Court Opinion

ID: 8880555
Source: CourtListenerOpinion
Date Created: 2022-11-26 20:24:41.860495+00
Date Added: 2024-06-11T17:06:36.525205
License: Public Domain

MANSFIELD, District Judge
(dissenting) :
The Court today holds that a cosmetic which is not in fact a “drug” must nevertheless be classified as such because of the vendor’s use in its labelling and advertising of two phrases deemed to carry “physiological connotations.” I find myself unable to go along with this view.
“Sudden Change” recognizes that wrinkles are but the irreparable footprints of time, and that they may be temporarily softened or masked, but not obliterated. The product does not enter the tissue, cells, or molecular structure of the skin, or work any physiological changes in the body. It merely alters the appearance of the face for a few hours by smoothing or toning the skin. Unless it is repeatedly applied at regular intervals the tell-tale wrinkles return. The product poses no threat to public health. Unless claims were made for it in labelling or advertising to the effect that it possessed the properties of a drug, it would not fall within the definition of a drug as an article “intended to affect the structure of the body,”1 21 U.S.C. § 321(g) (1).
As Judge Anderson points out, it is settled law that if a product is claimed by its vendor to possess the qualities of a drug, it must be classified as such, in *743order to assure the public of the protective requirement that a drug be pre-tested and cleared, and that its components be listed on the label (see decisions cited supra at p. 239). However, in construing advertising and labelling for the purpose of determining whether the claims made by the vendor require classification of a cosmetic as a drug, we must recognize that the issue to be resolved is the vendor’s intent rather than the need for protection of the consumer;, against fraud. Since 1914 the Federal Trade Commission has possessed broad statutory powers, which it has vigorously exercised, to protect the consumer against economic fraud in the sale of products, whether or not they are classified as “drugs,” 15 U.S.C. §§ 45(a) (1) and 52(a); Charles of the Ritz Dist. Corp. v. F.T.C., 143 F.2d 676 (2d Cir. 1944). Regardless whether the product “Sudden Change” is classified as a drug, it continues to be a “cosmetic.” If a cosmetic is adulterated or misbranded, it is subject to seizure and its vendor may be prosecuted, 21 U.S.C. §§ 333, 334; and misbranding of a cosmetic is broadly defined as labelling which is “false or misleading in any particular” (emphasis added), 21 U.S.C. § 362. When Congress in 1938 expanded the definition of a “drug” in the Food, Drug and Cosmetic Act to include articles “intended to affect the structure * * * of the body,” its essential purpose was to protect the public’s health rather than its pocketbook. See AMP Incorporated v. Gardner, 389 F.2d 825, 829 (2d Cir. 1968).2 As the legislative history of the 1938 revision amply demonstrates, Congress felt that the Act’s existing definition of a drug afforded loopholes which would permit the sale of certain types of products, such as remedies for obesity, without the safeguards of pre-testing, clearance and labelling of components, which are designed to protect the consumer against harm to his body. Although there was a passing reference by Senator Copeland to the existence of “worthless” devices and preparations on the market, Congress enacted separate provisions prohibiting the misbranding of cosmetics, 21 U.S.C. §§ 331, 362, and it was well aware of the Federal Trade Commission’s existing broad powers to curb fraudulent advertising.
In view of the existence of ample authority for regulation of cosmetics, it strikes me as unnecessary, in the absence of some imminent danger to public health —and none is suggested here — for the Court to adopt new standards of construction for the purpose of determining whether an article is intended as a “drug” rather than to follow time-proven rules. Yet that is exactly what the Court does here, with the result that it opens up a new — and in my view, unnecessary —avenue for regulation of cosmetics as drugs. If Congress believes that protection of the public requires pretesting and clearance of cosmetics by the Food and Drug Administration (Dept, of Health, Education and Welfare) and that their components be listed on the label, it has the power to act. I do not think the Court should do so by a process of tortuous construction.
It is only by fragmentizing the language used in the labelling and advertising of “Sudden Change,” and by applying the “gullible” instead of “reasonable” woman standard, that the Court reaches the conclusion that the vendor “intended” the product to “affect the structure * * of the body,” which would render it a “drug,” instead of “intended” it to be applied for the purpose of “altering the appearance” of the skin, which is the definition of a cosmetic, 21 U.S.C. § 321 (i). The Court’s decision rests essentially on two phrases, “Face Lift Without Surgery” and “Lifts the Puffs Under Your Eyes,” which it excerpts from the labelling and gives undue emphasis, de*744parting from the elementary principle that the text oí the labelling and advertising must be viewed as a whole. “The important criterion is the net impression which the advertisement is likely to make upon the general populace” (emphasis added), Charles of the Ritz Dist. Corp. v. F. T. C., 143 F.2d 676 (2d Cir. 1944). It is the “overall impression created” that governs, J. B. Williams Co. v. F. T. C., 381 F.2d 884, 889 (6th Cir. 1967). “Advertisements must be considered in their entirety,” Aronberg v. F. T. C., 132 F.2d 165, 167 (7th Cir. 1942). See, in accord, United States v. 47 Bottles, More or Less, 201 F.Supp. 915, 917 (D.N.J. 1962). These cases apply that standard to the question of misleading advertising; when the question of intent is involved it seems to me even more appropriate to look at the net impression conveyed by the advertisements and labels.
Applying the basic standard that the advertising and labelling must be viewed as a whole, the product “Sudden Change” appears as nothing more than a superficial wrinkle smoothing cosmetic or beautifier intended to give the surface of a lady’s skin a smoother or more attractive appearance for a few hours. Although the labelling refers to “Face Lift Without Surgery,” it also prominently states in bold print that the product “lasts for hours.” The advertising further emphasizes the temporary nature of the product’s effect upon the skin by stating that it “wears off gradually,” that it “does not change the structure or function of the skin in any way,” that “it will not eliminate them [wrinkles] permanently,” and that if the product is applied “several hours later * * * your skin is firmed and tightened again, and the more you use, the longer your wrinkle-free look will last.” The price is $2.95 per bottle.
I find it difficult to believe that any of the fairer sex, whether described as “gullible” or “reasonable,” would be led by the description of the product in its entirety, including the puffery, to believe that it is anything more than another one of the many lotions, creams, oils or similar cosmetics which are claimed by vendors to “lift,” “tone,” “smooth” or “moisturize” the skin. As Judge Weinstein pointed out, if the claim that a product will alter the appearance of the body, such as by “lifting” or “smoothing” the skin, requires that the product be classified as a drug, practically all cosmetics (and indeed articles such as girdles or brassieres) would be required to be so classified. The effect would be to render meaningless the distinction made by Congress between drugs and cosmetics, the latter of which are defined by Congress as articles intended to be applied for the purpose of “altering the appearance of the body,” 21 U.S.C. § 321 (i).
It may well be that the existence of fraud upon consumers of such products (whether drugs or cosmetics) should depend upon whether “the ignorant, the unthinking and credulous” would be deceived, supra p. 740. The issue before us, however, is not whether consumers may be defrauded by the labelling and enclosures used in connection with the sale of “Sudden Change.” The issue is whether the product must be classified as a “drug” which must be pre-tested, cleared and bear a label listing its components. Since that issue turns upon whether the article is “intended to affect the structure of the body” (emphasis added), it seems to me that the “gullible” woman standard is both irrelevant and unnecessary, and that the standard should be whether a reasonable person would construe the labelling and advertising as showing that the product was so intended.
To summarize my position, unless a product is in fact a “drug” as defined in the Food, Drug and Cosmetic Act or a reasonable person would conclude from a reading of the label and enclosure as a whole that it is intended to possess the properties of a drug as so defined, I would not classify it as such merely because one or two phrases, taken out of context, imply possible drug properties. The effect of such a course is to draw a line between permissible and impermis*745sible description of cosmetics that is altogether too illusory and shadowy to permit a workable standard, with the result that most cosmetics must be classified as drugs.

. Webster defines “structure” as the “Arrangement of parts, or organs, or of constituent tissues or particles in a substance or body.” New Collegiate Dictionary, p. 841 (1959). Implicit in the majority opinion is an acceptance of Judge Weinstein’s view that words such as “smoothes the skin,” “firms the skin,” “tones the skin” and “moisturizes the skin” do not imply that the product is “intended to affect the structure of the body.” It is unclear, however, whether the Court would deem the phrase “lifts the skin” to have physiological connotations in the absence of a reference to “surgery” or “puffs under the eyes.”

. In discussing the purposes of the 1938 amendments to the Act, the Court, per Smith, J., there stated:
“That purpose was, very clearly, to keep inadequately tested medical and related products which might cause widespread danger to human life out of interstate commerce.”