Health food has a long history in China. In 1990s, Chinese government admitted health food officially by defining it in the law, and then established a series of standards, test programs and management methods. However, the development of health food market is fluctuant. Some investigations showed that it is those "problematic products" that impact the prosperity of health food market. Therefore, it is important to strengthen the quality supervision of post-market products, which could play a key role in ensuring people's health, guaranteeing the steady development of the market and enlarging the market share in international market. By comparing the health food management in China, America and Japan, and analyzing the current status of market and change in policy, we draw the conclusion that establishing a quality re-evaluation system of Chinese health food is necessary. Using experience of quality management in food and drug for reference, we advance that the safety and functionality should be proofed by instrument inspection, practical effect and systematic evaluation. Besides, we also suggest that government, enterprises and guides should definite their duties. Although there are distinct differences between America and Japan in definition and approval procedure on health food, both of them have powerful market supervision system. American government manages all the label, advertisement through the cooperation of FDA and FTC; meanwhile, advanced technology provides effective backup on quality monitoring. In Japan, there are two kinds of functional food,,but both of them are under the control of a special office. The punishments on illegal enterprises are rigorous and open, forcing them controlling themselves strictly and actively. On the contrary, market supervision in China is weak, and we need to invest more attention into it to administer enterprises and improve health food quality. Other than disordered market condition, the particular characteristics of health food compared with food and drug, and the limitation of pre-market research, such as short experiment period, incomprehensive testees and single target, call for the 3 re-evaluation of post-market products. Furthermore, the necessity is also enhanced by the risk during practical use and modification of health food policy. The strategy about health food re-evaluation is considered from government, enterprises, guides and mass media. The responsibility of government is enacting regulations and regulating different departments' functions. Meanwhile, enterprises should strictly examine finished goods, and carry on further research on new develop products. Guides, as the connection between government and enterprises, should assistant the former to supervise and the latter to attest health food's safety and functionality. All of what they do should be surveiled by mass media. Based on the research above, we put forward the conception of quality re-evaluation system of Chinese health food. The aim of this system is to re-evaluate the safety and functionality objectively; the principle is dynamic evaluation; and the main character of it is appraising health food respectively according to their own specialities. The system is constituted with safety re-evaluation and function re-evaluation. The former includes evaluation of hygiene indexes, population toxicology experiments and adverse effect appraisement; the latter includes evaluation of functional quality indexes, nutrition indexes and outcome of practical use. Because any single method has its own deficiency, laboratory examination, population experiment, systematic evaluation and adverse effect appraisement are all required. In this system, government takes the leading responsibility. The setting up of a health food evaluation center is to distribute and manage all the work related to re-evaluation of post-market products. Guides, under the supervision of government, examine health food in market voluntarily, providing reference to government, and help enterprises carry through population experiment and systematic evaluation. After government making the decision, enterprises should actively implement the order, and involve in the health food re-evaluation. These three subjects should cooperate to improve the quality of health food and promote the continuable development of health food market in China. Key words: health food; quality re-evaluation system; necessity; safety re-evaluation; function re-evaluation 4

保健食品在我國有著悠久的發展歷史;20世紀90年代,我國政府正式確立 了其法律地位,制定了相關的標準、檢測程式和管理辦法。然而我國保健食品市 場一直呈現出波動發展的趨勢。調查研究表明,一些“問題產品”的存在,嚴重 影響了保健食品市場的正常發展。因此,加強上市產品的質量監管,成為保證人 們安全消費,維護保健市場平穩發展,從而進一步拓展國際市場佔有率的重要保 證。 本課題通過比較分析我國、美國和日本的保健食品質量監管措施,並對我國 保健食品市場和政策方面進行分析,提出保健食品質量再評價體系建立的必要 性。結合食品與藥品質量監管和再評價方面的經驗,從安全性和功能性方面,在 實驗室檢測、人群效果和不良反應認定等方面對保健食品質量進行再評價,並明 確了政府、企業和專業協會的分工責任,為完善我國上市保健食品質量再評價工 作提供參考意見。 通過對不同國家的保健食品質量監管措施比較發現 美國和日本雖然在保健 食品界定、審批要求等方面均存在較大差別,但二者都具有強大有力的市場監督 機制。其中美國主要通過 FDA 和 FTC 合作對上市產品標籤、宣傳品進行管理,並 以先進的科學技術為支撐對產品質量進行監測。日本對保健食品實行分類管理, 並在保健食品對策室的統一協調安排下進行市場監督;其嚴格而公開的懲罰措 施,使得生產企業必須對其自身產品負責以避免巨大的打擊。我國一直存在著 “重審批、輕監管”的問題;一些生產企業在通過審批後忽略了質量保證,導致 產品質量不穩。因此,加大市場監督可以認為是保證產品質量的有效途徑之一。 除了市場秩序混亂外,保健食品區別於食品、藥品的特殊性質,以及其上市 前評價的局限性,包括試驗週期短、受試對象選擇範圍窄、以及申報實驗研究目 的單純等原因要求對上市產品的質量進行進一步評估。此外,我國現有保健食品 特點,上市產品在銷售和食用過程中存在的風險,以及管理辦法的變更等因素都 顯示出,建立一套完整的質量再評價體系顯得尤為重要。 本論文提出了完善保健食品質量再評價的策略。一方面,政府需要對質量監 管政策法規進行完善,劃分和協調各部門職能,不断提升檢測水平。同時,生產 企業要規範出廠產品的檢驗工作,並對新研發產品的安全性和功能新進行追蹤評 1 澳門大學碩士學位論文 價。專業協會要起到橋樑作用,在協助企業進行功能驗證的同時,輔助政府職能 部門監測市售產品。而媒體應充分發揮監督指導作用,對產品質量進行輿論監督。 在此基礎上,本論文初步提出保健食品再評價體系的概念,以客觀評價產品 功能性和安全性為目的,以動態監測為原則,以產品針對性為評價體系的主要特 點。該體系的評價內容主要包括安全性評價和功能性評價:前者是對衛生學指 標、人群毒理學實驗和不良反應進行評價;後者主要對功能質量指標、營養學指 標和機體功能結果進行驗證。通過實驗室檢測,人群實驗,系統評價和不良反應 因果關係驗證等評價方法對產品質量進行再評價:這些評價方法互為補充,以彌 補單一評價方法的不足。 在這一評價體系中,政府起到主體負責作用,通過建立保健食品評價中心, 統一協調衛生、農業、水利等部門對產品安全性進行檢測;並委託藥品監督評價 部門對產品功能指標和不良反應進行評價。受到政府監督指導的專業協會自發開 展上市產品質量評價,為政府提供參考依據;並在政府制定的指導原則下受企業 委託進行人群實用結果驗證和系統評價。以評價結果為依據,評價中心對產品和 企業做出相應處理;企業在對處理決定做出迅速反應的同時,更應積極參與質量 評價工作。從而形成“政府負責,企業參與,協會輔助”的局面共同維護和促進 保健食品市場良性發展。 關鍵字:保健食品;質量再評價體系;必要性;安全性再評價;功能性再評價