Rules and Regulations for the Enforcement of the California Pure Foods and Drugs Acts.

GENERAL.

Regulation 1. Short Title of Acts.

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The act entitled "An act for preventing the manufacture, sale or transportation of adulterated, mislabeled or misbranded foods and liquors and regulating the traffic therein, providing penalties, establishing a state laboratory for foods, liquors and drugs and making an appropriation therefor," approved March 11, 1907, shall be known and referred to as "The California Pure Foods Act, March 11, 1907."

The act entitled "An act for the prevention of the manufacture, sale or transportation of adulterated, mislabeled or misbranded drugs, regulating the traffic in drugs and providing penalties for violation. thereof," approved March 11, 1907, shall be known and referred to as "The California Pure Drugs Act, March 11, 1907."

Regulation 2. Collection of Samples.

Samples of foods, liquors, or drugs shall be collected only by authorized agents of the state board of health, who shall be known as "inspectors.

Samples may be purchased or taken as provided by said acts. 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 identifying marks. All samples shall be sealed with a seal provided for the purpose. If the package be less than four pounds, or in volume less than two quarts, three packages, approximately of the same size, shall be purchased, and the marks and tags upon each package noted as above. One sample shall be delivered to the party from whom procured; one sample shall be sent to the director of the state laboratory, University of California, Berkeley, California; and the third sample shall be sent to and held under seal by the state board of health, Sacramento, California.

This regulation is for the guidance of employees, agents and inspectors of the California State Board of Health. Failure to comply with its provisions shall not constitute a defense in any action brought for the violation of "The California Pure Foods Act, March 11, 1907," or "The California Pure Drugs Act, March 11, 1907."

Adopted by the state board of health under the terms of section 3 of the California Pure Drugs Act, March 11, 1907. That these regulations so adopted have the force and effect of law, see United States vs. Grimaud, U. S. Supreme Court advance sheets of June 1, 1911, page 480 et seq.

Regulation 3. Methods of Analysis.

Unless otherwise ordered by the state board of health, the methods of analysis employed shall be those prescribed by the association of official agricultural chemists and the United States Pharmacopoeia.

Regulation 4. Hearings.

Hearings shall be held as prescribed by the terms of said acts. Notices and findings required by the said acts, or either of them, to be served, may be served in the following manner:

1. Upon individuals, by personal service, or if the party can not be found, by leaving the same at his residence or place of business.

2. Upon domestic corporations, by delivering the same to the president, secretary, vice president, treasurer, or managing agent of such corporation, or if such officer or agent can not be found, by leaving the same at its place of business.

3. Upon foreign corporations, by delivering the same to such officer or agent, or if such officer or agent can not be found, by leaving the same at its place of business within this state, or by leaving the same with the state agent of such corporation.

Upon the hearing the state board of health may order a re-examination of the sample, or have new samples drawn for further examination.

Regulation 5. Publication.

Publication may be made, after hearing, as provided by the terms of said acts.

Also, when a judgment of the court shall have been rendered, there may be a publication of the findings of the director of the state laboratory, together with the findings of the court. This publication may be made in the form of circulars, notices, or bulletins, as the State Board of Health may determine, and if an appeal has been taken from the judgment of the court, a notice of the appeal shall accompany the publication.

Regulation 6. Standard for Drugs.

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

A drug bearing a name recognized in the United States Pharmacopoeia 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.

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 state board of health may find this to be necessary to secure freedom from adulteration, mislabeling, and misbranding.

The factories in which proprietary foods are made shall be open at all reasonable times to the inspection of raw materials hereinafter provided for.

Regulation 8. Form of Guaranty.

No dealer will be liable to prosecution under the provisions of said acts, or either of them, when he can establish a guaranty, signed by the wholesaler, jobber, manufacturer, or other party residing in the United States, from whom he purchased such article, to the effect that the same is not adulterated, mislabeled, or misbranded within the meaning of said acts, designating them.

Such guaranty may be:

1. A special guaranty. This guaranty, to afford protection, must be substantially in the following form:

The undersigned hereby guarantees that the articles of (drugs, foods, or liquors, as the case may be, specifying them), this day sold to (name of dealer) and mentioned in the attached invoice, are not adulterated, misbranded, or mislabeled, within the meaning of The California Pure Foods (or Drugs, as the case may be) Act, March 11, 1907, as amended.

Dated____

(Name, place of business and address of the guarantor, and statement as to whether guarantor is corporation or copartnership.)

2. A general guaranty. This guaranty, to afford protection, must be substantially in the following form:

I [we], the undersigned, do hereby guarantee that the articles of foods, liquors, and drugs, manufactured, produced, prepared, compounded, 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, as amended, and are not adulterated, mislabeled, or misbranded, within the meaning of The California Pure Foods Act, March 11, 1907, as amended, or The California Pure Drugs Act, March 11, 1907, as amended. Dated___

-"

(Sign in ink)

(Name, place of business and address of the guarantor, and statement as to whether guarantor is corporation or copartnership.)

ADULTERATION.

Regulation 9. Confectionery.

Mineral substances of all kinds (except as provided in Regulation 14) are specifically forbidden in confectionery, whether they be poisonous or not.

Only harmless colors and flavors shall be added to confectionery.

The term "narcotic drugs" includes all the drugs mentioned in section 6 of the California Pure Drugs Act, March 11, 1907, and all other drugs of a narcotic nature.

Regulation 10. Substances Mixed and Packed with Foods.

No substance may be mixed or packed with a food product which will reduce or lower its quality or strength. Substances properly used in the preparation of food products for clarification or refining and eliminated in the further process of manufacture are not excluded under this provision.

Regulation 11. Coloring, Powdering, Coating, and Staining.

Only harmless colors may be used in food products.

The reduction of a substance to a powder to conceal inferiority in character is prohibited.

The term "powder" means the application of any powdered substance to the exterior portions of articles of food, or the reduction of a substance to a powder.

The term "coated" means the application of any substance to the exterior portions of a food product.

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.

Any food product which contains naturally a poisonous or deleterious ingredient does not come within the provisions of the California Pure Foods Act, March 11, 1907, except when the presence of such ingredient is due to filth, putrescence, or decomposition.

Regulation 13. External Application of Preservatives.

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.

When these products are ready for consumption, if any portion of the added preservative shall have penetrated the food product, then such food products shall be subject to the regulations for food products in general.

The preservative applied must be of such a character that, until removed, the food products are inedible.

Regulation 14. Wholesomeness of Colors and Preservatives. (a) Respecting the wholesomeness of colors, preservatives, and other substances which are added to foods, the 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.

(c) It having been determined that benzoate of soda mixed with food is not deleterious or poisonous and is not injurious to health, no objection will be raised under the food and drugs act to the use in food of benzoate of soda, provided that each container or package of such food is plainly labeled to show the presence and amount of benzoate of soda. Food Inspection Decisions 76 and 89 are amended accordingly.

Regulation 15. Character of the Raw Materials.

The state board of health, its secretary or duly authorized agent, when deemed necessary by said board or its secretary, shall examine the raw materials uesd in the manufacture of food and drug products, and determine whether any filthy, decomposed or putrid substance is used in their preparation.

MISBRANDING AND MISLABELING.

Regulation 16. Label.

(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 subject to the provisions of this act.

(b) The principal label shall consist, first, of all information which the food and drugs act, June 30, 1906, specifically requires, to wit, the name of the place of manufacture in the case of food compounds or mixtures sold under a distinctive name; statements which show that the articles are compounds, mixtures, or blends; the words "compound," "mixture," or "blend," and words designating substances or their derivatives and proportions required to be named in the case of foods and drugs. All this information shall appear upon the principal label, and should have no intervening descriptive or explanatory reading matter. Second, if the name of the manufacturer and place of manufacture are given, they should also appear upon the principal label. Third, preferably upon the principal label, in conjunction with the name of the substance, such phrase as "artificially colored," or any other descriptive phrase necessary to be announced should be conspicuously displayed. Fourth, elsewhere upon the principal label other matter may appear in the discretion of the manufacturer. If the contents are stated in terms of weight or measure, such statement should appear upon the principal label and must be couched in plain terms, as required by Regulation 29.

(c) If the principal label is in a foreign language, all information required by law and such other information as indicated above in (b) shall appear upon it in English. Besides the principal label in the language of the country of production, there may be also one or more other labels, if desired, in other languages, but none of them more prominent than the principal label, and these other labels must bear the information required by law, but not necessarily in English. The size of the type used to declare the information required by the act shall not