ban xia ban on monday

[Guest guest]

 

 

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

[Guest guest]

, " Bob Flaws " <

pemachophel2001> wrote:

 

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.

 

Bob

 

Are you saying that BP and others plan to defy the ban while petitions and

lawsuits are being enacted. I ask because if this is considered a reasonable

tactic, then PCOM should do the same. On tuesday, I present the summary of

this issue and how it will affect us all at our quarterly clinical supervisor

meeting.

 

I know many are enmeshed in finals right now, but please take some time this

weekend, just 5-10 minutes, to do your part. It makes no sense to tell

yourself that you are too busy with practice, finals, etc. when all of this will

matter not one bit when we lose our scope of practice.

 

[Guest guest]

 

 

Yes, that is what I am saying. This is also the position, I believe, of K'an,

Crane, Thorne, Mayway, Nuherbs, Brion, Qualiherb, Honso,

Health Concerns, Golden Flower, and KPC. As far as I know, Evergreen is the only

company that has cut and run.

 

BTW, here's something I just found on the Herbagram site regarding the Ma

Huang/Ban Xia ban. This should help clarify the issues for

anyone who is still undecided whether or not the FDA ruling is a direct threat

to our existence.

 

Several notable consequences of the FDA's final rule exist. First,

manufacturers, retailers and distributors

selling ephedra supplements after April 12, 2004 will be subject to civil and/or

criminal enforcement, and

likely serious product liability exposure. Second, all dietary supplements, not

just ephedra, will now be subject

to a risk/benefit safety analysis for the first time as opposed to only risk of

injury analysis which was

relevant in the past. The FDA's risk/benefit analysis weighs the quality,

persuasiveness, and seriousness of

presence of risks associated with the supplement against the quality and

importance of the related benefits,

with an emphasis on long term health outcomes opposed to temporary measures such

as feeling or looking

better.14 The FDA indicated its determination did not rely on adverse event

reporting because such reports

are not dispositive of a determination of unreasonable risk.15 Third, the FDA

will act proactively and the

industry can expect further rule-making instead of waiting for case-by-case

enforcement when an ingredient

safety issue arises. One of these proactive measures is indicated by the FDA

adding a new section to the

Code of Federal Regulations for " Dietary Supplements that Present a Significant

or Unreasonable Risk. " 16

Fourth, the FDA substantially raised the bar on safety substantiation. It is

significant to note for future safety

studies that the FDA rejected the ephedra safety studies because they were

either too small nor designed to

detect serious effects in susceptible individuals. Warning labels are

insufficient; the implications of this ruling

with respect to the sale of other herbs is not clear. Since few herbs on the

market possess the relatively

strong pharmacological activity as ephedra, the stringent warnings that would

have pertained to ephedra if

FDA's warnings previously proposed in February 2003 had stood are now moot.

Finally, various state

ephedra laws that conflict with the FDA's final rule will be preempted.

 

Bob