我国保健食品监管的历史与发展

自从1995年颁布实施的《中华人民共和国食品卫生法》将保健食品纳入法制化管理以来,我国对保健食品的监管机制与监管部门发生了许多变化,监管机制从单一的审批/注册制发展到注册与备案双轨制,监管部门从原卫生部/国家食品药品监督管理局负责保健食品审批/注册,质量监督管理部门和工商行政管理部门负责保健食品生产和市场监管的分段管理模式过渡到由国家市场监督管理总局负责保健食品注册和进口保健食品备案,省级市场监督管理部门负责国产保健食品备案,各级市场监督管理部门共同负责保健食品生产和市场监管的“一体化”管理模式。本文对此变化过程进行简要介绍与述评,以期能为感兴趣的读者了解我国保健食品监管的发展变化以及目前的状况提供参考。

History and development of health food supervision in China

Since the “Food Hygiene Law of the People’s Republic of China” promulgated and implemented in 1995 brought health food into legal management, many changes have taken place in supervision mechanism and department for health food. The supervision mechanism has developed from a single approval/registration system to a dual-track system of registration and filing. The supervision department has transitioned from a segmented management model in which the Ministry of Health/State Food and Drug Administration was responsible for the approval/registration of health food, and the quality supervision department and the administration for industry and commerce department were responsible for the production and market supervision of health food, to the “integrated” management model where the State Administration for Market Regulation is responsible for the registration of health food and the filing of imported health food, the provincial market supervision and management departments are responsible for the filing of domestic health food, and market supervision and management departments at all levels are jointly responsible for health food production and market supervision. This article briefly introduces and reviews this change process, to provide a reference for interested readers to understand the development and current status of health food supervision in China.