(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 14.—Wholesomeness of colors and preservatives.

(a) Respecting the wholesomeness of colors, preservatives, and other substances which are added to foods, the Director of Health shall determine, from chemical or other examination, the names of those substances which are permitted or inhibited in food products; and such findings shall, when published, become a part of these regulations.

(b) The Director of Health shall determine from time to time the principles which shall guide the use of colors, preservatives, and other substances added to foods, and the principles so established shall, when published, become a part of these regulations.

REGULATION 15.-Character of raw materials.

(Section 7, paragraph 1, under Drugs;" paragraph 6, under Foods.")

(a) The Director of Health, when he deems it necessary, shall cause to be examined 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 Director of Health shall cause such examinations to be made as often as he may deem necessary.

MISBRANDING.

REGULATION 16.-Label.

(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.

(b) The principal label shall consist, first, of all words which The Pure Food and Drugs Act specifically requires, to wit: The name of the substance or product; the name of the place of manufacture in the case of food compounds or mixtures; the words which show that the articles are compounds, mixtures, or blends; the words "compound," "mixture," or " blend;" or words designating the substances or their derivatives and proportions required to be named in the case of drugs and foods. All these required words shall appear upon the principal label with no intervening descriptive or explanatory reading matter. Second, if the name of the manufacturer and place of manufacture are given, they shall also appear upon the principal label. Third, elsewhere upon the principal label other matter may appear in the discretion of the manufacturer.

(c) The principal label on food or drugs for domestic commerce shall be printed in English (except as provided in Regulation 18), with or without the foreign label in the language of the country where the food or drug product is produced or manufactured. The size of type 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 capital type the size of the type may be reduced proportionately.

(d) The form, character, and appearance of the labels, except as provided above, are left to the judgment of the manufacturer.

(e) Descriptive matter upon the label shall be free from any statement, design, or device regarding the article or ingredients or substances contained therein, or quality thereof, or place of origin, which is false or misleading in any particular.

(f) 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.

(g) 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.

In every case where weights or measures are given for articles manufactured in the Philippine Islands, the same shall be expressed in the metric system.

(h) The use of any false or misleading statement, design, or device shall not be justified by any statement given as the 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.

(i) The regulation regarding the principal label will not be enforced until January 1, 1908, in the case of labels printed and now on hand, whenever any statement therein contained which is contrary to The Pure Food and Drugs Act, as to character of contents, shall be corrected by a supplemental label, stamp, or paster. All other labels now printed and on hand may be used without change until January 1, 1908.

REGULATION 17.-Name and address of manufacturer.

(Section 8.)

وو

(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 when in the opinion of the Director of Health the mention of any such place, to the exclusion of the others, misleads the public.

REGULATION 18.-Character of name.

(Section 8.)

(a) 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 contents 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, Territory, country, or dependency 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.

(e) Where the only fault found with an importation is the failure properly to mark or brand the name of the place of origin as above required, such marks or brands may be added under customs supervision at the expense of the importer, and when properly branded, goods may be delivered upon payment of such charges. In this case it is not necessary to send samples to the Director of Health.

REGULATION 19.-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 20.—Compounds, imitations, or blends without distinctire 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 1 pound to 800 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 21.-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 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 enter into, or to be sold, bartered, exchanged or given away in the Philippine Islands.

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 (a) and 27.

REGULATION 24.-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 25.-Waste materials.

(Section 8.)

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.

(Section 8, first proviso under "Food," paragraph 1.)

(a) The terms "mixtures" and " 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, countries, or dependencies, the name of the State, Territory, country, or dependency, as well as the name of the place, must be stated.

REGULATION 27.-Substances named in drugs and foods.

(Section 8, second under “Drugs;" second under “ Food.")

(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 16, 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, That 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 Regulation 28.

(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. Preparations containing alcohol

Bitters, brandies, cordials, elixirs, essences, fluid extracts, spirits, sirups, tinctures, tonics, whiskies, and wines.