New
Quality Seal Empowers Consumers (continued)
First
test results: ginkgo biloba
ConsumerLab.com
chose ginkgo biloba for its first round of testing, purchasing 30
brands from a variety of retail stores and outlets. Names of 23
passing brands were posted on the ConsumerLab web site on November
16, 1999 -- together with details of the specific tests used, minimum
potency levels of five chemical compounds required to be present,
and general information about ginkgo biloba.
Additional
products to be tested this year
During
this coming year (2000), ConsumerLab also plans to test calcium,
chondroitin, echinacea, garlic, ginseng, ginkgo biloba, glucosamine,
SAMe, saw palmetto, St. John's wort, vitamin B complex, vitamins
C and E, and multivitamins. Results for saw palmetto are scheduled
to be reported on January 31, and results for glucosamine and chondroitin
products in February.
Failing
brands
According
to Dr. Cooperman, ConsumerLab.com has received "thank you" email
from consumers, pharmacists, health food stores, and researchers
with only one complaint: Site visitors want the names of failing
brands.
Cooperman's
response? "We use a carrot, rather than a stick. ConsumerLab informs
manufacturers of test results." Cooperman also notes that manufacturers
of several failing brands have told him they are changing product
formulas to match clinically proven ingredients, and believe their
reformulated products will pass ConsumerLab tests.
Which
brands to test?
Any
single herbal may be represented by dozens, or even a hundred or
more branded products. "We would prefer to test every product out
there," Dr. Cooperman says, "but that would be prohibitively expensive,
so we focus on what will be of greatest value to consumers." Based
on market research, ConsumerLabs examines the top 30 brands based
on national use and availability.
Brands
that are not chosen for initial testing rounds can participate in
ConsumerLab's Ad hoc testing program: For a moderate fee,
ConsumerLab will test any brand on request. Those that pass receive
the same benefits as other passing brands (web site posting and
eligibility to license the ConsumerLab quality seal).
Is
testing truly independent?
One
of the most important questions in evaluating any testing program
is whether tests are performed independently of manufacturers' influence.
ConsumerLab.com is an independent, privately financed organization.
The company does anticipate significant operating revenues from
quality seal licensing. But this is the company's only connection
to the manufacturers whose products they test.
Notably,
an approach similar to that taken by ConsumerLabs has long proven
effective in the computer industry, where manufacturers of technical
products routinely present standard models to independent testing
laboratories for evaluation and certification. Such tests, which
follow protocols established by national standards organizations,
are an absolute precondition for product liability insurance coverage.
Insurance providers (in litigation parlance, the "payers of last
resort") have a clear economic interest in supporting the highest
levels of quality assurance.
This
approach is notable in that it takes place entirely without government
intervention. In an industry which has created the PC and the World
Wide Web, independent testing as part of a free market approach
to quality assurance has proven immeasurably productive. Whether
it will become accepted practice among producers and consumers of
dietary supplements remains to be seen.
Reaction
from industry trade associations
Corinne
Russell, a spokesperson for the Consumer Health Products Association,
says that "A better solution than creating new quality seals is
for the FDA to enforce DSHEA, which has full authority to do. DSHEA
already requires that bottle contents match the label. We favor
strong but reasonable enforcement of current law."
According
to Michael McGuffin, President of the American Herbal Products Association,
"ConsumerLab is doing great work. By providing third party certification,
they are acting as a supportive critic of the industry as a whole.
Seven companies got a wake-up call that their products do not meet
scientific standards. This process will help the industry develop
unified positions on what compounds to test for and what test methods
to use."
Dr.
Phil Harvey of the National Nutritional Foods Association (NNFA)
says that testing botanical products is quite challenging because
other substances in a product (such as another plant or various
inactive ingredients) can sometimes distort test results. Aside
from this concern, Dr. Harvey states, "There is obviously widespread
interest in having some kind of quality test results made available
to consumers, whether this is done through a private quality seal
or industry self regulation, so having a quality seal is basically
a good idea."
Noting
that ConsumerLab's licensing and ad-hoc testing fees are "somewhat
expensive," Dr. Harvey also says, "Having yet another logo may or
may not confuse consumers. We'll have to wait and see if the ConsumerLab
seal becomes widely accepted as a standard for the industry as a
whole." NNFA's TruLabel program tests to see if bottle contents
match the label, but has no associated seal. TruLabel test results
are published in NNFA Today, a newsletter for NNFA members.
NNFA's Good Manufacturing Practices program does have a seal; companies
that pass inspection can place a special logotype on their labels.
Dr.
John Cardellina of the Council for Responsible Nutrition notes that
"CRN applauds anyone who is raising the standards of quality in
the industry, and the general concept of a quality seal is a good
one. However, when a product doesn't appear on the ConsumerLab list,
consumers might assume it has failed the test -- but it might be
a high quality product that simply was not tested."
Dr.
Cardellina is also concerned that consumers will be inundated by
the current proliferation of seals (NNFA's GMP seal, Paracelsian's
BioFIT seal, ConsumerLab's seal, USP's seal), and wonders if any
specific one will become broadly accepted. Says Cardellina, "Quality
is the biggest issue facing the industry," -- while welcoming an
industry-wide consortium for developing uniform quality standards.
Impact
of testing on supplement quality
The
ConsumerLab approach to testing and quality certification fills
an obvious need. Consumers want to know if a particular bottle contains
an effective product whose formula provides proven health benefits.
Scientifically validated quality seals backed by rigorous testing
programs offer a simple, highly visible method for identifying brands
that meet high standards.
Increasing
numbers of consumers are likely to use quality seals as a measure
of a product's effectiveness. Others will continue to rely on their
knowledge of a particular manufacturer's quality practices, or on
their personal experience of a product's effectiveness. Overall,
quality certification holds manifold benefits for producers, consumers,
and insurers alike: the assurance that "what's on the label is in
the bottle."
This
apparently simple, yet somewhat elusive standard is critical to
individual consumers as well as large-scale health care delivery
systems. Validating dose and content levels in dietary supplements
is a small but critical step in the path for better health at lower
cost for all.
One
impact of this approach is already being seen: Several manufacturers
are changing product formulas to match standards established by
clinical research. More are sure to follow. Companies with products
containing different formulations will need to offer persuasive
alternative evidence of the effectiveness of their product, or risk
dwindling sales revenue.
Only
time will tell if the ConsumerLab quality seal will become a widely
accepted industry standard. But one thing is clear: Both consumers
and health practitioners are demanding quality standards for supplements.
If producers and their trade organizations do not take the next
step and establish democratically constituted bodies for setting
standards, then government will step in and do it for them.
New quality seal empowers consumers
How can consumers gauge the effectiveness of a dietary supplement?
A new quality seal helps separate the wheat from the chaff.
Source
of image:
Copyright 1999 ConsumerLab.com; reprinted with permission.
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