국내외 특수의료용도식품 표시 규제 비교를 통한 제도 개선 방안 제안 연구

Abstract

In Korea, Foods for Special Medical Purposes (FSMP) distribution is transitioning significantly from medical institution- centered sales to community-based Business-to- Consumer channels, increasing the need for clear and informative labeling for consumer understanding. This study compares FSMP labeling regulations across Codex, the European Union (EU), the United States (U.S.), and Korea to identify best practices and suggest regulatory improvements. Unlike conventional foods, FSMPs are intended for the dietary management of diseases and allow properties and/or descriptions of the characteristics that support appropriate product choice. The EU and U.S. permit such claims with scientific evidence and regulate FSMPs through post-market monitoring. In contrast, in Korea, the information or claims provided on the label of FSMP characteristics is very limited, making it difficult for consumers to make informed decisions. To address this, regulatory improvements are needed to expand permissible claims and ensure that consumers receive suitable information for safe and proper FSMP use.