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.
FDA’S food ingredient approval process Rulis, Alan M.; Levitt, Joseph A.
Regulatory toxicology and pharmacology,
02/2009, Letnik:
53, Številka:
1
Journal Article
Recenzirano
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.
Today, safety evaluation of food ingredients must be performed for a wide spectrum of substances and over a wide range of potential human exposures. Some of the traditional approaches to ...toxicological safety evaluation are not appropriate for certain of the more extreme examples across this spectrum. Yet the public and the regulated industry continue, rightfully, to expect that the system will function efficiently and effectively in their behalf. FDA must expand the range of its available tools to address the unique questions presented by nontraditional food chemicals, while maintaining the scientific credibility and integrity of the regulatory decision process that has protected public health for many decades. The safety standard that these materials must meet has not changed. Yet the types of questions pertinent to safety decisions may indeed be different than those traditionally used.
Toxicity data for a subset of food additives are combined (by means of a "Monte Carlo" computer analysis) with exposure information to indicate the characteristics of an overall profile of "safety ...assurance margins" for additives currently in use in the United States. It is demonstrated that safety concerns for (noncarcinogenic) toxic effects for these substances can seldom be expected a priori if they disappear into the U.S. food supply at levels of less than about 100,000 pounds annually.
