公眾健康與消費者自主權的平衡：重估我國保健食品的法制架構

Abstract

隨著民眾保健意識提升、預防醫學之興起，越來越多人藉由保健產品，來達成自我療護與促進健康的目的。然而，保健食品對人體機能的影響，雖未必直接而明顯，但若長期使用、劑量過高，或與藥物產生交互作用，其衍生的安全疑慮，使法治先進國家紛紛採取異於食品或藥品的獨立管制策略。就我國管制現況而言，坊間眾多保健食品，無法一概以藥品、健康食品或食品之規範相繩。許多未獲許可產品仍在市面上大肆宣稱其效用，主管機關卻無法律手段加以管制，反應出我國食品藥物法制在管制客體定義、認定標準與實際執行等層面，仍有許多改進空間。 本研究擬對保健食品管制體系進行反思，目的是希望提出更有效而實用的規範架構。研究進程分為二年，第一年對美國、歐盟、及中國等，針對膳食補充品與草藥製劑等立法例，與我國相關法制，作文獻蒐集與比較法分析，提出可行的架構理論；第二年則藉由實證研究，整理國內相關判解函釋，並訪談專家，瞭解實務問題，將上述研究成果轉化為可用於我國之管制模式，提出修法建議。相關成果將在中外文期刊及研討會發表。

The prosperity of the dietary supplements market, or herbal medicine and functional food, has seemed to give consumers more cost-effective choices to stay healthy. However, it also makes the Food and Drug Administration harder to strike a balance between ensuring food safety and promoting consumers’ choice. The complexity of governing supplements market comes from the regulatory system itself, which has long said to be in a terribly mass. The problems include the vague definition of dietary supplements, and the lack of comprehensive law enforcement standard. As a result, many products which claim to have the effect of providing extra nutrition and enhancing human body functions cannot be well examined and supervised before they enter the market. Though their safety and efficacy is under question, most of them are excluded from the existing regulatory system. This confusing regulatory structure and ensuing problems not only pose several risks on consumers’ life and health, but also erode people’s believe on our legal system. Therefore, this research aims to rethink about the regulatory system concerning dietary supplements. The purpose is to make the whole structure more feasible and practical through two approaches. The first one is to analyze regulatory options after thoroughly reviewing the regulatory schemes of foreign countries like United States, Members of European Union, and China. The other is to conduct empirical studies, such as reviewing litigation judgments or interviewing experts, to find out actual problems behind the scene. During the process, we will gather opinions from scholars and professionals from diverse fields, and present the result of this project in an international symposium. All the information, results and conclusions will be sum up to be published