消费者保护与全民健康汇编.ppt

Safety Assessment of Food Additives Anna P. Shanklin, Ph.D. Department of Health and Human Services U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition OVERVIEW Introduction Food Drug Law Evaluation of Safety Natural Rubber Latex (NRL) Latex Allergy and Food Safety Conclusion CFSAN’s Mission To promote and protect the public health by ensuring that: The food supply is safe and wholesome and cosmetics are safe Food and cosmetic products are honestly and accurately labeled OFAS’s “Food Ingredients” Universe Direct Food Ingredients Color Additives GRAS Ingredients Foods/Ingredients produced using modern biotechnology Processing Aids Food Irradiation Equipment Food Packaging/Food Contact Substances Food and Drug Law Federal, Food, Drug, and Cosmetic Act FFDCA FDA Authority FFDCA OFAS FFDCA Food Additive Provisions Sec. 409 Regulations LAW “PRE-MARKET” APPROVAL 1958 Food Additives Amendment of FFDCA Sec. 409 Any substance, that is reasonably expected to become a component of food as a result of its intended use, If such use in not Generally Recognized As Safe (GRAS) Food and Drug Law Sec. 409 Unsafe Food Additives: the use of a food additive is unsafe, unless that use conforms to a regulation, notification, or exemption issued by FDA under Sec. 409. Sec. 402 Adulterated Food: a food is adulterated…if it is, or if it contains any food additive that is unsafe. Sec. 301 Prohibited Acts: the introduction or delivery into interstate commerce of any food that is adulterated or misbranded. Standard of Review “Fair evaluation of the data …” From the Senate Report on the“Food Additives Amendment of 1958” “The committee has endeavored to prescribe a new statutory criterion requiring that a high standard of fairness be observed in administrative rule-making under this bill. Personal attitudes or preferences of administrative officials could not prevail on the basis of being supported by substantial evidence picked fro