The Methods of Health Tyranny: Codex Alimentarius “Risk Assessment” of Vitamins And Nutritional Supplements

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Brandon Turbeville — Activist Post 

In the previous article I addressed the issue of the language of “risk assessment” techniques used to determine the dangers of consuming vitamin and mineral supplements as well as how this methodology would be used to classify nutrients as toxins. For the most part, I focused on the fact that “risk assessment” is clearly an inappropriate testing method to apply toward vitamins and minerals. This is because “risk assessment” is designed to be applied to substances that are known to be toxic for the purpose of establishing an upper safe levels of toxicity to them.

But there are other problems with the process of risk assessment as well. First, the current methodologies are based upon the assessment of entire groups of nutrients as opposed to the individual nutrients that make up the group. This method is called the nutrient group approach, a method which depends upon the lumping of many different forms of a nutrient into one category rather than testing each individual form separately as is done for toxic chemicals.[1]

An example would be assessing Vitamin B as a whole group. Assessing Vitamin B3, Vitamin B12, and Vitamin B6 as separate and individual nutrients is called the nutrient form approach and would be the more rational method to apply (even though risk assessment should not be used in the first place) because the alleged risks posed by these supplements are themselves dependent upon the form in which it occurs.

For instance, Vitamin C, in the form of ascorbic acid, has been known to cause loose bowels in some people who take it in very high doses. Yet, when taken as calcium ascorbate, this does not occur. Indeed, this is about the most severe side effect from a vitamin supplement that one can document. Yet under the risk assessment process using the method of the nutrient group approach, Vitamin C as a whole would be regulated based upon the “risks” associated with the ascorbic acid form of Vitamin C. Therefore, the ascorbic acid form of vitamin C would be the basis for the setting of the upper safe levels or the Maximum Upper Limits of Vitamin C.  This is because this particular method takes the most “toxic” form of the tested substance and uses it for the basis of its regulation.[2] In this case, the nutrient group is considered only as safe as its most dangerous form.  

Indeed, this is the method advocated by the FAO and WHO. In a joint FAO/WHO report published in 2005 entitled “A Model for Establishing Upper Levels of Intake for Nutrients and Related Substances,” reports of conclusions dealing with Vitamin C, Iron, and Zinc are all listed as the nutrient group and not the various forms in which they occur.[3] 

Clearly, there is a double standard within the FAO, WHO, and Codex regarding the safety testing of vitamin/mineral supplements and that of chemicals. As Paul Anthony Taylor points out, in the process used for risk assessment of toxins, pesticides, etc., each individual substance is analyzed as a “separate chemical entity.”[4] This is a recurring theme in the discussion of Codex and its guidelines for various forms of food substances and supplements and can be easily seen in its regulation requirements for GMO’s as well. While GMO products are allowed in the international food chain, nutrients are treated as dangerous substances. In this case, simply giving nutrients the same treatment as toxic chemicals would be an improvement over their current treatment.

A second problem with the risk assessment methodology is the fact that it completely ignores the positive health benefits of nutritional supplements and focuses only on their risks.  This is especially important because when a regulatory agency determines, as Codex and other agencies apparently have, that any risk, no matter how insignificant it is, may constitute an “unreasonable risk of illness or injury” it may therefore be banned. Unfortunately, this is actually provided for under the DSHEA law passed in the United States in 1994. This, however, is essentially what the risk assessment procedure is all about – assessing dangers not benefits.

Not surprisingly, most of the evidence such as observational and clinical data that demonstrates a positive effect is ignored. Instead, all we are left with is “peer-reviewed” studies of isolated nutrient forms that are so varied in terms of experimental design, dosages, and even the nutrient forms themselves that they are virtually non-comparable. Not only that, but the form of the vitamin being tested is often in a synthetic form as opposed to its natural state with very little concern given to the individuals’ nutritional requirements or current state of health. Even follow up times vary significantly. [5]  Paul Anthony Taylor explains this in his article “Nutrient Risk Assessment: What You’re Not Being Told,” when he writes:

In some areas of the world, such as the United States and the United Kingdom, supplemental nutrients have been in use for over half a century now. As a result, some doctors and practitioners have built up extensive databases containing carefully documented case histories of patients who have used high doses of vitamin and mineral supplements, safely and effectively, for many years. Similarly, research scientists have conducted numerous small-scale clinical trials that have produced impressive results providing clear evidence of the safety of high dose supplements in human beings.

Nevertheless, a serious flaw in the current regulatory approach to nutrient risk assessment is that some of the most valuable potential sources of positive scientific evidence regarding the use and safety of supplements, such as the types of observational and clinical data described above, are generally ignored. Instead, the sole source of evidence that is considered are peer-reviewed scientific studies of particular nutrient forms, which are often non-comparable owing to differing experimental designs, nutrient forms delivered, dosages given, and so on.

The net result of this is that the evidence-base for nutrient risk assessment tends to be skewed towards consideration of negative outcome studies that used a single vitamin or mineral – frequently in a synthetic rather than a naturally-occurring form – without full and proper consideration of the participants’ overall state of health or individual nutritional requirements. Moreover such studies are often non-comparable owing to differences in their follow-up periods; the fact that many have been conducted on diseased rather than healthy populations; and that many were started well after disease states had already been initiated. As a result, a process that may appear rational, objective and scientific to the lay person or even the regulator, is, we discover, actually flawed and deeply unscientific. [6]

The S.510 and Codex Alimentarius Link