(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.1

(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.

(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.

As amended to accord with F. I. D. 104. See also F. I. D. 76, 89, 92, 101, 102, 135, and 138 for rulings on colors and preservatives.

(d) It having been determined that saccharin mixed with food is an added poisonous and deleterious ingredient such as is contemplated by the act, and also that the substitution of saccharin for sugar in foods reduces and lowers their quality, the Secretary of Agriculture will regard as adulterated under the food and drugs act foods containing saccharin which, on and after April 1, 1912, are manufactured or offered for sale in the District of Columbia or Territories or shipped in interstate or foreign commerce, or offered for importation into the United States. (F. I. D. 135, 138, and 142, dated April 26 and June 20, 1911, and March 1, 1912, respectively.) i

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 inspections as often as he may deem necessary.

MISBRANDING.

REGULATION 17. LABEL.2

(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 subject to the provisions of this act.3

(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 phrases as "artificially colored," "colored with sulphate of copper," or any other such descriptive phrases 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

1 See also F. I. D. 146, June 22, 1912.

2 As amended by F. I. D. 84, Jan. 31, 1908. See United States v. 779 Cases of Molasses, p. 218, post.

See United States v. 65 Casks of Liquid Extracts, p. 199, post; United States v. Eight Packages or Casks of Drug Products, p. 305, post; United States v. Dr. J. L. Stephens Co., p. 466, post; United States v. American Druggists' Syndicate, p. 406, post; McDermott, et al. v. Wisconsin, p. 629, post.

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 be smaller than 8-point (brevier) capitals: Provided, That in case the size of the package will not permit the use of 8-point type, the size of the type may be reduced proportionately.

(d) 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. 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.1

(e) 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. (f) The use of any false or misleading statement, design, or device appearing on any part of the label shall not be justified by any statement given as the opinion of an expert or other person, nor by any descriptive matter explaining the use of the false or misleading statement given as the opinion of an expert or other person, nor by any descriptive matter explaining the use of the false or misleading statement, design, or device.

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 on 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.

1 See United States v. Five Cases of Champagne, p. 662, post; and United States v. Sweet Valley Wine Co., p. 625, post.

REGULATION 19. CHARACTER OF NAME.1

(Section 8.)

(a) A simple or unmixed food or drug product not bearing a distinctive name should 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 the components or qualities is required, except as to content of alcohol, morphine, etc.

(b) The use of a geograpical 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.2

(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.3

(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."

1 As amended by F. I. D. 84, Jan. 31, 1908.

See also F. I. D. 115 on the use of geographical names.

3 See United States v. Thomson & Taylor Spice Co., p. 553, post; United States v. Finlayson et al., p. 672, post; United States v. Five Cases of Holland Gin, p. 681, post. See United States v. 300 Cases of Mapleine, p. 190, post; United States v. 100 Barrels of Calcium Acid Phosphate, p. 212, post; United States v. American Chicle Co., p. 524, post: United States . S. Gumpert & Co., p. 335, post; United States v. 40 Barrels and 20 Kegs of Coca-Cola, p. 395, post; United States v. One Carload of Corno Horse and Mule Feed, p. 434, post; United States v. Hygienic Health Food Co., p. 415, post; United States v. D. Auerbach & Sons, p. 520, post; United States v. BettmanJohnson Co., p. 460, post; and United States v. Five Cases of Champagne, p. 662, post. See United States v. 68 Cases of Syrup, p. 216, post; United States v. 10 Barrels of Vinegar, p. 410, post; and United States v. 75 Boxes of Alleged Pepper, p. 502, post.

(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.1

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.2

(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.3

(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

1 See United States v. Five Cases of Champagne, p. 662, post.

See William Henning & Co. v. United States, p. 506, post.

3 See United States v. 650 Cases of Tomato Catsup, p. 183, post.