Integrator Advisor Speaks: Levin on the FDA's New Dietary Supplement GMPs - Worth the Wait?
Written by John Weeks
Integrator Advisor Speaks: Levin on the FDA's New Dietary Supplement GMPs - Worth the Wait?
Summary: After 12 years of an unsteady and politicized process, the US Food and Drug Administration last month finally issued its new Good Manufacturing Practices (GMP) for dietary supplements. Integrator advisor Michael Levin has made his way through the 800+ pages of the GMP document. In this Part #1 filing for the Integrator, Levin reveals a strange conceptual approach to GMP which will allow companies to make claims that sound equivalent (ie, "we follow GMP") which actually give the consumer no information about the comparative quality of manufacturing processes. A September 13-14 conference led by Loren Israelsen and the United Natural Products Alliance will provide interested parties with a thorough briefing on the subject.
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Michael Levin
Integrator adviser Michael Levin is among a cadre of natural products specialists whose noses have recently been buried in an 800+ page document recently issues by the Food and Drug Administration (FDA). The document describes the FDA's Good Manufacturing Practices (GMP) for dietary supplements. These followed the passage of the Dietary Supplement Health and Education Act in 1993. In November, 94, FDA
announced a plan to have them published in 1995. The first "advance notice of
proposed rulemaking" on supplements was published in 1997. The
"proposed rule" was published for comment in 2003. They were finally published last month.
In this first of a series, Levin, a healthcare consultant who has held executive positions with both the dietary supplement companies and Big Pharma companies, notes a disturbing flaw in an apparent guarantee these GMP would appear to have for consumers.
The FDA’s New Dietary
Supplement GMPs – Worth the Wait? Part
#1
- Michael D. Levin, Health Business
Strategies
"On June 22, the FDA published the
final rules intended to establish minimum standards for dietary supplement
manufacturing practices. After 12 years of waiting, the new law weighs in at
829 pages. Were they worth the wait?
"Yes ...
because the FDA now has the
regulatory
framework necessary
for enforcing dietary
supplement manufacturing
practices."
"Yes and no.
"Yes, because the FDA now has the
regulatory framework necessary for enforcing dietary supplement manufacturing
practices. All companies must be in compliance by no later than August 2010
(yes: in 3 years). If they aren’t, and there’s a problem, FDA can point to the
chapter and verse by which to take legal action against the offender.
"No, because the rule requires
that manufacturers, not the FDA, define quality specifications for their
products– and those specifications can (with very few exceptions) be as loose or
as tight as determined by each manufacturer. The law simply requires the
manufacturer to define the specifications and to make certain that the
processes in place guarantee that the finished products meet those
specifications.
"Huh?
"For example, some companies may
choose to set very tight specifications for allowable limits of contamination.
They may choose to use ingredients that are free from such things as illegal
pesticides, herbicides, heavy metals, etc.
Other companies may NOT choose to include those requirements in their
specifications (because of the cost associated with testing). Both companies
may be in compliance with GMPs, but one may be selling a 'GMP compliant'
product that contains an illegal pesticide, while the other company is selling
the same product WITHOUT the illegal pesticide. Both companies are GMP
compliant. And the customer cannot tell the difference between the two.
"No ...
because the rule requires
that manufacturers, not the FDA, define quality specifications for their
products."
"This already happened. Federal
Marshals seized American ginseng that was contaminated with the illegal,
carcinogenic pesticide PCNB a few years ago. The 'GMP-certified' manufacturer
had never tested for the presence of that ingredient in the raw material. Now
they do.
"Bottom Line: The new GMPs will not assure any improvement
whatsoever in the quality of dietary supplements in the US. The rules are
comprehensive, detailed and very clear: its up to the market to define quality.
Some companies will continue to do a good job, and some will continue to do a
poor job. In this environment of food safety concerns, contamination and
economic adulteration, it’s only a matter of time before another problem
surfaces. Hopefully, our 'guardians at the gate', the companies themselves, will
stand tall and act responsibly to protect the public health. We’ll see."
Notice of Meeting on GMPs: Need to learn what the GMP sill mean to consumers or require of manufacturers? Attorney and long-time leader in natural products policy, Loren Israelsen, has announced that the United Natural Products Alliance, will have a conference on the DFA's GMP September 12-13, 2007. Those interested in a thorough understanding of these requirements will find this an excellent briefing. Presenters will include Israelsen as well as representatives of diverse organizations including the NIH Office
of Dietary Supplements, US
Pharmacopoeia, American
Herbal Pharmacopoeiaand the National
Institute of Science & Technology. For information, contact ldi@ldigroup.
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