Regulation 5. Hearings. [As amended to accord with F. I. D. 130.] (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 evidence 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 Pharmacopoeia or National Formulary, official at the time. (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. [As amended December 8, 1908, by F. I. D. 99, to take effect on January 1, 1909; see also F. I. D. 83 for opinion of the Attorney-General on the issue of a guaranty based upon a former guaranty.] (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. (b) A general guaranty may be filed with the Secretary of Agriculture by the manufacturer or dealer and be given a serial number, which number shall appear on each and every package of goods sold under such guaranty with the words "Guaranteed by [insert the 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 adulter ated 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. (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. 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 eliminate 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 the 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. (e) The term "stain" includes any change produced by the addition of any substance to the exterior portion of foods which in any way alters their natural tint. Regulation 13. Natural Poisonous or Deleterious Ingredients. (Section 7, paragraph 5, under "Foods.") Any food product which contains naturally a poisonous or deleterious ingredient does not come within the provisions of the Food and Drugs Act, June 30, 1906, except when the presence of such ingredient is due to filth, putrescence, or decomposition. Regulation 14. External Application of Preservatives. (Section 7, paragraph 5, under "Foods," proviso.) (a) Poisonous or deleterious preservatives shall only be applied externally, and they and the food products shall be of a character which shall not permit the permeation of any of the preservative to the interior, or any portion of the interior, of the product. (b) When these products are ready for consumption, if any portion of the added preservative shall have penetrated the food product, then the proviso of Section 7, paragraph 5, under "Foods," shall not obtain, and such food products shall then be subject to the regulations for food products in general. (c) The preservative applied must be of such a character that, until removed, the food products are inedible. Regulation 15. Wholesomeness of Colors and Preservatives. [As amended to accord with F. 1. 104. See also F. I. D. 76, 89, 92, 101, and 102 for rulings under this head.] (Section 7, paragraph 5, under "Foods.") (a) Respecting the wholesomeness of colors, preservatives, and other substances which are added to foods, the Secretary of Agriculture shall determine from chemical or other examination, under the authority of the agricultural appropriation Act, Public 382, approved June 30, 1906, the names of those substances which are permitted or inhibited in food products; and such findings, when approved by the Secretary of the Treasury and the Secretary of Commerce and Labor, shall become a part of these regulations. (b) The Secretary of Agriculture shall determine from time to time, in accordance with the authority conferred by the agricultural appropriation Act, Public 382, approved June 30, 1906, the principles which shall guide the use of colors, preservatives, and other substances added to PURE FOOD-54. foods; and when concurred in by the Secretary of the Treasury and the Secretary of Commerce and Labor, the principles so established shall become a part of these regulations. (c) It having been determined that benzoate of soda mixed with food is not deleterious or poisonous and is not injurious to health, no objec tion will be reaised under the food and drugs Act to the use in food of benzoate of soda, provided that each container or package of such food is plainly labeled to show the presence and amount of benzoate of soda. Food Inspection Decisions 76 and 89 are amended accordingly. Regulation 16. Character of the Raw Materials. (Section 7, paragraph 1, under "Drugs;" paragraph 6, under "Foods.") (a) The Secretary of Agriculture, when he deems it necessary, shall examine the raw materials used in the manufacture of food and drug products, and determine whether any filthy, decomposed, or putrid substance is used in their preparation. (b) The Secretary of Agriculture shall make such inspections as often as he may deem necessary. MISBRANDING. Regulation 17. Label. [As amended by F. I. D. 84, January 31, 1908, taking effect February 10, 1908.] (Section 8.) (a) The term "label" applies to any printed, pictorial or other matter upon or attached to any package of a food or drug product, or any container thereof subject to the provisions of this Act. (b) The principal label shall consist, first, of all information which the Food and Drugs Act, June 30, 1906, specifically requires, to wit, the name of the place of manufacture in the case of food compounds or mixtures sold under a distinctive name; statements which show that the articles are compounds, mixtures, or blends; the words "compound," "mixture," or "blend," and words designating substances or their derivatives and proportions required to be named in the case of foods and drugs. All this information shall appear upon the principal label, and should have no intervening descriptive or explanatory reading matter. Second, if the name of the manufacturer and place of manufacture are given, they should also appear upon the principal label. Third, preferably upon the principal label, in conjunction with the name of the substance, such phrases as "artificially colored," "colored with sulphate of copper," or any other such descriptive phrases necessary to be announced should be conspicuously displayed. Fourth, elsewhere upon the principal label other matter may appear in the discretion of the manufacturer. If the |