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Date: Wed, 09 Sep 1998 12:42:28 -0400
From: John Hammell <>


The FDA has just submitted a document titled "A Risk Assessment Model for
Establishing Upper Intake Levels for Nutrition" to the Codex Committee on
Nutrition and Foods for Special Dietary Use, but they have FAILED to make
this document available on the web, so American consumers have NO WAY TO
REVIEW what the FDA submitted, so we are UNABLE to provide the FDA with
FEEDBACK, and once again it becomes PAINFULLY APPARENT that we are
confronting a non transparent process, a shellgame, and still MORE PROOF
that the Codex process is plainly characterized by double talk and sleight
of hand, at every possible level!!

I urge everyone reading this to do 2 things:

1. Read the FDA's  Proposed Draft Guidelines for Vitamin and Mineral
Supplements. Its less than a page long (below). You will immediately see
the problem. The first paragraph tells us "what we want to hear" and leads
us to believe that the FDA is truly opposing the German Codex vitamin
proposal (as they are bound by US law to do), but THEN, in the SECOND
paragraph, they do some "fancy footwork" in an effort to ram "upper safe
limits of vitamins and minerals" down our throats.

I have only ONE THING to say about this: "OVER MY DEAD BODY!"

Here is what the FDA is saying: Ignore the first paragraph, (they're
telling you what you want to hear in that one... PAY ATTENTION TO THE SECOND!

US Agenda Item #5: Proposed Draft Guidelines for Vitamin and Mineral
(draft comments for CCNFSDU meeting September 1998/Berlin

"The United States remains 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

Now- Don't be put to SLEEP by that first paragraph! Read the SECOND ONE:

"The United States does, however, support consideration of one element of
the proposed guidelines, namely, the consideration of developing UPPER SAFE
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 Vitamins."

My comment: "Oh yeah??? And just what the HELL might this so called
"scientific risk assessment model" entail, anyway? Why the HELL hasn't the
FDA made this document available in a website for public viewing and
comments? Why should we, the American people, TRUST such a despicably
un-transparent process as this? How can ANY American consider this to be
fair to them? There is only one word to accurately describe this situation:
COM-PLETE BULL! (Theres a 4 letter word that often accompanies "BULL" that
I'd like to include here as well, but some might object... so I'll stick
with BULL!)

What we MUST do:

Please call Dr. Robert Moore at the FDA at 202-205-4605, and Dr. Elizabeth
Yetley at FDA at 202-205-4168. Read the paragraph above to their answering
machine, or to them PERSONALLY if they answer.

Then, call your Congressman and two Senators to discuss this with the aide
who handles FDA issues. Reach them via the Capital Switchboard at
202-225-3121. If you don't know the name of your Congressman or Senators,
just give them your zipcode and they'll connect you to the right offices.
Complain to Congress that the FDA is not allowing you to examine what they
are doing at Codex, and read the paragraph below to them too, and demand
that they put a demand in writing to Moore and Yetley in accordance with
your wishes.

Email the form letter below to Dr.Moore at FDA at RJM@VM.CFSAN.FDA.GOV, and
to Dr. Yetley at FDA at Get your Congressman and Senators
fax numbers and email addresses from them and Fax or email them the form
letter below RIGHT NOW because the CODEX meeting in Berlin starts on
September 21, in just a few days, and ask them to send you a copy of their
demand to Moore and Yetley on their letterhead.

We  DEMAND that the FDA immediately REMOVE the second paragraph from their
comments on Codex Agenda Item #5 on vitamins and minerals and publicly
announce, in writing, that they have done so by providing us with a copy of
a letter which they MUST send to the Codex Committee on Nutrition and Foods
for Special Dietary Use announcing that they have withdrawn that second
paragraph, along with the "risk assessment paper" because the American
people have never been consulted on this, and never had the opportunity to
SEE this paper and provide the FDA with feedback. Moreover, we are calling
our Congressmen and Senators to complain about this, and to urge them to
cosponsor Ron Paul's bill which would pull us out of the UN, because CODEX
is part of the UN, and it is obviously totally out of step with our
Constitution for this country to be involved in something as despicably
untransparent as this sort of shell game.


It has become apparent to me that the FDA is once again attempting to
deceive the American people by not making a document which they have
submitted to the Codex Committee on Nutrition and Food for Special Dietary
Use publicly available for download on the web so that we can comment on it.

The document is titled "A Risk Assessment Model for Establishing Upper
Intake Levels for Nutrition" and it apparently calls for the Codex
Committee on Nutrition and Foods for Special Dietary Use (CCFSNDU) to
develop recommended upper safe limits of vitamins and minerals. Although
the FDA attempts to make this sound "reasonable" in their draft comments to
the CCNFSDU by claiming that these limits would be "based on scientifically
sound risk assessment criteria" we have good reason to be distrustful of
what they consider to be "scientific" given their long standing bias
against the use of dietary supplements, as illustrated by Gary Dykstra's
now infamous comment that "the existence of dietary supplements in the
marketplace must never be allowed to act as a disincentive to new drug
development." Given that  on July 7, 1997 the FDA announced their intention
to harmonize their regulations to emerging Codex standards via a notice of
proposed rulemaking in the Federal Register (Vol. 62, 3129 pp.36243-36248),
and given the FACT that FDA's intent here is totally unconstitutional, I
hearby demand that the FDA immediately make public a letter to the CCFSNDU
announcing the complete WITHDRAWAL of the second paragraph of their draft
comments to CCFSNDU on agenda item #5, and with this, the complete
withdrawal of their document titled "A Risk Assessment Model for
Establishing Upper Safe Intake Levels for Nutrition" since we have had no
opportunity to review and comment on this document, and have no reason to
TRUST that the FDA is acting in our own best interests, given their long
standing BIAS against the use of high potency vitamins and minerals.

I DEMAND that the FDA's comments to CCNFSDU on agenda item #5/ Proposed
Draft Guidelines for Vitamin and Mineral Supplements ONLY include their
current first paragraph, and nothing ELSE. So it should read:

"The United States remains opposed to the continued considerations 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 dietary supplements in diet and health. We believe that standards for
vitamin and mineral dietary supplements are best addressed by national laws
and regulations."

I demand that the FDA provide me with a copy of their letter withdrawing
the second paragraph and their document " A Risk Assessment Model for
Establishing Upper Intake Levels for Nutrition" which they must send to
CCFSNDU, and also announce publicly at the Codex meeting of CCNFSDU in
Berlin Sept 21-25, 1998.

I hereby request that my Senators and Congressman reiterate this exact
request, to the FDA, on their letterhead, and that a copy of their demand
be cc'ed to me so that I can have the peace of mind of knowing that
Congress still provides this sort of oversight against this criminal agency.
Furthermore, I request that Congress back Ron Paul's bill to get us out of
the UN, since CODEX is part of the UN, and since it is painfully apparent
that the CODEX process is untransparent and non democratic.

City______________________________________  State______ Zip__________
(Info provided by John C. Hammell, legislative advocate, IAHF

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
Send Check or MO in US $ to:
John C. Hammell, legislative advocate
IAHF 2411 Monroe St.
Hollywood, Florida 33020 USA
800-333-2553, 954-929-2905 outside USA, fax 954-929-0507