|Author||Clare Hasler and Clare M. Hasler|
|File size||5.4 MB|
The IFT Press series reflects the mission of the Institute of Food Technologists—advancing
the science and technology of food through the exchange of knowledge. Developed in partnership with Blackwell Publishing, IFT Press books serve as essential textbooks for academic programs and as leading edge handbooks for industrial application and reference.
Crafted through rigorous peer review and meticulous research, IFT Press publications represent the latest, most significant resources available to food scientists and related agriculture 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,
Regulation of Functional Foods and Nutraceuticals: A Global Perspective (Clare M.
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)
A Global Perspective
Edited by Clare M. Hasler
Clare M. Hasler is 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 founding 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.
©2005 Blackwell Publishing
All rights reserved
Blackwell Publishing Professional
2121 State Avenue, Ames, Iowa 50014, USA
Blackwell Publishing Ltd
9600 Garsington Road, Oxford OX4 2DQ, UK
Tel.: +44 (0)1865 776868
Blackwell Publishing Asia
550 Swanston Street, Carlton, Victoria 3053, Australia
Tel.: +61 (0)3 8359 1011
Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Blackwell Publishing, provided that the base fee of $.10 per copy is paid
directly to the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923. For those organizations that have been granted a photocopy license by CCC, a separate system of payments has
been arranged. The fee code for users of the Transactional Reporting Service is 0-8138-1177-5/2005
Printed on acid-free paper in the United States of America
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.
Includes bibliographical references and index.
ISBN 0-8138-1177-5 (alk. paper)
1. Food industry and trade. I. Hasler, Clare M.
The last digit is the print number: 9 8 7 6 5 4 3 2 1
Table of Contents
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
Kathie L. Wrick (The Food Group)
02. The Regulatory Context for the Use of Health Claims and the
Marketing of Functional Foods: Global Principles
Michael Heasman (Food for Good)
03. Regulation of Quality and Quality Issues Worldwide
Joy Joseph (Pharmavite Corporation)
04. Organic Food Regulations: Part Art, Part Science
Kathleen A. Merrigan (Tufts University)
05. Health Claims: A U.S. Perspective
Victor Fulgoni (Nutrition Impact, LLC)
06. Food and Drug Administration Regulation of Dietary Supplements
Stephen H. McNamara (Hyman Phelps & McNamara, PC)
07. Tropicana Pure Premium and the Potassium Health Claim: A Case Study
Carla McGill (Florida Department of Citrus)
08. The Importance of the Court Decision in Pearson v. Shalala to the
Marketing of Conventional Food and Dietary Supplements in the
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
Daniel A. Kracov, Paul D. Rubin, Lisa M. Dwyer (Patton Boggs, LLP)
10. The Role of the Federal Trade Commission in the Marketing of
Lesley Fair (Federal Trade Commission)
Table of Contents
11. Functional Foods: Regulatory and Marketing Developments in the
Ilene Ringel Heller (Center for Science in the Public Interest)
12. The Nutraceutical Health Sector: A Point of View
Stephen L. DeFelice (Foundation for Innovation in Medicine)
13. Regulatory Issues Related to Functional Foods and Natural Health
Products in Canada
Kelley Fitzpatrick (University of Manitoba, Richardson Centre for
Functional Foods and Nutraceuticals)
14. The Regulation of Functional Foods and Nutraceuticals in the
Peter Berry Ottaway (Berry Ottaway & Associates, Ltd.)
15. Functional Foods in Japan: FOSHU (“Foods for Specified Health
Uses”) and “Foods with Nutrient Function Claims”
Ron Bailey (California Functional Foods)
16. Chinese Health (Functional) Food Regulations
Guangwei Huang and Karen Lapsley (Almond Board of California)
17. Report of ILSI Southeast Asia Region Coordinated Survey of
Functional Foods in Asia
E-Siong Tee (International Life Sciences Institute, SE Asia)
18. Germany and Sweden: Regulation of Functional Foods and
Joerg Gruenwald and Birgit Wobst (Phytopharm Research, Analyze &
19. Functional Foods: Australia/New Zealand
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
Luis García-Diz and Jose Luis Sierra Cinos (Universidad Complutense
21. Functional Food Legislation in Brazil
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
Mark Mansour (Keller and Heckman, LLP)
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. Allen is 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 startup company conducting research and development on food ingredients with potential
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 nutrition 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 expertise 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 Education 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
Lisa M. Dwyer is 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 handles 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 healthrelated 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 investigations 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 graduate 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 information resource for the Canadian nutraceutical and functional food sector and a leader in industry 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 completed 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-Diz is Professor of Nutrition at the Complutense University of Madrid, where
he is responsible for nutrition and dietetics, nutritional epidemiology, and computer science applied to the sciences of the health. His areas of expertise include nutrition, anthropometry, 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
Dr. Joerg Gruenwald is president and founder of Analyze & Realize, Inc., with its subsidiaries Phytopharm Consulting and Phytopharm Research, a specialized consulting company 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
strategy development, new product development, regulatory affairs, clinical trials, international partner finding and, especially, entering the European markets. Associated research
activities have resulted in the book projects Physicians Desk Reference (PDR) for Herbal
Medicines and Plant-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. Healy holds the position of Chief Scientist at Food Standards Australia/New
Zealand. In this role, she is responsible for the scientific advice that underpins the development of food standards. Dr Healy’s research training and experience is in the field of molecular genetics. However, her current interests are focused on food-related health risks.
Dr. Michael Heasman is 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 functional foods and nutraceuticals, from 1999–2002. He is co-author of the first book on business 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
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 extensive 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
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 firsthand 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 Hutt is 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
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 Washingtonian magazine as one of Washington’s
50 best lawyers (out of more than 40,000) and as one of Washington’s 100 most influential 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 Joseph is 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 expert 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
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 devices and related policy and legislative matters. Mr. Kracov’s clients include start-up companies, 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 research 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 startup 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.
Janine L. Lewis holds the position of Principal Nutritionist at Food Standards Australia/
New Zealand. Her primary responsibility is the provision of scientific advice in relation to
nutrition-related food standards. Ms. Lewis’s previous role was the development of national food composition data.
Erika King Lietzan is Assistant General Counsel of the Pharmaceutical Research and
Manufacturers of America (PhRMA) in Washington, D.C. She works primarily to support
its federal legislative team and covers issues such as drug importation, Hatch-Waxman issues, pediatric exclusivity and labeling, product liability, and bioterrorism. Before joining
PhRMA in 2002, she was a senior associate in the food and drug practice at Covington &
Burling. She advised clients in the food, drug, biologic, medical device, dietary supplement, and cosmetic industries on a variety of issues arising under the Public Health
Service Act, the Federal Food, Drug, and Cosmetic Act, the Freedom of Information Act,
the Trade Secrets Act, the Federal Advisory Committee Act, and the Administrative
Mark Mansour is an FDA/Healthcare Regulation Practice partner, resident in the
Washington, D.C. office of Morgan Lewis. His practice focuses on national and international food and drug regulation and issues relating to pharmaceutical, agribusiness,
biotechnology, and consumer products. He is a graduate of the Georgetown University
Law Center and holds a master’s degree from Harvard University and a bachelor’s degree
from Georgetown University. Mr. Mansour currently serves as a member of several
biotechnology-related task forces, including the State Department International Economic
Policy Task Force on Biotechnology and the Food Industry Codex Coalition. He is admitted to practice in the District of Columbia, Michigan, and the U.S. District Court, Eastern
District of Michigan.
Dr. Carla McGill is scientific research director for the Florida Department of Citrus.
Previously, she was a Tropicana Fellow, Nutrition Science, for Tropicana Products, Inc.
where her responsibilities included overseeing clinical research and nutritional analysis of
products, and providing nutrition expertise for product development and marketing. Dr.
McGill has experience in both teaching and clinical settings as an educator, researcher, and
lecturer. Dr. McGill received her Ph.D. from the Department of Nutrition and Food Science
at Auburn University.
Stephen H. McNamara is a member of the law firm of Hyman, Phelps & McNamara, PC,
a Washington, D.C.-based law firm that concentrates on Food and Drug Administration
(FDA)–related matters. Mr. McNamara formerly served as FDA Associate Chief Counsel
for Food, the agency’s senior supervisory lawyer for food-related matters. He twice received the FDA’s highest award for service, the FDA Award of Merit, and in 2004 he received the Food and Drug Law Institute (FDLI) Distinguished Service Award.
Dr. Kathleen A. Merrigan is Director of the Agriculture, Food and Environment Program
at the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy at Tufts
University. Her teaching and research focus is on sustainable agriculture, interest group
politics, and negotiation theory.
Peter Berry Ottaway, CSci, FIFST, is a food scientist and technologist with considerable
experience in food law, specializing in the food legislation of the European Union. He is
the author, co-author or editor of a number of books on aspects of food science and food
Paul D. Rubin is a partner in the Washington, D.C., office of Patton Boggs LLP. He specializes in food and drug law, including the regulation of foods, dietary supplements, and
drugs. He is a frequent speaker and author on FDA regulatory issues. Mr. Rubin received
his J.D., cum laude, from the University of Pennsylvania Law School and his B.S. in Economics, magna cum laude, from the Wharton School of the University of Pennsylvania.
Dr. E-Siong Tee is Scientific Director of the International Life Sciences Institute (ILSI),
Southeast Asia Region, as well as a nutrition consultant with TES NutriHealth Strategic
Consultancy. Dr. Tee is Chairman of the following committees of the Ministry of Health:
(a) Nutrition, Health Claims and Advertisement; (b) Classification of Food-Drug Interphase Products; and (c) National Codex Sub-Committee on Nutrition & Foods for Special
Dietary Uses. He is also a member of the National Technical Advisory Committee on Food
Regulations and the National Coordinating Committee on Food and Nutrition.
Elizabeth Martell Walsh is an associate with the food and drug practice group at
Covington & Burling. She primarily provides FDA regulatory advice to the firm’s pharmaceutical and medical device clients. Ms. Walsh received her J.D. in 2000 from the
University of Virginia, where she was an editor of the Virginia Law Review and was elected
to the Order of the Coif.
Dr. Birgit Wobst is a biologist who has worked for Phytopharm Research since 1999 as a
scientific consultant and medical writer. Her responsibilities are regulatory affairs concerning herbal medicines, dietary supplements, and functional foods. Dr. Wobst writes expert reports, scientific texts, articles, and books about phytopharmaceuticals and other natural products.
Dr. Kathie L. Wrick has more than 26 years of professional experience, more than half of
which have been with food companies such as Quaker Oats, H.J. Heinz, Stop and Shop
Manufacturing, M&M/Mars, and McNeil Consumer Products. Dr. Wrick also spent 12
years consulting with the Arthur D. Little (now TIAX LLC) Food Industries Practice. For
more than a decade she has specialized in market and technology analysis and strategic
planning for food ingredient and nutritional product companies, and has maintained a special interest in nutraceutical opportunities. She currently consults with The Food Group, a
boutique consulting firm based in Concord, MA, comprised of former senior staff of the
Arthur D. Little Food Industries Practice.
Functional foods and nutraceuticals have been a leading trend in the food industry for well
over a decade. Of the principal factors driving the interest in this food category, including
aging demographics (instrumental in the establishment of Foods for Specified Health Uses
in Japan) and scientific discovery regarding how foods or food components can optimize
health, regulatory issues have been the most controversial.
In the United States, the regulation of functional foods and nutraceuticals has been
viewed as pivotal to the marketing success of nutritional products for more than 20 years.
Indeed, it was in 1984 that Kellogg’s, in collaboration with the National Cancer Institute,
began marketing All-Bran cereal bearing label statements describing the colon cancer
chemoprevention benefits of fiber, thus stimulating the passage of the Nutrition Labeling
and Education Act of 1990 (NLEA). The decade between the promulgation of the NLEA
regulations (January 1993) and the summer of 2003 witnessed several pivotal changes in
food regulations, including the passage of the Dietary Supplement Health and Education
Act of 1994 and the FDA Modernization Act of 1997; Pearson v. Shalala and issues of free
speech protection; and, most recently, qualified health claims. These regulatory developments have provided a rather liberal environment for the marketing of functional foods and
nutraceuticals in the United States. As Wrick outlines in the first chapter of this book, “the
U.S. regulatory structure . . . has been a powerful force defining the industries that manufacture the products regulated by the FDA” and has “directly or indirectly shaped the structure, key success factors, barriers to entry, rules of competition, and manufacturing operations for conventional foods, various nutritional products, and pharmaceuticals.”
Outside the U.S. there has been a similar loosening of restrictions on the use of health
claims on foods stimulated by food industry demands to meet marketing goals. However,
enormous variation still exists among countries regarding the regulatory tolerance of nutrition and health messages on foods and beverages. Indeed, only Japan has a regulatory
structure specifically pertaining to functional foods. In most other countries, the use of disease risk reduction claims is very limited or nonexistent. This is thought to have stifled innovation, competition, and investment in the industry in some cases, and in others has
made it almost impossible to directly transfer products from markets such as the United
States or Japan.
Of major concern to regulatory authorities in many countries are safety assessment and
the need for quality control of products by the industry. Regulatory agencies must ensure
that functional foods are regulated in a manner that maximizes health benefits and minimizes health risk for all consumers.
The development and use of health claims is still an evolving area around the world, and
the future regulatory framework and climate, especially in the context of the global food
marketing and trade, is far from clear. Although numerous books and reports have summarized the latest developments on the science and marketing of functional foods and nu-
traceuticals, this is the first comprehensive review of how they are regulated from a global
perspective. It is my sincere hope that a wide variety of readers from academia, industry,
and government agencies around the world will find this text to be a valuable addition to
their library on the ever-evolving topic of functional foods and nutraceuticals.
Clare M. Hasler
==> of Functional
free ebooks Regulation
Edited by Clare M. Hasler
Copyright © 2005 by Blackwell Publishing
A Global Perspective
==> of Functional
free ebooks Regulation
Edited by Clare M. Hasler
Copyright © 2005 by Blackwell Publishing
The Impact of Regulations on the Business
of Nutraceuticals in the United States:
Yesterday, Today, and Tomorrow
Kathie L. Wrick
More than a decade has passed since the term nutraceuticals was coined by Dr. Stephen
DeFelice (1991), founder of the Foundation for Innovation in Medicine. His original definition was very broad:
A nutraceutical is any substance considered a food or part of a food which provides medical or health benefits including the prevention or treatment of disease and include isolated nutrients, dietary supplements, diets and dietary
plans, genetically engineered foods, herbal products and processed foods such
as cereals soups and beverages.
These products represented distinctly different types of businesses and markets. For example, isolated nutrients such as vitamins were a distinct segment of the specialty and fine
chemicals business with defined end-use markets including animal feeds, human food,
cosmetics, and parenteral and enteral solutions, and pharmaceuticals. Diets included product lines such as formulated meal replacements for weight loss or general nutritional supplementation, and dietary plans are a part of the weight loss services business, which
guides consumers who join these programs to change their eating habits. Genetically engineered foods were primarily herbicide-resistant soy and other agricultural commodities
sold to growers. At the time, herbs were legally considered as something used to season
and flavor food; any claims suggesting a use for disease treatment made them an unapproved drug in the United States and many European countries.
Despite disagreement and confusion over the definition, the term nutraceuticals captured the spirit of products at the food/drug interface: “Let food be thy medicine.”
Nutraceuticals could be derived from food and used for medicinal reasons. For example,
the beta glucan component of oat bran is recognized by the scientific and U.S. regulatory
community as being responsible for lowering elevated blood cholesterol levels (FDA,
2002). Certain dairy peptides, some of which have a mechanism of action similar to ACE
inhibiting drugs, have demonstrated a powerful capacity to lower moderately elevated
blood pressure at only milligram levels of intake (Seppo et al., 2003; Hata et al., 1996).
A decade beyond its first appearance in the food technology and marketing vocabulary,
nutraceuticals still has no agreed upon definition or regulatory standing. The emerging
world of nutritional products, including nutraceuticals (however defined), took on a life,
language, and segmentation of its own, catapulted by a grass-roots consumer curiosity in
alternative food and medicines. By 1990, consumers began to experiment in increasing
numbers with herbs, vitamins, and other supplements, natural and health foods, and eventually with mainstream food products marketed for unique health benefits. About the time
of the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the
nutritional products industry was growing by double digits. In only a few years, industry
publications, syndicated store-level tracking services, and consumer research companies
sprang up to monitor product introductions, company activities, product movement
through mainstream and emerging distribution channels, and trends and attitudes of the
health-conscious consumers; they also provided thoughtful industry analysis. Today, the
Nutrition Business Journal (NBJ, New Hope Natural Media, a division of Penton Media,
Inc., San Diego) is the industry’s lead paid-subscription publication monitoring the financial performance of nutritional products and the activities of their manufacturers.
Nutraceuticals World and Nutritional Outlook are among several trade journals that report
on new science, technologies, and market activities. NBJ uses nutraceuticals as an umbrella term for anything sold at retail (outside of OTC medications) that is consumed primarily or partially for health reasons. SPINS, a San Francisco–based market research firm,
works in conjunction with AC Neilsen to track consumer purchases of natural foods and
other health and wellness products through their primary retail channels. These include
natural food, health food, and mainstream grocery stores and supermarkets, drug stores,
and mass merchandisers. Market-research companies, including HealthFocus International
(Atlanta, GA) and The Hartman Group (Bellevue, WA) specialize in the demographics,
consumer attitudes, and purchasing patterns of the new consumer segment that spends
heavily on food and health-oriented products outside mainstream channels. The Freedonia
Group (Cleveland, OH) occasionally reports on the business outlook for nutraceutical
chemicals, such as herbal and nonherbal extracts, vitamins and minerals, and healthful
food ingredients utilized for their health benefits such as soy, fiber, probiotics, and highly
polyunsaturated fatty acids. This latter approach to a market definition is similar to that
proposed in the first market-outlook report on the topic (Wrick, 1994) prior to the passage
of DSHEA. There, nutraceuticals were defined as the bioactive substance in food agricultural commodities (both plant and animal) that showed demonstrable health benefits beyond satisfying the basic nutritional functions of growth, tissue repair, and energy for daily
living. This definition had the advantage of allowing the nutraceutical, or “bioactive,” to
be discussed as a separate, chemically identifiable substance (or family or combination of
substances) that could be isolated or extracted from the tissues in which it naturally occurred or even synthesized. It could then be commercialized through the appropriate regulatory pathway as a component of food, as a dietary supplement, or even as a drug. The
definition allowed for relatively easy market analysis, making nutraceuticals the raw material that could be followed down the chain to the end users.
However, the marketplace ignored the conundrum over a definition and cautiously wove
a path between communicating the messages implied by the emerging science and the regulatory framework governing product claims for foods and drugs. In the United States and
many other countries, the claims made for a product determine its status as a food or a
drug. The emerging science of food phytochemicals as a potentially safer means to cure,
treat, or prevent disease meant their commercialization in the United States under drug law
with its associated high development costs, now estimated at an average of $802 million,
up from $318 million in 1980 (Tufts, 2002). This barrier to market entry led to the passage
of DSHEA, spurred on by a small but zealous industry group convinced that many of the
products it wanted to sell for treating or preventing health problems were safe based on
their history of use in the Far East and other countries.
Despite the lack of regulatory standing or a universally agreed upon definition, the term
Impact of Regulations
nutraceuticals is still the subject of market research reports and is occasionally interchanged with some or all of the product segments in what is now known and accepted as
the nutrition industry. NBJ, launched in 1995, was the first publication to systematically
monitor the activities, trends, and financial performance, mergers, and acquisitions of the
industry whose products were purchased for nutrition and health reasons, as distinct from
mainstream food products purchased to satisfy hunger, taste, and family tradition. Today,
NBJ’s definition of the nutrition industry includes dietary supplements (pills, powders,
tablets, tonics, extracts, and supplemental beverages), meal replacements, functional
foods, natural/organic foods, sports and performance foods and beverages, and, more recently, natural personal care (NBJ, 2002a, b, c; 2003a, b).
In an attempt to bring focus to this update, this chapter reviews the nutritional product
segments utilizing nutraceutical actives in the U.S. marketplace today, including dietary
supplements and functional foods. These categories are defined as the consumer products
that utilize nutrients, specialized food components, or other naturally occurring chemicals
(or mixtures of chemicals) as components of pills and tablets and as ingredients in foods
intended to provide a health benefit beyond basic nutrition. Dietary supplements and functional foods comprise about 66 percent of the $62.9 billion U.S. nutrition industry and capitalize on the health benefits of added food ingredients, naturally occurring food components, or dietary ingredients they contain (see Table 1.1, Definitions).
Dietary ingredient—A substance used in a dietary supplement, which, by law is defined as a vitamin, a
mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the
diet by increasing the total daily intake, or a concentrate, metabolite, a constituent, extract, or combination of these ingredients. (Source: paraphrased from Food and Drug Law Institute Series (1995)
Compilation of Food and Drug Laws, Volume 1. Federal Food, Drug, and Cosmetic Act, Chapter 2,
Definitions. Section 201.
Dietary supplement—A dietary supplement is a product (other than tobacco) that is intended to supplement the diet and that bears or contains one or more specified dietary ingredients (see definition that
follows). It is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form. It may not
be represented for use as a conventional food or as the sole item of a meal or diet; and it must be labeled
as a “dietary supplement.” (Source: paraphrased from Food and Drug Law Institute Series (1995)
Compilation of Food and Drug Laws, Volume 1. Federal Food, Drug, and Cosmetic Act, Chapter 2,
Definitions. Section 201.
DSHEA—The Dietary Supplement Health and Education Act (DSHEA) was passed by Congress in 1994
and amended the Food, Drug, and Cosmetic Act to authorize the creation of a separate regulatory category for dietary supplements distinct from foods and drugs. DSHEA provided broad definition and
guidance for what dietary supplements are, how they should and should not be marketed, what they can
contain and what form they might take, and how they are to be regulated. (See preceding definition of
Food ingredient or additive—All foods in the United States must be made from ingredients that are
Generally Recognized As Safe (GRAS) according to FDA regulatory critera, or which have been approved by the FDA following an agency review of a submitted food additive petition. The petition must
present appropriate data demonstrating that the additive is safe for human consumption at the levels at
which they are expected to be used in human food.
Functional Food—A food that provides a health or performance benefit beyond providing basic nutritional
value. Some examples include products fortified with certain nutrients or phytonutrients, such as fortified cereals, breads, sports drinks, bars, and fortified snack foods, baby foods, and more. Functional
Foods is primarily a marketing term and there is no regulatory definition for it. These foods are subject
to all food regulations regarding their composition and claims.
GRAS (Generally Recognized As Safe)—General recognition of safety of food ingredients and additives
may be based only on the views of experts qualified to evaluate the safety of substances added directly
(or indirectly) to food. Today, FDA has developed specific procedures that industry must follow to establish GRAS status for new ingredients or additives. The process includes a review by a qualified expert
panel of all available data on the product’s safety for human consumption, and agreement by the panel
that the product is safe.
Health claim—A claim for a food or supplement product that describes the relationship between a food
substance and a disease or health-related condition. To secure a health claim, clinical evidence substantiating the relationship to FDA’s satisfaction must be presented to the agency as part of a formal petition
process. Most health claims describe a reduction in disease risk with use of the food substance to distinguish the claim from those allowed only for drugs (that is, “. . . cures, treats, mitigates, or prevents a
disease.”) Currently, health claims are subject to an evidence-based ranking system (A = highest; D =
lowest) as a means to provide FDA’s assessment of how well the publicly available scientific evidence
supports the claim. Unqualified health claims are those with clinical substantiation that meets FDA’s
significant scientific agreement (SSA) standard, and are awarded the highest ranking of “A.” Qualified
health claims are those that have less substantiating data than required for SSA, and they are ranked
from “B” to “D.” A “D” rank will indicate that FDA concludes that there is little scientific evidence to
support the claim, and this statement must be made on package labeling if the claim is used.
Natural foods—Foods derived from “natural” as opposed to chemically synthesized ingredients. Producers
of natural foods strive to use ingredients and raw materials that have not been exposed to pesticides, and
avoid preservatives and “synthetic ingredients” whenever possible. There is no legal or commercial
standard that defines the term natural.
Nutraceutical—Consumer products (foods or dietary supplements) that utilize nutrients, specialized food
components (phytonutrients), or other naturally occurring chemicals (or mixtures of chemicals) as
ingredients intended to provide a health benefit beyond basic nutrition. (Source: NBJ Functional Foods
Organic food—Foods derived from farms and growers who embrace certain principles of sustainable farm
management, pesticide and fertilizer use, and the humane treatment of animals. Federal laws now set
standards for growing, certifying, and labeling organic foods.
Phytonutrients—Plant food components other than macronutrients, vitamins, or minerals that have some
scientific data supporting a health benefit for humans. Examples include antioxidants from grape seed
extract, lycopene (the red pigment in tomatoes), or sitostanol ester, the plant sterol derivative from
vegetable oils that lower cholesterol at low levels of intake. Phytonutrients can be used as either dietary
ingredients in dietary supplements or food ingredients in Functional Foods as long as they meet the
appropriate FDA regulatory requirements.
Structure/Function Claim—Structure/function claims are used for dietary supplements and occasionally
for food products. Most structure/function claims describe the role that a nutrient or dietary ingredient
has on the structure or function of the body, for example, “calcium builds strong bones.” If a dietary
supplement label includes a structure/function claim, it must, by law, have a disclaimer that states: “This
statement has not been evaluated by the Food and Drug Administration. This product is not intended to
diagnose, treat, cure, or prevent any disease.”
Why discuss the marketplace in a volume on food regulations? Quite simply, the U.S.
regulatory structure governing foods and drugs has been a powerful force defining the industries that manufacture the products regulated by the FDA. Our regulatory framework
has directly or indirectly shaped the structure, key success factors, barriers to entry, rules
of competition, and manufacturing operations for conventional foods, various nutritional
products, and pharmaceuticals. Figure 1.1 summarizes the statutory or regulatory definitions of the products FDA regulates, and Figure 1.2 shows how these product categories
and their attendant regulations have ultimately shaped the boundaries around industries
and the scope of their product offerings. Nutraceuticals cut across most of the categories
Impact of Regulations
Figure 1.1. U.S. Food, Drug, and Cosmetic Act and its regulations define the product categories
for the delivery of health benefits to the American consumer. "Nutraceuticals" cuts across several
Figure 1.2. Representative global companies in the U.S. nutritional products business. The categories of products created by federal law and regulation for foods and drugs are the single
biggest determinant of the industrial and market structures now in place in U.S. nutritional products businesses.
Author Clare Hasler and Clare M. Hasler Isbn 978-0813811772 File size 5.4 MB Year 2005 Pages 432 Language English File format PDF Category Chemistry Book Description: FacebookTwitterGoogle+TumblrDiggMySpaceShare Regulation of Functional Foods and Nutraceuticals: A Global Perspective offers a comprehensive resource for information on regulatory aspects of the growing and economically important functional food industry. Regulatory systems and definitions of key terms-food, supplement, drug, etc-vary from country to country. A thorough understanding of laws and regulation within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements is critical to the direction of food companies that are developing products for these markets. International experts with legal and/or scientific expertise address relevant topics from quality issues, to organic foods to labeling. Innovative product development within the framework of existing regulations will be addressed in individual chapters. Overview chapters will discuss global principles, inter-country trading issues, and present a comparison of the laws and regulations within different countries graphically. A “must-have” handbook for research professionals, management, and marketing strategists in the worldwide functional foods/nutritional supplements business. Food technicians and engineers responsible for manufacturing quality in this industry should add it to their library to ensure that they have a thorough knowledge of the applicable legal requirements. The book will also serve as an indispensable shelf reference for lawyers in the food industry and government health professionals with regulatory responsibilities. Download (5.4 MB) Thin Layer Chromatography in Phytochemistry High Performance Liquid Chromatography In Pesticide Residue Analysis Essentials of Law and Ethics for Pharmacy Technicians, Third Edition The Chemical Century : Molecular Manipulation and Its Impact on the 20th Century Food Safety Assessment of Pesticide Residues Load more posts