August 8, 2002 - Bill Sardi Letter.

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Knowledge of Health, Inc.

457 West Allen Avenue #117 San Dimas, California 91773

Phone: 909 596-9507 Fax: 909 596-9189

 

 

August 8, 2002

 

U.S. Delegation to the CODEX Convention

Elizabeth Yetley, PhD

C/O Nancy Crane

Submitted by electronic transmission

 

Re: OBJECTIONS TO U.S. DRAFT POSITIONS (JULY, 2002)

CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES

 

While I have already written a letter to the U.S. CODEX delegation expressing my

concerns over the establishment of upper limits for nutrients in food

supplements, I have just obtained a copy of the Draft Positions of the U.S.

Codex delegation and wish to make additional open comment on them.

 

The U.S. delegation to CODEX is commissioned to develop draft positions

regarding vitamin and mineral supplements. While the Draft document addresses

other topics, I confine my comment to vitamin and mineral supplements defined as

" sources in concentrated forms of those nutrients alone or in combinations,

marketed in capsules, tablets, powders, solutions, etc., not in conventional

food form. "

 

The U.S. draft position states that " The United States supports consumer choice

and access to dietary supplements that are safe and are labeled in a truthful

and non-misleading manner. " The undefined term here is " safe. " No explanation

is given for the meaning of safe. Does this refer to morbidity and mortality?

Does this include trivial or passing symptoms which occur from time to time with

almost any medicine or supplement, such as nausea, transient diarrhea, headache,

etc.? Will the consumer be able to distinguish minor or transient side effects

from lethal or irreversible effects (i.e. liver toxicity). Since any substance

can produce undesirable side effects if taken in a large enough dose (water,

salt, spices, etc.), there is no such thing as absolute safety. So the CODEX

guideline needs to be more specific and address " relative safety. "

 

As previously stated, food supplements are safer than chlorinated tap water,

acetaminophen, aspirin and ibuprofen, iron-fortified cereals, aspartame

sweetener, and cow's milk, all which are sold over-the-counter without a

statement regarding upper safe limits.

 

As has been stated in previous communication with the U.S. CODEX delegation,

there is an assumption that there is a problem that needs to be fixed. Exactly

what are the documented side effects of food supplements consumed in high doses

and what is their incidence in the general population? Is CODEX protecting two

percent of the mega-dose vitamin E users from headaches, or what? Would the

establishment of an " upper limit " be expected to eliminate or just reduce the

occurrence of side effects?

 

The CODEX Draft notes that the Codex Guidelines for Vitamin and Mineral

Supplements will not, in any way, adversely affect the availability of safe and

truthfully labeled supplement products in the U.S. marketplace or to U.S.

consumers. While this sentence is encouraging to consumers of food supplements,

it is incomplete. There are other concerns regarding the effect of CODEX.

 

The very establishment of upper limits on food supplements would likely scare

away consumers from these products at a time when conventional medicine is

beginning to warm up to the idea of the value of food supplements for health

promotion. The first press releases issued upon the establishment of upper

limits are likely to create a mistaken belief that food supplements are

relatively unsafe. Consumers are likely to assume that since, let's say 2000

milligrams of vitamin C is the upper safe limit, that 2000 milligrams is the

toxic level and they should consume far less so as to never experience side

effects. In fact, if 2000 milligrams were established as a relatively safe

upper limit, it would likely have a safety margin built into it. Exceeding the

upper limit may produce no side effects whatsoever in a majority of consumers.

The consumer will probably not be told that the upper limit is the lower

threshold for side effects. I have observed adults who have never taken vitamin

C supplements experience diarrhea at doses as low as 500 milligrams.

 

The CODEX Draft states " Maximum amounts of vitamins and minerals in vitamin and

mineral supplements per daily portion of consumption as recommended by the

manufacturer should take the following criteria into account: (a) upper safe

levels of vitamins and minerals established by scientific risk assessment based

on generally accepted scientific data, taking into consideration, as

appropriate, the varying degrees of sensitivity of different consumer groups. "

Just how would CODEX address the variable nutritional needs of humans of mixed

genetic and environmental backgrounds? Excessive folic acid may mask a vitamin

B12 deficiency, but fertile women who seek motherhood need extra folic acid

(some experts say up to 2000 mcg) to reduce the risk of birth defects in their

offspring. So is the caveat to be aware of a masked B12 deficiency to be

discarded for women who take mega-dose folic acid? An upper limit of 2000 IU

for vitamin D has been proposed. How would that accommodate blacks

living in northern climates (near the Canadian border) whose skin pigmentation

reduces the production of vitamin D from sunlight?

 

Self care of illness and disease may be inappropriately discouraged by the

establishment of a safe upper limit. While self care is not likely to be

promoted by any health professionals, frankly many consumers have no health

insurance or suffer with disorders for which conventional medicine has no

answers. The fact is that informed consumers who seek alternatives to the

physician-promoted pharmaceutical drugs may not be able to obtain food

supplements in convenient or cost-effective doses for the self care of disease

if upper safe limits are established. For reasons of liability, manufacturers

of food supplements are likely to steer clear of providing vitamins and minerals

in doses that exceed the upper limit. Thus consumers who wish or need to

consume food supplements in mega doses may experience increased costs to obtain

nutrients in small-dose pills. The products would be available, but just not

convenient nor affordable.

 

The CODEX Draft states: " Supplements of some nutrients, such as vitamin A and

selenium, can be harmful if taken in large amounts. " This statement is again

misleading if not a falsehood. Vitamin A is potentially toxic to the liver, but

this problem only occurs in about 30 to 40 cases a year while millions of

Americans are believed to be deficient in vitamin A. Selenium is potentially

toxic, but selenium poisoning has only occurred in artificial circumstances such

as when strip mining exposed mineral beds and increased elemental mineral levels

in drinking water. Organically-bound selenium provided in plant foods (i.e.

garlic) has never been demonstrated to be toxic regardless of dose. CODEX

advocates science-based review of supplements but offers examples which are

inaccurate and disparaging.

 

The CODEX Draft states that " Some people need a vitamin-mineral supplement to

meet specific nutrient needs. " This sentence needs to be changed to " most if

not all people at some stage of their life will need vitamin-mineral supplements

to meet specific nutrient needs. "

 

Growing children would be less healthy if we did not already fortify our

overly-processed foods. All childbearing women require supplemental nutrition.

All older adults are at greater risk for age-related disease and malabsorption

and should supplement their diet. All full-grown males need to chelate iron

from their system to avoid iron overload. Recent studies indicate 40% of

Americans are deficient in vitamin D, 40% short on vitamin B12, 80% deficient in

magnesium, 80% deficient in essential fatty acids and the entire human

population suffers from a genetic failure to produce an enzyme that naturally

produces vitamin C.

 

How can it be said in the CODEX Draft that " Most people who have access to a

balanced diet can usually obtain all the nutrients they require from their

normal diet. Because foods contain many substances that promote health, people

should therefore be encouraged to select a balanced diet from food before

considering any vitamin and mineral supplement. In cases where the diet is

insufficient or where consumers consider their diet requires supplementation,

vitamin and mineral supplements serve to supplement the daily diet " ? This

statement is out of date and patently untrue. Even the American Medical

Association has now published reports which advocate multivitamin usage for the

population at large. This is further evidence that CODEX is currently out of

step with a rapidly changing body of nutritional science.

 

The CODEX Draft says: " The absence of science-based Codex guidelines, however,

could adversely affect the ability of U.S manufacturers to compete in the

international marketplace. " How so? This sentence goes unexplained. There are

no CODEX guidelines in force today and manufacturers are not impeded from

entering the international marketplace. Is this another non-problem in search

of a fix? Please explain.

 

Are we to assume that if an upper safe limit is established by the world

community, and U.S. CODEX does not agree, that U.S. manufacturers would be at

some disadvantage? All U.S. manufacturers need do is reduce the dosage in their

products to comply with foreign requirements, which is hardly much of an

inconvenience. This would likely result in higher-dose U.S. products being

coveted by the overseas market. This is the case today where Canada and various

European countries limit the types or dosage of food supplements. Foreign

travelers in the USA often purchase loads of food supplements to bring home.

The U.S.-made products are coveted, not rejected by consumers. It is only the

foreign governments, largely influenced by pharmaceutical interests, which

inhibit a free market.

 

The CODEX Draft states: " In the spirit of the protection of international fair

trade practices and the science-based resolution of international trade

disputes, we support the development of CODEX guidelines for vitamin and mineral

supplements that do not unduly limit consumer access to safe and truthfully

labeled dietary supplement products. " It becomes clear here that CODEX

addresses commercial interests over that of consumer needs. This sentence does

not indicate consumer needs supercede those of commercial interests.

 

The CODEX Draft states: " The selection of vitamin and mineral sources should be

based upon considerations such as safety and bioavailability. " This sentence

again requires further explanation. According to the Food & Drug

Administration, food supplement manufacturers are prohibited from making

statements that their products are safe or effective. Are consumers to assume

nutritional supplements are relatively safe if taken in lower doses, or toxic if

taken in higher doses? Furthermore, there is no current requirement for

nutritional products to list " bioavailability " on their label. How would a

consumer understand " bioavailability? "

 

The CODEX Draft states that " The minimum level of each vitamin and/or mineral in

a vitamin and mineral supplement per daily portion of consumption as suggested

by the manufacturer should be 15 percent of the recommended daily intake as

determined by FAO/WHO. " Otherwise the supplement will not be considered a

significant source of a particular nutrient. To amplify the above statement,

the CODEX Draft goes on to say: " Maximum amounts of vitamins and minerals in

vitamin and mineral supplements per daily portion of consumption as recommended

by the manufacturer should take the following criteria into account …the daily

intake of vitamins and minerals from other dietary sources. " This statement

requires additional explanation. The problem here is that the recommended daily

intake is comprised of the amount obtained from the diet and supplements. For

example, the recommended daily consumption of calcium is 1200 milligrams for

adults. The dairy-rich American diet provides

approximately 800 milligrams of calcium on average with a significant portion

of the population already consuming sufficient amounts (1200 mg+) of calcium

from the diet.

 

Ten percent of the daily calcium requirement, or 120 milligrams, would not be

considered a significant amount under the proposed guideline of 15% of the daily

requirement. However, the difference between the average daily consumption, 800

milligrams, and the recommended intake, 1200 milligrams, is only about 400

milligrams. The 400 milligram gap would be the suggested amount for dietary

supplementation. The consumption of 120 milligrams of supplemental calcium would

make up for 30 percent of the shortage between 800 and 1200 milligrams. Thus

120 milligrams of calcium in this example would provide a significant amount of

this mineral. Just 60 milligrams of calcium would meet the 15 percent

requirement outlined in the CODEX draft.

 

The CODEX Draft states that " All labels should bear a statement that the

supplement should be taken on the advice of a nutritionist, a dietician or a

medical doctor. " Is this provision going to result in sanctions against any

untrained person who recommends a nutritional supplement to a family member or

friend? In some other countries there is restriction of free speech as the

public faces certain sanctions if they speak out on the health benefits of food

supplements. Does CODEX promote a guideline that suggests only the elite-class

of trained nutritionists can offer advice on the use of food supplements? Would

this CODEX provision inhibit or prohibit answers to consumer question by sales

clerks at health food stores?

 

The CODEX Draft states: " The label should contain a warning statement, if the

product contains an amount of a nutrient that has been shown through

science-based risk assessment to be a health hazard under conditions of use. "

Does this mean that any product that provides an amount of a nutrient that

exceeds the safe upper limit will now have to carry a warning statement? What

if the nutrient poses potential hazards within the established safe range? For

example, take iron. Iron is a potentially toxic supplemental nutrient for

full-grown males. It accumulates in males beginning at the age of physical

maturation (about age 18) at about 1 milligram per day of life and worsens all

forms of infection and disease and leads to the early demise of males compared

to females. Supplemental iron, provided in a " safe dosage range " could still be

considered to be problematic. It is unlikely there will be sufficient space on

the product label to include such a lengthy explanation.

 

The CODEX Draft states: " These guidelines are intended to ensure a high level of

protection and to facilitate informed choice for consumers of vitamin and

mineral supplements. " The misinformation and non-specific guidelines in the

CODEX Draft provide contrary evidence to the above statement. Under the guise

of protection, food supplements in certain doses will be branded as toxic when

this is far from fact. The misinformation and lack of knowledge displayed in

the CODEX Draft of July, 2002 is enough to call for the resignation and

replacement of the current U.S. delegate to CODEX and a revision of the members

of the CODEX delegation to include parties who are more up to date in their

knowledge of this important subject.

 

Sincerely,

 

 

Bill Sardi

 

 

 

Copyright 2003 Knowledge of Health. .

 

 

 

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