The cosmetics industry is a $45-billion-a-year business with thousands of products embodied in 33 Food and Drug Administration (FDA) classifications (13,18). Cosmetics are defined by the Food, Drug and Cosmetic Act as "articles intended to be applied to the human body for cleaning, beautifying, promoting attractiveness or altering the appearance without affecting the bodys structural function" .The key words in this definition are "intended" and "bodys structural function." Intended use of the cosmetic must be clearly labeled and if the safety of a cosmetic product is not adequately substantiated for that intended use, the product is considered misbranded and may be subject to regulatory action. The physiological, or functional, altering of the body differentiates drugs from cosmetics. The FDA regulates this difference by not requiring premarket approval of cosmetics. At the same time, however, the FDA does expect that the manufacturer of a cosmetic has conducted toxicological and other appropriate tests to substantiate the safety of the product and can provide this data if challenged by the agency. While it has become fashionable for some manufacturers to apply the "cruelty-free" label to their products (indicating that animals were not used during safety testing), this claim can be misleading.
In vitro tests and other nonanimal methods for safety evaluation have come a long way and are being used in industry as initial screening procedures. However, given a new cosmetic derivative or a cosmetic incorporating a drug component, a standardized in vivo test, such as the Draize Ocular Irritation Test, may be in order. This in vivo test is still considered valuable in predicting human eye irritants when the irritation is subtle or when the chronic recovery phase data may be equally as important as the initial acute exposure data. Industry, in cooperation with regulatory agencies, has established multiple refinements to obtain the required data while minimizing the potential for pain or distress. Evaluation of the agents pH and the use of the primary dermal irritation tests are routinely used to screen out agents likely to evoke a response beyond moderate irritation (17). Agents having passed the preliminary screening could conceivably go on to the classic test but with the following refinements in place: use of three animals vs. the standard of six; use of smaller volumes of solution installed in the eye; use of one animal to evaluate an unknown and await a response before continuing or discontinuing with the remaining test animals; and use, when applicable, of anesthetics in the eye (10). In part, because of refinements to the Draize Ocular Irritation Test and use of available in vitro methods, the number of rabbits used in the cosmetic industry between 1980 and 1989 was reduced by 87 percent.