Frequently Asked Questions

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, 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" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. 

With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA. The Federal Food, Drug, and Cosmetic Act requires that color additives used in cosmetics must be tested for safety and be listed by FDA for their intended uses.

Regulations restrict or prohibit the use of the following ingredients in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene. 

The term "cosmeceutical" has no meaning under the law. While the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not recognize the term "cosmeceutical," the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits.

A product can be a drug, a cosmetic or both. The FD&C Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body, if a product makes such claims it will be regulated as a drug. Cosmetics are intended to beautify, promote attractiveness, alter appearance or cleanse; they are not approved by FDA for sale nor are they intended to effect structure or function of the body.