Not Listing exact formula will cause problems with FDA & EU Au...

[Guest guest]

Hi Phil

 

Many would tell us that CHM cannot or should not post percetages of

ingredients - to which I also disagree.

 

After working closely with Prof. Dr. Wu, Boping especially on several 'one

size fits most' templated formulations (such as Gan Su Pian (any type of

cold/flu), Chang Ji Re Pian (IBS/IBD), Yang Gan Xi Feng Pian (yang rising, yin

def

syndromes)......it is pure nonsense to hide. I understand the economic rationale

to keep formulations secret but any CH herbalist worth their salt doesn't

worry about that and can easily figure out percentages.

 

In many of the better CM herb books we will find formulations and their

percentages and then the better books list the modification potentials.

 

As to what the FDA is up-to with their recent presentation of their final

promulgation of administrative code ban on ephedrine alkaloids as diestary

supplements.....THIS IS the 'end run' game plan to go after the removal of all

herbs

from the market place. A certain high ranking official at the FDA told AOMNC

directly......under no uncertain terms that all acupuncturists utilziing herbs

to treat illnesses are using ILLEGAL DRUGS contrary to the US Federal Food &

Drug Act's definition of 'drug'. And he is correct as it stands.

 

The only reason at this present moment they are not coming after

acupuncturists has to do with limited funding....but make NO MISTAKE.....that is

within

their future plans. Federal law trumps state law so it makes no difference what

a number opf states have said in their laws regarding scopes of practice. When

they get around to it.....we are already defeated...UNLESS.....

 

That is why nationally and internationally we MUST call for and demand

legislative exemptions by an Act of Congress (in the US).

 

So what is the profession doing besides sitting on it's thumbs and

twidling?........not very much. Since this is the status quo and sad state of

affairs....I am already working on filing an Administrative challenge AGAINST

the FDAs

rule and if I have to do it 'pro se'.....so be it.

 

Richard

 

 

 

In a message dated 2/11/04 9:40:56 PM Eastern Standard Time,

writes:

 

> Subj: Re: Not Listing exact formula will cause problems with FDA & EU

> Authorities

> 2/11/04 9:40:56 PM Eastern Standard Time

>

> Reply-to: Chinese Medicine

> PulseDiagnosis

> CC: traditional_Chinese_Medicine ,

> , pa-l

> Sent from the Internet

>

>

>

> Hi All

>

> >Phil, Geez- This question really puts me on the spot. (1) only one

> >company that I am aware of has ever listed the quantity of

> >ingredients.(2) If you know your herbs you shouldn't need my

> >amounts. You can use the dose that makes sense for your patient.

> >Have you noticed that Blue Poppy's books don¹t include amounts?

> >It's for this very reason. Anyone administering herbs should know

> >enough to dose correctly for the patient. the recipe is NOT

> >secret. I gave you ALL the ingredients.

>

> Cara, thank you for the reply. Yes, you have stated the ingredients,

> but NOT the ratios, or the dose. Do yu really believe that ANY

> company can market a therapeutic product in today's world of

> quackbusters and legal eagles without giving a guideline as to he

> appropriate dose?

>

> Like it or not, there is a WORLD WAR on now between allopathic

> and holistic medicine. Unfortunately, allopathy is in the saddle.

> They have the ear of governments; they control the funding to the

> universities and research institutes; they have senior people in the

> regulation authorities on their side. Where are we?

>

> Unfortunately, we, believers/knowers of other systems, MUST play

> the game according to " conventional " rules of [organised] society.

> Therefore, we must abide by the principles of " safety, efficacy and

> QC " . The QC element demands a certificate of " active ingredients "

> That can be:

> (a) a list of raw materials (by DM ratios) and/or

> (b) a list of the most active ingrediants (and dangerous

> contaminants) in mg/kg material, or mg/dose of material.

>

> IF we do not play by these rules, we are HISTORY - gone with the

> dinosaurs within 10-20 years!

>

> As a devil's advocate (and one that believes in the power of CHM), I

> am NOT satisfied with your answer. IMO ALL herbal formulas

> should state the ratios of the ingredients on a fresh or dried matter

> basis. They should also state the recommended dosing

> recommendations.

>

> >If the FDA asks me, then I will happily acquiesce. No problemo.

> >Cara

>

> Cara, with respect, that is a fob-off!, especially to those of us who

> are still students of CHM! We, and practising professionals, ALSO

> need to know what is in every formula that we prescribe! How else

> can we make informed professional decisions?

>

> I urge you, and ALL herbal suppliers to the west, to be upfront with

> your specifications. Otherwise, we ALL go under, and very soon!

>

> As I said yeaterday, neither the Regulatory Authorities, nor the

> professions, should have any place (or time) for secret (technically

> non-specific) formulas.

>

> Sorry!

>