Atnaujinkite slapukų nuostatas

Nutraceutical and Functional Food Regulations in the United States and Around the World 2nd edition [Kietas viršelis]

3.50/5 (2 ratings by Goodreads)
Edited by (Professor, Department of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, USA; Chief Scientific Officer, Cepham Research Center, Piscataway, New Jersey; Adjunct Faculty, Texas Southern University, )
  • Formatas: Hardback, 592 pages, aukštis x plotis: 235x191 mm, weight: 1220 g
  • Serija: Food Science and Technology
  • Išleidimo metai: 10-Mar-2014
  • Leidėjas: Academic Press Inc
  • ISBN-10: 0124058701
  • ISBN-13: 9780124058705
Kitos knygos pagal šią temą:
Nutraceutical and Functional Food Regulations in the United States and Around the World 2nd editionDidesnis paveikslėlis
  • Formatas: Hardback, 592 pages, aukštis x plotis: 235x191 mm, weight: 1220 g
  • Serija: Food Science and Technology
  • Išleidimo metai: 10-Mar-2014
  • Leidėjas: Academic Press Inc
  • ISBN-10: 0124058701
  • ISBN-13: 9780124058705
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9780124058705.html

This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures. As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world.

  • Features fully revised and updated information with current regulations from around the world, including GRAS status and DSHEA regulators
  • Offers 45% new content including three new chapters -NSF: Ensuring the Public Health and Safety Aspects of Nutraceuticals and Functional Foods; Role of the United States Pharmacoepia in the Establishment of Nutraceuticals and Functional Food Safety; An Overview on the New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) Status, and the addition of cGMP regulations for dietary supplements
  • Includes insight into working with regulatory agencies, processes and procedures
  • Provides a link to the contact information for most regulatory bodies for readers wishing to gain further knowledge

Recenzijos

"This book on nutraceutical and functional food regulations clearly is the gold standard in this area." --Sidney J. Stohs, Ph.D., FACN, CNS, ATS, FAPhA, FASAHP, Dean Emeritus, Creighton University, School of Pharmacy & Health Professions

Daugiau informacijos

A comprehensive, organized overview of the regulatory landscape for nutraceuticals and functional foods
Preface xxiii
Preface to the First Edition xxvii
List of Contributors
xxxi
PART I INTRODUCTION
Chapter 1 Nutraceuticals and Functional Foods: Aligning with the Norm or Pioneering Through a Storm
3(10)
1.1 Myths devolve into faith and dogma
3(1)
1.2 Value addition or illusion?
4(3)
1.3 Landmines and weapons of brand destruction
7(1)
1.4 Opportunity awaiting: pioneering upstream
8(1)
1.5 Conclusion
9(4)
References
10(3)
Chapter 2 Nutritional Supplements and Functional Foods: Functional Significance and Global Reφulations
13(28)
2.1 Introduction
13(3)
2.2 Health behaviors and food markets
16(7)
2.2.1 Possibilities to promote food health-promoting properties
16(7)
2.3 Research needs: safety and efficacy
23(18)
2.3.1 DSHEA
24(2)
2.3.2 Codex: harmonizing food and supplement rules between all nations of the world
26(2)
2.3.3 International alliance of dietary food supplement associations
28(1)
Acknowledgment
29(1)
References
30(11)
Chapter 3 Global Market Entry Regulations for Nutraceuticals, Functional Foods, Dietary/Food/Health Supplements
41(14)
3.1 Introduction
41(1)
3.2 Market entry requirements
42(13)
3.2.1 Positive and negative ingredient lists
42(2)
3.2.2 Botanicals
44(1)
3.2.3 Notification versus registration
45(4)
References
49(6)
PART II MANUFACTURING COMPLIANCE AND ANALYTICAL VALIDATION
Chapter 4 Natural Health Products and Good Manufacturing Practices
55(8)
4.1 Overview
55(3)
4.1.1 Who does it apply to?
55(1)
4.1.2 GMPs: what are they?
55(1)
4.1.3 Key elements of GMP
56(1)
4.1.4 Places
56(1)
4.1.5 People
56(1)
4.1.6 Processes
56(1)
4.1.7 Products
57(1)
4.1.8 Benefits of GMP/HACCP
57(1)
4.2 GMP procedures: considerations for manufacturers
58(2)
4.2.1 Overview of quality management system
59(1)
4.2.2 Overview of GMP/HACCP process flow
60(1)
4.3 Conclusion
60(3)
Further reading
61(2)
Chapter 5 Current Good Manufacturing Practices for Nutraceuticals
63(12)
5.1 Introduction
63(1)
5.2 GMPs
64(7)
5.2.1 Premises
64(2)
5.2.2 Equipment
66(1)
5.2.3 Personnel
67(1)
5.2.4 Quality assurance
68(1)
5.2.5 Sanitation program
69(1)
5.2.6 Operations
69(1)
5.2.7 Specifications
69(1)
5.2.8 Stability
70(1)
5.2.9 Samples
70(1)
5.2.10 Records
70(1)
5.2.11 Recall
71(1)
5.3 Conclusion
71(4)
References
71(4)
PART III IMPORTANCE OF SAFETY ASSESSMENT
Chapter 6 Breaking Down the Barriers to Functional Foods, Supplements and Claims
75(30)
6.1 Introduction
75(1)
6.2 Terminology
76(2)
6.3 The struggle: players and issues
78(8)
6.3.1 Ontogeny and current status of the regulations
79(1)
6.3.2 Health claims and NLEA and FDAMA
80(3)
6.3.3 Qualified health claims
83(3)
6.4 DSHEA: SFCs and a new safety standard
86(8)
6.4.1 A closer look at the definition
86(3)
6.4.2 The exclusionary clause and section 912
89(3)
6.4.3 The standard for safety
92(2)
6.5 The immediate future and the path forward for FDA
94(6)
6.5.1 The immediate future
94(1)
6.5.2 Four things the FDA must do to resolve the impasse
95(5)
6.6 Discussion
100(2)
6.7 Conclusion
102(3)
Acknowledgments
103(1)
References
103(2)
Chapter 7 NSF International's Role in the Dietary Supplements and Nutraceuticals Industries
105(16)
7.1 A look at the market
105(1)
7.2 Brief history of NSF International
105(2)
7.2.1 History in standards development and independent third-party certification
105(1)
7.2.2 Organizational growth
106(1)
7.2.3 NSF testing and certification
106(1)
7.2.4 Why did NSF International start a certification program for dietary supplements?
106(1)
7.3 What are good manufacturing practices?
107(7)
7.3.1 GMP regulations
107(4)
7.3.2 GMPs and compliance issues
111(3)
7.4 Developing master manufacturing records and batch records
114(2)
7.4.1 Importance of GMP registration and GMP registration process
115(1)
7.5 Importance of independent, third-party certification
116(1)
7.5.1 Increase in dietary supplement product certification
116(1)
7.6 Future outlook
116(5)
References
117(4)
PART IV REGULATIONS AROUND THE WORLD
Chapter 8 FDA Perspectives on Food Label Claims in the United States
121(20)
8.1 Introduction
121(1)
8.2 Legal basis for U.S. regulation of food label claims
122(2)
8.3 Nutrient content claims
124(3)
8.4 Health claims
127(8)
8.4.1 Validity standard of health claims
127(1)
8.4.2 General health claim regulation
128(2)
8.4.3 Authorized health claims
130(3)
8.4.4 Qualified health claims
133(2)
8.5 Structure/function claims
135(6)
References
139(2)
Chapter 9 Nutrition and Health-Related Labeling Claims for Functional Foods and Dietary Supplements in the United States
141(10)
9.1 Introduction
141(1)
9.2 Nutrient content claims
141(3)
9.3 Structure/function claims
144(1)
9.4 Health claims
145(3)
9.5 Dietary guidance statements
148(1)
9.6 Factual statements
148(1)
9.7 Nutritional claims display on packages
149(2)
References
150(1)
Chapter 10 Assessment of Safety and Quality Assurance of Herbal Dietary Supplements
151(18)
10.1 Introduction
151(1)
10.2 Quality control of herbal dietary supplements
152(2)
10.2.1 Species authentication and standardization
152(1)
10.2.2 Selection of chemical markers
153(1)
10.2.3 The fingerprinting technique
153(1)
10.3 Safety assurance of herbal dietary supplements
154(2)
10.3.1 Contamination by microbes, heavy metals, and pesticides
154(1)
10.3.2 Adulteration
154(1)
10.3.3 Toxicity bioassays of herbal dietary supplements
155(1)
10.3.4 Herb---drug and herb---herb interaction and alteration of metabolizing enzymes
155(1)
10.4 Regulatory activities concerning botanical/herbal dietary supplements
156(2)
10.4.1 The U.S. Food and Drug Administration
157(1)
10.4.2 Regulation of Chinese herbs in China
158(1)
10.5 Toxicological study of herbal dietary supplements by the NTP and the NCTR
158(4)
10.5.1 Toxicological study by the NTP
158(1)
10.5.2 Toxicological studies by the NCTR
159(1)
10.5.3 Case study: mechanism of liver tumor induction by riddelliine
160(1)
10.5.4 Official actions by the FDA and NTP on herbal dietary supplements
161(1)
10.6 Difficulties in safety assurance of herbs and herbal dietary supplements
162(1)
10.6.1 Intrinsic problems: herbs and herbal products contain multiple chemical constituents
162(1)
10.6.2 Understanding the theory of traditional Chinese medicine
162(1)
10.7 Alternative approaches for safety assurance of herbal dietary supplements
163(1)
10.8 The role of the Chinese government in safety assurance of Chinese herbal medicine
163(1)
10.9 Perspectives
164(5)
Acknowledgments
164(1)
References
164(5)
Chapter 11 Understanding Medical Foods under FDA Regulations
169(14)
11.1 History of medical foods
169(6)
11.2 FDA guidance
175(2)
11.2.1 IEMs
176(1)
11.3 Good manufacturing practices and import/export
177(2)
11.4 FDA enforcement of medical foods
179(1)
11.5 Looking forward
180(3)
Chapter 12 Current Canadian Regulatory Initiatives and Policies for Natural Health Products (Dietary Supplements)
183(18)
12.1 Introduction
183(1)
12.2 What is an NHP?
184(1)
12.3 Current statistics on the NHPD regulatory products: what do the numbers show?
185(2)
12.4 NHPs transitioning to food products: a regulatory transition process
187(1)
12.5 A "new approach" to regulating NHPs
187(7)
12.5.1 Three-class system
188(1)
12.5.2 Guidance document 2012
189(2)
12.5.3 Site licenses
191(1)
12.5.4 Quality
192(1)
12.5.5 Compliance transition
193(1)
12.6 Recent modifications by NHPD facilitating business and regulatory processes
194(1)
12.7 The larger picture: mutual recognition agreements
195(2)
12.8 Post-market activities following product approval
197(1)
12.8.1 AR reporting
197(1)
12.8.2 Post-market surveillance
198(1)
12.9 Conclusion
198(3)
References
199(2)
Chapter 13 European Regulations on Food Supplements, Fortified Foods, Dietetic Foods, and Health Claims
201(20)
13.1 Introduction
201(1)
13.2 The General Food Law Regulation 178/2002
201(2)
13.3 The Food Supplements Directive 2002/46
203(3)
13.4 Regulation 1924/2006 on the addition of vitamins and minerals and other substances to food (fortified foods)
206(2)
13.5 Regulation 1924/2006 on nutrition and health claims made on foods
208(2)
13.6 Novel Foods Regulation 258/97
210(2)
13.7 Foods for particular nutritional uses (dietetic foods)
212(2)
13.8 The future of botanicals
214(7)
References
217(4)
Chapter 14 Botanical Nutraceuticals, (Food Supplements, Fortified and Functional Foods) in the European Union with Main Focus on Nutrition And Health Claims Regulation
221(36)
14.1 Introduction
221(1)
14.2 The nutraceutical concept in the US
222(1)
14.3 EU legislation on botanicals as medicines or foods
223(2)
14.4 Regulatory status and positioning of botanicals as food supplements, fortified, and functional foods
225(1)
14.4.1 Food supplement directive
225(1)
14.5 National control on botanicals in food supplements
226(1)
14.6 Regulation on mutual recognition
227(1)
14.7 Other regulations with an impact on functional foods
228(5)
14.7.1 Traditional herbal medicinal products
228(1)
14.7.2 Botanicals for enrichment of foods and functional foods
229(1)
14.7.3 EU legislation and functional foods
230(1)
14.7.4 EU legislation on fortified food
231(2)
14.8 EU legislation and parnuts
233(1)
14.9 EU legislation on novel foods
234(1)
14.10 Quality aspects
235(1)
14.11 Safety of botanicals
236(1)
14.12 Efficacy of botanicals
237(5)
14.12.1 NHCR
237(4)
14.12.2 Scientific substantiation of claims
241(1)
14.12.3 Qualified health claims
242(1)
14.13 Consequences of the NHCR
242(2)
14.13.1 Article 13.1 general function health claims
242(1)
14.13.2 Article 13.5 and Article 14 claims
243(1)
14.14 The article 13.1 list included in Commission Regulation 432/2012
244(2)
14.14.1 Regulation (EU) 432/2012
244(1)
14.14.2 Article 13.1 health claims put on hold
244(1)
14.14.3 Commission discussion paper on botanical health claims put on hold
245(1)
14.14.4 Criteria of evaluation of health claims adopted by EFSA under Article 13 (1) of NHCR
245(1)
14.14.5 Reasons for rejection of health claims by EFSA under article 13 (1) of NHCR
246(1)
14.15 Examples of negative and positive opinions on botanical health claims evaluated by EFSA
246(1)
14.16 Conclusions
246(11)
References
253(4)
Chapter 15 History and Current Status of Functional Food Regulations in Japan
257(8)
15.1 Introduction
257(1)
15.2 FoSHU
257(2)
15.3 Food with nutrient function claim
259(1)
15.4 Revision of FoSHU categories
260(1)
15.5 Function evaluation of FoSHU
260(1)
15.6 Safety evaluation of FoSHU
261(1)
15.7 The future of functional food regulations in Japan
262(3)
References
263(2)
Chapter 16 Health Foods and Foods with Health Claims in Japan
265(36)
16.1 Introduction
265(1)
16.2 Historical development of FFs
266(2)
16.2.1 CAA
268(1)
16.3 HF
268(4)
16.3.1 HF and FOSHU markets
268(1)
16.3.2 Implications of defining HF
269(1)
16.3.3 Necessity of regulation for HF
269(1)
16.3.4 Labeling and laws
270(2)
16.4 Regulatory systems on HF
272(6)
16.4.1 Food safety basic act
272(1)
16.4.2 Pharmaceutical affairs law
272(3)
16.4.3 Health promotion law
275(1)
16.4.4 Food sanitation law
276(1)
16.4.5 Japan agricultural standards law
277(1)
16.4.6 Act against unjustifiable premiums and misleading representations and other laws
278(1)
16.5 FA
278(1)
16.6 FHC
279(1)
16.7 FSDU
280(1)
16.8 FOSHU
281(6)
16.8.1 Approval system for FOSHU
281(1)
16.8.2 Number of FOSHU
282(1)
16.8.3 Qualified FOSHU and standardized FOSHU
283(3)
16.8.4 FOSHU and the Japanese traditional diets
286(1)
16.8.5 FOSHU and botanicals
287(1)
16.8.6 Disease risk reduction claims
287(1)
16.9 FNFC
287(1)
16.10 Safety
288(5)
16.10.1 Risk analysis by the FSC
288(1)
16.10.2 General foods and safety concern
289(3)
16.10.3 GMP guideline for HF products
292(1)
16.10.4 Guideline for self-investigation of the safety of raw materials
292(1)
16.11 Discussion
293(8)
Acknowledgments
298(1)
References
298(3)
Chapter 17 Complementary Medicine Regulation in Australia
301(8)
17.1 Introduction
301(1)
17.2 What are CMs?
301(1)
17.2.1 Designated active ingredients
301(1)
17.3 How CMs are regulated in Australia
302(2)
17.3.1 Two-tiered regulatory system
302(1)
17.3.2 Risk management
303(1)
17.3.3 ARGCM structure and content
304(1)
17.3.4 TGA post-market regulatory activity of CMs
304(1)
17.3.5 Adverse events reporting
304(1)
17.4 Advertising of CMs
304(1)
17.5 Attitudes of consumers and healthcare professionals to CMs
305(1)
17.5.1 Recent controversies
306(1)
17.6 Commentary
306(1)
17.7 Way forward
307(2)
References
307(2)
Chapter 18 Russian Regulations on Nutraceuticals and Functional Foods
309(18)
18.1 Introduction
309(2)
18.2 Russian regulations on nutraceuticals
311(5)
18.3 Russian regulations on functional foods
316(6)
18.4 Russian regulations on foods for special dietary uses
322(5)
References
325(2)
Chapter 19 Nutraceutical and Functional Food Regulations in India
327(16)
19.1 Introduction
327(2)
19.2 Positioning benefits
329(1)
19.3 Indian market and health
330(1)
19.4 Regulation
330(6)
19.4.1 Overview of regulations
332(1)
19.4.2 History of food regulations in India
333(3)
19.5 Emerging opportunities
336(1)
19.6 Regulation of claims pertaining to nutraceuticals
337(1)
19.7 Licensing and registration requirements
337(3)
19.7.1 Regulatory requirements for entry in India
338(2)
19.8 Recommendation and conclusion
340(3)
References
341(2)
Chapter 20 Regulations on Nutraceuticals, Functional Foods and Dietary Supplements in India
343(20)
20.1 Introduction
343(2)
20.2 Food Safety and Standards Act
345(12)
20.2.1 The Food Safety and Standards Regulations
346(1)
20.2.2 Licensing and registration
347(1)
20.2.3 Product approval
347(1)
20.2.4 Packaging and labeling regulations
347(2)
20.2.5 Food product standards and food additives
349(1)
20.2.6 Prohibition and restrictions on sales
350(1)
20.2.7 Regulations on contaminants, toxins, and residues
350(1)
20.2.8 Regulations on laboratory and sampling analysis
350(1)
20.2.9 Regulation on authorization of health claims
351(1)
20.2.10 Food recall procedures
351(2)
20.2.11 Food import and clearance regulations
353(1)
20.2.12 Advisory on misbranding/misleading claims/labeling claims
353(2)
20.2.13 Regulation of energy drinks and caffeinated beverages
355(1)
20.2.14 Offenses and penalties
356(1)
20.3 MLM/direct selling
357(1)
20.4 AYUSH
358(1)
20.5 Probiotic regulatory overview
359(1)
20.6 Conclusion
359(4)
References
360(3)
Chapter 21 Historical Change of Raw Materials and Claims of Health Food Regulations in China
363(26)
21.1 Introduction
363(1)
21.2 Definition of Health Foods in China
363(2)
21.3 Evolution of allowable claims of health foods
365(3)
21.3.1 New function claim
367(1)
21.4 Raw Materials used in health foods
368(4)
21.5 Nutrient supplements
372(5)
21.6 Historical approval
377(9)
21.7 Conclusion
386(3)
References
386(3)
Chapter 22 Regulations on Health/Functional Foods in Korea
389(12)
22.1 Introduction
389(1)
22.2 HFFA
389(2)
22.3 Generic HFFs
391(1)
22.4 Product-specific HFFs
392(5)
22.4.1 Standardization
392(2)
22.4.2 Safety evaluation
394(1)
22.4.3 Efficacy evaluation
394(2)
22.4.4 Specification
396(1)
22.4.5 Claims approved for product-specific HFFs
396(1)
22.5 Advisory committees
397(1)
22.6 Future perspectives
397(4)
References
400(1)
Chapter 23 Phytomedicines, Functional Foods, Nutraceuticals, and Their Regulation in Africa
401(18)
23.1 Introduction
401(3)
23.2 African herbal medicine
404(7)
23.2.1 African medicinal plants on the market
405(4)
23.2.2 Difficulties facing herbal medicine
409(2)
23.3 Reφulatory status of botanical drugs and functional foods in Africa
411(3)
23.4 Conclusion
414(5)
References
414(5)
Chapter 24 Regulation of Functional Foods in Selected Asian Countries in the Pacific Rim
419(46)
24.1 Introduction
419(1)
24.2 Taiwan
420(4)
24.2.1 Preamble
420(2)
24.2.2 Selling health (functional) foods in Taiwan
422(1)
24.2.3 Labeling
423(1)
24.3 Hong Kong
424(6)
24.3.1 Preamble
424(2)
24.3.2 Health foods regulations
426(1)
24.3.3 Food labeling regulations
427(1)
24.3.4 Nutrition labeling, nutrition claims, and health claims
428(2)
24.4 South Korea
430(11)
24.4.1 Preamble
430(1)
24.4.2 KFDA
431(2)
24.4.3 Food laws
433(4)
24.4.4 Business permit
437(1)
24.4.5 Quality and manufacturing process
438(1)
24.4.6 Labeling requirements
438(2)
24.4.7 Regulations pertaining to health functional foods
440(1)
24.4.8 Recognition of standards, specifications, and ingredients for health functional foods
440(1)
24.4.9 Importation of functional foods to Korea
441(1)
24.5 Malaysia
441(10)
24.5.1 Preamble
441(1)
24.5.2 Functional foods
442(1)
24.5.3 Food laws and regulations
443(7)
24.5.4 Health and medicinal food products
450(1)
24.6 Indonesia
451(2)
24.6.1 Preamble
451(1)
24.6.2 Functional foods
451(1)
24.6.3 Nutritional labeling
452(1)
24.6.4 Health claims
453(1)
24.7 Philippines
453(2)
24.7.1 Preamble
453(1)
24.7.2 Functional foods
454(1)
24.7.3 Nutritional labeling and health claims
454(1)
24.8 Singapore
455(3)
24.8.1 Preamble
455(1)
24.8.2 Functional foods
455(1)
24.8.3 Nutritional labeling and nutrition and health claims
456(2)
24.9 Thailand
458(7)
24.9.1 Functional foods
458(1)
24.9.2 Nutritional labeling and nutrition and health claims
458(1)
References
459(6)
Chapter 25 Overview of Regulations and Development Trends of Functional Foods in Malaysia
465(14)
25.1 Introduction
465(1)
25.2 Western versus eastern perspective on functional foods
466(1)
25.3 Functional foods and the unique Malaysian society
467(1)
25.4 Functional food research in Malaysia
468(2)
25.5 Overview of regulatory environment in Malaysia
470(3)
25.5.1 Regulations concerning nutrition labels and health claims
471(2)
25.6 Market size, structure, and development trends in Malaysia
473(2)
25.6.1 Demand for functional food in Malaysia
473(1)
25.6.2 Future demand and challenges
474(1)
25.7 Conclusion
475(4)
References
476(3)
Chapter 26 World Trade Organization and Food Regulation: Impact on the Food Supply Chain
479(18)
26.1 Food regulation, supply chain, and the world trade organization
479(6)
26.2 Sanitary and phytosanitary agreements
485(3)
26.3 HACCP
488(9)
Acknowledgment
493(1)
References
493(4)
PART V REGULATIONS ON PET FOOD
Chapter 27 Functional Ingredients in the Pet Food Industry: Regulatory Considerations
497(8)
27.1 Introduction
497(1)
27.2 Regulatory bodies
498(1)
27.3 Regulatory approval of the manufacturing facility
498(1)
27.4 Regulatory approval of the pet food ingredient
499(1)
27.5 Globally accepted pet food ingredients
500(1)
27.6 Regulation trends in pet food ingredients
500(5)
27.6.1 GMO
500(1)
27.6.2 Other trends in regulations
500(1)
27.6.3 Health claims regulations
501(1)
Links
501(1)
References
502(3)
PART VI VALIDATION APPROACH
Chapter 28 Validation Approach in Nutraceutical Industry
505(14)
28.1 Background
505(1)
28.2 Validation approach: V-model
505(9)
28.2.1 Validation master plan
506(1)
28.2.2 User requirements specification
507(1)
28.2.3 FAT
508(1)
28.2.4 Validation protocols
508(1)
28.2.5 IQ
509(1)
28.2.6 OQs
510(1)
28.2.7 PQ
511(1)
28.2.8 PV
512(1)
28.2.9 Cleaning validation
513(1)
28.2.10 Revalidation and change control
514(1)
28.3 Definitions
514(5)
References
515(4)
PART VII ADVERSE EVENT REPORTING
Chapter 29 Global Adverse Event Reporting Regulations for Nutraceuticals, Functional Foods, and Dietary/Food/Health Supplements
519(10)
29.1 Introduction
519(1)
29.2 Global AE monitoring and reporting regulations
520(2)
29.2.1 United States
520(1)
29.2.2 Canada
521(1)
29.2.3 Australia
521(1)
29.2.4 South Korea
522(1)
29.2.5 Peru
522(1)
29.2.6 France
522(1)
29.3 Post-market surveillance versus AE reporting
522(1)
29.4 Guidance for industry and regulators
523(6)
References
524(5)
PART VIII INTELLECTUAL PROPERTY, BRANDING, TRADEMARK, AND REGULATORY APPROVALS IN NUTRACEUTICALS AND FUNCTIONAL FOODS
Chapter 30 Intellectual Property, Branding, Trademark, and Regulatory Approvals in Nutraceuticals and Functional Foods
529(12)
30.1 Introduction
529(1)
30.2 Nutraceuticals, patent rights, and bioprospecting
530(5)
30.3 Branding: a hypothetical case scenario
535(4)
30.3.1 Protecting your patents with coded identities and branding... the right way
537(2)
30.4 Conclusion
539(2)
References
540(1)
Index 541(10)
Food Science and Technology International Series 551
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.