Regulation of Functional Foods and Nutraceuticals: A Global Perspective

417 Pages·2005·5.356 MB·English

Regulation of
Functional Foods
and Nutraceuticals
A Global Perspective
TheIFT Pressseries reflects the mission of the Institute of Food Technologists—advancing
the science and technology of food through the exchange of knowledge. Developed in part-
nership with Blackwell Publishing, IFT Press books serve as essential textbooks for aca-
demic programs and as leading edge handbooks for industrial application and reference.
Crafted through rigorous peer review and meticulous research, IFT Presspublications rep-
resent the latest, most significant resources available to food scientists and related agricul-
ture professionals worldwide.
• Biofilms in the Food Environment(Hans P. Blaschek, Hua Wang, and Meredith E. Agle)
• Food Carbohydrate Chemistry(Ronald E. Wrolstad)
• Food Irradiation Research and Technology(Christopher H. Sommers and Xuetong Fan)
• Microbiology and Technology of Fermented Foods(Robert W. Hutkins)
• Multivariate and Probabilistic Analyses of Sensory Science Problems (Jean-Francois
Meullenet, Hildegarde Heymann, and Rui Xiong)
• Preharvest and Postharvest Food Safety: Contemporary Issues and Future Directions
(Ross C. Beier, Suresh D. Pillai, and Timothy D. Phillips, Editors; Richard L. Ziprin,
Associate Editor)
• Regulation of Functional Foods and Nutraceuticals: A Global Perspective (Clare M.
Hasler)
• Sensory and Consumer Research in Food Product Development(Howard R. Moskowitz,
Jacqueline H. Beckley, and Anna V.A. Resurreccion)
• Water Activity in Foods: Fundamentals and Applications(Gustavo V. Barbosa-Canovas,
Anthony J. Fontana Jr., Shelly J. Schmidt, and Theodore P. Labuza)
Regulation of
Functional Foods
and Nutraceuticals
A Global Perspective
Edited by Clare M. Hasler
Clare M.Hasleris currently the Founding Executive Director of the Robert Mondavi Institute for
Wine and Food Science at the University of California, Davis (www.robertmondaviinstitute.
ucdavis.edu) She is one of the world’s foremost authorities on functional foods and served as found-
ing Executive Director of the Functional Foods for Health Program at the University of Illinois from
1992-2000. Dr. Hasler received a dual Ph.D. in environmental toxicology and human nutrition from
Michigan State University, an M.S. in nutrition science from The Pennsylvania State University and
an M.B.A. from the University of Illinois at Urbana-Champaign.
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First edition, 2005
Library of Congress Cataloging-in-Publication Data
Regulation of functional foods and nutraceuticals : a global
perspective / edited by Clare M. Hasler.—1st ed.
p. cm.
Includes bibliographical references and index.
ISBN 0-8138-1177-5 (alk. paper)
1. Food industry and trade. I. Hasler, Clare M.
TP370.R44 2005
363.19(cid:2)2—dc22
2004017179
The last digit is the print number: 9 8 7 6 5 4 3 2 1
Table of Contents
Contributors vii
Preface xiii
Clare M. Hasler (University of California, Davis)
01. The Impact of Regulations on the Business of Nutraceuticals in the
United States:Yesterday,Today,and Tomorrow 3
Kathie L. Wrick (The Food Group)
02. The Regulatory Context for the Use of Health Claims and the
Marketing of Functional Foods:Global Principles 37
Michael Heasman (Food for Good)
03. Regulation of Quality and Quality Issues Worldwide 55
Joy Joseph (Pharmavite Corporation)
04. Organic Food Regulations:Part Art,Part Science 69
Kathleen A. Merrigan (Tufts University)
05. Health Claims:A U.S.Perspective 79
Victor Fulgoni (Nutrition Impact, LLC)
06. Food and Drug Administration Regulation of Dietary Supplements 89
Stephen H. McNamara (Hyman Phelps & McNamara, PC)
07. Tropicana Pure Premium and the Potassium Health Claim:A Case Study 101
Carla McGill (Florida Department of Citrus)
08. The Importance of the Court Decision in Pearson v.Shalalato the
Marketing of Conventional Food and Dietary Supplements in the
United States 109
Elizabeth Martell Walsh, Erika King Lietzan, Peter Barton Hutt
(Covington & Burling)
09. Dietary Supplements and Drug Constituents:The Pharmanex v.Shalala
Case and Implications for the Pharmaceutical and Dietary Supplement
Industries 137
Daniel A. Kracov, Paul D. Rubin, Lisa M. Dwyer (Patton Boggs, LLP)
10. The Role of the Federal Trade Commission in the Marketing of
Functional Foods 149
Lesley Fair (Federal Trade Commission)
v
vi Table of Contents
11. Functional Foods:Regulatory and Marketing Developments in the
United States 169
Ilene Ringel Heller (Center for Science in the Public Interest)
12. The Nutraceutical Health Sector:A Point of View 201
Stephen L. DeFelice (Foundation for Innovation in Medicine)
13. Regulatory Issues Related to Functional Foods and Natural Health
Products in Canada 213
Kelley Fitzpatrick (University of Manitoba, Richardson Centre for
Functional Foods and Nutraceuticals)
14. The Regulation of Functional Foods and Nutraceuticals in the
European Union 227
Peter Berry Ottaway (Berry Ottaway & Associates, Ltd.)
15. Functional Foods in Japan:FOSHU (“Foods for Specified Health
Uses”) and “Foods with Nutrient Function Claims” 247
Ron Bailey (California Functional Foods)
16. Chinese Health (Functional) Food Regulations 263
Guangwei Huang and Karen Lapsley (Almond Board of California)
17. Report of ILSI Southeast Asia Region Coordinated Survey of
Functional Foods in Asia 293
E-Siong Tee (International Life Sciences Institute, SE Asia)
18. Germany and Sweden:Regulation of Functional Foods and
Herbal Products 303
Joerg Gruenwald and Birgit Wobst (Phytopharm Research, Analyze &
Realize Ag)
19. Functional Foods:Australia/New Zealand 321
Jane L. Allen, Peter J. Abbott, Sue L. Campion, Janine L. Lewis,
Marion J. Healy (Australian/New Zealand Food Authority)
20. Regulation of Functional Foods in Spain 337
Luis García-Diz and Jose Luis Sierra Cinos (Universidad Complutense
de Madrid)
21. Functional Food Legislation in Brazil 367
Franco M. Lajolo (Universidade de São Paulo)
22. Codex and Its Competitors:The Future of the Global Regulatory
and Trading Regime for Food and Agricultural Products 377
Mark Mansour (Keller and Heckman, LLP)
Index 389
Contributors
Dr. Peter J. Abbott holds the position of Principal Toxicologist at Food Standards
Australia New Zealand. His primary responsibility is the provision of scientific advice in
relation to food safety, particularly chemicals in food. Dr. Abbott’s academic training and
research background is in the area of mechanisms of chemically induced cancer. Since
1996, Dr. Abbott has participated as a technical expert to the World Health Organization
on the Joint FAO/WHO Expert Committee on Food Additives.
Jane L.Allenis a senior nutritionist at Food Standards Australia/New Zealand. In this role
her particular interests are in functional foods and risk analysis. Ms. Allen’s background is
in public health nutrition and dietetics, and academic and research activities focusing on
food-related consumer behaviors.
Ron Bailey has been an independent consultant for the past 19 years, focusing on the
transfer of food technology between the United States and Japan for U.S. and Japanese
clients. Mr. Bailey has traveled to Japan more than one hundred times over the past 28
years and has lived in Japan twice. He received his B.S. and M.S. in Chemical Engineering
from Iowa State University. Mr. Bailey is President of California Functional Foods, a start-
up company conducting research and development on food ingredients with potential
health-related benefits.
Sue L.Campion has a Masters degree in Human Nutrition from the University of Otago
in New Zealand. Ms. Campion has spent 13 years working for the Australian government
focusing on public health aspects of nutrition, including obesity prevention, food and nu-
trition policy, and food regulatory issues, particularly those relating to food labeling.
Dr.Jose Luis Sierra Cinos is a pharmacist, specialist in nutrition, and former associate
professor of Nutrition in the department of Madrid’s Complutense University. His expert-
ise is in topics related to foods and nutrition.
Stephen L.DeFelice,M.D.,is an internationally recognized authority on clinical research
and development of both drugs and natural substances and is also widely recognized as
being responsible for coining the term nutraceuticals. Dr. DeFelice is a graduate of
Jefferson Medical College and served as chief of Clinical Pharmacology, Division of
Medicinal Chemistry, at the Walter Reed Army Institute of Research. Dr. DeFelice is also
the Founder and Chairman of the Foundation for Innovation in Medicine (FIM) whose goal
is to accelerate medical discovery. FIM proposed the Nutraceutical Research and Educa-
tion Act, which was introduced in Congress by Frank Pallone in 1999. FIM also recently
proposed the Doctornaut Act, which would permit physicians to more freely volunteer for
clinical studies than nonphysician volunteers. Both acts can be found on the FIM Web site
at www.fimdefelice.org.
vii
viii Contributors
Lisa M.Dwyeris a sixth-year associate at Patton Boggs LLP, in the Food and Drug Law
practice group. She advises clients on issues relating to the development, promotion, and
sale of products regulated by the Food and Drug Administration (FDA). Ms. Dwyer han-
dles a variety of regulatory and litigation matters before the FDA, the Federal Trade
Commission (FTC), and federal and state courts, and she lobbies Congress and federal
agencies in connection with the laws governing FDA-regulated products and other health-
related issues.
Lesley Fair is a senior attorney with the Federal Trade Commission’s Division of
Advertising Practices, where she has represented the Commission in numerous investiga-
tions of deceptive advertising both in traditional media and online. She specializes in the
marketing of drugs, dietary supplements, foods, and other health-related products. A grad-
uate of the University of Notre Dame and the University of Texas School of Law, Ms. Fair
is a member of the adjunct faculty of the Columbus School of Law of the Catholic
University of America and holds the title of Distinguished Lecturer.
Kelley Fitzpatrick is the Marketing and Research Development Manager for a new $25
million research and development initiative, the Richardson Centre for Functional Foods
and Nutraceuticals, based at the University of Manitoba. Previously, Ms. Fitzpatrick was
the President of the Saskatchewan Nutraceutical Network (SNN), an organization that she
established in early 1998. Under her direction, the SNN, one of the first networks of its
kind in Canada, became recognized nationally and internationally as a superior informa-
tion resource for the Canadian nutraceutical and functional food sector and a leader in in-
dustry representation. Ms. Fitzpatrick holds a Master of Science degree in Nutrition and a
Bachelor of Arts degree.
Dr.Victor Fulgoni, III, is currently Senior Vice President of Nutrition Impact, LLC, a
consulting firm that helps food companies develop and communicate science-based claims
about their products and services. Prior to joining Nutrition Impact, Dr. Fulgoni worked
for the Kellogg Company as Vice President of Food and Nutrition Research. At Kellogg he
helped develop the company’s long-term research program and was intimately involved in
the company’s research and regulatory efforts to gain health claim approval from the U.S.
FDA regarding soluble fiber from psyllium and the risk of heart disease. Dr. Fulgoni com-
pleted his Bachelors degree at Rutgers University and his Ph.D. at the University of
Tennessee with a major in animal nutrition and a minor in statistics.
Luis García-Dizis Professor of Nutrition at the Complutense University of Madrid, where
he is responsible for nutrition and dietetics, nutritional epidemiology, and computer sci-
ence applied to the sciences of the health. His areas of expertise include nutrition, anthro-
pometry, alimentary behavior, and new technologies related to nutrition. For six years, Dr.
García-Diz was assistant manager for Consumer Protection in the Government of Madrid
(Spain).
Dr.Joerg Gruenwald is president and founder of Analyze & Realize, Inc., with its sub-
sidiaries Phytopharm Consulting and Phytopharm Research, a specialized consulting com-
pany for natural products based in Berlin, Germany, with a strong network in Europe. The
activities of the consulting company supports the natural products industry in questions of
Contributors ix
strategy development, new product development, regulatory affairs, clinical trials, interna-
tional partner finding and, especially, entering the European markets. Associated research
activities have resulted in the book projects Physicians Desk Reference (PDR) for Herbal
MedicinesandPlant-Based Ingredients for Functional Foods, as well as the performance
of dozens of clinical trials with natural products. Dr. Gruenwald is a leading international
expert in the field of botanicals and natural ingredients.
Dr.Marion J.Healyholds the position of Chief Scientist at Food Standards Australia/New
Zealand. In this role, she is responsible for the scientific advice that underpins the develop-
ment of food standards. Dr Healy’s research training and experience is in the field of mo-
lecular genetics. However, her current interests are focused on food-related health risks.
Dr.Michael Heasmanis an internationally recognized writer, researcher, communicator,
and opinion-leader in food and health with more than 15 years of experience gained at UK
universities. He is a leading commentator on functional foods, serving as co-editor of the
international business newsletter New Nutrition Business from 1995–2002, and Director
of Studies at the Centre for Food & Health Studies Ltd, a London-based think tank on func-
tional foods and nutraceuticals, from 1999–2002. He is co-author of the first book on busi-
ness and policy in functional foods called The Functional Foods Revolution: Healthy
People, Healthy Profits? (London: Earthscan, 2001) as well as Food Wars: The Global
Battle for Minds, Mouths and Markets(Stylus Pub Llc, 2003), a book on global food and
health policy.
Ilene Ringel Heller is a senior staff attorney with the Center for Science in the Public
Interest in Washington, D.C., where she has worked extensively on U.S. and international
food labeling issues, as well as dietary supplement matters. Mrs. Heller co-authored an ex-
tensive report on functional foods entitled “Functional Foods—Public Health Boon or 21st
Century Quackery.” Prior to joining CSPI, she was an associate at the law firms of Arnold
& Porter and Keller and Heckman. While in private practice, Mrs. Heller specialized in
counseling clients in the food, drug, and medical device industries on compliance with the
Federal Food, Drug, and Cosmetic Act and related laws. Mrs. Heller was awarded a Juris
Doctor degree, cum laude, from Georgetown University and is a member of the District of
Columbia Bar.
Guangwei Huang has been a Technical Manager for the Almond Board of California since
September 2001. In that capacity, he provides support to the Food Quality Safety Program,
the International Program, and other technical projects. Mr. Huang has eight years of first-
hand experience working in the California almond industry, most recently as a Quality
Assurance Director for a California company in charge of managing and implementing
quality procedures for almond processing. Before immigrating to the United States, Mr.
Huang worked for the Chinese Ministry of Health on development of health standards and
establishment of testing procedures. Mr. Huang holds a Master of Science in Food Science
from the University of California, Davis, and Bachelor of Science in Sanitary Technology
from the Wes-China University of Medical Science.
Peter Barton Huttis a partner in the Washington, D.C., law firm of Covington & Burling,
specializing in food and drug law. He graduated from Yale College and Harvard Law
x Contributors
School and obtained a Master of Laws degree in Food and Drug Law from New York
University Law School. Mr. Hutt served as Chief Counsel for the Food and Drug
Administration during 1971–1975. He is the co-author of the casebook used to teach food
and drug law throughout the country. He teaches a full course on this subject during Winter
Term at Harvard Law School and has taught the same course during Spring Term at
Stanford Law School. Mr. Hutt has been a member of the Institute of Medicine since it was
founded in 1971. He was named by The Washingtonianmagazine as one of Washington’s
50 best lawyers (out of more than 40,000) and as one of Washington’s 100 most influen-
tial people; by the National Law Journal as one of the 40 best health care lawyers in the
United States; and by European Counsel as the best FDA regulatory specialist in
Washington, D.C. Business Week recently referred to Mr. Hutt as the “unofficial dean of
Washington food and drug lawyers.”
Dr.Joy Josephis the Vice President of Quality, Research and Development, and Scientific
Affairs for Pharmavite LLC, a leading manufacturer of Dietary Supplements. She has
more than 40 years in quality control and GMP training and is a recognized industry ex-
pert in “Standard Operating Procedures” that are compliant with pharmaceutical and food
GMPs. Dr. Joseph is the chair of the USP Council of Experts on Non-Botanical Dietary
Supplements.
Daniel A. Kracov is Deputy Director of Patton Boggs’ Public Policy and Regulatory
Department and a partner in the firm. He concentrates his practice on matters relating to
the Food and Drug Administration’s regulation of drugs, biologics, foods, and medical de-
vices and related policy and legislative matters. Mr. Kracov’s clients include start-up com-
panies, trade associations, and large manufacturing companies.
Dr.Franco M.Lajolo is a pharmacist and biochemist with a Ph.D. in Food Science from
the Massachusetts Institute of Technology, where he was also a post-doctoral fellow. His
major areas of investigation have covered food biochemistry and molecular biology and,
more recently, functional foods. He has authored more than 200 scientific papers and
books and has advised 65 M.S. and Ph.D. students. Dr. Lajolo is a member of the
International Academy of Food Science and Technology and of the Functional Foods
Committee of the Sanitary Surveillance Agency in Brazil.
Dr.Karen Lapsley is Director of Scientific Affairs for the Almond Board of California
where, since August 1999, she has managed contracted-out nutrition and food safety re-
search programs with more than 15 universities and research centers worldwide. As a
member of the Health Canada Advisory Panel on Health Claims for Foods (1996–1999),
she was considered one of Canada’s experts on functional foods. Between 1996 and
February 1999, Dr. Lapsley was Vice President for Ceapro, Inc., an Edmonton-based start-
up life-sciences company, where she was responsible for the establishment of a Functional
Foods Division, which developed oat-based ingredients. From 1983 to 1996, Dr. Lapsley
was with Agriculture and Agri-food Canada, most recently in charge of the Food Research
Program in Ottawa, which focuses on the safety, quality, and nutritional value of food and
feed products. Dr. Lapsley received her Doctorate in Food Science from ETH, Zurich,
Switzerland, in 1989.