Skin Care Products – Cosmetics Versus Drugs

A skin care product's safety and efficacy depends in part on what type of product it is, a cosmetic or a drug.

Cosmetics do not need U.S. Food and Drug Administration (FDA) approval for efficacy before they are sold to the public. They must conform to certain regulations -- for example, color additives must be FDA-approved and certain substances deemed harmful must not be used -- but the FDA does not perform or review product safety testing on cosmetics. Cosmetics companies are required to do this on their own. The FDA also does not test how well a product works, nor does it require companies to test the efficacy of their own products.

Because of this, it's possible that claims made by cosmetics companies regarding how safe or effective a product is may be be unsubstantiated or untrue.

Drugs, on the other hand, must undergo rigorous scientific testing and demonstrate safety and effectiveness for the intended purpose before they are FDA approved and granted permission to be marketed.

• FDA definition of "cosmetic": cleansers, moisturizers, toners, and any other product applied to the body in order to clean, beautify, or enhance or alter appearance
• FDA definition of "drug": any substance that alters the structure or function of some process in the body, with the purpose of diagnosing, treating, or preventing disease
• Definition of "cosmeceutical": The FDA does not officially recognize this term. The cosmetics industry uses this as a marketing term to indicate any product that acts both as a drug and as a cosmetic. However, FDA approval is required for any cosmetic product that has drug properties, such as shampoo with dandruff medication or skin creams with medicine in prescription-level concentrations.