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Return-Path: jham@iahf.com
Errors-To: <jham@iahf.com>
X-Sender: jham@pop3.concentric.net (Unverified)
Date: Sat, 19 Sep 1998 14:21:13 -0400
To: jessica.zufolo@mail.house.gov
From: John Hammell <jham@iahf.com>
Subject: URGENT to Congressman De Fazio:Congressional Oversight Needed
  on FDA CODEX COMMENTS U.S.IAHF List: Please send your views on this to
  Congressman De Fazio co Jessica Zufolo International IAHF List- Please
  email this to your legislators
Cc: <Norman.Singleton@mail.house.gov>
X-MIME-Autoconverted: from quoted-printable to 8bit by halibut.pnc.com.au id LAA10443

Re: Congressman De Fazio: Please sign Ron Paul's letter to FDA in
opposition to the second paragraph of their codex comments which threaten
to "harmonize" our laws to those in Europe where consumer access to dietary
supplements is heavily curtailed as they're restricted as "drugs" there.

**For educational purposes I am bccing this letter to the IAHF global email
distribution list,Americans and dietary suppement consumers world wide
who's generous donations are making it possible for me to travel to Germany
to the CODEX meeting Sept. 21-25th.  (IAHF list- please forward this email
to all members of the US Congress, email addresses at http://www.house.gov/
and at www.senate.gov  If you would like to 2nd my views here, please email
your own members of Congress as well as the others listed below- especially
Congressman De Fazio via jessica.zufolo@mail.house.gov

Also send it to all members of the Canadian, Australian, S.African, New
Zealand Parliaments, and to other legislators world wide for educational
purposes.)
 

Congressman Peter De Fazio and Jessica Zufolo:
 

Congress has spoken out against anything that threatens to "harmonize" our
dietary supplement laws with other countries when the FDA Reform Bill was
amended in October of '97 to specifically EXEMPT dietary supplements from
the (so called) "harmonization" language.The "harmonization language"
threatened to make our food and drug laws identical to those in European
countries where access to dietary suppements is heavily restricted and
where they are sold as "drugs".If dietary supplements had NOT been exempted
from this "harmonization" language in the FDA Reform Bill, our Food, Drug,
and Cosmetic Act would have been "harmonized" to EEC 65/65, a European
Commission Directive wherein dietary supplements are regulated as "drugs",
and under which consumer access is heavily restricted.
 
As the person who spearheaded the grass roots lobbying drive which
generated the amendment to the FDA Reform bill in October of '97, and as an
NGO observer on the American CODEX delegation to the meeting of the
Committee on Nutrition and Foods for Special Dietary Use,

*** I urgently need you to fax me during the CODEX meeting in Germany at
the Hotel Berlinering FAX 011493370858888 indicating that you agree with
Congressman Paul's letter (signed by Congressmen Stump, and Cook (at very
end of this message) which draws a line in the sand that the FDA may not
cross, or they will (once again) be violating the will of Congress and
threatening consumer access to dietary supplements. I'll arrive in Berlin
tomorrow (Sunday) and the CODEX meeting runs through Friday of the coming
week.

****Congressman De Fazio- If you are too busy to read this whole letter,
please skip down to the end where it says "SUCCINCT DESCRIPTION OF THE
PROBLEM"- and then I have the letter from Congressman Ron Paul which I need
you to sign onto and to fax to me in Germany. The rest of this information
is to help educate Jessica, and if you have time to delve into it, so much
the better, but I know you're very busy.
 

Jessica, I enjoyed talking with you yesterday regarding health freedom
issues, and thanks for sending me a copy of your Dear Colleague Letter
regarding the need to stop the FDA from classifying Aging, Menopause and
Pregnancy as "Diseases" in an effort to rob consumers of their right to
truthful health information.  I thank you for your leadership on this
issue, Peter. It is gratifying to know that Congressmen Pallone, Kucinich,
Burton, Crapo, and Sanders have signed your Dear Colleague letter in an
effort to inform the FDA that they must not violate the will of Congress
concerning the right of American consumers to access truthful health
information about the healing properties of dietary supplements as
delineated under DSHEA.

I am forwarding this email to Norman Singleton in Congressman Ron Paul's
office, in the hope  that Congressmen Paul, Stump, and Cook (who signed
R.P.s letter at end of this message and which I have faxed you) will also
want to sign your Dear Colleague letter, as its goals are entirely
consistent with Congressman Paul's letter of September 16th to Dr. Moore of
the FDA. (In turn, I hope Congressman Pallone, Kicinich,Burton, Crapo, and
Sanders will also sign onto Ron Paul's letter- and urge Norman Singleton,
Clinton Miller, and Americans on the IAHF list to speak with their staff
about this important issue.

Congressman De Fazio, I'd like to thank you for cosponsoring Ron Paul's
bill HR 2868, the Consumer Health Free Speech Act--- this bill is going to
become increasingly important in the next Congress as the FDA keeps trying
to destroy health freedom via efforts to "harmonize" our laws to other
countries. HR 2868 represents a counterweight to FDA's ongoing drive to
usurp our constitutional rights. In the Federal Register, Vol.62, #129
pp.36243-36248 July 7, 1997 the FDA announced their intention to throw our
Constitution out the window and to "harmonize" their regulations to
emerging CODEX standards. This illegal move by the FDA would give more
power to the UN's Codex Alimentarius Commission than even the most
EXPANSIVE interpretation of our obligation under international law would
warrant and is indicative of the degree to which the FDA is influenced by
the pharmaceutically dominated World Health Organization.

**** Rather than harmonize "down" to EEC 65/65 and regulate dietary
supplements as "Drugs" from a public health standpoint, the rest of the
world should harmonize "up" to our definition of "dietary supplement" as
defined under DSHEA. Given their efforts to "harmonize" our laws to EEC
65/65, I predict the strong likelihood that the FDA will seek to IGNORE our
comments to their current proposed rule re structure function claims. More
support for HR 2868 is urgently needed as a counterweight to ongoing
"harmonization" efforts, and it will have to be reintroduced. Currently the
bill is cosponsored by Stump (R-AZ), De Fazio (D-OR), Pallone (D-NJ),
Duncan (R-TN), Bonilla (R-TX), Hostettler (R-IN) and Cook (R-UT).
 

"ROLL UP" Poses Threat to Consumer Access to Dietary Supplements World Wide

"Roll up" has been occurring within the dietary supplement industry as
multinational pharmaceutical giants keep buying their way in, and this is
of great concern to American and Canadian consumers who are painfully aware
of what has happened in  Norway, Australia, South Africa, and Canada where
ongoing "harmonization" towards full pharmaceutical GMP standards and a
slew of unecessary red tape has forced many small dietary supplement
companies out of business, while sharply curtailing consumer access to the
wide range products that are available here in the states. I faxed you an
email message received from Manfred Roemer (roemer.m@metronet.de) of
Germany who expressed his frustration at the severe limitations imposed by
the German government on the allowable potencies on vitamins, as well as on
what he is able to purchase without a prescription. I have received
numerous similar email messages from people in Germany, Norway, Sweden,
Canada, Australia, and all over Europe where customs blocks them from
purchasing dietary supplements from the USA.
 

IMPORTANT ARTICLE ILLUSTRATES ECONOMICS DRIVING PHARMACEUTICAL TAKEOVER
CAMPAIGN

A table which lists a large number of multinational pharmaceutical
companies which have acquired German phytopharmaceutical companies can be
seen in the article titled
The European Phytomedicines Market Figures, Trends, Analyses by Jörg
Grünwald, Ph.D.Director, Medical-Scientific Department, Lichtwer Pharma
GmbH Berlin,Germany
<http://www.healthy.net/hwlibraryjournals/herbalgram/1995/summer/features/ph
ytomed.htm>

This article presents numerous economic figures pertaining to the global
market in herbal medicines, and illustrates the BIG BUCKS driving the
pharmaceutical efforts to dominate the industry. In order to understand
what we are up against politically and economically in our effort to block
pharmaceutical domination of the industry and the usurpation of health
freedom its an important article to read.

Table 6 in this article shows that American Home Products (which recently
acquired Monsanto, and also Solgar vitamins) acquired Dr.Much (a German
phytopharmaceutical firm.) Boerhinger Ingleheim acquired Pharmaton (Swiss
phytopharmaceutical company) and Quest (the largest vitamin company in
Canada). Boots acquired Kanold (German phytopharmaceutical company), Bausch
and Lomb acquired
Dr. Mann (German phytopharmaceutical company. Degussa acquired Asta Medica
(German phytopharmaceutical company), Fujisawa acquired Klinge (German
phytopharmaceutical company), Johnson and Johnson/Merck acquired Woelm
Pharma (German phytopharmaceutical company), Pfizer acquired Mack (German
phytopharmaceutical company), Rhone Poulenc Rohrer acquired Natterman
(German phytopharmaceutical company), Sanofi acquired Plantorgan (German
phytopharmaceutical company), Searle acquired Heumann (German
phytopharmaceutical company), SmithKline Beecham acquired Fink (German
phytopharmaceutical company), Solvay acquired Kali Chemie, while Sandoz had
talks with Madaus (German phytopharmaceutical company)but was rejected.

The European American Phytomedicines Coalition is a group of German
phytopharmaceutical companies, and at least one multinational
pharmaceutical giant (Boerhinger Ingleheim), which has been seeking to move
into and dominate the N.American market in herbal products. I have a 2"
thick stack of petitions which the EAPC has submitted to the FDA since '92
in an effort to get the FDA to regulate herbs as "drugs". They have
exercised considerable political influence within vitamin trade
associations on both sides of the US/Canadian border, (via partnerships
with American companies) to the detriment of consumers, as they have been
seeking to drive their smaller competitors out of business by pushing for
the "harmonization" of Canadian and American food and drug laws to those of
such countries as Germany and Australia. A major push is underway world
wide to force the registration and classification of dietary supplements as
"Drugs". The FDA's current proposed rule to impose arbitrary and
restrictive limits on allowable "structure-function" claims, is just the
latest in a series of FDA moves to try to "harmonize" our laws to EEC 65/65
in the EU.

The FDA's anti vitamin campaign is part of a much larger international anti
vitamin campaign fueled by a pharmaceutically dominated mainstream press.
The recent media barrage citing 6 anti dietary supplement articles
published in the New England Journal of Medicine are examples of this sort
of biased reporting- and these PR campaigns are often politically timed to
support various restrictive regulatory actions world wide. In fact, the
current FDA proposed rule to limit allowable structure/function claims has
the EXACT SAME docket number as a proposed rule in S.Africa which led to
legislation that is currently being fast tracked there which would destroy
health freedom by forcing things to full pharmaceutical GMP standards,
indicating that the WHO is giving "marching orders" to regulatory bodies
world wide in the effort to orchestrate so called "harmonization." (See the
S.African Proposed Rule on the PHARMAPACT website, url given below.)
 
 
SOUTH AFRICAN BATTLE FOR HEALTH FREEDOM

Stuart Thomson is a health freedom activist and small supplement
manufacturer in S.Africa who has been working tirelessly in an effort to
try to bring that about there. I was recently invited to S.Africa where I
was the keynote speaker at a health freedom "Indaba" or "gathering of the
chiefs" a historic meeting in which the white and black people of S.Africa
united against the tyranny of the multinational pharmaceutical industry
which is actively seeking to turn herbs and other natural substances into
"Drugs". In order to gain more perspective on the American battle for
health freedom, you should learn of the S.African health freedom effort to
keep from being "harmonized" to the Australian listings system by visiting
Stuart Thomson's website at
http://www.angelfire.com/biz/pharmapact/MAIN.html PHARMAPACT stands for
People's Health Alliance Rejecting Medical Authoritarianism Prejudice and
Conspiratorial Tyranny.

CANADIAN BATTLE FOR HEALTH FREEDOM

Citizens Voice for Health Rights in British Columbia, Canada is another
true grass roots website which illustrates the global battle on the part of
consumers to defend access to dietary supplements, and I have made several
trips to Canada to work with them. Please visit their site at
http://www.citizen-tv.com/citizen's_voice/  There, in the article "CANADIAN
CODEX DELEGATION EXCLUDES CONSUMERS AND CONSUMER GROUPS" by Croft Woodruff,
who owns a health food store in Vancouver, you'll gain some perspective
regarding the international threat to health freedom posed by the German
Codex proposal (currently existing as the draft proposal for vitamins and
minerals which FDA is only PAYING LIP SERVICE towards "opposing" in their
current CODEX comments- which I faxed you. Canadian activist are currently
trying to stop the Australian listings system from being shoved down their
throuts. This unecessary red tape has already been driving small Canadian
manufacturers out of business. In Canada dietary supplements are regulated
as "Drugs" and access is steadily diminishing. Canadian customs is getting
tougher and tougher against consumer efforts to purchase supplement
products from the USA. Zoltan Rona, MD of Toronto had thousands of dollars
worth of vitamins which he sought to import for his patients impounded by
customs and returned to the American manufacturer (Life Extension
Foundation) because they are considered "illegal drugs" in Canada.

By working with true grass roots health freedom fighters world wide, IAHF
has been tracking the pharmaceutically driven campaign to "harmonize"
international laws in an effort to dominate the dietary supplement industry
by trying to "raise the regulatory hurdles"such that only the large
pharmaceutical companies would be able to "clear" them. They don't care
what they sell as long as they can monopolize sales and drive prices sky
high. "Harmony" is beautiful when it comes to music, but in this case,
"harmonization" is a technical term derived from trade law which means to
"make all the laws the same"-- and this trend is both unconstitutional, and
anti competitive-- it would usher in a pharmaceutical takeover of the
supplement industry if left unchecked.

The American Preventive Medical Association presented me with their
Directors Award for my successful campaign in October of '97 to get the FDA
Reform Bill amended, and it was a real cliff hanger to get the
harmonization language amended at the last possible minute in the
Conference Committee. Senator Jeffords had drafted the language, and was
the only one who could make the change that we sought. Congressman Paul,
his LD Joseph Becker, and Norm Singleton worked hard with me when I called
the threat of the harmonization language to their attention.

****SUCCINCT DESCRIPTION OF THE PROBLEM WITH FDA's CODEX COMMENTS ON
VITAMINS AND MINERALS

In the FDA's Codex Comments on Agenda Item #5, Vitamins and Minerals, their
first paragraph is acceptable, but their second and FINAL paragraph
CONTRADICTS the first paragraph, and to be consistent with the will of
Congress as expressed in the amending of the FDA Reform Bill to
specifically exempt dietary supplements from the "harmonization language"
the second paragraph must be removed, and Congress must stand behind
Congressmen Paul, Stump, in requesting this change.

The first paragraph (which is acceptable) says:

"The United States must remain opposed to the continued consideration of
the Proposed Draft Guidelines for Vitamin and Mineral Supplements. Public
health needs and safety concerns as they relate to the use of vitamin and
mineral supplements vary from country to country, depending on each
country's legal and regulatory framework, dietary patterns, the nature of
their public health concerns, and national cultural beliefs as to the role
of supplements in diet and health. We believe that standards for vitamin
and mineral dietary supplements are best addressed by national laws and
regulations."

The second (and final) paragraph (which is NOT ACCEPTABLE, OR CONSISTENT
with the will of Congress as expressed in amending the FDA Reform Bill to
specifically EXEMPT dietary supplements from the harmonization language,
reads as follows- and we urge you to join us in calling for its immediate
removal:

"The United States does, however, support consideration of one element of
the proposed guidelines, namely, the consideration of developing UPPER SAFE
LIMITS of vitamins or minerals in supplements, provided that the
recommendations are based on ...."SCIENTIFICALLY SOUND" risk assessment
criteria. To this end, the United States has submitted to the committee for
consideration and discussion, the document "A Risk Assessment Model for
Establishing Upper Intake Levels for Nutrition."

Illustrating the lack of TRANSPARENCY in the Codex process, which largely
EXCLUDES the oversight of consumers and members of Congress, this "Risk
Assessment" document is _NOT_ available in full on the world wide web for
public scrutiny. An "abridged" version is available in the USDA website,
and the FDA will send the complete document to anyone upon request, but how
many people even KNOW about this? I am on the US Codex Delegation, and I
wasn't sent a copy of this document until only a short time before the
meeting in Berlin. There wasn't much time at all for me to review it, much
less call it to other people's attention. The document was generated by the
Food and Nutrition Board, Department of Medicine, of the National Academy
of Sciences. The mainstream nutritionists who generated it come from
University settings where they have no clinical experience in the use of
nutrients in the treatment of patients, but work in laboratories that are
heavily funded by pharmaceutical grants.

They don't have the in depth knowledge regarding nutrients that
orthomolecular physicians such as Robert Atkins, MD have. Atkins book
"Dr.Atkins Vita-Nutrient Solution" Simon and Schuster, 1998 is just one of
many books written by physicians with first hand experience in the use of
nutrients who know, for example, that the 35 mg daily upper limit on niacin
called for by the National Academy of Sciences is UNSCIENTIFIC.

(I've taken megadoses of niacin for 20 years as part of an orthomolecular
treatment program, and can tell you that while some people may experience
the niacin "flush" at 35 mg, there is nothing "dangerous" about it-- its
just blood rushing to the surface of the skin which causes a mildly
irritating "tingling" in some people. I've taken HUGE doses of niacin for
20 years with no deletrious effect. If I were arbitrarily restricted to low
potency niacin, except by prescription, it would force me to pay FAR MORE
MONEY for my vitamins, for no good reason.

By supporting consideration of so called "UPPER SAFE LIMITS" of vitamins
and minerals via this largely UNTRANSPARENT process, the FDA CONTRADICTS
their first paragraph in which they CLAIM to "remain opposed" to the
continued consideration of the Proposed Draft Guidelines" for vitamins and
minerals. The insertion of their second paragraph represents a form of
"sleight of hand" by which the FDA is attempting to IGNORE the will of the
American people and the Congress, which has SPOKEN on this issue, first by
passing DSHEA, and then by AMENDING the FDA Reform Bill to specifically
EXCLUDE dietary supplements from the harmonization language in October,
1997. I applaud Congressmen Ron Paul, Bob Stump, and Merrill Cook for
recognizing FDA's sleight of hand maneuver, and for drawing a line in the
sand.

I urge Congressmen De Fazio, Pallone, Kucinich, Burton, Crapo, Sanders and
others to join in opposition. Congressman De Fazio, please help me. I need
my access to dietary supplements. If you go to www.iahf.com you can read my
story and find out WHY I care so much about this. PLEASE fax a note in to
my hotel room in Germany if you agree with Congressman Paul's letter below,
or please send me your own letter which echos his concerns. I will put your
concerns DIRECTLY before Dr.s Yetley and Moore of the FDA if you can help
in this way. I have no voting power at the Codex meeting, but am going as
an observer in an effort to monitor the proceedings on behalf of consumers
of dietary supplements all over the world. Your assistance in this urgent
matter is greatly appreciated!

Congressman Paul's letter to Dr.Moore of the FDA follows:

Dr. Robert Moore            9/16/98

Office of Special Nutritionals
Center for Food Safety and Applied Nutrition
200 C Street, SW
Washington, DC 200204

Dear Dr. Moore:

I am writing to urge the Food and Drug Administration (FDA) to withdraw the
second paragraph of the proposed draft guildlines for Vitamin and Mineral
Supplements and the document "A Risk Assessment Model for Establishing
Upper Intake Levels for Vitamins" from the FDA's submission to the Codex
Committee on Nutrition and Foods for Special Dietary Use (CCNFSDU) meeting
in Berlin, Germany September 21-25, 1998. These documents commit the United
States Government to adoption of the Codex proposals regarding upper safe
limits of vitamins and minerals, providing that the recommendations are
based on "scientifically sound risk assessment criteria."

As you are aware, last year Congress explicitly forbid the FDA from
harmonizing any of its regulations of dietary supplements with other
countries. Congress took this action because of concerns that if FDA
regulations were "harmonized" with those of other countries, Americans'
access to a wide range of products, including high-potency vitamins and
minerals, would be threatened since many European countries regulate
dietary supplements as drugs rather than foods. Regulating supplements as
drugs places incredible burdens on consumers. For example, in Germany, the
only nutritional supplements available to consumers are at pharmacies.
Germans can't even touch a nutritional supplement without first having a
pharmacist hand to them from behind the counter. Accepting any of CODEX's
guildlines regarding dietary supplements violates the clear congressional
intent to protect the American people from the type of restriction on the
availability of dietary supplements imposed in other countries.

Congress also expressed a clear desire to increase the American people's
access to truthful information about dietary supplements in the Dietary
Supplement Health and Education Act of 1994 (DSHEA). Any FDA action that
creates even the slightest risk that Americans will be subjected to
regulations such as those in Germany clearly violates the sprit of DSHEA,
the will of Congress, and most importantly, the demands of the American
people for access to dietary supplements unfettered by excessive federal
regulations.

In conclusion, I once again urge the FDA to comply with congressional
intent that the FDA not harmonize its regulations on dietary supplements by
harmonizing those regulations to match the restrictive regulations common
in Europe by withdrawing the second paragraph of your proposed draft
guildlines for Vitamin and Mineral Supplements and the document "A Risk
Assessment Model for Establishing Upper Intake Levels for Vitamins," from
any and all FDA submissions to the CCNFSDU.  I appreciate your cooperation
in this matter.

Sincerely,
 

Ron Paul
 

 

 
******************************************
CODEX MEETING IN BERLIN, GERMANY SEPTEMBER 21-25th
Am On the US Codex Delegation, But the Gov.
Doesn't Pay Our Way for NGO Observers
If YOU Want the Shell Game Monitored-
Kindly Help Met To Defend YOUR Access to
VITAMINS WITHIN THE THERAPEUTIC RANGE
Send Check or MO in US $ to:
John C. Hammell, legislative advocate
IAHF 2411 Monroe St.
Hollywood, Florida 33020 USA
http://www.iahf.com
800-333-2553, 954-929-2905 outside USA
jham@iahf.com, fax 954-929-0507