FDA PROPOSAL TO REGULATE ALL COMPLIMENTARY MEDICIN

[Guest guest]

hi liz

 

once again, the draft guidance document is not a proposed law and has

nothing to do with S1028

as far as i understand it, guidance documents do not equal law - they

are an interpretation/implementation of existing laws

 

however, the draft guidance document has been soundly criticized and

quite frankly the FDA should be and is being chastised for even

releasing it

read carefully again the AHPA comments i forwarded to the list -

according to a presidential order the FDA isn't even ALLOWED to issue

such documents:

 

" FDA is ignoring Executive Order 13422

On January 18, 2007 President Bush signed Executive Order 13422,

amending Executive Order 12866 on Regulatory Planning and Review of

September 30, 1993. Of significance to these comments is that the

amendments enacted on January 18, 2007 expanded the scope of this

Executive Order to place restrictions on federal regulatory agencies

not only when they promulgate regulations but also when they issue

guidance documents. Specifically, the draft guidance document raises

" novel legal or policy issues arising out of legal mandates, " this

triggering requirements under the Executive Order. These requirements

have not been met. "

 

source: http://www.ahpa.org/Portals/0/pdfs/

07_0427_AHPAComments_FDA_CAM_Guidance.pdf

 

one thing that is important to note, that regardless of the FDA's

draft guidance document, herbal therapies and supplements are not

allowed for general sale in the US as therapeutic agents without

getting approval as a drug - everybody knows this, and so we do the

DSHEA dance, skirting the issue with structure-function claims that

try to indicate therapeutic intent without actually doing so

 

this is the state of affairs NOW and on this issue specifically the

draft guidance does nothing except to essentially restate the same

hopefully with Canada to the north adopting a more rational framework

for the regulation of natural therapeutic products the US will adopt

something similar, some day

 

in the US, this has been the effort and intent behind the traditional

medicine congress:

http://www.ahpa.org/Portals/0/pdfs/05_1129_TMCongress_ProposedModel.pdf

 

best... todd

 

On 30-Apr-07, at 3:41 AM, ayurveda wrote:

 

> 4b.

> Re: FDA PROPOSAL TO REGULATE ALL COMPLIMENTARY MEDICINES!!!!!

>

> Posted by: " Liz A Hall " lizahallny lizahallny

>

> Sun Apr 29, 2007 8:58 pm (PST)

>

> If one would like to determine for themselves what this new law will

> do and what it's purpose is then read the law at this link -

>

> http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

>

> Just read the section on why the new law is proposed and the whole

> thing will become clear. The law states clearly that it is an attempt

> to tighten up exisiting laws around several important issues. Two of

> the most significant new regulations will have to do with the

> catagories of what is a 'drug' and what is a 'new drug. The

> Pharmacutical industry has been pressuring the FDA to classify most

> herbal medicines as 'drugs' becuase health claims are made for them.If

> a substance or theraputic procedure is classified as a 'drug' then it

> must go through the very expensive procedure of going through trials

> and certification. The new law attempts to strengthen the rules on

> what is a drug therefore making it more difficult to sell any product

> that makes health claims, practially shutting out most herbal

> products. This law has a special emphasis on what can be determined a

> 'new drug'. It says that all products that have not been described in

> the National Formulary of 1906 are to be considered 'new drugs' and

> must go through the approval process as drugs. This will potentially

> block the sell of all medicines from traditional medical systems like

> Ayurveda and TCM, since the medicines were not in the National

> Formulary.

Caldecott

todd

www.toddcaldecott.com

 

 

 

 

[Guest guest]

ayurveda , Todd Caldecott <todd wrote:

>

> hi liz

>

> once again, the draft guidance document is not a proposed law and has

> nothing to do with S1028

> as far as i understand it, guidance documents do not equal law - they

> are an interpretation/implementation of existing laws

 

The guidance document states the purpose of proposing the law. The law

is written as a proposed fee regulating bill, but as the guidance

document states the real purpose is to regulate the supplement and

medical device industry. These aspects of the bill are secreted in

obscure sections of the fee structuring, just as the establishment of

the new entity within the FDA that will have absolute control over all

substances that are proposed to have health benefits, the authority of

this internal organization of the FDA has an independent source and

funding from the FDA. Any substance which claims to effect health in

any way will be declared a drug and must go through trials. The appeal

procedure will be through this new internal agency which will be

irrevocably the last word on what is a 'drug' and what is a 'new drug'.

 

If one reads the law it looks innocent enough, this is true of many

bills, but be sure to read the fine print and the subsections. The

bill is being voted on today so it is probably academic to discuss the

issue since the die is cast. It will probably be a couple of years

before the new regulatory entitiy comes into existance, then we will

see what their objectives really are.

 

Why anyone in the 'alternative' health movement would defend the FDA

is beyond me. In the last two years there has been an increased effort

to stop the importation of medicinal herbs and their formulas. Several

of the biggest companies have had merchandise confiscated and been

warned not to advertise any health benefits for their products. There

is a never ending attempt to have herbs declared as medicines. The

pharmacutical industry has deep pockets and plenty of political

influence (both on the right and the left)they are determined to push

out the compition no matter how long it takes or how much it costs.

They have good reason to be optimistic, they have already been

successful in Europe. England is investigating, prosucuting, and

delicensing health care practioners, including MDs who use non

conventional therapies. The great Dr. Sarah Myhill who is an aleopath

practicing alternative therapies in her practice (she is an authority

in CFS)is being brought before investigation committees. They are

bringing many charges against her. But two of the charges have to do

with prescribing herbs and or supplements to cure disease. Alternative

practioners of all types are under fire, and all evidence is that this

is going to get worse. Let those who choose to put their heads in the

sand do so, but thank God there are those who are keeping vigilant,

that is the price of freedom, isn't it?

Liz

[Guest guest]

Here is a link to Life Extension Foundation's analysis of the issue

recently being discussed here. LEF is a leader in the protection of

health freedom and has spent millions engaging in the many political

battles being waged. They understand the potitics of the FDA as well

as anyone. They have been under attack by the FDA for twenty years or

more.

 

http://www.lef.org/featured-articles/consumer_alert_042707.htm

[Guest guest]

this is the same UNreferenced missive by Byron Richards that has been

widely circulated on the internet

it would be nice to find another statement that discusses this issue,

but its a copy and paste marketing campaign

 

best.... todd

 

On 1-May-07, at 4:01 AM, ayurveda wrote:

 

> Re: FDA PROPOSAL TO REGULATE ALL COMPLIMENTARY MEDICIN

>

> Posted by: " Liz A Hall " lizahallny lizahallny

>

> Mon Apr 30, 2007 9:04 pm (PST)

>

>

> Here is a link to Life Extension Foundation's analysis of the issue

> recently being discussed here. LEF is a leader in the protection of

> health freedom and has spent millions engaging in the many political

> battles being waged. They understand the potitics of the FDA as well

> as anyone. They have been under attack by the FDA for twenty years or

> more.

Caldecott

todd

www.toddcaldecott.com

[Guest guest]

hi liz

 

i am not defending the FDA - what i am objecting to is a supposedly

" grassroots " marketing campaign initiated by one person selling a

book on the very same issue, circulating the same UNreferenced letter

without any critical analysis

 

as a Canadian, and having lived and worked in the US, i would like to

draw your attention to one statement in this letter:

 

" The anti-American FDA is actively seeking to undermine U.S. laws and

harmonize our dietary supplement laws with Mexico and Canada. This

is being done through the Trilateral Cooperation Charter – an illegal

agreement set up with health regulatory agencies in Mexico and

Canada. It is part of the campaign towards a North American Union,

one which would be a catastrophe for health freedom in this country

as dietary supplement laws in Canada and Mexico are far more

restrictive than in the U.S. "

 

now, i cannot attest to whether or not the FDA is antiamerican - i

suspect that there are many FDA employees and high-ranking officials

that would punch Byron Richards in the mouth for making such

statements about their " patriotism " , but be that as it may - using

adjectives like this certainly doesn't inspire my trust or faith

because it oversteps the bounds of a rational discussion; its also a

too commonly used pejorative statement to cast derision on to one's

opponents - apparently everyone in the US who doesn't agree with

one's personal views is antiamerican - all this rhetoric from a

population that has a weak grasp of basic civil law and persists in

voting in presidents that act unilaterally with about 15% of the vote

- i call THAT antiamerican

 

anyway, back to the subject at hand!

 

i am not sure about Mexico, but the creation of the Natural Heath

Products Directorate in Canada was a collaborative process between

government and industry stakeholders to come up with a regulatory

framework whereby natural health products would be made available to

consumers and indicate on the label EXACTLY what they can and should

not be used for

 

this was to resolve the issue that consumers were using herbs and

supplements as therapeutic agents, but often only based on the

marketing information the company provided - and there were many

examples of companies deliberately deceiving consumers to make a

quick buck

 

as a result, a third category of regulation between food and drugs

was established, to address the unique nature of natural health

products, which are neither foods nor drugs - and this was an

extensive consultative process, with a lot of input by industry

 

now, consumers can pick up a bottle of triphala, such as the triphala

product produced by a company i work for, and instead of a DSHEA-

style structure-function claim such as " supports the healthy function

of the bowel " , the product says:

 

" traditionally used in Ayurvedic medicine in the treatment of

indigestion (ajirna) and constipation (vibandha), to strengthen the

eyes (caksusya), and to cleanse the body of impurities (malasodhana) "

 

heck, we would put MORE information if there was any more room on the

label!

 

currently, under the DSHEA laws, there would be NO WAY a product

would ever be allowed to make such claims, since according to current

laws ALL THERAPEUTIC CLAIMS are reserved for drugs

 

as a result, DSHEA institutionalizes consumer ignorance, and leaves

it up to creative marketers to find ways to push the envelope on

DSHEA laws without getting caught - quite frankly its a ridiculous

and laughable state of affairs, and speaks more to US inefficiency

and political pandering than the protection of health freedom

 

i believe you made an earlier claim was that Ayurvedic products would

not be allowed for sale in the US - you are aware of course that all

Ayurvedic products in India are regulated under federal law, and

based on this regulation, allowable health claims can be made for

these products - but when they get to the US they revert to " dietary

supplements " that have only structure-function claims - and how

preposterous is that!?

 

although i am a libertarian at heart, i recognize the need for

regulation in complex societies

in this case, harmonizing US laws with Canadian laws would mean a net

benefit for consumers

 

and you wouldn't even need to get rid of DSHEA - just have a third

option available to companies and consumers so real and useful

product claims could be made

this remains the situation in canada: any herb sold without a claim

does not need a license - however, 99% of companies choose to apply

for a license because it makes it a lot easier to create a market for

your product

 

in addition, the Canadian natural health products directorate

regulations actually protects a practitioners right to compound a

formula for a patient that has a specific therapeutic intent without

applying for a license - in this way, our rights are actually

protected and the days of FDA-style busts is no more

 

anyway, i can't afford any more time on this discussion - people can

choose to follow the kneejerk response of the Byron Richards of the

world, or they can get involved and create the government and

regulations they want, without resorting conspiracy theories - civics

101

 

nuff said.... todd

 

 

On 1-May-07, at 4:01 AM, ayurveda wrote:

 

> Re: FDA PROPOSAL TO REGULATE ALL COMPLIMENTARY MEDICIN

>

> Posted by: " Liz A Hall " lizahallny lizahallny

>

> Mon Apr 30, 2007 9:02 pm (PST)

>

> ayurveda , Todd Caldecott <todd

> wrote:

> >

> > hi liz

> >

> > once again, the draft guidance document is not a proposed law and

> has

> > nothing to do with S1028

> > as far as i understand it, guidance documents do not equal law -

> they

> > are an interpretation/implementation of existing laws

>

> The guidance document states the purpose of proposing the law. The law

> is written as a proposed fee regulating bill, but as the guidance

> document states the real purpose is to regulate the supplement and

> medical device industry. These aspects of the bill are secreted in

> obscure sections of the fee structuring, just as the establishment of

> the new entity within the FDA that will have absolute control over all

> substances that are proposed to have health benefits, the authority of

> this internal organization of the FDA has an independent source and

> funding from the FDA. Any substance which claims to effect health in

> any way will be declared a drug and must go through trials. The appeal

> procedure will be through this new internal agency which will be

> irrevocably the last word on what is a 'drug' and what is a 'new

> drug'.

>

> If one reads the law it looks innocent enough, this is true of many

> bills, but be sure to read the fine print and the subsections. The

> bill is being voted on today so it is probably academic to discuss the

> issue since the die is cast. It will probably be a couple of years

> before the new regulatory entitiy comes into existance, then we will

> see what their objectives really are.

>

> Why anyone in the 'alternative' health movement would defend the FDA

> is beyond me. In the last two years there has been an increased effort

> to stop the importation of medicinal herbs and their formulas. Several

> of the biggest companies have had merchandise confiscated and been

> warned not to advertise any health benefits for their products. There

> is a never ending attempt to have herbs declared as medicines. The

> pharmacutical industry has deep pockets and plenty of political

> influence (both on the right and the left)they are determined to push

> out the compition no matter how long it takes or how much it costs.

> They have good reason to be optimistic, they have already been

> successful in Europe. England is investigating, prosucuting, and

> delicensing health care practioners, including MDs who use non

> conventional therapies. The great Dr. Sarah Myhill who is an aleopath

> practicing alternative therapies in her practice (she is an authority

> in CFS)is being brought before investigation committees. They are

> bringing many charges against her. But two of the charges have to do

> with prescribing herbs and or supplements to cure disease. Alternative

> practioners of all types are under fire, and all evidence is that this

> is going to get worse. Let those who choose to put their heads in the

> sand do so, but thank God there are those who are keeping vigilant,

> that is the price of freedom, isn't it?

> Liz

Caldecott

todd

www.toddcaldecott.com

[Guest guest]

Law is a weapon

Mostly modern medicine people use it against

the alternate weaker section

The alternate people has less influence with

politicians.

financially weaker than modern people

They are dis organised as small groups

even though they contribute a lot to the public health

they are not much appreciated.

generally patients are silent spectators

who is going to suffer is the common man

it is the democracy of many nations

it is a pity that u.n is influenced by western

medicine.

 

R.Vidhyasagar.