Written by Michael Mannion
The Foundation for Innovation in Medicine 11th Nutraceutical
THE CURRENT NUTRACEUTICAL HEALTH SECTOR &
THE NEXT PHASE OF THE NUTRACEUTICAL REVOLUTION
The NREA (Nutraceutical Research & Education
February 3-4, 2000, The Waldorf-Astoria, New York
(Also see the conference
program as it was published on this web site.)
The 11th Nutraceutical Conference was well attended and highly
successful. Representatives from the food, pharmaceutical, dietary
supplement, herbal and health food industries, as well as from
academia, publishing and government, explored where the Nutraceutical
Revolution is today and where it is headed in the near future.
A nutraceutical is a food, medical food or dietary supplement
that has a medical-health benefit including the prevention and
treatment of disease. The speakers were engaging and thought-provoking.
Audience members offered challenging questions for the presenters
and valuable insights of their own, based on their experiences
in the new field of nutraceuticals.
The American public has recently embraced the promise of nutraceuticals--wholeheartedly
and justifiably. According to a survey conducted for FIM, 74%
of Americans say that they take nutraceuticals. And 51% of Americans
told researchers that they take nutraceuticals at least once a
FIM, The Foundation for Innovation in Medicine, maintains that
the nutraceutical industry is on the verge of a fundamental change,
from a market-driven enterprise to a business that will be driven
by the results of clinical research. Clinical studies of nutraceuticals
will power the next phase of development. This is only a matter
of when, not if.
At present, consumers face a major problem concerning nutraceuticals--the
market is flooded with products for which unsubstantiated health
claims are being made. Americans are increasingly becoming aware
that the claims of many manufacturers are not substantiated by
clinical research and this is causing them great concern. In a
poll conducted for FIM, 68% responded that they are not extremely
confident that the vitamins, minerals, herbal remedies and/or
special foods they are taking for health reasons can actually
help maintain health and/or cure disease
The public's growing demand that nutraceutical companies demonstrate
the safety and efficacy of their products, in combination with
the industry's increasing recognition of the enormous economic
and medical-health potential of nutraceuticals, will inevitably
lead manufacturers to perform clinical tests on their specific
products. These clinical tests will lead, in turn, to a highly
profitable market, one which is capable of generating enough profit
to pay for further nutraceutical research.
The potential of a fully-realized nutraceutical market based
on clinical research is enormous. About 140 million people--nearly
half of the adult population in the United States--spend approximately
$12 billion annually on dietary supplements (e.g., vitamins, minerals,
herbal remedies). And an overwhelming majority of the public --74%
in the FIM survey -- would like to see clinical testing of nutraceutical
products. People, both the healthy and patients with problems,
want to know which of these substances actually help them, hurt
them or have no effect at all.
However, there is one major obstacle in the way to the emergence
of true nutraceutical companies: the unclear and confusing ground-rules
for making health claims. For this reason, The Foundation for
Innovation in Medicine (FIM) has proposed the Nutraceutical Research
& Education Act (NREA), which was introduced in Congress on
October 1, 1999 by Representative Frank Pallone (D-NJ). The NREA
is based on the successful principles of the Orphan Drug Act.
During the two-day conference, a wide range of speakers provided
practical information about the current state of the nutraceutical
industry and useful guidance about how to move forward in this
arena successfully. The highlights of the conference follow.
THURSDAY, FEBRUARY 3
Stephen L. DeFelice, MD, the controversial and provocative
founder and chairman of FIM, opened the conference with his characteristic
ebullience and optimism. He caught most of those in attendance
off guard with an unusual question, "Who in this audience
is completely healthy, mentally and physically?" A few confident,
brave hands went up but most in the audience were not certain
they could claim to be completely healthy.
Dr. DeFelice noted that few of us are completely healthy and
that this fact is the basis for the enormous potential for nutraceuticals.
"We are all in this together," he said, "because
we are all sick to some degree either physically or mentally."
Fortunately for all of us, he observed, the Nutraceutical Revolution
is at hand. "The medical promise for healing through the
use of nutraceuticals and other natural substances is far, far
greater than that of pharmaceutical artificial molecules,"
Dr. DeFelice said. "The challenge is to deliver that promise
According to FIM's chairman, massive misinformation about nutraceuticals
floods the consumer daily. Dr. DeFelice noted that at present
products with little clinical data to support their claims frequently
sell very well, while nutraceuticals with good clinical data to
support claims do not do as well. However, the dynamics at play
in the Nutraceutical Revolution are forcing the industry to begin
to supply the public with accurate information about its products.
"Who represents the patient?" Dr. DeFelice asked.
The available products provide little or no clinical support to
demonstrate to patients and non-patients that they really work.
"Patients want prevention and treatment," Dr. DeFelice
said. "No one is even offering anything of substance in terms
of prevention. The products promising effective treatment are
currently on the shelves, but no one offers the clinical data
to prove nutraceuticals work, so their promise remains unfulfilled."
The information that does make its way to the public is often
incomplete or misleading. For example, nutrition experts put forth
a wide range of dietary recommendations to the public whose benefits
are not supported by acceptable clinical evidence. Some recommend
high-protein, low-carbohydrate diets. Other recommend low-protein,
high carbohydrate diets. Still others promote low-fat diets. In
addition, many health professionals tell their clients that dietary
supplements are not necessary when the evidence in the medical-nutrition
literature overwhelmingly indicates the value of and need for
supplementation. Diet, oftentimes, is simply not enough to fight
disease. Advice based on opinion, and not on clinical data, is
necessarily contradictory and confusing.
The clinical data being compiled concerning heart disease offers
a valuable contrast to what Dr. DeFelice calls "nutribabble".
Research shows that Vitamin E consumption may lead to a 40% reduction
in the risk of heart attack. As little as one ounce of alcohol
a dayówhether in wine, beer or spiritsómay reduce
that risk by 40% as well. The powerful class of cholesterol-lowering
drugs called statins also produce a 40% reduction in risk of heart
attack. According to Dr. DeFelice, one published study of a large
population of women reported that folic acid combined with moderate
amounts of alcohol daily produced an 80% reduction in the risk
of a heart attack. Physicians and patients can make sensible,
reasonable decisions about health care based on clinical data
such as the above.
Nearly 35 years ago, in a series of animal studies, Dr. DeFelice
and his colleague, Colonel James Vick, demonstrated the potential
medical value of carnitine in both the prevention and treatment
of heart disease. One such study showed that carnitine administration
blocked the cardiotoxicity of a very effective anticancer drug,
Adriamycin. By using the cardioprotective carnitine in combination
with the cardiotoxic adriamyicnóthat is, by combining a
nutraceutical with a pharmaceutical/oncologists could possibly
use higher doses of the anticancer drug. More cancer cells would
be killed and more patients would be saved.
However, the needed clinical trials have not been done. The
clinical data are not available to prove the effectiveness of
this combination. As a result, over the past three decades, lives
may have been lost that could have been saved by this combination
It is Dr. DeFelice's strong belief that the lack of clinical
data prevents patients from getting the full benefits that nutraceuticals
can provide. However, there is another down-side to the lack of
clinical data/patients and non-patients do not have vital information
about the toxicity of nutraceuticals themselves or about the interaction
among other nutraceuticals, pharmaceuticals available by Prescription
and over-the-counter products. This is true mainly because clinical
studies have not been done to evaluate both the clinical efficacy
and safety of single substances - either alone or in combination.
It is important to note that there are two types of toxicities
ñ those that are highly visible and dramatic and those
that are not. An example of the former is St. John's Wort's effect
on reducing the drug levels of important therapeutic agents such
as protease inhibitors used for the treatment of AIDS and cyclosporin
used to prevent body organ transplant rejection. An example of
the latter is when calcium is used for the prevention of post-menopausal
osteoporosis. Calcium can cause significant constipation which
can lead to significant mental and physical problems. This can
lead to powerful mood changes which can have a negatively impact
on family, friends and associates.
For example, most consumers, especially women, are aware of
the benefits of taking calcium to help prevent osteoporosis. However,
far fewer know that calcium can also cause constipation, which
can become a significant mental and physical problem for many
Even though a lack of clinical data leaves consumers with confusing
and contradictory information about nutraceuticals from a wide
variety of sources or sometimes information that can cause harmóthe
healthy and the sick are consuming these products at an unprecedented
To help end the existing confusion, and to provide a framework
within which true nutraceutical companies could flourish, Dr.
DeFelice and FIM have proposed the NREA. "The NREA or something
like it must happen," Dr. DeFelice said. "Social forces
are pushing for this. The NREA is necessary because the enormous
medical-health benefit awaits discovery and unsubstantiated and
false claims will not go away on their own." People and physicians
need accurate information about nutraceuticals and companies must
be rewarded for performing the clinical trials on their products
that will produce the information consumers need. According to
Dr. DeFelice, the NREA will do a great deal to accomplish both
of these goals.
The success of the Nutraceutical Revolution will depend on
three factors: (1) clinical data; (2) support from medical experts;
and (3) the delivery of nutraceutical information to the public
and physicians through the mass media. According to Dr. DeFelice
all three of these elements are essential to the successful creation
of an informed public and medical community, and a true clinical
research-based nutraceutical industry.
And the speakers at the conference provided much needed information
to those who are helping to shape the Nutraceutical Revolution.
Lyn Ciocca, the president of Wellness Resources, spoke on "How
a Nutraceutical Company Should Be Structured." Ms. Ciocca
began her presentation by referring to two recent articles that
appeared in The New York Times. In late 1999, William Safire discussed
the origin and spelling of the word "nutraceutical"
in his column on language. Ms. Ciocca noted that Mr. Safire accepted
Dr. DeFelice's explanation for the origin of the word (he coined
it) and its spelling. To her, this indicated that the field of
nutraceuticals was entering public consciousness. However, although
some progress was being made, a second Times article, which was
highly critical of alternative medicine, showed that there is
still a long way to go in achieving acceptance of nutraceuticals.
Ms. Ciocca's report was based on one-to-one interviews she
conducted with over 20 business leaders. She identified the following
factors as critical to the success of a nutraceutical company:
(1) scientific and medical evidence that supports health claims
for products; (2) products that are clinically effective; (3)
products that are designed to handle specific health conditions;
(4) consumer acceptance of products; (5) products that are safe;
and (6) products that offer a sufficient return on investment.
The experts who spoke with Ms. Ciocca all agreed that the safety
and quality of nutraceutical products were of paramount concern.
Also, customers need to perceive that they are getting a real
benefit from the product and that the price of the product is
worth the benefit gained. Scientific and medical support for nutraceuticals
was a key element in making consumers feel that products are safe
In addition, those interviewed stressed the importance of taste
for success in the nutraceutical food formulation marketplace.
A product that does not taste goodóbe it a drink or a candy
barówill not be accepted by consumers. The business executives
also said that price and product familiarity played important
roles in the success of a nutraceutical.
Looking at the bigger picture, Ms. Ciocca found that the ability
to gain a proprietary position in the market was very important
to the experts. This could be achieved through some form of patent
protection, legal recognition of intellectual property rights
or by the association of the new product with a line of products
that are part of an existing, well-recognized and highly regarded
brand name company.
According to Ms. Ciocca, the experts identified the following
as necessary to insure a good return on investment: (1) good,
skilled personnel; (2) sufficient capital; (3) an infrastructure
capable of developing the product successfully; and (4) medical
acceptance and endorsement of the nutraceutical product. Ms. Ciocca
said that glucosamine, in her opinion, was a good example of a
nutraceutical that was handled properly and successfully. In particular,
she noted that a good job was done getting information about the
potential benefits of glucosamine to both physicians and patients.
Over the next five years, Ms. Ciocca predicted increasing consumer
interest in nutraceuticals and great potential for companies in
this market. She said that media interest will continue to grow
and that physicians are the key to success with consumers. She
also pointed out that greater government regulation, heightened
competition, corporate mergers and the rise of E-commerce will
also shape tomorrow's nutraceutical market.
Ms. Ciocca concluded that most companies are now poorly prepared
to take advantage of the potential of the nutraceutical market.
She stressed that companies need to build consumer trust through
knowledge-based marketing; invest in medical-scientific research
to support product claims; and begin to develop brand names that
consumers know and trust. The industry, her investigation showed,
is entering a new phase and must develop new competencies to succeed.
Dr. DeFelice commented that he would have thought that the
major issue for the industry would be the fairness of the ground-rules
to make medical-health claims, be they related to healthy people
On January 6, 2000, the FDA issued new structure/function regulations
that will affect everyone in the nutraceutical field, according
to Stephen H. McNamara, Esq. He provided an update on FDA regulations
concerning medical foods and health-related claims. In addition,
Mr. McNamara supplied everyone in the audience with a 40-page
paper, "Use of Health-Related Claims in Food Labeling: A
Review of the Current Legal/Regulatory Situation Including FDA's
January 6, 2000 Regulations on ëStructure/Function Claims.'"
His focus was on a crucial areaómaking health-related claims
that do not trigger the FDA to respond by invoking drug status
for a nutraceutical. (Drug status refers to disease claims.)
Mr. McNamara stressed that it is essential for all involved
to understand the FDA's position completely. He emphasized that
a clear comprehension of the FDA's new regulations is imperative
for all manufacturers so they do not inadvertently cause their
product to be labeled a drug. "I'm personally troubled by
the FDA actions," Mr. McNamara said. He noted that there
are often great disparities between FDA regulations and how people
operate in the real world. He also explained how some aspects
of the recent FDA rulings are not in line with the intent of Congress,
as expressed in DSHEA. According to Mr. McNamara, the FDA needs
to develop more conformity and consistency in its rulings.
Mr. McNamara took the audience through four "exceptional
statements of nutritional support" that FDA allows companies
to make: (1) a statement that "claims a benefit related to
a classical nutrient deficiency disease and discloses the prevalence
of such disease in the United States;" (2) a statement that
"describes the role of a nutrient or dietary ingredient intended
to affect the structure or function in humans;" (3) a statement
that "characterizes the documented mechanism by which a nutrient
or dietary ingredient acts to maintain such structure or function;"
and (4) a statement that "describes general well-being from
consumption of a nutrient or dietary ingredient."
According to Mr. McNamara, any of the above four types of "statements
of nutritional support" may be made in labeling for a dietary
supplement, without the approval of the "health claim"
regulation if "the manufacturer has substantiation that such
a claim is truthful and not misleading;" the labeling prominently
displays the following text, "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;"
and if the manufacturer notifies the FDA "no later than 30
days after the first marketing of the dietary supplement with
such statement that such a statement is being made."
Some examples of permissible and impermissible structure/function
claims, according to the FDA regulations are:
Permissible: "helps to maintain cholesterol levels that
are already within the normal range."
Impermissible: "lowers cholesterol."
Permissible: "maintains healthy lung function."
Impermissible: "maintains healthy lungs in smokers."
Permissible: "for the relief of occasional sleeplessness.'
Impermissible: "helps to reduce difficulty falling asleep."
In Mr. McNamara's view, the January 6, 2000 FDA regulations
requires that every structure/function claim needs FDA notification
and also needs a disclaimer along with the claim. The FDA did
not propose this for comment. Mr. McNamara suggested that this
FDA rule-making is bad law and that IT needs to be reconsidered.
He said that he was very surprised that FDA took this procedural
rule-making step, pointing out that the disclaimers now required
did not need to be made before DSHEA. In his opinion, the new
rules are clearly not in line with the intent of Congress.
Mr. McNamara asked the audience to look at the FDA rulings
from a variety of viewpoints--such as that of consumers or the
drug industryóas well as from the point of view of the
dietary supplement industry. He said that the FDA actions would
be interpreted differently depending on "whose ox gets gored."
Mr. McNamara said he believes these issues will be played out
over the next few years. At times, the FDA may seem to be more
permissive of structure/function claims, he noted, but overall,
FDA is not very tolerant toward the dietary supplement industry.
Richard S. Rivlin, MD, Professor of medicine and Chief, Nutrition
Division, New York Hospital-Cornell Medical Center spoke on "Nutraceuticals
and Pharmaceuticals Taken Together: The Potential Benefits of
Nutraceuticals Given with Cancer Chemotherapy Agents." Dr.
Rivlin began with as assessment of where we are today. He reviewed
the role of diet in the development of cancer; the effects of
cancer on the patient's nutritional status; the effect of cancer
treatment on nutritional status; and the nutritional management
of the cancer patient.
Dr. Rivlin looked at the effect of cancer treatment on patients
and explored what role nutraceuticals may play in cancer care.
The American Institute for Cancer Research is now studying the
use of antioxidants with chemotherapeutic pharmaceuticals and
radiation therapy. Much clinical research has to be done in order
to adequately assess the medical potential of these combinations.
In addition to a possible role in cancer treatment, nutraceuticals
may play an important role in cancer prevention. Dr. Rivlin discussed
a number of challenging questions that face the profession regarding
nutraceuticals: How can funding be found to test nutraceuticals
and cancer prevention? Should whole foods or single nutrients
be used? How can the information being collected about the use
of nutraceuticals and pharmaceuticals together in cancer patients
best be communicated to physicians? What advice should be given
to patients when information on nutraceuticals is so incomplete?
One new focus of research, Dr. Rivlin said, is where treatment
and prevention overlap. For example, treatment and prevention
intersect in the area of environmental carcinogens. Pesticides,
herbicides and other chemical carcinogens that are illegal in
the United States are still used in agriculture in other countries.
These food products are imported into the U.S. and play a role
in the onset of cancer in many people. According to Dr. Rivlin,
nutraceuticals may have an important role to play in such situations
by possibly helping to prevent cancer from occurring, limiting
its extent when it does occur, and limiting or preventing metastases.
Dr. Rivlin looked at three nutraceuticals and reported on their
known and potential health benefits: resveratrol, garlic and soy.
Resveratrol has been an important part of Asian medicine for thousands
of years. It is found in grape stems, peanuts and a number of
weeds. It has long been a mainstay in Asia for heart disease and
infections. Modern Western technology has succeeded in making
resveratrol available and its anticancer properties are being
studied. According to Dr. Rivlin, modern science is documenting
the value of this ancient remedy. Resveratrol has been shown to
inhibit carcinogenesis and to have great potential in the treatment
and prevention of heart disease.
Garlic has a long and illustrious history in healing. It has
been found in the palace of Knossos in Crete and is known to have
been used as a performance-enhancing substance during the first
Olympics. Hippocrates used garlic, believing it improved health,
physical performance and strength. The benefits of garlic were
discovered independently in India, China and Europe. Today, garlic
is being studied for its value in the treatment and prevention
of cancer. Dr. Rivlin reported on encouraging work in which garlic
had a positive effect on human breast cancer cell lines and as
part of an approach to prostate cancer. Garlic is being evaluated
for its effectiveness in heart disease and other conditions.
Soy milk, tofu (coagulated soy milk) and miso soup all have
anticancer properties, Dr. Rivlin reported. Soybeans, too, show
powerful anticancer effects as well. These nutraceuticals contain
isoflavones, which are believed to be the chemicals that are effective
in fighting cancer. However, soy products may prove to be somewhat
of a double-edged sword. The anticancer chemicals in soy are also
estrogens, which may inhibit some forms of cancer and contribute
to the development of others.
Dr. Rivlin stated that the potential for nutraceuticals, alone
or together with pharmaceuticals, in the prevention and treatment
of cancer and other diseases is enormous. However, it is AS yet
untested. There is an exciting future ahead for resveratrol, garlic
and soy, both alone and in conjunction with pharmaceuticals, but
a great deal of research remains to be done before that potential
Derrick DeSilva, MD, president of the American Nutraceutical
Association, talked on the usefulness of nutraceuticals in fighting
the phenomenon of drug-induced depletion of natural substances
of the body. Before discussing his main topic, Dr. DeSilva explained
how his background has helped shape his medical views and practice.
Born and raised in Sri Lanka, he saw the harmony of Eastern and
Western medicine working together personified in his father, who
was a Western physician, and in his grandfather, who was a healer.
From his childhood on, Dr. DeSilva has known that combining the
best of both forms of medicine to achieve healthóa balance
of body, mind and spiritóonly made perfect sense.
In his work today, Dr. DeSilva combines nutraceuticals and
pharmaceuticals. For example, all of his patients who are receiving
a course of antibiotic therapy also receive probiotic agents.
If a patient requires an anticonvulsant drug, Dr. DeSilva also
prescribes Milk Thistle along with it. If a cholesterol-lowering
statin is indicated, Dr. DeSilva will also suggest that the patient
take CoQ10 as well. Patients taking cisplatinum will experience
magnesium depletion. Therefore, Dr. DeSilva will recommend magnesium
supplementation. Digoxin depletes the body of calcium and magnesium
so patients taking this valuable drug swill also be prescribed
Beta-blockers, H2 receptor agonists (e.g., Zantac, Tagamet),
cholesterol-lowering drugs and other staples of today's pharmaceutical
medicine, all deplete the body of much needed vitamins and minerals.
In his practice, Dr. DeSilva makes sure that his patients benefit
from the wise use of both nutraceuticals and pharmaceuticals.
In closing, he suggested that the key to good health might
lie, not in drugs or in natural remedies alone, but in three simple
activities: smiling, kissing and praying. According to Dr. DeSilva,
all three of these activities play essential roles in achieving
the harmony and balance of body, mind and spirit that are the
hallmarks of good health.
The afternoon session began with a presentation by Antonino
Amato, MD, the Medical Director of Sigma Tau Pharmaceuticals,
Inc. Dr. Amato spoke on "Carnitine Deficiencies: An Example
of the Largely Unrecognized ëPan Nutraceutical Insufficiency
Syndrome,'" a term coined by Dr. DeFelice.
Dr. Amato introduced the audience to carnitine, a naturally
occurring substance with many important body functions. Carnitine
is 25% endogenous and 75% exogenous in origin; does not bind to
protein; is filtered by the kidney and is 95% reabsorbed by the
body. There is 10-100 times more carnitine in body tissue than
in plasma; muscle has the highest concentration of carnitine in
the body. Carnitine helps transport fatty acids into the mitochondria
and produce ATP or energy. Carnitine not only helps shuttle fatty
acids in, it also helps remove toxic wastes from the cells.
Among the clinical conditions associated with carnitine deficiency
are cardiovascular disease, chronic obstructive pulmonary disease,
neurological disorders, and kidney, liver and endocrine conditions.
There is evidence that Muscular Dystrophy AIDS, CFS, low-sperm
count and other health problems are also associated with carnitine
deficiency. Certain drugs may cause carnitine deficiency as well.
Unfortunately, Dr. Amato said, carnitine deficiency often goes
unrecognized. Although this deficiency occurs in conjunction with
many conditions, it may be masked by the underlying disease, and
therefore, it is rarely tested for by clinicians.
Carnitine has many cardioprotective effects; is the key to
muscle metabolism; is essential to healthy kidney and liver function;
and improves glucose and lipid metabolism. Despite it many proven
benefits, carnitine remains the Cinderella of nutraceuticals,
awaiting the recognition that is due it.
Stephen P. Giannetti, the publisher of Prevention Magazine, and
Ed Slaughter, market research director of Prevention Magazine,
gave a presentation entitled, "Functional Foods or Nutraceuticals:
It's All About Self-Care." Mr. Gianetti presented the highlights
of a study of the growing self-care movement that was conducted
by Prevention. This landmark survey about dietary supplements
was not conducted among readers of the esteemed magazine but among
the general population of consumers. Nutrition and supplements
are very important to consumers but they are also topics the public
finds very confusing because of conflicting information about
The survey clearly demonstrated that there is a big movement
toward self-care in the United States today, especially among
those 45-64 years of age. At 25 years of age, Americans spend
on average $465 for health care. By age 65, the average American
spends $2,647 on health each year. A recent survey by Kaiser Permanente
found that 47% of Americans believe their health care provider
is more interested in earning money than in providing good health
For a number of reasons, more and more Americansóabout
40 % now--are attempting to treat illness themselves or to prevent
health problems from occurring in the first place. About 74.5
million Americans do not feel adequately cared for and have resorted
to self-care in the past 12 months. The Prevention survey revealed
that 72% of Americans use vitamins; from 59-77% use herbs; 15-20%
use homeopathic remedies; and 20% use aromatherapy. (Five years
ago, the percentage of Americans who used aromatherapy was nearly
zero.) The study showed that shoppers who use prescription drugs
and over-the-counter remedies also use complementary medicine
techniques, herbs, vitamins and supplements and buy organic foods.
The results indicate that consumers are far ahead of the nutraceutical
industry. According to Prevention, 106 million Americans use vitamins
dailyóand only 11% use a multi-vitamin. Nearly 45 million
people use herbs regularly and over 24 million take specialty
supplements regularly. Chain drugstores, discount stores and supermarkets
are the major outlets for these purchases, not health food stores.
It is likely that supermarkets will soon be the biggest outlets
for the great variety of nutraceuticals Americans use regularly.
Consumers are guided in their purchases by price, convenience
and the selection available. Strikingly, consumers appear to be
more concerned with a products' perceived effectiveness than with
concerns over safety. (In contrast, many medical professionals
and business executives appear to be more concerned with safety
Americans seem to believe in the healing powers of food. Nearly
50% of the public is actively seeking practical information about
nutrition and health. Nearly every other person interviewed by
Prevention believed that healthy eating naturally reduces the
risk of disease, including major conditions such as heart disease
and cancer. The survey showed that 54% of shoppers (representing
54.3 million households) recently purchased a food to achieve
a specific health benefit. And 58% (about 57 million households)
said that health concerns greatly affected their purchasing patterns.
Shoppers are more sophisticated than they were five years ago
and the study showed that consumers use food to treat and to prevent
illness. Self-care is a long-term trend that is here to stay.
People who are practicing self-care use prescription drugs, over-the-counter
products, vitamins and minerals, herbsóin other words,
whatever seems to work. These individuals are taking responsibility
for their own health.
What consumers urgently need is accurate, consistent advice
on using nutraceuticals, foods and dietary supplements, to prevent
illness and treat disease. The survey found that, basically, consumers
go to the store with health problems seeking health solutions.
The information uncovered by the Prevention survey provides invaluable
information for everyone involved in the Nutraceutical Revolution.
Linda S. Gilbert, the president of HealthFocus, Inc., gave
a presentation on "Consumer Attitudes Toward Nutraceuticals,"
in which she focused on consumer priorities regarding foods and
dietary supplements. She conducted a survey that consisted of
a telephone pre-recruit followed by a 300-question mailing to
over 2,000 people who were the primary grocery shoppers in their
household. Ms. Gilbert said that there was a high completion rate
in her survey.
Regarding food, "What we found," Ms. Gilbert said,
"is that taste is queen and pleasure is king." According
to 46% of those surveyed, it is possible to be overweight and
healthy and to be physically attractive and overweight. The consumers
who were involved in self-care were confident in their views.
They liked herbal remedies and nutritional solutions to health
problems. Three out of four consumers believed that they had special
health needs and were looking for individualized nutritional solutions.
They were not seeking new products; they were looking for simple
Those surveyed turned to healthy nutritional choices to satisfy
the needs of the body, mind and spirit; to feel good emotionally;
and to improve their self-esteem. The Baby Boomers expressed a
sense of entitlement concerning good health. Many were aware that
they will live an entire lifetime longer than a person born in
1900 and they are determined to live a healthy lifetime. Between
60-70% of those surveyed saw a connection between nutrition and
health, although only 17% said they were happy with their eating
habits. Fewer than 50% said they were careful eaters. And 42%
told the researchers that they were seeking only small, gradual
changes in their diets.
The majority of respondents said taste came first when eating.
And about 50% said they would not sacrifice taste for health benefits.
In this area, as in so many others, Boomers believe they can "have
it all." Although 50% of those surveyed said they believed
vegetables and fruits promote health, especially broccoli, oranges,
tomatoes and spinach, only 10% felt soy was good for you. Taste
seems to be the major factor in shaping this view.
While a majority of respondents said they prefer to get health
benefits from food, 62% said they don't have the time to do this.
Instead, they take supplements. Ms. Gilbert reported that consumers
are trying many different things: fortified foods, dietary supplements,
vitamins, minerals and herbs. Over 50% of Americans believe that
foods can reduce the need for prescription and over-the-counter
drugs. A whopping 79% believe that foods can prevent cancer and
heart disease. The results of Ms. Gilbert's survey demonstrate
that Americans really believe in the food-health connection.
Ms. Gilbert said that brands that promote a positive benefit
from using their products do better than brands that focus on
avoiding negatives and suggested that companies keep this important
finding in mind when developing and marketing a nutraceutical
product. She recommended that companies use one of the following
platforms when creating a brand and positioning it: prevention;
health enhancement; wellness; nurturing or cosmetic. She stressed
that the number one consumer concern is "taste, taste, taste"
and that the number two key to success with nutraceuticals is
a positive message about a simple, familiar, natural solution
for the consumer.
Peter Goldman, MD, Professor Emeritus, Department of Nutrition,
Harvard School of Public Health, spoke on "Physicians and
the Nutraceutical Dilemma." Dr. Goldman began his remarks
by noting that the surveys reported on by earlier speakers did
not include any physicians among those questioned. He brought
an important perspective to the conference dialogue, namely that
of a physician at a major medical center whose career has spanned
great changes in the practice of medicine in the United States.
Dr. Goldman said that some of his colleagues were skeptical
of his involvement with Harvard's Dr. David Eisenberg in studying
complementary medicine. "Although the skepticism is not as
bad today as it was a few years ago," he observed. Dr. Goldman
has noticed a great disparity in attitude between older and younger
physicians toward complementary medicine and subjects such as
nutraceuticals. Older physicians seem alienated from the new movements
in medicine, though "the rules of the game have changed dramatically,"
The great change in the economics of the practice of medicine
is of concern to older physicians, but so is the state of patient
care. Powerful prescription drugs are marketed directly to consumers;
HMOs demand that physicians see far too many patients each day;
and the empowerment of patients presents certain difficulties
for many physicians, especially older ones. According to Dr. Goldman,
many physicians now see themselves as advisors to their patients.
This is a profound change in the physician-patient relationship.
These changes have been accepted by the younger generation of
physicians but cause difficulty for a good number of older physicians.
They were trained and practiced in a very different social and
medical environment, one in which the physician was turned to
as an authority figure, not as a partner. The fact that such basic
shifts in the practice of medicine are occurring in a relatively
short period of time compounds the problem.
In Dr. Goldman's view, the majority of physicians see the clinical
evidence for the effectiveness of nutraceuticals as poor. He recognizes
that there is little money available for clinical trials of nutraceuticals
that could provide the kind of information physicians want. But
to the average doctor, the promise of nutraceuticals is not supported
by hard clinical data. In addition, according to Consumer Reports,
there are about 20,000 possible nutraceuticals, making it nearly
impossible for the busy clinician to keep up with developments
in the field.
Dr. Goldman acknowledged that there is also bias in the conventional
medical community against nutraceuticals. Adverse effects of natural
remedies are always widely reported in the medical literature.
When a remedy such as feverfew is evaluated, and three studies
show it to be effective against migraine, while one investigation
shows it to be ineffective, the one negative report will receive
most of the attention. In contrast, few people are aware that
15 years ago, when the blockbuster drug Tagamet was the subject
of randomized, controlled, double-blind clinical trials, only
13 of 27 trials showed the drug to have a statistically significant
positive clinical effect.
The design of clinical trials plays a big role in the outcome,
whether a pharmaceutical or a nutraceutical is being evaluated.
Different researchers may use different dosages or even different
types of products with patients, making it impossible to truly
compare the studies. Sampling errors also play a role in producing
different outcomes in clinical trials. Finally, the evidence compiled
in studies must be interpreted and this, too, can lead to different
interpretations of the results.
Dr. Goldman concluded his remarks with a few observations about
the importance of the placebo effect in medicine. He said that
about 40% of patients respond positively to placebos when they
receive them. What is the role of placebo in health care today,
he asked. Today, many physicians give patients prescriptions for
drugs when they would prefer not to do so. This is done, not solely
for medical reasons, but because of patient demand and also to
keep from losing their patients to another doctor. Do placebos
have a place in medicine in these circumstances? Dr. Goldman left
the question open.
Nancy M. Childs, PhD, is Professor of Food marketing at St.
Joseph's University. She is also associated with The Nutraceutical
Institute, an alliance of Rutgers, the State University of New
Jersey and Saint Joseph's University. Dr. Childs presented a talk
on "Advancing Nutraceutical Research Through Stakeholder
Alliances." She focused her remarks on four main topics:
industry segments and trends; research priorities; stakeholder
differences; and the implications of her findings.
Dr. Childs described a complex and diverse nutraceutical industry
composed of a number of main players: large pharmaceutical companies;
large food companies; mid-sized and small companies; herbal and
other health food companies; HMOs and insurers; healthcare providers;
retailers; regulators; farmers/growers; consumers; and activists.
According to Dr. Child's, certain trends were discernible.
She elaborated on such societal shifts as the move from a focus
on therapy to prevention; a de-emphasis on the role of the physician;
the empowerment of a nutritionally aware consumer; the demand
for customization and convenience; and the dramatic changes in
the demographics of disease.
Recent research has indicated the emerging need for the development
of proven, effective substances; the formulation of niche products;
increased education about nutraceuticals; the creation of marketing
strategies based on information; and third-party payer reimbursement
for those who pursue a healthy lifestyle. Dr. Child's identified
clinical safety as the major item influencing nutraceutical research,
followed by regulatory concerns. She noted that much remained
to be done in terms of critical issues such as the role of third-party
payers, self-regulation of the industry and the proprietary needs
of nutraceutical companies.
In Dr. Child's view, the critical drivers for research are
safety, standards for efficacy and commercial viability and marketability.
She said that research priority clusters included safety, standardization
and efficacy, marketability and commercial viability and education.
Dr. Childs observed that education is given a lot of lip service
with very little follow-through.
Among the industry "alliances" identified by Dr.
Child's were those among what she termed providers and protectors,
namely healthcare providers, HMOs/insurers, regulators and activists.
Dr. Child's also saw that alliances could be formed out of commercial
necessity among small nutraceutical, mid-sized and large food
companies and large pharmaceutical corporations. And she saw alliances
among "industry extremes," which she defined as retailers,
growers and health food and other nutraceutical companies.
Safety, according to Dr. Childs, was the common denominator
among all the participants in the industry alliances. Safety is
the bottom line for short-term and long-term success with nutraceuticals
by any measure. Interestingly, she reported that education was
a top priority only for consumers.
Dr. Childs's research has important implications for the emerging
nutraceutical industry. While research is strongly supported overall,
there are inherent conflicts in research goals, exemplified by
the differing concerns of companies and consumers. It is unlikely,
in Dr. Child's view, that full consensus will be reached among
all the participants in the industry alliances.
Mark Blumenthal. PhD, Executive Director of the American Botanical
Council, gave a talk on "The Impact of German Nutraceutical
Research in the United States." He reminded the audience
that nutraceuticals are considered to be drugs in Germany and
are sold as such. These products are an integral part of mainstream
health care. They are not viewed as "fringe" or "alternative"
approaches, separate from the practice of conventional medicine.
They are an important part of health care and are not relegated
to the margins of medicine or the periphery of clinical practice.
They are included in the Complete German Commission E Monograph,
an exhaustive review providing the product information Americans
are familiar with through prescription package inserts. Mr. Blumenthal
said that the German monographs could be a potential model for
the United States.
Another significant difference between Germany and the U.S.
involves physician education. Dr. Blumenthal said that all German
physicians study phyto-medicine as part of their medical school
training. Phyto-medicine is not considered "alternative"
medicine in Germany.
In Germany and Europe, clinical research drives the sales of
the top selling herbs, which include the top 12 herbs in the American
market. The clinical evidence of safety and effectiveness translates
directly into sales in Europe.
Dr. Blumenthal discussed in detail the clinical trials that
showed the effectiveness of many herbal remedies, among them black
cohosh, echinacea, saw palmetto, St. John's Wort, milk thistle,
hawthorn, horse chestnut, garlic and ginkgo biloba. He said there
were valuable and compelling studies on these products, published
in peer-reviewed journals, demonstrating their value for consumers.
However, he also added that the question of phyto-equivalence
remains to be answered. How do researchers know that the same
materials are used, for example, in a study of echinacea? There
are three different types of echinacea plants used in commercial
preparations and different species have different chemistries,
Dr. Blumenthal noted. In the studies of ginkgo biloba, two different
types of plants were used. With Saw palmetto, no one type of plant
dominated in the 18 clinical trials Dr. Blumenthal mentioned.
Even when labeled exactly the same, herbal products may perform
differently because of use of different parts of the plant, differences
in manufacturing procedures, and many other factors involved in
creating a product when there is no standardization in the field.
This dilemma, among many others, remains to be solved by those
who are creating the Nutraceutical Revolution in the United States.
Stephen L. DeFelice, M.D. opened the session on Friday morning
with his talk, "The Cost, Medical Health Claim and Research
Connection. Also, Is There a Difference Between a Medical and
a Health Claim?" According to Dr. DeFelice, industry is blind
to the potential of the nutraceutical market, which he described
as "the biggest market opportunity of my lifetime."
The food industry, the health food industry and other industries,
in his view, are doing virtually nothing to take advantage of
this enormous market.
There is no major research and development effort underway
, no clinical work by companies on their products, Dr. DeFelice
said. He observed that we now have a commodity market, not a proprietary
market. He urged industry to begin to patent and perform clinical
research "on your specific products." According to Dr.
DeFelice, the existing health-disease regulations will not have
a major impact on the Nutraceutical revolution that is underway.
Over fifty percent of Americans are taking nutraceuticals nowówith
no knowledgeable, authoritative guidance. What is needed, he said,
is for clinical research to be encouraged and for the industry
to learn how to use that research to make a profit.
Since the thalidomide tragedy, Dr. DeFelice said, questions
of safety and toxicity have become the number one concerns of
both consumers and regulators. "We don't have an efficacy-oriented
society," he said. This attitude contributes to the great
cost of an NDA and doing the clinical testing necessary to bring
a product to the market. What is the result when research costs
too much, he asked. "A market-driven nutraceutical industry
in which no real credible information on the clinical benefits
of products is available."
According to Dr. DeFelice, amidst all of the massive lobbying
of Congress, no one talks to the Senators and Congressmen about
the need to do clinical research or what is necessary for medical
discovery. He observed that there has never been a Congressional
hearing on the medical discovery process itself and how to both
improve and accelerate it. "The status quo is unacceptable,"
To begin to change the status quo, Dr. DeFelice said in 1989
he pulled together a small group of people to discuss how to go
about getting Congress to pass needed legislation regarding the
nutraceutical industry. The Orphan Drug Act was the model that
he proposed. It reduced costs for research and allowed companies
to make a profit and served the health needs of the public. The
result of the discussions the group engaged in is the Nutraceutical
Research and Education Act (NREA), which was introduced in Congress
by Representative Frank Pallone, Jr. (D-NJ). (Click
here for he complete text of the NREA is available here.)
In Dr. DeFelice's opinion, the NREA offers a workable and practical
solution to many of the difficulties facing the emerging nutraceutical
industry. It changes the "rules of the game" so that
clinical research costs for nutraceuticals are affordable and
dramatically lower than research costs for pharmaceuticals. Provisions
of the NREA would also reward companies that invest in clinical
research on their products by allowing them to use their clinical
data to make profits.
Dr. DeFelice deferred a more thorough look at the specifics
and the benefits of the NREA until later in the program.
Christine Lewis, PhD, Acting Director, The Office of Nutritional
Products, Labeling & Dietary Supplements of the Food and Drug
Administration, discussed the nature of this new FDA division.
Dr. Lewis said that two smaller resource-strapped offices had
been merged, producing one larger resource-strapped office. In
her view, this merger highlights nutrition as an entity within
FDA and also helps stakeholders identify where to go within FDA
for answers to their concerns. Dr. Lewis said that no functions
were lost in the merger and that the office was now taking a proactive
position to ensure success with its mission.
Dr. Lewis said that the new FDA office has developed a ten-year
strategic plan concerning dietary supplements. A major theme of
her officeóleveraging and partneringóis evident
in the focus of the plan. Stakeholder input is an integral part
of the new plan in which five strategy teams will work on areas
that are of concern to FDA: (1) safety; (2) improved reporting
of adverse effects; (3) publishing of GMPs; (4) stronger enforcement
of FDA regulations; (5) increased regulation of dietary supplements.
Elements of the plan-which can be seen as a marketing strategy
for educating Congressóinclude such issues as safety, efficacy,
distinguishing the boundaries between foods, drugs and dietary
supplements, enforcement, developing science-based information
on dietary supplements and FDA outreach to the industry. According
to Dr. Lewis, FDA is very interested in collaborative work with
FDA is concerned with oversight of human studies; developing
medical-based standards for studies of dietary supplements; and
creating a broad-based research agenda in which the Agency collaborates
with others in partnership. The theme of partnership and leveraging
is so important to Dr. Lewis that she told the audience she is
thinking of getting a T-shirt that reads "Born to Leverage."
"We can be visionary and creative in our work," Dr.
Lewis said. She promised that her office would make an honest
effort to leverage with others to get important and necessary
William Wardell, MD, PhD, Senior Scientific Officer and executive
Director of the Institute for Drug Research, Covance looked at
"Pharmaceutical Clinical Research Costs." Dr. Wardell
addressed three issues: the cost of research into conventional
drugs; the cost of herbals studied in the conventional system;
and costs under a new method of evaluating herbs.
Dr. Wardell said that estimates of drug development costs range
from $297 million to as high as $500 million, depending on the
methodology used. In his evaluation, the true out-of-pocket costs
to develop one specific drug (excluding the costs of the failures
of other products and the costs of capital) is about $75 million.
These figures, while still high, begin to make research look more
His research showed that it would take 3-8 years and cost $7-30
million for a botanical remedy, with thousands of years of clinical
experience supporting its safety and efficacy, to meet conventional
drug NDA approval standards. Instead, he proposed another review
process for nutraceuticals, one that would only go as far as Phase
II clinical trials in the drug model. Under these procedures,
the same botanical approval would generally take from six months
to one and a half years and cost between $750,000 and $2.5 million.
There are many unknown factors in nutraceutical research. For
example, how does a company choose the right botanical to test
out of the legion available. It is not known beforehand which
ones will prove to be successful. Which positive results are due
to the placebo effect and which to the botanical product? How
is the problem of the inconsistency of the product from lot to
lot to be handled? These and other vital questions remain to be
Dr. Wardell suggested that companies testing nutraceuticals
might want to perform their clinical research in the country of
origin of the product. In addition, further cost savings could
be obtained by performing clinical trials in academic institutions,
Dr. Wardell suggested. Antonio C. Martinez, II, Esq., Attorney
at Law, Government and regulatory Affairs Counsel, described the
NREA in detail. He provided the audience with an informative paper
on the NREA and the complete text of the NREA bill (H.R. 3001)
that was introduced in Congress on October 1, 1999.
Mr. Martinez said that the new structure/function regulations
introduced by the FDA in January 2000 might prove troubling for
many with nutraceutical products. Companies need to look at the
FDA regulations thoroughly and understand the gray zones. He stressed
the need to develop a system that will benefit companies that
undertake clinical research on their products and that will allow
them to use the clinical data to successfully commercialize them.
Mr. Martinez went through some of the key elements in his paper
on "The FDA Final Rule on Structure/Function Claims Issued
January 6, 2000, highlighting certain critical points. According
to Mr. Martinez, it will be more difficult to draw the line between
legal and illegal claims; the FDA will look to explicit or implied
disease claims; and third party literature use will become more
difficult. He did note "one bright star" in the new
regulationsóit will be possible now to make claims about
normal conditions that are associated with the aging process,
menopause, PMS, teenage acne, minor pain currently not considered
to be due to disease and a wide range of other conditions. (Click here to reference the DeFelice Commentary,
"Time to Correct the Epistemologic Chaos that Prevents Nutraceutical
Clinical Discovery", October 12, 1999.)
Mr. Martinez offered examples of claims that FDA considers
unacceptable because symptoms may imply disease (e.g., "relief
of heartburn," "relief of bronchospasm); unacceptable
because the product name implies drug treatment (e.g., herbal
Prozac, herbal Phen-Fen); or unacceptable because the claim refers
to a class of drugs (e.g., antibiotics, antidepressants). He also
provided examples of acceptable structure/function claims: "improves
absentmindedness," "relieves stress and frustration,"
"for relief of sour stomach," "arouses or increases
sexual desire and improves sexual performance."
Mr. Martinez urged everyone to let their congressmen and senators
know what is needed regarding delivering the medical-health value
of nutraceuticals as well as truthful information. He pointed
out that politics plays a big role in what does and does not happen
in terms of regulations and laws.
Representative Frank Pallone, Jr. (D-NJ) addressed the conference
about the NREA. He described it as a simple bill that is easy
to read and understand. Rep. Pallone said he considers the NREA
to be a starting piece of legislation that builds on DSHEA. He
noted that it didn't seem at first that DSHEA would pass but grassroots
political action resulted in 300 members of Congress sponsoring
the legislation. Rep. Pallone said that the NREA also needs grassroots
The NREA would require clinical trials that would then allow
companies to make a claim application for their specific products
to a Nutraceutical Board. It is important to note that the clinical
studies must be conducted on the specific product that is commercialized.
The NREA Nutraceuticals Board will make its decisions on a case-by-case
basis. The legislation would also allow companies to make an exclusive
marketing claim for their product for a ten-year period. In addition,
the NREA would allow small nutraceutical firms an antitrust exemption
so they could join forces to conduct the necessary clinical research.
The details of the NREA will be fleshed out, the congressman said,
after the bill is introduced and will incorporate input from the
public, industry representatives and professionals in the health
Rep. Pallone said he could not emphasize enough the need for
political involvement from people in all sectors of the nutraceutical
industry. It is paramount that those involved make their wishes
known to their representatives. Political action is vital to the
passage of the NREA.
Adrianne Bendich, PhD, Associate Director-New Products Research,
SmithKline Beecham Consumer Healthcare, presented a talk entitled,
"Nutraceuticals Can Significantly Reduce health Care Costs:
Dr. Bendich looked at three health conditions: heart disease,
adverse birth outcomes, and osteoporosis. She examined how cost
analyses can be used to improve public health and reduce health
Dietary supplements have a role to play in managing heart disease.
Antioxidants, such as vitamins E, appear to have a positive effect
in cardiovascular disease, the nation's number one killer. Folic
acid and B12 are able to reduce homocysteine levels. And certain
multivitamins can also reduce homocysteine levels. Dietary supplements
are also valuable in preventing birth defects and problems associated
with low birth weight. Clinically significant osteoporosis affects
six million American adults and this condition can be helped by
calcium and vitamin D supplementation.
According to Dr. Bendich, meta-analyses of published papers
showed that vitamin E produced a 38% reduction in cardiovascular
disease; vitamin supplementation reduced perinatal and prenatal
problems by 30-40%. These numbers translate into tremendous cost
savings: $20 billion a year for heart disease; $3 billion a year
for birth defects; and $2 billion a year for osteoporosis.
The evidence indicates that while prevention is more expensive
than treatment at first, the overall net benefit to society economically
outweighs the initial costs. The benefits in terms of reduced
or eliminated pain and suffering cannot be measured. According
to Dr. Bendich, "health economics makes cents." In her
view, 70% of diseases and associated costs are preventable and
nutraceuticals play an important role in such preventive efforts.
The conference concluded with a vigorous panel discussion.
Panelist included Vic P. Micati, former President Pfizer Europe
and Executive Vice-President, Pfizer Pharmaceuticals Group and
Vice President, Pfizer, Inc.; Robert A. Hoerr, MD, PhD, President,
Research-based Dietary Ingredient Association (RDIA) and President
and CEO of GalaGen, Inc.; Paul Lachance, PhD, Executive Director
of The Nutraceutical Institute and Professor of Nutrition &
Food Science, Rutgers, The State University; Representative Pallone;
Christine Lewis, PhD of the FDA; and Stephen L. DeFelice, MD,
Chairman of FIM (Click here
for complete list of participants of the conference.)
Mr. Micati said that there was an understandable reluctance
for companies to invest in nutraceuticals but believes that the
NREA would make a significant difference in this area. He observed
that protecting a claim is more difficult than protecting a patent.
The lack of clear ground rules for making truthful claims based
on the results of clinical studies is a powerful inhibiting factor
to establish a clinical research-based nutraceutical industry.
Dr. Hoerr said that DSHEA limits what health claims can be
made and how studies can be designed. He emphasized that clinical
data should be reviewed on a case-by-case basis. He also called
for more participation by the academic community and assessing
the data which support the proposed claims.
Dr. Lachance said that decreased health care costs might be
the "hook" that will bring the support needed for passage
of the NREA. Lower costs should appeal to both the public and
members of Congress. Dr. Lachance also said it was time to rewrite
the outdated, 60-year old Food and Drug laws to put them in line
with today's new technologies, products and attitudes. In his
opinion, an intelligent product delivery system, with traceability
through all stages, from the field to the consumer, is urgently
needed. In addition, new ways of thinking are also needed.
Dr. Lewis reiterated the major themes of her talkóthe
FDA's desire to partner and leverage with outside sources; the
importance of good clinical research on dietary supplements; and
the desire to work creatively with stakeholders and all participants
in the emerging nutraceutical marketplace.
Representative Pallone again emphasized the need for political
action at the grassroots level, particularly at a time when the
next election is sure to bring about major changes in government,
in both the Congress and the White House.
Dr. DeFelice again touched on the benefits of the NREA for
everyone involved in the Nutraceutical Revolution and urged all
in attendance to become actively involved in supporting its passage.
"Without the clinical research necessary to discover the
enormous medical-health benefits of nutraceuticals, the status
quo of a market and unsubstantiated claims-driven industry will
continue. All of us will pay the unfortunate price of suffering
needlessly and/or dying prematurely."
About the Author:
Michael Mannion has been a Professional writer since 1975 and
is uniquely positioned in his field. Mr. Mannion is one of the
few writers today who has a strong background in both established,
conventional, mainstream medicine and alternative/complementary
health. In addition, Mr. Mannion has extensive contacts with top
MDs and prominent complementary care practitioners.
He has written on a wide range of subjects, often before they
become well-known. For example, he researched and wrote on genetic
engineering in 1977; hospice care in 1978; medical marijuana in
1979; the dangers of medical radiation in 1979; carcinogens in
the workplace in 1979; and the cigarette-induced epidemic of lung
cancer in women in1981.
He was the Director of Professional Education Publications for the
American Cancer Society and the Managing Editor of the Society's
clinical journal, Ca-A Cancer Journal for Clinicians. Mr. Mannion is the
author of 365 Everyday Health Tips: A Daily Guide to Improving Health
and Increasing Energy (1996); The Pharmacist's Guide to OTC's and
Natural Remedies (1999); How to Help Your Teenager Stop Smoking (2000);
and two forthcoming books, Frankenstein Foods: Genetically Modified
Foods and Your Health (2000) and The New American Medicine (2000). In
addition, his 1978 novel, Colleen, is being re-published along with his
new novel, Erin's Daughters.