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Bob -

 

While your efforts are commendable, the letter you recommend will not

solve the problem and I think the lack of FDA response is evidence to

that effect. Scope definition is not within the purview of the FDA. I

wish the Chinese herbal companies could get this point. Such campaigns

are futile and do less than spread good will. Rather, they demonstrate

how little we as a profession understand the ways and means of federal

regulatory agencies.

 

Will Morris

 

<I use Ephedra (Ma Huang) occasionally and Pinellia (Ban Xia) regularly

in my practice and these herbs are administered safely according to my

extensive traditional Chinese herbal training and national

certification. Please communicate to FDA on my behalf. I would like to

request that this recent ban be revised, to allow access to dietary

supplements that contain ephedrine alkaloids in my practice, for use in

traditional formulas and for traditional uses.>

 

Message: 4

 

> Fri, 09 Apr 2004 15:16:09 -0000

> " Bob Flaws " <pemachophel2001

>Re: ban xia ban on monday

>

>

>

>As far as I know, the FDA has not yet responded to the AHPA petition.

Therefore, we have no reason to think that the ban will not go

>into effect as of Monday, Apr. 12. As for what companies are doing, I know that

several, including Blue Poppy Herbs, are going to

>continue selling to licensed professionals only. My assumption is that the herb

companies are going to have to bring a suit against the

>FDA. You are also correct that there has been a resounding silence from the

profession as evidenced by the number of CCs

>association and herb companies have received. The AT article really shot us in

the foot on this one. Perhaps, when people really

>understand this issue (hopefully not too late but maybe that's what it'll

take), we will also understand the poor quality of journalism

>practiced by AT. AT is not run by and for acupuncturists. It is published by a

malpractice insurance company with their own agenda.

>

>Below is a copy of an e-mail I sent out this morning to a couple of other

acupuncture/CM forums. If it helps motivate anyone on this

>list, great!

>

>Hopefully, readers of this forum understand by now that their right to

prescribe, dispense, sell, and even personally use

>ready-made Chinese medicines may disappear as early as Monday, Apr. 12, 2004.

That is the date the FDA has set for

>the ban on all dietary supplements containing any amount of ephedra alkaloids

from any and all herbal sources, including

>Ephedra, Pinellia, and Sida Cordifolia. All ready-made Chinese medicines (i.e.,

patent medicines), those manufactured in

>Asia and those manufactured in the U.S., are legally sold in the U.S. under

DSHEA (Dietary Supplement Health &

>Education Act) as " dietary " or " herbal " supplements. While the FDA ban does not

effect the prescription, dispensation, sale,

>and use of bulk-dispensed, water-based decoctions, very few U.S. practitioners

prescribe and dispense Chinese herbs in

>this form. Already, at least one well known company has had an entire shipment

of powdered Chinese herbal extracts

>embargoed by Customs on the order of the FDA. Not only will the FDA not allow

companies to import and sell any

>products containing any ephedra alkaloids, but product liability insurers will

not cover any product which has been banned

>by the FDA. This creates simply too much legal liability for companies to

disregard or flout this ban.

>

>Including products that contain Ma Huang and/or Ban Xia, we are talking about

over 900 ready-made Chinese medicinal

>products. If these are truly forced off the market, many herb companies will go

out of business as will book publishing and

>distributing companies and schools. It costs approximately $5000 to produce a

single run of a single formula/product,

>including labelling and packaging. Since approximately 40% of all Chinese

medicinal products contain one of these

>ingredients, this ban effectively guts our formulary. What's even worse, if

this ban is allowed to stand, the next set of

>ingredients on the FDA chopping block is all the citrus medicinals due to their

containing synephrine. This includes Chen Pi,

>Qing Pi, Zhi Ke, Zhi Shi, and Fo Shou.

>

>If you have any desire to practice Chinese herbal medicine either now or in the

future and you intend to prescribe and/or

>sell or even simply personally use any ready-made Chinese herbal medicines, it

is imperative that you contact your

>Congressional representatives and the FDA ASAP. You can easily do so with a

pre-prepared letter, addresses, e-mail

>addresses, etc. by going to www.bluepoppy.com.

>

>If you have been lulled into complacency by the recent AT article on this

issue, please wake up. The AT article was simply

>misinformed and wrong. Act now or you will have no one to blame but yourself.

Based on CCs sent to various herbal

>companies so far, your co-professionals are not responding en masse to this

threat, and we only have three days left till this

>ban goes into place.

>

>Bob Flaws

>

>

>

>

>

>

 

 

 

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Fish oils - Try Nordic Naturals.com, they provide good quality oils,

pure.

 

On another note, I wanted to pass this on for anyone in San Diego. I

feel that we need a good attendance at this to state our point when

Susan Davis asks for it. I received this invitation directly from her

office. This is a chance for the local community to voice their

thoughts on the FDA's actions.

 

The Truth About Weight Loss Ads, Dietary Supplements, and How to

Maintain Healthy Fitness

Saturday, April 17, 2004

1:00 - 2:00 p.m.

Westfield Shoppingtown UTC Mall

4545 La Jolla Village Drive

Canyon Room 1

 

Please join me, representatives from the Federal Trade Commission and

health care experts to discuss consumer protection issues regarding

weight loss ads and products. Please RSVP by calling my San Diego office

at 619-280-5353.

 

Marc

 

 

 

 

Marc Sklar, LAc

Oriental Medicine Practitioner

Body Evolution Wellness Center

858-571-0160

www.bodyevolution.org

sklarlac

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Way to go, Marc!

 

I think this would be a great way for San Diego L. Ac.'s to influence

and interact with our congressional representatives on the issues

facing our profession. I'll try to spread the word.

 

 

 

 

On Apr 10, 2004, at 10:22 AM, Marc Sklar, LAc wrote:

>

> On another note, I wanted to pass this on for anyone in San Diego. I

> feel that we need a good attendance at this to state our point when

> Susan Davis asks for it. I received this invitation directly from her

> office. This is a chance for the local community to voice their

> thoughts on the FDA's actions.

>

> The Truth About Weight Loss Ads, Dietary Supplements, and How to

> Maintain Healthy Fitness

> Saturday, April 17, 2004

> 1:00 - 2:00 p.m.

> Westfield Shoppingtown UTC Mall

> 4545 La Jolla Village Drive

> Canyon Room 1

>

> Please join me, representatives from the Federal Trade Commission and

> health care experts to discuss consumer protection issues regarding

> weight loss ads and products. Please RSVP by calling my San Diego

> office

> at 619-280-5353.

>

> Marc

>

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