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.