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According to the United States Food and Drug Administration (FDA), a personal care product can be classified as a drug, a cosmetic, or both. Moisturizers with skin protection factor (SPF) and antidandruff shampoos are examples of dermatologic products classified as both a drug and a cosmetic. The term “cosmeceutical” was introduced approximately 25 years ago by Albert Kligman, MD, at a meeting of the Society of Cosmetic Chemists because he felt that a new category of regulation should exist.1 Although this topic has been debated for decades, the category “cosmeceuticals” has still not been codified or officially recognized. In other words, it has no legal meaning. The term, however, is increasingly a part of the mainstream vernacular and frequently used to describe products that are known to have a biologic action but are regulated as cosmetics (e.g., products containing retinol). Although it is well known that retinol stimulates retinoic acid receptors resulting in biologic activity, retinol is a popular ingredient contained in numerous cosmetics. Companies often list retinol as an inactive ingredient on product labels to avoid regulatory action by the FDA.

The stage for this unforeseen regulatory loophole in which cosmeceuticals reside was set in 1938 when the US Congress passed a statute known as The Federal Food, Drug, and Cosmetic Act (FD&C Act), which outlined formal criteria for classification of drugs and cosmetics. In this document, cosmetics were defined as: “…articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance…” In contrast, a drug is defined as a substance “intended to affect the structure and function of the body.” Based on this definition, the actual intent of the product and not its actions govern how it is classified. This allows for the classification of retinol as a cosmetic because it is listed as an inactive ingredient on product labels; therefore, retinol is not intended to serve a biologic purpose.

As in several other realms of society during our era of rapidly propagating technology, numerous legal implications fail to anticipate future developments. In terms of the debate over classifying products as drugs, cosmetics, or cosmeceuticals, there are some salient points to consider. The first is that the current regulations discourage companies from publishing supportive scientific clinical trials to evaluate the efficacy of their products. For example, if a manufacturer establishes in a study that an ingredient increases collagen synthesis, the company is proving that its product affects the “function of the body.” If they were then to market or sell that product as a cosmetic intended to increase collagen synthesis, as would be desirable in an antiaging product or a wrinkle cream, they would be violating the 1938 statute. The only legal option for the manufacturer would be, instead, to market its product as ...

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