本文以我國健康食品管理法制為研究標的,從企業經營者的視角出發,探討我國現行健康食品制度運作與食品廣告管制規範下所產生之結構性問題。本文指出,現行制度下取得健康食品認證須負擔較高時間及金錢成本,相較於一般食品違規廣告之裁罰,致使合規成本與違規成本之間有明顯落差。此種成本結構失衡,使企業於經濟性考量下傾向規避健康食品制度,改以誇大或違規廣告作為市場競爭手段,進而產生制度逆向現象,削弱原欲遏止不實廣告規範功能。 本文採文獻分析、制度比較及實證資料分析方法,並以美國膳食補充品制度為比較基礎,檢視功效聲明分級之管制模式。研究發現,美國制度透過功效聲明與事後監管機制,在確保資訊透明及保護消費者食品安全前提下,提供企業經營者較彈性的市場進入機制。反觀,我國採取事前審查管制,輔以嚴格且僵化之廣告詞句限制,不僅壓縮企業經營者合法聲明之空間,亦未有效降低違規廣告之發生頻率。 本文主張現行制度過度偏重風險防範而忽略產業誘因,致使制度功能降低。本文建議應重新檢視制度架構,朝向擴充健康食品認證項目、放寬保健功效聲明方向,在有條件的放寬下,始可同時兼顧食品安全、消費者知情權與產業研發創新,達到三贏的目標。;This study focuses on Taiwan’s legal framework for health food management. From the perspective of business operators, it explores the structural issues arising from the current health food regulatory system and food advertising regulations. The research indicates that obtaining health food certification under the current regime entails significant time and financial costs. Compared to the administrative penalties imposed for illegal food advertising, a distinct disparity exists between the cost of compliance and the cost of violation. This imbalanced cost structure incentivizes businesses, driven by economic considerations, to circumvent the health food certification system and instead employ exaggerated or illicit advertising as a market competition strategy. Consequently, this may reduce the effectiveness of the regulatory framework in achieving its objective of preventing misleading advertising. Employing literature review, comparative institutional analysis, and empirical data analysis, this study uses the United States′ dietary supplement regulatory framework as a comparative baseline to examine the regulatory framework governing health-related claims in dietary supplements. The findings reveal that the U.S. system, through its framework of efficacy claims and post-market surveillance, provides a more flexible market entry mechanism for businesses while ensuring information transparency and protecting consumer food safety. In contrast, Taiwan relies on a strict pre-market approval system coupled with rigid restrictions on advertising terminology. This approach not only restricts the scope for lawful claims by businesses but also fails to effectively mitigate the frequency of illegal advertising. This thesis argues that the current system excessively prioritizes risk prevention at the expense of industry incentives, thereby diminishing its regulatory efficacy. It is recommended that the regulatory framework be re-evaluated to expand the scope of health food certification categories and conditionally relax restrictions on health claims. Such reforms may better balance food safety, consumers′ right to information, and incentives for industrial innovation.