Dietary Supplements, herbal regulation issues in America

[Guest guest]

One good reason that all herbalists should rally and join together with each

other, the TCM'ers, the American Herbalists Guild, AHPA -- each of us

contribute an herbal defense fund say of a meager $25 or more a year to hire

a lobbyist and to keep politicos on our side. With the possible change to a

Democratic administration in 2008-9 hopefully it will be a ray of sunshine

to have a change of the present administration but with it comes all the

protectionist, 'do-gooder' Democrats, probably headed by Hillary if she wins

that will stiffen regulations against herbs, supplements and alternative

medicine generally.

 

We desperately need an organization and special fund between the different

alternative, supplement and herbal people to protect our interests.

 

Regarding that, we should be aware that while many of us who are content

simply to assure access to herbs on a professional level there is a ground

swell with some very good arguments that resent herbs being only available

to an elite class.

 

I think commercially certain herbs should not be exploited and sold to the

general public -- though they should not be outlawed for use -- a

difference (one example being marajuana). Traditionally herbal medicine has

grown and continues to grow on a trial and error basis. Most of what we know

is based on that to confine herbs to use only by a duly qualified

professional class brings us back to the pre culpepper days when medicine

and other professions was only transmitted in Latin. sometimes think the

double speak of TCM lingo smacks of a kind of professional elitism but

that's another topic.

 

Michael Tierra

www.planetherbs.com

 

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On Behalf Of convergentmedical

Thursday, July 12, 2007 8:18 PM

 

Re: cGMPs for Dietary Supplements

 

 

 

Dear Bob,

I'd like to offer a somewhat different perspective. No matter what the

FDA representative said, the fact remains that under the terms of the

final rule, individual herbal practitioners are considered to be

manufacturers of dietary supplements engaged in interstate commerce,

and therefore subject to the rule. Such small entities have three

years to come into compliance.

 

The FDA may (or may not) choose not to enforce the rule on individual

practitioners. Their policy can change at any time, by processes

entirely internal to the FDA, and that policy can change very quickly.

 

The new FDA standards will be relied on by judges and lawyers as the

legal standard for herbal practice, if and when things go awry and

suits start flying. Thus it is not wise to ignore the rule just

because one believes one won't get busted by the FDA. If herbalists

spend the next three years ignoring the rule, they will be entirely

unprepared for the altered legal liabilities they will then face.

They will also be unprepared should the FDA not honor the verbal

assurance you heard, or should the FDA rapidly reverse that stance.

 

There are four options for herbalists to consider:

1. Ignore the final rule and do business as usual.

 

2. Close the in-office herbal pharmacy and fax patient herbal orders

to a CGMP-compliant herbal pharmacy that will custom compound.

 

3. Bring the in-office herbal pharmacy into full CGMP compliance.

 

4. Bring the in-office herbal pharmacy into modified CGMP compliance

by formally requesting some testing exemptions from the FDA.

 

I'd suggest that options 3 and 4 may not be financially viable.

I've already pointed out the problems with option 1.

 

Even though it will take several years to fully realize it, the game

has just been radically changed. I expect that when FDA considers the

time opportune, it will lower the axe on individual herbal

practitioners who are not CGMP compliant.

 

Best Regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.converge <http://www.convergentmedical.com> ntmedical.com

 

 

 

 

 

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