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Explanation of Requirements Under the FDA

The Federal Food, Drug and Cosmetic Act does not require manufacturers of cosmetics, personal care and other household products to test their products and ingredients on animals for safety. In fact, the Food and Drug Administration (FDA), which administers the Act, actually encourages the use of testing techniques that do not use whole living animals. However, the FDA does require that manufacturers of cosmetics substantiate the safety of their products and historically this meant that manufacturers have used animal tests, such as the Draize and LD-50 tests, to provide this substantiation. Today, many manufactures choose to use non-animal methods to test cosmetic and personal care products and the FDA readily accepts the results of those validated alternative tests.

However, cosmetics and personal care products that are also intended to treat or prevent disease, and chemical compounds that change the structure and func­tion of the human body, are considered “drugs” by the FDA. Some examples of these types of products are suntan preparations intended to protect against sunburn, anti-dandruff shampoos and topical acne medications. These products must comply with the drug testing requirements of the FDA, and animals are usually used as test models.

Some progress has been made at the federal level with regard to fostering the development of alternatives to animal testing. In 1997, the FDA joined with 13 other federal agencies to form 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 through the U.S. federal government. Dozens of methods have been officially validated. Once an alternative method has been validated, federal agencies are supposed to use that method instead of animals in testing done through its own agency.