The New Approach for Concentrated Chinese Medicines (CCM) in United States (U.S.) with Taiwan Norms as an Essential Reference

10.6968/TJCCM.202401_30(1).0003

Shu Yun HUANG

Concentrated Chinese Medicines (CCM) ； United States (U.S.) ； Taiwan

台灣中醫臨床醫學雜誌

30卷1期（2024 / 01 / 01）

31 - 53

英文

This article examines the regulatory challenges surrounding concentrated Chinese medicines (CCMs) in the United States, specifically focusing on the problem of their classification as dietary supplements since the enactment of the Dietary Supplement Health and Education Act (DSHEA). The potential benefits of implementing a regulatory framework for CCMs based on Taiwan's approach are explored. Stricter regulations can be imposed by establishing a distinct status for CCMs, limiting their use to designated practitioners, and specifying manufacturing and sales processes. The proposed system allows for the registration of standard formulas without extensive clinical trials, facilitating efficient regulation. The framework established for Chinese medicine can serve as a model for regulating other traditional treatments, promoting their safety and effectiveness for the public.