Vol. VI, No. I
January/February 2003
Return to
Pharmacotherapy
Update Index
|
Dietary Supplements Update:
Seals-of-Approval
There
continues to be a consistent use of dietary supplements in the United
States. Many consumers, however, do not realize that these products are
not standardized or regulated by The Food and Drug Administration (FDA)
as prescription and over-the-counter products are. It remains the responsibility
of the dietary supplement manufacturer to ensure the quality and consistency
of the product. There are, however, no universal standards for maintaining
this consistency and, therefore, several groups have begun to test products
for quality. Two independent organizations, the U.S. Pharmacopeia (USP)
and NSF International, have created fee-for-service certification programs
for testing the quality of dietary supplements.
In February
2001, the USP initiated the Dietary Supplement Verification Program (DSVP).
This program assesses the quality of dietary supplement ingredients as
well as the conformity of the ingredients and product specifications.
Health claims of the dietary supplements are not evaluated in this program.
Once the USP evaluates and approves the product for quality, a seal is
placed on the product. This label specifically indicates that the product
has been manufactured in compliance with good manufacturing practices
(GMPs), and it also tells the consumer that the product contains the stated
ingredients, in amount and strength, and that the product is pure and
meets limits for contaminants.
The USP
will continue to do random checks to ensure product compliance and maintain
certification, while audits of the manufacturing site will also be performed.
Two manufacturers, Kirkland and Nature Made, are expected to be the first
with DSVP labels by January 2003. NSF International began a certification
program in 1999. Similar to the USP program, NSF verifies products for
content and label accuracy, monitors for purity and contaminants, audits
the manufacturing process, as well as conducts continued surveillance
to ensure compliance. NSF also ensures manufacturers follow good manufacturing
practices (GMPs) and has already certified over 60 dietary supplements.
A third
independent group, ConsumerLab.com, is also testing herbs and supplements
for purity, active ingredient content, and consistency. Manufacturers
pay ConsumerLab between $2,500 and $4,000 to have their product tested
and, if approved, can pay an additional fee for the ConsumerLab (CL) seal-of-approval.
Products that pass ConsumerLab's testing will be listed on their website.
As of July 2002, 595 products have been tested with 454 passing.
"Seals-of-approval"
will assist patients in choosing quality products, however, consumers
should be aware that these seals do not indicate an herb or supplement
is safe and effective. Therefore, dietary supplements should still
be treated with the same precautions as prescription medication and should
not be taken without consultation from a physician or other health care
professional.
| Top Selling Herbs in 2001 ($ in millions) |
| Ginkgo |
$46 |
 |
| Echinacea |
$40 |
|
| Garlic |
$39 |
|
| Ginseng |
$31 |
|
| Soy |
$28 |
|
