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Nutraceutical and functiona...

Nutraceutical and functional food regulations in the United States and around the world

Bagchi, Debasis

Elsevier/Academic Press 2008

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

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monografia Rebiun19886335 https://catalogo.rebiun.org/rebiun/record/Rebiun19886335 c| 081212s2008 ne a sb 001 0 eng d 9780123739018 0123739012 9780080920528 0080920527 1281766208 9781281766205 UPCT u482747 OPELS eng OPELS OPELS CBUA 613.2 Nutraceutical and functional food regulations in the United States and around the world Recurso electrónico] edited by Debasis Bagchi 1st ed Amsterdam Boston Elsevier/Academic Press 2008 Amsterdam Boston Amsterdam Boston Elsevier/Academic Press xiv, 447 p. ill. 26 cm xiv, 447 p. Food science and technology international series por cap PART I. INTRODUCTION -- 1. An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional foods: A Special Emphasis on the Future Directions -- Anthony L. Almada -- 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations -- Osmo Hñninen and Chandan K. Sen -- PART II. REGULATORY HURDLES FOR MARKETING -- 3. New Dietary Ingredient Submissions: An Approval or Rejection Process? -- Chris Noonan and W. Patrick Noonan -- 4. Marketing Dietary Supplements and Functional Foods in the United States: The Federal Trade Center Advertising Substantiation Requirements -- Anne V. Maher -- PART III. MANUFACTURING COMPLIANCE AND ANALYTICAL VALIDATION -- 5. Dietary Supplement GMP regulations: the impact on industry, regulatory and consumer confidence -- Richard Crowley and Libby H. Fitzgerald -- 6. Development and validation of analytical methods to ensure the quality and safety of dietary supplements -- Darryl Sullivan and Richard Crowley -- PART IV. IMPORTANCE OF SAFETY ASSESSMENT -- 7. Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims -- George A. Burdock, Ioana G. Carabin and James C. Griffiths -- 8. Nutraceutical/Drug/Anti-Terrorism Safety Assurance through Traceability -- Paul A. Lachance -- PART V. REGULATIONS AROUND THE WORLD -- 9. FDA Perspectives on Food Label Claims in the United States -- James E. Hoadley and J. Craig Rowlands -- 10. Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in USA -- Sanjiv Agarwal, Stein Hordvik and Sandra Morar -- 11. World Trade Organization and Food Regulation: Impact on the Food Supply Chain -- Okezie I. Aruoma -- 12. Emerging Policies and Practices Under the Canadian Natural Health Product Regulations -- Stephanie Martyres, Melody Harwood, and Earle R. Nestmann -- 13. European Legislation on Dietary Supplements and Functional Foods: Safety is Key -- Patrick Coppens, Miguel Fernandes Da Silva and Simon Pettman -- 14. Botanical Nutraceuticals, (Food supplements, Fortified and Functional Foods) in the European Union With Main Focus on Nutrition and Health Claims Regulation -- Om P. Gulati and Peter B. Ottaway -- 15. Regulations for Nutraceuticals and Functional Foods in Europe and the United Kingdom -- Stephen Ruckman -- 16. Complementary and Alternative Medicines in Australia and New Zealand: New Regulations -- Dilip Ghosh, Lynnette R. Ferguson and Margot Skinner -- 17. Health Foods and Foods with Health Claims in Japan -- Hirobumi Ohama, Hideko Ikeda and Hiroyoshi Moriyama -- 18. Regulations on Health/Functional Foods in Korea -- Ji Yeon Kim, Dai Byung Kim and Hyong Joo Lee -- 19. Chinese Approach On Regulating Food Additives, Novel Foods, Functional Foods, and Dietary Supplements -- Ashley Roberts and Rebecca Rogerson -- 20. Legislative-Normative Turnover Base in Russian Federation -- Victor A. Tutelyan and Boris P. Sukhanov -- 21. Regulations for Nutraceuticals and Functional Foods in the Indian Subcontinent -- Kantha Shelke and Christopher Hewes -- 22. Botanical Drugs, Nutraceuticals and Functional Foods: The Context of Africa -- Theeshan Bahorun and Okezie I. Aruoma -- 23. Supplements and Functional Foods Legislation in Brazil -- Maria Ceclia de Figueiredo Toledo and Franco M Lajolo -- 24. Regulation of Functional Foods in Selected Asian countries in the Pacific Rim -- Dr. Jerzy Zawistowski -- PART VII. INTELLECTUAL PROPERTY, BRANDING, TRADEMARK AND REGULATORY APPROVALS IN NUTRACEUTICALS AND FUNCTIONAL FOODS -- 25. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods -- Leighton K. Chong, Lawrence J. Udell, and Bernard W. Downs -- 26. Challenges of Intellectual Property and Branding on Regulatory Approvals -- Meggan F. Duffy, Michael R. Graham, Alisa Simmons and Jeffrey S. Sharp Acceso restringido a los miembros de la UAL 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 Nutrición Dietary Supplements standards Food Industry legislation & jurisprudence Health Food standards Internationality Legislation, Food Functional foods Standards Food industry and trade Quality control Regional disparities Food industry and trade Safety measures Regional disparities Bagchi, Debasis ScienceDirect e-books (Servicio en línea)

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monografia Rebiun19886335 https://catalogo.rebiun.org/rebiun/record/Rebiun19886335 c| 081212s2008 ne a sb 001 0 eng d 9780123739018 0123739012 9780080920528 0080920527 1281766208 9781281766205 UPCT u482747 OPELS eng OPELS OPELS CBUA 613.2 Nutraceutical and functional food regulations in the United States and around the world Recurso electrónico] edited by Debasis Bagchi 1st ed Amsterdam Boston Elsevier/Academic Press 2008 Amsterdam Boston Amsterdam Boston Elsevier/Academic Press xiv, 447 p. ill. 26 cm xiv, 447 p. Food science and technology international series por cap PART I. INTRODUCTION -- 1. An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional foods: A Special Emphasis on the Future Directions -- Anthony L. Almada -- 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations -- Osmo Hñninen and Chandan K. Sen -- PART II. REGULATORY HURDLES FOR MARKETING -- 3. New Dietary Ingredient Submissions: An Approval or Rejection Process? -- Chris Noonan and W. Patrick Noonan -- 4. Marketing Dietary Supplements and Functional Foods in the United States: The Federal Trade Center Advertising Substantiation Requirements -- Anne V. Maher -- PART III. MANUFACTURING COMPLIANCE AND ANALYTICAL VALIDATION -- 5. Dietary Supplement GMP regulations: the impact on industry, regulatory and consumer confidence -- Richard Crowley and Libby H. Fitzgerald -- 6. Development and validation of analytical methods to ensure the quality and safety of dietary supplements -- Darryl Sullivan and Richard Crowley -- PART IV. IMPORTANCE OF SAFETY ASSESSMENT -- 7. Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims -- George A. Burdock, Ioana G. Carabin and James C. Griffiths -- 8. Nutraceutical/Drug/Anti-Terrorism Safety Assurance through Traceability -- Paul A. Lachance -- PART V. REGULATIONS AROUND THE WORLD -- 9. FDA Perspectives on Food Label Claims in the United States -- James E. Hoadley and J. Craig Rowlands -- 10. Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in USA -- Sanjiv Agarwal, Stein Hordvik and Sandra Morar -- 11. World Trade Organization and Food Regulation: Impact on the Food Supply Chain -- Okezie I. Aruoma -- 12. Emerging Policies and Practices Under the Canadian Natural Health Product Regulations -- Stephanie Martyres, Melody Harwood, and Earle R. Nestmann -- 13. European Legislation on Dietary Supplements and Functional Foods: Safety is Key -- Patrick Coppens, Miguel Fernandes Da Silva and Simon Pettman -- 14. Botanical Nutraceuticals, (Food supplements, Fortified and Functional Foods) in the European Union With Main Focus on Nutrition and Health Claims Regulation -- Om P. Gulati and Peter B. Ottaway -- 15. Regulations for Nutraceuticals and Functional Foods in Europe and the United Kingdom -- Stephen Ruckman -- 16. Complementary and Alternative Medicines in Australia and New Zealand: New Regulations -- Dilip Ghosh, Lynnette R. Ferguson and Margot Skinner -- 17. Health Foods and Foods with Health Claims in Japan -- Hirobumi Ohama, Hideko Ikeda and Hiroyoshi Moriyama -- 18. Regulations on Health/Functional Foods in Korea -- Ji Yeon Kim, Dai Byung Kim and Hyong Joo Lee -- 19. Chinese Approach On Regulating Food Additives, Novel Foods, Functional Foods, and Dietary Supplements -- Ashley Roberts and Rebecca Rogerson -- 20. Legislative-Normative Turnover Base in Russian Federation -- Victor A. Tutelyan and Boris P. Sukhanov -- 21. Regulations for Nutraceuticals and Functional Foods in the Indian Subcontinent -- Kantha Shelke and Christopher Hewes -- 22. Botanical Drugs, Nutraceuticals and Functional Foods: The Context of Africa -- Theeshan Bahorun and Okezie I. Aruoma -- 23. Supplements and Functional Foods Legislation in Brazil -- Maria Ceclia de Figueiredo Toledo and Franco M Lajolo -- 24. Regulation of Functional Foods in Selected Asian countries in the Pacific Rim -- Dr. Jerzy Zawistowski -- PART VII. INTELLECTUAL PROPERTY, BRANDING, TRADEMARK AND REGULATORY APPROVALS IN NUTRACEUTICALS AND FUNCTIONAL FOODS -- 25. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods -- Leighton K. Chong, Lawrence J. Udell, and Bernard W. Downs -- 26. Challenges of Intellectual Property and Branding on Regulatory Approvals -- Meggan F. Duffy, Michael R. Graham, Alisa Simmons and Jeffrey S. Sharp Acceso restringido a los miembros de la UAL 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 Nutrición Dietary Supplements standards Food Industry legislation & jurisprudence Health Food standards Internationality Legislation, Food Functional foods Standards Food industry and trade Quality control Regional disparities Food industry and trade Safety measures Regional disparities Bagchi, Debasis ScienceDirect e-books (Servicio en línea)