Atnaujinkite slapukų nuostatas

Nutraceutical and Functional Food Regulations in the United States and around the World 3rd edition [Minkštas 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: Paperback / softback, 714 pages, aukštis x plotis: 235x191 mm, weight: 1380 g
  • Išleidimo metai: 11-Jun-2019
  • Leidėjas: Academic Press Inc
  • ISBN-10: 0128164670
  • ISBN-13: 9780128164679
Kitos knygos pagal šią temą:
Nutraceutical and Functional Food Regulations in the United States and around the World 3rd editionDidesnis paveikslėlis
  • Formatas: Paperback / softback, 714 pages, aukštis x plotis: 235x191 mm, weight: 1380 g
  • Išleidimo metai: 11-Jun-2019
  • Leidėjas: Academic Press Inc
  • ISBN-10: 0128164670
  • ISBN-13: 9780128164679
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9780128164679.html

Nutraceutical and Functional Food Regulations in the United States and Around the World, Third Edition addresses the latest regulatory requirements designed to ensure the safe production and delivery of these valuable classes of foods. The book is well recognized, showing how food and nutrition play a critical role in enhancing human performance, and in overall health. The book discusses the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries, exploring the acceptance and demand for these products, regulatory hurdles, the intricate aspects of manufacturing procedures, quality control, global regulatory norms and guidelines.

  • Contains five new chapters that address regulations in Germany, New Zealand, Saudi Arabia, the United Arab Emirates, South Africa and Brazil, Argentina and other Southern American Countries
  • Provides foundational regulatory terminology
  • Describes GRAS status and its role in functional food
  • Presents a complete overview of cGMP and GMP
  • Identifies and defines the roles of NSF, DSHEA, FTC and FDA
List of contributors xxvii
Preface xxxiii
Part I Introduction
Chapter 1 Nutraceuticals and functional foods: innovation, insulation, evangelism, and evidence
3(10)
Anthony L. Almada
1.1 Introduction
3(1)
1.2 The mirage that moves
3(1)
1.3 Misinformation and missed opportunities
4(1)
1.4 Value addition or illusion?
5(1)
1.5 Transforming evangelism into evidence
6(2)
1.6 Land mines and weapons of brand destruction
8(1)
1.7 Mirage to mass demand
9(1)
1.8 Conclusion
10(1)
References
10(1)
Further reading
11(2)
Chapter 2 Nutritional supplements and functional foods: functional significance and global regulations
13(24)
Nandini Ghosh
Amitava Das
Chandan K. Sen
2.1 Introduction
13(1)
2.2 History
13(2)
2.3 Health behaviors and food markets
15(7)
2.3.1 Possibilities to boost food health-promoting properties
16(6)
2.4 Research needs: safety and efficacy
22(5)
2.4.1 Dietary Supplement Health and Education Act of 1994
23(1)
2.4.2 Codex: harmonizing food and supplement rules among all nations of the world
24(2)
2.4.3 International Alliance of Dietary Food Supplement Associations
26(1)
2.5 Conclusion
27(1)
Acknowledgments
27(1)
References
27(10)
Chapter 3 Global market entry regulations for nutraceuticals, functional foods, and dietary/food/health supplements
37(10)
Andrew Shao
3.1 Introduction
37(1)
3.2 Market entry requirements
37(7)
3.2.1 Positive and negative ingredient lists
39(2)
3.2.2 Botanicals
41(1)
3.2.3 Notification versus registration
41(3)
References
44(3)
Chapter 4 Industry self-regulatory activities complement FDA's dietary supplement regulations
47(14)
Haiuyen Nguyen
Julia Shenkar
James C. Griffiths
4.1 Introduction
47(1)
4.2 Brief overview of legislative and regulatory history
47(2)
4.3 Definitions
49(1)
4.4 Dietary supplement safety
49(2)
4.4.1 Current good manufacturing practices
49(1)
4.4.2 Adverse events reporting
50(1)
4.4.3 Ingredient safety
50(1)
4.4.4 Food and Drug Administration Food Safety Modernization Act
51(1)
4.5 Dietary supplement labeling
51(2)
4.5.1 Dietary supplement claims
52(1)
4.5.2 Dietary supplement claims enforcement
53(1)
4.6 Food and Drug Administration and Federal Trade Commission guidance
53(2)
4.7 Industry self-regulatory activities
55(1)
4.8 Transparency initiatives
56(1)
4.9 Online databases
56(1)
4.10 Accountability initiatives
57(1)
4.11 Best practices and voluntary guidelines
57(1)
4.12 Advertising
58(1)
4.13 Conclusion
59(1)
References
59(2)
Chapter 5 The Food Safety Modernization Act (FSMA)'s role in the safety of functional foods and their ingredients
61(14)
Willette M. Crawford
5.1 Introduction
61(1)
5.2 Existing food safety regulatory framework
61(3)
5.3 Challenges associated with the US regulatory approach
64(1)
5.4 The Food Safety Modernization Act
65(7)
5.4.1 Background
65(1)
5.4.2 Preventive Controls for Human Food rule
65(3)
5.4.3 Foreign Supplier Verification Programs rule
68(3)
5.4.4 Intentional Adulteration rule
71(1)
5.4.5 Accredited Third-Party Certification rule
72(1)
5.5 Summary and concluding remarks
72(1)
Reference
73(1)
Further reading
73(2)
Chapter 6 An overview of gluten-free foods and related disorders
75(14)
Imtiaz Ahmad
Anand Swaroop
Debasis Bagchi
6.1 Introduction
75(4)
6.2 Serological tests for gluten-related disorder-celiac disease
79(1)
6.3 Treatment of diagnosed individuals with gluten-related disorders/celiac disease
80(1)
6.4 Gluten-free flours for pasta-making
81(1)
6.5 Gluten-free flours for making bread
81(1)
6.6 Gluten-free foods and FDA recommendations
82(1)
6.7 Gluten-free food market
83(1)
6.8 Maintaining a balanced diet while eating gluten-free
83(1)
6.9 Conclusion
83(1)
References
84(5)
Part II Manufacturing compliance and analytical validation
Chapter 7 Analytical validation and method development for functional food and nutraceutical manufacturing
89(8)
Digambar Chahar
7.1 Introduction
89(1)
7.2 Analytical validation
89(1)
7.3 Method development
90(1)
7.4 Analytical method development process
91(1)
7.5 Specificity
91(1)
7.6 Linearity
92(1)
7.7 Accuracy
92(1)
7.8 Precision
93(1)
7.9 Limit of detection and limit of quantitation
93(1)
7.10 Stability
93(1)
7.11 Robustness
94(1)
7.12 Quality control on assay
94(1)
7.13 Challenges
94(1)
7.14 Conclusion
95(1)
References
95(2)
Chapter 8 Natural health products and good manufacturing practices
97(10)
Digambar Chahar
8.1 Overview
97(1)
8.2 Who do GMP guidelines apply to?
97(1)
8.3 GMPs: an introduction
97(1)
8.4 Basic elements of GMP
98(2)
8.4.1 Places
98(1)
8.4.2 People
99(1)
8.4.3 Processes
99(1)
8.4.4 Products
99(1)
8.4.5 Environment
99(1)
8.5 Benefits of GMP/HACCP programs
100(1)
8.6 GMP procedures: considerations for manufacturers
100(1)
8.7 Quality management system
101(2)
8.7.1 Overview of the quality management system
101(1)
8.7.2 Elements of the quality management system
102(1)
8.7.3 Establishing a quality management system
103(1)
8.8 Conclusion
103(1)
Further reading
103(4)
Part III Importance of safety assessment
Chapter 9 Safety assessment of herbal food ingredients and nutraceuticals
107(14)
Odete Mendes
Jayson Chen
Raghavendra Gowda
9.1 Introduction
107(1)
9.2 Ingredient characterization
107(4)
9.2.1 Manufacturing process considerations
107(1)
9.2.2 Raw material specifications
108(1)
9.2.3 Final product specifications
109(1)
9.2.4 Characterization of botanical extracts and mixtures
109(1)
9.2.5 Contaminants and impurities
110(1)
9.3 Generally Regarded as Safe
111(6)
9.3.1 Generally Regarded as Safe notification
114(1)
9.3.2 Evidence of safety
114(1)
9.3.3 Generally Regarded as Safe panel
115(1)
9.3.4 Generally Regarded as Safe criteria
116(1)
9.4 New Dietary Ingredient
117(3)
9.4.1 New Dietary Ingredient notification
117(1)
9.4.2 Evidence of safety
118(2)
References
120(1)
Chapter 10 Breaking down the barriers to functional foods, supplements, and claims
121(26)
George A. Burdock
Ioana G. Carabin
10.1 Introduction
121(1)
10.2 Terminology
122(2)
10.3 The struggle: players and issues
124(7)
10.3.1 Ontogeny and current status of the regulations
125(1)
10.3.2 Health claims and the NLEA and FDAMA
126(3)
10.3.3 Qualified health claims
129(2)
10.4 DSHEA: SFCs and a new safety standard
131(7)
10.4.1 A closer look at the definition
131(3)
10.4.2 The exclusionary clause and section 301(11) of the Food, Drug, and Cosmetic Act
134(2)
10.4.3 The standard for safety
136(2)
10.5 The immediate future and the path forward for the FDA
138(6)
10.5.1 The immediate future
138(1)
10.5.2 Four things the FDA must do to resolve the impasse
139(5)
10.6 Discussion
144(1)
10.7 Conclusion
145(1)
Acknowledgments
145(1)
References
146(1)
Chapter 11 NSF International's role in the dietary supplements and nutraceuticals industries
147(14)
John Travis
Lisa Glymph Lattimore
Michael Harvey
Thomas Frey
11.1 A look at the market
147(1)
11.2 Brief history of NSF International
147(3)
11.2.1 History of standards development and independent third-party certification
147(1)
11.2.2 Organizational growth
148(1)
11.2.3 NSF testing and certification
148(1)
11.2.4 Why did NSF International start a certification program for dietary supplements?
149(1)
11.3 What are Good Manufacturing Practices?
150(6)
11.3.1 Good Manufacturing Practices regulations
150(2)
11.3.2 Good Manufacturing Practices and compliance issues
152(4)
11.3.3 Good Manufacturing Practices, compliance, and costs
156(1)
11.3.4 Importance of Good Manufacturing Practices registration and Good Manufacturing Practices registration processes
156(1)
11.4 Importance of independent third-party certification
156(1)
11.4.1 Increase in dietary supplement product certification
157(1)
11.5 Future outlook
157(1)
References
158(1)
Further reading
158(3)
Part IV Regulations around the world
Chapter 12 US regulation of food label claims
161(16)
James E. Hoadley
12.1 Overview
161(1)
12.2 Food and Drug Administration's authority for regulating food label claims
162(2)
12.3 Health claims
164(8)
12.3.1 Substantiation standard for health claims
164(1)
12.3.2 General health claim regulation
164(2)
12.3.3 Authorized health claims
166(3)
12.3.4 Qualified health claims
169(3)
12.4 Structure-function claims
172(2)
12.5 Nutrient content claims
174(2)
12.5.1 Healthy, an implied nutrient content claim
175(1)
References
176(1)
Chapter 13 Regulatory constraints and considerations on new product formulation and advertising in the United States
177(18)
Rend Al-Mondhiry
Katie Bond
Jennifer Adams
13.1 Regulatory requirements surrounding product formulation
177(9)
13.1.1 Conventional foods
177(2)
13.1.2 Dietary supplements and dietary ingredients
179(4)
13.1.3 Specific constraints on formulation
183(3)
13.2 Product claim substantiation constraints and considerations
186(7)
13.2.1 The Federal Trade Commission
186(1)
13.2.2 The Food and Drug Administration, state regulation, and third-party organizations
187(1)
13.2.3 Specific types of claims
188(4)
13.2.4 Advertising challenges by private actors
192(1)
13.3 Conclusion
193(2)
Chapter 14 Conventional foods and dietary supplements labeling claims in the United States
195(8)
Sanjiv Agarwal
Stein Hordvik
Sandra Morar
14.1 Introduction
195(1)
14.2 Nutrient content claims
195(2)
14.3 Structure/function claims
197(1)
14.4 Health claims
198(3)
14.5 Dietary guidance statements
201(1)
14.6 Factual statements
201(1)
14.7 Nutritional claims display on packages
201(1)
References
202(1)
Chapter 15 Understanding medical foods under FDA regulations
203(12)
Claudia A. Lewis
Michelle C. Jackson
Jordan R. Bailey
15.1 History of medical foods
203(5)
15.2 FDA guidance
208(2)
15.2.1 Inborn errors of metabolism
209(1)
15.2.2 Pregnancy
209(1)
15.2.3 Diabetes mellitus (DM) types 1 and 2
209(1)
15.2.4 Nutrient deficiency diseases
209(1)
15.3 Good manufacturing practices and import/export
210(1)
15.4 FDA enforcement of medical foods
211(1)
15.5 Looking forward
212(3)
Chapter 16 Canadian regulatory initiatives for natural health products (dietary supplements)
215(20)
John R. Harrison
16.1 Introduction
215(1)
16.2 What is an NHP?
216(1)
16.3 Current statistics on the NHPD regulatory products: what do the numbers show?
217(2)
16.4 NHPs transitioning to food products: a regulatory transition process
219(1)
16.5 A "new approach" to regulating NHPs
220(6)
16.5.1 Three-class system
220(1)
16.5.2 Guidance document 2012
221(2)
16.5.3 Site licenses
223(1)
16.5.4 Quality
224(1)
16.5.5 Compliance transition
225(1)
16.6 Recent modifications by the NNHPD facilitating business and regulatory processes
226(1)
16.7 The larger picture: mutual recognition agreements
227(2)
16.8 Postmarket activities following product approval
229(1)
16.8.1 Adverse reaction reporting
229(1)
16.8.2 Postmarket surveillance
229(1)
16.9 Natural Health Products Program evaluation and audit
230(1)
16.9.1 Evaluation of the Natural Health Products Program
230(1)
16.9.2 Audit of the Natural Health Products Program
231(1)
16.10 Conclusion
231(1)
References
232(3)
Chapter 17 Regulation of dietary supplements and functional foods in Canada
235(18)
Jon-Paul Powers
Matthew Farrell
Colleen McMullin
Lewis Retik
Jessica White
17.1 Introduction
235(1)
17.2 Foods
236(15)
17.2.1 Food health claims
236(1)
17.2.2 Disease risk reduction and therapeutic claims
237(1)
17.2.3 Function claims
237(1)
17.2.4 Probiotic claims
237(1)
17.2.5 Supplemented foods
237(5)
17.2.6 Natural health products (NHPs)
242(1)
17.2.7 Premarket approval process
242(3)
17.2.8 Class I application
245(1)
17.2.9 Class II application
245(1)
17.2.10 Class III application
245(1)
17.2.11 Evidentiary requirements for products making traditional health claims
246(1)
17.2.12 Evidentiary requirements for products making modern health claims
247(1)
17.2.13 Quality
248(1)
17.2.14 Site licensing
248(1)
17.2.15 Post-license changes
249(1)
17.2.16 Future considerations
250(1)
References
251(2)
Chapter 18 Current legislation in the European context: a focus on food labeling, novel foods, nutrition, and health claims
253(14)
Daniela Martini
Cristian Del Bo
Alessia Cavaliere
18.1 Introduction
253(1)
18.2 The framework of European legislation on food
254(8)
18.2.1 Food supplements and nutraceuticals in Europe
254(1)
18.2.2 The mandatory information on foods
254(2)
18.2.3 The nutrition and health claims made on foods
256(4)
18.2.4 The rules on novel foods
260(2)
18.3 Conclusions
262(1)
References
263(2)
Web sites
265(2)
Chapter 19 Regulation of functional foods in European Union: assessment of health claim by the European Food Safety Authority
267(10)
Asim K. Duttaroy
19.1 Introduction
267(2)
19.2 Health claim assessment of water-soluble tomato extract by European Food Safety Authority
269(1)
19.3 Scientific substantiation of Fruitflow
270(4)
19.4 Compositional and structural aspects of Fruitflow
274(1)
19.5 Human trials using Fruitflow
274(1)
19.6 Commercially available Fruitflow
275(1)
19.7 Conclusions
275(1)
References
275(2)
Chapter 20 Botanical nutraceuticals (food supplements and fortified and functional foods) and novel foods in the EU, with a main focus on legislative controls on safety aspects
277(46)
Om P. Gulati
Peter Berry Ottaway
Sam Jennings
Patrick Coppens
Neelam Gulati
20.1 Introduction
277(2)
20.2 The concept of a nutraceutical, past and present
279(2)
20.3 European Union legislation defining botanicals as medicines or foods
281(3)
20.4 Novel foods and nutraceuticals
284(5)
20.4.1 Three examples of novel food (authorized novel foods from botanicals category)
288(1)
20.5 European Union regulatory status of botanicals nutraceuticals (food supplements and fortified and functional foods)
289(6)
20.5.1 Food supplements
289(4)
20.5.2 Fortified and functional food from botanical sources
293(1)
20.5.3 Regulation on mutual recognition
294(1)
20.6 Quality of botanical nutraceuticals
295(6)
20.6.1 Regulatory controls
296(3)
20.6.2 Industry guidance and actions
299(2)
20.7 Safety of botanical nutraceuticals
301(7)
20.7.1 Precautionary principle
301(1)
20.7.2 Contaminant safety
302(2)
20.7.3 Article 8 procedure in fortified foods regulation
304(1)
20.7.4 Other legal controls on nutraceutical safety
305(3)
20.8 Efficacy of botanical nutraceuticals
308(6)
20.8.1 Health claims
309(1)
20.8.2 Health claims and their substantiation
310(3)
20.8.3 Concept of traditional food use
313(1)
20.9 Discussion and future of botanical nutraceuticals in the European Union
314(2)
20.10 Conclusion
316(1)
References
317(6)
Chapter 21 Salient features of European Union regulations on nutraceuticals and functional foods
323(14)
Izabela Tanska
21.1 Introduction
323(1)
21.2 Introduction to food law
324(1)
21.3 Legal regulations applicable to the ingredients of "functional foods" and "nutraceuticals"
324(5)
21.3.1 Food fortification
324(1)
21.3.2 Food additives
325(2)
21.3.3 Botanical ingredients
327(1)
21.3.4 Novel food
327(2)
21.3.5 Genetically Modified Organisms
329(1)
21.4 Marketing principles
329(2)
21.5 Distribution of "functional food" and "nutraceuticals"
331(1)
21.6 Information on "functional food" and "nutraceuticals" provided to consumers
332(3)
21.6.1 Mandatory food information
332(1)
21.6.2 Declaring beneficial health effects
333(2)
21.7 Conclusions
335(1)
References
336(1)
Further reading
336(1)
Chapter 22 History and current status of functional food regulations in Japan
337(8)
Makoto Shimizu
22.1 Introduction
337(1)
22.2 FoSHU
337(2)
22.3 Food with nutrient function claim
339(1)
22.4 Revision of FoSHU categories
339(1)
22.5 Function evaluation of FoSHU
340(1)
22.6 Safety evaluation of FoSHU
341(1)
22.7 Food with functional claims, a new health claim labeling system
341(1)
22.8 Difference between FoSHU and FFC
342(1)
22.9 Current status of FFC
342
References
144(201)
Chapter 23 Health foods and foods with health claims in Japan
345(32)
Hirobumi Ohama
Hideko Ikeda
Hiroyoshi Moriyama
23.1 Introduction
345
23.2 Historical development of FFs
146(202)
23.2.1 CAA
347(1)
23.3 HF
348(2)
23.3.1 HF and FOSHU markets
348(1)
23.3.2 Implications of defining HF
348(1)
23.3.3 Necessity of regulation for HF
348(1)
23.3.4 Labeling and Acts
348(2)
23.4 Regulatory systems on HF
350
23.4.1 Food Safety Basic Act
352(1)
23.4.2 Pharmaceutical Affairs Act (prior to the revision of the Act in 2014)
352(3)
23.4.3 Health Promotion Act
355(1)
23.4.4 Food Sanitation Act
355(1)
23.4.5 Japanese Agricultural Standards
356(1)
23.4.6 The Act Against Unjustifiable Premiums and Misleading Representations, and other Acts
357
23.5 FA
157(201)
23.6 FHC
358(1)
23.7 FSDU
359(1)
23.8 FOSHU
359(7)
23.8.1 Approval system for FOSHU
359(2)
23.8.2 Number of FOSHU
361(1)
23.8.3 Qualified FOSHU and Standardized FOSHU
362(2)
23.8.4 FOSHU and Japanese traditional diets
364(1)
23.8.5 FOSHU and botanicals
365(1)
23.8.6 Disease risk reduction claims
365(1)
23.9 FNFC
366(1)
23.10 FFC
366(1)
23.11 Safety
367(4)
23.11.1 Risk analysis by the FSC
367(2)
23.11.2 General foods and safety concern
369(1)
23.11.3 GMP. guidelines for HF products
370(1)
23.11.4 Guidelines for self-investigation of the safety of raw materials
370(1)
23.12 Discussion
371(5)
Acknowledgments
376(1)
References
376(1)
Chapter 24 Foods with function claims emerging from the framework of so-called health foods
377(10)
Hiroyoshi Moriyama
Hideko Ikeda
Debasis Bagchi
24.1 Introduction
377(1)
24.2 Foods with function claims system
378(1)
24.3 So-called health foods to foods with function claims
378(5)
24.3.1 Documentation
379(4)
24.4 Impacts on stakeholders
383(1)
24.5 Potential challenges
384(1)
24.6 Conclusion
384(1)
References
385(2)
Chapter 25 Complementary medicine regulation in Australia
387(12)
Tobey-Ann Pinder
Dilip Ghosh
25.1 Introduction
387(1)
25.2 What complementary medicines are
387(1)
25.2.1 Designated active ingredients
388(1)
25.3 How complementary medicines are regulated in Australia
388(5)
25.3.1 Risk management
388(1)
25.3.2 A three-tiered risk-based framework for complementary medicines (https://www.tga.gov.au/complementary-medicines)
389(1)
25.3.3 Registered medicines (AUST R)
390(1)
25.3.4 Listed medicines (AUST L)
390(1)
25.3.5 Assessed listed medicines (AUST L(A))
390(1)
25.3.6 TGA postmarket regulatory activity of complementary medicines
391(1)
25.3.7 Summary of the regulatory requirements for complementary medicines pathways
391(1)
25.3.8 The Australian Regulatory Guidelines for Complementary Medicines
392(1)
25.4 Adverse events reporting for complementary medicines
393(1)
25.5 Advertising of complementary medicines
393(2)
25.6 Attitudes of consumers and healthcare professionals to complementary medicines
395(1)
25.7 Recent reforms
396(1)
25.7.1 Complementary medicine reforms that have been implemented
396(1)
25.7.2 Upcoming complementary medicine reforms
397(1)
25.8 Commentary
397(1)
References
398(1)
Chapter 26 Russian regulations on nutraceuticals, functional foods, and foods for special dietary uses
399(18)
Victor A. Tutelyan
Boris P. Sukhanov
Alla A. Kochetkova
Svetlana A. Sheveleva
Elena A. Smirnova
26.1 Introduction
399(3)
26.2 Russian regulations on nutraceuticals
402(3)
26.3 Russian regulations on functional foods
405(7)
26.4 Russian regulations on foods for special dietary uses
412(3)
References
415(2)
Chapter 27 Road map to enter Indian nutraceuticals and health supplements business
417(14)
Pradip Chakraborty
27.1 Introduction
417(1)
27.2 Scope of the regulations
418(1)
27.3 Categories of products
418(1)
27.4 General requirements of the regulations
418(1)
27.5 Schedules
419(1)
27.6 Claims 3
420(1)
27.7 Salient features of the regulations
420(8)
27.7.1 Health supplements
420(1)
27.7.2 Nutraceuticals
421(1)
27.7.3 Food with added probiotic ingredients
422(1)
27.7.4 Food with added prebiotic ingredients
423(1)
27.7.5 Food for special dietary use, other than infants, and those products intended to be taken under medical advice
423(2)
27.7.6 Food for special medical purpose
425(2)
27.7.7 Specialty food containing plant or botanical ingredients with safe history of usage
427(1)
27.7.8 Novel food
427(1)
27.8 Approval of nonspecified food and food ingredients
428(2)
27.9 Conclusion
430(1)
Further reading
430(1)
Chapter 28 Nutraceutical and functional food regulations in India
431(14)
Raj K. Keservani
Urmila Jarouliya
Anil K. Sharma
28.1 Introduction
431(2)
28.2 Positioning benefits
433(1)
28.3 Indian market and health
433(2)
28.4 Regulation
435(4)
28.4.1 Overview of regulations
435(1)
28.4.2 History of food regulations in India
436(3)
28.5 Emerging opportunities
439(1)
28.6 Regulation of claims pertaining to nutraceuticals
439(1)
28.7 Licensing and registration requirements
440(2)
28.7.1 Regulatory requirements for entry in India
440(2)
28.8 Recommendations and conclusion
442(1)
References
443(2)
Chapter 29 Regulations on nutraceuticals, functional foods, and dietary supplements in India
445(20)
Kiran Bhupathiraju
Alluri V. Krishnaraju
Krishanu Sengupta
Trimurtulu Golakoti
Sameer K. Akolkar
Praneel Datla
29.1 Introduction
445(1)
29.2 Food Safety and Standards Act
446(13)
29.2.1 Food Safety and Standards Regulations
447(1)
29.2.2 Licensing and registration
447(1)
29.2.3 Product approval
448(1)
29.2.4 Packaging and labeling regulations
449(2)
29.2.5 Food Product Standards and Food Additives
451(1)
29.2.6 Prohibition and restrictions on sales
451(1)
29.2.7 Regulations on contaminants, toxins, and residues
451(1)
29.2.8 Regulations on laboratory and sampling analysis
452(1)
29.2.9 Regulation on authorization of health claims
452(2)
29.2.10 Food recall procedures
454(1)
29.2.11 Food import and clearance regulations
455(1)
29.2.12 Regulations for energy drinks and caffeinated beverages
456(1)
29.2.13 Regulations for alcoholic beverages
457(1)
29.2.14 Offenses and penalties
458(1)
29.3 Multilevel marketing/direct selling
459(1)
29.4 Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha, and Homoeopathy AYUSH
460(1)
29.5 Probiotic regulatory overview
460(1)
29.6 Conclusion
461(1)
References
462(3)
Chapter 30 Change in raw materials and claims of health food regulations in China 2013-17
465(32)
Chun Hu
30.1 Introduction
465(1)
30.2 Definition of health functional foods
465(5)
30.3 Evolution of permitted claims for health foods
470(2)
30.4 Update on raw materials used in health functional foods
472(4)
30.5 Nutrient supplements
476(12)
30.6 Health functional food approval between 2013 and 2017
488(5)
References
493(4)
Chapter 31 Regulations on health/functional foods in Korea
497(12)
Ji Yeon Kim
Seong Ju Kim
Sewon Jeong
31.1 Introduction
497(1)
31.2 The Health/Functional Food Act
497(1)
31.3 Generic HFFs
498(1)
31.4 Product-specific HFFs
499(6)
31.4.1 Standardization
500(1)
31.4.2 Safety evaluation
501(1)
31.4.3 Efficacy evaluation
502(1)
31.4.4 Specification
503(1)
31.4.5 Claims approved for product-specific HFFs
503(2)
31.5 Advisory committees
505(1)
31.6 Future perspectives
506(1)
References
507(2)
Chapter 32 Phytomedicines, nutraceuticals, and functional foods regulatory framework: the African context
509(14)
Theeshan Bahorun
Okezie I. Aruoma
Vidushi S. Neergheen-Bhujun
32.1 Introduction
509(2)
32.2 African herbal medicine
511(5)
32.2.1 African medicinal plants on the market
512(3)
32.2.2 Difficulties facing herbal medicine
515(1)
32.3 Regulatory status of botanical drugs and functional foods in Africa
516(2)
32.4 Food nanotech applications
518(1)
32.5 Conclusion
519(1)
References
519(4)
Chapter 33 Regulation of functional foods in selected Asian countries in the Pacific Rim
523(38)
Jerzy Zawistowski
33.1 Introduction
523(1)
33.2 Taiwan
524(4)
33.2.1 Preamble
524(1)
33.2.2 Selling health (functional) foods in Taiwan
525(2)
33.2.3 Labeling
527(1)
33.3 Hong Kong
528(4)
33.3.1 Preamble
528(1)
33.3.2 Health foods regulations
529(1)
33.3.3 Food labeling regulations
529(2)
33.3.4 Nutrition labeling, nutrition claims, and health claims
531(1)
33.4 South Korea
532(9)
33.4.1 Preamble
532(1)
33.4.2 Korea Food and Drug Administration
533(2)
33.4.3 Food laws
535(1)
33.4.4 Business permit
536(1)
33.4.5 Quality and manufacturing process
536(3)
33.4.6 Labeling requirements
539(1)
33.4.7 Regulations pertaining to health functional foods
540(1)
33.4.8 Recognition of standards, specifications, and ingredients for health functional foods
540(1)
33.4.9 Importation of functional foods to Korea
541(1)
33.5 Malaysia
541(8)
33.5.1 Preamble
541(1)
33.5.2 Functional foods
542(1)
33.5.3 Food laws and regulations
543(5)
33.5.4 Health and medicinal food products
548(1)
33.6 Indonesia
549(2)
33.6.1 Preamble
549(1)
33.6.2 Functional foods
549(1)
33.6.3 Nutritional labeling
550(1)
33.6.4 Health claims
550(1)
33.7 Philippines
551(1)
33.7.1 Preamble
551(1)
33.7.2 Functional foods
551(1)
33.7.3 Nutritional labeling and health claims
552(1)
33.8 Singapore
552(3)
33.8.1 Preamble
552(1)
33.8.2 Functional foods
553(1)
33.8.3 Nutritional labeling and nutrition and health claims
553(2)
33.9 Thailand
555(1)
33.9.1 Functional foods
555(1)
33.9.2 Nutritional labeling and nutrition and health claims
556(1)
References
556(4)
Further reading
560(1)
Chapter 34 Regulations, opportunities, and key trends of functional foods in Malaysia
561(14)
Teck-Chai Lau
34.1 Introduction
561(1)
34.2 Western versus Eastern perspective on functional foods
561(1)
34.3 Functional foods and the unique Malaysian society
562(2)
34.4 Functional food research in Malaysia from business and marketing perspectives
564(1)
34.5 Overview of the regulatory environment in Malaysia
565(2)
34.5.1 Regulations concerning nutrition labels and health claims
566(1)
34.6 Functional foods opportunities in Malaysia
567(2)
34.6.1 The halal market
568(1)
34.7 Overview of the Malaysia food retail sector
569(1)
34.8 Key trends and challenges for functional foods
570(1)
34.9 Conclusion
571(1)
References
572(3)
Chapter 35 World Trade Organization and food regulation: impact on the food supply chain
575(14)
Okezie I. Aruoma
35.1 Introduction
575(5)
35.2 Sanitary and phytosanitary agreements
580(1)
35.3 Hazard at critical control point
581(4)
Acknowledgments
585(1)
References
585(4)
Part V Kosher & halal certification
Chapter 36 Kosher and halal regulations for nutraceutical and functional foods
589(12)
Joe M. Regenstein
36.1 Introduction
589(1)
36.2 Kosher and halal laws
589(1)
36.3 The kosher and halal market
590(1)
36.4 The kosher dietary laws with reference to halal dietary laws
590(7)
36.4.1 Allowed animals
591(1)
36.4.2 Prohibition of blood
592(1)
36.4.3 Prohibition of mixing of milk and meat
593(1)
36.4.4 Other kosher issues
594(2)
36.4.5 Kosher: other processing issues
596(1)
36.5 Additional information about the halal dietary laws
597(1)
36.5.1 Halal dietary laws
597(1)
36.5.2 Prohibited and permitted animals
597(1)
36.5.3 Prohibition of blood
597(1)
36.5.4 Proper slaughtering of permitted animals
597(1)
36.5.5 Prohibition of alcohol and intoxicants
597(1)
36.6 Both kosher and halal
598(1)
36.6.1 Biotechnology
598(1)
Acknowledgment
598(1)
References
598(1)
Further reading
599(1)
Additional readings
599(1)
Additional resources
600(1)
Chapter 37 Kosher certification of nutraceuticals and dietary supplements
601(10)
Rabbi Gavriel Price
37.1 Introduction
601(1)
37.2 Vitamin D3 from Peruvian fish oil
601(2)
37.3 Ashwagandha extract from India
603(1)
37.4 Kale chips from Mexico
604(1)
37.5 Kosher status of inactive ingredients: solvents, diluents, and excipients
604(2)
37.5.1 Ethanol
605(1)
37.5.2 Gelatin
605(1)
37.5.3 Glycerin
606(1)
37.5.4 Magnesium carbonate
606(1)
37.5.5 Magnesium and aluminum stearate
606(1)
37.5.6 Microcrystalline cellulose
606(1)
37.6 Status of uncertified nutraceuticals and functional foods
606(1)
Further reading
607(4)
Part VI Regulations on pet food
Chapter 38 Functional ingredients in the pet food industry: regulatory considerations
611(8)
Jennifer Radosevich
Nikita McGee
Nancy E. Rawson
38.1 Introduction
611(1)
38.2 Regulatory bodies
611(1)
38.3 Regulatory approval of the manufacturing facility
612(1)
38.4 Regulatory approval of pet food ingredients
613(1)
38.5 Globally accepted pet food ingredients
614(1)
38.6 Regulation trends in pet food ingredients
614(1)
38.7 Pet food safety
614(1)
38.8 GMO
614(1)
38.9 Labeling as natural
615(1)
38.10 Links
615(1)
References
616(3)
Part VII Adverse event reporting
Chapter 39 Global adverse event reporting regulations for nutraceuticals, functional foods, and dietary/food/health supplements
619(8)
Andrew Shag
39.1 Introduction
619(1)
39.2 Global adverse event monitoring and reporting regulations
620(2)
39.2.1 United States
620(1)
39.2.2 Canada
621(1)
39.2.3 Australia
621(1)
39.2.4 South Korea
621(1)
39.2.5 Peru
621(1)
39.2.6 France
622(1)
39.3 Postmarket surveillance versus adverse event reporting
622(1)
39.4 Guidance for industry and regulators
623(1)
References
624(1)
Further reading
624(3)
Part VIII Intellectual property, branding, trademark and regulatory approvals in nutraceuticals and functional foods
Chapter 40 Intellectual property, branding, trademark, and regulatory approvals in nutraceuticals and functional foods
627(10)
Leighton K. Chong
Lawrence J. Udell
Bernard W. Downs
40.1 Introduction
627(1)
40.2 Nutraceuticals, patent rights, and bioprospecting
628(4)
40.3 Branding: a hypothetical case scenario
632(3)
40.3.1 Protecting your patents with coded identities and branding...the right way
634(1)
40.4 Conclusion
635(1)
References
636(1)
Chapter 41 Challenges of intellectual property and branding on regulatory approvals
637(20)
Gregory J. Chinlund
Meggan F. Duffy
Danielle K. Johnson
Chelsea M. Murray
Jeffrey S. Sharp
41.1 Introduction
637(1)
41.2 Patents
637(7)
41.2.1 What are patents?
637(1)
41.2.2 Intent of the patent system
638(1)
41.2.3 What can be patented?
638(1)
41.2.4 Requirements of patentability
638(4)
41.2.5 Enforcement of patents
642(2)
41.3 Patents outside the United States
644(1)
41.4 Trade secrets
645(1)
41.5 Trademarks
646(8)
41.5.1 What are trademarks?
646(1)
41.5.2 Trademark protection for nutraceuticals and functional foods
647(4)
41.5.3 Trademark use guidelines
651(1)
41.5.4 Licensing opportunities
652(1)
41.5.5 Trademark enforcement
652(2)
41.5.6 Future marks-brand extension, product extension
654(1)
References
654(3)
Index 657
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.