FDA & Ban Xia

[Guest guest]

There are some comments within the text below.

Thanks

Chris

 

>>In a message dated 1/2/2004 12:34:50 PM Eastern Standard Time,

pemachophel2001 writes:

If the FDA has truly banned Rhizoma Pinelliae Ternatae (Ban Xia) from all

prepared herbal supplements, then this will be a huge blow

to the CM industry/community in the U.S. I'm not usually one to entertain

conspiracy theories, but, the more I think about this, the

more I think this move is very suspect.

 

 

From my perspective, it is all about power. The drug companies are

continually looking for ways to lesson the power of alternative medicine, along

with the ability of the people to take responsibility for their own health.

They

will take whatever action they think they can get away without regard for the

health of the American people.

 

 

 

 

>>First of all, as Todd has rightly pointed out, Ban Xia is not a significant

source of ephedring alkaloids I doubt there is any evidence of

people in the U.S. stroking out or dying from heart attacks due to Ban Xia.

 

This is really not the issue. They feel they can take power. If they

succeed, they will have power. If they can take an herb with such little danger

as Ban Xia, they will go after others using this case as an example of this

president. Think of all the compounds they can consider dangerous and how easy

it would be to take mass quantities off herbs off the market with this

strategy.

This is why I suggested we organize a National defense team to lobby for

our rights.

 

 

 

 

 

>>Secondly, Ban Xia is a much more widely used ingredient than Ma Huang in

prepared CM medicinals. It's virtually in all versions and

modifications of of Minor Bupleurum, all versions and modifications of Liu

Jun Zi Tang, all versions and clones of Er Chen Wan and

Wen Dan Tang, and Ban Xia Xie Xin Tang. It's present in many other formulas

for respiratory, cardiovascular, psychiatric, and digestive

formulas. In fact, it is one of the most cunningly chosen ingredients if you

wanted to knock out the largest number of prepared

Chinese herbal formulas. While there are possible substitutions for Ban Xia in

most of these formulas,

we don't know that they will work as well.

 

We should not allow this. And we have the opportunity to stop this

action. There have been legal actions in the past that dramatically limited the

power of the FDA because of their abuse of power. They have clearly acted as a

union lobby for the Drug Companies. That has been shown innumerable times.

If we were to join a national union ourselves, we would have an enormous

lobbying power behind us. I have seen this work for other professions. It

can work for us.

 

 

>>So, to me, the ban on Ban Xia seems like an exceeding well aimed arrow into

the center of our profession, not to mention my

personal pocketbook. I've always fantacized about opening a restaurant, or

maybe my son and I should do a Discovery Channel

number and build choppers.

 

Bob

 

 

The sad but true fact is that according to JAMA, Doctors are the third

cause of death in the USA. Remember,,,,, this comes from JAMA. The herbal

dangers power play is only to keep potent healing modalities out of the hands of

the citizens. The less choice poeple feel they have, the more power the FDA

will try to capture.

They must be stopped. Congress has bee alerted in the past to the power

play of the Drug lobby FDA. It is about time they were reminded again.

As a national united front, we could carve our way into history as the

organization that guaranteed the freedom of choice for the people. It would

also secure our right to prescribe.

 

Chris

[Guest guest]

If the FDA has truly banned Rhizoma Pinelliae Ternatae (Ban Xia) from all

prepared herbal supplements, then this will be a huge blow

to the CM industry/community in the U.S. I'm not usually one to entertain

conspiracy theories, but, the more I think about this, the

more I think this move is very suspect.

 

First of all, as Todd has rightly pointed out, Ban Xia is not a significant

source of ephedring alkaloids I doubt there is any evidence of

people in the U.S. stroking out or dying from heart attacks due to Ban Xia.

 

Secondly, Ban Xia is a much more widely used ingredient than Ma Huang in

prepared CM medicinals. It's virtually in all versions and

modifications of of Minor Bupleurum, all versions and modifications of Liu Jun

Zi Tang, all versions and clones of Er Chen Wan and

Wen Dan Tang, and Ban Xia Xie Xin Tang. It's present in many other formulas for

respiratory, cardiovascular, psychiatric, and digestive

formulas. In fact, it is one of the most cunningly chosen ingredients if you

wanted to knock out the largest number of prepared

Chinese herbal formulas.

 

While there are possible substitutions for Ban Xia in most of these formulas, we

don't know that they will work as well. Also, if

companies are forced to dump their current inventories, many of them will go

belly up. Many of us are just not big enough to absorb

this kind of loss. Within the CM industry as whole, it takes relatively big

bucks to play the herbal game (much bigger than being a

publisher, for instance). You have to buy in very large quantities. So, not only

will companies have to dump their current inventories,

they would also have to buy new inventories, new labels, develop all new

promotional materials, etc., etc. Perhaps the very biggest

companies can afford to do this, but not the majority of smaller ones. Just

think of all the inventory Mayway, Nuherbs, Min Tong,

Brion/Sun Ten, Qualiherb/Finemost, Pine Mt., Golden Flower, ITM, etc. will have

to dump.

 

Then consider the ripple effect. Easily more than 90% of practitioners in the

U.S. depend on prepared meds. All these meds are

legally sold only because of DSHEA. Their legal sale has nothing to do with our

legal scopes of practice. Our legal scope as

practitioners only affects our legal right to prescribe these meds. It does not

protect our legal right to sell these meds. If the FDA says

that only people dispensing bulk herbs can prescribe Ban Xia and many standard

Rx's are no longer available in prepared form, I don;t

see that many more practitioners moving to decoctions because I don't think most

Americans are willing to drink these. Hell, even

less and less Chinese are willing to drink them. So I would think there'd be

less practitioners prescribing Chinese herbs as a whole

and more doing homeopathy, nutritional supplements, and Western herbs. If that

were to happen, publishing companies like Blue

Poppy Press and Eastland Press would also get hammered, possibily past survival.

Most of our books are about Chinese herbal

medicine. If those books no longer sold, that would put the kabosh on that

element of the business. Even the schools would suffer. If

Chinese herbal medicine was not as practicable, then a large part of faculties

and courses would be superfluous.

 

So, to me, the ban on Ban Xia seems like an exceeding well aimed arrow into the

center of our profession, not to mention my

personal pocketbook. I've always fantacized about opening a restaurant, or maybe

my son and I should do a Discovery Channel

number and build choppers.

 

Bob

[Guest guest]

, " Bob Flaws "

<pemachophel2001> wrote:

> If the FDA has truly banned Rhizoma Pinelliae Ternatae (Ban Xia) from all

prepared

herbal supplements, then this will be a huge blow

> to the CM industry/community in the U.S. I'm not usually one to entertain

conspiracy theories, but, the more I think about this, the

> more I think this move is very suspect.

 

the FDA told me today that no one seems to know how " traditional chinese herbal

remedies " will be defined. But the information specialist told me that the FDA

has no

power to issue rules about WHO may use a substance or not. so the final rule

will

definitely not be like the CA and NY laws which exempt certain practitioner

classes.

This is the right of state legislatures, but not the feds (thus the current

battle between

DEA and the CA medical marijuana laws). the final rule will be in that area

which is

the domain of the FDA, the substances themselves. The FDA rep told me that me

that

sale of ma huang and ban xia as sole ingredients will definitely not be allowed.

Only

mixtures including these and then the amounts may be restricted. So this seems

to

imply some patents may still pass muster.

 

Perhaps all such products will just have to be registered in advance. so all

current

products will have to be reviewed for safety before being sold again. the

burden will

no doubt be on the manufacturers. But this raises another question about teas

and

granules and pills, too. If one cannot purchase ma huang as a single ingredient

even

on the wholesale level in the US, how is one to manufacture pills in the US or

stock

raw herbs that will be dispensed as mixtures. Perhaps this law actually

restricts the

sale of herb teas by this mechanism and allows a loophole for large companies to

produce patents that meet certain testing standards. This is how confused this

matter is. I get differing information about whether any of this is still open

to

comment, but there is no docket listed on the FDA website. BTW, kanp formuls

from

japan might meet the requirements as long as ma haubg wasn't used a single

ingredient.

 

I urge people to call the FDA, their congressman, etc. I do not believe proper

procedure was used to implement this rule. It can be overturned or amended by

an

act of congress if all else fails.

 

[Guest guest]

At 5:32 PM +0000 1/2/04, Bob Flaws wrote:

>I'm not usually one to entertain conspiracy theories, but, the more

>I think about this, the more I think this move is very suspect.

--

 

Bob,

 

I'm not so sure about this. I think they probably looked for any

substances that contain ephedrine alkaloids and banned them all, to

prevent some smart operators from loading people up on enough ban xia

to have the stimulant effect and causing god knows what damage to

them in the process. I agree with the fda about this, to the extent

that I think any ban is justified; ie if they were going to ban

ephedra, it made logical sense to ban pinellia as well.

 

I don't know how we should best respond to this, but we have to do

something. Personally I'm trying to think through the design of a

professionally regulated delivery system for the banned Chinese

medicinals and prepared products that would prevent exploitation by

the dietary supplement industry. It would involve certifying both

practitioners and suppliers, with a declared standard of practice,

and having recording system for each sale. If we can put something

together that looks responsible and reasonably watertight, we might

be able to get it legitimized.

 

Perhaps others have better ideas...

 

Rory

--

 

 

 

[Guest guest]

In the UK, Ma Huang has been banned for a long time, but has been

available to herbalists using no more than 600mg at a time, up to 3

times a day.

 

Regulation of herbal medicines in the UK is complex, but basically,

the UK Government is very keen for herbalists to become State

Registered. Once this occurs, there is a possibility that herbs that

have been deemed unsafe for sale to the general public use will still

be prescribable by State Registered herbalists.

 

 

Wainwright

[Guest guest]

At 6:36 PM +0000 1/2/04, wrote:

>the FDA told me today that no one seems to know how " traditional

>chinese herbal remedies " will be defined.

--

 

 

 

If this is the case, then we, I mean CHA, has an opportunity to

influence the definition by creating a definition by professional

consensus. My impression is that they need our help with this to get

it right. So why don't we take a stab at it?

 

Rory

--

 

 

 

[Guest guest]

, " wainwrightchurchill "

<w.churchill_1-@t...> wrote:

>

>

> In the UK, Ma Huang has been banned for a long time, but has been

> available to herbalists using no more than 600mg at a time, up to 3

> times a day.

 

which would be a very low dose in decotion, possibly below the therapeutic

threshold

if the textbook dose range is 3-10/day.

 

In Reuters, various people wrote:

 

" Ephedra " should not be in dietary weight loss products. That's not the proper

use of

it, " said Robert Wright, a licensed acupuncturist who has a private practice in

Napa,

California.

 

" It's commonly used for colds, in short-term, small-dose use, " he added. " It's

a great

herb, when used properly by trained professionals. "

 

according to Charlotte Furth, a history professor at the University of Southern

California who specializes in ancient Chinese medicine.

 

" If you look at the Ming dynasty texts on Chinese medicine, ma huang was

certainly a

widely used drug, but the doctors warned against using it in large quantities, "

she

said. "

 

: This is somewhat misleading as the textbook dosage at 10g/day, up to 20

in

xu and wang, can deliver 100-200 mg per day of ephedrine. this is considered a

very

high dose if one considers the british standard delivers about 18 mg/day. The

reason we can use ma huang safely has nothing to do with the dose we use it at.

It's

how and why we use it. If called for, it is safe. The prohibition against

large

quantities makes it seem as if the ancient chinese only dosed less than 1.8

grams per

day like the brits. Its actually a prohibition to protect against injuring the

qi and yin

from too much sweating. It does not bolster our case for safe use of ma huang

to

make statements like this. we do indeed use quite large doses of ma huang in a

number of circumstances and I would hate to see the british solution applied

here. If

it appears to authorities that one way to appease us is to allow ma huang with a

dose

limit like 600 mg TID because we don't use large doses anyway, we have lost the

battle.

 

Oh, BTW, stumbled across this well cited defense of OTC ephedra. I imagine in

all the

hoopla, no one searched medline. In fact, ephedra appears quite safe even OTC

when

one looks at the data. The FDA is citing 1000's of adverse incidents in making

its

ruling, very few of which have been confirmed as due to ephedra. That's another

red

flag for me. If ephedra has been trumped up as more dangerous than it actually

is,

why? This is clearly not near the public safety threat that many other things

are.

Aspirin kills far more people annually, I think.

 

http://www.mazzhealthsystems.com/drfarber.htm