More on FDA Ban

[Guest guest]

Dear Practitioners

 

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 Custo ms 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. If you are uncomfortable writing

a letter of your own, you can easily do this 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. While meant with the best intentions, the AT article was based

on misinformation. Please act now or you/we will have no one to blame but

yourself/ourselves. Based on " CCs " being sent to various herbal companies so

far, your co-professionals are not responding en masse to this threat, and we

this ban goes into place today.

 

Thank you for listening,

 

Bob Flaws

 

 

 

[Guest guest]

Hi Honora,

 

I'm sadly impressed by this point. Thanks for your post.

 

Respectfully,

Emmanuel Segmen

-

Honora

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.

 

 

[Guest guest]

Dear Honora & Bob Flaws

 

The profession should thank you both for having the common sense to speak out

about what is really happening. For what it is worth....we do thank you.

 

As an update......the move made by the two New Jersey manufacturers, in

United States District Court to stop the FDA, was the incorrect action to be

filed

and in the wrong venue in order to halt the rule in it's place.

 

What was feared by those who know that a real Administrative Petition was the

correct action now have the proof.

 

All should read and learn.

 

Richard

------

 

April 12 2004

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

 

FDA Announces Rule Prohibiting Sale of Dietary Supplements Containing

Ephedrine Alkaloids Effective April 12

 

The Food and Drug Administration (FDA) announced today that the final rule on

dietary supplements containing ephedrine alkaloids is effective immediately.

The rule, which was published on February 11, 2004 in the Federal Register,

declares dietary supplements containing ephedrine alkaloids (ephedra)

adulterated because such supplements present an unreasonable risk of illness or

injury.

Two manufacturers had asked the United States District Court in New Jersey to

enter a temporary injunction to prohibit FDA from enforcing the rule. However,

the court ruled today that it would not immediately stay the rule. The court

ordered the parties to submit additional briefs so that it may decide whether

to permanently stay the rule. " We will take appropriate enforcement actions if

needed to stop manufacturers from illegally selling and distributing dietary

supplements containing ephedra alkaloids, " Health and Human Services Secretary

Tommy G. Thompson said. " These products pose unacceptable health risks, and

any consumers who are still using them should stop immediately. " On December

30, 2003, FDA issued over 60 letters to manufacturers notifying them of our

intent to publish the rule as well as a consumer alert warning the public of the

dangers of ephedra and asking that they stop taking these products immediately.

" Dietary supplements containing ephedrine alkaloids have been shown to pose a

real risk to health, " said Dr. Lester M. Crawford, Acting FDA Commissioner.

" the court's decision today makes clear that these dietary supplements may not

be lawfully marketed while the matter remains under review by the Court. " FDA

plans to step up Internet surveillance to determine whether anyone, including

the original 60 + targeted firms, is continuing to actively promote and sell

these products. FDA has already seen progress in its regulatory efforts, as a

majority of the manufacturers to whom letters were sent have ceased selling

dietary supplements containing ephedrine alkaloids.

 

 

 

[Guest guest]

Dear Bob Flaws, thanks for putting your voice in about the urgency of herbal

bans and what is surely coming next. My dark take on this is that even if some

herbs are spared in the US, for the time being, the codex alimentaris that goes

into effect in the European Union in 2005, will spread round the globe by 2008

because of WTO harmonization, and make illegal then or soon after, the use and

sale of most herbs and supplements, except by MDs,(and they will have their own

formulary) . This is the invisible giant to confront. It is racketteering,

plain and simple.

This legislation originated in Germany from the pharmacuetical houses because

they wouldn't presently make law in USA. This is changing. As repeated and

gradually increased restrictions in alternative healthcare practices are

enacted, the public and many practitioners themselves seemed either unable to

grasp the truth of it, or that it somehow wouldn't happen --until it did. Pete

is right about the 'style' of delivery, but when you make a statement, people do

listen.

Thanks for speaking on this, and for all your work thru the years.

Fran Cahill

 

Honora <honora wrote:

Dear Practitioners

your co-professionals are not responding en masse to this threat, and we this

ban goes into place today.

 

Thank you for listening,

 

Bob Flaws

 

 

 

[Guest guest]

as someone more eloquent than I said about these issues in another

forum;

 

 

A post on this system gave a lot of clarity to the problem we're

facing, and it concerned the number of GM foods concerned with

Roundup. There is a parallel with the plans for the worldwide

totalitarian state. With GM foods, activists get active about corn,

then soybeans, then rapeseed, then ....., and the System just has

people running to combat the variety of created problems. The

billiant solution was the banning of Roundup, to which all the GM

foods were linked. No Roundup, no sense in planting GM foods. I do

not recall where I read this, but it was stated that the world trade

organization, and all the agreements, are flawed, in that beneath it

all, there is no legal basis for this organization. This is likely

where the challenge should be taking place. Many of the people and

corporations behind the the NWO have been named, and remain

unchallenged. The signatories to the agreements betray their own

countries, also subject to laws of their land. We are distressed by

loss of supplements, the rendering null of environmental & human

rights laws, national autonomy, and more, and behind it all is an

illegal system. This is where the attention needs to be directed.

Otherwise, we chase after crisis after crisis after crisis.

 

Chinese Medicine , mystir

<ykcul_ritsym> wrote:

> Dear Bob Flaws, thanks for putting your voice in about the urgency

of herbal bans and what is surely coming next. My dark take on this

is that even if some herbs are spared in the US, for the time being,

the codex alimentaris that goes into effect in the European Union in

2005, will spread round the globe by 2008 because of WTO

harmonization, and make illegal then or soon after, the use and sale

of most herbs and supplements, except by MDs,(and they will have

their own formulary) . This is the invisible giant to confront. It

is racketteering, plain and simple.

> This legislation originated in Germany from the pharmacuetical

houses because they wouldn't presently make law in USA. This is

changing. As repeated and gradually increased restrictions in

alternative healthcare practices are enacted, the public and many

practitioners themselves seemed either unable to grasp the truth of

it, or that it somehow wouldn't happen --until it did. Pete is

right about the 'style' of delivery, but when you make a statement,

people do listen.

> Thanks for speaking on this, and for all your work thru the years.

>

Fran Cahill

>

> Honora <honora@b...> wrote:

> Dear Practitioners

> your co-professionals are not responding en masse to this threat,

and we this ban goes into place today.

>

> Thank you for listening,

>

> Bob Flaws

>

>

>

[Guest guest]

Hi all,

 

Has anyone got any idea what the hell is going on in Europe

regarding herb bans? Is anyone doing anything about it?

 

Attilio

 

mystir <ykcul_ritsym> wrote:

 

My dark take on this is that even if some herbs are spared in the

US, for the time being, the codex alimentaris that goes into effect

in the European Union in 2005, will spread round the globe by 2008

because of WTO harmonization, and make illegal then or soon after,

the use and sale of most herbs and supplements, except by MDs,(and

they will have their own formulary).

[Guest guest]

Hi Attilio

 

Look at this site for more information about Codex and the struggle

against this proposition:

 

http://www4.dr-rath-

foundation.org/THE_FOUNDATION/Events/codex2003.html

 

Best wishes

 

Alwin

 

Chinese Medicine , " Attilio

DAlberto " <attiliodalberto> wrote:

> Hi all,

>

> Has anyone got any idea what the hell is going on in Europe

> regarding herb bans? Is anyone doing anything about it?

>

> Attilio

>

> mystir <ykcul_ritsym> wrote:

>

> My dark take on this is that even if some herbs are spared in the

> US, for the time being, the codex alimentaris that goes into effect

> in the European Union in 2005, will spread round the globe by 2008

> because of WTO harmonization, and make illegal then or soon after,

> the use and sale of most herbs and supplements, except by MDs,(and

> they will have their own formulary).

[Guest guest]

> the codex alimentaris that goes into effect in the European Union in 2005,

will spread round the globe by 2008 because of WTO harmonization, ...

 

Is it possible the WTO is trying to support a policy to protect indigenous

health systems worldwide by the FAO/WHO[1] but it is all going horribly

wrong?

 

As far as medicine preparations go the WHO has a mission to support

indigenous or traditional medical systems worldwide[2] and this looks

consistent with what the WTO are trying to do 'on paper' [3]. However as far

as legislation in the USA and EU goes regarding the banning of certain

substances that have hitherto been regarded as part of the traditional

medicine armamentarium, there may be a case against the promotors of

'severe legislation' * if it can be shown they are acting in a " disguised

protectionism " manner as suggested in the last footnote[3] e.g. " Article 20

of the General Agreement on Tariffs and Trade (GATT) allows

governments to act on trade in order to protect human, animal or plant life

or health, provided they do not discriminate or use this as disguised

protectionism. "

 

*I am thinking of the current state in Germany where it is virtually

impossible to obtain even raw fresh herbs if they are on a 'list' that only

medical doctors can prescribe. A short time ago someone I know tried to

import qinghao for his own use. The German authorities went mad when they

discovered this and almost prosecuted him for " importing dangerous drugs " .

This is where the EU CODEX ALIMERTARIUM has got Germany and it may well get

us all that way in a few years if we do not wake up to what is going on with

this legislation.

 

I suggest that most of it is illegal within the terms of reference of both

the WTO and the FAO/WHO but to prove that in a High Court

and overturn the vast amount of legislation already on the books is probably

going to require a great political initiative to outgun the pharmaceutical

lobby who are happy taking over ownership of traditional medical systems

'formulations' and then burying them or replacing them with 'patents'.

 

Incidentally, this 'takeover' has been going on big time since the end of

WW2 when the widespread use of penicillin started the great leap forward

from the 'formulating chemist's trade' to the 'pharmaceutical patents

industry'. In the centuries before that we had the 'ethnic cleansing' in

Europe and the Americas of naturalistic medicine systems. It is a sad tale

of opportunism in the field of medical quackery, where the quacks finally

ended up as the 'professionals' and the real healers all got burnt

(literally). This did not happen in the Far East luckily, so we still have

TCM and other branches of OM. [ 200 years of British legislation in India

practically wiped out Ayurvedic medicine.] It is a great shame the medical

systems of sub-Saharan Africa and South America will be swallowed up by

'patents' before the unique paradigms, herbologies and praxis of these

systems can be properly recorded and translated.

 

Sammy.

 

1.

http://www.codexalimentarius.net/

 

The Codex Alimentarius Commission was created in 1963 by FAO and WHO to

develop food standards, guidelines and related texts such as codes of

practice under the Joint FAO/WHO Food Standards Programme. The main purposes

of this Programme are protecting health of the consumers and ensuring fair

trade practices in the food trade, and promoting coordination of all food

standards work undertaken by international governmental and non-governmental

organizations.

 

2.

http://www.who.int/medicines/organization/trm/orgtrmmain.shtml

 

The WHO Strategy for Traditional Medicine for 2002-2005 has been in

preparation for more than three years. The objective of the strategy is to

discuss the role of traditional medicine in health care systems, current

challenges and opportunities and WHO's role and strategy for traditional

medicine. Many Member States and many of WHO's partners in traditional

medicine (UN agencies, international organizations, nongovernmental

organizations, and global and national professional associations)

contributed to the Strategy and have expressed their willingness to

participate in its implementation. The Strategy was reviewed by the WHO

Cabinet in July 2001 and, based on Cabinet comments, has since been revised.

The Strategy was printed in January 2002. Since this is at present a working

document, the proposed objectives and activities have started to be

implemented in early 2002 and the Strategy will be widely disseminated. We

understand that the situation in the use of traditional medicine is quite

different from country to country and region to region. For example, in AFRO

and in WPRO, the Member States consider that traditional medicine is a

priority for health care in their regions, but in other regions the role of

traditional medicine is treated as complementary or alternative medicine.

 

Fact sheet N°271 -- June 2002

 

 

 

Traditional Medicine: Growing Needs and Potential is the core of the WHO

Strategy for Traditional Medicine for 2002-2005. It provides brief

information on the growing needs and challenges faced by traditional

medicine worldwide. It also gives key messages and a checklist for the

safety, efficacy and quality to policy-makers. Finally, it sets out WHO's

role and how the WHO Strategy could meet the challenges to support WHO

Member States in the proper use of traditional and complementary/alternative

medicine. WHO Press Release Press Release WHO/38 16 May 2002

 

 

 

3.

 

http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm4_e.htm

 

UNDERSTANDING THE WTO: THE AGREEMENTS

Standards and safety

Article 20 of the General Agreement on Tariffs and Trade (GATT) allows

governments to act on trade in order to protect human, animal or plant life

or health, provided they do not discriminate or use this as disguised

protectionism. In addition, there are two specific WTO agreements dealing

with food safety and animal and plant health and safety, and with product

standards.

 

Food, animal and plant products: how safe is safe? back to top

Problem: How do you ensure that your country's consumers are being supplied

with food that is safe to eat - " safe " by the standards you consider

appropriate? And at the same time, how can you ensure that strict health and

safety regulations are not being used as an excuse for protecting domestic

producers?

 

 

 

-

" " <attiliodalberto

<Chinese Medicine >

Wednesday, April 14, 2004 9:23 AM

Re: More on FDA Ban

 

 

Hi all,

 

Has anyone got any idea what the hell is going on in Europe

regarding herb bans? Is anyone doing anything about it?

 

Attilio

 

mystir <ykcul_ritsym> wrote:

 

My dark take on this is that even if some herbs are spared in the

US, for the time being, the codex alimentaris that goes into effect

in the European Union in 2005, will spread round the globe by 2008

because of WTO harmonization, and make illegal then or soon after,

the use and sale of most herbs and supplements, except by MDs,(and

they will have their own formulary).

 

 

 

 

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