contents are stated in terms of weight or measure, such statement should appear upon the principal label and must be couched in plain terms, as required by Regulation 29. (c) If the principal label is in a foreign language, all information required by law and such other information as indicated above in (b) shall appear upon it in English. Besides the principal label in the language of the country of production, there may be also one or more other labels, if desired, in other languages, but none of them more prominent than the principal label, and these other labels must bear the information required by law, but not necessarily in English. The size of the type used to declare the information required by the Act shall not be smaller than eight-point (brevier) capitals: Provided, That in case the size of the package will not permit the use of eight-point type, the size of the type may be reduced proportionately. (d) Descriptive matter upon the label shall be free from any statement, design, or device regarding the article or the ingredients or substances contained therein, or quality thereof, or place or origin, which is false or misleading in any particular. The term "design" or "device" applies to pictorial matter of every description, and to abbreviations, characters, or signs for weights, measures, or names of substances. (e) An article containing more than one food product or active medicinal agent is misbranded if named after a single constituent. In the case of drugs the nomenclature employed by the United States Pharmacopoeia and the National Formulary shall obtain. (f) The use of any false or misleading statement, design, or device appearing on any part of the label shall not be justified by any statement given as the opinion of an expert or other person, nor by any descriptive matter explaining the use of the false or misleading statement given as the opinion of an expert or other person, nor by any descriptive matter explaining the use of the false or misleading statement, design, or device. Regulation 18. Name and Address of Manufacturer. (Section 8.) (a) 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. (b) 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 in the opinion of the Secretary of Agriculture the mention of any such place, to the exclusion of the others, misleads the public. Regulation 19. Character of Name. [As amended by F. I. D. 84, January 31, 1908, taking effect February 10, 1908.] (Section 8.) (a) A simple or unmixed food or drug product not bearing a distinctive name should 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 the components or qualities is required, except as to content of alcohol, morphine, etc. (b) 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. (c) 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 or Territory where any such article is manufactured or produced shall be stated upon the principal label. (d) 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 20. Distinctive Name. (Section 8.) (a) 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. (b) A distinctive name shall not be one representing any single constituent of a mixture or compound. (c) A distinctive name shall not misrepresent any property or quality of a mixture or compound. (d) 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 21. Compounds, Imitations, or Blends Without Distinctive Name. (Section 8.) (a) 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. (b) 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. (c) Coloring and flavoring can not be used for increasing the weight or bulk of a blend. (d) 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 one pound to eight hundred pounds of the blend. (e) A color or flavor can not be employed to imitate any natural product or any other product of recognized name and quality. (f) The term "imitation" applies to any mixture or compound which is a counterfeit or fraudulent simulation of any article of food or drug. Regulation 22. Articles without a Label. (Section 8, paragraph 1, under "Drugs;" paragraph 1, under "Foods.") 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 23. 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 enter into interstate commerce. Regulation 24. 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 Regulation 19 (a) and 28. Regulation 25. Substitution. (Sections 7 and 8.) (a) 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. (b) 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 26. 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 27. Mixtures of 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, mixt, 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. [As amended by F. I. D. 112, January 6, 1910, taking effect April 1, 1910.] (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 Pharmacopoeia 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. (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. (e) In case the actual quantity or proportion is stated it shall be the average quantity or proportion with the variations noted in Regula tion 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, 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, syrups, 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, syrups, 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, syrups, 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, syrups, tablets, tinctures, troches, and wines. |