derived, unless accompanied by a statement to that effect, shall be deemed a misbranding, Packages of such materials may be labeled pieces,' ,” “stems,” “trimmings," or with some similar appellation. REGULATION 27. MIXTURES OR COMPOUNDS WITH DISTINCTIVE NAMES. (Section 8. First proviso under "Foods," paragraph 1.) (a) The terms "mixtures" and "compounds" are interchangeable and indicate the results of putting together two or more food products. (b) These mixtures or compounds shall not be imitations of other articles, whether simple, mixed, or compound, or offered for sale under the name of other articles. They shall bear a distinctive name and the name of the place where the mixture or compound has been manufactured or produced. (c) If the name of the place be one which is found in different States, Territories, or countries, the name of the State, Territory, or country, as well as the name of the place, must be stated. REGULATION 28. SUBSTANCES NAMED IN DRUGS OR FOODS.1 (Section 8. Second under "Drugs;" second under "Foods.") (a) The term "alcohol" is defined to mean common or ethyl alcohol. No other kind of alcohol is permissible in the manufacture of drugs except as specified in the United States Pharmacopœia or National Formulary. (b) The words alcohol, morphine, opium, etc., and the quantities and proportions thereof, shall be printed in letters corresponding in size with those prescribed in regulation 17, paragraph (c). (c) A drug, or food product except in respect of alcohol, is misbranded in case it fails to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, heroin, cocaine, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein.2 (d) A statement of the maximum quantity or proportion of any such substances present will meet the requirements, provided the maximum stated does not vary materially from the average quantity or proportion.3 (e) In case the actual quantity or proportion is stated it shall be the average quantity or proportion with the variations noted in regulation 29. (f) The following are the principal derivatives and preparations made from the articles which are required to be named upon the label: ALCOHOL, ETHYL: (Cologne spirits, Grain alcohol, Rectified spirits, Spirits, and Spirits of wine.) Derivatives— Aldehyde, Ether, Ethyl acetate, Ethyl nitrite, and Paraldehyde. Bitters, Brandies, Cordials, Elixirs, Essences, Fluid extracts, Spirits, 1 As amended by F. I. D. 112, Jan. 6, 1910. 2 See United States v. Koca Nola Co., p. 213, post. See United States v. The Richie Co., p. 447, post; and United States v. The Piso Co., p. 484, post. MORPHINE, ALKALOID: Derivatives Apomorphine, Dionine, Peronine, Morphine acetate, Hydrochloride, Sulphate, and other salts of morphine. Preparations containing morphine or derivatives of morphine— Bougies, Catarrh Snuff, Chlorodyne, Compound powder of morphine, Crayons, Elixirs, Granules, Pills, Solutions, Sirups, Suppositories, Tablets, Triturates, and Troches. OPIUM, GUM: Preparations of opium— Extracts, Denarcotized opium, Granulated opium, and Powdered opium, Bougies, Brown mixture, Carminative mixtures, Crayons, Dover's powder, Elixirs, Liniments, Ointments, Paregoric, Pills, Plasters, Sirups, Suppositories, Tablets, Tinctures, Troches, Vinegars, and Wines. Derivatives Codeine, Alkaloid, Hydrochloride, Phosphate, Sulphate, and other salts of codeine. Preparations containing codeine or its salts Elixirs, Pills, Sirups, and Tablets. COCAINE, ALKALOID: Derivatives Cocaine hydrochloride, Oleate, and other salts. Preparations containing cocaine or salts of cocaine— Coca leaves, Catarrh powders, Elixirs, Extracts, Infusion of coca, Ointments, Paste pencils, Pills, Solutions, Sirups, Tablets, Tinctures, Troches, and Wines. HEROIN: Preparations containing heroin Sirups, Elixirs, Pills, and Tablets. ALPHA AND BETA EUCAINE: Preparations Mixtures, Ointments, Powders, and Solutions. CHLOROFORM: Preparations containing chloroform— Chloranodyne, Elixirs, Emulsions, Liniments, Mixtures, Spirits, and CANNABIS INDICA: Preparations of cannabis indica Corn remedies, Extracts, Mixtures, Pills, Powders, Tablets, and Tinctures. CHLORAL HYDRATE (Chloral, U. S. Pharmacopoeia, 1890): Derivatives Chloral acetophenonoxim, Chloral alcoholate, Chloralamide, Chloralimide, Chloral orthoform, Chloralose, Dormiol, Hypnal, and Uraline. Preparations containing chloral hydrate or its derivatives— Chloral camphorate, Elixirs, Liniments, Mixtures, Ointments, Suppositories, Sirups, and Tablets. ACETANILIDE (Antifebrine, Phenylacetamide) : Derivatives Acetphenetidine, Citrophen, Diacetanilide, Lactophenin, Methoxy-acetanilide. Methylacetanilide, Para-Iodoacetanilide, and Phenacetine. Preparations containing acetanilide or derivatives— Analgesics, Antineuralgics, Antirheumatics, Cachets, Capsules, Cold remedies, Elixirs, Granular effervescing salts, Headache powders, Mixtures, Pain remedies, Pills, and Tablets. (g) In declaring the quantity or proportion of any of the specified substances the names by which they are designated in the act shall be used, and in declaring the quantity or proportion of derivatives of any of the specified substances, in addition to the trade name of the derivative, the name of the specified substance shall also be stated, so as to indicate clearly that the product is a derivative of the particular specified substance.1 1See United States v. The Antikamnia Chemical Co., p. 684, post, and opinion of the Attorney General, p. 792, post. REGULATION 29. STATEMENT OF WEIGHT OR MEASURE.1 (Section 8. Third under "Foods.") (a) A statement of the weight or measure of the food contained in a package is not required. If any such statement is printed, it shall be a plain and correct statement of the average net weight or volume, either on or immediately above or below the principal label, and of the size of letters specified in regulation 17. (b) A reasonable variation from the stated weight for individual packages is permissible, provided this variation is as often above as below the weight or volume stated. This variation shall be determined by the inspector from the changes in the humidity of the atmosphere, from the exposure of the package to evaporation or to absorption of water, and the reasonable variations which attend the filling and weighing or measuring of a package. REGULATION 30. METHOD OF STATING QUANTITY OR PROPORTION. (Section 8.) In the case of alcohol the expression "quantity" or "proportion" shall mean the average percentage by volume in the finished product. In the case of the other ingredients required to be named upon the label, the expression "quantity" or "proportion" shall mean grains or minims per ounce or fluid ounce, and also, if desired, the metric equivalents therefor, or milligrams per gram or per cubic centimeter, or grams or cubic centimeters per kilogram or per liter; provided that these articles shall not be deemed misbranded if the maximum of quantity or proportion be stated, as required in regulation 28 (d).3 EXPORTS AND IMPORTS OF FOODS AND DRUGS. REGULATION 31. PREPARATION OF FOOD PRODUCTS FOR EXPORT. (Section 2.) (a) Food products intended for export may contain added substances not permitted in foods intended for interstate commerce, when the addition of such substances does not conflict with the laws of the countries to which the food products are to be exported and when such substances are added in accordance with the directions of the foreign purchaser or his agent.* (b) The exporter is not required to furnish evidence that goods have been prepared or packed in compliance with the laws of the foreign country to which said goods are intended to be shipped, but such shipment is made at his own risk. (c) Food products for export under this regulation shall be kept separate and labeled to indicate that they are for export. (d) If the products are not exported they shall not be allowed to enter interstate commerce. 1 The section of the act under which this regulation was made has been amended by the act of Mar. 3, 1913, 37 Stat., 732. See F. I. D. 154, May 11, 1914, amending this regulation. 2 But see amendment of Mar. 3, 1913, p. 15, ante, and F. I. D. 154. 3 See United States v. Richie Co., p. 447, post. See Philadelphia Pickling Co. v. United States, p. 612, post. REGULATION 32. IMPORTED FOOD AND DRUG PRODUCTS. (Section 11.) (a) Meat and meat food products imported into the United States shall be accompanied by a certificate of official inspection of a character to satisfy the Secretary of Agriculture that they are not dangerous to health, and each package of such articles shall bear a label which shall identify it as covered by the certificate, which certificate shall accompany or be attached to the invoice on which entry is made. (b) The certificate shall set forth the official position of the inspector and the character of the inspection. (c) Meat and meat food products as well as all other food and drug products of a kind forbidden entry into or forbidden to be sold, or restricted in sale in the country in which made or from which exported, will be refused admission. (d) Meat and meat food products which have been inspected and passed through the customs may, if identity is retained, be transported in interstate commerce. REGULATION 33. DECLARATION. (Section 11.) (a) All invoices of food or drug products shipped to the United States shall have attached to them a declaration of the shipper, made before a United States consular officer, as follows: I, the undersigned, do solemnly and truly declare that I am the (Manufacturer, agent, or shipper.) of the merchandise herein mentioned and described, and that it consists of food or drug products which contain no added substances injurious to health. These products were grown in and manufactured in by (Country.) (Country.) (Name and consigned (City.) no to (City.) The products bear no false labels or marks, contain added color ing matter or preservative some and are not of a character to cause (Name of added color or preservative.) prohibition or restriction in the country where made or from which exported. Dated at this day of —, 19—. (Signed): (b) In the case of importations to be entered at New York, Boston, Philadelphia, Chicago, San Francisco, and New Orleans, and other ports where food and drug inspection laboratories shall be established, this declaration shall be attached to the invoice on which entry is made. In other cases the declaration shall be attached to the copy of the invoice sent to the Bureau of Chemistry. REGULATION 34. DENATURING.1 (Section 11.) Unless otherwise declared on the invoice, all substances ordinarily used as food products will be treated as such. Shipments of substances ordinarily used as food products intended for technical pur 1 As amended by F. I. D. 93, May 12, 1908. poses should be accompanied by a declaration stating that fact. Such products should be denatured before entry, but denaturing may be allowed under customs supervision with the consent of the Secretary of the Treasury, or the Secretary of the Treasury may release such products without denaturing, under such conditions as may preclude the possibility of their use as food products. REGULATION 35. BOND, IMPORTED FOODS, AND DRUGS. (Section 11.) Unexamined packages of food and drug products may be delivered to the consignee prior to the completion of the examination to determine whether the same are adulterated or misbranded upon the execution of a penal bond by the consignee in the sum of the invoice value of such goods with the duty added, for the return of the goods to customs custody.' REGULATION 36. NOTIFICATION OF VIOLATION OF THE LAW. (Section 11.) If the sample on analysis or examination be found not to comply with the law, the importer shall be notified of the nature of the violation, the time and place at which final action will be taken upon the question of the exclusion of the shipment, and that he may be present, and submit evidence (Form No. 5), which evidence, with a sample of the article, shall be forwarded to the Bureau of Chemistry at Washington, accompanied by the appropriate report card. REGULATON 37. APPEAL TO THE SECRETARY OF AGRICULTURE AND REMUNERATION. (Section 11.) All applications for relief from decisions arising under the execution of the law should be addrest to the Secretary of Agriculture, and all vouchers or accounts for remuneration for samples shall be filed with the chief of the inspection laboratory, who shall forward the same, with his recommendation, to the Department of Agriculture for action. REGULATION 38. SHIPMENT BEYOND THE JURISDICTION OF THE UNITED STATES. (Section 11.) The time allowed the importer for representations regarding the shipment may be extended at his request to permit him to secure such evidence as he desires, provided that this extension of time does not entail any expense to the Department of Agriculture. If at the expiration of this time, in view of the data secured in inspecting the sample and such evidence as may have been submitted by the manufacturers or importers, it appears that the shipment can not be legally imported into the United States, the Secretary of Agriculture 1 See United States v. Psaki et al., p. 324, post. |