RULES AND REGULATIONS FOR THE ENFORCEMENT OF THE FOOD AND DRUGS ACT.

GENERAL.

Regulation 1. Short Title of the Act.

The 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,” approved June 30, 1906, shall be known and referred to as “The Food and Drugs Act, June 30, 1906.”

Regulation 2. Original Unbroken Package.
(Section 2.)

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 4.)

Samples of unbroken packages shall be collected only by authorized agents of the Department of Agriculture; or by the health, food, or drug officer of any State, Territory, or the District of Columbia, when commissioned by the Secretary of Agriculture for this purpose.

Samples may be purchased in the open market, and if in bulk the marks, brands, or tags upon the package, carton, container, wrapper, or accompanying printed or written matter shall be noted. The collector shall also note the names of the vendor and agent through whom the sale was actually made, together with the date of purchase. The collector shall purchase representative samples.

A sample shall be divided into three parts, and each part shall be labeled with the identifying marks. All samples shall be sealed by the collector with a seal provided for the purpose. If the package be less than 4 pounds, or in volume less than 2 quarts, three packages of approximately the same size shall be purchased and the marks and tags upon each noted as above. One sample shall be delivered to the party from whom purchased or to the party guaranteeing such merchandise. One sample shall be sent to the Bureau of Chemistry, or to such chemist or examiner as may be designated by the Secretary of Agriculture, and the third sample shall be held under seal by the Secretary of Agriculture.

Regulation 4. Methods of Analysis.
(Section 4.)

Unless otherwise directed by the Secretary of Agriculture, the methods of analysis employed shall be those prescribed by the Association of Official Agricultural Chemists and the United States Pharmacopœia.

Regulation 5. Hearings.
(Section 4.)

(a) When the examination or analysis shows that the provisions of the food and drugs act, June 30, 1906, have been violated, notice of that fact, together with a copy 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 food and drugs act, June 30, 1906, and a date shall be fixed at which such party or parties may be heard before the Secretary of Agriculture, or such other official connected with the food and drug inspection service as may be commissioned by him for that purpose. The hearings shall be had at a place, to be designated by the Secretary of Agriculture, most convenient for all parties concerned. These hearings 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 Agriculture may order a re-examination of the sample or have new samples drawn for further examination.

(b) If the examination or analysis be found correct the Secretary of Agriculture shall give notice to the United States District Attorney as prescribed.

(c) Any health, food, or drug officer or agent of any State, Territory, or the District of Columbia who shall obtain satisfactory evidence of any violation of the food and drugs act, June 30, 1906, as provided in section 5 thereof, shall first submit the same to the Secretary of Agriculture, in order that the latter may cause notice to be given to the guarantor or to the party from whom the sample was obtained.

Regulation 6. 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 in the form of circulars, notices, or bulletins, as the Secretary of Agriculture 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 the appeal shall accompany the publication.

Regulation 7. Standards for Drugs.
(Section 7.)

(a) A drug bearing a name recognized in the United States Pharmacopœia 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 Pharmacopœia or National Formulary, official at the time.

(b) A drug bearing a name recognized in the United States Pharmacopœia 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 8. Formulas—Proprietary Foods.
(Section 8, last 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 Secretary of Agriculture may find this to be necessary to secure freedom from adulteration and misbranding.

(b) The factories in which proprietary foods are made shall be open at all reasonable times to the inspection provided for in [Regulation 16].

Regulation 9. 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 United States from whom purchased.

(b) A general guaranty be filed with the Secretary of Agriculture 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 food and drugs act, June 30, 1906.”

(c) The following form of guaranty is suggested:

I (we) the undersigned do hereby guarantee that the articles of foods 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 food and drugs act, June 30, 1906.

(Signed in ink.)

.

[Name and place of business of wholesaler, dealer, manufacturer, jobber, or other parties.]

(d) If the guaranty be not filed with the Secretary of Agriculture 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 of the articles sold.

ADULTERATION.

Regulation 10. Confectionery.
(Section 7.)

(a) Mineral substances of all kinds (except as provided in [Regulation 15]) 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, food and drugs act, June 30, 1906, relating to foods, their derivatives and preparations, and all other drugs of a narcotic nature.

Regulation 11. Substances Mixed and Packed with Foods.
(Section 7, under “Foods.”)

No substance 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 12. Coloring, Powdering, Coating, and Staining.
(Section 7, under “Foods.”)

(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 13. Natural Poisonous or Deleterious Ingredients.
(Section 7, paragraph 5, under “Foods.”)

Any food product which contains naturally a poisonous or deleterious ingredient does not come within the provisions of the food and drugs act, June 30, 1906, except when the presence of such ingredient is due to filth, putrescence, or decomposition.

Regulation 14. External Application of Preservatives.
(Section 7, paragraph 5, under “Foods,” proviso.)

(a) Poisonous or deleterious preservatives shall only be applied externally, 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 15. Wholesomeness of Colors and Preservatives.
(Section 7, paragraph 5, under “Foods.”)

(a) Respecting the wholesomeness of colors, preservatives, and other substances which are added to foods, the Secretary of Agriculture shall determine from chemical or other examination, under the authority of the agricultural appropriation act, Public 382, approved June 30, 1906, the names of those substances which are permitted or inhibited in food products; and such findings, when approved by the Secretary of the Treasury and the Secretary of Commerce and Labor, shall become a part of these regulations.

(b) The Secretary of Agriculture shall determine from time to time, in accordance with the authority conferred by the agricultural appropriation act, Public 382, approved June 30, 1906, the principles which shall guide the use of colors, preservatives, and other substances added to foods; and when concurred in by the Secretary of the Treasury and the Secretary of Commerce and Labor, the principles so established shall become a part of these regulations.

Regulation 16. Character of the Raw Materials.
(Section 7, paragraph 1, under “Drugs”; paragraph 6, under “Foods.”)

(a) The Secretary of Agriculture, when he deems it necessary, shall examine 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 Secretary of Agriculture shall make such inspection as often as he may deem necessary.

MISBRANDING.

Regulation 17. 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 food and drugs act, June 30, 1906, specifically requires, to wit, the name of the substance or product; the name of place of manufacture in the case of food compounds or mixtures; 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 foods or drugs for domestic commerce shall be printed in English (except as provided in [Regulation 19]), 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 8-point (brevier) caps: Provided, That in case the size of the package will not permit the use of 8-point cap 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 the 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 Pharmacopœia and the National Formulary shall obtain.

(g) The term “design” or “devise” applies to pictorial matter of every description, and to abbreviations, characters, or signs for weights, measures, or names of substances.

(h) The use of any false or misleading statement, design, or devise 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 devise.

(i) The regulation regarding the principal label will not be enforced until October 1, 1907, in the case of labels printed and now on hand, whenever any statement therein contained which is contrary to the food and drugs act, June 30, 1906, 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 October 1, 1907.

Regulation 18. Name and Address of Manufacturer.
(Section 8.)

(a) The name of the manufacturer or producer, or the place where manufactured, except in case of mixtures and compounds having a distinctive name, need not be given upon the label, but if given, must be the true name and the true place. The words “packed for ————,” “distributed by ————” or some equivalent phrase, shall be added to the label in case the name which appears upon the label is not that of the actual manufacturer or producer, or the name of the place not the actual place of manufacture or production.

(b) When a person, firm, or corporation actually manufactures or produces an article of food or drug in two or more places, the actual place of manufacture or production of each particular package need not be stated upon the label except when in the opinion of the Secretary of Agriculture the mention of any such place, to the exclusion of the others, misleads the public.

Regulation 19. Character of Name.
(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 Pharmacopœia or National Formulary. No further description of its components or qualities is required, except as to content of alcohol, morphin, etc.

(b) The use of a geographical name shall not be permitted in connection with a food or drug product not manufactured or produced in that place, when such name indicates that the article was manufactured or produced in that place.

(c) The use of a geographical name in connection with a food or drug product will not be deemed a misbranding when by reason of long usage it has come to represent a generic term and is used to indicate a style, type, or brand; but in all such cases the State or Territory where any such article is manufactured or produced shall be stated upon the principal label.

(d) A foreign name which is recognized as distinctive of a product of a foreign country shall not be used upon an article of domestic origin except as an indication of the type or style of quality or manufacture, and then only when so qualified that it can not be offered for sale under the name of a foreign article.

Regulation 20. Distinctive Name.
(Section 8.)

(a) A “distinctive name” is a trade, arbitrary, or fancy name which clearly distinguishes a food product, mixture or compound from any other food product, mixture or compound.

(b) A distinctive name shall not be one representing any single constituent of a mixture or compound.

(c) A distinctive name shall not misrepresent any property or quality of a mixture or compound.

(d) A distinctive name shall give no false indication of origin, character or place of manufacture, nor lead the purchaser to suppose that it is any other food or drug product.

Regulation 21. Compounds, Imitations, or Blends Without Distinctive Name.
(Section 8.)

(a) The term “blend” applies to a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only.

(b) If any age is stated, it shall not be that of a single one of its constituents, but shall be the average of all constituents in their respective proportions.

(c) Coloring and flavoring can not be used for increasing the weight or bulk of a blend.

(d) In order that colors or flavors may not increase the volume or weight of a blend, they are not to be used in quantities exceeding 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 22. Articles without a Label.
(Section 8, paragraph 1, under “Drugs”; paragraph 1, under “Foods.”)

It is prohibited to sell or offer for sale a food or drug product bearing no label upon the package or no descriptive matter whatever connected with it, either by design, device, or otherwise, if said product be an imitation of or offered for sale under the name of another article.

Regulation 23. Proper Branding not a Complete Guaranty.

Packages which are correctly branded as to character of contents, place of manufacture, name of manufacturer, or otherwise, may be adulterated and hence not entitled to enter into interstate commerce.

Regulation 24. Incompleteness of Branding.

A compound shall be deemed misbranded if the label be incomplete as to the names of the required ingredients. A simple product does not require any further statement than the name or distinctive name thereof, except as provided in [Regulations 19] (a) and [28].

Regulation 25. Substitution.
(Sections 7 and 8.)

(a) When a substance of a recognized quality commonly used in the preparation of a food or drug product is replaced by another substance not injurious or deleterious to health, the name of the substituted substance shall appear upon the label.

(b) When any substance which does not reduce, lower, or injuriously affect its quality or strength, is added to a food or drug product, other than that necessary to its manufacture or refining, the label shall bear a statement to that effect.

Regulation 26. Waste Materials.
(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 27. Mixtures or Compounds with Distinctive Names.
(Section 8. First proviso under “Foods,” paragraph 1.)

(a) The terms “mixtures” and “compounds” are interchangeable and indicate the results of putting together two or more food products.

(b) These mixtures or compounds shall not be imitations of other articles, whether simple, 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, or countries, the name of the State, Territory, or country, as well as the name of the place, must be stated.

Regulation 28. Substances Named in Drugs or Foods.
(Section 8. Second under “Drugs”; second under “Foods.”)

(a) The term “alcohol” is defined to mean common or ethyl alcohol. No other kind of alcohol is permissible in the manufacture of drugs except as specified in the United States Pharmacopœia or National Formulary.

(b) The words alcohol, morphin, opium, etc., and the quantities and proportions thereof, shall be printed in letters corresponding in size with those prescribed in [Regulation 17], paragraph (c).

(c) A drug, or food product except in respect of alcohol, is misbranded in case it fails to bear a statement on the label of the quantity or proportion of any alcohol, morphin, opium, heroin, cocain, alpha or beta eucain, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances contained therein.

(d) A statement of the maximum quantity or proportion of any such substances present will meet the requirements, provided the maximum stated does not vary materially from the average quantity or proportion.

(e) In case the actual quantity or proportion is stated it shall be the average quantity or proportion with the variations noted in [Regulation 29].

(f) The following are the principal derivatives and preparations made from the articles which are required to be named upon the label:

Regulation 29. Statement of Weight or Measure.
(Section 8. Third under “Foods.”)

(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 shall be a plain and correct statement of the average net weight or volume, either on or immediately above or below the principal label, and of the size of letters specified in [Regulation 17].

(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 the reasonable variations which attend the filling and weighing or measuring of a package.

Regulation 30. 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 case of the other ingredients required to be named upon the label, the expression “quantity” or “proportion” shall mean grains or minims per ounce or fluid ounce, and also, if desired, the metric equivalents therefor, or milligrams per gram or per cubic centimeter, or grams or cubic centimeters per kilogram or per liter; provided that these articles shall not be deemed misbranded if the maximum of quantity or proportion be stated, as required in [Regulation 28] (d).

EXPORTS AND IMPORTS OF FOODS AND DRUGS.

Regulation 31. Preparation of Food Products for Export.
(Section 2.)

(a) Food products intended for export may contain added substances not permitted in foods intended for interstate commerce, when the addition of such substances does 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 goods have been prepared or packed in compliance with the laws of the foreign country to which said goods are intended to be shipped, but such shipment is made at his own risk.

(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 enter interstate commerce.

Regulation 32. Imported Food and Drug Products.
(Section 11.)

(a) Meat and meat food products imported into the United States shall be accompanied by a certificate of official inspection of a character to satisfy the Secretary of Agriculture 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 from which exported, will be refused admission.

(d) Meat and meat food products which have been inspected and passed through the customs may, if identity is retained, be transported in interstate commerce.

Regulation 33. Declaration.
(Section 11.)

(a) All invoices of food or drug products shipped to the United States shall have attached to them a declaration of the shipper, made before a United States consular officer, as follows:

I, the undersigned, do solemnly and truly declare that I am the .......................... (Manufacturer,
agent, or shipper.) of the merchandise herein mentioned and described, and that it consists of food or drug products which contain no added substances injurious to health.

These products were grown in ................ (Country.) and manufactured in ................ (Country.) by ........................ (Name of
manufacturer.) during the year ......, and are exported from ................ (City.) and consigned to ................ (City.).

The products bear no false labels or marks, contain nosome added coloring matter or preservative ............................................. (Name of added color
or preservative.), and are not of a character to cause prohibition or restriction in the country where made or from which exported.

Dated at ........ this ........ day of ........, 19.. .

(Signed): ........ ........ ........

(b) In the case of importations to be entered at New York, Boston, Philadelphia, Chicago, San Francisco, and New Orleans, and other ports where food and drug inspection laboratories shall be established, this declaration shall be attached to the invoice on which entry is made. In other cases the declaration shall be attached to the copy of the invoice sent to the Bureau of Chemistry.

Regulation 34. 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 35. Bond, Imported Foods, and Drugs.
(Section 11.)

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 penal 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.

Regulation 36. Notification of Violation of the Law.
(Section 11.)

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, which evidence (Form 15), with a sample of the article, shall be forwarded to the Bureau of Chemistry at Washington, accompanied by report card (Forms 16, 17, 18, 19, and 20).

Regulation 37. Appeal to the Secretary of Agriculture and Remuneration.
(Section 11.)

All applications for relief from decisions arising under the execution of the law should be addressed to the Secretary of Agriculture, and all vouchers or accounts for remuneration for samples shall be filed with the chief of the inspection laboratory, who shall forward the same, with his recommendation, to the Department of Agriculture for action.

Regulation 38. Shipment Beyond the Jurisdiction of the United States.
(Section 11.)

The time allowed the importer for representations regarding the 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 Department of Agriculture. If at the expiration of this time, in view of the data secured in inspecting the sample and such evidence as may have been submitted by the manufacturers or importers, it appears that the shipment can not be legally imported into the United States, the Secretary of Agriculture shall request the Secretary of the Treasury to refuse to deliver the shipment in question to the consignee, and to require its reshipment beyond the jurisdiction of the United States.

Regulation 39. Application of Regulations.

These regulations shall not apply to domestic meat and meat food products which are prepared, transported, or sold in interstate or foreign commerce under the meat-inspection law and the regulations of the Secretary of Agriculture made thereunder.

Regulation 40. Alteration and Amendment of Regulations.

These regulations may be altered or amended at any time, without previous notice, with the concurrence of the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce and Labor.

The above rules and regulations are hereby adopted.

Leslie M. Shaw,

Secretary of the Treasury.

James Wilson,

Secretary of Agriculture.

Victor H. Metcalf,

Secretary of Commerce and Labor.

Washington, D. C., October 17, 1906.