Supplement Quality, Stage Right . . .
twists in the health-claim scenario
membership is in large part defined by large, multinational food
manufacturers -- who want to make health claims about functional
foods (which combine a botanical supplement with a food, such
as breakfast cereals, soups and teas). In order to make such claims,
they need to have evidence that the scientific community will accept.
any research that a company conducts on the safety or effectiveness
of a supplement would benefit all manufacturers of that supplement.
Since plants cannot be patented, anyone can produce a supplement
to the specifications that research has found to be effective --
and can make health claims based on that research. But here, the
order to protect their investments in research, the members of RDIA
want exclusive rights to these validated health claims -- and conference
participants agreed this would be possible to arrange. Even though
any supplement producer can publicize scientific findings in their
marketing materials, only one manufacturer would be able to use
the validating seal. One suggestion for accomplishing this is to
have a waiting period of several months (perhaps 6, 12 or 18 months)
between validating one manufacturer's health claim and investigating
a similar claim from another manufacturer.
validating seal of approval for health claims would enable consumers
to rely on specific products that had earned the seal, but like
many a modern-day hero, this initiative also has a dark side: "Giving
a validated seal of approval to only one manufacturer when dozens
of other manufacturers' products are equally effective discourages
competition and is not in the best interests of the consumer," according
to Candace Campbell, Executive Director of the American Preventive
Medical Association (APMA).
four: Testing the products
curtain rises next on the issue of testing the products themselves:
the classic question of what's really in this bottle. In the opening
scenes of this act, the spotlight shines on the previously mentioned
ConsumerLab.com, a private laboratory that conducts randomized,
off-the-shelf testing of supplements and publishes the names of
passing brands on their website, www.ConsumerLab.com.
Companies whose products pass the tests can license the ConsumerLab
quality seal to put on their label and marketing materials.
to Lisa Savin, VP of Business Development at ConsumerLab, business
is booming: "More companies are licensing our seal and asking to
be among the first group of products tested in a particular category
-- as well as asking that their products be tested in our ad hoc
program." Approximately 85 percent of ConsumerLab's 25,000 email
subscribers are individual consumers who want to stay apprised of
supplement testing news.
seasoned performer now entering the drama is NSF International (NSF)
-- formerly the National Sanitation Foundation -- which is developing
a third-party testing and certification program for dietary supplements.
Founded in 1944, NSF develops quality standards in the areas of
public health safety and environmental protection, most notably
in such little-noticed but critical areas as bottled water products
and supermarket baked goods. Products with the NSF certification
mark have passed third-party tests of manufacturing processes as
well as product quality, purity, and shelf-life.
addition to offering a certification program, NSF plans to write
an American national standard for dietary supplements. This, like
NSF's other standards, would be designated as an American National
Standard through the American National Standards Institute (ANSI).
ANSI is the national authority on industrial and consumer standards
formed at the beginning of the 20th century as a means to promote
consistency in industry and the sciences.
US Pharmacopoeia (USP) is now developing a business plan for a quality
certification program that would cover both verification (that a
bottle's contents match the stated amounts on the label) and GMPs
(inspection of manufacturing plants). The plan would also address
marketing surveillance: that products conform to claims made on
the label. The USP will present this plan to its Board of Trustees
in January 2001.
the scenes: Making sure tests are reliable
all productions, ConsumerLab's success story would not be possible
without the contribution of experts working behind the scenes. In
this case, most of the testing procedures used at ConsumerLab were
screened and evaluated by the Institute for Nutraceutical Advancement
(INA) in their Methods Validation program. In testing botanicals,
it is crucial that any testing method be reliable, meaning that
different labs who test the same sample will get the same results
-- and rigorous, meaning that the test can be used on different
kinds of samples and still determine what that sample contains.
more information on the challenges of testing botanicals, see also
our interviews with Mark
Blumenthal at ABC and with Loretta
Zapp and Mark Lange at
five: Ensuring product quality
Randomized, off-the-shelf testing is an essential part of quality
assurance -- but ultimately is little more than a single snapshot
. . .
two: Reference materials
Like a fingerprint in a "whodunit" . . .
Supplement Quality, Stage Right
In the ongoing drama of controversy surrounding nutritional
supplements . . .