FDA PROPOSAL TO REGULATE ALL COMPLIMENTARY MEDICINES!!!!!

[Guest guest]

Dear Friends,

I looked into this and it is frightening and NO hoax the FDA wants to

regulate all alternative medicines , including vitamins , which means

you will need to go to a doctor if you want some vitamin C . The

bottom line is the Pharmeceutical companies want more $$$ and they

dont care if it takes away your freedoms to choose how you heal

yourself .

Alternative practitioners like myself will be told they can no

longer perform certain therapies and all others must come from a

allopathic doctors referral . I am regulated educated and licensed by

the board of health sate and nationally I find it rather

insulting that my field my career would suddenly be in the hands

of someone not specifically trained in my field of practice. Please

take a moment to read and reflect and sign your opinion HELP STOP

THIS NOW ! The FDA has NO business in regulation of alternative

medicine , massage therapy , accupunture , energy healing such as

reiki or the vitamins you choose to take, which botanicals you can

use for your skin or a bath soak or herbs and herbal teas , or if

you want to take yoga for that matter . In my opinion this is

bordering on COMMUNISM in the USA . We can only oppose until APRIL

30!!! All of our futures depend on it . PLEASE FORWARD THIS TO

EVERYONE YOU KNOW !

Sincerely

Kellee Ray ; LMT , CNMT

 

to read the complete docket click this link , or continue reading

below on how you can let your voice be heard .

http://www.FDA.gov/cber/gdlns/altmed.htm

 

IF YOU HAVE NOT TAKEN STEPS TO HAVE YOUR VOICE HEARD, PLEASE READ THIS

AND KNOW WHAT IS GOING ON:

 

 

A guidance like this is very confusing and there are legal issues that

must be carefully examined and responded to in writing. Therefore, as a

first step, we have officially requested the FDA extend the deadline for

comment to July 31, 2007. The time the FDA has provided for comment is

simply too short for something this complex and important. We are

working with Congress to ask them to have FDA extend the comment period.

Click here to read our letter to the FDA requesting an extension.

 

 

 

CLARIFICATION

 

We wanted to clarify that much of the regulation proposed in the

document has already been claimed by the FDA. For example, making

health claims as it pertains to dietary supplements and foods is

currently not permitted, and people who do so are vigorously pursued by

both the FDA and the Federal Trade Commission.

 

 

 

MAJOR CONCERNS

 

While we have several concerns with the CAM Regulation Guidance, the two

biggest are broadening the definition of " health claim " and the

desire to pre-empt the states in the regulation of some health care

issues.

 

 

 

Example: The document attempts to define how vegetable juice might be

defined as a drug, " This means, for example, if a person decides to

produce and sell raw vegetable juice for use in juice therapy to promote

optimal health, that product is a food subject to the requirements for

food in the Act and FDA regulations...If the juice therapy is intended

for use as part of a disease treatment regimen instead of for the

general wellness, the vegetable juice would be subject to regulation as

a drug under the Act. "

 

 

 

The FDA defines a drug as " ...(B) articles intended for the use in the

diagnosis, cure, mitigation, treatment or prevention of disease in man

or other animals; and © articles (other than food) intended to affect

the structure or any function of the body of man or other animals.

 

 

 

What the FDA is stating is that they believe that any person (or

product) that states " drink some vegetable juice to prevent [insert

disease] " is actually making a drug claim; and if vegetable juice is not

recognized by the FDA as a legally available drug in the United States,

the person (or manufacturer) making the claim is now subject to

prosecution if they are not a medical professional licensed to practice

medicine.

 

 

Who is going to fund a $50,000 investigational new drug application to

get carrot juice approved as a drug, or the follow-on millions in

research dollars to conduct a study on the toxicity ($200,000) and

efficacy of carrot juice ($3 million and up.) Keep in mind this would

have to be done separately for any disease process carrot juice might

have an impact on.

 

 

 

WHY NOW?

 

Why did the FDA create this document? There are a couple of theories.

One is that the National Center for Complementary and Alternative

Medicine (NCCAM) asked the FDA to " harmonize " with their way of

thinking. Another idea is that importation of products (which is a

major concern to the FDA) will soon be a top issue. Functional foods

could also be a target (as forewarned by the FDA December meeting on

functional foods - read about our response and presentation). Regardless

of the why, we do know that the health freedom community was not

consulted in the preparation of the document. Furthermore, the clumping

of food, products, medical devices, and therapies makes for an awkward,

confusing, and unconstitutional " way of thinking " and does not

represent what is best for the consumer.

 

 

 

THE IMPACT

 

The draft guidance, when finalized, will represent the agency's current

thinking on the regulation of complementary and alternative medicine

products by FDA. Though it does not change the law, it does represent a

potential major expansion on how foods, therapies, and products could be

regulated. Of further concern, is that this document could be used by

health freedom " opposition " and regulators to pressure Congress

to change legislation. The language in the document gives us great

concern and we cannot allow an agency such as the FDA to finalize the

document in its present form.

 

 

 

ACTION

 

The comment period expires on April 30. It has been our experience that

citizen letters to the FDA during the comment period rarely have an

impact on the FDA's decision-making process. This is important to

know, since the appropriate response to this situation is not to just be

busy (as in writing letters to the FDA) but to be effective. What the

FDA has told us is that they want to hear from practitioner groups and

trade associations. Remember, that the FDA officials are not elected

and generally the wishes of the public fall on deaf ears.

 

 

 

The two things that are most likely to influence the FDA's actions

as it pertains to the issues outlined in this document are:

 

Members of Congress who have a variety of mechanisms for shaping the

authority of the FDA.

State Attorneys General who can threaten legal action if the agency

tries to usurp the authority of the states in regulating health care

activities within their states.

 

In consideration of the above, we are taking these actions:

 

We are alerting our Congressional friends about this issue, and asking

them to take appropriate action. We will notify you when it is time to

write to these elected officials and make your wishes known.

We have commissioned an extensive, legal response to the guidance that

has the kind of technical detail the FDA bureaucracy wants (or actually

DOESN'T want) to see as they strive to give this document the force

of law.

We are planning to communicate with the proper officials in each state

to notify them of the potential for federal interference in state

regulatory activities.

If you do write the FDA, please send a copy of your concerns to your

representatives in Congress. These elected officials DO care about your

opinion and your voice matters. CLICK HERE to contact Congress.

SUMMARY

 

We believe the CAM Regulation Guidance would set the tone of the FDA in

regards to functional foods; alternative medicine therapy, devices, and

products; as well as dietary supplements and could help set the stage

for future legislation that would restrict access. While public

comments to the FDA by individuals are a course of action, we want you

to be aware that fighting FDA's " way of thinking " will need

a stronger course of action and we are prepared to follow though. We

have fought the FDA before and have been successful.

 

 

 

There are numerous issues facing the health freedom community that need

attention where your action can make a big different: a draft bill to

restrict access to individualized/compounding medicine, the right of the

practitioner to practice being threatened by individual states, and Rep.

Dingall wanting to " kill " dietary supplements because they are a

" snake " to be killed.

 

 

 

Please know that we are working diligently on the important issues

facing the health freedom community. It takes both time and money and

your financial support is greatly appreciated.

 

 

 

SUBMIT COMMENTS

 

If you would like to submit your written comments to the FDA, please use

one of the following methods

 

 

 

MAIL:

 

Division of Dockets Management (HFA-305)

 

Food and Drug Administration

 

5630 Fishers Lane, Room 1061

 

Rockville, MD 20853

 

 

 

EMAIL:

 

Click here or copy & paste this link:

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.C\

FM?EC_DOCUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA

 

 

 

NOTE: No matter which method, be sure to refer to Docket No. 2006D-0480

 

 

 

Brenna Hill

Executive Director

Health Freedom Foundation and American Association for Health Freedom

4620 Lee Highway, Suite 210

Arlington, VA 22207

1.800.230.2762

Fax: 703.294.6380

www.healthfreedom.net

P.S. Don't forget to JOIN, DONATE, TAKE ACTION, and TELL-A-FRIEND!

[Guest guest]

consensus among my colleagues is that there is a lot of noise going

on here without much insight or analysis, on all sides of the issue

we all need to protect health freedom but we should also be careful

of crying wolf too many times, otherwise people become apathetic

 

to see a good analysis of the issue the following link represents the

position and statement of the american herbal products association

(AHPA):

 

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

07_0427_AHPAComments_FDA_CAM_Guidance.pdf

 

best... todd caldecott

 

 

On 27-Apr-07, at 3:27 AM, ayurveda wrote:

 

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

>

> Posted by: " Kellee " hokuwahinelee hokuwahinelee

>

> Thu Apr 26, 2007 7:52 pm (PST)

>

> Dear Friends,

> I looked into this and it is frightening and NO hoax the FDA wants to

> regulate all alternative medicines , including vitamins , which means

> you will need to go to a doctor if you want some vitamin C .

<snip>

> to read the complete docket click this link , or continue reading

> below on how you can let your voice be heard .

> http://www.FDA.gov/cber/gdlns/altmed.htm

Caldecott

todd

www.toddcaldecott.com

[Guest guest]

ayurveda , Todd Caldecott <todd wrote:

>

> consensus among my colleagues is that there is a lot of noise going

> on here without much insight or analysis, on all sides of the issue

> we all need to protect health freedom but we should also be careful

> of crying wolf too many times, otherwise people become apathetic

>

>

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

> 07_0427_AHPAComments_FDA_CAM_Guidance.pdf

>

> best... todd caldecott

 

the article from the AHPA that you posted a link for does not say

or imply anything you said, it is the opposite. You should have read

the article. That article in no way supports the FDA and it's

drachonian attempts to control Supplements. The fact is that this

bill, introduced by Senator Edward Kennedy, is a part of a strategy by

the pharmacutical industry to institute a Codex type of system in the

US like they did in Europe. These types of bills have only one purpose

and that is to gather more power to the mainstream medicos and the

pharmacutical industry, they want total control over all alternative

medicines and practices, so they and they alone can determine what is

a medicine and what is the proper mode for the practice of medicine.

Alternative medical practioners are being pushed out because they are

becoming more and more of a threat to the established medical industry.

 

Here is a real analysis of this bill. Everyone please send a message

to your Congress person to stop this nonsense. As this article points

out they are trying to set up a medical monopoly within the FDA itself

which will control all medicines and their costs. I once ordered some

medicines from Canada which were manufactured in the US but the FDA

would not allow them in because the Canadian medical system allows

drugs to be sold cheaper than in the states, but the pharmucutical

indusatry has shut us out from buying products cheaper. This new

organization within the FDA will be nothing but an arm of the

pharmacutical industry working within the FDA itself, this

organization will define and control all medicines, and fix the prices

on the same. This is something the Pharmacutical industry has strived

to create for decades. We must never allow the pharmacutical industry

to take even more control of the FDA.

 

Liz

 

Major Expansion of FDA Powers will Target Dietary Supplements

 

A new attack against health freedom, drug safety, and dietary

supplements was launched last week by Senator Edward Kennedy (D-MA)

with major support from Michael Enzi (R-WY). It is called the Food

and Drug Administration Revitalization Act (S1082). This legislation

was planned over the past few years working hand-in-glove with the

FDA's dysfunctional management and legal team – meaning this

legislation was written for the profits of Big Pharma and Big Biotech

AT THE EXPENSE OF SAFETY AND HUMAN HEALTH.

 

S1082 is a Trojan Horse bill that pretends to address safety issues.

Unbelievably, the bill turns the FDA into a drug development company

that will expose Americans to new and dangerous biological drugs that

have little testing to prove safety or effectiveness. And to top it

off, the bill gives broad new regulatory powers to the FDA that can be

used to frivolously attack dietary supplements and forward the FDA

management's anti-American globalization agenda.

 

On April 18, 2007, S1082 was approved by the HELP committee (which

Kennedy and Enzi control) and now moves to the floor of the Senate.

In a slick move, Kennedy has attached his long-planned FDA/Big Pharma

" reform " measures to the renewal of PDUFA (Prescription Drug User Fee

Act). Current PDUFA law expires later this year and must be reviewed

by Congress. PDUFA allows Big Pharma to pay the FDA fees to speed the

approval of its drugs. The new Kennedy bill will increase these FDA

bribes to 380 million dollars in 2008, well over 50% of the FDA budget

for new drug approvals. This is like paying the mob for protection.

Kennedy, by replacing the existing PDUFA law with this new bill

(S1082), is ensuring that his twisted legislation is the one that will

be put before the Senate for a vote.

The FDA Drug Company, an Agency with New Regulatory Power

 

It is hard for anyone to comprehend that the agency that is supposed

to be in charge of drug safety is about to become a drug company. It

is astonishing that the FDA will now manage a full scale business

activity that uses a " non profit " foundation as a shield to avoid

international patent problems, protect proprietary rights of its

commercial drug-development enterprise, and massively expands FDA

regulatory powers to quickly remove anything from the market that is

competition to its own products and licensing agreements.

 

This new FDA business enterprise is called the Reagan-Udall Foundation

for the Food and Drug Administration (see pages 105-125). In previous

versions of the Kennedy bill it was going to be an independent drug

company within the FDA (the Reagan-Udall Institute for Applied

Biomedical Research). In the current bill it is a " non profit "

collaboration of the FDA, private industry, government funding, and

private funding. It is run directly by the FDA even though it

pretends to not be part of the government. Under this scam taxpayers

will foot the bill for drug development and then be charged outrageous

prices for the drugs. Furthermore, the new bill seeks to allow a

massive expanse of FDA regulatory power through this new foundation.

For example, on pages 106-107 the bill states:

 

" The purpose of the Foundation is to advance the mission of the

Food and Drug Administration to modernize medical, veterinary, food,

food ingredient, and cosmetic product development, accelerate

innovation, and enhance product safety….The Foundation shall [take]

into consideration the Critical Path reports and priorities published

by the Food and Drug Administration, identify unmet needs in the

development, manufacture, and evaluation of the safety and

effectiveness, including post approval, of devices, including

diagnostics, biologics, and drugs, and the safety of food, food

ingredients, and cosmetics. "

 

Through this foundation the FDA is seeking broad new regulatory power

that it currently does not possess. This will include the authority

to attack any dietary supplement (which are food ingredients) as

unsafe based on its use of " Critical Path " technology. This means the

FDA will use proteomics (the advanced study of proteins in biological

systems) to assess changes in biomarkers (the change in the state of a

protein at the molecular level) in order to establish whatever it

wants to consider as a risk. The FDA can slant this technology, based

on their own personal opinions, to make anything they want appear as a

risk – including your favorite dietary supplements that you use to

stay healthy.

Deceiving the Public

 

This new bill panders to concerns of Americans regarding the safety of

drugs. This legitimate worry is used by Kennedy and Enzi to garner

support when in reality the bill does just the opposite - exposing

Americans to almost unfathomable new drug risks and dangers while

simultaneously making it possible to remove super safe, therapeutic,

and helpful dietary supplements. The entire Critical Path initiative

is a plan to race new and untested powerful biological drugs onto the

market and experiment on patients all over the country – throwing

caution to the wind as far as drug safety is concerned.

 

While S1082 also pretends to address the issues of drug safety, in

reality all the needed Big Pharma loopholes are firmly in place.

Additionally, the establishment of a clinical trial database as

written in this proposed law will enable Big Pharma to hide

experimental and undesirable side effects. Instead of full disclosure

we will have a sterilized clinical trial database that will have the

net effect of being used as a tool by Big Pharma to promote off label

use of drugs. This is a far cry from disclosure that results in safety.

 

In response to the Kennedy con Charles Grassley (R-IA) immediately

attacked the legislation on the floor of the Senate:

 

" The bill [s1082] does not address the outstanding critical

problem that the office responsible for post-market drug safety lacks

the independence, lacks the authority to promptly identify serious

health risks and take necessary steps that will protect the public.

As I think we all agree, the FDA is in desperate need of major overhaul. "

 

The problem for Grassley, and all Americans, is that his true safety

reform measures for the FDA are being held hostage by the HELP

committee which is under the control of Kennedy and Enzi. His

proposed legislation is S. 468: Food and Drug Administration Safety

Act of 2007 and S. 467: Fair Access to Clinical Trials Act of 2007.

As Grassley told the Senate:

 

" Let me be clear: Big Pharma does not like these bills. FDA

management does not like these bills. Lobbyists are spending hours

upon hours lobbying against these bills…What is wrong with

establishing a separate center within the FDA--not outside the FDA,

within the FDA--with its only job being that of a watchdog for those

drugs already in the market?...What is wrong with supporting a

clinical trial registry and results database that also requires

sponsors to reveal their negative trials?...I propose there is nothing

wrong with any of these proposals. "

 

The situation is rather grave for all Americans. Kennedy has attached

repressive legislation to replace the PDUFA funding thereby ensuring

that his agenda will come before the Senate for a vote. The only real

opposition to the legislation is coming from Grassley, who is

attacking the weakness in FDA reform regarding drug safety and

clinical trials. An even greater threat to the public – turning the

FDA into a drug company and creating new regulatory powers that can be

used to attack dietary supplements and remove them from the market –

is being ignored by everyone – until now. Kennedy knows he can defeat

Grassley and keep Grassley's bills from ever seeing the light of day.

Can Kennedy defeat the American public? Solving this problem is up

to you.

The Secret FDA Agenda – Government Against the People

 

The FDA is a puppet organization. Its management is a revolving door

with Big Pharma, Big Biotech, and Big Agriculture. The behavior of

its management team, set by its current leader Andrew von Eschenbach –

but fully entrenched in its long and ugly history, is one of acting as

a police-force bully to forward the profits of those with money and

stamp out all competition (under the false guise of consumer

protection). The FDA management fully believes it is above any law

that is in its way or any attempt at Congressional oversight. It

gives lip service to its safety mission. It is a cult unto itself.

 

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.

 

The FDA would also like to harmonize our dietary supplement laws with

the evolving international standards set by Codex, thus branding

therapeutic nutrition as dangerous and risky and needing to be sold by

Big Pharma or removed from the market altogether (if it competes with

a blockbuster category of drugs). Codex is planning to use the same

proteomics and biomarker technology that will be used by the FDA's

Critical Path Initiative to remove therapeutic dietary supplements

from the international market and force their policies on America,

thereby superseding the sovereignty of American law on threat of trade

sanctions. The FDA fully supports draconian Codex guidelines to

regulate dietary supplements and is working with the Germans to

concoct technology to brand nutrients as drugs. The FDA management is

as bad as any government agency can get. Under the leadership of

Andrew von Eschenbach it has plummeted to an all time low.

What You Can Do

 

1. Call, fax, phone, and write your Senators and tell them you are

opposed to bill S1082 - Food and Drug Administration Revitalization

Act. Tell them you want no legislation of any kind that will enable

the FDA to frivolously attack dietary supplements. Tell them you do

not want Big Pharma funding the FDA with user fees for drug approvals.

Demand an independent office within the FDA to monitor drug safety.

And tell them you want full disclosure by Big Pharma of all their

clinical trials. Tell them you support the Grassley legislation (S467

and S468) which offers true reform of the FDA.

2. Tell your Senators you are completely opposed to any law that

would enable the FDA to act as a drug company, such as S1082, which is

proposing the formation of the Reagan-Udall Foundation for the FDA.

3. Sign this petition demanding congressional oversight of the

FDA's Trilateral Cooperation Charter – a key point the FDA is using to

illegally support the formation of the North American Union while at

the same time undermining health freedom. This is the FDA's front

line attack that undermines American law and seeks to harmonize us

with the laws of other countries. We must win this battle to stop

Codex and preserve our health freedom – including access to

therapeutic dietary supplements and all alternative health options.

 

If S1082 becomes law and the FDA is allowed to enter relationships

with foreign countries without any Congressional mandate or oversight

we can kiss health freedom goodbye – as well as our dietary

supplements. It is time for dietary supplement companies and trade

groups to get their heads out of the sand and quit jockeying for

position in the New World Order at the expense of the future well

being of their own customers.

 

The issue of health freedom is an issue for all Americans who believe

in our constitution and our founding documents. America is the last

bastion of health freedom on earth. If we fall, the world will be

plunged into a Dark Ages of health. Our future health will be

dictated by a multinational sickness industry driven by profits for

drug and biologic companies with little to do with real quality of

health. This is a crossroads – a moment in time. Health freedom is

fundamental to all other freedoms as without health freedom the minds

and bodies of a population are easy to control.

 

take action now

[Guest guest]

ayurveda , " Liz A Hall " <lizahallny

wrote:

> ayurveda , Todd Caldecott <todd@> wrote:

> >

> > consensus among my colleagues is that there is a lot of noise going

> > on here without much insight or analysis, on all sides of the issue

> > we all need to protect health freedom but we should also be careful

> > of crying wolf too many times, otherwise people become apathetic

> >

> >

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

> > 07_0427_AHPAComments_FDA_CAM_Guidance.pdf

> >

> > best... todd caldecott

 

 

> yes i agree with you

 

 

 

>

the article from the AHPA that you posted a link for does not say

> or imply anything you said, it is the opposite.

<snip>

[Guest guest]

hi Liz

 

i did read the entire article - bottom line is that the FDA's

Guidance Document is just that - a draft of a guidance document with

NO authority of law, with NOTHING new to say and POORLY conceived and

widely criticized by the industry including knowledgeable and

respected organizations like the AHPA

 

you seem to persist in confusing the FDA's Guidance Document with

S1028, but it is draft guidance document, not an imminent law - a BIG

difference

 

the ONLY capacity to change access to herbs and supplements lies with

Congress modifying Dietary Supplement Health And Education Act

(DSHEA), which i can guarantee will not happen without the entire

industry becoming mobilized against it

 

as for S1028, this has nothing to do with the FDA Guidance Document -

further, the proposed law does not mention the regulation of CAM

products

here is the entire bill for all to read: http://help.senate.gov/

Hearings/2007_04_18_E/S1082.pdf

i searched through it and did not find one mention of the phrases or

words: " dietary supplement " " vitamin " or " herb "

 

have you actually read the bill itself? or are you relying on self-

proclaimed " experts " like Byron Richards, the author of the article

you attached, and is replicated on many other websites

usually academic researchers take pains to declare competing

interests, but Mr. Richards never once states that he is selling a

brand new book " exposing " the FDA

many such as yourself are a part of his marketing campaign - he

relies upon it

never underestimate the power of selling fear!

 

best... todd

 

On 29-Apr-07, at 3:17 AM, ayurveda wrote:

 

the article from the AHPA that you posted a link for does not say

> or imply anything you said, it is the opposite. You should have read

> the article. That article in no way supports the FDA and it's

> drachonian attempts to control Supplements. The fact is that this

> bill, introduced by Senator Edward Kennedy, is a part of a strategy by

> the pharmacutical industry to institute a Codex type of system in the

> US like they did in Europe<snip>

[Guest guest]

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.

 

Already the FDA has tried to block the sell of herbs in the Internet,

and in each instance the warning paper said that the seller must not

make health claims for their products as this will put the products

into the catagory of a 'new drug' and it will have to go through the

many millions of dollars worth of testing and trials. In the past few

years the FDA has sent hundreds of warning letters to companies

selling herbal products warning that any reference to any healing

potential is illegal. The new bill has no other purpose than to

strengthen the FDA in regulating these products and their sellers.

This bill is formulated by those who support the agenda and objectives

of the Pharmacutical industry, why would we expect it to be in the

best interest of the consumers who use these products?

 

The most drachonian aspect of this law are the provisions that allow

drug companies to enter into a 'fast track' process for approval of

their products by paying the FDA an extra fee (millions of dollars)

for 'fast track' approval. This procedure means the pharmacutical

industry can by pass many ordinary barriers simply by paying a

privilage fee. This of course would never relate to herbs since no

herbal company could afford this procedure.

 

The bill clearly states it's objectives, nothing is hidden, they want

to exclude most of the new herbal and supplement products from

commerce because they have not gone through the same approval

processes as other medicines. The FDA wants total control over all

herbs, supplements, medical devices, and procedures. The vast majority

of professionals in the FDA have come from the pharmacutical industry

and are in reality simply part of a bogus 'self regulating' cabal

within the FDA, this bill is simply an attempt to strengthen the

authority of these self serving regulators.

 

Read the bill, do not fall for the attempts to confuse the issues by

the pharmacutical industry, I assure you that your interests and

theirs are not the same.

[Guest guest]

Thanks for the detailed clarification about this. The day I realized that I

hadn't seen a word in any newspaper about it, or on TV news, was the day I

started assuming issues were being overly built up ~ and at least for the

time being.

 

 

-

" Todd Caldecott " <todd

>

> i did read the entire article - bottom line is that the FDA's

> Guidance Document is just that - a draft of a guidance document with

> NO authority of law, with NOTHING new to say and POORLY conceived and

> widely criticized by the industry including knowledgeable and

> respected organizations like the AHPA

<snip>