Abstract:Objective To Investigate the current status and the reasons of disapproval of health foods in China,to provide support and guidance for registration.Method Through the Health Food Registration Management System and related statistical data analysis,the rate of disapproval and the distribution of its reasons in 2004-2010 was studied.Results In recent years the disapproval rate of health food remained at a high level,accounting for 20% of all applications.The common reasons are: the authenticity of registration data,the irrationality of formula and technology,product quality problems,and the lack of normative tests,etc.,which accounted for 3/4 of all disapproval reasons.But the proportion of disapproval caused by the informal tests and reports has decreased significantly.Conclusions The problems reflected by the disapproval of products are the focus of technical reviews.The applicants should be familiar with relevant laws,regulations of technical evaluation for health food,especially the new information released by SFDA.On this basis,research and development input should be expanded for product with high technical content and good quality.The materials submitted by applicants should be completed and all application information must be real and correct.