Regulating Cosmetics
by Dori Stehlin
updated on 05/22/2006 at 05:22PM
The Federal Food, Drug, and Cosmetic Act defines cosmetics as "articles other than soap which are applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."
FDA has classified cosmetics into 13 categories:
- skin care (creams, lotions, powders, and sprays)
- fragrances
- eye makeup
- manicure products
- makeup other than eye (e.g., lipstick, foundation and blush)
- hair coloring preparations
- shampoos, permanent waves, and other hair products
- deodorants
- shaving products
- baby products (e.g., shampoos, lotions and powders)
- bath oils and bubble baths
- mouthwashes
- tanning products
It is against the law to distribute cosmetics that contain poisonous or harmful substances that might injure users under normal conditions. Manufacturing or holding cosmetics under insanitary conditions, using non-permitted colors, or including any filthy, putrid or decomposed substance is also illegal.
Except for color additives and a few prohibited ingredients, a cosmetic manufacturer may use any ingredient or raw material and market the final product without government approval. The prohibited ingredients are:
- biothionol
- hexachlorophene
- mercury compounds (except under certain conditions as preservatives in eye cosmetics)
- vinyl chloride and zirconium salts in aerosol products
- halogenated salicylanilides
- chloroform
- methylene chloride
Manufacturers must test color additives for safety and gain FDA approval for their intended use.
Cosmetic firms may voluntarily register their manufacturing plants with FDA, file cosmetic formulas, and report adverse reactions.
Cosmetics sold to consumers must bear labels that list ingredients in descending order of predominance. Trade secrets (as defined by FDA) and the ingredients of flavors and fragrances do not have to be specifically listed.
Dori Stehlin is a staff writer for FDA Consumer.
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
Publication No. (FDA) 95-5012 - November 1991; revised May 1995
