E-drug: Public drug testing labs (cont'd)
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Dear e-drug participants,
Nancy Blum at USP forwarded me this e-drug posting. She
suggested that I provide a brief summary of our certification
program.
My name is Forouz Ertl and I am in charge of the USP dietary
supplement certification program.
The dietary supplement industry has reached its peak, $16B, in
1997 as the result of Dietary Supplement Health and Education Act
(DSHEA) which was passed by congress in 1994. Starting late
1997 and beginning in 1998, there has been numerous media
coverage questioning the quality of dietary supplement products,
and their safety and efficacy. As a result, consumers are confused,
losing their confidence and the industry is facing 20% decline in
sales. Most of the challenges are related to botanical and some
other dietary supplements such as glucosamine and chondroitin
sulfate.
FDA is also concerned about the safety of these products, but the
industry is not supportive of further regulations. There is a
pronounced conflict and disagreement between the industry and
FDA. There is a desperate need for a third party certification of
dietary supplement products (DS) and manufacturers. However,
such a program can only be effective and supported by both
industry and FDA if it is offered by a trusted, knowledgeable and
unbiased organization. USP meets that definition.
USP has come up with a certification program that is voluntary and
open to all DS manufacturers. It consists of 3 elements:
a) Auditing of manufacturing facility for compliance with GMP and
review of manufacturing and QC records to confirm that the firm is
operating under sound quality system
b) Random testing of DS products for conformance to specifications
including label declarations
c) Post certification surveillance testing to insure continuous
compliance to USP requirements.
The program is in its pilot phase, with some DS manufacturers
participating. The pilot phase is expected to be completed by early
Oct 2001. Upon successful completion of the pilot, the program will
be launched nationwide.
We are planning to expand the program to the suppliers and
manufacturers outside US since most of botanical are manufactured
and extracted oversees.
Please contact me with any comments or questions you might
have. You can reach me via e-mail at fe@usp.org
Sincerely,
Forouz Ertl
United States Pharmacopoeia
e-mail: fe@usp.org
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