Codex Draft Guidelines: a "Translation"
Dan Milosevich, C.N. July, 2000
Over the last 25 years, I have talked to thousands of nutritional supplement consumers. Together we have gained important information about nutrition and health, and we continue to learn - just last month I learned that the well-known function of vitamin D in facilitating the proper utilization of calcium may be much more crucial than we suspected, and that at current recommended levels, there may be a widespread state of chronic, subclinical vitamin D deficiency that adversely affects a vast array of bodily functions. (See article on Vitamin D.) It's even possible that a cheap form of calcium, say from dolomite or bone meal, and sufficient vitamin D, may offer more benefits than the newer high-tech super-chelated calciums - which, after all, aren't too shabby themselves. It will be interesting to see.
But nobody I know is concerned that there is some looming danger in these calciums - or in other products. These are not drugs, and there are significant differences between nutritional supplements and drugs. The Upper Safe Level Risk Assessment that is so necessary for drugs - a way of finding out at what level these substances so strange to the body pose a danger to life and limb - is not easily transferred to supplements. The rare problems that occur with supplements are well-known and usually reversible by simply stopping.
This is borne out by the history of supplement use in the last thirty years in the United States, during which tens of millions of people have taken supplements with a insignificant number of problems and virtually no deaths. Yet, In the name of protecting the health of consumers and their dogs, the CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES issued the following PROPOSED DRAFT GUIDELINES FOR VITAMIN AND MINERAL SUPPLEMENTS for their Twenty-second Session, that was just held at the Federal Institute for Health Protection of Consumers and Veterinary Medicine, Berlin, Germany, 19 – 23 June 2000. (This is available online at ftp://ftp.fao.org/codex/ccnfsdu22/nf00_05e.pdf - requires Acrobat Reader.)
If there isn't really a problem of health protection here, what is the purpose of trying to implement these guidelines? What problem do they fix, and for whom? A hint: it isn't for you or me! Sure, differences of opinion about how to make and take supplements will exist, but why do we need an international agreement on the ONE RIGHT WAY? The following literal translation from Codex Speak into Plain English may offer some answers.
What they wrote:
PROPOSED DRAFT GUIDELINES FOR VITAMIN AND MINERAL SUPPLEMENTS 2
PREAMBLE
Most people who have access to a balanced diet should usually obtain all
the nutrients they require from their normal diet. People should therefore
be encouraged to select such a balanced diet from food before considering
any dietary supplement.
Translation:
Although we have set ourselves up as an international body to regulate
the manufacture and sale of vitamin and mineral supplements, we have no
first-hand experience and no actual knowledge about the proper use of
supplements, so we want to state at the get-go that we don't believe
in them. You, the consumers of the world, need to be protected
from yourselves, and from spending one thin dime on that garbage, all
of which is already in your food, no matter how much you eat or what you
eat, as our expert medical shills have told you countless times.
However, when we are able to pass these guidelines, then your doctors
will write you a prescription for supplements and those supplements will be all good. (But I'm getting ahead of myself...)
What they wrote:
1. SCOPE
These guidelines apply to vitamin and mineral supplements intended for
use in supplementing the daily diet with vitamins and/or minerals. It
is left to national regulations to decide whether vitamin and mineral
supplements are drugs or foods. These Guidelines do not apply in those
jurisdictions where products defined in 2.1 are regulated as drugs.
2. DEFINITIONS
2.1 Vitamin and mineral supplements for the purpose of these guidelines
derive their nutritional relevance primarily from the minerals and/or
vitamins they contain. They can be marketed in capsules, tablets, powders,
liquids etc. [They serve to supplement the daily diet with these nutrients
in cases when the intake from food is insufficient or where the consumers
consider their diet requires supplementation.]
2.2 For the purpose of the Guidelines, vitamin and mineral supplements
are considered as foods (as defined in the Procedural Manual of the Codex
Alimentarius, 9th edition, 1995, p.59), if not otherwise stated in national
regulations.
2.3 Vitamin and mineral supplements can serve special nutritional purposes,
if their composition and contents of minerals and vitamins corresponds
to particular dietary requirements that result from certain physical or
physiological conditions and they are marketed for that particular purpose.
Translation:
Scope and Definition
These guidelines apply to vitamin and mineral supplements in countries
where you can, as of right now, freely buy them in Health Food stores
and consume them as you see fit, countries such as the United States.
They do not apply in countries where you first need to go to a doctor,
obtain a prescription, and then go to a licensed pharmacist and pay 5
to 20 times as much for them; in other words, these don't apply in countries
where supplements are already safely classified as drugs.
We're talking about all those capsules, tablets, powders, liquids, etc. that silly consumers insist on taking, in those countries where such concoctions are not yet classified as drugs. They may be marketed for special nutritional purposes, until such time as we are able to reclassify all such purposes as disease states and therefore the supplements as drugs.
What they wrote:
3. COMPOSITION
3.1 SELECTION OF VITAMINS AND MINERALS
3.1.1 Vitamin and mineral supplements shall contain vitamins/provitamins
and only minerals in conjunction with the relevant Codex standards whose
indispensability for human beings has been proven by scientific data [up
to a level considered safe as determined by risk analysis] [and which
are covered by recommendations for the daily intake or estimated values
for safe and adequate intake established by recognized scientific authorities].
3.1.2 The selection of admissible nutrient compounds may be based on nutrient
criteria of the FAO/WHO or Pharmacopoeias and national legislation.
3.1.3 The use of supplements of individual vitamins and minerals can be
[limited] for reasons of health protection and consumer safety, taking
into account regional or national peculiarities concerning the supply
situation of the population.
3.1.4 Vitamin and mineral supplements may contain all vitamins and minerals
that comply with the criteria in 3.1.1, a single nutrient or an appropriate
combination of nutrients. [The suitability of a single nutrient or a combination
of several nutrients in a vitamin and mineral supplement for the special
nutritional purpose for which it is marketed should be proven by scientific
data.]
3.2 CONTENTS OF VITAMINS AND MINERALS
3.2.1 The minimum level of each nutrient contained in a vitamin and mineral
supplement should be [15%] of the recommended daily intake or the estimated
safe and adequate daily intake.
3.2.2 [The maximum level of each nutrient contained in a vitamin and mineral
supplement should not exceed [100%] of the recommended daily intake or
the estimated safe and adequate intake per daily dose.] [Alternatively
for 3.2.1 and 3.2.2, vitamin and mineral supplements should contain nutritionally
relevant nutrient levels. The daily dose shall not exceed the physiological
quantity. These dosages shall remain below the dose range that produces
pharmacological effects.] or [3.2.1 Supplements may contain vitamins and
minerals up to a level that is considered safe on the basis of risk assessment
considerations, as determined by appropriate risk assessment methodology,
taking into account all sources of nutrients in the diet.]
3.2.3 For vitamins and minerals with a narrow safety margin between the
recommended daily intake and the adverse effect level, difference maximum
limits for the daily dose may be established at the national level.
Translation:
Composition
Vitamin and mineral supplements shall contain only the substances we officially
allow, and one way or the other, only at levels established by "recognized
scientific authorities." Since we'll be doing the recognizing,
that pretty much means levels established by ... us.
On the other hand, we can limit the use of vitamins and minerals at any time in the name of "health protection and consumer safety."
If you decide to market a vitamin or mineral supplement anyway - we hope you're getting the idea not to - you must not say anything about it's use that can't be proven by information only we can authorize. Get it?
As to how much of any nutrient can be in a product, we will come up with some way of saying that no supplement can contain any amount of a nutrient that might possibly give a result exceeding that of staving off stark deficiency disease.
What they wrote:
4. FOOD ADDITIVES
The additives authorized by the Joint FAO/WHO Expert Committee on Food
Additives (JECFA) are permissible, provided they are necessary for technological
reasons and do not exceed the equivalent of their acceptable daily intakes
(ADI).
Translation:
Food Additives
Feel free to throw these in, but only if they don't confer any health
benefits. They may only help in the production and packaging and
marketing of the pills. You may only use the additives we ourselves
have authorized already.
What they wrote:
5. CONTAMINANTS
The product shall be prepared with special care under good manufacturing
practices and shall be free of pesticides and other contaminants to the
maximum extent possible.
Translation:
Contaminants
Contaminants are not good, but since 90% of the non-governmental members
of Codex represent the international corporations that make these chemical
contaminants, we propose no specific "risk" standards for these;
just reduce them "to the max".
What they wrote:
6. HYGIENE
6.1 To the extent possible in good manufacturing practice, the product
shall be free from objectionable matter.
6.2 When tested by appropriate methods of sampling and examination, the
product:
(a) shall be free from pathogenic microorganisms;
(b) shall not contain any substances originating from microorganisms in
amounts which may represent a hazard to health; and
(c) shall not contain any other poisonous or deleterious substances in
amounts which may represent a hazard to health.
Translation:
Hygiene
Keep it clean, especially from those nasty bugs. As to hazardous
chemicals, we name no names, but definitely keep them below levels that
might trigger a real public health scare, or you'll blow the whole
game.
What they wrote:
7. PACKAGING
7.1 The product shall be packed in containers which will safeguard the
hygienic and other qualities of the food.
7.2 The containers, including packaging material, shall be made only of
substances which are safe and suitable for their intended use. Where the
Codex Alimentarius Commission has established a standard for any such
substance used as packaging material, that standard shall apply.
7.3 Vitamin and mineral supplements should be distributed in child-resistant
packagings, if necessary.
Translation:
Packaging
Use the Codex-Approved packaging standards. Even though the Health
Food Industry has long ago adopted child-resistant packaging for iron
supplements (and before drugstore supplements did), we remind you anyway.
What they wrote:
8. LABELING
8.1 Dietary supplements are labeled according to the Codex Standard for
the Labeling of Prepackaged Foods (Codex-Stan 1-1985) as well as according
to the General Guidelines on Claims (CAC/GL 1-1979), the Guidelines on
Nutrition Labeling (CAC/GL 2-1985).
8.2 The name of the product shall be "vitamin and mineral supplement"
or "dietary mineral/vitamin preparation to supplement the diet with
...", with an indication of the nutrients contained therein or "
vitamin and mineral supplement in cases of ...", with an indication
of the special nutritional purposes for products that meet the criteria
of 2.2 and 3.1.4.
8.3 The label must indicate the biologically active part of all vitamins
and minerals in units of weight per product unit and in the case of liquids
per recommended dose unit. Additionally, the percentage of the [recommended
daily intake] of the vitamin or mineral that is covered by the consumption
of the recommended daily dose of the product must be indicated.
8.4 The label must indicate the recommendations on how to take the product
(quantity, frequency, special conditions).
8.5 The label must contain a warning statement [if the product contains
a significant amount of a nutrient with respect to the toxicity level.]
Translation:
Labeling
No fancy names! Who do you think you are, drug companies?
All products shall be "vitamin and mineral supplement" (it really
does say this!) Include recommendations of how to take this product
(even though you must not actually say on the label what benefit the consumer
might gain by taking it), and always use warning statements about the
little-known toxicity levels of nutrients, which we will soon "prove".
These statements have not been evaluated by the Food and Drug Administration. The products listed in this newsletter are not intended to diagnose, treat, cure, or prevent any disease. Consult with your physician before taking any of these products.
