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Integrator Advisor Speaks: Levin on the FDA's New Dietary Supplement GMPs - Worth the Wait? PDF Print E-mail
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.

Levin's recent columns here have included one on a supplement quality issue and reporting on the apparent bias of the New York Times relative to the extent of adverse events for dietary supplements.


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
for enforcing


"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.

Image "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 Pharmacopoeia and the National Institute of Science & Technology. For information, contact ldi@ldigroup.

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