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Editorial: A coda for CODEX?

By Len Monheit, NPIcenter

[email protected] The adoption, this past week, of the Codex Guidelines for Vitamin and Mineral Food Supplements, by the Codex Alimentarius Commission, depending on your point of view, represents, a) the beginning, 2) a milestone in, or 3) the end, of an international dialogue to discuss how countries should treat vitamins and mineral food supplements. The adoption of the guidelines presumably give rise to as many questions as answers, and getting clarity around such an emotional issue charged with significant fear about restricted access or restricted trade, will be a challenge for those involved in the ongoing dialogue - and there will be significant issues to be resolved and clarified.

The three major US trade associations all published comments on the guideline’s adoption. The Council for Responsible Nutrition (CRN) noted that "adoption of the guideline means the acceptance of science as a rational approach, the freedom of trade for the industry, and the increased freedom of choice for the public." This comment focuses on the fact that agreement had previously been reached that "maximum levels for vitamins and minerals in supplement products in international trade are to be set on the basis of safety evaluation through risk assessment, and not on the basis of recommended dietary allowances (RDA)." The point about the guidelines allowing increased freedom of choice is a direct hit against those who argue that choice will be restricted and that the adoption of the guidelines will trigger eventual overriding or undoing of DSHEA in the United States.
It should be clearly noted that that the adoption of the guidelines only has implications where supplements of this type are regulated as foods, hence there are no real implications for the Canadian marketplace.

Although there have been vocal and persuasive arguments against the adoption of the guidelines at this time, many, including NGO IADSA (International Alliance of Dietary/Food Supplement Associations), observed the investment that had gone into the drafting over the past ten years, and certain consensus that had been achieved along the way, to support their contention that the guidelines should now be adopted.

Incidentally, CRN suggested that "the guideline should improve the international market for U.S.-made products" and "cannot override DSHEA for U.S. domestic policy".

The American Herbal Products Association also weighed in, "“After more than a decade of debate and discussion, the Codex Guidelines have been finalized,” said AHPA President Michael McGuffin. “And despite the fact that the document unfortunately downplays the importance of vitamin and mineral supplements, American consumers still have full access to dietary supplements that conform to our domestic laws.”

AHPA specifically points out that maximum levels for vitamins and minerals have yet to be established, underscoring the need for industry to refute suspect safety analyses (such as last year's vitamin E meta-analysis) and to continue to convincingly provide its own safety evidence for vitamins and minerals. AHPA also points out another compelling reason for the adoption of the guidelines at this time. "These guidelines will now serve as a model for many countries that do not currently have supplement regulations in place, and may be used under World Trade Organization agreements to force countries to allow the importation and sale of products that conform to the guidelines."

The National Nutritional Foods Association (NNFA) noted in its 'Update', "Codex Guidelines: Adopted, But No Threat to U.S. Supplement Sales", also recognizing the perceived threat on the minds of many health freedom supporters. In its update, NNFA noted its continued opposition to maximum upper limits on vitamins and minerals in general, but agrees that if they are set, then it is better they be set based on sound science (risk assessment) rather than on RDIs (recommended dietary intake).

So while a chapter is now complete, the story is still unfolding. I think we can expect the subject to be on many minds at events in the next few weeks, and it is quite conceivable that fear and mistrust (often quite justified) might distort facts and absolutes. This issue bears watching, and for those involved in international trade, interests should be protected. For those on the forefront in science and safety substantiation, industry's full and active support should be offered.

I am concerned, though, that fear might, in fact, prevent many of us from doing what we should be doing - focusing on building and supporting safe, efficacious products, manufactured in an environment and under conditions that prevent contamination and ensure products have what they say they have on their labels - and only what they say they have.

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