Will Moisturizers become Drugs?

Abstract

Whether moisturizers will become drugs is founded in the legal debate over the U.S. Food and Drug Administration's (FDA) definitions of cosmetics and drugs. Clarification of such legal definitions is usually found in the statements and actions of such a regulatory body. However, in the case of cosmetic moisturizers, the record is both uneven and intermittent, with no consistent position since the 1938 revision of the Food, Drug and Cosmetic Act. In fact, the administrative record of the revision of the Act clearly reveals that an ingested cosmetic example is cited: the use of arsenic for clearing the complexion. The subsequent history of implementing the 1938 definition of cosmetic products shows no basic regulatory action between 1938 and 1969. In 1969, the FDA went to court over three wrinkle-removing product claims, winning two of the three law suits. A quiet period ensued until 1987 when letters were sent by the FDA to 21 cosmetics manufacturers of skin care products. While copy and, therefore, claims have been changed by the companies receiving these letters, the actual skin care products themselves have remained virtually unchanged. Predicting what the FDA will do next is difficult; however, it is likely that the FDA will become tougher on enforcement issues yet make no broad policy statements. Consumer product manufacturers therefore need to respond by regaining the respect of the Agency by putting their own house in order. The FDA should concentrate on its legally grounded mission of overseeing the safety of cosmetic products like moisturizers. The FDA should ensure that whatever physiological effects moisturizer products claim to have on the skin, these are adequately and properly substantiated.