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Raising
the Herbal Bar
Excerpt
By Neil Sherman, HealthScoutNews
(HealthScoutNews) -- When
you pop that echinacea tablet to help your cold, it's a crapshoot
as to whether you're really getting that herb, thanks to the fact
that supplements lie outside of the reach of regulators.
But that's about to change, says the organization that sets voluntary
standards guaranteeing vitamins and herbal supplements are what
they say they are. Designed to gain consumer's confidence, U.S.
Pharmacopeia (USP) of Rockville, Md., says that beginning in 2002,
its USP mark on a dietary label supplement will mean that what's
on the label is what's in the pill. USP is a non-profit, non-governmental
organization that sets standards to ensure the quality of medicines
for human and veterinary use. It has set standards for about 3,400
prescription and non-prescription drugs.
Outside what's listed on the label, you really don't know whether
the quality or the quantity of an herbal supplement is good or
true, says Forouz Ertl, the USP vice president who is overseeing
the certification program for dietary supplements.
"The principle behind our new certification program is to
insure that quality systems are in place at the manufacturer's
facility," Ertl says. "We will audit that facility.
The company will have to be in compliance with USP's good manufacturing
standards as well as be in compliance with the rules for dietary
supplements published by the U.S. Food and Drug Administration
(FDA). In addition, we will look at a company's documentation
for quantity control, which will go under extensive review by
USP's scientific staff."
"In other words, we will test the products submitted to
the program, and then, when we test the products and they are
in compliance with their labels and meet our standards, the manufacturer
will be allowed to label the supplement with a USP certified mark,"
Ertl says. "As an example, you go to the market, and you
buy echinacea. As a consumer, you need to know which species of
echinacea you are buying, since there are three species. If the
product has a USP symbol on it, the bottle contains that specific
species in exactly the amount specified on the label."
Dietary supplements come in many forms, including tablets, capsules,
powders, soft gels, gel caps and liquids. Though commonly associated
with health food stores, dietary supplements also are sold in
grocery, drug and national discount chain stores, as well as through
mail-order catalogs, TV programs, the Internet and direct sales.
In 1996, sales of dietary supplements topped $6.5 billion in the
United States, reports the FDA.
The federal law known as the 1994 Dietary Supplement Health and
Education Act (DSHEA) requires manufacturers of dietary supplements
to ensure that products they sell are safe. But unlike regulations
that govern drugs or food additives, supplement manufacturers
do not have to provide information to the FDA to get a product
on the market. And the FDA is not required to review and approve
dietary supplement ingredients and products before they come to
market.
So will a USP symbol mean the dietary supplement is safe or that
it works?
"USP does not deal with safety and efficacy," Ertl
says. "But the certification program is going to help the
consumer have confidence that if the bottle has a USP label on
it, the product itself has been tested, certified, including the
manufacturing facility, and the consumer can have greater confidence
in the product."
USP announced the new certification program at last week's Natural
Products Expo East in Washington, D.C.
"This is very good news," says Charles Fetrow, author
of The Complete Guide to Herbal Medicine and a clinical
specialist at the University of Pennsylvania Medical Center Passavant
in Pittsburgh. "The FDA commissioned an ad hoc committee
a number of years ago, and this is really an FDA/USP partnership
in an effort to get the herbal industry standardized. It's a great
idea and I'm all for it."
Given the number of herbal supplements, Fetrow says it's going
to take some time before the entire program is in place. "There
are all kinds of standards to set. Things like heavy metals; you
want to keep those out. So they will set maximum thresholds for
heavy metal content. They will set maximum thresholds for contaminants,
or standards for moisture contents or a standard for insoluble
matter."
"There's certainly a need for it," Fetrow says. "Every
company that's producing these things should adopt these standards.
It's voluntary now, but who knows what's going to happen in the
future?"
What To Do
For more information on dietary supplements, see the
Center for Food Safety and Applied Nutrition. And for more
on the new certification program, see the
USP, but you'll need
Adobe Acrobat to read it.
For more about herbal supplements, check
American Herbal Pharmacopoeia.
Reference
Source 101
For more information on how to prevent other diseases, use
PreventDisease.com's "Quick
Prevention Resources".
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