The federal Food, Drug, and Cosmetic Act (FD&C Act) requires that every cosmetic product and its individual ingredients be substantiated for safety before going to market and that 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 a product, the law requires the product to carry a conspicuous warning.
The law provides severe penalties for products that do not meet these standards. Specifically, the law gives FDA the authority:
To mandate warning labels
To inspect manufacturing facilities
To issue warning letters
To seize unsafe or misbranded 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 Food, Drug, and Cosmetics Act, the Fair Packaging and Labeling Act authorizes FDA to require ingredient labeling of cosmetic and personal care products sold to consumers. Detailed FDA regulations govern where and how ingredients must be listed on the package.
Cosmetics are among the safest of all consumer products sold in the U.S. Their continued safety is ensured by FDA's regulatory program and additional safety measures undertaken by the personal care products industry.
