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Interview
with Loretta Zapp
President, Industrial Labs and Founder, Institute
for Nutraceutical Advancement (INA)
March 20, 1999
On
March 20, 1999, we spoke with Mark Lange, INA's Science Director,
and Loretta Zapp, President of Industrial Labs and the driving force
behind formation of both the Institute for Nutraceutical Advancement
and the MVP. Read the context for this interview.
| DSQI:
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What
do you see as the central purpose of the INA Methods Validation
Program?
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Zapp:
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Our
methods establish consistency in testing, which is really our
goal. If five different labs get a different result from the
same sample -- or if a manufacturer gets different results from
different labs, it calls the entire testing process into question.
By peer-validating analytical methods, we ensure that manufacturer
can rely on specific methods of testing. Valid tests are tools
to aid in production of safe and correctly labeled products.
If a label says a substance has a 24% ginkoside level, we want
to be able to verify that with certainty.
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| DSQI: |
How
well is INA doing in fulfilling this need?
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| Zapp:
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INA
is enjoying some success, because we are accomplishing what
we set out to do. We had hoped to have methods peer-validated
for 6 botanical by the end of our first year and it looks
like that will happen. Many of our sponsors are competitors
who have chosen to put aside their competitive swords and
came together in a cooperative effort for the good of the
industry. There are no special privileges or exclusive rights.
Everything we develop goes out to the general public. Anyone
who wants one of the validated methods can simply ask for
it.
The
fact that these companies stepped up to the plate and paid
for this effort I believe, is a testimonial to the credibility
and good intentions of these companies. We currently have
funding for two years. At the end of year one, we will come
together again and look at how to keep going.
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| DSQI: |
Who
do you see as the users of the INA MVP?
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| Zapp:
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Test
laboratories, suppliers of raw materials and ingredients, distributors,
manufacturers, retailers, and of course anyone doing studies:
the press and clinical researchers. As a test lab, we do a lot
of quality control for manufacturers and suppliers, and increasingly
for retailers as well. We've been getting samples from all levels
of retailers, from large chains to small stores. Although INA
MVP produces validated methods for ingredients, many of these
methods will apply with little additional validation work to
final products.
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| DSQI: |
Are
other labs involved in INA?
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| Zapp:
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Yes.
About 35 labs around the globe. We solicit labs they solicit
us and we qualify and pay them to do the validation work. Other
labs definitely cooperate in this effort; it's not just manufacturers
who are involved. It seems like every week another lab wants
to be involved as word is getting out. The response has been
really positive from both industry and academia, and as I've
mentioned from labs in other countries as well.
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| DSQI: |
Do
you expect MVP to be adopted industry-wide?
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| Zapp:
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We're
not asking people to adopt MVP as an industry-wide standard.
If a manufacturer has a method that works for them, they can
compare our method to their in-house method. Hopefully, the
two tests results will agree. If not, they probably need to
look a little harder at the methods. Sometimes steps in an
extraction or processing protocol might interfere with a method's
performance -- We may discover something that INA needs to
know about the performance of its method.
Botanical
chemistry is challenging and we always welcome information
related to improving the robustness of our methods. In taking
a method through the validation process, we try to utilize
a very broad array of extracts in order to be sure we address
the most common denominators. However, someone may have a
unique extraction process which prevents the INA method from
working on their particular product. The best solution is
to have an open dialogue. It's important to make our methods
available to the public so people can try them and we can
learn from those who use them. Botanical methods validation
is still new in the United States.
One
of the negative events that is occurring in our industry is
the media hype surrounding what are described as sub-potent
products. Perpetuating the "buyer beware" sentiment. If the
press continues its investigative reporting, it is in everyone's
best interest that the test methods used in a study are validated.
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| DSQI: |
What
do you see as INA's biggest challenges and accomplishments?
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| Zapp:
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The
fact is that we've taken the first step. A lot of work still
needs to be done. Right now, the Methods Validation Program
addresses only raw materials and extracts, not final products.
Final products method validation is be much more complicated,
but does need to be addressed. There is so much variety in final
product formulations. Manufacturers use different procedures
to create extracts -- and to create the wide range of final
forms: tablets, capsules, gelcaps, liquids, tinctures, etc.
To cover all these matrices is a laborious task. This program
is a first step and a worthy beginning.
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| DSQI: |
Where
do you expect to go with MVP?
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| Zapp:
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Our
goal is to establish methods that are included in the peer-verified
methods book of the AOAC (Association of Official Analytical
Chemists). We additionally will submit methods to the US Pharmacopoeia.
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| DSQI: |
Might
this lead to more government regulation of the manufacturing
process?
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| Zapp:
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Not
necessarily. Companies that make product should already be implementing
testing in their process. This program is designed to aid in
good manufacturing by providing consistency in testing tools.
Dr. Jim Tanner with the FDA sits on our advisory board. We believe
that there is mutual benefit gained from this relationship.
Involvement in our program allows FDA to learn as we continue
to ourselves, the analytical challenges faced by herbal supplement
makers. FDA has limited resources for method development and
validation. This program helps fill some gaps and attempts to
keep the industry and the agency on the same page.
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| DSQI: |
Is
it possible for a company to have a valid method that is different
from the MVP's method?
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| Zapp:
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Yes,
it is possible. In that case, the company should be able to
show they have a method that works and not be held to our method.
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| DSQI: |
Supposing
that the FDA adopted INA's methods once accepted by the AOAC.
Does it follow that a manufacturer might have to change its
manufacturing process to pass the AOAC method even if its own
method was valid?
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| Zapp:
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I
don't see the FDA making an issue of this. In the dietary supplement
industry, the technology is evolving so rapidly. There's a lot
of science to be learned about how to quantify and qualify these
botanicals products. It would not make sense for the FDA to
be cut and dried or to say "You must use method X!" -- especially
for final products. Companies should always verify that methods
work on their product forms.
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| DSQI: |
Is
the INA planning an MVP label or certification process?
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| Zapp:
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Not
at this point.
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| DSQI: |
Any
other plans in store for INA?
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| Zapp:
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Our
goal is to provide tools that support production of high-quality
botanicals. The industry has a strong need for self-regulation,
and we're looking to provide resources for a self-regulation
process. Right now, we're in the discussion stages of figuring
out where our analytical expertise fits in best, in providing
these tools for industry.
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INA Developing
Standardized Tests of Botanical Products
Botanical
products have complex chemical structures -- and different manufacturers
use different formulas and procedures for creating different products.
Many useful methods have been developed by manufacturers and independent
test labs to analyze and ensure the quality of these botanicals.
But these methods vary among manufacturers and among test labs.
Given such an array, is it even possible to create standardized
test procedures that are equally valid for every product that contains
a particular plant?
The
Institute for Nutraceutical Advancement (INA) believes it is both
possible and necessary. Organized by Industrial Laboratories, Inc.,
INA is a consortium joined by thirty manufacturers and suppliers
of herbal products to develop standard methods for analyzing dietary
supplements. By establishing standard test methods, it is hoped
that producers and labs can obtain consistent, accurate results.
In
early 1998, INA launched their Methods Validation Program (MVP):
"an international project designed to select, validate and
publish scientific methods for use in analyzing raw botanical materials."
The
INA is broadly represented by a number of organizations in an advisory
capacity, including the American Herbal Products Association (AHPA),
The National Nutritional Foods Association (NNFA), the American
Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP),
the Association of Official Analytical Chemists (AOAC), the Council
for Responsible Nutrition (CRN), the U.S. Food and Drug Administration
(FDA), and the Herb Research Foundation (HRF).
To
date, the INA has published test methods for three raw materials:
Kavalactones in Piper Methysticum, Flavonol Glycosides in Ginkgo
Biloba, and Ginsenosides in Panax Ginseng and American Ginseng.
On
March 20, 1999, we spoke with Mark Lange, INA's Science Director,
and Loretta Zapp, President of Industrial Labs and the driving force
behind formation of both the Institute for Nutraceutical Advancement
and the MVP.
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