Not Listing exact formula will cause problems with FDA & EU Authorities

[Guest guest]

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!

 

 

 

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

[Guest guest]

I totally agree with you Phil.

 

Perhaps I lean more towards simply knowing ratio/dosage for clinical

application reasons foremost. How can you professionally prescribe a

pill to a patient when you don't know the ratio and therefore precise

actions of a formula?

 

In australia, all patents I have seen have dosage in mg or %. Perhaps

it is different in the US.

 

I also think CM texts should ALWAYS include a recommended dosage so

that one can see exactly how the author sees the actions of this

formula for that dose/ratio. This then allows PROFESSIONALS to adjust

from the given formula to change the actions in a certain direction for

their particular patient.

 

I have never understood the justification of some authors for not

giving dosages when listing formula. It seems more to me that they are

simply trying to obscure this knowledge from the layman to discourage

use. However, this is illogical.........any layman who plans to

self-prescribe will do so anyway............and now without ANY idea of

proper and safe dosages due to it being kept SECRET by the author.

 

Go figure.

 

 

On a slight tangent....I also feel authors should ALWAYS use tones on

any pinyin in a text. What is pinyin without tones? Well it isn't

pinyin anymore! Having tones also allows us to better communicate with

chinese speakers during clinically training, class or private practice.

 

Steve

 

 

On 12/02/2004, at 1:37 PM, wrote:

 

> 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?

[Guest guest]

Phil:

I appreciated your post. Lately I've been wondering whether it is wise

(given the current zeitgeist)or even ethical to just hand a patient a

bag of herbs labeled only with the formula name and not provide a

list of the single herbs contained within. Without a list of the

herbs if a patient were to have a reaction to the formula and were

to seek outside medical counsel they would have no idea what they

might be reacting to. Isn't it both wise and ethical to inform the

consumer?

I wonder how many members of this group would be comfortable going to

an MD who prescribed medicine without any indication of what was in

it?

I agree with Phil. We may be treading on unsteady ground here.

Warren

 

- In , " "

<@e...> wrote:

> 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!

>

>

>

>

> Best regards,

>

> Email: <@e...>

>

> WORK : Teagasc Research Management, Sandymount Ave., Dublin 4,

Ireland

> Mobile: 353-; [in the Republic: 0]

>

> HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

> Tel : 353-; [in the Republic: 0]

> WWW : http://homepage.eircom.net/~progers/searchap.htm

[Guest guest]

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!

 

 

 

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

[Guest guest]

Hi, Phil and all,

Right on, Phil! I agree 100% with you. One of my vendors, Evergreen Herbs

(John Chen's company) lists the quantity and the dose, as all herb companies

should. It doesn't matter that we as herbalists should know that

information, it's a matter of ethics. If we want to be respected, we must do

our part ethically, too.

 

As a matter of fact,there is a local western herb company that sells, get

this!, a product specified for Crohn's with UNLISTED herbs, meaning No herbs

let alone quantity or dosage, and states it's proprietary! When I heard this

from a patient of mine, I strongly emphasized that it was illegal for the

company to do that and to get the ingredients list, give me and her MD a

copy. Will see whether the company gives it to her or not. Side note; yes,

she had a reaction to it, severe itching with lots of heat signs on the

skin. She had take CHM from me a year or so ago and had no problems. Go

figure! And, no, the western product was not cheaper. As a matter of fact,

it was twice as much.

 

Pam Price

=========================================

 

 

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!

 

 

 

 

Best regards,

 

Email: <

 

WORK : Teagasc Research Management, Sandymount Ave., Dublin 4, Ireland

Mobile: 353-; [in the Republic: 0]

 

HOME : 1 Esker Lawns, Lucan, Dublin, Ireland

Tel : 353-; [in the Republic: 0]

WWW : http://homepage.eircom.net/~progers/searchap.htm

 

 

 

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