November 4, 2004
HEALTH FREEDOM TAKES A DOUBLE HIT AT CODEX
© 2004 The Law
Loft
THIS YEAR’S CODEX
COMMITTEE MEETING ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES
STARTED WITH A NASTY SHOCK, SOMETHING THAT WE ALL WERE EXPECTING BUT
NOT THIS YEAR. DR. CHRISTINE TAYLOR OF THE FDA, NOW ON ASSIGNMENT
TO THE WORLD HEALTH ORGANIZATION IN GENEVA, ANNOUNCED THE FORMAL
OPENING OF A NEW JOINT FAO/WHO PROJECT. THE JOINT FAO/WHO
DEVELOPMENT OF A SCIENTIFIC COLLABORATION TO CREATE A FRAMEWORK FOR
RISK ASSESSMENT OF NUTRIENTS AND RELATED SUBSTANCES. BEHIND THIS
FANCY TITLE LURKS AN OMINOUS PROJECT – THE CREATION OF A FRAMEWORK
RISK ASSESSMENT MODEL TO GOVERN THE ASSIGNMENT OF UPPER LIMITS (ULs)
TO VITAMINS AND MINERALS AND PRESUMABLY OTHER NUTRIENTS AS WELL.
SOUND LIKE PROGRESS? IT IS NOT! BASED ON THE PROJECT DESCRIPTION
SO FAR, THE CURRENT PROPOSAL ENVISIONS:
• going forth to set ULs on vitamins and
minerals using expanded uncertainty factors, a fan name for guesswork
even where the data is unclear,
• setting levels based on intakes calculated
on the basis of both maximum supplementation and food source consumption
of nutrients and then setting the Upper Limits low enough for the
general population to protect even the most sensitive (sensitive to over
exposure to nutrients) within the generally applied upper intake levels.
This is bad, bad news indeed and probably
much worse than the general health freedom oriented observer at Codex
realized since a little-known wrinkle within the Sanitary Phytosanitary
Agreement allows the WTO to pick the international organization that
sets these standards. In other words, it could be this joint FAO/WHO
committee without reference back to Codex.
Or, equally bad, it could be this joint
FAO/WHO Committee then referring back its framework to another entity
within the Codex immediate parent, the Joint FAO/WHO Food Standards
Programme, that entity then acting in concert with Codex in the final
stages of risk management under the guideline finalized at CCNFSDU this
week (to be adopted by the full Codex Commission next summer.) Yes,
it’s confusing, but international bureaucracies often are! The point is
whether they take path A or path B, the news seems equally grim and
equally imminent. This is true in part because on Tuesday of this week,
the USA caved in on disputed language in part 3.2.2 of the proposed
draft guideline for vitamin and mineral food supplements. As now
agreed, the guideline’s part 3 on contents of vitamins and minerals,
maximum amounts now contains three dangerous pegs:
• first, the statement that safe upper levels
per daily portion shall be based on scientific risk assessment. That is
a seemingly innocuous statement until you realize that that risk
assessment is going to be set within the framework of the new FAO/WHO
joint project described above.
• second, that daily intake of vitamins and
minerals (maximum values) shall also be set by taking into account daily
intake from ‘other dietary sources.’ That phrase hides another EU
victory, namely, that in setting upper levels, both nutrients consumed
from standard food sources and nutrients consumed from estimated high
end dietary supplement consumption will be counted together in order to
suppress general upper levels to protect the sensitive consumer.
• and third, that when maximum values are set,
regulators may use relatively low levels established in population
reference values as part of the UL setting process. While the FDA
claims this latter is acceptable compromise language, don´t you believe
it!
While only the third peg is new as of
this meeting, the changed meaning of the first two ’scientific risk
assessment’ and ‘other dietary sources’ is new, too, thanks to the
unveiling of the new joint FAO/WHO project discussed above. Could it
possibly get any worse? Yes, and it will unless intelligent concerted
action is taken now.
PREVIEW OF COMING REPORT:
Next week we will give you and update on
events at the equally important Codex Committee on General Principles
and we’ll have interviews that give industry sources a chance to rebut
the analysis stated above. And the week after that, we will have a
basic action plan designed to help protect the rights of consumers and
small manufacturers acting within these global fora. Stay tuned.
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