UNITED STATES OF AMERICA v. ANTIKAMNIA CHEMICAL COMPANY.

ERROR TO AND APPEAL FROM THE COURT OF APPEALS OF THE DISTRICT OF COLUMBIA.

No. 118. Argued December 9, 1913.—Decided January 5, 1914.

Where the validity of regulations made by officers to whom power to make them is delegated by the Food and Drugs Act of 1906 is denied, an authority exercised under the United States is drawn in question, and not merely the construction of the statute, and this court has jurisdiction to review the judgment of the Court of Appeals of the District of Columbia. Steinmetz v. Allen, 192 U. S. 543, followed, and United States ex rel. Taylor v. Taft, 203 U. S. 461, distinguished. In this case the question of authority of the officers to whom the power to make regulations is delegated by the Food and Drugs Act is substantial and not frivolous. United States v. Grimaud, 220 U. S. 506 distinguished.

The purpose of the Food and Drugs Act of 1906 is to secure purity of

food and drugs and to inform purchasers of what they are buying. Its provisions are directed to that purpose and must be construed to effect it.

The power given by § 3 of the Food and Drugs Act to the specified heads of departments to make regulations is an administrative power and not one to alter, or add to, the act, and the extent of the power must be determined by the purpose of the act and the difficulties its execution might encounter.

Regulation No. 28 for the enforcement of the Food and Drugs Act requiring labels to state not only what drugs contain but also what the contents are derivatives of, is within the delegated power of the act and does not enlarge or alter its provisions.

It is a violation of the Food and Drugs Act of 1906 and of Regulation No. 28 to label tablets as containing acetphenetidin without stating that acetphenetidin is a derivative of acetanilid.

The Food and Drugs Act itself requires that not only primary substances be labelled but also their derivatives, and no regulations are necessary to support this requirement.

The purpose of a statute is the ever insistent consideration in its interpretation, and this court will not attribute to a statute so

231 U. S.

Argument for the United States.

important as the Food and Drugs Act the defect of ineffectiveness as to its execution.

The fact that a statute has penal character does not mean that it should not be given its reasonable intendment.

37 App. D. C. 343, reversed.

THE facts, which involve the construction of provisions of the Food and Drugs Act of 1906 in regard to labelling drugs, are stated in the opinion.

The Solicitor General, with whom former Solicitor General Lehmann and Mr. Karl W. Kirchwey were on the brief, for the United States:

This court has jurisdiction. Smoot v. Heyl, 227 U. S. 518.

The regulation violated was within the power of the Secretaries to make uniform rules and regulations, and its violation constituted a misbranding within the meaning of the act.

Debates in Congress may be looked to in order to show the evil which Congress sought to remedy. American Twine Co. v. Worthington, 141 U. S. 468; Binns v. United States, 194 U. S. 486; Blake v. National Banks, 23 Wall. 307; Holy Trinity Church v. United States, 143 U. S. 457; Jennison v. Kirk, 98 U. S. 453.

This court will recognize well-known scientific facts upon which Congress acted. Austin v. Tennessee, 179 U. S. 343; Muller v. Oregon, 208 U. S. 412; Schollenberger v. Pennsylvania, 171 U. S. 1.

Permitting name of derivative alone to be stated on label would defeat purpose of act.

Reasonably construed, § 8 of the act requires a statement of the name of the parent substance; and the regulation to that effect was purely administrative.

The act is not penal for purposes of strict construction. Cliquot's Champagne, 3 Wall. 114; 443 Cans of Egg Product, 226 U. S. 172; Hipolite Egg Co. v. United States, 220 U. S.

Argument for the United States.

231 U.S.

45; N. Y., N. H. &c. R. R. v. Int. Com. Comm., 200 U. S. 361; Smythe v. Fiske, 23 Wall. 374; Taylor v. United States, 3 How. 197; United States v. Five Boxes of Asafoetida, 181 Fed. Rep. 561; United States v. Hodson, 10 Wall. 395; United States v. Stowell, 113 U. S. 1.

Even penal statutes should be construed to effectuate the legislative intent. Northern Securities Co. v. United States, 193 U. S. 197; United States v. Harris, 177 U. S. 305; United States v. Lacher, 134 U. S. 624.

The only alternative is that § 8 was left incomplete and the Secretaries were intended and authorized to fill in the outline. Pickett v. United States, 216 U. S. 456; United States v. Hartwell, 6 Wall. 385.

The power to make regulations having the force of law may be conferred by general language. Bong y. Campbell Art. Co., 214 U. S. 236; Buttfield v. Stranahan, 192 U. S. 470; Caha v. United States, 152 U. S. 211; Coopersville Creamery Co. v. Lemon, 163 Fed. Rep. 145; In re Kollock, 165 U. S. 526; Roughton v. Knight, 219 U. S. 537; United States v. Bailey, 9 Pet. 238; West v. Hitchcock, 205 U. S. 80.

The power delegated to the Secretaries was constitutional. Buttfield v. Stranahan, supra; Field v. Clark, 143 U. S. 649; In re Kollock, 165 U. S. 526; St. Louis & I. M. Ry. v. Taylor, 210 U. S. 281; Union Bridge Co. v. United States, 204 U. S. 364; United States v. Breen, 40 Fed. Rep. 402; United States v. Grimaud, 220 U. S. 506.

The statement on the label of each package that no acetanilid was contained therein was false and misleading.

A statement may be misleading under § 8, although literally true. Brina v. United States, 179 Fed. Rep. 373; Frank v. United States, 192 Fed. Rep. 864; Schraubstadter v. United States, 199 Fed. Rep. 568; United States v. Morgan, 181 Fed. Rep. 587; United States v. 100 Cases of Apples, 179 Fed. Rep. 985; United States v. Scanlon, 180 Fed. Rep. 485; United States v. 75 Boxes of Pepper, 198

231 U. S. Argument for Defendant in Error and Appellee.

Fed. Rep. 934; United States v. Ten Barrels of Vinegar, 186 Fed. Rep. 399.

The statement was calculated to suggest that no derivative of acetanilid was contained in the tablets.

Section 8 was intended to cover just such deceptions as to identity. United States v. Johnson, 221 U. S. 488.

Mr. D. W. Baker, with whom Mr. Joseph C. Sheehy, Mr. Frank J. Hogan and Mr. Wilton J. Lambert were on the brief, for defendant in error and appellee:

The libel fails to charge a misbranding of the article therein within the meaning of the act of June 30, 1906.

The act gives neither authority nor power to the several Secretaries to promulgate a regulation requiring the name of the parent substance to be added.

The statement that no acetanilid is contained in the drug is neither misleading nor false. In support of this contention, see 443 Cases of Egg Product v. United States, 226 U. S. 172; United States v. Antikamnia Co., 37 App. D. C. 343; Hipolite Egg Co. v. United States, 220 U. S. 45; United States v. Johnson, 177 Fed. Rep. 313; Huntington v. Attrill, 146 U. S. 667; Chouteau v. United States, 102 U. S. 603; Boyd v. United States, 116 U. S. 616; Coffey v. United States, 116 U. S. 436; Lees v. United States, 150 U. S. 476; Hepner v. United States, 213 U. S. 111; United States v. Harris, 177 U. S. 305; United States v. Lacher, 134 U. S. 629; Northern Securities Co. v. United States, 193 U. S. 358; Todd v. United States, 158 U. S. 282; Fozer v. United States, 52 Fed. Rep. 919; United States v. Traction Co., 34 App. D. C. 597; Morrill v. Jones, 106 U. S. 566; United States v. 200 Barrels of Whiskey, 95 U. S. 751; United States v. Three Barrels of Whiskey, 77 Fed. Rep. 965; Taylor v. Kercheval, 82 Fed. Rep. 504; United States v. Symonds, 120 U. S. 46; Williamson v. United States, 207 U. S. 425; Payne v. Railway Publishing Co., 20 App. D. C. 581; United States v. Eaton, 144 U. S. 677; United States v. VOL. CCXXXI-42

Argument for Defendant in Error and Appellee. 231 U. S.

Sandfuhr, 145 Fed. Rep. 49; United States v. Grimaud, 220 U. S. 506; Standard Oil Co. v. United States, 222 U. S. 77; United States v. George, 228 U. S. 14; Brown v. Piper, 91 U. S. 37; Manufacturing Co. v. Adkins, 36 Fed. Rep. 554; Engraving Co. v. Hoke, 30 Fed. Rep. 444; Lagler v. Bye, 42 Ind. App. 592; Diversey v. Smith, 103 Illinois, 390; Commonwealth v. Crane, 158 Massachusetts, 219; State v. Mann, 2 Oregon, 241; Brown v. State, 131 Wisconsin, 543.

See page 3, Pharmacopoeia of the United States of America, defining Acetanilid and Acetphenetidin, and page 8, United States Dispensatory, giving uses and effects of Acetanilid and Acetphenetidin.

See also Report No. 301 of Senate Committee on Manufactures, 58th Cong., 2d Sess., Jan. 15, 1904, accompanying Senate Bill 198, relating to "Adulteration of Foods, etc.," and containing statements of Dr. Wiley, of Department of Agriculture, relative to phenacetine (Acetphenetidin) and Acetanilide and hearings before Senate Committee, January 20, 1903, on H. R. 3109, being the Pure Food and Drugs Act, containing statements relative to the use of Acetanilid as an adulteration of or substitution for Acetphenetidin (Phenacetine).

An examination of 2350 judgments filed by the Agricultural Department up to February 1, 1913, shows that in no case, except the instant case, does the libel, indictment, or information charge a violation of a rule or regulation of the Department.

In No. 438, The Ice Cream Case, United States v. Bishof, there was charged a violation of the law and not any regulation of the Department.

Regulations have been held valid not under the Pure Food Act, but under act of Congress, March 3, 1903.

In Hurdle Brand Holland Gin, No. 807, the libel charged a violation of the law and not of any regulation. The court held the label was sufficient under the law.

The act of June 3, 1903, has been before the court on