4261 %I ● NUTRACEUTICALS

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4261
NUTRACEUTICALS
CHALLENGES AND OPPORTUNITIES FOR THE NEW MILLENIUM
THAT AFFE~
CONSUMERS AND HEALTHCARE PROFESSIONALS WHO USE AND
RECOMMEND NUTRACEUTICALS
Presentation for FDA public hearing, June 8, 1999-
Washington,
DC by
Gary L. Huber, MD, FACP - ANA Vice President for Scientific Communications
Medical Director, Olympic Center and Texas Nutrition
Institute
East Texas Medical Center (ETMC) Healthcare System
~MC
Rehabilitation
Tyler, TX
Center
75701
c>+
qqri-llpf
22 Inverness
Phone
(205] 980-5710
Center
●
3 Fax (205) 991-9302
Parkway,
Suite
150 4* Birmingham,
+ E-Mail: Ana@AmericaNutra
AL 35242
.com ●
:* WebSite:
www.AmericaNutra
.com
[n the past five years, many dramatic changes have occurred that are related to
wellness,
health and the practice
especially
through
positioning
Health
With the growth
of medicine.
Maintenance
Organizations
of major health insurance companies,
improvement
in efficiency
and decreased
of managed
care,
(HMO’s), and the aggressive
we have seen in some instances an
cost in certain
aspects
of medical
care.
However, one of the most serious costs of these changes appears to be a growing
frustration
on the part of both patients and medical practitioners,
and other dynamics,
the United States healthcare
and, at times, it is in conflict.
and preventive
rapidly
medical
increasing
seeking, if not demanding,
delivery system is in a state of flux
This has lead to a greater emphasis on outpatient
programs,
number
which
are struggling
of now middle-aged
Congress
guidelines
supplements
used
freed
in
supplement
regulation
are not promoted
of
information
More
professional
At times,
concerning
from
pharmaceuticals,
regarding
the
provided
pharmaceutical
nutraceutical
DSHEA has resulted
stringent
that
FDA
dietary
uses. Not surprisingly,
product advertising,
as
in the dissemination
of misleading
for
or
product activity and quality.
importantly,
it
is
often
difficult
to obtain the necessary confidence
they use or choose to recommend.
nutraceutical
Health and Education Act (DSHEA) in
manufactures
for traditional
this Act has resulted in some confusion
well as labeling.
to meet the needs of the
a better quality of life.
dietary
the
care
“Baby Boomers” that are continually
With the passage of the Dietary Supplement
1994,
As a result of these
supplements
the
consumer
in a given nutraceutical
And, of course, manufacturers
themselves
have contributed
2
in many
healthcare
product
and suppliers
instances
that
of
to the
.
serious problem of not only what information
consumers but also how that information
Another
issue that
healthcare
professionals
estimated
that
nutraceutical
is the
70
percent
untrained
should be provided
of
of educational
or alternative
Americans
now
training
medicine.
purchase
and
for
It is
use
on a regular basis. Above all, they would like to turn primarily
to their physician for advice and guidance.
remain
lack
in the field of complementary
as
a product
should be provided.
has developed
as many
products
concerning
and uneducated
Unfortunately,
on how to counsel
physicians for the most part
their
patients
on the use of
nutraceuticals.
especially
Consumers,
supplements
health.
during
Boomers,
are
illness, impairment,
critical
issue for
perspective
the
nutraceutical
and dietary
nutraceutical
supplements
industry
and regard for claim substantiation
into the shortest
duration
or disability.
In unprecedented
population
at all age levels are
larger and larger segments of the American
to nutraceutical
to
basic desire of everyone to have as much good health as is
any chronic
turning
turning
freedom in taking some control over their own
to live as long as is possible, and to compress
our lifetime
numbers,
Baby
in order to have additional
It is an inherent
achievable,
the
in the quest of these goals. The
involves
developing
that will justify
a science-based
this generational
turn
toward nutraceuticals.
Preliminary
instances
studies
are
help the consumer
and consumed
properly,
contain the ingredients
showing
that
nutraceutical
products
can in many
achieve some of these goals if they are selected wisely
and if the products,
especially
necessary to provide the promised
3
herbals,
activity.
are standardized
For example,
to
in a
double-blind
Arizona
controlled
Cancer
study by Dr. Larry Clark and colleagues
Center,
it was
demonstrated
that
dietary
at the University
supplementation
of
with
selenium might reduce prostate cancer by as much as 30%. This can provide a longer
life and at the same time reduce the healthcare
country.
This initial study has been expanded
costs for thousands
to five countries
of men in this
and will cover other
forms of cancer in more extensive investigations.
All of this may sound promising,
but there is a real challenge that the consumer
now faces when they choose to consider
extraordinarily
using a dietary
careful not to overstate the state of science.
patient, encourage research, and responsibly
supplement.
We must be
To this end, we must be
evaluate that research.
One area, however, that we can act in right away involves product
these
products
are not currently
quality, there are three important
purchasing
.
regulated
questions
for content,
purity
quality.
As
and manufacturing
that the consumer needs answers to when
a dietary supplement:
Is the product
manufactured
under
current
Good Manufacturing
Practices
(cGMP’s)?
.
Does the
product
contain
a standardized
extract
that
is validated
by
scientific and clinical studies?
●
.
How consumers
know
that
the products
required
dosage of ingredients
promised
in marketing
Most importantly,
required
they
take actually
to produce
the
the desired results as
materials provided by companies?
does the product have integrity?
contain
Need for Third
Party Validation
To whom can the consumers of this country turn for advice and consultation
the proper
use of nutraceutical
supplements?
Eisenberg, it was found that three-quarters
prefer to have this guidance
least, this remains a wishful
physicians and to pharmacists
in the Alew England Journal
percent of individuals
provided
by their physician.
revealed an alarming
medicine, including
campaign
focused
on encouraging
consumers
physicians
should
be considered.
A joint
American
Nutraceutical
Consumers
Association,
Healthcare
physicians!
statistic.
Seventy-five
nutraceuticals,
neglect
A consumer awareness
Medical
in cooperation
to
A study published
by organizations
American
Products Association,
provided
to share this information
venture
the
for now at
training
on the proper use of nutraceuticals.
with their conventional
surveyed would
Unfortunately,
desire because of a lack of proper
of Medicine
by Dr. David
or more of the consumers
using complementary
to share this information
In a survey conducted
on
with
their
such as the
Association
and
the
with FDA, could be very
beneficial to consumers.
As the use of nutraceuticals
both consumers
and healthcare
toward self-diagnosis
nutraceutical
programs,
inappropriate
enhance
proper
are sometimes
their
use
treatments
with pharmaceuticals
the training
professionals
and self-management
products
but
by consumers
in
body’s structure and function
chronic
products.
may
wellness
result
in
delays. The risk of interactions
that we facilitate
in the subjects
St. John’s wort
as would an antidepressant,
5
Herbal and
in personal
disorders
It is imperative
professionals
and herbal
approach
management
and foods is enormous.
about the trend
of disease by consumers.
an excellent
and dangerous
use of nutraceuticals
should be concerned
self-diagnosed
of healthcare
in the United States is increasing,
and
dealing with the
may affect the
but how many patients can
.
differentiate
debilitating
between
depression
and anxiety?
disorders for which the treatments
Both are extremely
are quite different.
common
and
Furthermore,
how
much of that which is now labeled as “St John’s Wort” in this country
active nutraceutical
large numbers
themselves with nutraceutical
an herb with an antihypertensive
how well controlled
blood pressure
pharmacists
knowledgeable
of patients with congestive heart failure
containing
products,
such as hawthorn,
Patients cannot accurately judge,
action.
however,
their blood pressure is based on how they feel; it requires careful
In some cases, this monitoring
measurements.
(most
any
constituents?
As another example,
are self-treating
contains
of whom
own
independent
in the use of nutraceuticals,
is being shifted
pharmacies)
who
and are coordinating
are
to
becoming
their patients’
use of
these products with physicians.
As an additional
benign prostatic
illustration,
hyperplasia
It could
supplement/n
the symptoms of this condition
be extremely
utraceutical
of saw palmetto
it can be a major problem for consumers.
cancer, for which a delay in diagnosis
death.
popularity
for
appears to be a benefit at first glance, but if improperly
used in the case of self–diagnosing,
cannot reliably differentiate
the enormous
from undiagnosed
can be the difference
dangerous
for patients,
for its purported
functional
between
therefore,
Patients
prostate
survival and
to use a dietary
effect unless they are under the
care and supervision of their primary physician or urologist.
Another
concern on the part of consumers
‘rperform as advertised”
American
Nutraceutica/
is the question:
Do nutraceuticals
and are they safe? In the Winter edition of the Journa/ of the
Association,
there
6
was a landmark
study
published
on
commonly
used nutraceuticals
that summarized
Darryl M. See, MD, at the University of California,
196 natural products
questions,
for toxicity
of a six-year
of antioxidant,
antiviral
gave us a preliminary
and medical communities
activity,
and immune
tested appeared to be beneficial
and at the same time
interaction.
An additional
potential
benefit
potential
for toxicity
exhibited
for the activity parameters
activity.
Only five
by all three tests for nutraceutical
of the 196 studied demonstrated
drug interaction
activity,
and a lack of potential
by at least one of the three activity
and potential
answer to these
well accepted assays
(NK Cell) system
a lack of toxicity
71 products
study by
lrvine. His in vitro screening study of
While his study was in vitro, not in vivo, it utilized
employed by the pharmaceutical
products
and activity
the results
tests
products tested by Dr. See. While this study was limited,
at least some
employed.
was found
drug
A serious
in over half of the
it was a landmark
initial step
in the right direction.
What conclusions
Without
buyer beware.”
examining
can be drawn from the study by Dr. See? For one, “let the
outside
or self-regulation,
we are in a position
the trust we place in those who manufacture
For the manufacturers
of nutraceutical
products,
for “corporate
responsibility,”
they generate.
To do otherwise will be to compromise
the fundamental
for self-testing,
hopefully
needs to responsibly
and distribute
nutraceuticals.
this study will be a message
and for self-regulation
substantiate
of blindly
the integrity
claims and
of the products
of the process and
assiduously
safety.
Issues that should
be of concern
professionals
regarding
to both consumers
and healthcare
the use of nutraceuticals.
7
assure
.
As we approach the close of this century, there are a number of issues that deal
with
nutraceuticals
importance
that
the American
for both consumers
validate or recommend
Nutraceutical
as well as healthcare
products to their patients.
Association
feels are of great
professionals
that are asked to
Here is a brief overview of the most
critical issues:
Qualitv Assurance.
Good
Manufacturing
consumer.
Manufacturers
Practices
and distributors
(cGMP) and
The FDA has been mandated
need guidelines
production
standards
and is the logical
with input from trade associations,
Association
(AHPA), the Consumer Healthcare Products Association
Nutrition
Drug
Manufacturers
(CRN), and the National Nutritional
Standardization.
manufacturers
company’s
Association,
Both
are doing
marketing
source
such as the American
Foods Association
suppliers
(formerly
will
benefit
from
products
these
for
the Non-
Responsible
(NNFA).
and
some
much in this area, This is a consumer
strategy
the
Herbal Products
‘NDMA), the Council
material
protect
choice to develop
regulations,
Prescription
to
for current
that
nutraceutical
driven issue, as a
are standardized,
reliable, and dependable.
This is a more complex challenge than most consumers and
health care professionals
realize.
have profound
effects
For example, growing conditions
on active constituent
concentration
And just what bioactive markers for dietary supplement
be measured?
and harvesting
of certain
constituents
can
nutraceuticals.
can and need to
Clear answers to these issues are needed.
Product Stability.
prone to degradation.
Most nutraceuticals
are derived from natural sources that are
Once active components
are standardized,
their stability
and
.
shelf
life can be determined.
expiration
Nutraceuticals
dates and recommended
Bioavailabiltv.
of pharmaceuticals
this issue. There is much that is unknown
they be taken...
dosage
is best...
form
nutraceuticals?
must
tablet,
with
be labeled
with
with
about the assimilation
food...
capsule,
are more than well aware of
without...
tincture?
the consumer
of natural products.
on an empty
stomach? Vi/hat
What is the pharmacokinetics
These are areas that must be explored,
be shared
must
storage instructions.
Manufacturers
When should
of the future
in an effective
of
and the answers generated
manner
and with
healthcare
professionals.
Clinical Validation.
Safety and clinical
This is an essential and critical
nutraceutical
activity
are definite
priority
for nutraceuticals.
consumer
concerns.
progress
is being made in this arena, but still much more needs to be done.
reviewed
publications
and scientifically-based
American
Nutraceutica/
Association
alike. And nutraceutical
publishable
forums,
such as The Journa/
(JANA), are welcomed by clinicians
companies are responding
by sponsoring
Peer
of the
and consumers
scientifically
clinical studies. This must become more than a trend,
Much
sound,
it must become a
way of doing business.
As a nation, we are going to continue
progressively
increasing
demonstrated
effects
what is purported
numbers,
to buy and to consume nutraceuticals
What we need most are safe products
on the body’s function.
The consumer
to be there is actually in the product.
“first rule of medicine” for those who deliver nutraceutical
no harm” - is operative.
We need to be able to trust
9
in
with true
needs assurances that
We need to know that the
healthcare
- to trust
products - “to do
that those who
manufacture
distribute
nutraceuticals
them
professionals
do so appropriately
the consumers
of nutraceuticals
guidance; this means that these healthcare professionals
and more knowledgeable
about
nutraceutical
reliance on sound science-based
integrity,
market
to trust
and
healthcare
will have to become educated
products.
We can gain that trust
safety, by assuring
In summary,
consumers.
who
will turn to for advice and
data, by documenting
and by never misleading
healthcare professionals
those
We also need to be able
do so honestly.
to whom
and that
need to know that nutraceuticals
both
by
product
consumers
and
are produced and marketed
with integrity.
The American
professionals
programs
Nutraceutical
and consumers,
Association,
whose members
are both healthcare
is dedicated to these objectives and is currently
to address these issues. We welcome
the opportunity
these and other issues related to dietary supplements
pursing
to work with FDA on
and nutraceuticals
that impact
is an alliance of individuals
with interest
both consumers and healthcare professionals.
The American Nutraceutical
in nutraceuticai
Association
science, technology,
marketing
and production.
members in eight countries. The ANA was established
educational
materials and continuing
on nutraceuticals.
journal
ANA publishes
of the American
education
a quarterly
newsletter,
Visit the ANA website at www.Americanutra.
organization.
10
in 1997 to develop and provide
programs
NutraceuticalAssociation
There are over 3,500
for healthcare
professionals
The Grapevine,
and the
flANA).
com for more information
on the
.
References:
1. Clark, LC. Decreased Incidence of Prostate Cancer with Selenium Supplementation: Results
of a Double-Blind Cancer Prevention Trial. British Journal of Urology 1998;81:730-734
2. Addendum to above article by Clark, LC. JNA.
1999; 2:18
3. Eisenberg DM, Kessler RC, et al. Unconventional Medicine in the United States: Prevlalance,
costs and Patterns of use. New England Journal of Medicine 1993; 328 (4):246-252
4. See, DM, Gurnee, K, LeClair, M. An In Vitro Screening Study of 196 Natural Products for
Toxicity and Efficacy. J~A.
1999;2:25-39.