我国特殊医学用途配方食品的发展及其监管

Development and supervision of food for special medical purpose(FSMP)in China

我国将特殊医学用途配方食品(特医食品)定义为“为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要,专门加工配制而成的配方食品”。我国特医食品的发展起步较晚,自2015年修订的《中华人民共和国食品安全法》将特医食品正式纳入法制管理的轨道以来,特医食品的监管逐渐完善,获准注册的产品也逐渐增加。本文对我国特医食品相关法规标准与监管要求,以及获准注册产品的基本情况进行简要介绍,并提出若干建议,为相关人员和感兴趣的读者提供参考。

In China,food for special medical purpose(FSMP)is defined as“formula food specially processed and prepared in order to meet the special nutrient or diet needs for people with food restriction,digestion and absorption disorder,metabolic disorder or specific disease state”.The development of FSMP in China started relatively late.Since the revised“Food Safety Law of the People’s Republic of China”in 2015 officially brought FSMP into the track of legal management,the supervision of FSMP has gradually improved,and the number of products approved for registration has gradually increased.This article briefly introduces the relevant regulations,standards and regulatory requirements of FSMP in China,as well as the basic situation of the products approved for registration,and puts forward some suggestions for the reference of relevant personnel and interested readers.