title: Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.
abstract: In the United States, the Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food are safe for all consumers. In order to determine the safety of these additives for consumption, appropriate information and results from a series of tests must be made available to the agency. In 1982, in an effort to provide guidance to the food industry concerning the appropriate tests for the determination of safety, the FDA issued the Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Foods, commonly referred to as the Redbook. In 1993, based on the expansion of technology and the use of food additives, as well as the refinement of the scientific criteria for establishing safety, the FDA updated its guidelines and issued the draft Redbook II. Since Redbook II was issued, additional refinements have been made in the procedures for the multigeneration reproduction study and for the assessment of effects on male reproduction. The latest proposed guidelines for multigeneration studies are provided here.
authors.affiliation: Center for Food Safety and Applied Nutrition, Food and Drug Administration, Laurel, MD 20708, USA.
authors.forename: T F
authors.initials: TF
authors.lastname: Collins
authors.forename: R L
authors.initials: RL
authors.lastname: Sprando
authors.forename: M E
authors.initials: ME
authors.lastname: Shackelford
authors.forename: D K
authors.initials: DK
authors.lastname: Hansen
authors.forename: J J
authors.initials: JJ
authors.lastname: Welsh
mesh_terms: D000818:Animals; D017408:Guidelines as Topic; D006801:Humans; D012098:Reproduction / Q000187:drug effects*; D018675:Toxicity Tests / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration