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Return-Path: jham@iahf.com
Errors-To: <jham@iahf.com>
X-Sender: jham@pop3.concentric.net
Date: Tue, 15 Sep 1998 20:30:20 -0400
To: jham@iahf.com
From: John Hammell <jham@iahf.com>
Subject: RED ALERT!! FDA IS PUSHING FOR MAXIMUM POTENCY LIMITS AT
  CODEX: SIMPLE INSTRUCTIONS: WE MUST FLOOD ENCLOSED FORM LETTER IN THIS
  WEEEK!!

IAHF LIST WORLD WIDE: We are in a crisis situation, and I badly need all of
your help between now and the end of this week as the Codex meeting in
Berlin begins on monday the 21st. Thanks to your timely contributions, I
will be able to attend the meeting in Berlin, but we MUST try this week to
get the FDA to amend their draft codex comments, or the FDA will think
we're not paying attention!
(I won't have any vote at the Codex meeting- I'm just an observer, if we
don't work hard NOW in advance of the meeting, we'll have ZERO chance at
the meeting to change the US draft comments!)

We MUST get some Congressional oversight due to the fact that the FDA is
pushing hard for really restrictive maxiumum potency limits in their Codex
comments, while simultaneosly PRETENDING to GENUINELY oppose the draft
guidelines for vitamins and minerals (aka the German Codex proposal.)

We only have THIS WEEK to flood the enclosed form letter, and put in calls
into the following Senators and Congressmen and their aids who care the
most about access to dietary supplements: Senator Hatch (Tricia Knight)
Senator Harkin (Peter Reineke), Senator Spector, Congressman De Fazio
(Jessica Zufallo),Congressman Burton (Lori Taylor),Congressman Barton (Beth
Hall),Congressman Ron Paul (Norman Singleton)

We must also flood the letter into Dr.Moore of the FDA.
 

IAHF PUT FDA ON NOTICE & DEMANDED CHANGES TO THE US DRAFT COMMENTS- TO NO
AVAIL- FORCING US TO ACT

On sunday I emailed the FDA demanding that they remove the 2nd paragraph
from their comments because it contradicts their first paragraph. (See form
letter with simple instructions:
 

Emergency Instructions:
You must call the following Senators and Congressmen to demand oversight of
the FDA's draft comments on Codex agenda item #5.

WHAT TO SAY WHEN YOU CALL:

Demand that Congress ask the FDA to remove the second paragraph in their
comments which call for developing ludicrously restrictive maximum potency
limits on vitamins and minerals such as 35 mg/day maximum on niacin except
by prescription.

Complain that the FDA has submitted a document to the Codex Commission
which you have no access to, so can't review, "A Risk Assessment Model for
Establishing Upper Intake Levels for Vitamins" and that the FDA has ignored
the request of John Hammell, a member of the Codex delegation to the
meeting in Germany, so is obviously not interested in input on their draft
comments even when coming from people on their delegation, which is
allegedly a "working group."

This makes the Codex process a FARCE: a SHELL GAME, and we are demanding
oversight THIS WEEK (Since the Codex meeting starts next monday): we demand
that Congress intervene and communicate with Dr.s Yetley and Moore: We
would like the following form letter put on Congressional letterhead and
send to Dr.s Yetley and Moore, and we would like Congress to communicate
with the FDA regarding the problem of their not being any transparency or
honesty in how CODEX is being run. We must DEMAND that the FDA act in
compliance with current US law and TOTALLY, UNEQUIVOCALLY OPPOSE THE DRAFT
PROPOSAL FOR VITAMINS AND MINERALS- and that they NOT contradict themselves
in their comments. Don't JUST fax or email, you must ALSO call!

Senator Hatch (Tricia Knight), 202-224-5251,202-224-6331,
email:senator_hatch@hatch.senate.gov

Senator Harkin (Peter Reineke), 202-202-224-3254, 202-224-9369, email:
tom_harkin@harkin.senate.gov

Senator Specter,202-224-4254, fax 202-228-1229, email:
senator_specter@specter.senate.gov

Congressman De Fazio (Jessica Zufallo),202-225-6416, fax 202-225-0373,
pdefazio@hr.house.gov

Congressman Burton (Lori Taylor),202-225-2276,202-225-0016,

Congressman Barton (Beth Hall),202-225-2276, fax 202-225-0016,
202-225-2002, fax 202-225-3052, barton06@hr.house.gov
 

Congressman Ron Paul (Norman
Singleton)202-225-2831,202-226-4871,rep.paul@mail.house.gov
Note: I am already working on this with Ron Paul's staff, but please call
anyway.
 

Form letter follows:
 

AN URGENT DEMAND TO CONGRESS AND THE FDA

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 calls for the Codex Committee on
Nutrition and Foods for Special Dietary Use (CCFSNDU) to develop (so
called) recommended upper safe limits of vitamins and minerals (eg "35
mg/day for niacin" which is absurdly low. Athough some people experience
flushing at 35 mg, there is nothing dangerous about it.) 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, since their second paragraph
contradicts the first. 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 to the Codex
Commission withdrawing their second paragraph (which calls for grossly
overly restrictive maximum potency limits and their document " A Risk
Assessment Model for Establishing Upper Intake Levels for Nutrition" which
sent to CCFSNDU.

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. I request that
you support HR 2868 The Consumer Heath Free Speech Act.

Fax to Dr. Moore at FDA at 202-260-8957, email RJM@VM.CFSAN.FDA.GOV

Signed:____________________________________________________________
Address:___________________________________________________________
City______________________________________  State______ Zip__________
(Info provided by John C. Hammell, legislative advocate, IAHF www.iahf.com)
 
 

******************************************
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