FDA Requirements for Animal Testing

The FD&C Act does not specifically require the use of animals in testing cosmetics for safety, nor does the Act subject cosmetics to FDA premarket approval. However, the agency has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products.

It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to marketing.

Animal testing by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient.

FDA supports the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available within the limits of scientific capability when animals are used for testing the safety of cosmetic products. The FDA is a strong advocate of methodologies for the refinement, reduction, and replacement of animal tests with alternative methodologies that do not employ the use of animals.