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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 Pharmacopæia 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.)
Aldehyde, Ether, Ethyl acetate, Ethyl nitrite, and Paraldehyde.
Sirups, Tinctures, Tonics, Whiskies, and Wines.
Apamorphine, Dionine, Peronine, Morphine acetate, Hydrochlorid,
Sulphate, and other salt of Morphine.
, Chlorodyne, Compound powder of morphine, Crayons, Elixirs, Granules, Pills, Solutions, Sirups, Sup
positories, Tablets, Triturates, and Troches. OPIUM, GUM:
Preparations of Opium
Extracts, Denarcotized opium, Granulated opium, and Powdered
gars, and Wines.
Codeine, Alkaloid, Hydrochlorid, Phosphate, Sulphate, and other
salts of Codeine.
Elixirs, Pills, Sirups, and Tablets.
Cocaine hydrochlorid, Oleate, and other salts.
Coca leaves, Catarrh powders, Elixirs, Extracts, Infusion of coca,
tures, Troches, and Wines. HEROIN:
Preparations containing Heroin
Sirups, Elixirs, Pills, and Tablets. ALPHA AND BETA EUCAINE:
Mixtures, Ointments, Powders, and Solutions.
Chloranodyne, Elixirs, Emulsions, Liniments, Mixtures, Spirits,
Preparations of Cannabis Indica
Corn remedies, Extracts, Mixtures, Pills, Powders, Tablets, and
Chloral acetophenonoxim, Chloral alcoholate, Chloralamide, Chlor-
Chloral camphorate, Elixirs, Liniments, Mixtures, Ointments, Sup.
positories, Sirups, and Tablets. ACETĂNILIDE (ANTIFEBRINE, PHENYLACETAMIDE) :
Acetphenetidine, Citrophen, Diacetanilide, Lactophenin, Methoxy-
Analgesics, Antineuralgics, Antirheumatics, Cachets, Capsules,
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.
EXPORTS OF FOODS AND DRUGS.
Regulation 30. Preparation of Products for Export.
(Section 2.) Food products intended for export may contain added substances not permitted in foods intended for domestic commerce, when the addition of such substances does not confțict with the laws of the countries to which the food product is to be exported and when such substances are added in accordance with the directions of the foreign purchaser or his agent.
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.
Food products for export under this regulation shall be kept separate and labeled to indicate that they are for export.
If the products are not exported they shall not be allowed to enter domestic commerce.
Regulation 31. Denaturing. Unless otherwise declared on the invoice or entry, all substances ordinarily used as food products will be treated as such. Shipments of substances ordinarily used as food products intended for technical purposes must be accompanied by a declaration stating that fact, and must be so denatured as to prevent their use as foods.
Regulation 32. Alteration and Amendment of Regulation.
These regulations may be altered or amended at any time, without previous notice.
Adopted by the State Board of Health of the State of California, at a regular meeting of said Board, held January 4, 1908.
N. K. FOSTER, Secretary of the State Board of Health.