澳門大學碩士論文 ABSTRACT Owing to the positive relationship between health food products, good health and reduced health care expenses, such products should remain available to the people what want to use them. Currently Macao SAR has no legal definition of health food products. There is also no specific legislation governing these products in place. In addition, several independent departments are involved in regulating health food products. In the absence of a statutory control mechanism, ambiguous responsibilities, lack of regulatory coordination and existence of loopholes are not difficult to see. These result in infiltration of counterfeit products, exaggerative promotion of health and medicinal claims so as to cheat and mislead the public in return for massive profit, which might present significant or unreasonable risk of injury or illness to people. Facing all these problems, the Legislative Council urged the government to set up a legal regulatory framework specifically designed for health food products in 2002 health policy address and debate. For years, legislators and health associations have also been requesting government to respond quickly to the rapidly growing problems arising from health food products. In the current regulatory system, prepackaged food and products carrying health claims are subject to different degrees of control according to various regulations in Macao SAR. This study aims at comparing different regulatory mechanisms with a focus on the legislations in order to explore the existing problems in the current legal systems for controlling health food products in Macao SAR. United States of America, mainland China and Taiwan province are selected in the study because each of them adopts a regime that is unique for the regulation of health food products and similarities exist in terms of label claims and product types between Macao SAR, mainland China and Taiwan province. IV 澳門大學碩士論文 Research results showed that although Macao SAR has a general regulatory framework governing health food products, absence of a general legislation as well as involvement of multi-authorities obviously undermine the effectiveness of her regulatory capacity. In mainland China and Taiwan province, rigid control of health food products has been placed by the government on regulation of manufacture, pre-market assessment, post-market vigilance, substantiation of health and related claims and regulation of advertisement, etc. Besides lack of legislation, Macao does not have precautionary measures in place for successfully safeguarding the safety of health food products and interests of consumers, which leads to a variety of loopholes in the regulatory regime. It is therefore suggested that government of Macao SAR should introduce specific regulation, registration system and setting up a regulatory body for controlling health food products. Key words: health food products; regulation; legal system; Macao Special Administrative Region (Macao SAR) V

澳門大學碩士論文 摘要 由於保健食品關係到市民健康的促進和醫療成本的降低,因此市 民對使用該類產品趨之若驚。目前澳門特區並沒有保健食品的法定定 義,亦沒有一個專屬法規進行規管,與此同時,保健食品目前由多個 部門管理。在缺乏相關管理的法律依據下,往往造成管理權限不清、 管理不協調或部分監管環節出現真空,亦衍生劣產品充斥市場、不 法商人乘機誇大產品保健功能或療效,或利用不法直銷方式欺騙消費 者以牟取暴利,為消費者造成重大及不合理的傷害,亦為其健康帶來 隱患。面對上述問題,立法會在2002年辯論醫療衛生政策時已促請 政府建立保健食品的法律管理制度,多年來,澳門立法會議員及醫療 團體等均促請政府儘快解決與日俱增的保健食品問題。 在現行管理制度上,保健食品零散在不同的法規中分別以預先包 裝食品、聲稱對健康有好處產品等作相應的監管,本研究的目的在於 比較不同權限實體對保健食品管理的機制,從而揭示澳門特區現行對 保健食品管理的法律制度中所存在的問題。本研究選取美國、中國大 陸及中國台灣作比較的目的是基於三者均具有對保健食品管理的專 有制度,此外,澳門特區、中國大陸及中國台灣的保健食品的種類及 標籤聲稱內容類同。 研究結果顯示,雖然本澳存在對保健食品管理的一般規範性框 架,但涉及的法律零散,且分散由多部門管理,削弱了有效的管理。 比較中國大陸及中國台灣,保健食品的管理涵蓋生產、上市前審批、 市場監管、保健聲稱確證以及廣告宣傳等一系列全過程的監管,相對 澳門除缺乏統一法規對保健食品作出監管外,亦缺乏預防性保障措施 來確保保健食品的安全性以及保障消費者的健康,從而導致現行管理 上的各種漏洞。因此建議澳門特區政府考慮制訂專屬法規、建立註 冊制度和成立專責部門對保健食品作出監管。 關鍵詞 保健食品 監管 法律制度 澳門特別行政區 III