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FDA’S food ingredient approval process:Safety assurance based on scientific assessment

Authors
Journal
Regulatory Toxicology and Pharmacology
0273-2300
Publisher
Elsevier
Publication Date
Volume
53
Issue
1
Identifiers
DOI: 10.1016/j.yrtph.2008.10.003
Keywords
  • Food
  • Food Ingredient
  • Food Additive
  • Food Safety
  • Toxicology
  • Safety Assessment
  • Acceptable Daily Intake
  • Gras

Abstract

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.

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