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[ Act No. 1655, May 18, 1907 ]
AN ACT FOR PREVENTING THE MANUFACTURE, SALE, OR TRANSPORTATION OF ADULTERATED OR MISBRANDED OR POISONOUS OR DELETERIOUS FOODS, DRUGS, MEDICINES, AND LIQUORS, AND FOR REGULATING TRAFFIC THEREIN, AND FOR OTHER PURPOSES.
By authority of the United Stales, be it enacted by the Philippine Commission , that:
SECTION 1. It shall be unlawful for any person to manufacture within the Philippine Islands any article of food or drug which is adulterated or misbranded, within the meaning of this Act; and any person who shall violate any of the provisions of this section shall, for each offense, be punished by a fine not to exceed one thousand pesos or by imprisonment for one year, or by both such line and imprisonment in the discretion of the court, and for each subsequent of sense he shall be punished by a fine of not less than two thousand pesos nor more than five thousand pesos, or by imprisonment for one year, or by both such fine and imprisonment, in the discretion of the court.
SEC. 2. The introduction into the Philippine Islands from the United States or from any foreign country, or the shipment to the prohibited. United States or to any foreign country from the Philippine Islands, of any article of food or drugs which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited; and any person who shall ship or deliver for shipment from the Philippine Islands to the United States or to a foreign country, or who shall receive in the Philippine Islands from the United States or from any foreign country, and having so received, shall deliver, in original unbroken packages, for pay or otherwise, or . offer to deliver to any other person, any such article so adulterated or misbranded within the meaning of this Act. or any person who shall sell or offer for sale in the Philippine Islands any such adulterated or misbranded foods or drugs, or export or offer to export the same to the United States or to any foreign country, shall be punished for the first offense by a fine not to exceed four hundred pesos, and for each subsequent offense he shall be punished by a fine not to exceed six hundred pesos, or by imprisonment not to exceed one year, or by both such fine and imprisonment, in the discretion of the court: Provided, That no article shall be deemed and "adulterated." misbranded or adulterated within the provisions of this Act when intended for export to the United States or to any foreign country and prepared or packed according to the specifications or directions of the purchaser in the United States or in any foreign country when no substance is used in the preparation or packing thereof in conflict with the laws of the United States or of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption in the Philippine Islands, then this proviso shall not exempt said article from the operation of any of the other provisions of this Act.
SEC. 3. The Insular Collector of Customs, the Director of Health, and the Collector of Internal Revenue of the Philippine Islands shall make uniform rules and regulations, subject to the approval of the Secretary of the Interior of the Philippine Islands, for carrying out the provisions of this Act, including the collection and examination of specimens of foods and drugs manufactured or offered for sale in the Philippine Islands or which shall be received from the United States or from any foreign country, or intended for shipment to the United States or to any foreign country, or which may be submitted for examination by the Director of Health for the Philippine Islands.
SEC. 4. The examinations of specimens of foods and drugs shall be made in the Bureau of Science, or under the direction and supervision of that Bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this Act; and if it shall appear from any such examination that any of such specimens is adulterated or misbranded within the meaning of this Act, the Secretary of the Interior of the Philippine Islands shall cause notice thereof to be given to the party from whom such sample was obtained. Any party so notified shall lie given an opportunity to be heard, under such rules and. regulations as may be prescribed as aforesaid, and if it appears that any of the provisions of this Act have been violated by such party, then the Secretary of the Interior of the Philippine Islands shall at once certify the facts to the Attorney-General of the Philippine Islands with a copy of the results of the analysis or a report of the examination of such article duly authenticated by the analyst or officer making such examination, under the oath of such officer. After judgment of the court, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid, prosecution.
SEC. 5. It shall be the duty of the Attorney-General of the Philippine Islands, to whom the Secretary of the Interior of the Philippine Islands shall report any violation of this Act, or to whom the Director of Health shall present satisfactory evidence of any such violation, to cause appropriate proceedings to be commenced and prosecuted in the proper courts of the Philippine Islands, without delay, for the enforcement of the penalties as in such ease herein provided.
SEC.6. The term "drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the Cure, mitigation, or prevention of disease of either man or other animals. The term "food," as used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compounded.
SEC. 7. For the purposes of this Act an article shall be deemed to be adulterated:
That for the purposes of this Act an article shall also be deemed to be misbranded in case of drugs:
SEC. 10. Any article of food, drug, or liquor that is adulterated or misbranded within the meaning of this Act, that, having been transported, remains unloaded, unsold, or in original unbroken packages, or if it be sold or offered for sale in the Philippine Islands, or if it be imported from the United States or a foreign country for sale, or if it is intended for export to the United States or to a foreign country, shall be liable to be proceeded against in the Court of First Instance in the Philippine Islands of the judicial district within which the same is found, and shall be seized for confiscation and condemnation, and may be confiscated and condemned by said court in the proceedings so initiated. And if such article is condemned as being adulterated or misbranded, or as of a poisonous or deleterious character, within the meaning of this Act. the same shall be disposed of by destruction or sale, as the said court" may direct, and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treasury of the Philippine Islands, but such goods shall not be sold in any jurisdiction contrary to the provisions of this Act or to the laws of that jurisdiction: Provided, however, That upon the payment of the costs of the proceedings as provided in this section and the execution and delivery of a good and sufficient bond to the effect that such articles shall not be sold or otherwise disposed of contrary to the provisions of this Act or the laws of the United States, or of any State, Torritory, District, or insular possession of the United States, the court may order direct that such articles be delivered to the owner thereof. The proceedings hereinbefore mentioned admiralty shall conform, as near as may be, to the proceedings in admiralty in the Courts of First, Instance of the Philippine Islands, and all such proceedings shall be at the suit of and in the name of the United States.
SEC. 11. The Insular Collector of Customs shall deliver to the Director of Health, upon his request from time to time, samples of food and drugs which are being imported into the Philippine Islands or offered to import, giving notice thereof to the owner or consignee, who may appear to the Secretary of Interior of the Philippine Islands or any official designated by him and have the right to introduce testimony, and if it appear from the examination of such samples that any article of food or drug offered to be imported into the Philippine Islands is adulterated or misbranded within the meaning of this act, or is otherwise dangerous to the health of the people of the Philippine Islands, or is of a sale in the country in which it is made or from which it is exported, or is otherwise falsely labeled in any respect, the said article shall be refused admission, and thew Insular Collector of Customs shall refuse delivery to the consignee and shall cause the destruction of any goods refused delivery shall not be exported by the consignee within three months from the date of notice of such refusal under such regulations as the Insular Collector of Customs may prescribe; Provided, That the insular Collector of Customs may deliver to the consignee such goods ponding examination and decision in the matter, on execution of a penal bond for the amount of the full invoice value of such goods, together with the duty thereon, and on refusal to return such goods for any cause to the custody of the Insular Collector of Customs, when demanded, for the purpose of excluding them from the country, or for any other purpose, said of consignee shall forfeit the lull amount of the bond: And provided further, That all charges for storage, cartage, and labor on goods which are refused admission or delivery shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any future importation made by such owner or consignee.
SEC. 12. The word '"person" as used in this Act shall be construed to import both the plural and the singular, as the ease demands, and shall include corporations, companies, societies, associations, and other commercial or legal entities. When construing and enforcing the provisions of this Act, the act, omission, or failure of any officer, agent, or other person acting for or employed by any corporation, company, society, association, or other commercial or legal entity, within the scope of his employment or office, shall in every case be also deemed to be the act, omission, or failure of such corporation, company, society, association, or other commercial or legal entity, as well as that of the person.
SEC. 13. The public good requiring the speedy enactment of this bill, the passage of the same is hereby expedited in accordance with section two of "An Act prescribing the order of procedure by the Commission in the enactment of laws," passed September twenty-sixth, nineteen hundred.
SEC. 14. This Act shall take effect on its Passage: Provided, That any article, the importation, offer, sale, transportation, or use of which is prohibited or restricted by this Act, which is in transit to the Philippine Islands at the time of the passage of this. Act, shall not be subject to the lines, penalties, or forfeitures herein prescribed, but may, under rules and regulations to be prescribed by the Insular Collector of Customs, and approved by the Secretary of Finance and Justice, lie returned to the port from which it was shipped: Provided further, That this privilege shall not be extended beyond a period of sixty days after the date of the passage of this Act.
Enacted, May 18, 1907.
APPENDIX.
RULES AND REGULATIONS FOR THE ENFORCEMENT OF THE PURE FOOD AND DRUGS ACT
GENERAL
REGULATION 1.—Short title of the Act.
The act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," enacted Hay 18, 1907, shall be known and referred to as "The Pure Food and Drugs Act."
REGULATION 2.—Original unbroken package.
The term "original unbroken package" as used in this act is the original package, carton, case, can, box, barrel, bottle, phial, or other receptacle put up by the manufacturer, to which the label is attached, or which may be suitable for the attachment of a label, making one complete package of the food or drug article. The original package contemplated includes both the wholesale
and the retail package.
REGULATION 3.—Collection of samples.
(Section 2.)
(a) Whenever a customs, health, or internal-revenue officer has , cause for believing or suspecting that an article of food or drug which is being imported into, manufactured, or offered for sale in the Philippine Islands, or which is for the purpose of exportation from the Philippine Islands to the United States, or any foreign country or which has been imported into the Philippine Islands from the United States, or any foreign country, a sample or specimen of the articles suspected as being adulterated or mis-brawled. except in the cases provided for in Regulations 17 to 20, will be seined from the owner thereof and a receipt given therefor, and such sample will be forwarded to the Director of Health through the Thief of the Bureau to which the seizing officer belongs with a full and complete statement of the case, giving name of the person from whom taken, quantity of same on hand, in which capacity the person from whom taken was acting—whether as an importer, a manufacturer of the article, or dealer therein, or a consumer thereof—and will furnish such other information as in the opinion of the customs, health, or internal-revenue officer will be of as-q stance in the proper administration of the law.
(b) Representative samples shall be taken, discretion being used as in tile amount thereof; in general, one kilogram of bulk goods, or one liter of liquid goods being sufficient. Much smaller samples will serve in the case of drugs. In the case of bottled goods, one bottle will usually be found to be sufficient.
(c) Sample of bulk goods will be immediately placed in tin boxes or other suitable coverings and sealed by the officer taking the same.
(d) In all cases where samples of goods are to be taken the owner will lie given such notice thereof as the circumstances of the ease permit, and wherever possible, samples shall be taken and sealed in his presence. Samples shall be taken and sealed in duplicate, one .Mich sample to be transmitted as above stated to the Bureau of Health, and the other to be delivered to the importer or owner thereof, if he desire the same.
In order properly to perform the duties set forth above, customs, health, and internal-revenue officers should give all publicity to revenue officers. the fact that they are charged with the duty of carrying out the provisions of The Pure Food and Drugs Act, and should invite complaints and reports from all persons in their respective districts regarding adulteration or misbranding articles of food or drugs.
REGULATION 4.—Hearings.
(Section 4.)
(a) When the examination or analysis shows that the provisions of of The Pure Food and Drugs Act have been violated, notice of that fact, together with a ropy of the findings, shall be furnished to the party or parties from whom the sample was obtained or who executed the guaranty as provided in The Pure Food and Drugs Act, and a date shall be fixed at which such party or parties may be heard before the Secretary of the Interior, or other officer designated by him. The hearings shall be had at a place, to be designated by the Secretary of the Interior, most convenient for all parties concerned. These hen rings shall be private and confined to questions of fact. The parties interested therein may appear in person or by attorney and may propound proper interrogatories and submit oral or written evidence to show any fault or error in the findings of the analyst or examiner. The Secretary of the Interior may order a reexamination of the sample or have new samples drawn for further examination.
(b) If the examination or analysis be found correct the Secretary of the Interior shall give notice to the Attorney-General of the Philippine Islands as prescribed.
(c) Any customs, health, or internal-revenue officer who shall obtain satisfactory evidence of any violation of The Pure Food and Drugs Act, as provided in section 5 thereof, shall first submit the same to the Director of Health, through the Chief of his Bureau, in order that the former may cause notice to be given to the guarantor or to the party from whom the sample was obtained.
REGULATION 5.—Publication.
(Section 4.)
(a) When a judgment, of the court shall have been rendered, there may be a publication of the findings of the examiner or analyst, together with the findings of the court.
(b) This publication may be made by means of circulars, notices, or bulletins, or the Official Gazette, as the Secretary of the Interior may direct, not less than thirty days after judgment.
(c) If an appeal be taken from the judgment of the court before such publication, notice of (lie appeal shall accompany the publication.
REGULATION 6.—Standards for drugs.
(Section 7.)
(a) A drug bearing a mime recognized in the United States Pharmacopceia or "National Formulary, without any further statement respecting its character, shall be required to conform in strength, quality, and purity to the standards prescribed or indicated for a drug of the same name recognized in the United States Pharmacopceia or National Formulary, official at the time.
(b) A drug bearing a name recognized in the United States Pharmacopceia or National Formulary, and branded to show a different standard of strength, quality, or purity, shall not be regarded as adulterated if it conforms to its declared standard.
REGULATION 7.—Formulas—Proprietary foods.
(Section 8, second paragraph.)
(a) Manufacturers of proprietary foods are only required^ to state upon the label the names and percentages of the materials used, in so far as the Director of Health may find this to be necessary to secure freedom from adulteration and mis-branding.
(b) Factories in which proprietary foods are made shall be open at all reasonable times to the inspection provided for m Regulation 15.
REGULATION 8.—Form of guaranty.
(Section 9)
(a) No dealer in food or drug products will be liable to prosecution if he can establish that the goods were sold under a guaranty by the wholesaler, manufacturer, jobber, dealer, or other party residing in the Philippine Islands from whom purchased.
(b) A general guaranty may be filed with the Director of Health by the manufacturer or dealer and be given a serial number, which number shall appear on each and every package of goods sold under such guaranty with the words, "Guaranteed under The Pure Food and Drags Act."
(c) The following form of guaranty is suggested:
I (we), the undersigned, do hereby guarantee that the articles of food or drugs manufactured, packed, distributed, or sold by me (us) (specifying the same as fully as possible) are not adulterated or misbranded within the meaning of the Pure Food and Drugs Act. (Signed in ink)
................................................................................................................................................................
(Name of place of business of wholesaler, dealer, manufacturer, jobber, or other party.)
(d) If the guaranty be not filed with the Director of Health as above, it should identify and be attached to the bill of sale, invoice, bill of lading, or other schedule, giving the names and quantities
ADULTERATION.
REGULATION 9.—Confectionery.
(Section 7.)
(a) Mineral substances of all kinds (except as provided in Regulation 14) are specifically forbidden in confectionery whether they be poisonous or not.
(b) Only harmless colors or flavors shall be added to confectionery.
(c) The term "narcotic drugs" includes all the drugs mentioned in section 8, The Pure Food and Drugs Act, relating to foods, their derivatives and preparations, and all other drugs of a narcotic nature.
REGULATION 10.—Substances mixed and packed with foods.
(Section 7, under "Food.")
No substances may be mixed or packed with a food product which will reduce or lower its quality or strength. Not excluded under this provision are substances properly used in the preparation of food products for clarification or refining, and eliminated in the further process of manufacture.
REGULATION 11.—Coloring, powdering, coating, and staining.
(Section 7, under "Food.")
(a) Only harmless colors may be used in food products.
(b) The reduction of a substance to a powder to conceal inferiority in character is prohibited.
(c) The term "powdered" means the application of any powdered substance to the exterior portion of articles of food, or the reduction of a substance to a powder.
(d) The term "coated" means the application of any substance to the exterior portion of a food product.
(e) The term "stain" includes any change produced by the addition of any substance to the exterior portion of foods which in any way alters their natural tint.
REGULATION 12.—Natural poisonous or deleterious ingredients.
(Section 7, paragraph 5, under "Food.")
Any food product which contains naturally a poisonous or deleterious ingredient does not come within the provisions of The Pure Food and Drugs Act, except when the presence of such ingredient is due to filth, putrescence, or decomposition.
REGULATION 13.—External application of preservatives.
(a) Poisonous or deleterious preservatives shall-fee applied externally only, and they and the food products shall be of a character which shall not permit the permeation of any of the preservative to the interior, or any portion of the interior, of the product.
(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.
(Section 7. paragraph 5, under "Food.")
(a) Respecting the whole scenes 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 examination be made as often as he may deem necessary.
MISBRANDING.
REGULATION 10.—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; or 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 limited in English (except as provided in Regulation 18), with or without the foreign label m 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 ease 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 deyiee 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 medioinal agent is misbranded if named after a single constituent.
In the case of drugs the nomenclature employed by the United Drugs, nomencia-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 nianufaclured 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 anv 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 Drags Act, as to character of contents, shall he 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.)
(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, w the name of the place not the actual place of manufacture of production.
(b) When a person, firm, or corporation actually manufactures or produces an article of food or drug in two or more places, 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 snob 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 Ik; 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.
(c) 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.
(6) 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 distinction 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 of 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 ,i counterfeit or fraudulent simulation of any article of food or drug.
REGULATION 21.—Articles without a label.
(Section 8. paragraph 1, under "Drugs," paragraph", 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.
A compound shall be deemed misbranded if the label be incomplete as to the names of the required ingredients. A simple product docs 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 injuriouslv 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 boar 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
(Section 8, first proviso under "Food," 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, 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 Formula it.
(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 cucaine, 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 he the average quantity or proportion with the variations noted in Regulation 28.
(f) The following are the principal derivatives and preparations to be named made from the articles which are required to be named upon the on labels.
Alcohol, ethyl (Cologne spirits, grain alcohol, rectified spirits, spirits, and
spirits of wine) :
REGULATION 28.—Statement of weight or measure.
(Section 8, paragraph 3, under "Food.")
(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 snail 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 16.
(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 to the reasonable variations which attend the filling and weighing or measuring of a package.
REGULATION 29.—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 ease 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 (d).
EXPORTS AND IMPORTS FOODS AND DRUGS.
REGULATION 30.—Preparation of food products for export.
(Section 2.)
(a) Food products intended for export may contain added substances not permitted in foods intended for local consumption when the addition of such substance docs 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 the goods have been prepared or packed in compliance with the laws of the foreign country to which said goods are intended to he 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 be consumed locally.
REGULATION 31.—Imported food and drug products.
(Section 11.)
(a) Meat and meat food products imported into the Philippine Islands shall be accompanied by a certificate of official inspection of a character to satisfy the Director of Health 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 which exported, will be refused admission.
REGULATION 32.—Denaturing.
(Section 11.)
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 33—Bond, imported foods and drugs.
(Section 11.)
(a) 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 punal 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.
(b) In case the goods have already been delivered on ten days' penal bond for return of unexamined packages and it is desired to hold them for examination under The Pure Food and Drugs Act, demand must be made upon the importer for return within the ten days of the original bond, when a bond under section (a) above may be accepted in lieu of an actual physical return of the goods to customs custody.
(c) Where the importer does not desire to keep possession of the goods they will be stored in the warehouse of the custom-house, or in a public bonded warehouse at his expense for storage, cartage, and labor.
(d) No delivery of imported food or drugs suspected of being adulterated or misbranded will be made until the question is finally settled as hereafter provided, nor shall final liquidation of the entry be made while such question is pending.
REGULATION 34.—Notification of violation of the law.
(Section 11.)
(a) 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 in connection therewith.
REGULATION 35.—Appeal to the Secretary of the Interior.
(Section 11.)
All applications for relief from decisions arising under the execution of the law shall be addressed to the Secretary of the Interior.
REGULATION 36.—Shipment beyond the jurisdiction of the Philippine Islands.
(Section 11.)
The time allowed the importer for representations regarding 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 Bureau of Health. If at the expiration of this time, in view of the data secured in inspecting the sample and such evidence as may have been submited by the manufacturers or importers, it appears that the shipment can not be legally imported into the Philippine Islands, the Director of Health shall request the Insular Collector of Customs to refuse to deliver the shipment in question to the consignee, and to require its reshipment as authorized by law.
REGULATION 37.—Samples.
The samples made necessary under The Pure Food and Drugs Act, and by these regulations, shall be furnished by the owner or the importer thereof, at his expense.
REGULATION 38.—Inspection of samples.
All articles of food and all food and drink sold or offered for sale, and all places for their preparation, manufacture, or sale, shall be at all times subject to inspection by the Director of Health or the Collector of Internal Revenue, or their duly authorized representatives. Necessary samples of food or drink shall be furnished for examination upon the written request of the Director of Health or the Collector of Internal Revenue, and no remuneration shall be charged or paid therefor.
REGULATION 39.—Alteration and amendment of regulations.
By and with the approval of the Secretary of the Interior these regulations may be altered or amended at any time, without previous notice, with the concurrence of the Insular Collector of Customs, the Director of Health, and the Collector of Internal Revenue, or any two of them.
SECTION 1. It shall be unlawful for any person to manufacture within the Philippine Islands any article of food or drug which is adulterated or misbranded, within the meaning of this Act; and any person who shall violate any of the provisions of this section shall, for each offense, be punished by a fine not to exceed one thousand pesos or by imprisonment for one year, or by both such line and imprisonment in the discretion of the court, and for each subsequent of sense he shall be punished by a fine of not less than two thousand pesos nor more than five thousand pesos, or by imprisonment for one year, or by both such fine and imprisonment, in the discretion of the court.
SEC. 2. The introduction into the Philippine Islands from the United States or from any foreign country, or the shipment to the prohibited. United States or to any foreign country from the Philippine Islands, of any article of food or drugs which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited; and any person who shall ship or deliver for shipment from the Philippine Islands to the United States or to a foreign country, or who shall receive in the Philippine Islands from the United States or from any foreign country, and having so received, shall deliver, in original unbroken packages, for pay or otherwise, or . offer to deliver to any other person, any such article so adulterated or misbranded within the meaning of this Act. or any person who shall sell or offer for sale in the Philippine Islands any such adulterated or misbranded foods or drugs, or export or offer to export the same to the United States or to any foreign country, shall be punished for the first offense by a fine not to exceed four hundred pesos, and for each subsequent offense he shall be punished by a fine not to exceed six hundred pesos, or by imprisonment not to exceed one year, or by both such fine and imprisonment, in the discretion of the court: Provided, That no article shall be deemed and "adulterated." misbranded or adulterated within the provisions of this Act when intended for export to the United States or to any foreign country and prepared or packed according to the specifications or directions of the purchaser in the United States or in any foreign country when no substance is used in the preparation or packing thereof in conflict with the laws of the United States or of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption in the Philippine Islands, then this proviso shall not exempt said article from the operation of any of the other provisions of this Act.
SEC. 3. The Insular Collector of Customs, the Director of Health, and the Collector of Internal Revenue of the Philippine Islands shall make uniform rules and regulations, subject to the approval of the Secretary of the Interior of the Philippine Islands, for carrying out the provisions of this Act, including the collection and examination of specimens of foods and drugs manufactured or offered for sale in the Philippine Islands or which shall be received from the United States or from any foreign country, or intended for shipment to the United States or to any foreign country, or which may be submitted for examination by the Director of Health for the Philippine Islands.
SEC. 4. The examinations of specimens of foods and drugs shall be made in the Bureau of Science, or under the direction and supervision of that Bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this Act; and if it shall appear from any such examination that any of such specimens is adulterated or misbranded within the meaning of this Act, the Secretary of the Interior of the Philippine Islands shall cause notice thereof to be given to the party from whom such sample was obtained. Any party so notified shall lie given an opportunity to be heard, under such rules and. regulations as may be prescribed as aforesaid, and if it appears that any of the provisions of this Act have been violated by such party, then the Secretary of the Interior of the Philippine Islands shall at once certify the facts to the Attorney-General of the Philippine Islands with a copy of the results of the analysis or a report of the examination of such article duly authenticated by the analyst or officer making such examination, under the oath of such officer. After judgment of the court, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid, prosecution.
SEC. 5. It shall be the duty of the Attorney-General of the Philippine Islands, to whom the Secretary of the Interior of the Philippine Islands shall report any violation of this Act, or to whom the Director of Health shall present satisfactory evidence of any such violation, to cause appropriate proceedings to be commenced and prosecuted in the proper courts of the Philippine Islands, without delay, for the enforcement of the penalties as in such ease herein provided.
SEC.6. The term "drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the Cure, mitigation, or prevention of disease of either man or other animals. The term "food," as used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compounded.
SEC. 7. For the purposes of this Act an article shall be deemed to be adulterated:
In case of drugs :SEC. 8. The term ''misbranded," as used herein, shall apply to all drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein, which is false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced.First, If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality, or purity, as determined by the lest laid down in the United States Pharmacopoeia or National Formulary, official at the time of investigation: Provided, That no drug defined in the United States Pharmacopeia or National Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.If it contain terra alba, barytcs, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt, or spirituous liquor compound or narcotic drug.
Second, If its strength or purity fall below the professed standard or quality under which if is sold.
In case of confectionery:
In the case of food :First, If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength.
Second, If any substance has been substituted wholly or in part for the article.
Third, If any valuable constituent of the article has been wholly or in part abstracted.
Fourth, If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed.
Fifth, If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this Act shall be construed as applying only when said products are ready for consumption.
Sixth, If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of discard animal, or one that has died otherwise than by slaughter.
That for the purposes of this Act an article shall also be deemed to be misbranded in case of drugs:
First, If it be an imitation of of another article.In the case of food:
Second, If the contents of the package as originally put up shall have been removed, in whole or in part, and other contents shall have been placed in such package, or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta cucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein.
First, If it be an imitation of. or offered for sale under, the distinctive name of another articleSEC. 9. No dealer shall be prosecuted under the provisions of this Act when he can establish a guaranty signed by the wholesaler, jobber, manufactured, or other party residing in the Philippine Islands, from whom he purchases such articles, to the effect that the same is not adulterated or misbranded within the meaning of this Act, designating it. Said guaranty, to afford protection, shall contain the name and address of the party or parties making the sale if such articles to such dealer, and in such case said party or parties shall he amenable to the prosecutions, fines, and other penalties which would attach, in due course, to the dealer under the provisions of this Act.
Second, If it be labeled or branded so as to deceive or mislead the purchaser, or purport to he a foreign product when not so, or if the contents of the package as originally put up shall have been removed in whole or in part and other contents shall have been placed in such package, or if it fail to bear a statement on the label of the quantity or proportion of any morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide or any derivative or preparation of any of such substances contained therein.
Third, If in packages form, and the contents are stated in terms, of weight or measure, they are not plainly and correctly stated on the outside of the package.
Fourth, If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or the substances contained therein, which staieinent, design, or device is false or misleading in any particular: Provided, That an article of food which does not contain any added poisonous or deleterious ingredients shall not be deemed to he adulterated or misbranded in the following cases:First, In the case of mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with a statement of the place where said article has been manufactured or produced.
Second, In the case of articles labeled, branded, or tagged so as to plainly indicate that they are compounds, imitations, or blends, and the word "compound," "imitation,"' or "blend," as the case may be, is plainly stated on the, package in which it is offered for sale: Provided, that the term blend as used herein shall be construed to mean a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only: And provided further, That nothing in this Act shall be construed as requiring or compelling proprietors or manufacturers of proprietary foods which contain no unwholesome added ingredient to disclose their trade formulas, except in so far as the provisions of this Act may require to secure freedom from adulteration or misbranding.
SEC. 10. Any article of food, drug, or liquor that is adulterated or misbranded within the meaning of this Act, that, having been transported, remains unloaded, unsold, or in original unbroken packages, or if it be sold or offered for sale in the Philippine Islands, or if it be imported from the United States or a foreign country for sale, or if it is intended for export to the United States or to a foreign country, shall be liable to be proceeded against in the Court of First Instance in the Philippine Islands of the judicial district within which the same is found, and shall be seized for confiscation and condemnation, and may be confiscated and condemned by said court in the proceedings so initiated. And if such article is condemned as being adulterated or misbranded, or as of a poisonous or deleterious character, within the meaning of this Act. the same shall be disposed of by destruction or sale, as the said court" may direct, and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treasury of the Philippine Islands, but such goods shall not be sold in any jurisdiction contrary to the provisions of this Act or to the laws of that jurisdiction: Provided, however, That upon the payment of the costs of the proceedings as provided in this section and the execution and delivery of a good and sufficient bond to the effect that such articles shall not be sold or otherwise disposed of contrary to the provisions of this Act or the laws of the United States, or of any State, Torritory, District, or insular possession of the United States, the court may order direct that such articles be delivered to the owner thereof. The proceedings hereinbefore mentioned admiralty shall conform, as near as may be, to the proceedings in admiralty in the Courts of First, Instance of the Philippine Islands, and all such proceedings shall be at the suit of and in the name of the United States.
SEC. 11. The Insular Collector of Customs shall deliver to the Director of Health, upon his request from time to time, samples of food and drugs which are being imported into the Philippine Islands or offered to import, giving notice thereof to the owner or consignee, who may appear to the Secretary of Interior of the Philippine Islands or any official designated by him and have the right to introduce testimony, and if it appear from the examination of such samples that any article of food or drug offered to be imported into the Philippine Islands is adulterated or misbranded within the meaning of this act, or is otherwise dangerous to the health of the people of the Philippine Islands, or is of a sale in the country in which it is made or from which it is exported, or is otherwise falsely labeled in any respect, the said article shall be refused admission, and thew Insular Collector of Customs shall refuse delivery to the consignee and shall cause the destruction of any goods refused delivery shall not be exported by the consignee within three months from the date of notice of such refusal under such regulations as the Insular Collector of Customs may prescribe; Provided, That the insular Collector of Customs may deliver to the consignee such goods ponding examination and decision in the matter, on execution of a penal bond for the amount of the full invoice value of such goods, together with the duty thereon, and on refusal to return such goods for any cause to the custody of the Insular Collector of Customs, when demanded, for the purpose of excluding them from the country, or for any other purpose, said of consignee shall forfeit the lull amount of the bond: And provided further, That all charges for storage, cartage, and labor on goods which are refused admission or delivery shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any future importation made by such owner or consignee.
SEC. 12. The word '"person" as used in this Act shall be construed to import both the plural and the singular, as the ease demands, and shall include corporations, companies, societies, associations, and other commercial or legal entities. When construing and enforcing the provisions of this Act, the act, omission, or failure of any officer, agent, or other person acting for or employed by any corporation, company, society, association, or other commercial or legal entity, within the scope of his employment or office, shall in every case be also deemed to be the act, omission, or failure of such corporation, company, society, association, or other commercial or legal entity, as well as that of the person.
SEC. 13. The public good requiring the speedy enactment of this bill, the passage of the same is hereby expedited in accordance with section two of "An Act prescribing the order of procedure by the Commission in the enactment of laws," passed September twenty-sixth, nineteen hundred.
SEC. 14. This Act shall take effect on its Passage: Provided, That any article, the importation, offer, sale, transportation, or use of which is prohibited or restricted by this Act, which is in transit to the Philippine Islands at the time of the passage of this. Act, shall not be subject to the lines, penalties, or forfeitures herein prescribed, but may, under rules and regulations to be prescribed by the Insular Collector of Customs, and approved by the Secretary of Finance and Justice, lie returned to the port from which it was shipped: Provided further, That this privilege shall not be extended beyond a period of sixty days after the date of the passage of this Act.
Enacted, May 18, 1907.
RULES AND REGULATIONS FOR THE ENFORCEMENT OF THE PURE FOOD AND DRUGS ACT
The act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," enacted Hay 18, 1907, shall be known and referred to as "The Pure Food and Drugs Act."
The term "original unbroken package" as used in this act is the original package, carton, case, can, box, barrel, bottle, phial, or other receptacle put up by the manufacturer, to which the label is attached, or which may be suitable for the attachment of a label, making one complete package of the food or drug article. The original package contemplated includes both the wholesale
and the retail package.
(Section 2.)
(a) Whenever a customs, health, or internal-revenue officer has , cause for believing or suspecting that an article of food or drug which is being imported into, manufactured, or offered for sale in the Philippine Islands, or which is for the purpose of exportation from the Philippine Islands to the United States, or any foreign country or which has been imported into the Philippine Islands from the United States, or any foreign country, a sample or specimen of the articles suspected as being adulterated or mis-brawled. except in the cases provided for in Regulations 17 to 20, will be seined from the owner thereof and a receipt given therefor, and such sample will be forwarded to the Director of Health through the Thief of the Bureau to which the seizing officer belongs with a full and complete statement of the case, giving name of the person from whom taken, quantity of same on hand, in which capacity the person from whom taken was acting—whether as an importer, a manufacturer of the article, or dealer therein, or a consumer thereof—and will furnish such other information as in the opinion of the customs, health, or internal-revenue officer will be of as-q stance in the proper administration of the law.
(b) Representative samples shall be taken, discretion being used as in tile amount thereof; in general, one kilogram of bulk goods, or one liter of liquid goods being sufficient. Much smaller samples will serve in the case of drugs. In the case of bottled goods, one bottle will usually be found to be sufficient.
(c) Sample of bulk goods will be immediately placed in tin boxes or other suitable coverings and sealed by the officer taking the same.
(d) In all cases where samples of goods are to be taken the owner will lie given such notice thereof as the circumstances of the ease permit, and wherever possible, samples shall be taken and sealed in his presence. Samples shall be taken and sealed in duplicate, one .Mich sample to be transmitted as above stated to the Bureau of Health, and the other to be delivered to the importer or owner thereof, if he desire the same.
In order properly to perform the duties set forth above, customs, health, and internal-revenue officers should give all publicity to revenue officers. the fact that they are charged with the duty of carrying out the provisions of The Pure Food and Drugs Act, and should invite complaints and reports from all persons in their respective districts regarding adulteration or misbranding articles of food or drugs.
(a) When the examination or analysis shows that the provisions of of The Pure Food and Drugs Act have been violated, notice of that fact, together with a ropy of the findings, shall be furnished to the party or parties from whom the sample was obtained or who executed the guaranty as provided in The Pure Food and Drugs Act, and a date shall be fixed at which such party or parties may be heard before the Secretary of the Interior, or other officer designated by him. The hearings shall be had at a place, to be designated by the Secretary of the Interior, most convenient for all parties concerned. These hen rings shall be private and confined to questions of fact. The parties interested therein may appear in person or by attorney and may propound proper interrogatories and submit oral or written evidence to show any fault or error in the findings of the analyst or examiner. The Secretary of the Interior may order a reexamination of the sample or have new samples drawn for further examination.
(b) If the examination or analysis be found correct the Secretary of the Interior shall give notice to the Attorney-General of the Philippine Islands as prescribed.
(c) Any customs, health, or internal-revenue officer who shall obtain satisfactory evidence of any violation of The Pure Food and Drugs Act, as provided in section 5 thereof, shall first submit the same to the Director of Health, through the Chief of his Bureau, in order that the former may cause notice to be given to the guarantor or to the party from whom the sample was obtained.
(a) When a judgment, of the court shall have been rendered, there may be a publication of the findings of the examiner or analyst, together with the findings of the court.
(b) This publication may be made by means of circulars, notices, or bulletins, or the Official Gazette, as the Secretary of the Interior may direct, not less than thirty days after judgment.
(c) If an appeal be taken from the judgment of the court before such publication, notice of (lie appeal shall accompany the publication.
(a) A drug bearing a mime recognized in the United States Pharmacopceia or "National Formulary, without any further statement respecting its character, shall be required to conform in strength, quality, and purity to the standards prescribed or indicated for a drug of the same name recognized in the United States Pharmacopceia or National Formulary, official at the time.
(b) A drug bearing a name recognized in the United States Pharmacopceia or National Formulary, and branded to show a different standard of strength, quality, or purity, shall not be regarded as adulterated if it conforms to its declared standard.
(a) Manufacturers of proprietary foods are only required^ to state upon the label the names and percentages of the materials used, in so far as the Director of Health may find this to be necessary to secure freedom from adulteration and mis-branding.
(b) Factories in which proprietary foods are made shall be open at all reasonable times to the inspection provided for m Regulation 15.
(a) No dealer in food or drug products will be liable to prosecution if he can establish that the goods were sold under a guaranty by the wholesaler, manufacturer, jobber, dealer, or other party residing in the Philippine Islands from whom purchased.
(b) A general guaranty may be filed with the Director of Health by the manufacturer or dealer and be given a serial number, which number shall appear on each and every package of goods sold under such guaranty with the words, "Guaranteed under The Pure Food and Drags Act."
(c) The following form of guaranty is suggested:
I (we), the undersigned, do hereby guarantee that the articles of food or drugs manufactured, packed, distributed, or sold by me (us) (specifying the same as fully as possible) are not adulterated or misbranded within the meaning of the Pure Food and Drugs Act. (Signed in ink)
................................................................................................................................................................
(Name of place of business of wholesaler, dealer, manufacturer, jobber, or other party.)
(d) If the guaranty be not filed with the Director of Health as above, it should identify and be attached to the bill of sale, invoice, bill of lading, or other schedule, giving the names and quantities
(a) Mineral substances of all kinds (except as provided in Regulation 14) are specifically forbidden in confectionery whether they be poisonous or not.
(b) Only harmless colors or flavors shall be added to confectionery.
(c) The term "narcotic drugs" includes all the drugs mentioned in section 8, The Pure Food and Drugs Act, relating to foods, their derivatives and preparations, and all other drugs of a narcotic nature.
No substances may be mixed or packed with a food product which will reduce or lower its quality or strength. Not excluded under this provision are substances properly used in the preparation of food products for clarification or refining, and eliminated in the further process of manufacture.
(a) Only harmless colors may be used in food products.
(b) The reduction of a substance to a powder to conceal inferiority in character is prohibited.
(c) The term "powdered" means the application of any powdered substance to the exterior portion of articles of food, or the reduction of a substance to a powder.
(d) The term "coated" means the application of any substance to the exterior portion of a food product.
(e) The term "stain" includes any change produced by the addition of any substance to the exterior portion of foods which in any way alters their natural tint.
Any food product which contains naturally a poisonous or deleterious ingredient does not come within the provisions of The Pure Food and Drugs Act, except when the presence of such ingredient is due to filth, putrescence, or decomposition.
(Section 7, paragraph 5, under "Food," proviso.)
(a) Poisonous or deleterious preservatives shall-fee applied externally only, and they and the food products shall be of a character which shall not permit the permeation of any of the preservative to the interior, or any portion of the interior, of the product.
(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.
(a) Respecting the whole scenes 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.
(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 examination be made as often as he may deem necessary.
(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; or 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 limited in English (except as provided in Regulation 18), with or without the foreign label m 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 ease 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 deyiee 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 medioinal agent is misbranded if named after a single constituent.
In the case of drugs the nomenclature employed by the United Drugs, nomencia-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 nianufaclured 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 anv 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 Drags Act, as to character of contents, shall he 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.
(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, w the name of the place not the actual place of manufacture of production.
(b) When a person, firm, or corporation actually manufactures or produces an article of food or drug in two or more places, 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.
(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 snob 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 Ik; 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.
(c) 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.
(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.
(6) 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.
(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 of 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 ,i counterfeit or fraudulent simulation of any article of food or drug.
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.
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 33.—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 docs not require any further statement than the name or distinctive name thereof, except as provided in Regulations 18 (a) and 27.
(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 injuriouslv 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 boar a statement to that effect.
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.
(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, countries, or dependencies, the name of the State, Territory, country, or dependency, as well as the name of the place, must be stated.
(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 Formula it.
(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 cucaine, 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 he the average quantity or proportion with the variations noted in Regulation 28.
(f) The following are the principal derivatives and preparations to be named made from the articles which are required to be named upon the on labels.
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,
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 sirups.
Cannabis indica :
Preparations of cannabis indica—
Corn remedies, extracts, mixtures, pills, powders, tablets, and tinctures.
Chloral hydrate (chloral. United States Pharmacopoeia, 1890) :
Derivatives—
Chloral acetophenonoxim, chloral alcoholate, chloralamide, chloral-imide, chloral orthoform, chloralose, dormiol, hypnal, and uraline.
Preparations containing chloral lrydrate or its derivatives—
Chloral campliorate, elixirs, liniments, mixtures, ointments, suppositories, sirups, and tablets.
Acetanilide (antifebrine. phenylacetamide) :
Derivatives—
Acetphenetidine, citrophen, diacetanilide, lactophenin, methoxy-acetanilide, methylacetanilide, paraiodoacetanilide, and phenacetine.
Preparations contaning acetanilide or derivatives—
Analgesics, antineuralgics, antirheumatics, cachets, capsules, cold remedies, elixirs, granular effervescing salts, headache powders, mixtures, pain remedies, pills, and tablets.
(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 snail 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 16.
(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 to the reasonable variations which attend the filling and weighing or measuring of a package.
In the case of alcohol the expression "quantity" or "proportion'' shall mean the average percentage by volume in the finished product. In the ease 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 (d).
(a) Food products intended for export may contain added substances not permitted in foods intended for local consumption when the addition of such substance docs 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 the goods have been prepared or packed in compliance with the laws of the foreign country to which said goods are intended to he 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 be consumed locally.
(a) Meat and meat food products imported into the Philippine Islands shall be accompanied by a certificate of official inspection of a character to satisfy the Director of Health 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 which exported, will be refused admission.
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.
(a) 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 punal 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.
(b) In case the goods have already been delivered on ten days' penal bond for return of unexamined packages and it is desired to hold them for examination under The Pure Food and Drugs Act, demand must be made upon the importer for return within the ten days of the original bond, when a bond under section (a) above may be accepted in lieu of an actual physical return of the goods to customs custody.
(c) Where the importer does not desire to keep possession of the goods they will be stored in the warehouse of the custom-house, or in a public bonded warehouse at his expense for storage, cartage, and labor.
(d) No delivery of imported food or drugs suspected of being adulterated or misbranded will be made until the question is finally settled as hereafter provided, nor shall final liquidation of the entry be made while such question is pending.
(a) 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 in connection therewith.
All applications for relief from decisions arising under the execution of the law shall be addressed to the Secretary of the Interior.
The time allowed the importer for representations regarding 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 Bureau of Health. If at the expiration of this time, in view of the data secured in inspecting the sample and such evidence as may have been submited by the manufacturers or importers, it appears that the shipment can not be legally imported into the Philippine Islands, the Director of Health shall request the Insular Collector of Customs to refuse to deliver the shipment in question to the consignee, and to require its reshipment as authorized by law.
The samples made necessary under The Pure Food and Drugs Act, and by these regulations, shall be furnished by the owner or the importer thereof, at his expense.
All articles of food and all food and drink sold or offered for sale, and all places for their preparation, manufacture, or sale, shall be at all times subject to inspection by the Director of Health or the Collector of Internal Revenue, or their duly authorized representatives. Necessary samples of food or drink shall be furnished for examination upon the written request of the Director of Health or the Collector of Internal Revenue, and no remuneration shall be charged or paid therefor.
By and with the approval of the Secretary of the Interior these regulations may be altered or amended at any time, without previous notice, with the concurrence of the Insular Collector of Customs, the Director of Health, and the Collector of Internal Revenue, or any two of them.
Approved, May 23, 1907: Dean C. Worcester, Secretary of the Interior.