Stop FDA Power Grab- Creating A Drug Company in FDA and Endangering DSHEA

[Guest guest]

IAHF List: Byron Richards called me yesterday with news of a horrific new

bill that we've got to stop in Congress or DSHEA will be blown sky high and our

health freedom will be shreaded via a variety of different means. In the 18

years that I've been earning a living fighting the FDA, this is the WORST

BILL I have EVER seen!!

Please read Byron's article about S. 1082, the Food and Drug Administration

Revitalization Act at _http://www.wellnessresources.com/news/042407.php_

(http://www.wellnessresources.com/news/042407.php %20and)

Please ALSO listen to Byron on the radio tonight (Wednesday April 25th) at

9:30 PM pacific time for ½ hour on Extreme XM talk channel 152 which you can

hear over your computer by going to _http://www.thepowerhour.com/news.htm_

(http://www.thepowerhour.com/news.htm) see the link to the Satellite Feed on

the Right (_http://www.gcnlive.com/listenlive.htm_

(http://www.gcnlive.com/listenlive.htm)

If you want to read S.1082, the Food and Drug Revitalization Act in its

entirety, you can do so here:

_http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf_

(http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf) (p 105-125)

IN A NUTSHELL- WHATS BAD ABOUT THIS BILL & WHAT TO DO ABOUT IT

Its a trojan horse bill that PRETENDS to address SAFETY ISSUES, while in

REALITY it puts us all far more at risk of being harmed by dangerous biological

drugs that have had little or no safety testing and INCREDIBLY it even turns

the FDA itself into a DRUG COMPANY!

It contains specific language that shreds DSHEA, and unfortunately the bill

is GUARAN-DAMN-TEED to come to a vote on the Floor of the Senate because it

renews the Prescription Drug User Fee Act- (which expires this year.)

Heres what Richards has to say about this: 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.

 

See this excerpt from Byron's article: " It is astonishing that the FDA will

now manage a full scale business activity that uses a “non profitâ€

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. " He goes on to say

that

this Drug company located inside FDA would be called the " Reagan-Udall

Foundation for the Food and Drug Administration "

(Our tax dollars would be used to create an actual DRUG COMPANY inside the

FDA that would aggressively ATTACK any products that interfere with its

PROFITS! This is the worst damn thing I've EVER seen in my 18 years of fighting

these bastards!

HOW THIS TERRIBLE BILL WOULD TOTALLY SCUTTLE DSHEA In Byron's words:

" 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.â€

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.

IAHF Note: DSHEA does not allow FDA to use risk assessment as a basis for

removing dietary supplements from the market, yet FDA illegally DID use a very

biased " risk assessment " (which totally IGNORED the many health BENEFITS of

ephedra) as the " basis " for banning ephedra.

The Circuit court reversed the FDA's ban, but then a higher court corruptly

upheld it and this is now being appealed to the US Supreme Court which could

hear the case in October. I have read the Nutraceutical Corporations Writ of

Certiorari which was filed with the Supreme court on April 5, 2007.

What you need to know, however is this: even if the Supreme Court were to

find in Nutraceutical's favor, if this bad bill of Kennedy's were to pass into

law, FDA would be re-armed with the same power that the Supreme court would

have (temporarily) stripped them of (assuming Nutraceutical were to win its

case), and THAT would put us back to square ONE!!

So we MUST pull out ALL the stops to try to KILL this bill!

Call Byron Richard's article to the attention of every health food store in

your area!

Send copies of his article to the ceo of every Vitamin company whose

products you use!

Call it to the attention of the pharma dominated vitamin trade associations

and put PRESSURE on them if you are a member so that they don't attempt to

IGNORE this (as they are given to doing.)

Call Byron Richard's article to the attention of Senators Hatch and Harken

(who I don't trust at all any more due to recent corrupt actions and due to

the huge amount of pharmaceutical money now flowing to them both) but since

they were the Sponsors of DSHEA back in '94, if they get ENOUGH CALLS, LETTERs,

FAXES, and PERSONAL VISITS about this--- at least in THEORY they MIGHT go to

bat for us and try to get the DANGEROUS LANGUAGE in this bill changed

SPECIFICALLY to PROTECT DSHEA!

You can reach ANY member of Congress via the US Capital Switchboard at

202-225-3121.

Tell your own Senators to vote NO on S.1082, The Food and Drug

Revitalization Act and tell Hatch and Harkin (and your own Senators) you want

to know what

THEY are doing to CHANGE the bill to make sure dietary supplement consumers

are protected! Call Byron Richards article to their attention!

I am going to ask Life Extension Foundation to create a Cap Advantage alert

on their site against this bill so that with one mouse click you'll be able

to flood every member of the Senate with complaints about this bill, and will

tell you when they've done that, but for now, please join IAHF in spreading

the WORD and simultaneously, please also carefully read ALL of Byron's article

at the link above.

Also, please continue urging more people to sign IAHF's petition calling for

Congressional oversight on FDA's Trilateral Cooperation Charter- see

_http://www.thepetitionsite.com/takeaction/373269232#body_

(http://www.thepetitionsite.com/takeaction/373269232#body)

A lot of people have been seriously distracted from where their attention

should have been by the scare campaign started by controlled opposition group

" Natural Solutions Foundation " which diverted attention away from getting

congressional oversight on FDA's Trilateral Cooperation Charter by instead

focusing people's attention on a non issue- a recent FDA Guidance Document. The

sky

is not falling due to that Guidance document, but it WILL FALL if people

continue utilizing NSF as an information source. See the past 5 alerts at

_http://www.ymlp.com/pubarchive.php?jham_

(http://www.ymlp.com/pubarchive.php?jham)

for clarification and make sure everyone you know signs on to the IAHF

email distribution list for updates at _http://www.iahf.com_

(http://www.iahf.com/) because there is safety in numbers.

Donations needed to send IAHF to Capital Hill to lobby against S.1082 and

For Congressional Oversight on FDA's Trilateral Cooperation Charter- I'd like

to go very soon if possible like middle of May- the Hotel on Capital Hill that

I stay at isn't cheap so please give generously for airfare and hotel to

help IAHF continue to defend your access to supplements- if you have a friend

in

DC who can crash me at their house that would be good info to have:

IAHF 556 Boundary Bay Rd.

Point Roberts WA 98281 USA

or via paypal at _http://www.iahf.com/index1.html_

(http://www.iahf.com/index1.html)

 

 

 

 

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