Cosmetic or a Drug

The FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”[4]

Cosmetics include “skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, cleansing shampoos, permanent waves hair colors, and deodorants,” or any of their component parts.[5]  Cosmetics marketed in the US, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the FD&C Act.

By contrast, drugs are defined as products that are “intended for use in diagnosis, cure, mitigation, treatment or prevention of a disease.”  FD&C Act, sec. 201(g)(1). Some products are both a cosmetic and a drug. An example of this is an SPF moisturizer, which acts as both a cosmetic in its moisturizing function and a drug in its ultraviolet protection. Products that are both cosmetics and drugs are often referred to as“cosmeceuticals,” and must comply with both the drug and cosmetic provisions of the law.[6]

The focus in defining both cosmetics and drugs is on their intended use.  Intended use can be established through marketing, consumer perception, or the ingredients used.[7] In regulating the cosmetics industry, the FDA has spent a considerable amount of energy focusing on the product labeling, advertising, internet, or other marketing activities that may operate to establish the product as a drug based upon its intended use. When companies market anti-aging products as having a physiological impact on the body or one’s appearance, the cosmetic becomes a drug.

…/…