Congress responded in 1938 by passing The Federal Food, Drug and Cosmetic Act which required for the first time that all drugs be tested for safety before they are marketed. Today the Food and Drug Administration is only one of several federal agencies that regulate the safety of various consumer products and chemicals. Not all product testing involves animals. The federal regulations for the approval of new drugs or pesticides require animal test data, while cosmetic safety laws simply require that product safety be demonstrated. However, even where some animal data are required, animals are used sparingly, and every effort is made to keep the numbers to a minimum.
Scientists first review existing data on the chemicals in the product.
If their safety has already been established through prior animal testing and safe human use, no further animal tests may be needed. If the ingredients are very similar to ones already in use, non-animal tests using cell or tissue cultures may be all that is needed before proceeding directly to clinical studies with human volunteers. Database research and computer analysis of the chemical structure or physical and chemical properties of the new ingredient may be used to predict likely effects. Animal tests are used when neither the existing safety information nor non-animal tests can provide enough information about how the compound could affect human or animal health or the environment.