Cosmetology, cosmetics, cosmeceuticals: definitions and regulations.

The growth of the cosmetic industry, together with the dramatic increase in advances in cosmetic chemistry, has been one of increasing interface with dermatologists. The change especially in dermatology has found less emphasis on medical dermatology and growth in the areas of cosmetic dermatology and dermatologic surgery. With this, the dermatologist has had to become more aware of principles and products in the field of cosmetics. The use of these newer products as an adjunct to the practice of dermatology coincides nicely with recent international congresses, whose theme has been “healthy skin for all” and variations on such. Perhaps the major body for the oversight of this growth remains the U.S. Food and Drug Administration (FDA), which for many parts of the world provides the assurance of safety and quality for various foods, drugs, and cosmetics. The mandate for much current regulation and oversight began in 1938 with the Food, Drug, and Cosmetic Act, which placed active oversight on various drugs and cosmetics and was further modified in 1960 by the Delaney Amendment, which focused on the growing awareness of carcinogenic potential of various agents, topical and systemic.1 Since the radium scare of the 1920s and 1930s, the increasing use of synthetic materials has focused on delayed long-term potential cancer risks and health hazards. More recently, such agents as Dioxin, Agent Orange, and certain other fungicides and pesticides have seemingly justified this new role of the FDA. Of particular confusion at the present time are certain dyes—FD&C Red #3, FD&C Yellow #5, hair dyes—and other agents that are essential in the cosmetic and “cosmeceutical” practice. The variability of interpretation of safety still confounds easy interpretation of the administration’s role in the approval of new uses, particularly in the cosmeceutical area. At the present time, FD&C Red #3 has been banned for provisional usages, and there has been expanded oversight on tartrazine, or FD&C Yellow #5. Simply put, according to the FDA, drugs are defined as “products that cure, treat, mitigate or prevent disease, or that effect the structure or function of the human body.” The identification of a particular agent as fitting these categories changes the process in the United States of FDA oversight. The cosmetic industry is continually on the edge of this area, making subtle claims of certain additives (Retinol, for example) that purport to effect the structure of the human body. In the case of Retinol, which has been shown to penetrate the epidermis,2 this interpretation is that regular usage will provide antioxidant properties for the skin, retarding the aging process. Such claims should initiate a careful review by the FDA. Even when such claims (often verbal or made in newspapers, rather than distributed through scientific channels) are made, that they rarely change the FDA requirements on such products. This usually has not been the case because the volume of new products exceeds the FDA’s ability to review and/or regulate. The FDA does not accept or define the term “cosmeceutical”, whereas nearly universally around the world this has become the new phrase (catch-word) for the millennium change in cosmetics to retard aging. Kligman offers this guidance in a dermatologist’s evaluation of new cosmeceuticals: