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Dr. Rath Health Foundation

Nutrient Risk Assessment:

What You’re Not Being Told
By Paul Anthony Taylor
January 2007 (Revised August 2007) - Pro-pharmaceutical and anti-health
freedom forces have made significant strides in recent years towards their
ultimate aim of removing all higher-dose, innovative and effective nutritional
supplements from the global marketplace. With the passing of the European
Union’s Food Supplements Directive in 2002, for example, and the adoption
by the Codex Alimentarius Commission of its global Guidelines for Vitamin
and Mineral Food Supplements in 2005, the stage became potentially set for
stringent restrictions on the levels of nutrients contained in supplements to
become enforceable on a global scale over the next few years.
The pro-pharmaceutical and anti-health freedom forces are trying to disguise
this threat, however, by claiming that the upper safe levels for each nutrient
will be calculated scientifically, via a process called “scientific risk
assessment”. In reality, however, most current methodologies for assessing
the supposed “risk” of consuming nutritional supplements are anything but
scientific, and are actually deeply flawed.
Moreover, and as this article will show, unless these flaws are corrected, the
eventual outcome, for many nutrients, could well be the global enforcement
of maximum levels in supplements that are little different to the meagre
government recommended daily allowances (RDAs). Should this happen, of
course, the ultimate beneficiary would be the pharmaceutical industry and its
“business with disease”.

The nutrient group approach versus the nutrient form

approach
Arguably the most serious problem with most current nutrient risk assessment
methodologies is that they are based upon the assessment of entire nutrient groups (e.g.
vitamin D, vitamin E, calcium, zinc or iron), as opposed to individual nutrient forms (egg
vitamin D3, gamma-tocopherol, calcium hydroxyapatite, zinc sulphate or iron bisglycinate).
Why is this important? Because, in short, the supposed “risks” from consuming a particular
vitamin or a mineral are highly dependent upon the chemical form in which it is presented.
For example, ferrous sulphate, commonly prescribed by medical doctors to treat anaemia,
is generally recognized as the most toxic form of iron, and can potentially cause a number of
unpleasant side effects, including gastro-intestinal discomfort and nausea. However, iron
bisglycinate, the form widely recommended by clinical nutritionists and nutritional
therapists is a far gentler form of iron, and does not share the unpleasant the side effects of
its relatively more toxic cousin.
Similarly, magnesium hydroxide can cause diarrhoea in some people, whilst other forms of
this mineral, such as magnesium gluconate, are less likely to cause this problem.
Likewise, vitamin C, when taken as ascorbic acid, is well-known for its potential to cause
looseness of the bowels when taken in very high doses. However, this side-effect does not
occur when vitamin C is taken as calcium ascorbate.
Nevertheless, the risk assessment methodology advocated by the World Health
Organization (WHO) and the Food and Agriculture Organization of the United Nations
(FAO), in a joint report, published in 2005, recommends the setting of one single upper
safe level for all forms of iron, one single upper safe level for all forms of magnesium, one
single upper safe level for all forms of vitamin C, and so on. With this approach, therefore,
the upper safe level for each nutrient source is essentially determined by the toxicity profile

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The Dr. Rath Health Foundation | Responsibility for a healthy world http://www4.dr-rath-foundation.org/features/risk_assessment.html

of that member of a given nutrient group shown to be the most toxic in the published,
peer-reviewed scientific literature. In other words, the upper safe level for ferrous sulphate
will also be applied to iron bisglycinate, the upper safe level for magnesium hydroxide will
also be applied to magnesium gluconate, the upper safe level for ascorbic acid will also be
applied to calcium ascorbate, and so on.
This “nutrient group” approach is convenient for the regulator since only one risk
assessment needs to be conducted for each nutrient group. However, it very unfairly
discriminates against those nutrients that are not only safer, but are usually both more
beneficial and popular with consumers of supplements. This approach to risk assessment is
scientifically irrational, and, if utilised by national regulatory agencies, would ultimately
prevent consumer access to safe and beneficial levels of a wide range of nutrients.
A more scientifically rational methodology for nutrient risk assessment, therefore, would be
to treat each individual nutrient form (e.g. ferrous sulphate, iron bisglycinate, magnesium
hydroxide, magnesium gluconate, ascorbic acid, calcium ascorbate, etc) as an individual
chemical entity, and to set a separate upper safe level for each. This is what is termed a
“nutrient form” approach, and is essentially the same approach that risk assessment
scientists already take when examining toxins, such as pesticides, herbicides and so on,
where each individual substance is treated as a separate chemical entity.
Worryingly, therefore, the nutrient group approach is the one that currently seems most
likely to become adopted by the European Union for setting the upper safe levels for its
Food Supplements Directive, and by the Codex Alimentarius Commission to set the upper
safe levels for its global Guidelines for Vitamin and Mineral Food supplements. As such,
and as we shall discover, this approach could ultimately lead to the global enforcement of
‘maximum permitted levels’ (MPLs) for supplemental nutrients that are little different to
the meagre government recommended daily allowances (RDAs).

The need to consider nutrient benefits

An additional problem with the nutrient group approach is that it ignores the health
benefits of nutrients, and concentrates solely upon the assessment of their supposed risks.
Disconcertingly, despite the obvious flaws and bias of this approach, the United States
(U.S.) judiciary is nonetheless showing signs that it might give it the backing of law.
For example, an August 2006 ruling by a three-judge panel of the 10th U.S. Circuit Court of
Appeals overturned an April 2005 ruling by the District Court of Utah that the US Food
and Drug Administration ( FDA) was incorrect in using risk-benefit analysis to support its
ban of the herb ephedra . This Appeals Court ruling was highly significant, because, when
conducting its analysis of ephedra, the FDA had refused to acknowledge that the herb had
any benefits.
As a result, if, in future, the FDA decides, when conducting a risk-benefit analysis of a
nutrient, that its benefit is non-significant, then any level of risk could now seemingly
qualify as "unreasonable risk of illness or injury", as provided for under section 4 of the
Dietary Supplement Health and Education Act (DSHEA), the law under which supplements
are regulated in the U.S.
In other words, if the FDA decides, for instance, that there is no benefit to be had in
consuming supplements containing vitamin C at levels above the U.S. recommended daily
amount (RDA) - currently set at a mere 7 5 mg/day for females and 90 mg/day for males -
then the fact that vitamin C, in its ascorbic acid form, can cause diarrhoea above tolerance
levels could potentially trigger an "unreasonable risk of illness or injury" classification and
subsequent restrictions upon its sale.
As such, given that many of the health benefits attributed to nutritional supplements
effectively put them in the area of what is currently defined as drug use (i.e. they prevent,
reduce the risk of, or even treat diseases), the implication is that the FDA could, in future,
simply decide that such benefits do not apply to products regulated as supplements, and
assign the benefit portion of any risk-benefit analysis for nutrients to zero. By establishing
this precedent, and ruling in favor of this methodology, the 10 th U.S. Circuit Court of
Appeals would therefore seem to have tipped the U.S. regulatory scales significantly in the
FDA’s favor.
Clearly, therefore, the continued ignoring by national regulatory agencies of the health
benefits of consuming above-RDA levels of supplemental nutrients is now a serious threat
to their future availability.

The need to consider all of the evidence

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

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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.

Upper safe levels versus maximum permitted levels

As we have seen, the risk assessment methodologies that seem most likely to be used to
calculate the upper safe levels for nutrients contain some serious flaws. However, what is
not commonly understood is that these levels, once calculated via the nutrient group
approach outlined above, will then be ‘risk managed’ downwards even further by
subtracting from them the highest amounts - as determined from national dietary surveys -
that we are supposedly already getting in our diets from conventional foods, beverages and
drinking water. The Codex Guidelines for Vitamin and Mineral Food Supplements and the
European Union’s Food Supplements Directive, for example, both require that this
procedure should be utilised when setting the maximum permitted levels in supplements.
To illustrate this, if the upper safe level for vitamin B6 is calculated to be 10mg, as
recommended by the UK’s Expert Group on Vitamins and Minerals, and the average daily
intake of vitamin B6 from food is calculated to be 2.9mg, as was stated to be the case for
men in the UK’s National Diet & Nutrition Survey in 2003, then the ‘maximum permitted
level’ of vitamin B6 in supplements could potentially be set by regulators at a mere 7.1mg.
The first organization in the world to carry out vitamin and mineral risk assessment and
management studies according to these procedures was the German Federal Institute for
Risk Assessment (BfR). The Institute’s studies were led by a team of scientists including Dr.
Rolf Grossklaus, who, as well as being the Institute's Director, is also the Chairman of the
Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). (The
CCNFSDU was the Codex committee that drafted the Guidelines for Vitamin and Mineral
Food Supplements ). Published in January 2005, the BfR recommendations for the
maximum levels in vitamin and mineral supplements are as follows:

Vitamin A 400 mcg

Beta carotene 2mg
Vitamin B1 4 mg
Vitamin B2 4.5 mg
Niacin (B3) 17 mg (but nicotinic acid not permitted)
Pantothenic Acid (B5) 18 mg
Vitamin B6 5.4 mg
Folic Acid 400 mcg
Vitamin B12 3-9 mcg
Biotin 180 mg
Vitamin C 225 mg
Vitamin D 5 mcg
Vitamin E 15 mg
Vitamin K 80 mcg
Calcium 500 mg
Chloride 0 mg (not permitted)
Chromium 60 mcg
Copper 0 mg (not permitted)
Fluoride 0 mg (not permitted)
Iodine 100 mg
Iron 0 mg (not permitted)

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Magnesium 250 mg (where appropriate broken down into 2 single doses)

Manganese 0 mg (not permitted)
Molybdenum 80 mcg
Potassium 500mg
Phosphorus 250 mg
Selenium 25-30 mcg
Sodium 0 mg (not permitted)
Zinc 2.25 mg

As can be seen, despite being calculated using so-called "scientific risk assessment",
combined with a rationalized risk management step to convert the 'upper safe levels' to
'maximum levels' (the regulatory end-point), in many cases these numbers correspond
closely to RDA-type values. Worse still, however, some nutrients would only be permitted
at lower than RDA levels, whilst others – such as copper, iron and manganese – would not
be permitted at all.
Further evidence that the use of nutrient group based “scientific risk assessment”
methodologies could contribute to the setting of unacceptably low maximum permitted
levels subsequently emerged in June 2006, when the European Commission issued a
Discussion Paper on the setting of maximum and minimum amounts for vitamins and
minerals in foodstuffs. The Annex of the Paper included five examples of existing nutrient
risk assessment models, all but one of which would be virtually guaranteed to lead to the
setting of highly restrictive maximum permitted levels if adopted on a European-wide basis.
Moreover, even the one relatively less restrictive example, a risk management model
designed by the European Responsible Nutrition Alliance (ERNA) and the European
Federation of Associations of Health Product Manufacturers (EHPM), leaves much to be
desired, in that it proposes maximum supplement levels of 2mg for manganese, 10-15mg
for zinc and 4.8-7mg for beta-carotene. Putting this beta-carotene figure into perspective,
for example, a good-sized portion of cooked carrots will deliver a highly bioavailable 50mg
of the nutrient, around 10 times the potential maximum supplement level!

One man’s risk is another man’s benefit

Another major problem with most current nutrient risk assessment methodologies is that
they totally ignore the fact that what might be a minor and inconsequential risk to one
person may, in contrast, be profoundly beneficial to another.
For example, whilst some nutrient forms, such as magnesium hydroxide and the ascorbic
acid form of vitamin C, can cause looseness of the bowels when taken in high doses, to
somebody suffering from persistent constipation, the ability of the aforesaid nutrient forms
to loosen the bowels would not be seen as a risk, but as a highly desirable benefit.
As such, it can be seen that because people are genetically and biochemically different to
each other, restricting nutrient levels in supplements to near-RDA amounts will ultimately
increase the risks to people’s health by limiting their treatment options to the infinitely
more dangerous synthetic-drug medicines produced by the pharmaceutical industry.
Furthermore, an individual’s nutrient requirement varies greatly over time. A person
suffering from a viral infection, for example, will typically find that his or her bowel
tolerance for vitamin C will increase more than 10-fold; such is the higher requirement of
the body for this nutrient while the immune system is fighting an infection.

Conclusion
The setting of globally-enforced maximum permitted levels for nutrients in supplements is
arguably the most crucial of all the various threats currently facing the future of natural
therapies and health freedom.
Whilst the pro-pharmaceutical and anti-health freedom forces are trying to disguise these
threats, by claiming that the upper safe levels for each nutrient will be calculated
scientifically, via a process called “scientific risk assessment”, the reality is that this
methodology, combined with the risk management step which determines maximum
amounts in supplements, may still lead to legal enforcement of maximum permitted levels
that are little better than the RDAs.
In Europe, in particular, naturopaths have long feared that the setting of maximum
permitted levels for nutrients in supplements will not be carried out according to rational
science, but through a process of political horse-trading. The European Union’s Food
Supplements Directive, for example, specifically states that the adoption of the specific
values for maximum levels for vitamins and minerals in food supplements should be
entrusted to the European Commission - the unelected and unaccountable executive body
responsible for proposing and implementing European legislation.
Perhaps not surprisingly, therefore, s easoned observers are already beginning to suggest

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that the consumer outrage that occurred prior to the passing of the European Union’s Food
Supplements Directive in 2002 and the Codex Guidelines for Vitamin and Mineral Food
Supplements in 2005 may yet pale in comparison to the protests expected when the
maximum permitted levels are eventually announced, probably in 2008.
So, protest to your political leaders and elected officials, now, while you still have time,
telling them that your vote at the next election depends upon their response to this issue.
Ring them, write to them, visit their offices, and become a persistent irritation to them. If
you’re not prepared to do this then you shouldn’t expect to have access to higher-dose
supplements in the future.
And don’t, whatever you do, leave it up to other people to fight this batt le for you - because
those other people, may, in turn, be leaving it up to you!

Paul Anthony Taylor would like to thank Dr. Robert Verkek,

Executive & Scientific Director of the Alliance for Natural Health,
for his invaluable scientific input into the writing of this article.

© 2008 by Dr. Rath Health Foundation | www.Dr-Rath-Foundation.org

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