By Byron J. Richards, CCN

April 25, 2007

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

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 [S1802] 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

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.

*Related Article:
**1,* Feds eye control of vitamins, supplements – even water!
2, FDA Wants to Eliminate Natural Health Care

2007 Truth in Wellness <>, LLC - All
Rights Reserved

* <>

E-Mails are used strictly for NWVs alerts, not for sale


/Byron J. Richards, Founder/Director of Wellness Resources
<>, is a Board-Certified Clinical
Nutritionist and nationally-renowned health expert, radio personality,
and educator. He is the author of Mastering Leptin
<>, The
Leptin Diet <>,
and Fight for Your Health: Exposing the FDA's Betrayal of America
<>. /

/Richards encourages individuals to take charge of their health, stand
up for their health rights, and not blindly succumb to propaganda from
the vested-interests who profit from keeping Americans sick. As founder
of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned
fine-quality dietary supplement company since 1985, he has personally
developed 75 unique nutraceutical-grade nutritional formulas. <> /

/E-mail: <> // /