Food, Drug, and Cosmetic Act

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that every cosmetic product and its individual ingredients be substantiated for safety 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 stating that its safety has not been substantiated.

The law provides severe penalties for products that do not meet these standards. Specifically, the law gives FDA the authority:

  • Ban or restrict cosmetic ingredients for safety reasons
  • Mandate warning labels
  • Inspect manufacturing facilities
  • Issue warning letters
  • Seize unsafe or misbranded products
  • Enjoin unlawful activities
  • Prosecute and jail violators
  • Work with cosmetic manufacturers in implementing nationwide product recalls
  • Collect samples for examination and analysis as part of cosmetic plant inspections, import inspections, and follow-up to complaints of adverse reactions
  • 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 cosmetic and personal care products industry in addition to decades of safe use by consumers who trust and enjoy them every day.