日前,《食品安全法》的修订已经过全国人大二审,但在如何对保健食品实施有效监管以及采取何种模式监管的问题还有较大争议。焦点问题之一便是市场准入的模式,即保健品的审批是实行注册审批制还是备案制,抑或两者并行的双轨制。一直以来,我国对保健食品、保健食品说明书以及保健食品的生产实行注册审批制度,对市售的保健食品实行标志管理,即大家熟悉的“蓝帽子”。这一方面极大地规范了保健品市场,将大量不合规的产品挡在门外,但另一方面也带来了很多问题。比如审批制弱化了生产经营者是“第一责任人”的法律责任和法律 Recently, the revision of the Food Safety Law has passed the second hearing of the NPC, but there is still much controversy over how to regulate health food effectively and on what kind of model it should take. One of the key issues is the market access model, that is, approval of health products is the implementation of the registration examination and approval system or filing system, or both parallel dual-track system. All along, our country on the health food, health food manuals and health food production registration and approval system implemented on the market for the implementation of health food labeling management, that is, we are all familiar “blue hat ”. On the one hand, it greatly regulated the market of health care products and blocked a large number of non-compliant products, but on the other hand, it also brought many problems. For example, the examination and approval system weakens the production and managers is the “first person in charge” legal responsibility and the law