title: Making regulatory decisions across the food ingredient spectrum.
abstract: 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.
authors: Office of Premarket Approval, Food and Drug Administration, Washington, DC 20204, USA.
authors: A M
authors: AM
authors: Rulis
mesh_terms: D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D005503:Food Additives / Q000009:adverse effects / Q000592:standards; D005504:Food Analysis / Q000592:standards*; D005506:Food Contamination; D005519:Food Preservation / Q000191:economics / Q000592:standards; D006801:Humans; D007408:Intestinal Absorption; D007881:Legislation, Food; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005503:Food Additives