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Citizens for Health Update on Codex Vitamins/Supplements Issue

From: Citizens for Health <www.citizens.org
July 12, 2005

The Rome 2005 Codex Supplement Guidelines Aftermath: Risk and Opportunity

Washington, DC, July 12, 2005: The 2005 Rome Codex meeting ended early

Saturday afternoon, July 9. Delegates took Friday off, as the Codex Secretariat prepared definitive drafts of the four days of deliberations for final official Saturday approval. During the half-day Saturday meeting, the parmesan cheese standard took the largest amount of time while the vitamin and mineral guidelines and the WHO/FAO initiative to create a bigger role for nutrition in future Codex guidelines drew barely a notice. FAO/WHO reported the supplement guidelines approval:

The CAC adopted global guidelines for vitamin and mineral food supplements as one of its first decisions. The guidelines recommend labeling that contains information on maximum consumption levels of vitamin and mineral food supplements, assisting countries to increase consumer information, which will help consumers use them in a safe and effective way.

According to WHO, the guidelines ensure that consumers receive beneficial health effects from vitamins and minerals.

"The guidelines say that people should be encouraged to select a balanced diet to get the sufficient amount of vitamins and minerals. Only in cases where food does not provide sufficient vitamins and minerals should supplements be used." The vitamin and mineral guidelines, while not overriding national legislation, provide national governments with a blueprint for domestic vitamin and mineral regulation which is much more restrictive than American dietary supplement law. The restrictions in the guidelines create a risk for supplement consumers worldwide. As nations begin adopting laws consistent with the guidelines to avoid losing international trade disputes, there is a risk that the world market in supplements will sink to a lowest common denominator of a relatively few low potency products. As the market contracts around such limitations, pressure will mount on the U.S. to adjust its law to the international standard. The American supplement industry advocates of the international Codex guidelines say they will resist such pressures but, critics fear, they have little commercial incentive to do so.

The industry Codex advocates assert that consumers and manufacturers worldwide will benefit from adoption of the guidelines, because they require acceptance of science as a rational approach to setting upper intake limits, create freedom of trade for the industry, and increase freedom of choice for the public. This might turn out to be true for countries such as Greece, Norway, Spain, or France, which currently significantly restrict dietary supplement products. However, countries just beginning to establish dietary supplement regulations will be inclined to adopt the Codex standard rather than laws similar to the much less restrictive U.S. Dietary Supplement Health and Education Act (DSHEA).

In response to this concern, industry guidelines advocates argue that it could have been much worse. They site maximum levels of nutrients set on the basis of safety evaluation through risk assessment as far superior to maximum levels set the basis of Recommended Dietary Allowances (RDA), as called for in the original proposed Codex guidelines. The population reference intakes (PRI) and RDA, they point out, are based on nutritional need, and are not scientifically valid for assessing safety and setting maximum levels of intake. The current guidelines also treat supplements as food and minimize the impact of the precautionary principle, which blocks products from marketing until proven safe even if there is no suggestion of harm. These are significant accomplishments. However, the cost for these successes is enormous.

Under the Codex guidelines, vitamins and minerals will be evaluated for safety as if they were toxic chemicals. Nothing prevents the unbridled use of this approach from discovering very low safe upper limits (it is technically possible, though unlikely, that they could even, in some instances, be lower than the RDA). Fifty years of U.S. legislative and judicial determinations, culminating in the passage of DSHEA, oppose this
concept. The opposition often had to overcome the repeated and shrill objections of the U.S. Food and Drug Administration. It appears to critics of the Codex guidelines that, having failed domestically, the U.S. FDA now hopes to get the international community to treat nutrients as poisons. The critics point out that a senior FDA official supportive of treating nutrients as toxins has taken FDA leave in order to run the Codex-supported toxicological review of vitamins and minerals. The critics find this fact troubling. Industry supporters of the guidelines say they will stand firm against unfair treatment of nutrients as toxins. A battle looms.

In addition to the battle over safety standards, supplement guidelines critics support the FAO/WHO observation that Codex must do more to include nutrition standards in its commercial trade guidelines. In this context, supplement advocates, while opposing the use of improper standards for the safety evaluation of supplements, support the role of dietary supplements in the campaign to end world hunger and promote world health. They point out that researchers have shown that $1 of vitamin A supplementation equals $30 of development aid. They argue that similar results are likely for all essential vitamin and mineral supplements but that the Codex guideline could make it more difficult to achieve these benefits. This position is one they believe is not antithetical to supplement industry interests. The dietary supplement community of consumers, producers, researchers, sellers and others could play a leading role in the FAO/WHO contribution to the global effort to end world hunger. This appears to be a position that the manufacturers who support the current guidelines could embrace.

During the first day of the Codex meeting's five minute supplement guidelines discussion, China, while not objecting, gave a glimpse of the unfolding discourse. It stated that every government, in making decisions about vitamins and minerals, should be allowed to take into account the dietary limitations of their own countries, that governments be allowed to select vitamins and minerals according to the customs and habits of their country, and that definitions of the sources of vitamins be permitted and publicized. This is not the way the Codex guidelines envision the international supplement trade unfolding. International trade rules permit a country to diverge from an international standard if it has a sound scientific basis to do so. It is possible that some countries China? supplements than is Codex.

The road out of Rome runs between the Palatine, the hill from which Romulus and Remus launched the Roman adventure, and Claudius' palace, overlooking the Circus Maximus. Authorities removed the final remains of 2005's Live Roma from Circus Maximus on Wednesday. FAO world headquarters sits at the bottom of the hill, cattycorner from Claudius¹ palace and the Roman Forum.

This was the center of the Roman Republic.