What is FDA's authority over cosmetics?

It is important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including FDA, to create and enforce regulations, but only as authorized under the law. A change in FDA's statutory authority over cosmetics would require Congress to change the law.

FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, 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 additional information, see Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded" February 9, 2006

Source: Excerpted from Office of Cosmetics and Colors Fact Sheet, March 3, 2005: FDA Authority over Cosmetics