title: FDA'S food ingredient approval process: Safety assurance based on scientific assessment.
abstract: Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers.
authors.affiliation: Exponent, Inc., Center for Chemical Regulation and Food Safety, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036, USA. arulis@exponent.com
authors.forename: Alan M
authors.initials: AM
authors.lastname: Rulis
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Levitt
mesh_terms: D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D003657:Decision Making; D005503:Food Additives / Q000633:toxicity*; D005504:Food Analysis / Q000379:methods; D005523:Food Supply / Q000331:legislation & jurisprudence / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D005503:Food Additives