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

(Section 8)

(a) A "distinctive name" is a name that distinguishes one kind of food from another.

(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, cannot 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, chloro

form, 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 conspic

uous 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 be stated in terms of grains or minims per fluid ounce; in a solid, the quantity shall be stated in terms of grains

or minims per avoirdupois ounce, provided that statements may be in terms of the metric system, if preferred.

(c) When two or more pills, wafers, tablets, powders, capsules, and the like are put up for sale or distribution in the same container, the quantity of the specified substance or derivative present in each pill, wafer, tablet, powder, capsule, or other unit shall be stated.

(d) A statement of the maximum quantity or proportion of any substance specified in regulation 24 present will meet the requirements, provided the maximum stated does not vary materially from the average quantity or proportion.

Regulation 26. Statement of Weight, Measure, or Count

(Section 8, paragraph third, in the case of food)

(a) Except as otherwise provided by this regulation, a package of food shall be plainly and conspicuously marked with the quantity of the contents in terms of weight, measure, or numerical count on the outside of the container, or of the covering of the package usually delivered to the consumer.

(b) The quantity of the contents so marked shall be the quantity of food in the package.

(c) The statement of the quantity of the contents shall be plain and conspicuous, shall not be a part of or obscured by any legend or design, and shall be so placed and in such characters as to be readily seen and clearly legible when the size of the package and the circumstances under which it is ordinarily examined by purchasers or consumers are taken into consideration.

(d) The quantity of the contents when stated by weight or measure shall be marked in terms of the largest unit contained in the package, except that, in the case of an article with respect to which there exists a definite trade custom for marking the quantity of the article in terms of fractional parts of larger units, it may be so marked in accordance with the custom. Common fractions shall be reduced to their lowest terms; fractions

expressed as decimals shall be preceded by zero and shall be carried out to not more than two places.

(e) Statement of weight shall be in terms of the avoirdupois pound and ounce; statement of liquid measure shall be in terms of the United States gallon of 231 cubic inches and its customary subdivisions, i.e., gallons, quarts, pints, or fluid ounces, and shall express the volume of the liquid at 68° F. (20° C.); statement of dry measure shall be in terms of the United States standard bushel of 2150.42 cubic inches and its customary subdivisions, i.e., bushels, pecks, quarts, or pints, or, in the case of articles in barrels, in terms of the United States standard barrel and its lawful subdivisions, i.e., third, half, or three quarters barrel, as fixed by the act of March 4, 1915 (38 Stat. 1186): Provided, That statement of quantity may be in terms of metric weight or measure. Statement of metric weight shall be in terms of kilograms or grams. Statement of metric measure shall be in terms of liters or cubic centimeters. Other terms of metric weight or measure may be used if it appears that a definite trade custom exists for marking articles with such other terms and the articles are marked in accordance with the custom.

(f) The quantity of solids shall be stated in terms of weight and the quantity of liquids in terms of measure, except that in case of an article in respect to which there exists a definite trade custom otherwise the statement may be in terms of weight or measure in accordance with such custom. The quantity of viscous or semisolid foods or of mixtures of solids and liquids may be stated either by weight or measure, but the statement shall be definite and shall indicate whether the quantity is expressed in terms of weight or measure, as, for example, "weight 12 oz." or "12 oz. avoirdupois," "volume 12 ounces" or "12 fluid ounces."

(g) The quantity of the contents shall be stated in terms of weight or measure unless the package is marked by numerical

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