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The Codex Alimentarius Committee
on Food Labelling in its recent meeting in Montreal, Canada,
heard a proposal of the Republic of South Africa, to re-think
its rules which prohibit food manufacturers saying or implying
that a food may aid in the prevention or cure of a disease.
Although various foods clearly do prevent and even cure
diseases, any claims for such effects are strictly limited to
pharmaceutical products registered as medicines.
The South African proposal to the labelling committee of Codex
points out this inconsistency and argues that the rules should
be revised; that it should be possible to inform people about
the health properties of foods by indicating on food labels
what is increasingly obvious from the results of scientific
studies.
Unfortunately the proposal of South Africa did not find
agreement in the Codex Committee. The representatives of other
Codex member countries did not believe that the
medical/pharmaceutical monopoly on cure and prevention could
or should be challenged.
Please take a moment to read the proposal and the responses it
received from the other members of the committee. If you do
not agree that the information about food and health should be
withheld from consumers, there IS something you can do:
Contact your country's
Codex Alimentarius representation
and ask them what their viewpoint is on food and prevention of
disease. Engage your health authorities in a discussion of
this subject. Try to find out whether they are willing to
concede that the maxim "let your food be your medicine" is as
relevant today as it was when Hippocrates coined it.
Read the South African proposal and the discussion in
Committee here:
REPUBLIC OF SOUTH AFRICA
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON FOOD LABELLING
Thirty-second Session
Montréal, Canada, 10-14 May 2004
OTHER BUSINESS AND FUTURE WORK
PROPOSAL FROM SOUTH AFRICA
CO-WRITTEN BY ANTOINETTE BOOYZEN & DR. ANTHONY REES
PRESENTED BY ANTOINETTE BOOYZEN
ORAL PRESENTATION ?
(12TH May 2004)
Thank you Madam Chair,
In searching for the truth, South Africa wishes to propose a
revision of the Codex General Guidelines on Claims (CAC/GL
1-1979) which was revised in 1991, and specifically point 3.4
that prohibits “Claims as to the suitability of a food for use
in the prevention, alleviation, treatment or cure of a
disease.”
Thirteen years have passed since the last revision of these
guidelines. In this time a huge body of scientific information
has become available to prove without dispute that point 3.4
is no longer sustainable or morally justifiable considering
Codex’s mandate that when setting forth a standard or
guideline, Codex Committees must base all decisions on
scientific evidence.
Scientific evidence now proves beyond a doubt that food and
nutrients can offer an alternative option in the prevention,
alleviation and cure of disease.
Nutritional ‘cures’ include classical deficiency diseases and
metabolic disorders. Taking into account the role of genetic
dispositions, environmental factors and pathogenic diseases,
the onset of most chronic diseases of lifestyle can be either
be prevented or alleviated by the use of optimal nutrition.
Madam Chair, In the title of the W.H.O document “W.H.O
Technical Report on Diet, Nutrition and the Prevention of
Chronic Diseases” (2003) the W.H.O also acknowledges the fact
that nutrition plays a role in the prevention of chronic
diseases. We must remember that the W.H.O is a parent body of
Codex Alimentarius.
In our written proposal before you, (CX-FL 04-11) we refer to
other science-based examples of evidence where nutrition
provides a safe and effective alternative option to
conventional medical intervention. We want to emphasize that
these examples represent only a small selection of balanced
scientific opinions contained in reputable, international,
peer-reviewed medical journals.
In this proposal we wish to emphasize that nutrients, as
essential facilitators in human physiology, rightfully belong
within the scope of Codex Alimentarius Committees such as the
CCFL and the CCNFSDU. We emphasize that Codex deals with food
and nutrition, despite the ‘perceived’ overlapping
characteristics of nutrients and medicines in terms of their
healing properties.
The principles of biochemistry and cellular physiology clearly
demonstrate the essential role of nutrients and food
constituents at optimal levels in maintaining and preserving
health, including the prevention, alleviation, treatment and
even cure of disease.
Continuing to allow clause 3.4 to exist in these guidelines in
this 21st century, denies consumers the right to take
responsibility for their own health. By not allowing for these
life-saving statements, South Africa truly believes that Codex
is indirectly misleading the public at large. For the majority
of nutritionally uneducated consumers, food labels may be
their only source of information in making an informed choice.
Nutrients act mainly as prophylaxis by assisting the body to
heal itself in supporting the mechanism of biochemical
homeostasis on the cellular level, while most medicines are
designed to address existing pathological conditions on a
symptomatic basis without affecting a sustainable, permanent
cure. Nutrients nourish and heal simultaneously - a
characteristic which is certainly not true for any medicine.
Madam Chair, if we consider the purpose of food fortification,
it is to prevent diseases such as mental retardation in the
case of Iodine deficiency, blindness in the case if Vitamin A
deficiency, and in the case of Folic Acid deficiency in Neural
Tube Defects etc.
According to the UNICEF document – A Global Progress Report of
2003 – vitamin and mineral deficiencies contribute to the
impairment of hundreds of millions of growing minds and the
lowering of national IQ’s. It means wholesale damage to immune
systems and the deaths of 1 million children per year, as well
as 250 000 serious birth defects annually. A simple cure in
the form of food fortification or nutritional supplementation
could have prevented these tragic diseases, yet Codex denies
these facts by allowing a non sustainable clause such as 3.4
referred to previously. We want to emphasize that these
solutions are nutritional solutions and NOT medical solutions.
In allowing this clause to remain in this Codex Guideline,
this committee evades its responsibility to people of this
planet, by censoring evidence-based scientific information of
the role of nutrition in prevention, alleviation, treatment
and cure of disease.
For several years now CCFL has worked on a document called
“Health Claims”. The principle that nutrition can prevent,
enhance, improve and in certain instances, cure illness, is
already embodied in the definitions for “Other function
claims” and “Reduction of disease risk claims”.
Taking into account these facts Madam Chair, the question this
committee must consider today is:
Are we fully prepared to acknowledge the role of optimum
nutrition in the prevention, alleviation, treatment and cure
of disease, and thereby acknowledge the Codex principle of
basing its standards and guidelines on science?
Thank you Madam Chair.
THE CONTINUED TRANSCRIPTION
CHAIR
Committee members, you have heard this proposal from South
Africa and wish ask committee members as to their opinion on
the proposal … um …. which in fact if it was fully supported
would mean that we would have to put a question to the
Commission as to whether we engage in new work on this
subject. That is the issue before you, and now I open the
floor.
Mexico please….
MEXICO
Thank you Madam Chair
I must say that this document was circulated with very little
fore notice for this meeting and further more, the version in
Spanish was done in with - lets just call it honestly a very
bad translation.
In the document some paragraphs remain in English and there
are a number of errors throughout the whole document. All of
this means that we could not consider it in great detail. In
our committee of the national level we can not give it a
favorable opinion at this stage. However we can say in that
general terms in Mexico, there is a great concern, because
consumers tend to stop taking their medication on the pretext
of taking in some foods and supplements, instead of their
medication.
This we believe would lead to serious public health problems.
The examples that we see in the document do not refer to
foods, but rather substances, …. which can help with the
treatment of certain diseases and illness.
But, these substances are dealt in Mexico as if they are
medications and not as foods. And therefore they have to
comply with the formalities required for the registration of
medicine.
So, even though we may recognize that some foods may have high
concentrations of some of these substances … when their use is
for therapeutic reason, it seems to us and it should be
promoted more as a medicine rather than as a food.
So in this sense, we are not in the position to support this
proposal for new work for this committee.
Thank you Madam Chair
CHAIR
Thank you Mexico, Ireland please.
IRELAND
Thank you Madam Chair.
I speak behalf of the member states of the EU.
This is certainly a fascinating paper … um … and I would like
to stress to South Africa that the severity of our response is
not meant to be unreflecting on the amount of work that we
feel has gone into this document, but the member states of the
European Union do not support the proposal for the revision of
3.4 of the Codex General Guidelines on Claims as requested of
South Africa.
Thank you.
CHAIR
Thank you, Australia please.
AUSTRALIA
Thank you Madam Chair
Australia recognizes that food has an important role to play
in chronic disease, but Australia does not support the
proposed amendments to paragraph 3.4 in the Code …. Codex
General Guidelines on Claims.
This paragraph is important generic delineator of claims
appropriate to foods and those which are appropriate to
medicines. Although the previously strong separation between
foods and medicines are fading through the developments of
Codex, such as the Health Claims Guidelines and the drafting
of the Vitamin and Mineral Food Supplement Guidelines, it is
important that we maintain a cautious approach.
These should be judged on a case-by-case basis, giving each
national jurisdiction sovereignty over its own food - medicine
interface.
Thank you.
CHAIR
Thank you Australia, New Zealand please.
NEW ZEALAND
I thank you Madam Chair.
New Zealand believes that if the Commission adopts the
Guidelines to Health and Nutrition Claims, that a review of
point 3.4 is necessary to provide consistency between the two
areas, however we would say that we are not supportive of any
claims which describe the role of foods and nutrients in the
cure of any diseases.
Thank you.
CHAIR
Thank you New Zealand, Japan please.
JAPAN
Thank you Madam Chair.
We are of the opinion any substance which exclusively and
specifically targets a disease or a medical condition, or to
treat, is not a food but a pharmaceutical product.
Therefore for we believe that the proposal is outside of the
mandate of Codex, and that the work should not be undertaken.
Thank you very much.
CHAIR
Thank you Japan, the US …. United States please.
USA
Thank you Madam Chair.
We want to join with the other delegations that oppose work on
this item.
Thank you.
CHAIR
Thank you. Brazil please.
BRAZIL
Thank you Madam Chair.
Brazil does not support the review of this item, on the
grounds that the Guidelines for Use of Health and Nutrition
Claims … only allows claims that make reference to risk
reduction of disease.
Thank you.
CHAIR
Thank you Brazil, Argentina please.
ARGENTINA
We are not able to support this point of view, basically
because my country has many dietary supplements that are more
in the pharmaceutical area than the food stuffs … and are
taken or ingested as homoeopathic medication.
CHAIR
Thank you Argentina,
Well South Africa, thank you very much for preparing the paper
and putting this issue before the Committee.
But, one last intervention … the Council for Responsible
Nutrition please.
THE COUNCIL FOR RESPONSIBLE NUTRITION (CRN)
Thank you Madam Chair.
Um… At the November 2003 meeting of the Codex Committee for
Nutrition and Foods for Special Dietary Uses, CRN described in
a conference room document that nutrient disease relationships
fall into three primary categories.
One, is the classic deficiency diseases. In these, nutrients
do indeed prevent, treat and can cure disease.
But there is a much larger category …. or much larger number
of diseases that are what I have termed Nutrient Responsive
Diseases. These are certain chronic diseases that have their
incidence or risk modified by dietary patterns and nutrient
intakes. These certainly include obesity, hypertension,
certain cancers, cardiovascular disease, and adult-onset
diabetes.
And then there is a third category called Nutrients Used as
Drugs. For these Nicotinic Acid is a prime example. It can be
used as an effective drug in the treatment of hyperlipidemia,
but dosages that make it unsafe for use casually as a
nutrient.
It must be recognized that risk reduction for the individual,
as allowed in health claims in several countries and in now
the proposed documents being forwarded by this committee …
these risk reductions in a population will lead to prevention
of disease in a sizable number of individuals. We simply don’t
know which individuals those are.
Thus, Codex should not categorically prohibit the term
‘prevent’ in Health Claims unless it is used as a promise to
the individual.
It’s noteworthy in this context senior officials at the U.S.
Food and Drug Administration … in the General Council Office
for example … are using the word ‘prevent’ in exactly this
context … in their public speeches, although I recognize that
this has not yet made it way into U.S. regulations.
These factors lead CRN to support the concept of general
principle that the Codex General Guidelines on Claims should
be revised to accommodate the updated science.
Thank you Madam Chair.
CHAIR
Thank you for that intervention.
The International Alliance of Dietary Food Supplement
Associations please.
IADSA
Thank you madam chair.
The International Alliance of Dietary Food Supplement
Associations would like to be associated comments expressed by
CRN.
CHAIR
Thank you.
Well South Africa, I will come back to my summary on this.
I think Committee members appreciate that you put considerable
work into preparing this brief, putting it before the
Committee for perusal and comment, however there is clearly no
support for your proposal, and therefore we will not be
discussing this further.
Thank you once again for bringing this issue up … you have
heard the opinion of Committee members who have spoken on
this.
The written proposal of South Africa:
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON FOOD LABELLING
Thirty-second Session
Montréal, Canada, 10 – 14 May 2004
OTHER BUSINESS AND FUTURE WORK
PROPOSAL FROM SOUTH AFRICA
South Africa wishes to propose a revision of the Codex General
Guidelines on Claims (CAC/GL 1-1979 (Rev. 1-1991), and
specifically point 3.4 that prohibits "Claims as to the
suitability of a food for use in the prevention, alleviation,
treatment or cure of a disease, disorder, or particular
physiological condition unless they are:
a) in accordance with the provisions of Codex standards or
guidelines for foods under jurisdiction of the Committee on
Foods for Special Dietary Uses and follow the principles set
forth in these guidelines. or
b) in the absence of an applicable Codex standard or
guideline, permitted under the laws of the country in which
the food is distributed."
Thirteen years have passed since the last revision and a huge
body of scientific information is now available to prove that
the above-mentioned point 3.4 is no longer sustainable
considering Codex’s mandate that when setting forth a standard
or guideline Codex Committees must base all decisions on
scientific evidence. Scientific evidence now proves beyond a
doubt that food and nutrients can offer an alternative option
in the treatment of disease, can prevent disease and in the
case of classical deficiency diseases and metabolic disorders,
can cure disease. A selection of abstracts totaling 1523
references (971 pages) from internationally reputable
scientific peer-reviewed medical journals is available
electronically upon request as substantiation. This
information demonstrates conclusively that nutrients can be
used for the prevention/treatment of the following diseases or
medical conditions:
- Asthma
- Arthritis
- Adrenoleukodistrophy and other metabolic disorders such as
maple syrup urine disease, phenylketonuria etc.
- Hypertension
- Osteoporosis
- Migraine
- Artherosclerosis
- Cholesterol reduction
- Constipation
- Bacterial infections
- Cardiac Arrythmias
- Acne
- Allergies
- Alzheimers disease
- Anxiety and stress
- Attention deficit Hyperactivity Disorder
- Multiple sclerosis
- Epilepsy
- Breast cancer
- Thyroid deficiency
- Parkinson’s Disease
- HIV/AIDS
- Glucoma
- Influenza virus
- Diabetes Mellitus
- Depression etc.; and
- II the classical nutrient deficiency diseases such as
scurvy, beri-beri, pellagra, ricketts, kwasiorkor etc.
Nutrients act mainly as prophylaxis, while medicines are
designed to address existing pathological conditions.
Nutrients nourish and heal simultaneously - a characteristic
which is certainly not true for any medicine. A short summary
of the nutrients that are implicated in the treatment of the
above-mentioned diseases, excluding the well- documented
classical nutrient deficiency diseases and metabolic disorders
is attached.
At International level (Codex Alimentarius) nutrients are
acknowledged as a food and not a medicine, notwithstanding
their overlapping properties in terms of prevention and
treatment of diseases. At the recent CCNFSDU meeting
(25thSession), when the agenda item on Proposed Draft
Guidelines for Vitamin and Mineral Supplements was discussed,
South Africa proposed new wording in the preamble because they
are convinced of the healing properties of nutrients: "Most
people who have access to a balanced diet can usually obtain
all the nutrients they require from their normal diet to
prevent deficiencies. Because foods contain many substances
that promote health and prevent chronic diseases, people
should therefore be encouraged to select a healthy diet and
supplement this diet with those nutrients for which the intake
from the diet is insufficient to meet the requirements
necessary for the prevention of chronic diseases and/or for
the promotion of health beyond the demands of preventing
micronutrient deficiencies."
In the title of the WHO document "WHO Technical Report on
Diet, Nutrition and the Prevention of Chronic Diseases" (2003)
the WHO also acknowledges the fact that nutrition plays a role
in the prevention of chronic diseases. It is therefore the
opinion of South African that inconsistencies exist within
Codex because CCNFSDU objects to
the inclusion of the words "prevention of chronic diseases" in
a Codex Guideline and Standard. The report (Alinorm 04/27/26)
reads: "The CCNFSDU Committee noted the proposal of the
Delegation of South Africa to amend the Preamble to highlight
the role of vitamins and minerals in the prevention of Chronic
diseases. The Committee however noted that claims related to
the prevention of disease were prohibited according to the
General Guidelines on Claims". It is difficult to understand
how in a Nutrition Committee such as the CCNFDSU, nutrition
can be considered so inferior to medicine in keeping people
healthy, despite the fact that there is overwhelming evidence
in reputable scientific literature proving that nutrition can
prevent, enhance, improve and in certain instances cure
illness.
For several years now CCFL has worked on a document called
"Health Claims". The principle that nutrition can prevent,
enhance, improve and in certain instances cure illness, is
already embodied in the definitions for "Other function
claims" and "Reduction of disease risk claims".
Other function claims means "These claims concern specific
beneficial effects of the consumption foods or their
constituents, in the context of the total diet on normal
functions or biological activities of the body. Such claims
relate to a positive contribution to health or to the
improvement of a function or to modifying or preserving
health.
"Reduction of disease risk claims means "Claims relating the
consumption of a food or food constituent, in the context of
the total diet to the reduced risk of developing a disease."
As a compromise the following amendments are proposed for the
above-mentioned point 3.4, although it is a false assumption
that medicines can truly cure disease. In most cases the role
of medicine in chronic disease is palliative and seeks to keep
symptoms under control (e.g., asthma, hypertension, diabetes
etc.) while often being unable to bring about permanent
healing.
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