The Food and Drug Administration (FDA) has broad legal authority to regulate the safety of cosmetic products. The federal Food, Drug, and Cosmetics Act (FD&C Act) requires that every cosmetic product and its individual ingredients be substantiated to be safe, and that cosmetic product labeling be truthful and not misleading.
Cosmetic manufacturers are responsible for ensuring that products comply with the law before they are marketed. This process includes analyzing a cosmetic ingredient´s testing and safety data. If the manufacturer is unable to substantiate the safety of the cosmetic product, the law requires the product to carry a conspicuous warning.
The law provides severe penalties for personal care products that do not meet FDA standards. Specifically, the law gives FDA the authority
To mandate cosmetic warning labels
To inspect cosmetic manufacturing facilities
To issue warning letters
To seize unsafe or misbranded cosmetic products
To enjoin unlawful activities
To prosecute and jail violators
To work with cosmetic manufacturers in implementing nationwide product recalls
To collect samples for examination and analysis as part of cosmetic plant inspections, import inspections, and follow-up to complaints of adverse reactions.
To conduct research on cosmetic and personal care products and ingredients to address safety concerns.
In addition to the Federal Food, Drug, and Cosmetics Act safety authority, the Fair Packaging and Labeling Act authorizes FDA to require ingredient labeling of cosmetic products sold to consumers. Detailed FDA regulations govern where and how cosmetic ingredients must be listed on the package.
Cosmetics are among the safest of all consumer products sold in the United States. Their continued safety is ensured by FDA´s authority to regulate and ongoing personal care product industry voluntary programs. A long history of use demonstrates the exemplary safety record of cosmetics in the United States.
