FDA does not have the legal authority to approve cosmetics before they go on the market, except color additives which FDA regulates.

Under the law, cosmetics must not be "adulterated" or "misbranded" and safe for consumers when used according to directions on the label. 

Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.

FDA has stated that "the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information." (Federal Register, March 3, 1975, page 8916).

FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA. 

FDA may take regulatory action if we have reliable information indicating that a cosmetic is adulterated or misbranded. For example, FDA can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market.

Cosmetics that are not in compliance with the law may be subject to seizure. “Seizure” means that the government takes possession of property from someone who has violated the law, or is suspected of doing so. FDA also may initiate criminal action against a person violating the law.

Cosmetic firms are encourage to participate in FDA's Voluntary Cosmetic Registration Program (VCRP) using the online registration system. Cosmetic manufacturers, distributors, and packers can file information on their products that are currently being marketed to consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP database.

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