FDA Letter: astragalus not approved for use for H1N1 flu virus p

[Guest guest]

Dear Colleagues,

 

There's nothing at all " frightening " about this level of rigor in our FDA

administration. We have given the FDA the governmental, executive branch power,

to qualify or disqualify marketing claims that do not fit into the FDA

procedures for " new drugs " . This does not disqualify formulas with Huang Qi to

correctly do what Chinese medicine has demonstrated that they do. While the

Chinese government during the Revolution some decades ago attempted to create a

dual and parallel practice for CM and WM in China, at no time did the Beijing

government ask or demand our U.S. FDA or any other nation state's agencies to

share in their ideals.

 

As far as the FDA's mandate goes, virtually none of CM exists. So why would

they break their mandate and their integrity on behalf of Huang Qi? We would

have to create new legislation and new laws in the U.S. to cause the FDA to have

a new mandate. Alternatively, when W.H.O. comes out with a new ICD-10 or ICD-11

code listing that includes CM treatments of Western disease states, then the

U.S. government will have to decide how such broader codes will be implemented

and administered in the U.S.

 

The current U.S. administration is open to letting individual states administer

local control over some aspects of health care delivery. But that does not

change the general federal mandate of the FDA. It's worth noting that Chinese

medicine is still somewhat best practiced under it's own internal principles of

dialogue and practice.

 

made some reference recently to the idea that when a sufficient

critical mass of the population feels the need to have access to these

principles and protocols, then there will be the necessary legislative and

structure overhaul that will make it a reality. China, Taiwan and Japan have

arrived at this stage in their cultures medical paradigm. For instance, there

is a Japanese Pharmacopeias (the JP) that contains 240 root formulas of CM. The

U.S. has clearly not yet arrived. The FDA mandate here is much narrower in

scope. So we can not make marketing claims from CM principles that cross over

into WM treatment domains that are not yet approved by the FDA.

 

It's possible that the World Health Organization may soon push WTO members to

find a way to honor the overlap of these domains. It's something we can look

forward to and to promote. It's also something we in the U.S. can learn to live

without until then, while still enjoying the benefits of each system.

 

Respectfully and gratefully,

 

Em Segmen

 

 

[Guest guest]

Hmm, well thought. Thnx Em

 

--- On Sat, 10/24/09, Em_Segmen <mrsegmen wrote:

 

Em_Segmen <mrsegmen

Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus p

Chinese Medicine

Cc: " " <zrosenbe

Saturday, October 24, 2009, 7:42 PM

 

 

 

 

 

 

 

 

 

 

 

 

Dear Colleagues,

 

 

 

There's nothing at all " frightening " about this level of rigor in our FDA

administration. We have given the FDA the governmental, executive branch power,

to qualify or disqualify marketing claims that do not fit into the FDA

procedures for " new drugs " . This does not disqualify formulas with Huang Qi to

correctly do what Chinese medicine has demonstrated that they do. While the

Chinese government during the Revolution some decades ago attempted to create a

dual and parallel practice for CM and WM in China, at no time did the Beijing

government ask or demand our U.S. FDA or any other nation state's agencies to

share in their ideals.

 

 

 

As far as the FDA's mandate goes, virtually none of CM exists. So why would

they break their mandate and their integrity on behalf of Huang Qi? We would

have to create new legislation and new laws in the U.S. to cause the FDA to have

a new mandate. Alternatively, when W.H.O. comes out with a new ICD-10 or ICD-11

code listing that includes CM treatments of Western disease states, then the

U.S. government will have to decide how such broader codes will be implemented

and administered in the U.S.

 

 

 

The current U.S. administration is open to letting individual states administer

local control over some aspects of health care delivery. But that does not

change the general federal mandate of the FDA. It's worth noting that Chinese

medicine is still somewhat best practiced under it's own internal principles of

dialogue and practice.

 

 

 

made some reference recently to the idea that when a sufficient

critical mass of the population feels the need to have access to these

principles and protocols, then there will be the necessary legislative and

structure overhaul that will make it a reality. China, Taiwan and Japan have

arrived at this stage in their cultures medical paradigm. For instance, there

is a Japanese Pharmacopeias (the JP) that contains 240 root formulas of CM. The

U.S. has clearly not yet arrived. The FDA mandate here is much narrower in

scope. So we can not make marketing claims from CM principles that cross over

into WM treatment domains that are not yet approved by the FDA.

 

 

 

It's possible that the World Health Organization may soon push WTO members to

find a way to honor the overlap of these domains. It's something we can look

forward to and to promote. It's also something we in the U.S. can learn to live

without until then, while still enjoying the benefits of each system.

 

 

 

Respectfully and gratefully,

 

 

 

Em Segmen

 

 

 

 

[Guest guest]

Em, As far as I understand the FDA has been free to class any " thing " as a

" New Drug " if it is used to treat a disease. For example Ginseng in the

treatment of diabetes and Xiao Chai Hu Tang (SST) in the treatment of Liver

diseases / cancer, hepatitis. Xiao Chai Hu Tang is presently undergoing

clinical trails (stage 2) under FDA approval. IF it gains FDA acceptance as

a suitable treatment then the natural herbal remedy will be classified a

" new drug " and in order to dispense the formula for cancer / hepatitis then

one will have to have a Federal (US) license (MD). Presumably I will still

be able to prescribe Xiao Chai Hu Tang to my patients for liver qi / shao

yang disorders, but I can not treat " their " LIVER - in any western defined

sense. What IMO will laky evolve is something along the lines of that

(prescription) drugs and animals. Many prescription drugs are available off

the shelf in animal feed stores. I am just pointing out areas for

consideration.

 

 

 

Ed Kasper LAc

 

...........

 

Dear Colleagues,

 

There's nothing at all " frightening " about this level of rigor in our FDA

administration. We have given the FDA the governmental, executive branch

power, to qualify or disqualify marketing claims that do not fit into the

FDA procedures for " new drugs " . This does not disqualify formulas with Huang

Qi to correctly do what Chinese medicine has demonstrated that they do.

While the Chinese government during the Revolution some decades ago

attempted to create a dual and parallel practice for CM and WM in China, at

no time did the Beijing government ask or demand our U.S. FDA or any other

nation state's agencies to share in their ideals.

 

 

 

 

 

 

[Guest guest]

Hi Ed,

 

I'd look more carefully at this. Some of what you are describing, like herbs in

trials are as yet not regulated and therefore not yet needing a prescription.

No one can make a claim while a drug is in the trials stage. Most new drugs

require years of trials and generally over $500 million of investment capital in

those trials. I would not want to go there and especially not with an entire

plant tissue filled with thousands of varieties of molecules. Recall that Merck

won their case in federal appeals court regarding their trademarked Lovastatin.

The appeals court did not review their patent as regards a naturally occurring

molecule ... which is why they lost in the lower court. The appeals court

reviewed the trademark infringement.

 

The point the FDA was making in the earlier post was about " claims " for the

treatment of a specific viral pathogen by a method or medicine not approved by

the FDA for that purpose. Nothing else. If ginseng becomes a " new drug " , we

might no longer be free to use it depending on how it's categorized. If it

remains OTC, then we would have to provide it in the " regulated " manner. Pretty

tough for the importers. This is not a really easy area for the current

population of LAc.s in the U.S. to gain any benefits. San Francisco only

marginally looks a bit like Hong Kong or Shanghai only because things are pretty

uncategorized as regards CM.

 

One has to be careful for what one wishes for in the world of governmental

regulation.

 

Respectfully,

 

Em Segmen

 

Chinese Medicine , " Happy Herbalist "

<eddy wrote:

>

> Em, As far as I understand the FDA has been free to class any " thing " as a

> " New Drug " if it is used to treat a disease. For example Ginseng in the

> treatment of diabetes and Xiao Chai Hu Tang (SST) in the treatment of Liver

> diseases / cancer, hepatitis. Xiao Chai Hu Tang is presently undergoing

> clinical trails (stage 2) under FDA approval. IF it gains FDA acceptance as

> a suitable treatment then the natural herbal remedy will be classified a

> " new drug " and in order to dispense the formula for cancer / hepatitis then

> one will have to have a Federal (US) license (MD). Presumably I will still

> be able to prescribe Xiao Chai Hu Tang to my patients for liver qi / shao

> yang disorders, but I can not treat " their " LIVER - in any western defined

> sense. What IMO will laky evolve is something along the lines of that

> (prescription) drugs and animals. Many prescription drugs are available off

> the shelf in animal feed stores. I am just pointing out areas for

> consideration.

>

>

>

> Ed Kasper LAc

>

> ..........

>

> Dear Colleagues,

>

> There's nothing at all " frightening " about this level of rigor in our FDA

> administration. We have given the FDA the governmental, executive branch

> power, to qualify or disqualify marketing claims that do not fit into the

> FDA procedures for " new drugs " . This does not disqualify formulas with Huang

> Qi to correctly do what Chinese medicine has demonstrated that they do.

> While the Chinese government during the Revolution some decades ago

> attempted to create a dual and parallel practice for CM and WM in China, at

> no time did the Beijing government ask or demand our U.S. FDA or any other

> nation state's agencies to share in their ideals.

>

>

>

>

>

>

[Guest guest]

Em. I did not mean to imply that the FDA has already classified any herbs as

a " new drug " .

 

 

 

However, They do have the authority to do so today.

 

And Xiao Chai Hu Tang is currently under FDA approved clinical trials.

 

Xiao Chai Hu Tang has not (yet) been approved for use.

 

But once approved . will IMO change the landscape

 

 

 

A few years back the FDA issued me a warning letter regarding Ginseng. I had

a link frlom my website to another website that contained variuos research

on using ginseng in the treatment of diabetes. In summary the FDA said that

that link constitued " labeling " . The " label " connected ginseng to diabetes

and hence become perscribing medicine. The FDA went on to say that IF

ginseng was approved for treating diabetes then that would [automaticlly]

classify ginseng as a " new drug " . AND to perscribe drugs you need their FDA

license. I did prominetly note that I was a licensed California

acupunturists,and noted the traditional TCM uses regarding ginseng. The

FDA did read my " label " about ginseng and Chinese herbal medicine but took

no action or issued no warning about me perscribing and

the use of ginseng within that framework. ..

 

 

 

My understanding from that exchange (the FA and myself) was that I can not

prescribe treatments for any disease " licensed " by the FDA unless I held

their license. I can prescribe treatments for non-defined (FDA) diseases.

 

 

 

Ed Kasper LAc

 

 

 

 

 

<Chinese Medicine/message/35445;_y

lc=X3oDMTJybHVxZThyBF9TAzk3MzU5NzE1BGdycElkAzk0OTU5NzcEZ3Jwc3BJZAMxNzA1MDYwO

DE0BG1zZ0lkAzM1NDQ1BHNlYwNkbXNnBHNsawN2bXNnBHN0aW1lAzEyNTY1NjYyMTA-> Re: FDA

Letter: astragalus not approved for use for H1N1 flu virus p

 

 

Posted by: " Em "

<esegmen?Subject=%20Re%3A%20FDA%20Letter%3A%20astragalus%

20not%20approved%20for%20use%20for%20H1N1%20flu%20virus%20p>

esegmen <http://profiles./emmanuelsegmen>

emmanuelsegmen

 

 

Sun Oct 25, 2009 9:38 pm (PDT)

 

 

 

 

Hi Ed,

 

I'd look more carefully at this. Some of what you are describing, like herbs

in trials are as yet not regulated and therefore not yet needing a

prescription. No one can make a claim while a drug is in the trials stage.

Most new drugs require years of trials and generally over $500 million of

investment capital in those trials. I would not want to go there and

especially not with an entire plant tissue filled with thousands of

varieties of molecules. Recall that Merck won their case in federal appeals

court regarding their trademarked Lovastatin. The appeals court did not

review their patent as regards a naturally occurring molecule ... which is

why they lost in the lower court. The appeals court reviewed the trademark

infringement.

 

The point the FDA was making in the earlier post was about " claims " for the

treatment of a specific viral pathogen by a method or medicine not approved

by the FDA for that purpose. Nothing else. If ginseng becomes a " new drug " ,

we might no longer be free to use it depending on how it's categorized. If

it remains OTC, then we would have to provide it in the " regulated " manner.

Pretty tough for the importers. This is not a really easy area for the

current population of LAc.s in the U.S. to gain any benefits. San Francisco

only marginally looks a bit like Hong Kong or Shanghai only because things

are pretty uncategorized as regards CM.

 

One has to be careful for what one wishes for in the world of governmental

regulation.

 

Respectfully,

 

Em Segmen

 

 

 

...

 

Em, As far as I understand the FDA has been free to class any " thing " as a

" New Drug " if it is used to treat a disease. For example Ginseng in the

treatment of diabetes and Xiao Chai Hu Tang (SST) in the treatment of Liver

diseases / cancer, hepatitis. Xiao Chai Hu Tang is presently undergoing

clinical trails (stage 2) under FDA approval. IF it gains FDA acceptance as

a suitable treatment then the natural herbal remedy will be classified a

" new drug " and in order to dispense the formula for cancer / hepatitis then

one will have to have a Federal (US) license (MD). Presumably I will still

be able to prescribe Xiao Chai Hu Tang to my patients for liver qi / shao

yang disorders, but I can not treat " their " LIVER - in any western defined

sense. What IMO will laky evolve is something along the lines of that

(prescription) drugs and animals. Many prescription drugs are available off

the shelf in animal feed stores. I am just pointing out areas for

consideration.

 

Ed Kasper LAc

 

 

 

 

[Guest guest]

Ed,

 

The FDA is saying is that you can't make any advertising or labeling claims for

herbs that include a reference to diseases. This has nothing to do with our

clinical practice and will not affect it.

 

If somebody gets a new drug license for an herb formula like Xiao Chai Hu Tang,

they will be able to make disease treatment claims for that formula. The claims

will be related to whatever disease they treated and documented with expensive

clinical trials. This will not automatically turn that formula into a drug for

the rest of us. We won't be able to make a disease claim in advertising or

labeling, but we will not lose access to the herb. This is all about label and

advertising claims, not clinical practice.

 

- Bill Schoenbart

 

 

 

Chinese Medicine , " Happy Herbalist "

<eddy wrote:

>

> Em. I did not mean to imply that the FDA has already classified any herbs as

> a " new drug " .

>

>

>

> However, They do have the authority to do so today.

>

> And Xiao Chai Hu Tang is currently under FDA approved clinical trials.

>

> Xiao Chai Hu Tang has not (yet) been approved for use.

>

> But once approved . will IMO change the landscape

>

>

>

> A few years back the FDA issued me a warning letter regarding Ginseng. I had

> a link frlom my website to another website that contained variuos research

> on using ginseng in the treatment of diabetes. In summary the FDA said that

> that link constitued " labeling " . The " label " connected ginseng to diabetes

> and hence become perscribing medicine. The FDA went on to say that IF

> ginseng was approved for treating diabetes then that would [automaticlly]

> classify ginseng as a " new drug " . AND to perscribe drugs you need their FDA

> license. I did prominetly note that I was a licensed California

> acupunturists,and noted the traditional TCM uses regarding ginseng. The

> FDA did read my " label " about ginseng and Chinese herbal medicine but took

> no action or issued no warning about me perscribing and

> the use of ginseng within that framework. ..

>

>

>

> My understanding from that exchange (the FA and myself) was that I can not

> prescribe treatments for any disease " licensed " by the FDA unless I held

> their license. I can prescribe treatments for non-defined (FDA) diseases.

>

>

>

> Ed Kasper LAc

>

>

>

>

>

> <Chinese Medicine/message/35445;_y

> lc=X3oDMTJybHVxZThyBF9TAzk3MzU5NzE1BGdycElkAzk0OTU5NzcEZ3Jwc3BJZAMxNzA1MDYwO

> DE0BG1zZ0lkAzM1NDQ1BHNlYwNkbXNnBHNsawN2bXNnBHN0aW1lAzEyNTY1NjYyMTA-> Re: FDA

> Letter: astragalus not approved for use for H1N1 flu virus p

>

>

> Posted by: " Em "

> <esegmen?Subject=%20Re%3A%20FDA%20Letter%3A%20astragalus%

> 20not%20approved%20for%20use%20for%20H1N1%20flu%20virus%20p>

> esegmen <http://profiles./emmanuelsegmen>

> emmanuelsegmen

>

>

> Sun Oct 25, 2009 9:38 pm (PDT)

>

>

>

>

> Hi Ed,

>

> I'd look more carefully at this. Some of what you are describing, like herbs

> in trials are as yet not regulated and therefore not yet needing a

> prescription. No one can make a claim while a drug is in the trials stage.

> Most new drugs require years of trials and generally over $500 million of

> investment capital in those trials. I would not want to go there and

> especially not with an entire plant tissue filled with thousands of

> varieties of molecules. Recall that Merck won their case in federal appeals

> court regarding their trademarked Lovastatin. The appeals court did not

> review their patent as regards a naturally occurring molecule ... which is

> why they lost in the lower court. The appeals court reviewed the trademark

> infringement.

>

> The point the FDA was making in the earlier post was about " claims " for the

> treatment of a specific viral pathogen by a method or medicine not approved

> by the FDA for that purpose. Nothing else. If ginseng becomes a " new drug " ,

> we might no longer be free to use it depending on how it's categorized. If

> it remains OTC, then we would have to provide it in the " regulated " manner.

> Pretty tough for the importers. This is not a really easy area for the

> current population of LAc.s in the U.S. to gain any benefits. San Francisco

> only marginally looks a bit like Hong Kong or Shanghai only because things

> are pretty uncategorized as regards CM.

>

> One has to be careful for what one wishes for in the world of governmental

> regulation.

>

> Respectfully,

>

> Em Segmen

>

>

>

> ..

>

> Em, As far as I understand the FDA has been free to class any " thing " as a

> " New Drug " if it is used to treat a disease. For example Ginseng in the

> treatment of diabetes and Xiao Chai Hu Tang (SST) in the treatment of Liver

> diseases / cancer, hepatitis. Xiao Chai Hu Tang is presently undergoing

> clinical trails (stage 2) under FDA approval. IF it gains FDA acceptance as

> a suitable treatment then the natural herbal remedy will be classified a

> " new drug " and in order to dispense the formula for cancer / hepatitis then

> one will have to have a Federal (US) license (MD). Presumably I will still

> be able to prescribe Xiao Chai Hu Tang to my patients for liver qi / shao

> yang disorders, but I can not treat " their " LIVER - in any western defined

> sense. What IMO will laky evolve is something along the lines of that

> (prescription) drugs and animals. Many prescription drugs are available off

> the shelf in animal feed stores. I am just pointing out areas for

> consideration.

>

> Ed Kasper LAc

>

>

>

>