Regulation 13.-Colors and Preservatives.

(Section 7, in the case of food.)

(a) Only harmless colors and harmless preservatives may be

used in articles of food.

(b) A color, preservative, or other substance, even though harmless, shall not be used in the preparation of any article of food in a manner whereby damage or inferiority is concealed.

(c) The Secretary of Agriculture shall determine from time to time the wholesomeness of colors, preservatives, and other substances which are added to foods, and shall make publie announcement in such manner as he may deem appropriate of the results of the investigations. When so published the results of the investigation shall serve as a guide in enforcing the act.

(d) The Secretary of Agriculture may authorize the certification of colors found by him to be in compliance with the law and these regulations.

Regulation 14.-Label.

(Section 8.)

(a) The term "label,” as used in the act, includes any legend and descriptive matter or design appearing upon the article or its container, and also includes circulars, pamphlets, and the like which are packed and go with the article to the purchaser, and such letters, circulars, and pamphlets to which reference is made either on the label attached to the package or on the package itself.

(b) The label shall bear, plainly and conspicuously displayed, all the information specifically required by the act, e. g., the quantity of the contents of food in package form, in accordance with regulation 26, and the quantity or proportion of the drugs named in section 8 of the act, in accordance with regulations 24 and 25. The label shall also bear such other descriptive matter as the character of the product may require.

(c) A label in a foreign language shall conform to these regulations and shall bear all the information required by the act in English, as well as in each of the foreign languages used to describe the article of food or drugs.

(d) 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. The terms "design" and "device" include pictorial matter of every description, abbreviations, characters, and signs.

(e) A food or drug product shall not be labeled or branded in such a manner as to deceive or mislead the purchaser. Direct misstate

ments and indirect misrepresentations regarding the article or its ingredients by means of designs, printed testimonials, devices, or artifices in the arrangement, style or dress of the package, or in the arrangement of the printed or pictorial matter in or upon the label or package are prohibited.

(f) An article containing more than one food product or active medicinal agent is misbranded if named after a single constituent. In the case of drugs the nomenclature employed by the United States Pharmacopoeia and the National Formulary shall obtain.

(g) The statement of the formula is not required on the label except in so far as may be necessary to prevent adulteration or misbranding.

(h) An article so labeled as to convey the impression that all of its ingredients are declared is misbranded if the list of ingredients is incomplete.

Regulation 15.-When Label is Required.

(Section 8.)

The use of a label is not compulsory except in the following cases: (a) Imitations (regulation 20, (a))..

(b) Foods and drugs containing the ingredients mentioned in section 8, paragraph second, in the case of drugs, and paragraph second, in the case of foods (regulations 24 and 25).

(c) Drugs which fall within the proviso of section 7, paragraph first, in the case of drugs (regulation 8, (b)).

(d) Foods in package form (regulation 26).

(e) Compounds and blends which are brought within the proviso of section 8, paragraph fourth, in the case of foods (regulations 19 and 20).

(f) Substitution (regulation 21).

(g) Foods which fall within the proviso of section 7, paragraph fifth, in the case of food (regulation 12).

(h) By-product or waste material (regulation 22).

(i) Articles intended for export which fall within the proviso of section 2 of the act (regulation 27, (b)).

(j) Articles which require specific labeling to avoid adulteration or misbranding.

Regulation 16.-Name and Address of Manufacturer.

(Section 8.)

(a) The name of the manufacturer or producer need not be given upon the label, but if given it must be the true name. 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.

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(b) The place of manufacture or production need not be given upon the label except where, in order to avoid misbranding, it is necessary to indicate clearly that the article is of domestic and not foreign origin, and also in the case of mixtures and compounds sold under their own distinctive names (regulation 19), to bring the articles within the terms of the proviso of section 8, paragraph fourth, of the act.

(c) The place of manufacture or production, if given, must be correctly stated.

(d) When a person, firm, or corporation actually manufactures or produces a food or a drug in two or more places, the actual place of manufacture or production of each particular package need not be stated on the label except when the mention of any place, to the exclusion of the others, deceives or misleads.

Regulation 17.-Character of Name.

(Section 8.)

(a) A simple or unmixed food or drug product shall be sold by its common name in the English language; or, if a drug recognized in the United States Pharmacopoeia or National Formulary, by the name or names therein designated.

(b) A geographical name indicating that a food or drug product was manufactured or produced in a specific place shall not be used unless such product was manufactured or produced in that place.

(c) A name which is distinctive of a product of a specific foreign country shall not be used upon an article not manufactured or produced in that country, except as an indication of the type or style of quality or manufacture, and then only when the product possesses substantially the characteristic qualities of the product of that foreign country. Such name shall be so qualified as to remove any impression that the article was manufactured or produced in the country in which the name is distinctive.

Regulation 18.-" Distinctive Name" and "Own Distinctive Name."

(a) A "distinctive name food from another.

(Section 8.)

is

a name that distinguishes one kind of

(b) The expression "own distinctive name " as used in section 8, paragraph fourth, means a name which is purely arbitrary or fanciful and distinguishes a particular article of food from all other articles of food. It shall not give a false indication of origin, character, composition, ingredients, or place of manufacture, and shall not lead the purchaser to suppose that the product is other than what it is.

Regulation 19.-Mixtures or Compounds with Distinctive Names. (Section 8, paragraph fourth, in the case of food, subparagraph first.) (a) The terms "mixtures" and "compounds" are interchangeable. (b) Mixtures or compounds with distinctive names shall not be imitations of other articles, whether simple, mixed, or compound, or offered for sale under the names of other articles. In addition to the distinctive name, they shall bear on the same label or brand the name of the place of manufacture or production. 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.

(c) An article of food is not within the terms of the proviso of section. 8, paragraph fourth, subparagraph first, unless it is labeled in accordance with this regulation.

Regulation 20.-Imitations, Blends, Compounds without Distinctive

Names.

(Section 8, paragraph first, in the case of food, and paragraph fourth, in the case of food, subparagraph second.)

(a) An imitation shall bear on the label the word " imitation," and, in addition, a clear statement of the principal or essential ingredients of the article.

(b) Compounds and blends, in order to be within section 8, paragraph fourth, in the case of food, subparagraph second, shall bear on the label the word "compound" or "blend," as the case may be, and, in addition, a clear statement of the principal or essential ingredients of the article.

Regulation 21.-Substitution.

(Sections 7 and 8.)

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

Regulation 22.-By-product or Waste Food Material.

(Sections 7 and 8.)

A food which consists in whole or in part of sound by-product or waste food material, such as pieces, stems, trimmings, and the like, shall not be labeled with the unqualified name of the substance from which such material is derived.

Regulation 23.-Certain Adulterations not Corrected by Label.

(Section 7.)

Proper labeling alone will not remove an article from the operation of the law. Certain forms of adulteration, e. g., the addition of a poisonous or deleterious ingredient which may render the article injurious to health, can not be corrected by any form of labeling.

Regulation 24.-Substances Required to be Stated on the Label. (Section 8, paragraph second, in the case of drugs, and paragraph second, in the case of food.)

(a) A drug is misbranded if it fails to bear a statement on the label of the quantity or proportion of alcohol of any kind, morphine, opium, heroine, cocaine, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, acetanilid, or any derivative or preparation of any such substances therein contained. Such statement shall be made in a plain and conspicuous manner.

(b) A food is misbranded if it fails to bear a statement on the label of the quantity or proportion of any morphine, opium, heroine, cocaine, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances therein contained. Such statement shall be made in a plain and conspicuous manner.

(c) The term "alcohol" without qualification means ethyl alcohol. If any alcohol other than ethyl alcohol be present in a drug the kind must be stated on the label. No statement is required of the presence of alcohol in foods.

(d) In declaring the quantity or proportion of any of the substances specified in paragraphs (a) and (b) of this regulation, the names by which they are designated in the act shall be used. In declaring the quantity or proportion of derivatives of any of the specified substances, in addition to the trade name of the derivative, the name of the specified substance shall also be stated so as to indicate clearly that the product is a derivative of the particular specified substance.

Regulation 25.—Method of Stating Quantity or Proportion.

(Section 8.)

(a) The quantity of alcohol in a drug shall be stated in terms of the average percentage by volume of absolute alcohol in the finished product.

(b) In a liquid the quantity of any substance specified in regulation 24, except alcohol, and the quantity of any derivative or preparation of any such substance, including derivatives of alcohol, shall