Is the CODEX Threat to Vitamin and Mineral Supplements for Real?
By Bill Sardi
Note to readers: This report has been written with links to original source documents so you can check sources of information.
There is a growing concern over the upcoming establishment of worldwide upper limits for dosage of vitamins and minerals in dietary supplements by CODEX. Some consumer groups and trade organizations dismiss CODEX as a threat to the availability of dietary supplements in doses consumers may wish to employ in their daily health regimens, while other health freedom organizations and individuals urge a mass campaign to write Congressional rep-resentatives to block CODEX restrictions. But the two bills pending in Congress that would enforce onerous restrictions on dietary supplement manufacturers, which include mandated adverse reaction reporting and proof of safety, are tabled in committee and not due to emerge for a vote without modifications. CODEX is being decided offshore, this summer, beyond the reach of Congress or the public. The question arises, what should concerned citizens do?
There is a concerted effort by the U.S. Food & Drug Administration, the National Academy of Science, the Food & Nutrition Board, and Codex Alimentarius, an international food stand-ards organization established by the United Nations/World Health Organ-ization, to place an upper limit on the dosage of vitamins and minerals in food supplements. The Center for Science in the Public Interest also supports CODEX restrictions of dietary supplements.
This effort had been underway for some time and finally came into view in 1998 when the National Academy of Science/Institute of Medicine first published proposed “safe upper limits” for vitamin and mineral supplements.
The fact that CODEX, an offshore trade and food standards organization run by the United Nations, may set US policy, has many citizens concerned. However, the US Food & Drug Administration has assured US citizens that the CODEX upper limits are not binding. According to the FDA: “Nothing in the trade agreements or process will restrict either the sale of dietary supplements in the United States or the type of information that manufacturers may provide to consumers about their products.” So many involved groups and individuals have fallen for this false assurance.
Within the same document, the FDA also said at :
Special Note: After the original posting of this report, the FDA removed the page and replaced it with a more obsequious letter. Here is what the FDA said about CODEX in 1997.
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“In the October 11, 1995 Federal Register (60 FR 53078 at 53084), FDA announced the agency’s general policy on the development and use of standards with respect to international harmonization of regulatory requirements and guidelines and addressed, in detail, the conditions under which FDA plans to participate with standards-setting-bodies outside of FDA in the development of standards for products regulated by the agency. Three key aspects of this policy that bear directly on the commonly expressed concerns about the United States’ participation in the development and use of international standards are that the standards must: (1) ensure product safety, (2) be based on sound scientific and technical information, and (3) not be in conflict with any statute, regulation, or policy under which FDA operates. These policies ensure that the United States position is consistent with applicable U.S. laws.”
The statement above clearly indicates CODEX will be enforceable in the US as long as it “doesn’t conflict with any statute, regulation or policy” already established by the FDA. The FDA appears to be talking out of two sides of its mouth here. Bottom line: the CODEX threat is real.
CODEX has already forced upper limits upon the dietary supplement industry. All that remains is to affix numbers to upper limits for each vitamin and mineral. In CODEX meetings, all the dietary supplement industry could do was win a concession that the numbers be established on science rather than the flawed RDA (Recommended Dietary Allowance). The supplement industry’s trade group, The Council For Responsible Nutrition, had to accept the upper limits or face standing in the way of regulations that would supposedly protect consumers from over-dosage. Mark LeDoux, chairman of the Council for Responsible Nutrition’s (CRN) International Trade and Market Development Committee and a board member of CRN (www.crnusa.org) said: “In agreeing to this standard’s progress today, Codex has taken a giant step toward ensuring that consumers will have access to dietary supplements based on clear and fair, scientifically supportable criteria.”
That’s where the problem lies. There is a lot of pseudo-science published in medical journals. There is also a false assumption an upper limit exists for each vitamin and mineral.
Upper Limit for Vitamin C
For example, the proposed upper limit by the Institute for Medicine for vitamin C is 2000 milligrams. The primary objection to high-dose vitamin C is gastric upset and diarrhea. It is difficult to understand how a self-limiting, undesirable side effect is classified as an adverse reaction used to establish an upper limit for an entire planet full of people. The body’s need for vitamin C depends upon how much biological stress it is undergoing (infection, inflammation, radiation
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exposure, etc.). Robert Cathcart MD has clearly described how mega-dose vitamin C can be safely consumed in certain disease states, with increasing doses to “bowel tolerance.” [Australasia Nurses Journal 9: 9-13, 1980]
Self medication with high-dose vitamin C has not produced significant morbidity or mortality in healthy or ill individuals.
Drs. Steve Hickey and Hilary Roberts, graduates of Manchester University, in England, have clearly outlined how consumers can take relatively high doses of vitamin C at intervals throughout the day to maintain high blood levels without diarrhea. [Ascorbate: The Science of Vitamin C, 2004]
Carol Johnston, a vitamin C researcher at Arizona State University, says: “The available data indicate that very high intakes of vitamin C (2000-4000 milligrams/day) are well tolerated biologically in healthy mammalian systems. Currently, strong scientific evidence to define and defend a UL for vitamin C is not available.” [Nutrition Reviews 57:71-7, 1999] See:
The concern with vitamin C is that CODEX reviewers will establish the upper limit for supplemental vitamin C at the 200 milligram dose since this is what the National Institutes of Health (NIH) researchers mistakenly claim is the point where blood serum concentration becomes saturated. [Proceedings National Academy Science 93:3704-9, 1996]
Also see: NIH Report
National Institutes of Health researchers have recently published a paper showing oral vitamin C can produce blood serum concentrations three times greater than previously thought possible. But they have failed to issue retractions on their previous flawed experiments and this new data may be overlooked by CODEX reviewers. [Annals Internal Medicine 2004 140:533-7, 2004] Also see: The Ridiculous Daily Allowance, Hickey and Roberts.
Despite this new information, CODEX will likely establish an upper limit for vitamin C somewhere between 1000-2000 milligrams, but possibly as low as 250 mg.
Upper Limit for Vitamin D
Another vitamin that is difficult to establish an upper limit for is vitamin D. There are misleading claims that high-dose vitamin D may induce cellular overload of calcium, a condition called hypercalcemia. [Supportive Care Cancer 11:232-5, 2003]
Reports of hypercalcemia from vitamin D supplements may just be chance since many adults take vitamin D pills. Physicians have reported that their patients taking vitamin D supplements sometimes develop hypercalcemia, but this does not prove a causal relationship. A man can stand in the sun in swim trunks at noontime, for an hour, in a southern latitude, and produce over 10,000 units of natural vitamin D and never develop hypercalcemia. It is inexplicable how
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vitamin D supplements get blamed for hypercalcemia.
Reinhold Veith, a Canadian vitamin D researcher, has conclusively shown that toxicity for vitamin D3 begins at 40,000 International Units (IU) after many months of consumption, and 4000 IU per day is perfectly safe in a supplement. [Am J Clinical Nutrition 69:842-56, 1999]
Dr. Michael Holick of Boston University indicates vitamin D is undersupplied in the American diet and that blacks may require ten times the sun exposure as Caucasians to produce the same amount of vitamin D from sunlight exposure. Oral vitamin D supplementation for blacks should be many times greater than for Caucasians. [US Pharmacist, 29:10, 2004]
An upper limit for supplemental vitamin D may not factor what blacks need in northern latitudes where solar UV intensity is low. An upper limit for blacks may be deemed biased or even racist. People living in far northern climates where months of darkness are prolonged will require even greater amounts of supplemental vitamin D, beyond the proposed upper limit.
Nonetheless, anticipate CODEX will establish an upper limit anywhere from 200-2000 IU.
Upper Limit for Iron
How a safe upper limit for iron will be established is unknown. In 2001, the Institute of Medicine set a tolerable upper intake level (UL) of 40 mg per day for infants and children through age 13, and 45 mg per day for adolescents ages 14 to 18 years, and adults 19 years of age and older. But is no safe dose for supplemental iron in full-grown males and postmenopausal females, as well as females who have undergone hysterectomy, all who accumulate iron in their liver. Females escape this fate by monthly removal of iron via menstruation. Up to 35% of adult females are anemic and may require iron supplementation from time to time. Iron pills are a quick poison to young children, a slow poison to full-grown males, and a fast cure for young anemic women. An upper limit on iron is surely not going to prevent iron overload among individuals genetically predisposed to iron overload. [Nutrition Clinical Care 5:236-50, 2002]
Upper Limit for Thiamin/Vitamin B1
The same difficulties emerge for an upper limit for vitamin B1 (thiamin). The European Union Scientific Committee on Food has concluded that a “tolerable upper intake level” for vitamin B1 “cannot be numerically defined.” [Functional Foods & Nutraceuticals, Sept-Oct, 2001] see:
Upper Limit for Calcium
The proposed safe upper limit for calcium is 2500 milligrams, but many Americans are close to this figure with consumption of dairy products alone. Large doses of calcium without accompanying mag-nesium may predispose consumers to anxiety and mental depression, ©Bill Sardi, Knowledge of Health, Inc., www.AskBillSardi.com Not for posting on other websites
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constipation, blood clots, migraines and heart muscle seizures. [J Am College Nutrition 12:442-58, 1993] The upper limits do not consider nutrient balance.
How Will Consumers Respond to Upper Limits?
There is going to be a collective effort to frighten consumers away from perfectly safe doses of supplemental nutrients. The news media will likely issue a barrage of misinformation about dietary supplements once CODEX restrictions are finalized.
Recognize, with the exception of iron and calcium, the “safe upper limits” are perfectly safe, with the lowest observed side-effect dose usually five to ten times greater than the safe upper limit. But consumers are likely going to see the words “upper limit” and back away from getting even near to that dose. Already various consumer organizations have blindly adopted upper limits as guidelines for public health.
Dietary supplement manufacturers may be required to print the Safe Upper Limit on their product labels, which will cause consumers to back away. To save customers, dietary supplement companies may water-down their products without a fight. Supplement manufacturers may, at some future date, be required to limit the dosage of certain vitamins and minerals in supplements.
A confusing question is what is the impetus for limitations on dosage of supplemental vitamins and minerals? Exactly what is CODEX protecting the public from? The following chart shows that the number of adverse reports from the use of multivitamins is relatively small and the number of deaths is zero. What is the need for such restrictions?
Annual Report of Poison Control Centers 2002
Number of Adverse Reports
Number of Deaths
Multivitamins
2811
0
Oral contraceptives
9948
1
Insulin
1686
8
Diuretics
7710
10
Cough and cold remedies
97710
14
Aspirin (adult)
5249
14
Acetaminophen (Tylenol)
28991
63
Alcohol
40782
93
Antidepressants
92675
255
Source: American Journal Emergency Medicine 20: 391-452, 2002
At this point, the best approach to oppose CODEX appears to be public education. Informed consumers will ignore the upper limits printed on vitamin product labels. CODEX will only prevail because a significant portion of the population falsely believes dietary supplements are “unregulated, unsafe and inaccurately labeled.” In reality, dietary supplements are far safer than aspirin tablets, other over-the-counter pain relievers, oral contraceptives, vaccines and even table salt. In fact, dietary supplements are safer than food (there are millions of cases of food borne infection each year and a few thousand deaths from food poisoning). The public’s unhindered access to vitamin and mineral supplements in doses they choose to consume should be a freedom the public seeks to maintain as strongly as it does its other Constitutional freedoms. ©Bill Sardi, Knowledge of Health, Inc., www.AskBillSardi.com Not for posting on other websites
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http://www.knowledgeofhealth.com/pdfs/codexreal.pdf