opinion of an expert or other person, appearing on any part of the label, nor by any descriptive matter explaining the use of the false or misleading statement, design, or device. The regulation regarding the principal label will not be enforced until July 1, 1908, in the case of labels printed and on hand December 31, 1907, whenever any statement therein contained which is contrary to the said Foods and Drug Acts, March 11, 1907, or either, as to character of contents, shall be corrected by a supplemental, label, stamp, or paster. Regulation 17. Name and Address of Manufacturer. The name of the manufacturer or producer, or the place where manufactured, except in case of mixtures and compounds having a distinctive name, need not be given upon the label; but if given, must be the true name and the true place. The words "packed for"'"'distributed by"or some equivalent phrase, shall be added to the label in case the name which appears upon the label is not that of the actual manufacturer or producer, or the name of the place not the actual place of manufacture or production. When a person, firm, or corporation actually manufactures or produces an article of food or drug in two or more places, the actual place of manufacture or production of each particular package need not be stated on the label, except when, in the opinion of the Secretary of the State Board of Health, the mention of any such place, to the exclusion of the others, misleads the public. Regulation 18. Character of Name. A simple or unmixed food or drug product not bearing a distinctive name shall be designated by its common name in the English language, or, if a drug, by any name recognized in the United States Pharmacopoeia or National Formulary. No further description of its components or qualities is required, except as to content of alcohol, morphine, etc. The use of a geographical name shall not be permitted in connection with a food or drug product not manufactured or produced in that place, when such name indicates that the article was manufactured or produced in that place. The use of a geographical name in connection with a food or drug product will not be deemed a misbranding when by reason of long usage it has come to represent a generic term and is used to indicate a style, type, or brand; but in all such cases the State, Territory, or country where any such article is manufactured or produced shall be stated upon the principal label. A foreign name which is recognized as distinctive of a product of a foreign country shall not be used upon an article of domestic origin except as an indication of the type or style of quality or manufacture, and then only when so qualified that it can not be offered for sale under the name of a foreign article. Regulation 19. Distinctive Name. A "distinctive name" is a trade, arbitrary, or fancy name which clearly distinguishes a food product, mixture, or compound from any other food product, mixture, or compound. A distinctive name shall not be one representing any single constituent of a mixture or compound. A distinctive name shall not misrepresent any property or quality of a mixture or compound. A distinctive name shall give no false indication of origin, character, or place of manufacture, nor lead the purchaser to suppose that it is any other food or drug product. Regulation 20. Compounds, Imitations, or Blends Without Distinctive Name. The term "blend" applies to a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only. If any age is stated, it shall not be that of a single one of its constituents, but shall be the average of all constituents in their respective proportions. Coloring and flavoring can not be used for increasing the weight or bulk of a blend. In order that colors or flavors may not increase the volume or weight of a blend, they are not to be used in quantities exceeding 1 pound to 800 pounds of the blend. A color or flavor can not be employed to imitate any natural product or any other product of recognized name and quality. The term "imitation" applies to any mixture or compound which is a counterfeit or fraudulent simulation of any article of food or drug. Regulation 21. Articles Without a Label. It is prohibited to sell or offer for sale a food or drug product bearing no label upon the package or no descriptive matter whatever connected with it, either by design, device, or otherwise, if said product be an imitation of or offered for sale under the name of another article. Regulation 22. Proper Branding not a Complete Guaranty. Packages which are correctly branded as to character of contents, place of manufacture, name of manufacturer, or otherwise, may be adulterated, and hence not entitled to protection under said Acts; or their sale, except upon prescription, may be forbidden by the Poisons Act, March 6, 1907. Regulation 23. Incompleteness of Branding. A compound shall be deemed misbranded if the label be incomplete as to the names of the required ingredients. A simple product does not require any further statement than the name or distinctive name thereof, except as provided in Regulations 18 and 27. Regulation 24. Substitution. When a substance of a recognized quality, commonly used in the preparation of a food or drug product, is replaced by another substance not injurious or deleterious to health, the name of the substituted substance shall appear upon the label. When any substance which does not reduce, lower, or injuriously affect its quality or strength is added to a food or drug product, other than that necessary to its manufacture or refining, the label shall bear a statement to that effect. Regulation 25. Waste Materials. When an article is made up of refuse materials, fragments, or trimmings, the use of the name of the substance from which they are 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 26. Mixtures or Compounds with Distinctive Names. The terms "mixtures" and "compounds" are interchangeable, and indicate the results of putting together two or more food products. 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. 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 27. Substances Named in Drugs or Foods. 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 Pharmacopoeia or National Formulary. 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 16. A drug 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. 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. In case the actual quantity or proportion is stated it shall be the average quantity or proportion with the variations noted in Regulation 28. 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, and Spirits of wine.) Derivatives— Aldehyde, Ether, Ethyl acetate, Ethyl nitrite, and Paraldehyde. Bitters, Brandies, Cordials, Elixirs, Essences, Fluid extracts, Spirits. MORPHINE, ALKALOID: Derivatives— Apamorphine, Dionine, Peronine, Morphine acetate, Hydrochlorid, Preparations containing Morphine or derivatives of Morphine— OPIUM, GUM: Preparations of Opium Extracts, Denarcotized opium, Granulated opium, and Powdered opium, Bougies, Brown mixture, Caminative mixtures, Crayons, Dover's powder, Elixirs, Liniments, Ointments, Paregoric, Pills, Plasters, Sirups, Suppositories, Tablets, Tinctures, Troches, Vinegars, and Wines. Derivatives Codeine, Alkaloid, Hydrochlorid, Phosphate, Sulphate, and other salts of Codeine. Preparations containing Codeine or its salts Elixirs, Pills, Sirups, and Tablets. COCAINE, ALKALOID: Derivatives Cocaine hydrochlorid, 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 Sirups. 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, Choralose, 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, Methoxyacetanilide, 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. Regulation 28. Statement of Weight or Measure. 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. 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 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 29. Method of Stating Quantity or Proportion. In the case of alcohol the expression "per cent. of volume" 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 27. |