The following article appeared as an article in Nutraceutical
News, Aug. 1998
Paracelsian, Inc. Add A New Meaning To Quality For The Herbal Products Industry
With the herbal supplement market set to reach $2 billion by the year
2002 the number of different herbal products available to consumers
can be expected to rise dramatically in the near future. Anticipating
the fierce competition in the market, companies need to be sure they
are offering products of only the highest quality By quality we mean
products which make only justified structure/function claims
authorized under DSHEA. Consumers are told that St. John's Wort
helps depression, Ginkgo Biloba helps the memory and Echinacea
helps ward off flu. A new system utilizing a unique functional quality
assurance method is now in place which can reproducibly test such
claims. The system, developed by Paracelsian, Inc. is better known
as BioFITtm (Bio Functional Integrity Tested) and manufacturers will
method to prove the quality and value of their products, but
consumers are often concerned as to whether particular brands will
actually deliver those benefits. The question has been raised whether
these products actually do what they are claimed to do. The
BioFIT(tm) testing system opens new doors for herbal manufacturers
and raw material suppliers seeking to optimize their market
positioning.
BioFITtm
BioFITtm evaluates products on the basis of how they perform in a
variety of functional tests. The tests are conducted in the form of
bioassays which demonstrate in vitro biological activities closely
associated with the benefits stated on product labels. As herbs
constitute a mixture of potentially active compounds the end effect
can result from the interaction of these compounds in various ways
thus making it essential to test the biological activity. The potency of raw materials, alternate extractions, formulations and the finished
product can all be assessed. Current testing often boasted by
companies checks that the product is standardized but up until now a
satisfactory method testing functionality did not exist as an industry
standard. If consumers could choose their products according to a
functionality standard then some of the confusion will be taken out of
purchasing the right product for them. As we reported recently in NN
(1;5:4), various recent market studies have revealed that many
consumers are hesitant in purchasing herbal supplements due to lack
of confidence. In order for the industry to progress the consumer
must be sure the product works.
Examples of initial BioFITtm assays offered by Paracelsian to aid in
the future growth of the industry and its consumer acceptance are as
follows:
St. John's Wort
Seratonin and Dopamine Assays
The assays measure St. John's Wort effect on neurotransmitter
re-uptake inhibition, i.e. its ability to prevent Seratonin from returning to the original brain cells to be reused or degraded thus elevating the mood. This subsequently directly tests the overall efficacy of St. John's Wort product.
Echinacea
Tumor Necrosis Factor (TNF-alpha) and Phagocytosis Assays
Echinacea promotes phagocytoses and promotes the activity of
lymphocytes which results in a rise in the cytokine, tumor necrosis
factor. By using TNF-alpha as the marker the functionality of the
product is measured.
Ginkgo Biloba
Nitric Oxide, Membrane Damage and Platelet Aggregating
Factor (PAF) Assays
Gingko may act as a free radical scavenger thus inhibiting lipid
peroxidation of cell membranes and may help reduce capillary fragility
and increase the threshold of blood loss from capillary vessels.
Ginkgo also comprises ginkgolides which inhibit platelet aggregating
factor subsequently improving blood circulation. By measuring nitric
oxide and PAF concentrations, the efficacy of the compound can be
observed.
These are just several of the potentially numerous assays which can
be run using this method. Once companies' product lines undergo this
quality assurance, BioFIT (tm) certification will provide the first
independent confirmation of consistent biological activity, and the
BioFIT (tm) logo on products certified by Paracelsian may enhance a
product's marketing power and facilitate consumer purchasing.
Paracelsian, Inc. recently signed an agreement with R. P. Scherer that
establishes R. P. Scherer North America as Paracelsian's exclusive
agent for the marketing and distribution of its BioFIT (tm)
Certification program. Additionally, the agreement provides for
collaboration between the two companies in the development of new
dietary supplements and OTC products. R. P. Scherer is a leading
manufacturer of herbal and other dietary supplement products, and
the world leader in soft gel technology and drug delivery systems.
"We need to see that the herbal products industry is built on fact and not trust," said Bernard Landes, President and CEO of Paracelsian,
"before BioFIT(tm) there was no guarantee consumers were getting
what they thought they were paying for, functionality testing changes
the landscape for everyone. BioFIT(tm) not only has vital implications
for the herbal products industry but also the food industries."
When asked about the impact of BioFIT(tm) on the future of the
herbal supplement industry, Chris Kilham, known for his outstanding
work on kava stated, "Many companies will flee in terror from the
BioFIT program, because it will naturally help to weed out schlock
products. But quality manufacturers who want to deliver real health
benefits will at last have a program that helps them to achieve that
noble end. After all, if companies are going to sell herbs on the
promise of better health, then they should ensure that better health is truly delivered."
Alongside Paracelsian's focus on functionality testing, the company
signed an agreement with the Southern Research Institute, one of
America's leading centers for research and development of new
anticancer drugs. Under this agreement, Southern Research will invest
in testing a series of Traditional Chinese Medicine herbal extracts
from Paracelsian's comprehensive library for in vivo anti-tumar
activity against human breast cancer and prostate cancer tumors in
mice. The target extracts were selected based on their high level of
activity in Paracelsian's in vitro anticancer assays. This agreement
clearly reflects the determination of Paracelsian to fully explore and
develop new pharmaceutical opportunities arising from their library of Traditional Chinese Medicines.
With the herbal superstar market virtually saturated, companies will
be turning their attention to new ways of gaining market share via
combination products, super quality products and competitively
priced products. Paracelsian is certainly a company which will be
instrumental in allowing companies to achieve their goals. |
