Safety and Regulatory Information
February 24, 2000
Various products have been promoted in the skin care market as thigh and stomach slimmers. Some advertising claims also promise the reduction of "cellulite", waffly looking or orange-peel type skin caused by fatty deposits.
Aminophylline, an approved prescription drug used in the treatment of asthma, is an ingredient used in many of these thigh cream products that marketers claim will dissolve the fat and smooth the skin. Since some individuals suffer from allergic reactions to ethylenediamine, a component of aminophylline, the FDA is concerned about the use of this ingredient in cosmetics.
Consumers need to be aware of this potential for developing an allergic reaction and carefully read product labels and follow directions. Persons who suffer from asthma may wish to avoid these products so that they don't develop a sensitization (become allergic) to aminophylline.
Drugs, unlike cosmetics, alter the structure or function of the body and are subject to an intensive review and approval process by FDA before their release to the public. Thigh creams may more appropriately be classified as drugs under the Food, Drug, and Cosmetic Act since removal or reduction of cellulite affects the "structure or function" of the body.