进入美国膳食补充剂市场的中草药制剂的功能确定

近年来美国草药类膳食补充剂市场的持续扩大,为中草药进入美国膳食补充剂市场提供了发展机遇。FDA规定膳食补充剂标签中可以出现符合规定的结构/功能声称(Structure/Function Claims),并列出了10条判断是否属于结构/功能声称的标准。美国市场中的中草药膳食补充由于产品标签中功能不明确、消费者对产品的功能不理解等因素,导致其真正的保健价值很难得到实现。因此,正确地表达并传递出中草药类膳食补充剂的功能,是中草药制剂进入美国膳食补充剂市场的重要环节。

Functions establishment of Chinese herbal medicine preparations as dietary supplements in US dietary supplement market

Herbal dietary supplements of USA have been increased recently, which brings more opportunities for herbal medicine marketing into USA.Dietary supplements can bring some functions by FDA laws and regulations.Guidance has been issued to help entities determine if a statement is a disease claim or a structure/function claim.The Chinese herbal medicine as dietary supplements has not enough market shares among the herbal dietary supplements because of their inappropriate function claims.To enter into the main market of dietary supplement, the functions must be expressed and delivered properly.