Cosmetic? Drug? How Puffery May Cause Your Product to be a Drug

The post “When Puffery Crosses the Line” discussed the basic tenets of puffery, or seller’s puff, in cosmetic advertising.  In addition to running the risk that advertising claims may fall into the realm of false advertising, classic cosmetic puffery may also cause a cosmetic to be a drug under the Federal Food, Drug, & Cosmetic Act (“FD&C Act”).

The FD&C Act defines a drug, in part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”  A cosmetic is defined, in part, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  Thus, whether a product is a drug or a cosmetic is determined by its intended use. (For further discussion, see FDA’s discussion on the topic.)

Both the FDA and courts recognize that a product will be deemed a drug if the labeling, including separate promotional, advertising, or marketing claims, attributes characteristics to the product that would bring it within the FD&C Act’s definition of a drug. In other words, what is the intended use of the product? Indeed, the courts are not necessarily even concerned with whether a product is compositionally a drug, because it is the intended use of the drug that controls.

Moreover, the fact a product is a beautifying agent or “cosmetic,” does not preclude its also being a drug for purposes of the FD&C Act.  This reality is a function of how the FD&C Act define a drug and a cosmetic.

So how can puffery cause your cosmetic to become a drug?  A good case study of the issue can be found in the 1971 case of U.S. v. Article of Drug, Etc., 331 F.Supp. 912.  The case was the last of a group filed by the Government in 1964 against manufacturers of bovine serum albumin products.  In two earlier cases, the Government had prevailed in arguing that the products were intended to affect the structure of the body and thus were drugs (see Line Away and Sudden Change). In the 1971 case, however, even though the product was comprised of the same underlying ingredients, the court held that the intended purpose of the product, known as Magic Secret, was simply to alter the appearance.

In its ruling, the court applied a test enunciated in the Sudden Change case, declaring it to be “a sound one”:

In other words, with the exception of those claims which have become so associated with the familiar exaggerations of cosmetics advertising that virtually everyone can be presumed to be capable of discounting them as puffery, the question of whether a product is “intended to affect the structure * * * of the body of man * * *” is to be answered by considering, first, how the claim might be understood by the “ignorant, unthinking or credulous” consumer, and second, whether the claim as so understood may fairly be said to constitute a representation that the product will affect the structure of the body in some medical—or drug-type fashion, i.e., in some way other than merely “altering the appearance.”

The court explained that the “only two claims made for “Magic Secret” which even approach the magnitude of the claims made in Line Away and Sudden Change are that “Magic Secret” is a “pure protein” which causes an “astringent sensation.” But, because the Magic Secret marketing did not emphasize these two claims, and because the advertising for Magic Secret was not as exaggerated as the those evaluated in the other cases, the court determined that Magic Secret was not intended to affect the structure of the body, and even an ignorant consumer would not expect the product to do anything but change her appearance for a few hours after use.

Table: Claims evaluated by the courts in the Line Away and Sudden Change cases.

Line Away *Repeated statements emphasizing the protein content of the product;  *”Super active” and “amazing”; *tightening the skin; *discouraging new wrinkles from forming”; *made in a “pharmaceutical laboratory”; *packaged under “biologically aseptic conditions”
Sudden Change *The Perfected Anti-Wrinkle Face Lift; *Face Lift Without Surgery; *”By simple dynamic contraction, it lifts, firms, tones slack skin * * * smoothes out wrinkles, lifts puffs under eyes * * * It acts noticeably, visibly — and so quickly you will see and feel results minutes after you apply it.”; *”That tingling sensation you will feel, tells you that SUDDEN CHANGE is beginning to work.”; * “During this time, the firming sensation may seem to disappear ___ ___ ___ but the moisturizing effect of Sudden Change will continue to act: bringing you a new smoothness that will last for hours.”; *”Acts in Minutes”; *”Lasts for Hours”; *”Wears off Gradually”; *Not a hormone or chemical astringent, Sudden Change is a concentrated purified natural protein.”

Take Away… If it looks like a duck and quacks like a duck, it’s a duck. If it looks like a duck, but baas like a sheep, you may want to revisit marketing’s drawing board.

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