulation 3.-Collection of Samples and Evidence for Action Under Sections 1, 2, and 10.

(Section 8.)

(a) A sample for examination by or under the direction and supervision of the Bureau of Chemistry shall be collected by

(1) An authorized agent of the Department of Agriculture. (2) A health, food, or drug officer of any State, Territory, city, or the District of Columbia, commissioned by the Secretary of Agriculture for this purpose.

(3) An agent of any health, food, or drug officer of any State, Territory, city, or the District of Columbia when such agent is authorized by the Secretary of Agriculture through such health, food, or drug officer commissioned by the Secretary of Agriculture for this purpose.

(b) Foods or drugs within the scope of sections 1, 2, and 10 of the act may be sampled wherever found. The sample shall be represen

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tative in all cases. A sample of packaged goods shall consist usually of three packages when the individual package is 4 pounds or less in weight or 2 quarts or less in volume. If the goods are in larger packages, one or two packages may suffice, depending on the character of the goods and the nature of the examination to be made. Samples whether from package or bulk goods shall, when practicable, be divided into three parts or subdivisions. All subdivisions shall be properly identified and sealed with a seal provided for the purpose by the Department of Agriculture.

(c) The sample shall be delivered for examination by or under the supervision of the Bureau of Chemistry. Subdivisions of the sample remaining intact after analysis, except when perishable, shall be held under seal. Upon request one subdivision if available shall be delivered to the party or parties interested.

(d) At the time of collection all marks, brands or tags, or accompanying printed or written matter pertaining to the article, sampled shall be recorded. The names of the vendor and agent from whom the sample is collected, together with the date of collection, shall also be recorded. All original invoices, bills of lading, freight bills, and other documentary evidence of shipment or sale, or copies thereof, shall be procured from the dealers, carriers, warehousemen, or other persons having possession of such documents.

(e) Records of common carriers and warehousemen shall be examined from time to time for the purpose of obtaining evidence of violations of the Federal food and drugs act.

(f) Establishments in which foods or drugs are prepared in whole or in part for sale in the Territories or the District of Columbia or for transportation in interstate or foreign commerce may be inspected by any authorized agent of the Department of Agriculture.

Regulation 4.-Methods of Analysis.

(Section 4.)

(a) Drugs recognized in the United States Pharmacopoeia or National Formulary for which methods of analysis have been prescribed in said Pharmacopoeia or National Formulary shall be analyzed by these methods.

(b) All foods and such drugs as are not included in paragraph (a) of this regulation shall be analyzed by the methods prescribed by the Association of Official Agricultural Chemists, when applicable, provided, however, that any method of analysis or examination satisfactory to the Bureau of Chemistry may be employed.

(c) All foods or drugs for which no methods of analysis have been prescribed, either in the Pharmacopoeia or National Formulary or by the Association of Official Agricultural Chemists, shall be

analyzed or examined by methods satisfactory to the Bureau of Chemistry.

Regulation 5.-Hearings-Procedure without Hearing.

(Sections 4 and 5.)

(a) Whenever it appears that an article is adulterated or misbranded within the meaning of the act, and proceedings are contemplated under section 1 or 2, notice shall be given to the party or parties against whom prosecution is under consideration and to other interested parties, and a date shall be fixed at which such party or parties may be heard. The hearing shall be held at the office of the Bureau of Chemistry most convenient to the parties cited, and shall be private and confined to questions of fact. The parties notified may present evidence, either oral or written, in person or by attorney, to show cause why the matter should not be referred. for prosecution as a violation of the Federal food and drugs act.

(b) After a hearing is held, if it appears that the act has been violated, the Secretary of Agriculture shall report the facts to the proper United States attorney.

(c) The health, food, or drug officer or agent of any State, Territory, city, or the District of Columbia who shall obtain satisfactory evidence of a violation of the act may present such evidence direct to the proper United States district attorney for appropriate action under the Federal food and drugs act.

(d) When the procedure outlined in paragraph (c) is not followed, the health, food, or drug officer or agent of any State, Territory, city, or the District of Columbia, commissioned by the Secretary of Agriculture, who obtains satisfactory evidence of any violation of section 1 or 2 of the act shall submit such evidence to the Bureau of Chemistry in order that a date for a hearing may be fixed and notice given to the proper party.

Regulation 6.-Guaranty.

(Section 9.)

(a) Any wholesaler, manufacturer, jobber, or other party residing in the United States may furnish to any dealer to whom he sells any article of food or drug a guaranty that such article is not adulterated or misbranded within the meaning of the Federal food and drugs act.

(b) Each guaranty to afford protection shall be signed by, and shall contain the name and address of, the wholesaler, manufacturer, jobber, dealer, or other party residing in the United States making the sale of the article or articles covered by it to the dealer, and shall be to the effect that such article or articles are not adulterated or misbranded within the meaning of the Federal food and drugs act. specifically designating said act.

(c) If a particular guaranty in respect to any article or articles be given, it should be incorporated in or attached to the bill of sale, invoice, bill of lading, or other schedule, giving the name and quantity of the article or articles sold, and shall not appear on the label or package. A guaranty, if worded substantially according to the following form, will comply with all the requirements of the act:

I (we), the undersigned, do hereby guarantee that the articles of food (or drugs) listed herein (or specifying the same) are not adulterated or misbranded within the meaning of the Federal food and drugs act.

(Signature and address of guarantor.)

(d) In lieu of a particular guaranty for each consignment, lot, or article of food or drugs, a general continuing guaranty may be furnished by the guarantor to actual or prospective purchasers. Such general guaranty shall conform to the requirements of paragraph (b) of this regulation.

(e) It having been determined that the legends "Guaranteed under the food and drugs act, June 30, 1906," and "Guaranteed by (name of guarantor), under the food and drugs act, June 30, 1906,” borne on the labels or packages of foods and drugs, are each misleading and deceptive, in that the public is induced by such legends to believe that the articles to which they relate have been examined and approved by the Government and that the Government guarantees that they comply with the law, the use of either legend, or any similar legend, on labels or packages is prohibited.

(f) A dealer in food or drug products will not be liable to prosecution if he can establish that the articles were sold to him under a guaranty given in compliance with this regulation.

Regulation 7.-Publication.

(Section 4.)

(a) After judgment of the court in any proceeding under the act, notice shall be given by publication. Such notice shall include the finding of the court and may include the findings of the analyst and such explanatory statements of facts as the Secretary of Agriculture may deem appropriate.

(b) This publication may be made in the form of a circular, notice, or bulletin, as the Secretary of Agriculture may direct.

(c) If an appeal be taken from the judgment of the court before such publication, that fact shall appear.

Regulation 8.-Standards for Drugs.

(Section 7, in the case of drugs.)

(a) A drug sold under or by a name, or a synonym, recognized in the United States Pharmacopoeia or National Formulary, unless

labeled as prescribed by paragraph (b) of this regulation, shall conform to the standard of strength, quality, or purity for the article as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation. An article shall not be deemed to conform to such standard of strength, quality, or purity unless it conforms in every respect to all the requirements and specifications of the United States Pharmacopoeia or the National Formulary for the article.

(b) A drug sold under or by a name, or a synonym, recognized in the United States Pharmacopoeia or the National Formulary which does not conform to the standard of strength, quality, or purity for the article as determined by the test laid down therein shall be labeled with a statement to the effect that the drug is not a United States Pharmacopoeia or National Formulary article; in addition it shall be labeled with a statement showing its own actual strength, quality, or purity, or else with a clear and exact statement of the nature and extent of the deviation from the standard of strength, quality, or purity set out for such article in the United States Pharmacopoeia or National Formulary.

Regulation 9.-Confectionery.

(Section 7.)

The term "food" includes articles used for confectionery. The provisions of the act relating to food, as well as the specific provisions relating to confectionery, apply to confectionery.

Regulation 10.-Powdered.

(Section 7, paragraph fourth, in the case of food.)

An article of food shall neither be covered with a powder nor reduced to a powder in such manner that damage or inferiority is concealed.

Regulation 11.-Poisonous or Deleterious Ingredients.
(Section 7, paragraph fifth, in the case of food.)

A poisonous or other deleterious ingredient shall not be added to an article of food in such quantity as may by any possibility render the article injurious to health. Any ingredient artificially introduced into an article of food is an added ingredient.

Regulation 12.-External Application of Preservatives.

(Section 7, proviso of paragraph fifth, in the case of food.)

A food to which a preservative is applied externally, in order to be within the proviso of section 7, paragraph fifth, must bear on the covering or package directions for the effective removal of such preservative.

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