"Test results on herbal supplements are complex
. . . and can be misleading."
with Mark Blumenthal, Executive Director, American Botanical Council;
Editor & Publisher, HerbalGram.
19 December 2000
Blumenthal founded the American Botanical Council (ABC) in 1988.
His organization is dedicated to promoting the safe and effective
use of medicinal plants and herbs. In particular, ABC educates the
public, government agencies, research institutions, industry, and
the media about scientific research as a means to guide decisions
about producing and consuming herb-based products.
October, Wyn Snow of SupplementQuality.com (SQ) asked Mark about
a range of issues in botanical quality and testing. His responses
highlight the complexity of supplement testing while giving the
interested consumer some insight into how responsible supplement
producers are approaching an important aspect of supplement quality.
Our questions -- and Mark's responses -- follow . . .
Over the past year we've seen a lot of headlines in the media
about supplements "not measuring up" to the potency levels on
the labels. Are these stories accurate?
Test results on herbal supplements are complex, and depending
on how they are reported, can be misleading.
good example is The Boston Globe story on St. John's
wort, which I described in an article that was also published
in Whole Foods Magazine. Initially, the headline was
intended to read "5 of 7 products fail to meet label claims"
-- but they were comparing apples and oranges.
were looking for the 0.3% hypericin content that many manufacturers
state on their labels as the standardization parameter. However,
as most herbal experts know, this is done only as a quality
assurance (QA) mechanism; there is no correlation between this
chemical marker and clinical results for depression. Hypericin
is biologically active, but it is linked to potential photosensitization
in fair-skinned individuals, not to anti-depressant action.
first of all, testing needs to be done for the appropriate chemical
marker. Next, it's important to have a second lab confirm the
results of the analysis. It's also crucial for everyone to be
using the same test. Results from the HPLC method developed
in Germany in 1991 are not the same as those from the 1986 DAC
(German Pharmaceutical Codex) method.
companies use the older, 1986 DAC method for testing their products
because extract material that is standardized that way is less
expensive. They can lower the QA cost of testing their raw material
by 20%. There is no rule or policy as to which method to use
for testing -- so if a company makes a claim based on the older
DAC method and its product is tested by the newer HPLC method,
of course the two results don't match.
the Globe reporter called me and other experts to comment
on the results she was seeing. We explained the problems they
were facing and recalculated what they thought were "fails"
on their one laboratory test.
to the older 1986 method of standardization, all the products
passed, except for one that was off by only about 15 percent
(which is not much as lab assays go). As a result, the lead
of the story changed to "We thought it would be easy" -- and
the thrust of the story changed to why it's not easy to test
product quality after all.
as there are challenges and variability in the quality of herbal
products, there is also wide ranging quality in media reports
on herbal products.
So the Globe story is an example of good, knowledgeable
reporting on herbal testing. Can you describe a worst case scenario?
In April 2000, D Magazine in Dallas did a story called
"Herbal Remedy Ripoffs." They bought 5 brands of 7 kinds of
herbal supplements, and sent them to an FDA-approved lab in
first problem was that they sent the samples with the labels
showing, so the testing was not blinded.
this "FDA-approved lab" was not familiar with botanicals. They
tested the products using non-validated methods from the Merck
Manual, not the INA's Methods Validation program.
the magazine did not use a second lab to check the accuracy
of the test results, and didn't have a chemist or pharmacognosist
checking for accuracy of the test design. With some of the herbs
tested, D Magazine claimed they did not contain sufficient
levels of "active" ingredients, but these were not the real
active ingredients at all -- they were marker compounds. So
neither the magazine reporter nor, as it appears, the analytical
lab had a clear understanding of what they were doing.
of these problems, the results of this test were close to useless.
Comparing the Globe story with that of D Magazine
is totally black and white.
What has your experience with HerbalGram 's Ginseng Evaluation
program (GEP) taught you about how to do testing?
When we started the ginseng testing program at the American
Botanical Council, we too thought it would be easy -- and it's
not. We learned a lot of things about the procedures to follow.
use two labs. If their results don't match, you know there is
a problem and can investigate.
have knowledgeable chemists, people who know what they are doing.
use methods developed through the Methods Validation Program
(MVP) of the Institute for Nutraceutical Advancement (INA) or
the Association of Official Analytical Chemists (AOAC). INA
has been very successful in determining which methods give consistent
results and can be used with a wide range of formulations.
it came to choosing a test method for ABC's Ginseng Evaluation
Program, we did not have access to INA's Methods Validation
Program (it did not yet exist), and AOAC had not developed a
method. In fact, our GEP method for ginseng testing has been
submitted to 15 laboratories around the world for validation
under AOAC's strict peer review procedure -- and will become
the standard testing method to analyze dosage forms of commercial
ginseng products (such as tablets, capsules and soft-gels for
both American and Asian ginseng species.).
make sure the samples are properly blinded. Don't send a sample
to the lab with the brand name still on it.
store all samples in fireproof cabinets (or other reasonable
way to ensure they are not tampered with) to ensure proper chain
use peer reviews to make sure your methods are responsible and
have a good reference standard in the testing devices. Without
this, your results won't be accurate. In fact, purity of the
reference standard is an issue in and of itself.
What do you think of the ConsumerLab testing program? (ConsumerLab.com
regularly tests a variety of dietary supplements and botanicals,
then publishes the names of passing brands on its Web site.)
For the most part, I agree with the intention of ConsumerLab
-- to test commercial products and publish their results. I
think they are doing an excellent job -- especially with respect
to the type of analytical protocols they use in their testing,
using the most up-to-date testing methods and buying products
off the shelf in a randomized fashion. And of course, companies
whose products are not included in the first round can request
ConsumerLab's Ad Hoc testing program for their products.
there is talk in the industry that the U. S. Pharmacopoeia (USP)
is considering developing a testing program -- which would be
both less expensive and more comprehensive in covering more
products and more brands. The implications for this initiative,
if it is developed, are not clear at this time, although it
would likely mean a lower cost for industry. Having two separate
testing programs may not be ultimately viable, but there are
many issues at play here.
What is the biggest quality challenge facing the botanical supplement
The fact that there are no published federal rules for good
manufacturing practices (GMPs). This means the industry does
not have a level playing field for production quality.
been six years since DSHEA was passed, mandating more stringent
GMPs for dietary supplements. Since then, three industry trade
organizations gave the FDA their recommendations for GMP regulations
-- which the FDA published three years ago as an advanced notice
of proposed rulemaking (ANPR) on GMPs. And still we don't have
a final rule. Supposedly, the FDA will publish a proposed final
rule by the end of 2000.
the time the GMP regulations are published, maybe we'll have
new recommendations from the industry. Also, there's the compliance
period. And what about the exclusion for small business? How
will they define a small business? $100 million in sales? Less
than 300 employees?
it's totally unclear right now what kind of GMP regulations
any particular company will soon have to follow. Some companies
are going for really high GMPs based on the rules for pharmaceuticals.
Others are following the currently required level -- which is
food GMPs. The recommended GMPs for supplements are between
the two: more stringent than food and less stringent than pharmaceuticals.
But we don't know yet what the FDA will publish in its final
What do you think of the current trend towards standardization
of herbal products?
The question is: "Standardization to what and by what method?"
HerbalGram's Ginseng Evaluation Program, some manufacturers
were claiming a particular level of ginsenosides -- which are
active, marker compounds in American and Asian ginseng root
-- based on one method, while others were claiming the same
level using HPLC. So you have two products, both claiming standardization
to 3-4%, but using different methods to test that "standardization".
The result being that the two don't match.
simply means that the manufacturer says the product contains
a guaranteed specified range of a chemical compound or group
of compounds. For example, standardized milk thistle products
typically claim to contain 70-80% silymarin (a name for three
flavonolignans). But this is highly concentrated and not typical
of most standardized herbal products, which is usually either
at a 3-5% level or at 24%, depending on the particular herb
and parameters of standardization.
is now investigating which of the chemicals are the correct
ones to standardize on. In St. John's wort, as noted earlier,
the hypericin marker is related to photosensitivity and is not
related to anti-depressant activity. The compound called hyperforin
has been shown to be more directly correlated to anti-depressant
many herbs have more than one biologically active compound which
work synergistically -- so standardization to only one compound
may not be the best way to make a product that delivers consistent
health results. It also depends on what clinical outcome you
want. Some products might be standardized to one compound (or
group of compounds) for one desired effect, and to another chemical
or group of chemicals for another. It's not a cut and dried
standardization is not just a matter of chemistry. With some
companies, standardization starts with the seed and horticulture.
Most plants grow best in specific environmental conditions.
There's also the matter of selecting the best seed -- one that
yields a preferred chemical profile in an extract or essential
oil. Plus, there are cultural issues of using good harvesting
and processing methods, and so on.
great example of this is a German company that makes a line
of chamomile products for external use. All their chamomile
extract is made from chamomile grown in Spain from a specific
strain of seeds. This strain was selected because years of research
show that this chemotype of chamomile produces the optimum extract
from the perspective of biological activity. So standardization
is not as simple as some people make it out to be.
is a complex issue. Standardization is only one of many factors
that contribute to making a quality product. In some cases,
there is compelling evidence to support the safety and efficacy
of nonstandardized products. Francis Brinker, a naturopathic
physician and a leading author in botanical medicine, wrote
a well-referenced 16-page article in HerbalGram #46 about
the "Variations in Effective Botanical Products" -- the case
for non-standardized herbs being given their due. He cited much
European research on non-standardized herbal preparations that
indicates their safety and efficacy.
as we want biological diversity and cultural diversity, there
is a strong case for herbal diversity. There are many different
uses for herbs, and various types of dosage forms are appropriate
for different applications. For example, I don't think I must
have a chemically standardized chamomile tea-bag for me to enjoy
a flavorful cup of tea that also gives me the added benefit
of helping me digest a big meal!
American Botanical Council's Ginseng Evaluation Program
began the Ginseng Evaluation Program (GEP) in 1993, motivated by
the concerns of research scientists and veterans of the ginseng
and herbal industries -- concerns that some ginseng products might
be mislabeled (meaning that they did not contain the amount of ginseng
listed on the label) or adulterated with any of a variety of contaminants.
ABC purchased randomized, off the shelf samples of approximately
500 ginseng products throughout the US and Canada, and sent them
to laboratories for testing.
passage of DSHEA in 1994 changed the regulatory environment for
herbal supplements, including ginseng, so the GEP evolved into three
regular (original) phase tested products manufactured before
"new lot" phase tested products that failed in the original
phase but had changed formulation after DSHEA.
"standardized" phase tested products that claimed to be "standardized".
of the GEP will be reported in two special issues of HerbalGram
devoted to ginseng. Standardized phase test results are being published
in HerbalGram #51, due out in March 2001; the regular and
new lot testing phases will be reported in #52, due in June 2001.
HerbalGram is the journal of ABC and the Herb Research Foundation.
website has a full description of the GEP program at www.herbalgram.org/browse.php/defaulthome.