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U.S. Department of Health and Human Services

For Industry

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Does FDA approve cosmetics before they go on the market?

Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives (other than those intended for use as coal-tar hair dyes). In addition, there are some cosmetic ingredients that are prohibited and restricted by regulation. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products and ingredients.

FDA's authority over cosmetics is post-market. FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Violative cosmetics may be subject to seizure. FDA also may initiate criminal action against a person violating the law. For more information, see "FDA Authority Over Cosmetics."

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