United States v. Article... Consist. of 216 Carton. Bot.

• Decision Date: 08 April 1969
• Docket Number: No. 367,Docket 32847.,367
• Citation: 409 F.2d 734
• Parties: UNITED STATES of America, Appellant, v. An ARTICLE . . . CONSISTING OF 216 individually CARTONED BOTTLES, MORE OR LESS, of an Article Labeled in part: SUDDEN CHANGE, etc., Hazel Bishop, Inc., Appellee.
• Court: U.S. Court of Appeals — Second Circuit

409 F.2d 734 (1969)

UNITED STATES of America, Appellant, v. An ARTICLE . . . CONSISTING OF 216 individually CARTONED BOTTLES, MORE OR LESS, of an Article Labeled in part: SUDDEN CHANGE, etc., Hazel Bishop, Inc., Appellee.

No. 367, Docket 32847.

United States Court of Appeals Second Circuit.

Argued February 11, 1969.

Decided April 8, 1969.

Carl Golden, Special Asst. U. S. Atty. (Joseph P. Hoey, U. S. Atty., Eastern District of New York, on the brief), for appellant.

Andrew J. Graham, New York City (Graham, McGuire & Campaign, William L. McGuire, and Joseph J. Bosco, New York City, on the brief), for appellee.

Vincent A. Kleinfeld, Alan H. Kaplan, Stanley J. Krieger, Kleinfeld & Kaplan, Washington, D. C., Fuller Holloway Hamel, Morgan, Park & Saunders, Washington, D. C., on the brief of the Toilet Goods Association, Inc., as amicus curiae.

Before ANDERSON and FEINBERG, Circuit Judges, and MANSFIELD, District Judge.^*

ANDERSON, Circuit Judge:

This is an appeal in a seizure action from an order of the United States District Court for the Eastern District of New York entered on July 30, 1968, denying the Government's motion for summary judgment and granting summary judgment for the claimant. The seizure concerned 216 bottles of a cosmetic product called "Sudden Change" which is a clear liquid lotion consisting primarily of two ingredients: bovine albumen (15%) and distilled water (over 84%). It is meant to be applied externally to the surface of the facial skin, and it is claimed, inter alia, in its labeling and advertising that it will provide a "Face Lift Without Surgery." The court below¹ described the effects of the product as follows:

Allowed to dry on the skin, it leaves a film which (1) masks imperfections, making the skin look smoother and (2) acts mechanically to smooth and firm the skin by tightening the surface. Both effects are temporary. There is apparently no absorption by, or changes in, skin tissue resulting from its applications; it washes off.

The central issue presented in this appeal is whether Sudden Change is, within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321 (g) (1), a "drug." That Section, in pertinent part, provides: "The term `drug' means * * * (C) articles (other than food) intended to affect the structure * * * of the body of man * * *." The question posed is whether, by reason of its labeling and promotional claims, Sudden Change is to be deemed a drug for purposes of the Act.

The civil in rem action was instituted by the United States in the United States District Court for the Southern District of Florida, pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. The Libel of Information was filed by the Government on May 8, 1964, seeking seizure and condemnation of 216 bottles in individual cartons, allegedly misbranded, labeled in part "Sudden Change by Lanolin Plus." The Libel alleges that the article seized is a "drug" within the meaning of 21 U.S.C. § 321 (g) (3) subsequently redesignated as § 321(g) (1) (C), 52 Stat. 1040 (1965) and a "new drug" within the meaning of 21 U.S.C. § 321(p), which had been shipped in interstate commerce without an approved New Drug Application filed pursuant to 21 U.S.C. § 355(b), effective with respect to such drug, in violation of 21 U.S.C. § 355(a). The Libel further alleges that the article was misbranded when introduced into and while in interstate commerce within the meaning of 21 U.S.C. § 352(a), in that the labeling for the article contains false and misleading statements with respect to the effectiveness of the drug for eliminating facial wrinkles and giving a face lift without surgery; and within the meaning of 21 U.S.C. § 352(e) (1) (A) (ii), in that the article is fabricated from two or more ingredients and that the label fails to bear the established name of each active ingredient.

Pursuant to monition issued by the District Court, the United States Marshal for the Southern District of Florida seized the article and labeling material accompanying it. Following the seizure, Hazel Bishop, Inc., now known as Bishop Industries, Inc., intervened, filed a claim to the article and answered the Libel. Claimant's answer admits that the article and its accompanying label were shipped in interstate commerce; that the article was seized within the jurisdiction of the United States District Court for the Southern District of Florida; and that the article has a "temporary cosmetic effect on wrinkles." All other allegations in the Libel are denied. On September 2, 1964, the action was removed on claimant's motion to the United States District Court for the Eastern District of New York.

Following discovery proceedings, the Government moved for summary judgment contending, inter alia, that the claims appearing in the article's labeling constituted it a drug under the law and that the product was misbranded as a matter of law since its label failed to bear the established name of each of its active ingredients. To support its motion, the Government relied on claimant's admissions in answers to interrogatories, the deposition of claimant's medical expert, and the affidavits of government experts.

Claimant interposed affidavits in opposition to the Government's motion and in support of its cross-motion for summary judgment, in which it contends that the article is solely a cosmetic which functions simply as a mask for facial lines and wrinkles and that the product's labeling claims were not understood otherwise by cosmetic consumers. It argues that the Government's construction of 21 U.S.C. § 321(g) (1) (C) is so broad that every "cosmetic" would automatically be a "drug," since by definition a cosmetic must have some "effect" on the human body, even though that effect is only a change of appearance. In support of claimant's cross-motions and in opposition to the Government's motion, affidavits of claimant's vice-president, a cosmetologist and a medical expert were submitted.

Claimant also filed a statement of claimed uncontested facts pursuant to Rule 9(g) of the General Rules of the United States District Court for the Eastern District of New York, which admits, inter alia:

1. That the label for Sudden Change does not specify its ingredients.

2. That the specific ingredients for the article are Bovine Serum, Albumin 15.00%, Sodium Benzoate 0.70%, Ethylmercurithiosalicylate 0.005%, 6 Acetoxy-2, 4 dimethyl-N-diozaul 0.05% and distilled water to make 100.00%.

3. That the article\'s labeling made the following claims:

(a) "it gives a face lift without surgery"

(b) "it lifts the skin"

(c) "it firms the skin"

(d) "it tones the skin"

(e) "it smoothes the skin"

(f) "it moisturizes the skin"

(g) "it provides a tingling sensation to indicate the article is working"

(h) "it lifts puffs under the eyes"

(i) "it provides the user with beneficial results for hours"

(j) "it is more effective if applied regularly"

4. Claimant further admits that its labeling claims achieved the foregoing results by the following mechanisms of action:

"When `Sudden Change\' dries on the surface of the skin, the residual solids are deposited as a film. This effect is achieved by the cohesive properties of this substance which cause the particles to be attracted to each other. The film on the surface of the skin thus achieves a dynamic multilateral tensing action and as said deposit ultimately undergoes an isometric process, it smoothes the surface of the skin by a virtually invisible masking effect and imparts to the facial tissues a lift, firmness and tone which smooth out the skin surface. In so doing, the preparation does not enter into the tissues of the skin or bring about any change in the skin\'s cellular structure or function."

* * * * * *

"As the aqueous portion of `Sudden Change\' evaporates after application and the contractile film is formed, the evaporative and contractile processes result in a tactile sensation of tightening that is perceptible to the user. As the film is formed and lines are, in fact, smoothed out, a visible difference is apparent to the user."

5. Claimant concedes that there is no approved New Drug Application in effect for the article "Sudden Change."

A statement by the Committee on Cutaneous Health and Cosmetics of the American Medical Association, which was an exhibit annexed to claimant's Answers to Interrogatories, stated, inter alia:

"In the absence of an excessive amount of pharmacologically active preservative agents, the bovine serum albumin products apparently have no biochemical or physiological activity when applied to the skin and their application results only in temporary physical surface changes. The pertinent results indicate that the effect on the skin produced by these products can be (a) totally eliminated if the skin is washed with soap and water, (b) reduced significantly by vigorous use of the facial muscles of expression, (c) simulated by using test materials which produce contracting films when applied to the skin, (d) shown not to promote or retard the transportation of water through the horny layer of the skin (as demonstrated on isolated sheets of stratum corneum), and (e) correlated to no demonstrable changes in the histology of the skin.

The Committee on Cutaneous Health and Cosmetics therefore concludes that bovine serum albumin products are safe for use on human skin and cause temporary physical surface changes."

The box in which Sudden Change is sold bears the capitalized words "SUDDEN CHANGE" * * * "THE PERFECTED ANTI-WRINKLE FACE LIFT." Another side of the box bears the following description:

"SUDDEN CHANGE by Lanolin Plus is the new and improved, dramatically different wrinkle-smoothing cosmetic. By simple, dynamic contraction, it lifts, firms, tones slack skin * * * smooths out wrinkles, lifts the puffs under eyes, leaving your contours looking beautifully defined. It acts noticeably, visibly * * * and so quickly you will see and feel results minutes

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