Table Of ContentNutraceutical and
Functional Food
Regulations in the
United States and
Around the World
Second Edition
Food Science and Technology
International Series
SeriesEditor
Steve L. Taylor
University ofNebraska (cid:1)Lincoln, USA
Advisory Board
Ken Buckle
TheUniversity of New South Wales,Australia
Mary Ellen Camire
University ofMaine, USA
Roger Clemens
University ofSouthern California, USA
Hildegarde Heymann
University ofCalifornia(cid:1)Davis, USA
Robert Hutkins
University ofNebraska (cid:1)Lincoln, USA
Ron S. Jackson
Quebec, Canada
Huub Lelieveld
Bilthoven, The Netherlands
DarylB. Lund
University ofWisconsin,USA
Connie Weaver
Purdue University, USA
Ron Wrolstad
Oregon State University, USA
A complete list of books in thisseries appearsatthe endof thisvolume.
Nutraceutical and
Functional Food
Regulations in the
United States and
Around the World
Second Edition
Edited by
Debasis Bagchi, PhD MACN CNS MAIChE
Department of Pharmacological and Pharmaceutical Sciences
University of Houston College of Pharmacy
Houston, TX, USA
AMSTERDAM(cid:129)BOSTON(cid:129)HEIDELBERG(cid:129)LONDON
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This Book is Dedicated to My Beloved Nephew, Neel Nanda
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In Memoriam
Dr. Hirobumi Ohama, Ph.D., contributed an esteemed chapter in this book, and
unfortunately passed away before the publication of the second edition. During
the last two decades, Dr. Ohama San contributed immensely to the field of
Nutraceutical and Functional Food Regulations in Japan and around the world.
He also contributed significantly in the fields of nutraceutical and functional food
research. Dr. Ohama San was an excellent person, a great friend, a wonderful
human being, and an outstanding scientist. On behalf of all of the contributors
of this book, I convey our sincere regards and respect to our beloved, late
Dr. Ohama San. May his soul rest inpeace.
vii
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Contents
Preface.................................................................................................................xxiii
Preface tothe FirstEdition................................................................................xxvii
List ofContributors..............................................................................................xxxi
PART I INTRODUCTION
CHAPTER 1 Nutraceuticals and Functional Foods: Aligning
with the Norm or Pioneering Through a Storm............3
1.1 Myths devolve into faith and dogma............................................3
1.2 Value additionor illusion?............................................................4
1.3 Landminesand weapons ofbrand destruction..............................7
1.4 Opportunityawaiting:pioneering upstream..................................8
1.5 Conclusion.....................................................................................9
References...........................................................................................10
CHAPTER 2 Nutritional Supplements and Functional Foods:
Functional Significance and Global Regulations......13
2.1 Introduction..................................................................................13
2.2 Health behaviorsand foodmarkets.............................................16
2.2.1 Possibilities to promote foodhealth-promoting
properties...........................................................................16
2.3 Research needs: safety and efficacy...........................................23
2.3.1 DSHEA..............................................................................24
2.3.2 Codex: harmonizing food andsupplement rules
between all nations of the world.......................................26
2.3.3 International alliance of dietary food supplement
associations........................................................................28
Acknowledgment.................................................................................29
References...........................................................................................30
CHAPTER 3 Global Market Entry Regulations for
Nutraceuticals, Functional Foods,
Dietary/Food/Health Supplements................................41
3.1 Introduction..................................................................................41
3.2 Market entry requirements..........................................................42
3.2.1 Positive and negativeingredient lists................................42
ix
Description: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