One Small Step for Codex, One Giant Leap for Science

One Small Step for Codex, One Giant Leap for Science

byMark Mansour

Very few outside of Bonn, Germany, noticed, but on Nov. 4, alandmark decision by a U.N. Codex Alimentarius committee was taken. That movebroke an eight-year stalemate and, for the first time, established scientificintegrity as the cornerstone of the international standard-setting process byCodex for dietary supplements.

After two days of deliberations and the culmination of yearsof largely fruitless debate, the Codex Committee on Nutrition and Foods forSpecial Dietary Uses (CCNFSDU) moved the Guideline for Vitamin and MineralSupplements from Step 3 to Step 5 in Codexs eight-step internationalfoodstandard- setting process. The committeewhich had been deadlocked on thequestion of whether upper limits for vitamins and minerals should be based on arecommended daily allowance (RDA) or determined by safety evaluation through arisk assessment methodreached consensus that effectively removedconsideration of the RDA-based approach advocated by a few governments thatfavor subjectively based government controls over science-based criteria.

The implications of this development transcend the obviousconsequences. Codex, like other international policy-making organizations,debates at length and moves slowly. However, the influence it wields in theinternational food and supplement manufacturing communities is enormous, whichis why such organizations as the Council for Responsible Nutrition (CRN) and theInternational Alliance of Dietary Supplement Associations (IADSA) have long beenactively and intensely engaged in this debate.

The supplement industry has worked for years to providerationale for the safety approach and against RDA-based limits, in addition topersuading government delegations against paternalistic regulation withoutobjective justification. What happened in Bonn significantly increases thelikelihood that Codex will ultimately adopt a guideline based on therecommendation to identify upper limits through risk assessment, rather thanthrough the use of RDA-based limits.

The implications, in their most fundamental form, arethree-fold: 1) the acceptance of science as a rational approach, 2) freedom oftrade for the industry and 3) increased freedom of choice for the public.

More specifically, this development is important for severalreasons. While the use of the RDA mechanism to set upper limits forvitamin and mineral supplements may have appeared to some to be a convenientapproach, RDA-based limits have no scientific validity for this purpose. The RDAis neither defined nor identified to describe safety, nor does it represent asafety limit for total or supplemental nutrient intake. To have allowed RDAs tobecome the defining criterion for the establishment of upper limits would havebeen a highly damaging precedent.

There is well-documented evidence demonstrating a clearbenefit for nutrient quantities at levels above the RDA. For example, accordingto CRNs safety expert, John Hathcock, Ph.D., the RDA in the United States forchromium is 35 mcg/d for adult men, yet supplementation of diets containing lessthan 40 mcg/d of chromium with an additional 200 mcg/d to 400 mcg/d helpsmaintain normal blood glucose levels and minimizes the signs and symptoms ofType II diabetes. Additionally, clinical trials confirm the safety of up to1,000 mcg/d of supplemental chromium. Another example is vitamin C supplements,where the RDA ranges from 60 mg/d to 90 mg/d, depending on the country. Bycontrast, CRNs Vitamin and Mineral Safety review, to be published nextspring, will reaffirm the Institute of Medicines (IOM) Food & NutritionBoards assessment of an upper limit for that nutrient of 2,000 mg/d.

Perhaps the most specious reasoning for relying on RDAs forthe establishment of upper limits may be found in the arguments surrounding theappropriate levels for nutrients such as lutein, lycopene, boron and others, forwhich RDA values have not been established. As positive scientific researchaccumulates in support of the use of these nutrients, consumer demand rises. Itis difficult to justify denying consumers access to these products, when riskassessments can be used to identify appropriate safety limits for thoseimportant nutrients for which no RDAs have been set.

Nor does the imposition of RDA-based upper limits make sensewhen juxtaposed against the absence of established limits for conventional foodscontaining the same nutrients, particularly when there are conventional foodsthat contain many multiples of the RDA of some nutrients. Vitamin B12constitutes an ideal example. A CRN Conference Document submitted as part of theBonn meeting notes mentioned there is no known toxicity attached to orallyadministered vitamin B12. The adult RDA for this nutrient is commonly set atapproximately 2 mcg/d to 2.5 mcg/d, but natural amounts of vitamin B12 inconventional foods such as liver can approach 100 mcg per 100 g servingmorethan 40 to 50 times the amount of vitamin B12s RDA.

Using risk assessment-based safety criteria is a preferableapproach. It is labelingnot limitsthat should be the means for addressingproper use of supplements. The next steps require the industry remain vigilantto ensure follow-through next year and ensure the decisions taken in Bonn remainconstant. Nov. 4, 2003, represented a small but critical step for the globalregulatory process. The result, if the decision stands, will in many ways be aproverbial giant leap for science.

For more information on Codex Alimentarius, visit www.codexalimentarius.net.

Mark Mansour is a partner at the law firm of Keller andHeckman LLP, and serves as legal counsel to the CRN International Trade andMarket Development Committee. Mansour specializes in the internationalregulation of, and trade in, packaged foods, food ingredients, dietarysupplements, functional foods and pharmaceuticals. He can be reached at [email protected].