FDA Consumer

Clarifications – Botox Cosmetic

Clarifications – Botox Cosmetic – Brief Article

Despite its name, Botox Cosmetic is a drug and not a cosmetic (see “Botox Cosmetic: A Look at Looking Good,” July-August 2002 FDA Consumer). The Federal Food, Drug, and Cosmetic Act defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, and articles (other than food) intended to affect the structure or any function of the body. Drugs, including those used for cosmetic purposes, are subject to a strict FDA approval process to assess their safety and efficacy. Cosmetics (articles intended to be rubbed, poured, sprinkled, or applied to the body such as shampoos, makeup and moisturizers) do not undergo the same rigorous review. Increasingly, the word “cosmetic” is being used as a medical term to describe a number of surgical and non-surgical treatments that are intended to enhance appearance and are performed only by a licensed healthcare professional. Botox Cosmetic is one such treatment.

COPYRIGHT 2002 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group