Unlike drugs and medical devices, neither cosmetic products nor cosmetic
ingredients are reviewed or approved by the FDA before they are sold to the public. The agency only acts
against cosmetic products found to cause harm after they are on the market.
Cosmetics or Drugs?
Much confusion exists about the status of cosmetic products having medicinal or drug-like benefits, says Linda
Katz, M.D., M.P.H., director of the FDA's Office of Cosmetics and Colors. Although the FDA does not consider the
term "cosmeceutical" to be a valid product class, Katz says it is used throughout the cosmetic industry to describe
products that are marketed as cosmetics but that have drug-like effects. Tretinoin (retinoic acid), the
biologically active form of vitamin A, for example, is not prohibited from use in cosmetics. However, when it is
used topically for treating mild to moderate acne, sun-damaged skin, and other skin conditions, it is recognized by
the FDA as a drug. This is because it acts deep at the skin's cellular level by increasing