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United States v. an Article of Drug Consisting of 36 Boxes

decided as amended september 2 1969.: July 24, 1969.

UNITED STATES OF AMERICA
v.
AN ARTICLE OF DRUG CONSISTING OF 36 BOXES, MORE OR LESS, EACH CONTAINING 1 BOTTLE OF AN ARTICLE LABELED IN PART "LINE AWAY TEMPORARY WRINKLE SMOOTHER, COTY" CHAS. PFIZER & CO., INC., APPELLANT



Hastie, Chief Judge, and Ganey and Van Dusen, Circuit Judges.

Author: Hastie

Opinion OF THE COURT

HASTIE, Chief Judge.

This is an appeal from a judgment of condemnation entered in a seizure action under section 304 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 334. Involved is an article known as "Line Away Temporary Wrinkle Smoother, Coty," or more simply, "Line Away."

The action was initiated in the United States District Court for the District of Delaware by a Libel of Information that alleged that Line Away is a "drug" within the meaning of section 201 of the Act, 21 U.S.C. § 321(g) (1) (C), and was "misbranded" in violation of 21 U.S.C. § 352(a) in that its labeling was false and misleading, and was further "misbranded" in violation of 21 U.S.C. § 352 (e) (1) (A) (ii) in that it consisted of two or more ingredients which were not named on the label. After both the claimant, Charles Pfizer & Co., Inc. and the government had so moved, summary judgment was entered in favor of the government. This appeal followed.*fn1

The sole issue before this court is whether Line Away is a "drug" within the meaning of section 201 of the Food, Drug, and Cosmetic Act.*fn2 So far as is relevant to this case, section 201 provides:

"The term 'drug' means * * * (C) articles * * * intended to affect the structure * * * of the body of man * * *" 21 U.S.C. § 321(g) (1) (C).

The district court found that since the admitted effect of Line Away is to smooth, firm, and tighten the skin, it does "affect the structure" of the skin within the literal definition of "drug" contained in section 201. The court also observed that it could find nothing to warrant a less comprehensive construction of the language of the statute. We do not find it necessary at this time to express any opinion as to these views. For regardless of the actual physical effect of a product, it will be deemed a drug if the labeling, including separate promotional claims, attributes characteristics to the product that would bring it within the Act's definition. Kordel v. United States, 1948, 335 U.S. 345, 69 S. Ct. 106, 93 L. Ed. 52; United States v. Hohensee, 3d Cir. 1957, 243 F.2d 367, cert. den. 353 U.S. 976, 77 S. Ct. 1058, 1 L. Ed. 2d 1136. See United States v. Article of Drug, 3d Cir. 1966, 362 F.2d 923. Nor can it be doubted that the fact that an article is a beautifying agent or "cosmetic," as is claimed here, does not preclude its also being a drug for purposes of the Act. See S.Rep. No. 361, 74th Cong., 1st Sess., reprinted in Dunn, The Federal Food, Drug and Cosmetic Act 239-240 (1938).

Accordingly we turn to an examination of the promotional claims made for Line Away. The leaflet packed in each box of Line Away contains application instructions and makes it clear, as does the promotional material, that the effect of the product is temporary, lasting only up to five hours. Prior to the instructions, however, some introductory material is included. Recited prominently in italics is the preface:

"Manufactured exclusively for Coty in the pharmaceutical laboratories of Charles Pfizer & Co., Inc."

There follows, inter alia:

"Line Away is not a face lift, not a treatment. It's a clear protein cosmetic. Contains absolutely no harmful chemicals, no hormones.

"To assure superior performance, Line Away is sealed and packaged under biologically aseptic conditions. You can be absolutely certain your protein lotion will stay fresh, superactive."

"You'll feel a tingling sensation the instant you smooth Line Away on. It means that Line Away is at work -- ...


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