Codex: WHO/FAO Told Nutrient Risk Assessment Must Consider Benefits

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In a submission to the FAO/WHO nutrient risk assessment project, Dr. Robert Verkerk, Director of the Alliance for Natural Health charges that assessment of the possible risks of nutrient overdose must also consider the beneficial effects of nutrients. He says that risk assessments undertaken to date "are not based on a sufficiently rational scientific platform" and "will provide misleading information for policy decision-makers".

At stake is the continued availability of vitamin and mineral supplements for millions of consumers world wide who fear that the FAO's Codex Alimentarius guidelines may eventually establish dosage limits for such products that restrict their health choices. Limits would be based on scientific risk assessment but if the scientists do not consider all the data, including the benefits of nutrients and their immense value in achieving optimal health, the contemplated rules are likely to do more harm than good.

"There is a risk that key scientific data are ignored", says Verkerk in the ANH submission (download here), if the selection criteria are too rigid and exclude the wealth of experience with supplementation that has been gained in clinical nutrition, functional medicine and related disciplines. One of the points raised in the ANH submission was that the nutrient content in fruits and vegetables has been steadily declining since the introduction of 'modern' agricultural methods and that therefore, supplementation is increasingly the only way to "top up" needed nutrients, let alone strive for optimal health.

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Risk assessment one-sided - nutrients need a different approach

Currently, risk assessment is geared to the toxicological evaluation of chemical poisons and other contaminants, which really have no place in our food supply. Nutrients are different, argues Verkerk and several others, in their submissions to the FAO project, seem to share this concern:

Lisa Intemann, who pleads for low tolerance towards the chemical safety hazard posed by fluoride, echoes the ANH concerns when she points out the "essentially different nature of a non-Nutrient and Nutrient with respect to human physiology and risk management."

Michael-Anthony Seegers introduces a new concept when he says that "perhaps even more relevant to concerned sectors of society than a UL [upper level] is what I would call an OL or OPTIMUM LEVEL."

Gerd Stueckler goes even further. In a submission written in less than perfect but nevertheless perfectly understandable English, the German scientist perhaps best sums up the sentiments that are widely felt by consumers of supplements: The Codex legislative process and associated risk assessment work is seen as a threat to their health, an attempt to leave them without proper nutritional health support, rather than as a genuine effort to protect them. Some quotes from Stueckler's submission:

This is the first time in mankind's history that organizations like the FAO/WHO are trying to implement laws which will regulate and limit the access of the world's populations to nutrients and related substances. These laws would supersede all national laws of any country and would be enforced by the WTO. Any flaw within these laws would severely hamper any progress in the health and well being of the people worldwide. The resulting damage could easily become much more severe than the damage done to the people during all wars on this planet.

The application of risk assessment procedures for hazardous chemicals and pharmaceuticals can never be applied to nutrients. The human organism is perfectly adapted since millions of years to all molecules which are part of used natural food nutrients - contrary to the artificial molecules of chemicals like pesticides and pharmaceuticals. This can be easily seen in the light of several hundred thousand deaths per year caused by correctly prescribed pharmaceuticals compared to virtually no deaths caused by nutrients from food or food supplements.

So the risk lies mostly in the lack of sufficient nutrients. All this leads to a completely different risk assessment procedure which must also take into consideration the many scientific discoveries of major health benefits of some nutrients (Vitamins, Minerals, etc.) when taking much higher doses of them [than] the average modern food provides.

Until the before mentioned issues regarding quality of scientific evidence are not principally and extensively solved there is not the slightest excuse left for the WHO not to immediately cease this Codex process.

When the WHO continues anyway on this fast track I must conclude that the whole Codex Alimentarius endeavor is not about protecting the world's public health but that it is only about protecting the profits of pharmaceutical companies and the profits of the health industry in general and that the WHO is willing to support the enforcement of a genocide on a world wide scale.

Dr. John Hathcock of the Council for Responsible Nutrition (CRN) who has proposed some of the current risk assessment methods, points out a flaw that is expected to lead to restrictions of the availability of niacin - vitamin B 3 to just 35 milligrams:

Identification of an effect that qualifies as a “hazard” is a critical part of the UL risk assessment procedure. Effects may be undesirable but not qualify as a hazard. An undesirable effect may in be only a nuisance when it is expected, but may be considered a hazard if it occurs unexpectedly. Niacin (as nicotinic acid) provides an excellent example:

1. The vasodilative flushing reaction is undesirable but does not cause any known pathology. The EC SCF [European Community Scientific Committee on Foods] set its UL on the hypothetical possibility that vasodilation might cause positional hypotension and risk of falls, but did not cite any case in example. Notably, CRN (Hathcock 2004) has used the flushing effect to require a warning label at the level equal to the FNB UL [the US Food and Nutrition Board's Upper Level].

2. The data used by the FNB, SCF and EVM [the UK's Expert Group on Vitamins and Minerals] to derive UL values are of questionable relevance to foods or supplements. Those data were produced by giving bolus doses of free nicotinic acid to subjects with empty stomachs, thus maximizing the vasodilative potency of the nicotinic acid. The UL values derived from such data are apt to be unduly restrictive.

3. At much higher intakes than those that clearly cause flushing, nicotinic acid can cause liver and/or gastrointestinal pathology. Clinical trial data indicate a LOAEL [Lowest Observed Adverse Event Level] of 1,000 mg and a NOAEL [No Observed Adverse Event Level] of 500 mg for these effects. These effects obviously would qualify as hazards and therefore be appropriate endpoints for nicotinic acid risk assessment.

4. The flushing effect may be the appropriate basis for a UL for products without a warning label (such as conventional foods and most manufactured foods). On the other hand, products, such as supplements, that can carry a flush warning label could have a UL based on the liver/gastrointestinal effects.

CRN's Dr. Hathcock also criticizes the science used to justify calls for overly restrictive dosage limits on products containing vitamin B 6, some of them as low as 10 milligrams:

The differences in data selection and the uncertainties of extrapolation are well illustrated in the FNC, SCF and EVM risk assessment on pyridoxine (vitamin B-6). All risk assessments agreed that excessive intakes of pyridoxine can cause a sensory neuropathy that only slowly or perhaps incompletely recovers. The differences in evaluation of pyridoxine data are summarized below:

• FNB considered the long-term uses of high-dose pyridoxine in subjects who were monitored by physical neurology methods to be sufficient and most appropriate for the setting of the pyridoxine UL. In contrast, the FNB considered the survey data on Dalton and Dalton (1986) to be of such low scientific quality as to not be an appropriate basis for the UL.

• SCF recognized the limitation of the Dalton and Dalton data but nonetheless used it as the basis of the UL. The UL was calculated from the median adverse effect level and an uncertainty factor of 4.0.

• EVM considered all the human data to be of insufficient quality and therefore identified a UL (SUL in EVM terminology) from animal (dog) data through application of a composite uncertainty factor of 300 to the NOAEL. For pyridoxine, the EVM considered the high quality of the animal data and poor quality of the human data to warrant acceptance of the uncertainty of extrapolation between species...

A comment from the chemical industry in the person of Dr Klaus Kraemer of BASF, argues that regulation should be left to industry, citing the example of the GRAS [Generally Regarded As Safe] classification of food ingredients, which he says is working well in the U.S.:

The concept of “GRAS,” as found in the food additive definition (US Food Drug and Cosmetic Act, Section 201(s)), provides a touchstone for a discussion since this has worked effectively for decades and has broad support and credibility among the scientific and regulated industry communities.

Under a contract with the US FDA, the Food the Nutrition Board (FNB) of the National Academies of Science Institute of Medicine (IOM) initiated a project “Dietary Supplements: A Framework for Evaluating Safety”. In April 2004, the FNB published the framework for evaluating dietary supplement ingredients. The framework for evaluating the safety, outlines a science-based process for assessing supplement ingredients, even when data about a substance's safety in humans is scarce. The framework includes a methodology to review the available peer-reviewed literature with regard to the role of the dietary supplement ingredients in health, taking into consideration methods other expert bodies have used to categorize and review supplement safety and efficacy issues.

The use of any of these panels or variation of these could be an efficient means of providing the finest and most critical evaluation of the safety of new dietary ingredients for dietary peer-reviewed journals as critical reviews. GRAS determinations and supporting information would be submitted to the respective regulatory bodies as part of a revie