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Date: Sun, 30 Aug 1998 01:14:26 -0400
To: jham@iahf.com
From: John Hammell <jham@iahf.com>
Subject: GERMAN EMBASSY WANTS FDA TO TURN HERBS INTO "DRUGS" SEE LETTER
  ENCLOSED!!
X-MIME-Autoconverted: from quoted-printable to 8bit by halibut.pnc.com.au id DAA08387

PLEASE NOTE THE FOLLOWING LETTER SENT FROM GERMAN EMBASSY TO FDA in 1994 IN
EFFORT TO TURN HERBS INTO "DRUGS" !!! THE LETTER IS ONLY ONE ITEM OUT OF A
2" STACK OF VERY INTERESTING MATERIAL SUBMITTED BY THE EUROPEAN AMERICAN
PHYTOMEDICINES COALITION TO FDA WHICH YOU MUST BE AWARE OF!!

I am sending it to you because I was just attacked by a clueless woman
defending Nature's Way who works in a health food store who doesn't grasp
the fact that she is being manipulated by so called "Citizens for Health"
which is being manipulated by Loren Israelson, attorney for the
European-American Phytmedicines Coalition, (and Nature's Way) which has
submitted an inch and a half thick stack of petitions to the FDA since 1992
in an effort to turn herbs into "drugs".

(This is why CFH is not behind HR 2868 the way they should be- they
represent "controlled opposition" which is helping the pharmaceutical
industry to gradually get control of our supplements via a PHONY campaign
to "SAVE" health freedom! They oppose HR 2868 because the level playing
field which it would create would not be in the best interests of the EAPC
which hopes to boost the sale of herbal medicines in N.America from $1,500
Million closer to the $6 Billion dollar figure in the EU (where dietary
supplements are regulated as "drugs".

Please read the following letter from the German Embassy to the FDA in
support of the EAPC's petition to the FDA to turn herbs into "drugs": (And
my comments following it.)

LETTER FROM GERMAN EMBASSY TO FDA IN EFFORT TO TURN HERBS INTO "DRUGS"

Botschaft der Bundesrepublik Deutschland    Washington October 4, 1994
Embassy of the Federal Republic of Germany
Volkwer Schlegel (Minister of Economics)

Dr.David Kessler
Commissioner
Food and Drug Administration
Room 14-71
5600 Fishers Lane
Rockville, MD 20857

Re: July 24, 1992 EAPC Citizen Petition

Dear Dr.Kessler:

 I am writing to inquire into the status of the FDA's deliberations on its
policy regarding the use of scientific data in evaluating products,
especially phytomedicines and sunscreen milk. Previous letters of inquiry
were written to Michael Taylor on November 3, 1992 and in January 1994.
However the FDA has not yet provided a formal response despite assurances
that the policy would be reviewed.

 A petition filed by the European-American Phytomedicines Coalition (EAPC)
on July 24, 1992, asks the FDA to change its policy that exludes from the
OTC Drug Review ingredients that have no United States marketing history.
The petition asks the FDA to accept marketing histories on phytomedicines
from my country and several other European countries, as well as scientific
data and information supporting the safe and effective use of these
phytomedicines as non prescription drugs. As the representative of a
country that has a long standing tradtion on the use and marketing of
phytomedicines, I fully support the EAPC's request.

 This embassy has also made several attempts to receive a definitive answer
with regard to the data on sunscreen milk. Again, no response has been
received.

 I understand that an important meeting is coming up on October 13, 1994. I
would very much appreciate your taking the time to look into the matter
before that date.

Sincerely,
Volker Schlegel
 

How the Pharmaceutical Industry is Engineering a Takeover of the Natural
Products Industry:

In 1993 the world market in herbal medicines was $12.4 Billion, with 6
Billion (almost half) of the world market being in the European Union and
only $1,500 Million coming from sales in N.America.
(see:
http://www.healthy.net/hwlibraryjournals/herbalgram/1995/summer/features/phy
tomed.htm)
 
In order to boost sales figures herbal drugs in N.America, you have to be
able to STOP the sale of herbal products as dietary supplements, and START
selling them as "DRUGS"-- but FIRST, you have to STEAL them from the grass
roots, and to do THAT, you have to be DECEPTIVE. You can't just wade in and
take over the American dietary supplement industry because attempts to do
that have generated huge public backlashes. What you must be able to do is
to CONTROL the public backlash to your efforts in such a way that you STEER
things in the direction of an EVENTUAL takeover, without the grass roots or
the supplement industry REALIZING whats going on.

Over the past 10 years, through immersion in the health freedom battle,
I've come to see exactly HOW the other side is manipulating so called
"Citizens for Health" as "Controlled Opposition" , and there have been
constant efforts made to discredit me as a result.

Be aware that I was once heavily involved in Citizens for Health, and it
was only through unusually heavy involvement with the group that I came to
see the hidden agenda, which most CFH members NEVER see. When I got to
where I could see the agenda, efforts have been made to destroy my career
by Alex Schauss,PhD, the groups original executive director, and by
Nature's Way, which appears to be one of Schauss's clients.

In 1993, when I was organizing a demonstration to be held in front of the
FDA's Headquarters in Rockeville Maryland, complete with a phone and fax
protest in order to sever the FDA's communications lines for one day,
everyone in the health movement was helping me, except Alex...

When I called to ask for his support, he angrily denounced my efforts, and
SCREAMED at me that I MUST NOT hold the demonstration (!) I thought this
was odd. In theory, CFH was supposedly a health freedom organization, but
this wasn't the first time Schauss did something which ran contrary to
CFH's stated purpose. I didn't like his attitude and demanded to know why
CHF opposed the demonstration, and he told me something very interesting,
which he didn't MEAN to reveal and I could tell after he said it that he
REGRETTED saying it. He said "John, if you don't back off, you are going to
INTERFERE with OUR EFFORTS TO NEGOTIATE WITH THE FDA." (!) I got really
interested in that, let me tell you! When I queried him to tell me exactly
WHO was trying to "negotiate" with the FDA, and exactly "WHAT" was being
negotiated, he SHUT UP IMMEDIATLY, realizing that he had SAID TOO MUCH!
(What was being "negotiated" was the EAPC's petitions to turn herbs into
"drugs"!)

Then, he wrote a letter to Saul Kent and Bill Faloon of Life Extension
Foundation, my former employer, in an effort to get me FIRED from my job,
and to KILL the demonstration! When his Nortern Virginia Chapter helped me
demonstrate (against his will), he ANGRILY kicked the WHOLE CHAPTER out of
Citizens for Health, including an old man in a wheelchair, and a number of
OTHER retired people who stood out in the cold ALL DAY to express their
feelings to the FDA. Our demonstration resulted in a Front PAge photo in
USA Today, and COULD have had major TV News coverage if not for Schauss's
efforts to keep people away. All the major networks sent camera crews to
cover the demonstration, but we didn't have enough demonstrators for them
to shoot, so we lost an opportunity to make far MORE of an impact. The
phone and fax protest did go well, however, mainly because a lot of people
in Citizens for Health didn't listen to Schauss and helped with it anyway.
 

Citizens for Health is a very dangerous organization: a front for
pharmaceutical interests, and their current campaign to generate comments
to the FDA in opposition to their current proposed rule is a BIG LIE
because they aren't making ANY attempt to simultaneously get support for HR
2868, the bill which would SOLVE our current problem with the FDA by
STOPPING them from being able to attack products based on intended use!
Moreover, Citizens for Health is circulating
 

If you want to REALLY defend health freedom, you've got to stop and take a
minute to THINK like the CEO of a big pharmaceutical company who is trying
to figure out how to infiltrate and dominate the dietary supplement
industry and to manipulate and control the health freedom movement, in
order to shift things in his favor.

The Pharmaceutical Industry can't just wade STRAIGHT IN to FLATTEN the
dietary supplement industry the way they'd LIKE to in the USA because there
would be too much of a public BACKLASH. So what they have to do, is to
attack, then be able to MANIPULATE and be in position to CONTROL the public
backlash so as to be able to CONTAIN it, while GRADUALLY shifting things
more in their FAVOR. To control the public backlash, they must be able to
dominate the vitamin trade associations, as well as the health freedom
movement.

This way, the public can THINK they are defending health freedom, when in
REALITY we are being killed gradually be a death from a thousand cuts.
Citizens for Health opposed HR 1951 a couple years ago for the same reason
they oppose HR 2868 today: both bills would fill the gaping holes in DSHEA,
but if they WERE filled, we'd ba able to make therapeutic claims for
dietary supplements, including herbal products, and THIS would go directly
against the business interests of the EAPC, and the EAPC is tied into
Citizens for Health through Nature's Way which publicly admits funding them
as part of a PR campaign to generate public trust in both their company and
in Citizens for Health.

What a SCAM! Nature's Way was built on the back of a REAL health freedom
fighter, the late master herbalist John Christopher, a man who went to JAIL
for "practicing medicine without a license" when his herbal clinic in Salt
Lake City competed too much with local MDs and they retaliated. He was
ALWAYS being attacked by the FDA and AMA, and he would be ROLLING IN HIS
GRAVE if he could see how Nature's Way stopped paying Christopher
Enterprises for the right to use his formulas. When Nature's Way formed a
partnership with Madaus AG and Schwabe, the two largest German
Phytopharmaceutical companies, they "standardized" their products and
changed the original formulas. Standardization changes the natural synergy
of the whole herb by "potentizing" the batches, making the final product
more "drug like".

The EAPC would like the German system of natural products regulation
brought to America, and to the rest of the world. Thats why they had the
German Embassy send the letter (above) to the FDA. They are using so called
"Citizens for Health" as controlled opposition to "steer" the grass roots
in such a way that they will eventually be able to get control.

CFH is currently making a big splash, engaging in a very expensive
nationwide PR campaign to get the public to flood FDA with comments to
their proposed rule. On the surface, their campaign seems GREAT! The
problem is that they make NO mention of HR 2868, which this would be a
perfect opportunity to also get support for it, but that is by design.
Craig Winter of CFH provides a "history" of DSHEA, which extolls the
alleged virtue of the Commission on Dietary Supplement Labels, citing it as
one of the 4 major "ACCOMPLISHMENTS" of DSHEA, when in REALITY it SET UP
the drafting of the FDA's current PROPOSED RULE.

If CFH _REALLY_ were opposed to the FDA, they would have supported HR 1951
two years ago which would have KILLED the Commission on Dietary Supplement
Labels, and they would be supporting HR 2868 today because it would allow
us to make therapeutic claims on dietary supplements. But they don't want a
level playing field. What they want to appear strongly to want to do is to
usher in a German takeover of the natural products industry on behalf of
Nature's Way and the rest of the EAPC. Nature's Way is certified by the FDA
as an OTC drug manufacturing facility. How many other American companies
are? If they could get FDA to approve herbal products as OTC drugs, this
would BLOCK any possibility of major therapeutic claims from being made on
herbal products. Think about it, OTC drugs are used to treat MINOR
AILMENTS. Only Prescription Drugs are used to treat serious diseases.

What the EAPC is trying to do is NOT in the best interests of American
consumers. Their efforts are fostering "roll up" within the dietary
supplement industry as the multinational giants eyeball the market. Proof
that multinational pharmaceutical giants are entering the dietary
supplement industry via the herbal door is provided abundantly in fig. 6 of
"The European Phytomedicines Market:Figures, Trends, Analyses" by Jörg
Grünwald, Ph.D.,Director, Medical-Scientific Department, Lichtwer Pharma
GmbH  Berlin, Germany which you can download from
http://www.healthy.net/hwlibraryjournals/herbalgram/1995/summer/features/phy
tomed.htm

For the reasons cited above, please DO NOT use Citizens for Health's
petitions. They SHOULD reference HR 2868, but don't. They SHOULD put
pressure on the US Codex Delegate, Dr.Yetley to make SURE she gets the
message that we expect her to call for the complete withdrawal of the
German Codex Vitamin Proposal. IAHF generated the international pressure
that got herbs removed from the Codex proceedings,and which drove the
German proposal back to step 3 from step 5 in Geneva last June. Now we are
leading the charge to pass HR 2868 and to kill the German Codex Proposal
while exposing fake grass roots "Controlled Opposition" front groups for
the pharmaceutical industry which as Citizens for Health all over the
world. In Canada, you can't trust the Canadian Coalition for Health Freedom
(which receives funding from CFH) and in S.Africa you can't trust the Cape
Lobby for Health Freedom. In Canada, IAHF endorses Citizens Voice for
Health Rights and in S.Africa we endorse PHARMAPACT (People's Health
Alliance Rejecting Medical Authority Prejudice and Conspiratorial Tyranny).

URGENT FIRST AMENDMENT & CODEX ALERT
FDA COMMENTS PERIOD EXTENDED- - BUT....
CSPI ASKS FDA TO BACK GERMAN CODEX PROPOSAL
BURY FDA WITH COMMENTS & PROTESTS PRIOR TO CODEX MEETING-- by Sept. 19

Dear Dietary Supplement Consumer:

 We have flooded the FDA with so many comments against their proposed rule
to block your access to truthful health information on the labels of
dietary supplements, that they have extended their comments period an extra
month until September 27th, 1998. It is of critical importance that we keep
the pressure on, right up until the deadline! The form letter below fully
explains this situation, as well as another which we must also protest! The
German Codex proposal which threatens to internationally limit consumers to
untherapeutic potencies of vitamins and minerals, as well as to regulate
any dietary supplement not having an RDA as a drug threatens to advance,
once again, at the upcoming Codex meeting in Berlin from September 21-25th.
Beth Yetley, Ph.D. and Robert Moore, Ph.D, of the FDA will represent
America at this meeting. An inside the beltway pressure group called
Center for Science in the Public Interest has submitted comments to the
FDA in an effort to pressure them to stop opposing the German Codex
proposal, alleging falsely that dietary supplements are dangerous to
consumers. CSPI is urging the FDA to exploit several loopholes existing in
DSHEA, claiming that they allow FDA to back the German Codex proposal.
These loopholes require us to ask Congress to pass HR 2868, so cc the form
letter to your Congressman. It is imperative that we bury the FDA with
complaints about CSPIs comments, and that we insist that the FDA demand
the complete withdrawal of the German Codex proposal which diametrically
opposes our domestic policy regarding access to dietary supplements. For
more information on how you can help carry this warning to consumers all
over the world, please visit the IAHF website at iahf.com, email us at
jham@iahf.com, for more info call 800-333-2553.  (Get in to FDA by Sept.
19, if possible, Sept. 27th at latest.)
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Submit comments to: Dockets Management Branch (HFA 305) FDA, 200 C. St. SW,
Washington, DC 20204 (email FDADockets@bangate.fda.gov or fax 301/827-6870)
Re: (Docket # 98 N-044) RIN 0910-AA59 Regulations on Statements Made for
Dietary Supplements Concerning the Effect of the Product on the Structure
or Function of the Body/   email to Dr.Yetley EAY@cfsan.fda.gov

To: FDA Dockets Management Branch & Beth Yetley, Ph.D., Robert Moore,
Ph.D., US Codex Delegates:

Your Proposed Rule on dietary supplement labeling will have an adverse
effect on public health by placing arbitrary and capricious limits on the
allowable health information that can be presented to consumers at the
point of sale on dietary supplements, in compliance with the First
Amendment. Your definition of disease is overly broad, and you are clearly
over reaching. In your zeal to insure that dietary supplements dont act
as a disincentive to new drug development (Gary Dykstra, FDA), you would
even disallow structure-function claims relative to aging: i.e.: hot
flashes (since when are aging or menopause disease states?)

In the US District Court in Utah, Judge Dale Kimball just issued an
injunction against the FDA forcing you to lift your ban on cholestin, which
he declared was a dietary supplement under DSHEA. You tried to ban this
safe Chinese red rice yeast extract which helps lower cholesterol because
its sale angers pharmaceutical giant Merck. We remind you that dietary
supplements were specifically exempted from the harmonization language in
the FDA Reform Bill and that Congress was flooded with faxes, email, and
outraged calls on this issue as recently as October, 1997. Prior to that,
in 1994, Congress received more mail on this issue than on anything since
the Vietnam war. For the sake of the public health, we strongly urge you to
change the proposed rule and stop blurring the distinction between disease
and a health condition. ADDITIONALLY: I request that you forward this
message to Dr.s Yetley and Moore at FDA Office of Special Nutritionals
(CFSAN) to inform them that at the CODEX meeting in Berlin (September
21-25), I INSIST that they demand the complete withdrawal of the German
Codex Proposal which diametrically opposes US law, and which threatens the
public health world wide.

cc to my Congressman in support of HR 2868, Consumer Health Free Speech
Act- removes food from the overly broad statutory definition of a drug-
allowing for therapeutic claims, as long as they are true.

Signed:____________________________________________________

Address:___________________________________________________

City:____________________________________State: ____Zip:___________
info provided by IAHF 800-333-2553, www.iahf.com,jham@iahf.com
 

 
 
 
 
 
 

******************************************
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
jham@iahf.com    http://www.iahf.com
y2kbug threatens your LIFE:access to food,water,
vitamins- Donations to IAHF Keep Updates Coming
FDA Comments Period Ends September 27 on Structure-
Function Claims- Be Sure to Download Form
Letter and Send In! (Breaking News www.iahf.com)