Food and Drug Administration proposed testing guidelines for developmentaltoxicity studies

The Food and Drug Administration (FDA) is the agency responsible for ensuri ng that the direct food additives and color additives used in food in the U nited States are safe for all consumers. In 1982, in an effort to provide g uidance concerning appropriate tests, the FDA issued Toxicological Principl es for the Safety Assessment of Direct Food Additives and Color Additives U sed in Food, commonly known as the Redbook. The Redbook included detailed g uidelines for testing the effects of direct and indirect food and color add itives on mothers and their developing fetuses. Based on refinements in saf ety assessment and risk evaluation as well as expansion of knowledge concer ning the metabolism and pharmacokinetics of food and color additives, the n eed to revise and update the 1982 document became apparent. In 1993, Redboo k II in draft form was made available for public comment. Since then, test end points and developmental landmarks have been refined. The latest propos ed guidelines for developmental toxicity studies are provided here.