To:
Ellen Anderson, FDA, fax (202) 205-5532
Dear FDA:
In your draft comments for the Codex CCNFSDU meeting
coming up in Berlin (June 19-23), you state: "The proposed
Codex Guidelines for Vitamin and Minerals Supplements will
not, in any way, adversely effect the availability of these
products to US consumers. The absence of science based
Codex Guidelines however, could adversely affect the
ability of US manufacturers to compete in the international
marketplace."
We disagree with FDA's Melinda Plaiser's legal
interpretation of the Federal Statute by which the US
ratified the World Trade Organization (WTO) agreement in
the Uruguay Round: It says "No provision of any of the
Uruguay Round Agreements, nor the application of any such
provision to any person or circumstance, that is
inconsistent (emphasis added) with any law of the United
States shall have any effect." [19 USC section
3512(a)(1)]
The problem is how will this be argued in each case? On
the surface it appears that we're protected by US dietary
supplement laws (Proxmire and DSHEA), but what if we don't
have something in our law that could be called for by a
finalized Codex vitamin standard (eg restrictions on
availability of high potency vitamins except by
prescription)? Could such a restriction be said to be
"inconsistent" with our law? (It would all depend on who is
doing the interpretation.) The problem is that there is
nothing comparable to a restrictive Codex vitamin standard
currently IN our law, so if it's not IN our law, it can't
be said to be inconsistent!
This opens a Pandora's box as to how it will be
interpreted, and given that it could be interpreted by the
WTO's Dispute Settlement Body, which disallows testimony
from individuals, no matter how well qualified, as well as
from NGO organizations. Given that it only hears testimony
from government Codex representatives such as Dr. Yetley of
FDA, who we do not trust, given that she is currently being
sued for contempt of court due to refusing to implement the
Pearson decision (wherein a Judge ruled that the FDA had to
allow four specific health claims for nutrients), I hereby
make the following demand:
I demand that FDA call for a discontinuance of all
deliberations at Codex pertaining to the Codex vitamin
issue. I demand that FDA remove the NAS paper "A Risk
Assessment Model for Establishing Upper Levels for
Vitamins" from the table as it never underwent a public
review, it was funded by pharmaceutical interests, its
conclusions aren't scientific and it goes diametrically
against the will of the people as expressed via the
Proxmire Act and DSHEA. It is not legal for FDA to attempt
to help Germany build consensus on the Codex vitamin issue.
The NAS paper and rebuttal can be viewed at
http://www.iahf.com Malter's rebuttal has been submitted in
comments by IAHF and has been accepted for publication by
the Journal of Orthomolecular Medicine. Additional comments
discrediting NAS's attack on vitamins have been submitted
by the Life Extension Foundation in the form of an article
by Bill Faloon, available at http://www.lef.org
additionally I demand that FDA remove the guidance doc on
significant scientific agreement from Agenda Item #10 as
FDA is being charged with contempt of court over this
issue. I am apprising Senator Hatch, Congressman Burton,
and my own members of Congress of these facts.
With Real Concern,
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