FDA on Animal Testing of Cosmetics

The Food and Drug Administration (FDA) is responsible for assuring that cosmetics are safe and properly labeled. This mission is accomplished through enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), related statutes, and regulations promulgated under these laws. 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 a product or ingredient. FDA supports and adheres to the provisions of applicable laws, regulations, and policies governing animal testing, including the Animal Welfare Act and the Public Health Service Policy of Humane Care and Use of Laboratory Animals. Moreover, in all cases where animal testing is used, FDA advocates that research and testing derive the maximum amount of useful scientific information from the minimum number of animals and employ the most humane methods available within the limits of scientific capability. We also believe that prior to use of animals, consideration should be given to the use of scientifically valid alternative methods to whole-animal testing. In 1997, FDA joined with thirteen other Federal agencies in forming the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM and its supporting center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), coordinate the development, validation, acceptance, and harmonization of alternative toxicological test methods throughout the U.S. Federal Government. The ICCVAM/NICEATM mission statement indicates that these organizations "focus efforts on alternatives that may improve toxicity characterization, increase savings in time and cost, and even refine, reduce, or replace animal use." Additional information about the ICCVAM and NICEATM programs and conclusions can be found on their web site. 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. We will continue to be 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.