Source: © 2005 Peter Byrne. Peter Byrne is an award-winning investigative journalist. He hangs out at

If you use vitamin and mineral supplements for health, you might want to fly over to Rome, Italy and crash the July 4-9 meeting of the Codex Alimentarius Commission, a little-known international body that wields immense power over the global food market. Should the Codex Commission approve the Draft Guidelines for Vitamin and Mineral Supplements on its agenda, 300 of the 420 basic vitamin and mineral products commonly used by European consumers will be banned from manufacture and trade inside the European Community.

The ban will seriously impact the export business of U.S.-based supplement companies and could eventually result in similar product restrictions being implemented here. The Codex story has received almost no attention in the corporate press and media; although badly garbled versions of the tale zing about in cyberspace, confusing many readers with conspiracy-laden mixtures of fact and fantasy. Which is not to blame the authors of these emails, since the Codex Alimentarius (Latin for "food code") Commission is so pathologically bureaucratic that its real intentions, and the probable consequences of its actions, are difficult to discern when wading through thousands of pages of jargon in its public reports. For example, it is not true that over-the-counter vitamins and minerals will be banned in the United States after August 2005.

There are so many self-interested players in the "L'affair Codex," that it is nearly impossible to get a straight answer about what it all means from any single participant. It is possible to piece together the basic story from public records, and by listening to what the various interest groups have to say (with several tons of heavily iodized salt). The bottom line of the story is that the emerging Codex regulations on vitamins and mineral supplements have almost nothing to do with promoting human health, and everything to do with facilitating the profits of multinational food and chemical corporations.

The Five Major Codex Players

From the point of view of the American health consumer, there are five major players: the Codex Commission, the European Parliament and the Council of the European Union, the United Nations, the World Trade Organization, and the U.S. Food and Drug Administration/U.S. Department of Agriculture. All of these institutions are involved in formulating rules and regulations to govern the production and distribution of food supplements. It is easy to conflate their separate, but related, institutional efforts. The fate of food supplements is not dependent upon any one of these institutions, but upon how they interact as a whole. The five organizations are working syncretically to transform the supplements market, not in favor of the consumer, but in favor of certain multinational corporations that stand to benefit from the resulting restriction of trade under the guise of promoting "free trade."

The History of Codex and Their Guidelines

Codex was created in 1962 by the Food and Agriculture Organization of the United Nations (FAO) and the U.N. World Health Organization (WHO) to "harmonize" world food trade. The several hundred regular "participants" at Codex meetings are drawn from the ranks of government regulatory agencies; food, chemical, and pharmaceutical corporations; industry trade groups; and non-profit "watchdogs" with various political agendas. To date, Codex has established 250 sets of rules regarding the manufacture and distribution of a variety of foods, from sardines to peanuts to pineapples, and including food additives and infant formula. (It is illuminating to learn that Codex has approved the use of cyclamates and saccharine—artificial sweeteners long banned in the U.S. as health risks—as well as Monsanto's aspartame.) After more than a decade of wrangling over political aims and technical details—far removed from the public eye—the commission will likely approve the Draft Guidelines for Vitamin and Mineral Supplements in July.

The Codex guidelines begin: "Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet." Vitamin and mineral food supplements are defined as concentrated forms of nutrients whose purpose is to supplement the normal diet when the vitamin and mineral intake from food is insufficient. From the point of view of universal healthcare, deciding exactly which nutrients, and how much of each, constitute a "normal" or a "balanced" diet is a large variable when attempting to prescribe a single standard across hundreds of dietary cultures.

But Codex is not about health. The guidelines define the minimum level of supplement use as 15 percent of the recommended daily allowance (RDA) suggested by the manufacturer. Maximum levels of use, or upper safe levels, are not to be calculated by reference to RDAs, but, and this is important, by "scientific risk assessment" based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups andthe daily intake of vitamins and minerals from other dietary sources.

The key phrase here is "scientific risk assessment." This investigatory technique is, according to many experts, more properly reserved for testing safe usage levels for chemicals and substances known to be inherently toxic or poisonous, not for evaluating nutrients that are known to be generally safe as ordinarily ingested. This emphasis in the guidelines, according to expert critics, closes the door on the possibility of setting upper safe limits based upon the benefits of using a particular nutrient. And by setting upper limits based upon the sensitivity of the most sensitive group—say, pregnant women who probably should not use a lot of Vitamin A—the legitimate needs of the rest of the population for healthy doses of Vitamin A are ignored; indeed, the masses may be forbidden to use more Vitamin A than pregnant women, except, perhaps, by a doctor's prescription. The "safe" upper limit paradigm is further driven downwards by the admonition that it be reduced in accord with the amount of, say, Vitamin A obtained from a normal diet. Under Codex, labels will advise the consumer not to exceed the maximum daily amount; and that the product "should be stored out of the reach of young children," (replacing a sentence in an earlier draft that required containers to be child-proof).

The Codex Commission, which is composed of voting representatives of most of the world's nations, has not yet set the exact maximum doses for vitamins and mineral supplements, but it is looking to the European Union Parliament, and other arms of the FAO/WHO for "scientific risk assessment" guidance in that regard. And that is basically all that the Codex guidelines say at this time.

Corporate Participants

It is instructive at this point to take a look at the American participants at the Codex Commission, i.e. public and private sector agencies, corporations, and organizations that actively participate in the commission's deliberations and wield considerable influence upon issues in which they are acknowledged to be "expert." Staff from the Dept. of Agriculture and the Food and Drug Administration represent the official position of the United States at Codex meetings. They are deeply involved in setting global standards, as are the staffs of food and drug regulatory agencies in most industrialized countries. (Codex funds "scholarships" for representatives from third world countries, many of which lack any regulatory bodies, but are still subject to WTO agreements and are affected by Codex regulations.)

From the corporate sector, official Codex participants include Amway Corp., Wyeth Pharmaceutical Co., DSM Nutritional Products, Mead Johnson Nutritionals, Bristol Myers Squibb Co., Nestle USA, Herbalife International, and a trade group called the Council for Responsible Nutrition (CRN). The latter's Web site features a "Myth vs. Facts" on Codex, which, to be blunt, is a self-serving spin that underplays the negative ramifications of the guidelines on mom & pop supplement businesses. CRN's membership includes Archer Daniels Midland Co., Cargill Health & Food Technologies, Bayer Corp., Wyeth Consumer Health, Weider Nutrition International Inc., Shaklee Corp., Nutraceutical Corp., Herbalife International of America, Kemin Foods, General Nutrition Centers, Inc., Cadbury Adams USA LLC, DSM Nutritional Products, Eastman Chemical Company, Mingtai Chemical LLC, and Monsanto Life Sciences Company. (A number of these corporations have several voices at the meetings, since representatives of corporate subsidiaries sit alongside participants from their parent companies. And corporate-funded lobby groups have separate voices.)

CRN had this to say about the Draft Guidelines—which it helped to write and of which it approves: "We in the industry have long maintained that maximum levels set by Codex or governments for contents of vitamins and minerals in supplements should be based solely and completely on safety, not on nutritional policy in general or the RDA in particular." It is instructive that the chemical formulations for naturally-occurring vitamins and minerals are not patentable, unlike pharmaceutical formulas. And the supplement market is huge—$16 billion a year in the U.S. alone. It easy to presume that pharmaceutical, chemical and agricultural concerns are working to grab market share through the back door: Codex.

Public Interest Groups

On the other side of the corporate interest equation, in theory, is the Washington D.C.-based Center for Science in the Public Interest, which along with sister non-profits from Japan and the United Kingdom has official status in the Codex proceedings. CSPI is funded by social engineering projects such as the Rockefeller Family Fund, John Merck Fund, and the Robert Wood Johnson Foundation. A spin-off from Ralph Nader's public interest organization, CSPI claims that Vitamin A, Vitamin D, and Vitamin B6 cause a host of horrible diseases. The non-profit, which is a quote mill for The New York Times reporters, pooh-poohs the common understanding that a variety of foods and supplements are healthy, such as soy, Vitamin C, antioxidants, and dietary fiber. To back-up its ultra-precaution, CSPI refers to media-ballyhooed studies of antioxidants and Vitamins A & E which purport to show that these substances are bad for health. (Experts at Harvard Medical School and Tufts University say that these studies are deeply flawed, largely because they were focused upon particular at-risk sub groups, and did not take the needs of general populations into account.)

CSPI's stance supporting restrictive standards for vitamin and minerals undercuts the usefulness of an otherwise fine environmentalist tool, the Precautionary Principle, by taking the position that since a vitamin could cause harm to relatively small groups of people if improperly used, it is permissible to ban it universally, regardless of its obvious and well-documented benefits for millions of people.

Further complicating the mix of opinion massaging the medium is the Hoover Institution, which has taken the position that Codex regulations hurt "free trade," (a loosely defined, if politically useful concept that is most often employed to justify the expansionist agendas of monopoly corporations). And the Center for Consumer Freedom, a restaurant trade association set up to counter "food police lies" about the dangers of tobacco, olestra, trans fats, and obesity, frames Codex as the "global food cop." Neither of these two organizations participate in Codex.

Institute of Medicine

And then there is the Institute of Medicine (IOM), a quasi governmental body based in Washington D.C. that performs scientific studies on spec from government and private companies. It is under U.S. government contract to develop standards for vitamins and minerals that reflect the standards being considered by Codex. From the point of view of the scientific establishment, IOM is no lightweight; it is very influential at the FDA, and inside the Codex/WTO complex.

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.

The Codex restrictions ensure that the quantity and quality of supplements that can be imported by the European market from America will diminish. But in the U.S. there is a government-corporate propaganda campaign dedicated to assuring American consumers and small supplement producers that they are in no danger of ending up like their European counterparts. Large companies such as Herbalife International say that anyone who suggests that Americans will lose access to supplements is plying "misinformation." The company goes so far as to tell its international network of distributors that corporate HQ represents them at Codex meetings, and they will be told when, if ever, to open their mouths. In July 2003, the Consumers Union hailed the scientific risk assessment standards of Codex. American Herbal Products is slightly more perspicacious. This trade association recognizes that the WTO can, at least in theory, push the Codex standards upon Americans.

Why Is There Confusion About Codex?

One of the reasons that U.S. trade associations and consumers are confused about Codex—and why pro-Codex lobbyists, such as the FDA and the CRN, can dismiss the legitimate concerns of consumers as conspiracy theories—is because, due to the complexity of the bureaucracy at work, people have conflated the Codex Guidelines (which has no positive list, nor an upper dose limit, yet) and the EU directive (which does have a positive list, but no upper dose limit, yet). Reading the FDA's or CRN member's barrage of disclaimers about the negative impact of Codex upon the U.S., one is struck by the shared mantra that compliance with Codex is "voluntary," when, in truth, non-compliance may result in trade sanctions or expulsion from the WTO. Another popular phrase that pops up in the campaign, "science-based risk assessment," sounds nice until you realize it is a technique more aptly applied to arsenic or cyclamates, than to Vitamin E, which has known benefits (as well as some risk if used improperly).

The fact that too much of a good thing can cause harm has been blown out of proportion by Codex proponents. For instance, a study of the effects of Vitamin E upon smokers and cancer victims has been widely publicized as "proving" that the vitamin has no positive effect on health (and may result in death); whereas dozens of unpublicized, scientifically-superior studies show that Vitamin E has many benefits (and that the negative study was deeply flawed). Or take the case of the amino acid, L-tryptophane, demonized a few years back after a genetically-engineered batch manufactured in Japan was fatally contaminated. Instead of questioning the efficacy of genetic engineering as a manufacturing strategy, or the wisdom of replacing natural substances with synthetic, proprietary goop, the pharmaceutical-regulatory establishment attacked L-tryptophane in all of its forms, many of which are beneficial. Underlying all the public relations blather, and reams of subjectivized, financially compromised studies, is the fact that world trade in food supplements is being restricted and transformed for the worse under the guise of eliminating trade restrictions and promoting health.

Enter the WTO

Contrary to rumor, Vitamin C will not be banned in the U.S. in August. But some forms of it will be banned in the EU; and a similar ban could eventually appear in the U.S., although that event is not inevitable. On the other hand, it will be much more difficult for ordinary consumers to stop this eventuality than it was for them to affect DSHEA, which was transformed by consumer pressure from a restrictive measure into its opposite. In fact, the very existence of DSHEA is used by Codex proponents as "proof" that the U.S. is protected against Codex, because DSHEA is "less restrictive" than Codex and the EU directive. That is hollow reassurance.

DSHEA is a malleable act of Congress, subject to constituent pressure. The implementing force of Codex—the WTO—is based upon an international treaty to which the United States is a party. And the WTO does not care a fig for people's health concerns. It is designed to manipulate the formation and deformation of trade barriers in favor of the strongest monopolists.

Here is how it works. The WTO derives its power to regulate international trade through treaties. In the age of the political, cultural, and economic dominance of multinational corporations, it acts as a kind of clearing house, or court of last resort, to settle trade disputes short of war. In theory, the WTO is concerned that no country favor its own exports by placing "unfair" restrictions upon competing imports.

Run by and for the interests of large industrial and financial enterprises, the WTO views "harmonization" of food standards as promoting "free trade." Unfortunately, free trade as conceptualized and actualized by the dominant WTO members (United States, European Union, Japan) is not about leveling the playing field so that small producers or underdeveloped countries can compete with the big guys. It is about ensuring that the most powerful corporations can continue to grow, eating up the small fish and expanding into new markets in both industrialized and industrializing economies. It is about maximizing the extraction of profit for stock-holders, as opposed to maximizing the health or economic well-being of a population.

To that end, WTO members have agreed to abide by the Agreement on Sanitary and Phytosanitary Measures (SPS), and the Technical Barriers to Trade Agreement (TBT), which mandate that no country will impose unfair barriers to trade, and that they will work to harmonize regulations that affect trade by abiding by international standards, or face trade sanctions. In theory, this could mean that the United States, by allowing the internal sale of substances and supplement doses that are disallowed in Europe is, in effect, imposing a barrier to the "free trade" of EU supplements, since consumers are less likely to buy products that are diluted by Codex restrictions. And the FDA, which is clearly controlled by the pharmaceutical and agribusiness sector, is in the process of harmonizing the internal market, partly through the scientific auspices of the IOM, in a way that par