Really In The Bottle?
manufacturers say they use the highest quality production standards,
yet until very recently there have been few independent certification
or inspection programs serving the industry. Alarmingly, several
recent stories in the media have claimed that some brands don't
actually contain the full potency of substances as stated on their
is a new organization that provides independent testing of a wide
range of health and nutrition products, including vitamins, minerals,
herbals and other supplements. Subsequent to testing, ConsumerLab.com
will publish the names of passing products/manufacturers on their
website. Then, manufacturers whose products pass ConsumerLab tests
can purchase a license to carry the ConsumerLab certification seal
on their label.
ConsumerLab.com plans to test off-the-shelf samples of herbs and
dietary supplements, then publish results without first informing
manufacturers. This approach, originally pioneered by Consumer
Reports, is one way the company will analyze and report to consumers.
Companies whose products were not included in the initial set of
tests can request that ConsumerLab test their products as well.
On November 16, 1999, ConsumerLab published their first test results:
the names of 23 products containing ginkgo biloba that passed these
is testing for accuracy (does the bottle contain what the label
says it contains), consistency (does each tablet contain the same
amount as the other tablets in the bottle), and purity (is the product
free of contaminants). Read more about it on their website: www.ConsumerLab.com.
Are products adequately made?
Good Manufacturing Practices (GMP) certification program of the
National Nutritional Foods Association (NNFA) is already underway.
Passing this rigorous third party inspection system entitles a company
to use the NNFA's GMP seal on their product labels. Two manufacturers
have already passed the program's requirement and thirty more are
scheduled for audits as of this writing.
NNFA requires all of their members who manufacture dietary supplements
to meet these GMP quality standards for testing of raw and finished
materials, staff training, cleanliness, equipment maintenance and
record keeping. They estimate that all their members will have gone
through this inspection and certification process by 2002. For more
information about the NNFA's GMP and TruLabel programs, see the
Science and Quality Assurance section of their website: www.nnfa.org.
this product really work?
laboratory, Paracelsian Inc. (Ithaca, NY), has tackled the complex
question of testing herbal products to see if they actually produce
biological activity associated with their claimed benefit. According
to Paracelsian's Director of Business Development, Jeffrey Morrison,
"Many herbal supplements are `standardized' to a specific plant
component or components called `marker compound(s).'" The standardized
marker may or may not be the active component of the herb.
BioFIT[tm] quality control certification program is designed to
ensure that individual product batches show consistent activity
associated with claimed benefit. Says Paracelsian's Dina Berlin,
"Herbal products are complex mixtures of naturally associated compounds.
Biological activity can result from more than one constituent, and
these constituents can act synergistically. Even though the active
component(s) of an herb is sometimes difficult to determine, activity
is not. Measuring for consistent activity using bioassays that mimic
the human response ensures that consumers get the same product and
benefit from bottle to bottle, even if content varies slightly.
Paracelsian's BioFIT[tm] quality control certification program is
designed to ensure that individual product batches show consistent
activity associated with claimed benefit."
according to Berlin, Paracelsian has completed its first wave of
research and developed a certification program for five herbs (two
assays have been developed and validated to pharmaceutical standards
for each of the five): St. John's wort, echinacea, saw palmetto,
ginseng, and ginkgo. Paracelsian's BioFIT[tm] tests can be used
on both raw materials and finished products. Products that have
passed their tests are eligible to carry Paracelsian's BioFIT[tm]
certification symbol. For more details, see the BioFIT section of
Paracelsian's website: www.paracelsian.com.
Making quality choices
many of the programs reported above are still in development, the
rigor and comprehensive approach taken by all three testing organizations
promise to advance the cause of quality in dietary supplements.
Earlier, we interviewed Michael
Lange at Industrial Labs, a Denver-based organization whose
Institute for Nutraceutical Advancement (INA) represents a joint
effort with thirty major manufacturers of dietary supplements, together
with several trade organizations and the FDA. The INA's Methods
Validation Program is working to develop reliable, standardized
tests of botanical substances and products.
though these programs are new and evolving, one thing is clear:
Products that bear the quality seals of one or more of these four
programs are more likely to be reliable, consistent in content,
safe, and to provide claimed biological activity.