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.1 SEC. 2. That this Act shall take effect and be in force from and after its passage: Provided, however, That no penalty of fine, imprisonment, or confiscation shall be enforced for any violation of its provisions as to domestic products prepared or foreign products imported prior to eighteen months after its passage. Approved, March 3, 1913. 1 See regulations published in F. I. D. 154, May 11, 1914. RULES AND REGULATIONS.1 GENERAL. 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, shall be known and referred to as The Food and Drugs Act, June 30, 1906." REGULATION 2. ORIGINAL UNBROKEN PACKAGE.2 (Section 23.) The term "original unbroken package" as used in this act is the original package, carton, case, can, box, barrel, bottle, phial, or other receptacle put up by the manufacturer, to which the label is attached, or which may be suitable for the attachment of a label, making one complete package of the food or drug article. The original package contemplated includes both the wholesale and the retail package.* REGULATION 3. COLLECTION OF SAMPLES." (Section 4.) ized agents of the Department of Agriculture, or by the health, food, Samples of unbroken packages shall be collected only by authoror drug officer of any State, Territory, or the District of Columbia, when commissioned by the Secretary of Agriculture for this purpose. Samples may be purchased in the open market, and, if in bulk, the marks, brands, or tags upon the package, carton, container, wrapper, lector shall also note the names of the vendor and agent through or accompanying printed or written matter shall be noted. The colwhom the sale was actually made, together with the date of the purchase. The collectors shall purchase representative samples. Food and Drugs Act, June 30, 1906, were adopted by the Secretaries of the Treasury, 1 Under date of Oct. 17, 1906, 40 Rules and Regulations for the Enforcement of the the act. Since that time eight regulations, Nos. 3, 5, 9, 15, 17, 19, 28, and 34, have Agriculture, and Commerce and Labor by virtue of authority conferred in section 3 of been amended, as shown in the text; and one regulation, No. 39, has been revoked by F. I. D. 151. The initial letters "F. I. D.," as used herein, mean Food Inspection Decision. See also F. I. D. 86. The sections mentioned after the titles of these regulations refer to sections of the Food and Drugs Act, June 30, 1906. of Liquid Extracts, p. 199, post; United States v. 300 Cases of Mapleine, p. 190, post; See United States v. Five Boxes of Asafoetida, p. 318, post; United States v. 65 Casks J. L. Stephens Co., p. 466, post; Hipolite Egg Co. v. United States, p. 378, post; and United States v. Two Barrels of Desiccated Eggs, p. 388, post; United States v. The Dr. McDermott et al. v. Wisconsin, p. 629, post. As amended by F. I. D. 79, Oct. 8, 1907. 40066-14 -2 17 A sample taken from bulk goods shall be divided into three parts, and each shall be labeled with the indentifying marks. If a package be less than 4 pounds, or in volume less than 2 quarts, three packages shall be purchased, when practicable, and the marks and tags upon each noted as above. When three samples are purchased, one sample shall be delivered to the Bureau of Chemistry or to such chemist or examiner as may be designated by the Secretary of Agriculture; the second and third samples shall be held under seal by the Secretary of Agriculture, who, upon request, shall deliver one of such samples to the party from whom purchased or to the party guaranteeing such merchandise. When it is impracticable to collect three samples, or to divide the sample or samples, the order of delivery outlined above shall obtain, and in case there is a second sample the Secretary of Agriculture may, at his discretion, deliver such sample to parties interested. All samples shall be sealed by the collector with a seal provided for the purpose. REGULATION 4. METHODS OF ANALYSIS.1 (Section 4.) Unless otherwise directed by the Secretary of Agriculture, the methods of analysis employed shall be those prescribed by the Association of Official Agricultural Chemists and the United States Pharmacopoeia. REGULATION 5. HEARINGS.2 (Section 4.) (a) When the examination or analysis shows that samples are adulterated or misbranded within the meaning of this act notice of that fact shall be given in every case to the party or parties against whom prosecution lies under this act for the shipment or manufacture or sale of the particular product and such other interested parties as the Secretary of Agriculture may direct, and a date shall be fixed at which such party or parties may be heard before the Secretary of Agriculture or such other person as he may direct. The hearings shall be had at places designated by the Secretary of Agriculture most convenient for all parties concerned. These hearings shall be private and confined to questions of fact. The parties interested therein may appear in person or by attorney and may submit oral or written evidence to show any fault or error in the findings of the analyst or examiner. Interested parties may present proper interrogatories to analysts, to be submitted to and propounded by the Secretary of Agriculture or the officer conducting the hearing. Such privilege, however, shall not include the right of cross-examination. The Secretary of Agriculture may order a reexamination of the sample or have new samples drawn for further examination. (b) If, after hearings held, it appears that a violation of the act has been committed, the Secretary of Agriculture shall give notice to the proper United States attorney. (c) Any health, food, or drug officer or agent of any State, Territory, or the District of Columbia who shall obtain satisfactory evi 1 See United States v. 100 Barrels of Vinegar, p. 448, post. 2 As amended by F. I. D. 130, Jan. 18, 1911. dence of any violation of the Food and Drugs Act, June 30, 1906, as provided by section 5 thereof, shall first submit the same to the Secretary of Agriculture in order that he may give notice and fix dates for hearings to the proper parties. REGULATION 6. PUBLICATION. (Section 4.) (a) When a judgment of the court shall have been rendered there may be a publication of the findings of the examiner or analyst, together with the findings of the court. (b) This publication may be made in the form of circulars, notices, or bulletins, as the Secretary of Agriculture may direct, not less than .thirty days after judgment. (c) If an appeal be taken from the judgment of the court before such publication, notice of the appeal shall accompany the publication. REGULATION 7. STANDARDS FOR DRUGS. (Section 7.) (a) A drug bearing a name recognized in the United States Pharmacopoeia or National Formulary, without any further statement respecting its character, shall be required to conform in strength, quality, and purity to the standards prescribed or indicated for a drug of the same name recognized in the United States Pharmacopoia or National Formulary, official at the time.1 (b) A drug bearing a name recognized in the United States Pharmacopoeia or National Formulary, and branded to show a different. standard of strength, quality, or purity, shall not be regarded as adulterated if it conforms to its declared standard. REGULATION 8. FORMULAS PROPRIETARY FOODS. (Section 8, last paragraph.) (a) Manufacturers of proprietary foods are only required to state upon the label the names and percentages of the materials used, in so far as the Secretary of Agriculture may find this to be necessary to secure freedom from adulteration and misbranding. (b) The factories in which proprietary foods are made shall be open at all reasonable times to the inspection provided for in regulation 16. REGULATION 9. FORM OF GUARANTY.2 (Section 9.) (a) No dealer in food or drug products will be liable to prosecution if he can establish that the goods were sold under a guaranty by the wholesaler, manufacturer, jobber, dealer, or other party residing in the United States from whom purchased.3 (b) A general guaranty may be filed with the Secretary of Agriculture by the manufacturer or dealer and be given a serial number, 1 See United States v. Lehn & Fink, p. 384, post. As amended by F. I. D. 99, Dec. 8, 1908. For information concerning the use of guaranties under section 9 of the Food and Drugs Act, see F. I. D. Nos. 40, 62, 70, 72, 83, 96, and 99. See also F. I. D. 153, May 5, 1914, amending this regulation. See United States v. Heinle Specialty Co., p. 236, post. which number shall appear on each and every package of goods sold under such guaranty with the words "Guaranteed by [insert name of guarantor] under the Food and Drugs Act, June 30, 1906." (c) The following form of guaranty is suggested: I (we) the undersigned do hereby guarantee that the articles of foods or drugs manufactured, packed, distributed, or sold by me (us) [specifying the same as fully as possible] are not adulterated or misbranded within the meaning of the Food and Drugs Act, June 30, 1906. (Signed in ink.) [Name and place of business of wholesaler, dealer, manufacturer, jobber, or other party.] (d) If the guaranty be not filed with the Secretary of Agriculture as above, it should identify and be attached to the bill of sale, invoice, bill of lading, or other schedule giving the names and quantities of the articles sold. ADULTERATION. REGULATION 10. CONFECTIONERY. (Section 7.) (a) Mineral substances of all kinds (except as provided in regulation 15) are specifically forbidden in confectionery whether they be poisonous or not.1 (b) Only harmless colors or flavors shall be added to confectionery. (c) The term "narcotic drugs" includes all the drugs mentioned in section 8, Food and Drugs Act, June 30, 1906, relating to foods, their derivatives and preparations, and all other drugs of a narcotic nature. REGULATION 11. SUBSTANCES MIXED AND PACKED WITH FOODS. (Section 7, under "Foods.") No substance may be mixed or packed with a food product which will reduce or lower its quality or strength. Not excluded under this provision are substances properly used in the preparation of food products for clarification or refining, and eliminated in the further process of manufacture. REGULATION 12. COLORING, POWDERING, COATING, AND STAINING. (Section 7, under " Foods.") (a) Only harmless colors may be used in food products. (b) The reduction of a substance to a powder to conceal inferiority in character is prohibited. (c) The term "powdered" means the application of any powdered substance to the exterior portion of articles of food, or the reduction of a substance to a powder. (d) The term "coated" means the application of any substance to the exterior portion of a food product. 1 But see French Silver Dragée Co. v. United States, p. 276, post. |