臺灣博碩士論文加值系統

隨著經濟成長，國人總體生活水準提升，民眾對於健康養生的意識也逐漸提高。在華人自古存在的藥膳養生觀推波助瀾下，台灣保健食品的興盛有目共睹。然而，自台灣健康食品標章開辦至今已近20年，註冊品項卻僅有四百餘種。本研究透過研讀健康食品與相關產品的法規與主管機關的管理方式，第一章探討我國健康食品制度可能未被滿足的原因。
第二章至第五章介紹台灣、中國、美國和澳大利亞的健康食品及相關產品監督管理制度。每章從各國健康食品的發展現況出發，探討主管機關的行政管理。著重於闡述查驗登記的申請流程與功效驗證的科學方法與產品廣告標示。第六章通過健康食品及其相關產品的審批程序、健康宣明和廣告標示比較台灣、中國、美國和澳大利亞的不同之處與台灣健康產業與法律體制的競爭態勢分析。台灣健康產業的優勢與劣勢，從產業面而言，注重學術與品質的特性可提升歐美國家對產品的信任度。但內需市場太小，資本額不足為台灣眾多中小企業的共同劣勢。專注海外華人市場，與當地廠商進行策略聯盟，可能是進軍國際市場的競爭方式之一。從法規面而言，健康食品法規定義明確且詳細，審查單位專業嚴謹，對於健康產業與消費者都是一種良性的助力，但保健功效評估方法項目不足、審查時間過長與健康食品的知識教育，都需要政府單位持續努力及完善的規劃。

As the economy and the standard of living improve, the demand for health and wellness is rapidly increasing. Under the influence of the traditional Chinese concept of health, the functional food grows quickly and becomes a flourishing industry in Taiwan. According to the flourishing of functional food industry, Taiwan government legislated the law of Health food to strengthen the supervision and control in 1999. However, there are only four hundred registered Health Foods until now. This study focused on the requirements that may be unsatisfied in the regulatory affairs on Health Food by searching the laws and the competent authorities of Health Foods and related products.
Chapters 2 to 5 introduce the supervision and control systems of health foods and related products in Taiwan, China, the United States and Australia. Each chapter start from the development status of health foods in these countries, then discuss the administrative of the competent authorities. Above all regulatory, this study focused on approval processes, scientific efficacy verification and the appropriate product labeling and advertising. Chapter 6 compares the different between Taiwan, China, the United States, and Australia by the approval processes, health claims, and labels of Health Food and its related products, and analysts the strengthen and weakness of Taiwan health industry and regulation system. From an industry perspective, the characteristics of emphasizing on academic research and quality management can win the trust of occidental world on products. However, the small domestic market and the lack of capital are common disadvantages for many Small and medium-sized enterprises in Taiwan. Focusing on the overseas Chinese market and conducting strategic alliances with local manufacturers may be the solutions to involve in the international market. In terms of regulations, the health food regulations are clearly defined and detailed, and the review units are professional and rigorous. They are a benign help to the health industry and consumers, but the government need to make more efforts on the insufficient health care efficacy assessment methods, the procrastination of examination, and the inadequate health food knowledge education by well planning.

目錄 I
附圖目錄 V
附表目錄 VII
第一章 緒論 1
第一節 研究背景與動機 1
第二節 研究範圍 8
第三節 研究方法 8
第四節 研究架構 9
第二章 台灣健康食品管理概況 10
第一節 台灣健康食品發展現況 10
第二節 主管機關與立法沿革 14
一、 主管機關組織編制 14
二、 健康食品管理法立法沿革 20
第三節 查驗登記與功效驗證 25
一、 健康食品查驗登記 25
第四節 廣告宣傳與標示 38
第三章 中國健康食品管理概況 43
第一節 中國健康食品發展現況 43
一、 保健食品現狀 47
第二節 主管機關與立法沿革 51
一、 主管機關組織編制 51
二、 管理法規與立法沿革 53
第三節 查驗登記與功效驗證 58
一、 保健食品註冊流程 59
二、 保健食品備案流程 60
三、 安全性、功效性評價與穩定性試驗 63
第四節 廣告宣傳與功效宣稱 74
一、 保健食品標誌 76
二、 保健食品標籤與說明書規定 77
第四章 美國健康食品管理概況 79
第一節 美國健康食品發展現況 80
一、 膳食補充劑定義 80
二、 美國政府對於膳食補充劑的管理 81
三、 民眾對於膳食補充劑的態度 81
四、 美國膳食補充劑市場狀態 83
第二節 主管機關與立法沿革 84
一、 主管機關組織編制 85
二、 健康食品法規立法沿革 86
第三節 查驗登記與功效驗證 96
一、 美國膳食補充品管理制度 98
二、 健康功能宣稱的區別與審批 99
三、 基於證據的健康宣稱審查系統 106
第四節 廣告宣稱與標示 112
一、 膳食補充品的標籤聲明 112
二、 膳食補充品的廣告宣傳 115
第五章 澳洲健康食品管理概況 117
第一節 澳洲健康食品發展現況 117
一、 澳洲健康食品定義 118
二、 澳洲健康食品市場狀態 121
第二節 澳洲主管機關與立法沿革 121
一、 主管機關組織編制 122
二、 健康食品法規立法沿革 124
第三節 查驗登記與監督管理 128
一、 特殊目的食品查驗登記與監督管理 128
二、 補充藥品查驗登記與監督管理 129
第四節 廣告宣傳規定 139
一、 特殊目的食品 139
二、 補充藥品 141
第六章 台灣、中國、美國及澳洲健康食品監管模式比較與總結 145
第一節 健康食品定義與制度差異 145
一、 健康食品名稱與定義比較 145
二、 健康食品管理比較 145
三、 健康食品功效宣稱比較 149
四、 健康食品主管機關比較 150
五、 健康食品製造與進口制度比較 151
六、 健康食品廣告刊登與上市後監管規定比較 151
第二節 結論與建議 155
一、 保健功效項目不夠多 157
二、 健康食品申請案審查時間過長 158
三、 健康食品知識教育不足 159
參考書目 161
一、 中文部分 161
二、 西文部分 166

一、中文部分
(一).圖書
1.邱繼明 (2006)。健康食品之保健功效成分規格參考標準建立之研究。臺北市：行政院衛生署。1-2。
(二).期刊論文
1.吳怡萱、黃維生、謝碧蓮、遲蘭慧(2017)。健康宣稱之規範及管理制度。食品藥物研究年報. vol 8，271-278。
2.陳鋕雄、劉庭妤(2013)。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。司法新聲，vol 107，32-46。
3.溫譽鈴(2016)。各國健康食品之法規發展、管理制度及市場概況。當代醫藥法規月刊vol 67，5-17。
4.王姝、富曉楠、李松波、張穎、孟雪蓮(2015)。對「保健食品注冊管理辦法」修訂稿的解析及思考。中國衛生產業。vol 3，194-195。
5.蘇佳琪(2015)。我國保健食品監管法律制度的研究。黑龍江省政法管理幹部學院學報。vol 4，24。
6.王瑋(2011)。美國條約行為的模式。美國研究，vol 3。
7.蔡敬民主持；廖偉翔研究(2000)。健康食品管理及審查體制之研究。99年度食品藥物管理局委託研究計畫期末報告(編號: DOH99-FDA31064)。臺北市 : 行政院衛生署食品藥物管理局。56-62。
8.陳鋕雄(2017)。美國食品標示與國際貿易爭端。
9.黃麗菁(2001)。澳洲有關健康食品的規管。香港立法會秘書處資料研究及圖書館服務部。
10.衛生福利部國家中醫藥研究所(2012)。淺談代謝質體學在中醫藥研究的應用趨勢。中醫藥新知。
(三).網路資源
1.陳國隆(2005)。中國大陸保健食品市場的發展經緯與法規新動向。食品所。檢https://www2.itis.org.tw/netreport/NetReport_Detail.aspx?rpno=349D073EBE8C62FD4825701C00517DEF (Dec 12, 2017)
2.火箭科技評論(2017)。保健食品食用行為。檢自https://rocket.cafe/talks/84177 (Dec. 4. 2017)
3.政府資料開放平台(2016)。多層次傳銷業歷年營業總額。檢自https://data.gov.tw/dataset/32387 (Dec. 4. 2017)
4.用藥安全網，一般食品和保健功能食品的共性與區別(2012)。檢自http://www.yongyao.net/zhuanti/spyyp/111.html (Apr 9, 2018)
5.王俊忠(95年6月21日)。製黑心食品 保力胺-S負責人判刑3年。自由時報。檢自http://news.ltn.com.tw/news/society/paper/77743 (Apr 9, 2018)
6.食品藥物消費者知識網。衛生福利部審核通過之健康食品資料查詢。https://consumer.fda.gov.tw/Food/InfoHealthFood.aspx?nodeID=162 (Nov 7, 2017)
7.衛生福利部食品藥物管理署(2017)。使命、願景與目標。檢自https://www.fda.gov.tw/TC/siteContent.aspx?sid=75 (Nov 9, 2017)
8.衛生福利部食品藥物管理署(2016)。食品通報入口。檢自https://www.fda.gov.tw/tc/siteContent.aspx?sid=9097 (Apr 9, 2018)
9.財團法人醫藥品查驗中心。財團法人醫藥品查驗中心2016年報。檢自http://www.cde.org.tw/about/mop (Apr 9, 2018)
10.衛生福利部(2016)。衛生福利部行政組織圖。檢自https://www.mohw.gov.tw/cp-7-8-1.html (Dec 1, 2017)
11.中國產業信息網(2017)。2017年中國保健品產業市場規模及競爭態勢分析。檢自http://www.chyxx.com/industry/201609/445679.html
12.日本國立健康營養研究所(National Institute of Health and Nutrition)。特定保健用食品類別一覽(2017)。檢自http://www.nibiohn.go.jp/eiken/index.html (Dec 12, 2017)
13.廣東省食品藥物監督管理局(2017)。廣東省發放全國首個註冊轉備案的保健食品備案憑證。檢自http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s5818/201708/340734.htm (Apr 9, 2018)
14.中華人民共和國國家統計局(2017年2月28日)。中華人民共和國2016年國民經濟和社會發展統計公報。檢自http://www.stats.gov.cn/tjsj/zxfb/201702/t20170228_1467424.html (Dec 12, 2017)
15.中國產業信息網(2016)。中國保健品產業市場新特點分析。檢自http://www.chyxx.com/industry/201611/462712.html (Apr 9, 2018)
16.中華人民共和國國家食品藥品監督管理總局(2017)。什麼是保健食品。檢自http://www.sda.gov.cn/WS01/CL2009/179182.html (Apr 9, 2018)
17.中華人民共和國國家食品藥物監督管理局(2017)。特殊食品註冊管理司的工作職責。檢自http://www.sda.gov.cn/WS01/CL1934/ (Apr 9, 2018)
18.壹讀。我國保健品市場法規亟待完善(2015年6月15日)。檢自https://read01.com/0KOMzk.html (Apr 9, 2018)
19.健康醫師網。中國大陸保健食品法規發展淺釋(2013年10月1日)。檢自http://www.doctorhealth.tw/index.php/2013-09-18-05-01-18/2013-10-01-05-14-49
20.中華人民共和國國家食品藥品監督管理局。保健食品註冊與備案管理辦法解讀。檢自 http://www.sda.gov.cn/WS01/CL1961/145580.html (Apr 9, 2018)
21.中華人民共和國國家食品藥物監督管理總局(2018年1月6日)。保健食品的功能範圍包括哪27種？檢自http://www.sda.gov.cn/WS01/CL1975/221832.html (Apr 9, 2018)
22.財團法人台灣食品產業策進會。「人類食品預防性控制」法規標準培訓課程(PCQI證照班)。檢自 https://www.tfif.org.tw/service.asp?id=128 (Apr 9, 2018)
23.中國保健食品協會法規信息交流委員會。美國膳食補充劑的管理比較及對我國保健食品註冊備案管理的建議。檢自http://www.chc.org.cn/ricc/forum/forum.php?mod=viewthread&tid=4 (Apr 9, 2018)
24.搜狐。今年雙11淘寶天貓最全類目終極榜單出爐(2017年11月14日)。檢自https://www.sohu.com/a/204323224_100026893 (Dec 30, 2017)
25.億邦動力網。2016全網雙11保健食品店鋪排行榜(2016年11月15日)。檢自http://www.ebrun.com/art/201955.shtml (Dec 30, 2017)
26.中華人民共和國國家食品藥物監督管理總局。數據查詢。檢自http://app1.sfda.gov.cn/datasearch/face3/base.jsp?tableId=30&tableName=TABLE30&title=&bcId=118103385532690845640177699192 (Dec 20, 2017)
(四).法規命令
1.中華民國衛生福利部食品藥物管理署「106年度國產維生素類錠狀膠囊狀食品手冊」(2015年12月)
2.中華民國「食品標示宣傳或廣告詞句涉及誇張易生誤解或醫療效能之認定基準」。(2015年3月16日修正)
3.中華民國「衛生福利部食品藥物管理署處務規程」第四條。(2013年7月23日發布)
4.中華民國「健康食品安定性試驗指引(草案)」。(2015年8月1日發布)
5.中華民國「健康食品保健功效評估方法提案申請作業指引」。(2017年4月17日發布)
6.中華民國「非傳統性食品原料申請作業指引修正草案」。(2011年6月24 日發布)
7.中華民國「健康食品申請許可作業流程」。
8.中華人民共和國GB/T15901-1994「食品工業基本術語」第2.1條
9.中華人民共和國GB16740-2014食品安全國家標準-保健食品第2.1項
10.中華人民共和國GB 29923-2013特殊醫學用途配方食品良好生產規範第2.1項
11.中華人民共和國「藥品管理法」第一百零二條
12.中華人民共和國「藥品管理法」第六十八條
13.中華人民共和國「中華人民共和國藥品管理法」第五十四條
14.中華人民共和國「中藥保健藥品的管理規定」第二條
15.中華人民共和國「中藥保健藥品的管理規定」第三條
16.中華人民共和國「食品衛生法」第二十二條
17.中華人民共和國「食品衛生法」第二十三條
18.中華人民共和國「保健食品註冊管理辦法(試行)」第2條
19.中華人民共和國「保健食品註冊管理辦法(試行)」第20條
20.中華人民共和國「保健食品註冊管理辦法(試行)」第5條
21.中華人民共和國「保健食品註冊管理辦法(試行)」第72條
22.中華人民共和國「保健食品註冊管理辦法(試行)」第70條第二項
23.中華人民共和國「保健食品註冊管理辦法(試行)」第33條
24.中華人民共和國「保健食品註冊與備案管理辦法」第57條
25.中華人民共和國「保健食品註冊與備案管理辦法」第58條
26.中華人民共和國「保健食品註冊與備案管理辦法」第60條
27.中華人民共和國「保健食品註冊技術審評細則」。
28.中華人民共和國「保健食品註冊技術審評細則（徵求意見稿）」。
29.中華人民共和國「實驗動物管理條例」
30.中華人民共和國「保健食品穩定性試驗指導原則」。
31.中華人民共和國「中國人民共和國廣告法」第18條
32.中華人民共和國「中國人民共和國廣告法」第46條
33.中華人民共和國「中國人民共和國廣告法」第19條
34.中華人民共和國「中國人民共和國廣告法」第40條
35.中華人民共和國「中國人民共和國廣告法」第57條第6項
36.中華人民共和國「網路食品安全違法行為查處辦法」第19條
37.中華人民共和國「保健食品標籤標識檢查要點」第2條第3項
38.中華人民共和國國家工商行政管理局工商廣字(2000)第257號「衛生部關於加強保健食品廣告監督管理的通知」第3條
39.中華人民共和國國家食品藥物監督管理總局(2005)。關於印發「保健食品廣告審查暫行規定」的通知。國食藥監市(2005)211號。
一、西文部分
(一).Books
1.John Mc. (2007). A History of Therapeutic Goods Regulation in Australia. Australian Government Department of health therapeutic Goods Administration. 1-57

(二).Journal Articles
1.Mitsuoka T. (2014). Development of Functional Foods. Biosci Microbiota Food Health 33(3), 117-128. doi:10.12938
2.Kevin K. and Wan He. (2009). An Aging World: 2008. Report Number: P95/09-1, Retrieved from https://www.census.gov/library/publications/2009/demo/p95-09-1.html (Dec. 5. 2017)
3.Blendon R.J., DesRoches C.M., Benson J.M., Brodie M. and Altman D.E. (2001). Americans'' views on the use and regulation of dietary supplements. Archives of Internal Medicine. 161(6), 805-810. PMID: 11268222
4.Blendon R.J., Benson J.M. and Botta M.D. (2013). Users'' Views of Dietary Supplements. Archives of Internal Medicine. 173(1), 74-76. doi:10.1001
5.Steven W. (2008). The FDA, Vitamins, and the Dietary Supplement Industry. US Pharmacist. 33 (10), 10-15.
6.Christopher-Paul Milne, DVM, MPH, JD. (2000). The Food And Drug Administration Modernization Act And The Food and Drug Administration: Metamorphosis Or Makeover? Drug informarion Journal. 34(3), 681-692.
7.Ellwood K.C., Trumbo P.R. and Kavanaugh C.J.(2009) How the US Food and Drug Administration evaluates the scientific evidence for health claims. Nutrition Reviews. 68(2), 114–121. doi: 10.1111/j.1753-4887.2009.00267.x
8.Hasler C.M. and Brown A.C. (2009). Position of the American Dietetic Association: Functional Foods. Journal of the American Dietetic Association. 109(4), 735-746
9.World Health Organization. (2010). Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. WHO Technical Report Series, No. 978
(三).Electronic Resources
1.U.S. Department of Health and Human Services Food and Drug administration. (2018). FDA Rules and Regulations. Retrieved from https://www.fda.gov/RegulatoryInformation/RulesRegulations/default.htm (Apr 9, 2018)
2.U.S. Department of Health and Human Services Food and Drug administration. (2018). GRAS Substances (SCOGS) Database. Retrieved from https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/default.htm (Apr 9, 2018)
3.U.S. Department of Health and Human Services Food and Drug administration. Background on the FDA Food Safety Modernization Act (FSMA). Retrieved from https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm239907.htm (Apr 9, 2018)
4.U.S. Department of Health and Human Services Food and Drug administration. FSMA Rules & Guidance for Industry. Retrieved from https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm#guidance (Apr 9, 2018)
5.U.S. Department of Health and Human Services Food and Drug administration. FSMA Final Rule for Preventive Controls for Human Food. Retrieved from https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm (Apr 9, 2018)
6.U.S. Department of Health and Human Services Food and Drug administration. Guidance documents represent FDA''s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. https://www.fda.gov/RegulatoryInformation/Guidances/#about (Apr 9, 2018)
7.U.S. Department of Health and Human Services Food and Drug administration. Label Claims for Conventional Foods and Dietary Supplements. Retrieved from https://www.fda.gov/Food/LabelingNutrition/ucm111447.htm (Apr 9, 2018)
8.U.S. Department of Health and Human Services Food and Drug administration. Dietary Supplements. Retrieved from https://www.fda.gov/Food/DietarySupplements/ (Apr 9, 2018)
9.U.S. Department of Health and Human Services Food and Drug administration. Is It Really ''FDA Approved?'' Retrieved from https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm (Apr 9, 2018)
10.U.S. Department of Health and Human Services Food and Drug administration. Dietary Supplements - How to Report a Problem. Retrieved from https://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm (Apr 9, 2018)
11.U.S. Department of Health and Human Services Food and Drug administration. Nutrition Labeling and Education Act (NLEA) Requirements- Attachment 4. Retrieved from https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114092.htm#ATTACHMENT_4 (Apr 9, 2018)
12.U.S. Department of Health and Human Services Food and Drug administration. Summary of Qualified Health Claims Subject to Enforcement Discretion. Retrieved from https://www.fda.gov/Food/LabelingNutrition/ucm073992.htm (Apr 9, 2018)
13.U.S. Department of Health and Human Services Food and Drug administration. Label Claims for Conventional Foods and Dietary Supplements. Retrieved from https://www.fda.gov/Food/LabelingNutrition/ucm111447.htm (Apr 9, 2018)
14.U.S. Department of Health and Human Services Food and Drug administration. Structure/Function Claims. Retrieved from https://www.fda.gov/Food/LabelingNutrition/ucm2006881.htm (Apr 9, 2018)
15.U.S. Department of Health and Human Services Food and Drug administration. Qualified Health Claims. Retrieved from https://www.fda.gov/Food/LabelingNutrition/ucm2006877.htm (Apr 9, 2018)
16.U.S. Federal Trade Commission. Dietary Supplements: An Advertising Guide for Industry https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry (Apr 9, 2018)
17.U.S. Office of the Federal Register. Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Proposed Extension of Compliance Dates. Retrieved from https://www.federalregister.gov/documents/2017/10/02/2017-21019/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels-and-serving-sizes-of-foods-that (Apr 9, 2018)
18.U.S. Department of Agriculture, Agricultural Research Service. (2010). Functional Foods Research in ARS. Retrieved from https://www.ars.usda.gov/ARSUserFiles/00000000/NPS/FinalFunctionalFoodsPDFReadVersion6-25-10.pdf (Dec. 5. 2017)
19.U.S. Department of Health and Human Services Food and Drug administration. FDA updates draft guidance on premarket safety notifications for dietary supplement industry. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm516197.htm
20.U.S. Department of Health & Human Services. HHS Agencies & Offices. Retrieved from https://www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html
21.U.S. Department of Health & Human Services Office of Disease Prevention and Health Promotion. (1997). Commission on Dietary Supplement Labels. Retrieved from https://health.gov/dietsupp/
22.U.S. National Conference of State Legislatures. Separation of Powers -- An Overview. Retrieved from http://www.ncsl.org/research/about-state-legislatures/separation-of-powers-an-overview.aspx
23.U.S. government. Branches of Government. Retrieved from https://www.usa.gov/branches-of-government
24.Findlaw. Durk PEARSON and Sandy Shaw, American Preventive Medical Association and Citizens for Health, Appellants, v. Donna E. SHALALA, Secretary, U.S. Department of Health and Human Services, et al., Appellees. No. 98-5043, 98-5084. Decided: January 15, 1999. Retrieved from http://caselaw.findlaw.com/us-dc-circuit/1311814.html (Apr 9, 2018)
25.Government of Japan Ministry of Health, Labour and Welfare. Food for Specified Health Uses. Retrieved from http://www.mhlw.go.jp/english/topics/foodsafety/fhc/02.html (Dec. 5. 2017)
26.Grand view research. North America Dietary Supplements Market Analysis By Ingredient (Botanicals, Vitamins, Minerals), By Product (Tablets, Capsules, Gel Caps), By Application, By End-use, And Segment Forecasts, 2014 – 2025. Retrieved from https://www.grandviewresearch.com/industry-analysis/north-america-dietary-supplements-market
27.Grand view research. Dietary Supplements Market Size, Share & Trend Analysis Report By Ingredient (Botanicals, Vitamins, Minerals, Amino Acids, Enzymes), By Product, By Application, By End-use, And Segment Forecasts, 2014 – 2024. Retrieved from https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market?utm_source=google&utm_medium=cpc&utm_campaign=AdWords_dietary-supplements&gclid=Cj0KCQiAq6_UBRCEARIsAHyrgUxMYDBGFpOwswn66aywDD8_7c1yU5nFaAacAGotXYolNskDyUyYDEcaApNaEALw_wcB
28.Grand View Research. (2016). Functional Foods Market Analysis by Product (Carotenoids, Dietary Fibers, Fatty Acids, Minerals, Prebiotics & Probiotics, Vitamins), by Application, by End-Use (Sports Nutrition, Weight Management, Immunity, Digestive Health) and Segment Forecasts, 2014 to 2024. (Report ID: GVR-1-68038-195-5) Retrieved from https://www.grandviewresearch.com/industry-analysis/functional-food-market
29.Congress.Gov. (1994). S.784 - Dietary Supplement Health and Education Act of 1994. Retrieved from https://www.congress.gov/bill/103rd-congress/senate-bill/784 (Apr 9, 2018)
30.Australian Government Department of health therapeutic Goods Administration. Complementary medicines: what they are. Retrieved from https://www.tga.gov.au/complementary-medicines-what-they-are (Apr 9, 2018)
31.Australian Government Department of health therapeutic Goods Administration. What are ''therapeutic goods''? Retrieved from https://www.tga.gov.au/what-are-therapeutic-goods (Apr 9, 2018)
32.Australian Government Department of health therapeutic Goods Administration. Australian Register of Therapeutic Goods. Retrieved from https://www.tga.gov.au/australian-register-therapeutic-goods (Apr 9, 2018)
33.Australian Government Department of health therapeutic Goods Administration. How Government Works Retrieved from https://www.australia.gov.au/about-government/how-government-works (Apr 9, 2018)
34.Australian Government Department of health therapeutic Goods Administration. The Australian Constitution. Retrieved from https://www.aph.gov.au/About_Parliament/Senate/Powers_practice_n_procedures/Constitution.aspx (Apr 9, 2018)
35.Australian Government Department of health therapeutic Goods Administration. The role of the TGA. Retrieved from https://www.tga.gov.au/role-tga (Apr 9, 2018)
36.Australian Government Department of health therapeutic Goods Administration. Advisory Committee on Complementary Medicines. Retrieved from https://www.tga.gov.au/committee/advisory-committee-complementary-medicines-accm (Apr 9, 2018)
37.Australian Government Department of health therapeutic Goods Administration. Regulation basics. Retrieved from https://www.tga.gov.au/regulation-basics (Apr 9, 2018)
38.Australian Government Federal register of legislation. Therapeutic Goods Advertising Code 2015. Retrieved from https://www.legislation.gov.au/Details/F2015L01787 (Apr 9, 2018)
39.Australian Government Department of health therapeutic Goods Administration. Manufacturing therapeutic goods. Retrieved from https://www.tga.gov.au/manufacturing-therapeutic-goods (Apr 9, 2018)
40.Australian Government Australia Pesticides and Veterinary Medicine Authority. Acceptable evidence of overseas GMP compliance. Retrieved from https://apvma.gov.au/node/146 (Apr 9, 2018)
41.Australian Government Department of health therapeutic Goods Administration. Identification of herbal materials and extracts. https://www.tga.gov.au/publication/identification-herbal-materials-and-extracts (Apr 9,2018)
42.Australian Government Department of health therapeutic Goods Administration. Equivalence of herbal extracts in complementary medicines. https://www.tga.gov.au/equivalence-herbal-extracts-complementary-medicines (Apr 9,2018)
43.Australian Government Department of health therapeutic Goods Administration. Use of modified unprocessed herbal materials in complementary medicines. https://www.tga.gov.au/use-modified-unprocessed-herbal-materials-complementary-medicines (Apr 9,2018)
44.Australian Government Department of health therapeutic Goods Administration. Registered complementary medicines. Retrieved from https://www.tga.gov.au/registered-complementary-medicines (Apr 9, 2018)
45.Australian Government Department of health therapeutic Goods Administration. ARTG search. Retrieved from https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg (Apr 9, 2018)
46.Australian Government Department of health therapeutic Goods Administration. List of evaluated registered complementary medicines. Retrieved from https://www.tga.gov.au/list-evaluated-registered-complementary-medicines (Apr 9, 2018)
47.Australian Government Department of health therapeutic Goods Administration. Listed medicines application and submission user guide. Retrieved from https://www.tga.gov.au/publication/listed-medicines-application-and-submission-user-guide (Mar 5, 2018)
48.Australian Government Department of health therapeutic Goods Administration. Registration process for complementary medicines. Retrieved from https://www.tga.gov.au/registration-process-complementary-medicines#step14 (Mar 5, 2018)
49.Australian Government Department of health therapeutic Goods Administration. Proposing a new ingredient name. Retrieved from https://www.tga.gov.au/proposing-new-ingredient-name (Mar 5, 2018)
50.Australian Government Department of health therapeutic Goods Administration. Scheduling basics. Retrieved from https://www.tga.gov.au/scheduling-basics (Mar 5, 2018)
51.Australian Government Department of health therapeutic Goods Administration. ARGCM Part D: Registered complementary medicines. Retrieved from https://www.tga.gov.au/application-categories (Apr 9, 2018)
52.Australian Government Department of health therapeutic Goods Administration. Restricted representations. Retrieved from https://www.tga.gov.au/restricted-representations (Mar 5, 2018)
53.Australian Government Department of health therapeutic Goods Administration. General dossier requirements. Retrieved from https://www.tga.gov.au/publication/general-dossier-requirements (Mar 5, 2018)
54.Australian Government Department of health therapeutic Goods Administration. Data requirements matrix for RCMs. Retrieved from https://www.tga.gov.au/data-requirements-matrix-rcms (Mar 5, 2018)
55.Australian Government Department of health therapeutic Goods Administration. Fees and charges: summary - from 19 March 2018. Retrieved from https://www.tga.gov.au/book-page/non-prescription-medicines-2 (Mar 12, 2018)
56.Australian Government Department of health therapeutic Goods Administration. Common Technical Document. Retrieved from https://www.tga.gov.au/publication/common-technical-document-ctd (Mar 12, 2018)
57.Australian Government Department of health therapeutic Goods Administration. CTD Module 1: registered complementary medicines. Retrieved from https://www.tga.gov.au/ctd-module-1-registered-complementary-medicines#s13-3 (Mar 12, 2018)
58.Australian Government National Health and Medical Research Council. Recommended Dietary Intakes for Use in Australia. Retrieved from https://www.nhmrc.gov.au/guidelines-publications/n6 (Mar 12, 2018)
59.Australian Government Department of Health Therapeutic Goods Administration. Making a complaint about the advertising of a therapeutic product. Retrieved from http://www.tga.gov.au/making-complaint-about-advertising-therapeutic-product (Mar 12, 2018)
60.Australian Government Department of Health Therapeutic Goods Administration. Regulation of therapeutic goods advertising in Australia. Retrieved from https://www.tga.gov.au/regulation-therapeutic-goods-advertising-australia (Mar 12, 2018)
61.Australian Institute of Food Safety. The Official AIFS Food Safety Supervisor Course. Retrieved from https://www.foodsafety.com.au/courses/food-safety-supervisor (Apr 9, 2018)
62.Australian Institute of Food Safety. Everything You Need to Know about Starting a Food Business. Retrieved from https://www.foodsafety.com.au/resources/articles/everything-you-need-to-know-about-starting-a-food-business (Apr 9, 2018)
63.Food Standards Australia New Zealand. Notified food-health relationships to make a health claim. Retrieved from http://www.foodstandards.gov.au/industry/labelling/fhr/Pages/default.aspx?utm_source=Cochrane+Australia+News&utm_campaign=1d301b66cb-Elements_June_2016_6_28_2016&utm_medium=email&utm_term=0_986f9ba88a-1d301b66cb-204854413 (Mar 12, 2018)
64.Food Standards Australia New Zealand. Completed ISFR food surveys. Retrieved from http://www.foodstandards.gov.au/science/surveillance/pages/isccomponent1.aspx (Apr 9, 2018)
65.Food Standards Australia New Zealand. Monitoring nutrients in our food. Retrieved from http://www.foodstandards.gov.au/science/monitoringnutrients/Pages/default.aspx (Apr 9, 2018)
66.Food Standards Australia New Zealand. Australian Total Diet Study. Retrieved from http://www.foodstandards.gov.au/science/surveillance/Pages/australiantotaldiets1914.aspx (Apr 9, 2018)
67.Food Standards Australia New Zealand. Labelling. Retrieved from http://www.foodstandards.gov.au/consumer/labelling/Pages/default.aspx (Mar 12, 2018)
68.Food regulations. Australia and New Zealand Ministerial Forum on Food Regulation (Forum) retrieved from http://foodregulation.gov.au/internet/fr/publishing.nsf/Content/Forum (Apr 9, 2018)
69.Cochrane Australia. Substantiating health claims on food: systematic reviews and Australia''s new labelling standards. Retrieved from http://australia.cochrane.org/news/substantiating-health-claims-food-systematic-reviews-and-australias-new-labelling-standards (Mar 12, 2018)
(四).Act, Regulation and Guideline
1.21 U.S. Code § 321 (ff) (1), (3)(B)
2.21 U.S. Code § 321 (f)
3.21 CFR 101.93
4.21 CFR Q 101.14(c)
5.21 CFR 101.14
6.21 CFR 101.14(a) (2)
7.21 CFR 101.14(a) (5)
8.Nutrition Labeling and Education Act (NLEA) Requirements- Attachment 4
9.Dietary Supplement Health and Education Act chapter 9
10.Dietary Supplement Health and Education Act chapter 13
11.Dietary Supplement Health and Education Act chapter 12
12.Dietary Supplement Health and Education Act chapter 3 (c) Form of Ingestion.
13.Food and Drug Administration Modernization Act. Section 303 and 304
14.Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. (June 11, 1998)
15.Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Retrieved from https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm257563.htm
16.Guidance for Industry：Significant Scientific Agreement in the Review of Health Claims for Conventional Food and Dietary Supplement.
17.Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.
18.Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.
19.Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act.
20.Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements
21.Guidance for industry: Significant Scientific Agreement in the review of Health Claims for Conventional Food and Dietary Supplement, 1999
22.Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 10, 2003
23.Food Standards Code Standard 2.9.1
24.Food Standards Code Standard 2.9.2
25.Food Standards Code Standard 2.9.3-5
26.Food Standards Code Standard 2.9.3-7
27.Food Standards Code Standard 2.9.4
28.Food Standards Code Standard 2.9.5
29.Food standards code standard 1.2.7
30.Therapeutic Goods Regulations. Schedule 14 Designated active ingredients.
31.Therapeutic Goods Advertising Code 2015
32.Therapeutic Goods Regulations Schedule 4- Therapeutic goods required to be included in the part of the Register for listed goods.
33.Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017.
34.Therapeutic Goods (Permissible Indications) Determination No.1 of 2018.
35.Therapeutic Goods (Charges) Regulations 1990 regulations Regulation 3(1)(a)(i), 3(1)(c)(i) and 3(1A)(c)(i)
36.Guidance 10: Adventitious agent safety of medicines.
37.Poisons Standard March 2018
38.Food standards code, Schedule 4, Nutrition, health and related claims
39.Australian regulatory guidelines for complementary medicines