Food, Drug, and Cosmetic Act

The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 requires that every cosmetics product and its individual ingredients be substantiated for safety and that product labeling be truthful and not misleading. Cosmetics 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 the FDA authority to:

  • Ban or restrict cosmetics ingredients for safety reasons
  • Mandate warning labels
  • Inspect manufacturing facilities and records
  • Issue warning letters
  • Seize unsafe or misbranded products
  • Prohibit unlawful activities
  • Prosecute and jail violators
  • Mandate product recalls
  • Collect samples for examination and analysis as part of cosmetics plant inspections, import inspections and follow up to complaints of adverse reactions
  • Conduct research on cosmetics and personal care products and ingredients to address safety concerns

In addition to the FD&C Act and MoCRA, the Fair Packaging and Labeling Act authorizes the FDA to require ingredient labeling of cosmetics and personal care products sold to consumers. Detailed FDA regulations govern where and how ingredients must be listed on the package.

Cosmetics’ continued safety is ensured by the FDA’s regulatory program, as well as additional safety measures undertaken by the cosmetics and personal care products industry and the decades of safe use by consumers who trust and enjoy them every day.