我國健康食品之管理及法制規範

Regulation and Management of Health Food in Taiwan

由於生物科技及工業技術的快速發展，食品產業因應科技發展之需求，發展出各式各樣的營養補充品，包括：補充品（Supplements）（維他命、礦物質、草藥、運動飲料、特殊營養品）、天然及有機食品（Natural & Organic Foods）、功能性食品（Functional Foods）、天然的個人與家用保健品（Personal Care＆Household Items ）。 1989 年 Dr. Stephen Defelice 結合「 Nutrition 」和「Pharmaceuticals」，提出「Nutraceuticals」一字，定義為提供醫療或健康之功效，包括預防或治療疾病的食品或成分。一時之間，琳瑯滿目之保健食品充斥市場，誇大不實之食品行銷宣傳誤導消費者，有鑑與此，各國政府紛紛制定相關法規予以規範。有鑒於合理保護我國消費者資訊權以及維護消費者健康安全性之需求，特別是「健康食品」，並非「食品衛生管理法」得以統籌管理，而必須以特別立法強制規範。本文以「健康食品管理法」為中心，析論我國對健康食品管理之法律建制。論文分為兩大部分，第一部分分析「健康食品管理法」對健康食品之重要規範，首先就健康食品與一般食品之不同，作扼要之定義說明，進而分析健康食品管理法標示及廣告用詞管理原則及違反類型、案例與罰則；繼而，探討我國推動健康食品認證制度之法制基礎，包括推動健康食品查驗登記委外、「健康食品」查驗登記雙軌制等。第二部分分析我國政府應如何推動輔導保健食品產業發展，我國中草藥資源豐富，且已有長期使用之經驗，輔導中草藥業者轉型為具特定「保健功效」之健康食品，技術門檻並不困難，應能快速擴充我國「健康食品」的市場規模。另外，為保障全民食用健康食品之安全性，建構健康食品非預期反應通報系統，以助於保健食品產業更能安全穩定的發展。

Due to the fast development of biotechnology and the industrial technology, food industries develop many innovative foods such as nutrition replacement, including dietary supplements, natural and organic foods, functional foods, personal care and household items. Different terms are used on different occasions to refer to similar products. The term "nutraceutical" was coined from "nutrition" and "pharmaceutical" in 1989 by Stephen DeFelice. According to DeFelice, a nutraceutical is any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease. At once, the dazzling foods claiming health flood the market and some over-exaggerate advertisement or marketing propaganda misled consumers. Many countries start to enact health foods regulations to protect consumers. In order to protect the health of citizens and safeguard the safety, rights and interests of consumers, Taiwan government concerned the food products claiming specific nutrient and health maintenance effects should be regulated by specific law instead of the Food Sanitation Control Act. The Health Food Control Act was passed and came into effect in 1999. This article discusses the regulation and management of health food in Taiwan. There are two parts in this article, the first part analyze the definition of health food, requirements on the manufacture and importation of health food, labeling and advertisement, penalty. The second part discussed the strategies and governance to promote the health food industries developments such as promoting the index health food Chinese medicine and constructing healthy food non-anticipated response notification system.