In the United States, cosmetics are regulated under the Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Accordingly, cosmetic ingredients, with the exception of color additives, are not subject to premarket approval. However, they must not be adulterated or misbranded. This article describes the statutes and regulations relevant to cosmetic regulation by the Food and Drug Administration (FDA). It also describes relevant domestic programs of the FDA (Voluntary Cosmetic Registration Program, Good Manufacturing Practice guidance, Adverse Event Reporting System, Recalls) and international efforts regarding cosmetics regulation.
Keywords: Adulteration; Cosmetics; Food and Drug Administration; Misbranding; Personal care products; Regulatory; Safety; Toxicity.
Published by Elsevier Inc.