Globalization of the nutraceutical and functional food industries presents significant challenges, not the least of which is the regulatory variance between countries active in the marketplace. Nutraceutical and Functional Food Regulations in the United States and Around the World has been written by eminent experts in the field with the specific intention of addressing these important considerations.
Beginning with insights into the scope, importance and growing opportunities in these industries, the book demonstrates the global scenario on the acceptance and demand for nutraceuticals and functional foods. It explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as the intricate aspects of manufacturing procedures.
Including regulations from South America, Canada, European Union, Australia, New Zealand, Africa, Japan, Korea, China, India and Southeast Asia as well as the United States, Nutraceutical and Functional Food Regulations in the United States and Around the World provides a valuable resource for understanding the key considerations of operating in this rapidly expanding area.
Key Features:
*Overview of nutraceutical and functional food regulations around the world
*Discusses the important of GRAS status and DSHEA regulations
*Provides insight on quality manufacturing techniques, cGMP and standardized analytical techniques
*Includes salient features on overcoming regulatory hurdles
*Addresses the importance of safety, efficacy and human clinical studies for worldwide acceptance
*Highlights anti-terrorism safety assurance through traceability
*Explores the significance of intellectual property, trademark and branding on marketing
Globalization of the nutraceutical and f
Key Features:
*Overview of
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ix | |
| Preface |
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xi | |
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1 | (36) |
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An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional Foods: A Special Emphasis on the Future Directions |
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3 | (8) |
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Nutritional Supplements and Functional Food: Functional Significance and Global Regulations |
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11 | (26) |
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Part
2. Regulatroy Hurdles for Marketing |
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37 | (20) |
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New Dietary Ingredient Submission: A Review of Past and Present |
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39 | (8) |
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Marketing Dietary supplements and Funcational Foods in the USA: The Federal Trade Commission's Advertising Substantiation Requirements |
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47 | (10) |
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3. Manufacturing Compliance and Analytical Validation |
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57 | (24) |
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Dietary Supplemtn GMP Regulations: The Impact on Industry, Regulatory and Consumer Confidence |
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59 | (12) |
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Development and Validation of Analytical Methods to Ensure the Quality and Safety of Dietary Supplements |
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71 | (10) |
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Part
4. Importance of Safety Assessment |
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81 | (32) |
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Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims |
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83 | (26) |
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Nutraceutical/Drug/Anti-Terrorism Safety Assurance Through Traceability |
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109 | (4) |
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Part
5. Regulations Around the World |
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113 | (290) |
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FDA Perspectives on Food Label Claims in the USA |
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115 | (18) |
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Helath and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in the USA |
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133 | (10) |
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World Trade Organization and Food Regulation: Impact on the Food Supply Chain |
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143 | (16) |
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Emerging Policies and Practices Under the Canadian Natural Health Product Regulations |
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159 | (14) |
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European Legislation on Dietary Supplements and Functional Foods: Safety is Key |
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173 | (26) |
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Miguel Fernandes da Silva |
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Botanical Nutraceuticals (Food Supplements, Fortified and functional Foods) in the European Union with Main Focus on Nutrition and Health Claims Regulation |
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199 | (22) |
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Regulations for Nutraceuticals and Functional Foods in Europe and the United Kingdom |
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221 | (18) |
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Complementary and Alternative Medicines in Australia and New Zealand: New Regulations |
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239 | (10) |
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Health foods and Foods with Health Claims in Japan |
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249 | (32) |
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Regulations on Health/Functional Foods in Korea |
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281 | (10) |
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Chinese Approach on Regulating Food Additives, Novel Foods, Functional Foods and Dietary Supplements |
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291 | (14) |
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The Legislative Regulation of Biologically Active Food Supplements Circulation in the Russian Federation |
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305 | (18) |
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Regulations for Nutraceuticals and Functional Foods in the Indian Subcontinent |
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323 | (18) |
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Botanical Drugs, Nutraceuticals and Functional Foods: The Context of Africa |
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341 | (8) |
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Supplements and Functional Foods Legislation in Brazil |
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349 | (16) |
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Maria Cecilia de Figueiredo Toledo |
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Regulation of Functional Foods in Selected Asian Countries in The Pacific Rim |
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365 | (38) |
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Part
6. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods |
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403 | (36) |
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Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods |
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405 | (12) |
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Challenges of Intellectual Property and Branding on Regulatory Approvals |
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417 | (22) |
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| Index |
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439 | (6) |
| Series List |
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445 | |
Debasis Bagchi, PhD, MACN, CNS, MAIChE, received his Ph.D. in Medicinal Chemistry in 1982. He is a Professor in the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston College of Pharmacy, Houston, TX, and Chief Scientific Officer at Cepham Research Center, Piscataway, NJ, Adjunct Faculty in Texas Southern University, Houston, TX. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Inc, Benicia, CA, from 1998 until Feb 2011, and then as Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, until June 2013. Dr. Bagchi received the Master of American College of Nutrition Award in October 2010. He is the Past Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), Past President of American College of Nutrition, Clearwater, FL, and Past Chair of the Nutraceuticals and Functional Foods Division of Institute of Food Technologists (IFT), Chicago, IL. He is serving as a Distinguished Advisor on the Japanese Institute for Health Food Standards (JIHFS), Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. He has published 321 papers in peer reviewed journals, 30 books, and 18 patents. Dr. Bagchi is also a Member of the Society of Toxicology, Member of the New York Academy of Sciences, Fellow of the Nutrition Research Academy, and Member of the TCE stakeholder Committee of the Wright Patterson Air Force Base, OH. He is also Associate Editor for the Journal of Functional Foods, Journal of the American College of Nutrition, and the Archives of Medical and Biomedical Research, and is also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, and The Original Internist, among others.
