FDA's legal authority over cosmetics is different from other products we regulate, such as drugs, biologics, and medical devices. FDA does not have the legal authority to approve cosmetics before they go on the market, although we do approve color additives used in them (except coal tar hair dyes). However, under the law, cosmetics must not be "adulterated" or "misbranded." For example, they must be safe for consumers when used as directed in their labeling or under customary conditions of use, and they must be properly labeled. Companies and individuals who market cosmetics have a legal responsibility for the safety and labeling of their products.

 

FDA can take action against a cosmetic on the market if we have reliable information showing that it is adulterated or misbranded. FDA takes action within our legal authority, based on public health priorities and available resources.

 

To learn more, see