itself, which requires a preparation containing a derivative of any such enumerated drugs to be so labeled or branded as to show not only the quantity or proportion of the named derivative contained in the preparation as required by that section, but also to name the drug from which the substance in question is derived.

6. It is not a matter of common knowledge, of which the court will take judicial notice, that a chemical derivative necessarily contains, or is of the same nature as, the substance whence it may be derived. 7. For the common meaning or signification of the term "chemical derivative," this court examined accredited dictionaries of the language, and gave the definitions contained in them.

8. Whether the addition or substraction of elements through which acetphenitidin may, in theory or in practice, be derived from acetanilid, produces such a chemical change of substance that it may be truly said to contain no acetanilid, or produces a substance which still contains an appreciable quentity or proportion of the same, presents a question of fact to be determined on the evidence of witnesses skilled in chemistry, and not a question of law.

9. To authorize the introduction of evidence, an issue must be raised in the pleadings.

10. Where a libel under the food and drug act of Congress of June 30, 1906, charged that a drug preparation labeled as containing a specified quantity of acetphenitidin, but as containing no acetanilid, with being misbranded, because of the statement in the label that the preparation contained no acetanilid, failed to expressly charge that acetphenitidin contained acetanilid, it was held that exceptions to the libel were properly sustained, and the libel was dismissed.

No. 2257. Submitted April 10, 1911. Decided May 29, 1911.

HEARING on an appeal by the United States from a judgment of the Supreme Court of the District of Columbia, sitting as a District Court, sustaining exceptions to and dismissing a libel for the seizure and condemnation of packages of drugs alleged to be misbranded under the food and drugs act of June 30, 1906. Affirmed.

The COURT in the opinion stated the facts as follows:

This is an appeal by the United States from a judgment sustaining exceptions to and dismissing a libel.

The libel prayed the seizure and condemnation of 100 packages of a certain drug, describing the same as follows:

"Twenty packages, more or less, of said drug, labeled and branded as follows: Antikamnia tablets, contain 305 grains of acetphenitidin, U. S. P. per ounce, guaranteed by the Antikamnia Chemical Company under the food and drugs act, June 30th, 1906, U. S. Serial Number 10. The antikamnia tablets in this original ounce package contain no acetanilid, antifebrin, antipyrin, morphin, opium, codein, heroin, cocain, alpha or beta eucain, arsenic, strychnin, chloroform, cannabis indica or chloral hydrate. Antikamnia tablets five grains. One ounce antikamnia tablets. Manufactured in the United States of America by the Antikamnia Chemical Company, St. Louis, U. S. A.'

"Also seventy other packages, more or less, of said drug, labeled and branded as follows: 'Antikamnia and codein tablets. Contain 296 grains acetphenitidin, U. S. P. per ounce. Contain 18 grains supl. codein per ounce. Guaranteed by the Antikamnia Chemical Company under the food and drugs act, June 30th, 1906, U. S. Serial No. 10. The antikamnia and codein tablets in this original ounce package contain no acetanilid, antifebrin, antipyrin, morphin, opium, heroin, cocain, alpha or beta eucain, arsenic, strychnin, chloroform, cannabis indica, or chloral hydrate. One ounce antikamnia and codein tablets. Manufactured in the United States of America by the Antikamnia Chemical Company, St. Louis, U. S. A.'

"Also ten other packages, more or less, of said drug labeled and branded as follows: 'Antikamnia and quinin tablets. Contain 165 grains acetphenitidin, U. S. P. per ounce. Guaranteed by the Antikamnia Chemical Company under the food and drugs act, June 30th, 1906, U. S. Serial No. 10. The antikamnia and quinin tablets in this original ounce package contain no acetanilid, antifebrin, antipyrin, morphin, opium, codein, heroin, cocain, alpha or beta eucain, arsenic, strychnin, chloroform, cannabis indica, or chloral hydrate. One ounce antikamnia and quinin tablets. Manufactured in the United

States of America by the Antikamnia Chemical Company, of St. Louis, U. S. A.'"

The libel charges that the packages of said drug are subject to condemnation as misbranded, in violation of the provisions of the food and drugs act, approved June 30th, 1906.

"Because each and all of said packages of drug contain a large quantity and proportion of acetphenitidin, which your libellant charges is a derivative of acetanilid, and that, under the provisions of the said act of Congress and of the regulations lawfully made thereunder, it is provided and required that the label on each of said packages should bear a statement that the acetphenitidin contained therein is a derivative of acetanilid; and yet your libellant charges that each and all of said packages fail to bear a statement in any form that the acetphenitidin contained therein is a derivative of acetanilid, or that the drug contains any derivative of acetanilid.

"Your libellant further charges that each and all of said packages of drug are further misbranded in that the labels thereon are false and misleading, for the reason that each and all of the said labels bear the statement that no acetanilid is contained therein, and that said statement imports and signifies that there is no quantity or proportion of any derivative of acetanilid contained in said drug."

Under the warrant ordered to issue, the marshal seized ninety-three packages in all, bearing the labels aforesaid. By leave of the court, the Antikamnia Chemical Company, alleging itself to be the owner of the packages, was permitted to appear as party defendant.

The exceptions on which the libel was dismissed are substantially that the act does not require that the label on each of said packages shall have a statement that the acetphenitidin contained therein is a derivative of acetanilid, nor is it necessary under said act that a derivative of any parent substance should state that it is a derivative of such substance, provided the derivative itself is named by its proper name. That the statement on the packages that it contains no acetanilid is neither false nor misleading, but true, and the libel, while

charging that acetphenitidin is a derivative of acetanilid, does not charge that there is any acetanilid in acetphenitidin.

Sec. 1 of the food and drugs act [34 Stat. at L. 768, chap. 3915, U. S. Comp. Stat. Supp. 1909, p. 1187] makes it unlawful to manufacture within any territory or the District of Columbia, an article of food or drug which is adulterated or misbranded, "within the meaning of this act," and imposes a penalty therefor.

Sec. 2 prohibits the introduction into any State or territory or the District of Columbia, and the shipment from the same to any other State, territory, etc., or foreign country, any article of food or drug, in the original packages, adulterated or misbranded, within the meaning of this act, and the sale or offer for sale in the District of Columbia or territories, of any such adulterated or misbranded foods or drugs; and provides a penalty therefor.

Sec. 3 provides: "That the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce and Labor shall make uniform rules and regulations for carrying out the provisions of this act, including the collection and examination of specimens of foods and drugs," etc.

Sec. 4 provides for the examination of foods and drugs, and the giving of notice if found to be adulterated or misbranded. Sec. 5 makes it the duty of the district attorney, to whom report shall be made of any violation of the act, to cause appropriate proceedings to be commenced without delay, for the enforcement of the penalties provided in the act.

Sec. 6 defines the meaning and inclusion of the terms "drug" and "food."

Sec. 7 declares that, for the purposes of this act, an article shall be deemed to be adulterated: "In case of drugs: First: If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoia or National Formulary, official at the time of investigation; Provided that no drug defined in the United States

^

1

Statement of the Case.

[37 App.

Pharmacopoeia or National Formulary shall be deemed to be adulterated under this provision, if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof, although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.

"Second: If its strength or purity fall below the professed standard or quality under which it is sold." (Other portions of the section relate to confectionery and foods.)

Sec. 8. "That the term 'misbranded' as used herein shall apply to all drugs or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein, which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, territory, or country in which it is manufactured or produced. That, for the purposes of this act, an article shall also be deemed to be misbranded, in case of drugs: First: If it be an imitation of, or offered for sale under the name of, another article. Second. If the contents of the package as originally put up shall have been removed in whole or in part, and other contents shall have been placed in such a package, or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphin, opium, cocain, heroin, alpha or beta eucain, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances contained therein." (Remainder of section applies to foods.)

Sec. 9 relates to guaranties by wholesalers, jobbers, and manufacturers.

Sec. 10 provides for the seizure and condemnation of adulterated or misbranded foods, drugs, and liquors, through proceedings instituted for the purpose, which proceedings "shall conform, as near as may be, to the proceedings in admiralty, except that either party may demand trial by jury of any