ABSTRACT
The term “cosmetic” is familiar, and its meaning has been expanded by an increase in the variety and complexity of substances used for cosmetic purposes. There are numerous ways to defi ne and describe cosmetics. The Food, Drug, and Cosmetic Act, which the Food and Drug Administration (FDA) administers, defi nes cosmetics in the following manner (Code of Federal Regulations, 1986):
Defi nitions pertaining to Europe and Japan are found in Barel,3 Elsner,4,5 and Baran.6 Note two important aspects of this legal defi nition of cosmetics. First, in the United States, cosmetics in theory do not contain “active drug” entities of any type nor can they be promoted as altering any physiological state either in disease or health. Many countries do not recognize this legal distinction. The U.S. FDA classifi es products into cosmetics, over-the-counter (OTC) drugs, and prescription drugs. By the U.S. defi nition, antiperspirants are OTC drugs regulated by the FDA through the OTC drug monograph system, while deodorants are cosmetics. The second aspect of the U.S. defi nition of cosmetics is the so-called soap exemption. Soap in the classic sense, as made of natural ingredients, is the type of soap that is exempted from the foregoing defi nition. However, if the soap product is made of detergent chemicals (synthetic surfactants), the product is regulated by the consumer product safety commission under the Federal Hazardous Substances Act (1960), as a household product. If the soap contains a therapeutic ingredient for a medical condition it is regulated as a prescription drug.2 Likewise the classifi cation of cosmetics is equally complex. The cosmetic industry itself divides the products into more general categories oriented as to their purpose as described in the defi nition.
