A series of IMO studies over the past half-decade assert that high-fat diets lead to obesity and heart disease; that omega-3 fatty acids and linoleic acid are good for health; and that there is no safe level of consumption of trans fatty acids. (Codex regulations, on the other hand, allow for trans fats in food, and consider meat to be a source of dietary fiber!) A 2000 IOM report found that Vitamins C and E and the mineral selenium are health-positive, but that ceilings should be set on their usage. IOM believes that antioxidants can be beneficial. It suggests daily intakes of 75 milligrams of Vitamin C (upper level 2,000 milligrams); 22 IU of natural Vitamin E from food (upper level 1,500 IU of a synthetic variety); 55 micrograms of selenium, (upper level 400 micrograms). Beta Carotene supplementation, IOM says, should only be used to prevent Vitamin A deficiency. Pregnant women should take B vitamins, such as folate and choline to prevent neural tube defects. IOM posits that most Americans get sufficient Vitamin B12 in their food, except for people over 50 who should use supplements. IOM says there is promising evidence that B vitamins play a role in reducing cardiovascular disease, cancer, and psychiatric disorders. The Institute recommends upper levels of B6 at 100 milligrams per day; folic acid at 1,000 micrograms; and being wary of the rest of the B vitamins.

On the one hand, IOM has a higher regard for the health benefits of supplements than does Codex officialdom, which is focused upon risk. On the other hand, IOM is tending in the opposite direction of many knowledgeable health practitioners who typically recommend larger doses. For example, the medical doctors and nutritionists staffing Santa Rosa, California-based Farmacopia suggest, based on numerous studies and years of practice, a daily Vitamin C intake of 500-1,000 milligrams; Vitamin E intake of 400-800 IU; Vitamin A intake of 2,500-5,000 IU; Beta Carotene at 15 milligrams; and regular doses of the B vitamins, depending on need. Farmacopia's well-researched protocols spell out possible dangers from overdosing, such as nausea, diarrhea, and fingernail loss. However, they do not throw out entire nutrient groups, or suggest upper limit doses for whole populations based upon possible dangers to the most at-risk groups.

In reality, IOM's protocols are closer to Farmacopia's than to the more restrictive protocols supported by the ultra-precautionary forces at the Codex Commission. And this is, in part, because the IOM studies were funded by many of the same multinational corporations that are monitoring the Codex deliberations to make sure that government and non-profit bureaucrats do not go too far and end up liquidating the marketability of their supplement products. The IOM studies referred to above were funded not just by the U.S. Dept. Health and Human Services, but also by a variety of companies with varying degrees of interest in influencing Codex to set dose limits favorable to their respective business plans. These include Daiichi Fine Chemicals Inc., Kemin Foods Inc., M&M/Mars, Mead Johnson Nutrition Group, Nabisco Foods Group, Roche Vitamins Inc., U.S. Borax, and Weider Nutrition Group. The FDA, as we shall see, is now moving in the opposite direction of the less-restrictive IOM recommendations. It funded a new IOM study, the results of which reflect that sea-change in supplement policy.

Codex is nothing if not complicated. Its deliberations are fraught with competition and collusion by profit-driven companies and the non-profits that they fund to promote particular ideologies to justify particular business aims. Everybody at Codex is focused on grabbing the brass ring: as much market control as they can pinch off for themselves and their allies by tailoring the standards to fit their marketing needs. At stake in all the studies, discussions, political games, legal maneuvers, and media manipulation is nothing less than the determination of which vitamins and minerals end up on the "positive list," i.e. an exclusive list of approved dietary substances that spells life and death for any number of global product lines.

The Positive List

On April 5, 2005, the Alliance for Natural Health, an association of health food manufacturers and distributors in the United Kingdom announced a victory before the European Court of Justice in Luxembourg in the form of an opinion by Advocate General Geelhoed. The opinion will probably be adopted by the full court in June. The Alliance's victory, however, is likely to prove minor and temporary.

Here is the gist of the case. As of August 2005, dietary supplements in the European Union will be regulated by the Food Supplement Directive approved by the European Parliament and the Council of the European Union in June 2002. The directive calls for regulating vitamins and minerals by establishing a "positive list," which, in its current incarnation, includes 13 vitamin forms and 15 mineral forms. Nutrients not on the list will be banned from being sold in the EU. The approved substances are broken down by chemical composition, favoring synthetic compounds of natural forms, according to the Alliance for Natural Health. Substances not on the list include several forms of Vitamin C, natural forms of folic acid, certain antioxidants, and a range of minerals including boron, vanadium, silicon, mixed tocopherols, tocotrienols, sulphur, chelated/plant derived forms and natural forms of Vitamin E and selenium. Based on the positive list, the EU directive will effectively ban 300 of the 420 forms of vitamins and minerals present in 5,000 products currently on the UK market.

In response to the Alliance's lawsuit, the judge recommended invalidating the EU directive, but he upheld the concept of using a positive list to shape international markets, and he urged EU officials to correct what amounts to technical glitches in the wording of the directive, so that the positive list can be effectuated this summer.

Will the Existence of the Positive List Affect the American Market?

Undoubtedly, and here is how. First, in and of itself, the positive list will prohibit the importation of excluded substances and products into European Community markets. Second, the list is sure to be incorporated into the Codex guidelines for vitamins and minerals. That is because Codex is mandated to look to "accepted international standards" to determine which substances are allowed and not allowed and at what doses. It is widely accepted by informed observers that Codex will adopt the EU directive's positive list as its own standard, since there is no other internationally accepted standard.

In order for a nutrient substance to be added to the positive list, a comprehensive risk-assessment study must be performed, with favorable results submitted to the Office of the EU Communities by July 12, 2005. Even then, it can only remain on the positive list until 2009. These expensive scientific studies can only be undertaken by governments or corporations with deep pockets. In sum, the EU directive will likely destroy any European health supplement business which produces or sells commonly accepted vitamin and mineral products.

As for upper limit doses, the Codex Commission is looking to adopt the specifications of a study conducted by the FAO/WHO and various parties, including the Alliance for Natural Health. The study will set upper limit supplement dosage levels in the near future; and those standards, which will be based upon risk-assessment values, not health benefits, will be incorporated into the Codex Alimentarius regulations.

What does this mean for American consumers? Last year, the IOM, under contract with the FDA, issued a report called the Proposed Framework for Evaluation of Dietary Supplements. The report shifts IOM's previous focus upon health benefits to focus on scientific risk assessment. As in the Codex Guidelines, and the EU directive, IOM's report calls for safety issues to be considered as if there are no health benefits attached to the use of a vitamin or mineral. Furthermore, it recommends a method of setting maximum doses that may end up separating out ordinary usage (at relatively low levels) from prescriptive use (i.e., only medical professionals will be authorized to prescribe supplements above certain dosages in the course of medical interventions). And, as does Codex, the IOM report recommends putting the burden of supplying safety data upon industry—a strategy that has been proven not to work—see Merck's murderous mendacity about Vioxx.

The Argument for Codex

The FDA and several large US manufacturers, like DSM Nutritional Products, and Herbalife International, argue that the EU positive list directive and its doppelganger, the Codex guidelines, will not affect the ability of American consumers to use high doses of any supplement they wish to consume because the Codex guidelines and the EU directive are more restrictive than the Dietary Supplement Health and Education Act of 1994 (DSHEA); and the FDA is not adopting the positive list and its presumed low dosage standards, per se. In other words, American consumers will still be able to import European supplements because those products will be lower dosed than the current unlimited dosage levels allowed in the U.S. However, American supplement manufacturers and distributors will be locked out of the European regional markets, and the local markets of any country that adopts the Codex standards in order to benefit from trade with Europe.

Let us not forget that the same American corporations that sit on the Codex Commission as participants also wield tremendous power within the FDA and Congress. Above all, these corporations want access to—and exclusive control of—existing and emerging markets. For DSM Nutrition, for example, the Codex restrictions bring multiple benefits. They kill off small competitors, for all the reasons listed above, and also facilitate the development of two-tiered supplement products, a low dose vitamin for over the counter purchase, and a high dose, more expensive item for prescriptive use. Supplement users stuck in a Codex-controlled market will no longer be able to legally supply themselves with nutrients and doses of their own choosing; rather, they will be captive to the monopolies.

In March, the FDA observed that, "The absence of science-based Codex guidelines [in America] could adversely affect the ability of U.S. manufacturers to compete in the marketplace." This is true because the trade ministries of countries that adopt the Codex standards will repel non-Codexed products. But what the FDA did not say is that European supplement companies will no longer be able to compete in the U.S. market, because their products will be inferior to American products by fiat. And that phenomenon, under the WTO treaties that prohibit a government from "artificially" restricting "free trade," could hypothetically be construed to mean that our relatively loose FDA regulations "unfairly" restrict the ability of European producers to export to the American market, potentially forcing, under the WTO treaties, Congress to adopt Codex standards to facilitate "free trade." Whether or not it falls out like that, it is clear the FDA is moving under its own steam toward cloning the emerging Codex standards, which it helped to develop as a leading participant in commission deliberations.

A Brief Summary

To sum up so far: the Codex Commission is mostly composed of corporate officials from the agribusiness, pharmaceutical, and chemical industries, and government officials that "regulate" those industries (often after or before working for those same privately-owned industries). Codex is poised to adopt a "scientific risk assessment standard" for evaluating vitamins and mineral food supplements. Due to the use of that method of analysis, as opposed to a "risk-benefit" analysis method, the Codex standard will likely incorporate the positive list of the EU directive. It may adopt upper dosage limits that are lower than RDA doses currently available in ordinary supplements. (Higher doses may later be regulated as prescription-only drugs.) In Europe, hundreds of relatively small supplement manufacturers and distributors fear that the new Codex restrictions will annihilate their businesses—leaving the field open to corporations that can afford the expense of having proprietary, synthetic supplements added to the positive list through 2009, long enough, perhaps, to ensure domination of a drastically reshaped market.