Cosmetics

Cosmetics Safety Q&A: Prohibited Ingredients

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What ingredients are prohibited from use in cosmetics?

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.

In the early 1970s, FDA received a number of complaints of personal injury associated with the use of fingernail extenders containing methyl methacrylate monomer. On the basis of its investigations of the injuries and discussions with medical experts in the field of dermatology, FDA concluded that liquid methyl methacrylate was a poisonous and deleterious substance that should not be used in fingernail preparations. The agency chose to remove products containing 100 percent liquid methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls.

In addition to the ingredients that are controlled by regulation or were the subject of a court ruling, cosmetic and fragrance trade associations have recommended eliminating or limiting the use of certain ingredients associated with health risks.

It is against the law to market a cosmetic that is harmful to consumers when they use it according to labeled directions, or in the customary or expected way, even if it does not contain an ingredient that is specifically prohibited or restricted by a regulation.

To learn more, see Ingredients Prohibited and Restricted by FDA Regulations.

More Resources:

FDA Basics Cosmetics Page

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Page Last Updated: 03/23/2014
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