David H. McDaniel
The Institute of Anti-Aging Research, Virginia Beach, Virginia, U. S.A.
Joseph DiNardo and Joseph Lewis
Pharma Cosmetix Research, LLC, Richmond, Virginia, U. S.A.
WHAT ARE “COSMECEUTICALS”—COSMETICS VS. RX DRUGS History and Background
The term “cosmeceuticals” was first popularized about twenty-five years ago by Albert Kligman, MD, PhD, to bridge the gap between cosmetics and drugs or pharmaceuticals. Historically, after the Food, Drug, and Cosmetic Act of 1938, the world of topical skin care products was divided into two groups: cosmetics and drugs. Drugs were for the treatment or prevention of diseases, and it was required that safety and efficacy be established before sales and marketing could proceed. In contrast, cosmetics were viewed as agents to enhance the beauty of the skin or improve the appearance of the skin, and safety and efficacy were not required to be demonstrated before sales and marketing of these products (1).
Another organization, the Cosmetic, Toiletry, and Fragrance Association (CFTA), in the United States was formed in 1894 and today serves as a valuable liaison among suppliers, manufacturers, and distributors of cosmetic products for the personal care industry. No formal organization exists at this time specifically for the cosmeceutical realm.
At a fundamental level cosmetics are products which affect the appearance of the skin, while drugs affect the structure and function of the skin. Thus the term “cosmeceutical” is intended to describe skin care products that fall in between these categories. Increasingly though products which are considered cosmeceuticals actually do affect the structure or function of the skin and thus have drug-like effects but are marketed using appearance-based claims. This has given rise to much confusion and ironically may provide some disincentive for manufacturers to conduct or publicize clinical testing since the data generated may support the drug-like effects. For example, a drug may be marketed as a product that “reduces wrinkles by stimulating collagen production,” but a cosmetic which could potentially have essentially the same mechanism of action and clinical effects would be marketed as a product that “reduces the appearance of wrinkles.” While some
cosmeceuticals are “drugs in disguise” as cosmetics, if marketing claims push the edge of the claims envelope too hard, then the Food and Drug Administration (FDA) may intervene with various warnings or actions; thus, the issue of “when” does a cosmeceutical become a drug is likely to become more significant in the future (2,3).
If one looks at sunscreens and antiperspirants, these are regulated as over-the – counter (OTC) drugs in the United States but not in Europe. One need only look at the delays in availability in the United States of some of the new and highly effective sunscreens to appreciate some of the archaic aspects of the 1938 legislation. Thus the term “cosmeceutical” encompasses a broad range of the ill-defined territory which lies between cosmetics and drugs. It is a very useful concept scientifically and has been accordingly embraced on a broad global scale. The years ahead will see a struggle to define and refine this cosmeceutical concept. Some exemplary efforts towards this have been made in Japan, but a global uniform concept is yet to emerge (4).