Will International Laws Restrict Your Supplements? 

Law vs Supplements
A Statement Regarding the Establishment of Tolerable Upper Limits and Dosage Harmonization of Food Supplements 
by Bill Sardi  BSardi@aol.com

The dietary supplements sector-working group of the Trans Atlantic Business Dialogue (TABD), composed of manufacturers of nutritional supplements, has agreed to "harmonize the regulatory framework for vitamin and mineral food supplements on both sides of the Atlantic." (Statement from the http://www.crnusa.org website) The fact that the food-supplement industry has embraced the idea of "maximum levels" for food supplements is of serious concern to every health-conscious consumer. 

There are a number of concerns regarding the establishment of "maximum levels" for nutritional supplements. These are: 

1. The establishment of "tolerable upper limits" may assume there are no health benefits, and only undesirable side effects, beyond a certain point of consumption. No mention is made of a therapeutic range. For example, some heart disease patients take 3200 units of vitamin E, which exceeds current maximum recommendations. 

2. The establishment of "tolerable upper limits" for developed Atlantic nations is likely to be adopted as a world standard, since consumers in many undeveloped countries consider western-made products to be superior. However, the nutritional needs of human populations vary. Factors such as age, sex, geography, skin pigmentation, season, health habits (tobacco and alcohol consumption), nutrient soil levels, cultural dietary practices, dependence upon processed foods, prescription drug usage, individual health status and other factors may not be encompassed by a one-size fits all "upper limits" standard. For example, the safe range for vitamin D consumption is not likely to be sufficient to prevent immune system dysfunction among Blacks living in northern climates in winter months (dark skin pigmentation reduces natural vitamin D production). Likewise, the safe upper limit may not accommodate the! need for folic acid by fertile Caucasian females living in equatorial climates (solar ultraviolet radiation significantly reduces folic acid levels among light-skinned individuals). 

3. There is concern that "tolerable upper limits" will be intentionally set at levels that will be below therapeutic dosages. Consumers are fully aware that pervasive pharmaceutical interests, which exert influence through corporate ownership or material supply, may sway "upper tolerable limits" in food supplements so as not to compete with prescription drugs. The public is aware that the biological action of virtually every prescription drug can be duplicated with nutritional supplements and that the therapeutic effect of many nutrients depends upon dosage. 

4. The fact that a profit-minded group of manufacturers is entrusted with the establishment of such an important standard is questionable on its face. Manufacturers may not represent the interests of consumers who desire to use food supplements as part of a health maintenance regimen. The validity of an "upper limits" standard may later be called into question should the public not have a voice in their formation. For example, a court recently threw out the well-publicized food pyramid when its authors were found to have conflicts of interest with food suppliers. Without notice or ample opportunity for public comment, the National Academy of Sciences recently introduced tolerable upper limits for antioxidant vitamins. These maximal limits were apparently established without scientific consensus (see the report below on vitamin C). 

5. The establishment of "tolerable upper limits" is likely to be based upon outdated or inaccurate information. Recently published scientific studies indicate the daily dosage levels for vitamin B12, vitamin D, iron, calcium, folic acid, and other nutrients may need to be re-evaluated. There is concern that the latest science may not be included in the development of the maximum nutrient levels. 

For example, much of the information provided in nutritional textbooks, regarding vitamins A and D is outdated. 

Consumers are mistakenly warned by the US Food and Drug Administration that excessive vitamin A supplementation can produce a toxic liver buildup. However, an estimated 30-60 cases of vitamin A overdose are reported annually, while over a million older Americans report symptoms of night vision problems due to a lack of vitamin A. Cases of liver/vitamin A toxicity often involve alcoholics and others who have liver disease. Vitamin A toxicity is completely reversible. The US FDA has only chosen to warn doctors and consumers of the potential for vitamin A overdose without a balanced reporting on vitamin A deficiencies. The only reported case of mortality from vitamin A toxicity involved a hunter in Canada who consumed bear liver, which provided over 1 million units of vitamin A. There is concern over birth defects with high-dose vitamin A supplementation, but conflicting studies are still a puzzlement. 

Due to the potential risk of liver buildup, the US FDA restricts vitamin supplements to no more than 1000 international units of vitamin D per pill. However, blood levels of vitamin D do not even rise till 5000 units is consumed, and the full-body skin exposure to midday sunlight in a mid-equatorial zone in the summer would produce 10,000 units of vitamin D, which completely confounds any notion that vitamin D is toxic. Toxicity from vitamin D does not begin till 40,000 units of vitamin D are consumed daily for an extended period of time. [American Journal Clinical Nutrition 69: 842-56, 1999] Doctors used to inject 50,000 units of vitamin D for therapeutic purposes. Vitamin D3 is the proper form of vitamin D for human nutrition. The inferior form of vitamin D, vitamin D2, is provided in milk. [Am Journal Clinical Nutrition 68: 854-88, 1998] 

6. The exclusion of certain nutrients from the "maximum level" list may unfairly infer that they are not necessary for human nutrition. There is evidence that certain nutrients should be added to the list of essential life factors. This list may include nutrients such as lutein, sulfur, phytic acid/inositol hexaphosphate (IP6), essential fatty acids, and others. 

There is no daily requirement established for essential omega-3 fatty acids, even though 8 in 10 Americans do not consume adequate amounts of these fats. Omega-3s are required for maintenance of the nervous system (myelin sheath), production of hormones, reduction of inflammation, lining of the retinal photoreceptors, control of triglycerides and regulation of immune system. An estimated 20 percent of Americans do not exhibit detectable levels of omega-3 fatty acids in their tissues. Essential omega-3 fats have been removed from eggs, meat, grain and even fish. This is largely a result of the use of feeding pens for domesticated animals. Chickens, turkeys, hogs and steers are all fed corn meal rather than foraging in the wild for foods that are a source of omega-3 fatty acids. Grass-fed animal meat will provide a significant amount of omega-3 fatty acids, whereas animals sent to the feeding pen two weeks prior to slaughter will provide little or no omega-3 fatty acids and plentiful amounts of saturated fat. [http://www.eatwild.com] 

The widespread use of processed grains also eliminates omega-3s from the human food chain. Cereals and grains are engineered for storage, not human nutrition. 

Finally, the practice of fish farming prevents fish from acquiring the phytoplanktons that are the source of omega-3s for waterborne animals. The result is an omega-3 nutritional deficiency that is of epidemic proportion. Nearly every human being now must supplement their diet to acquire maintenance levels of omega-3 fatty acids. For health officials to ignore this nutritional deficiency is akin to ignoring outbreaks of pellagra and beri beri over a century ago. 

The need for omega-3 fats is particularly critical among newborns, even more so among preemies. Currently, infant formulas do not provide these essential fats, though the Food & Drug Administration is soon due to make a statement regarding the provision of omega-3 fats in infant formulas. 

There is also no daily requirement for sulfur, a mineral required for the production of glutathione, the major antioxidant produced within all living cells (plants, insects, animals, humans). Glutathione consumption from foods ranges from 25-125 milligrams per day. With the provision of sufficient amounts of sulfur, the liver will produce far more glutathione (up to 14,000 milligrams per day) than what the diet provides. Sulfur-rich foods (garlic, eggs, asparagus, onions) may be lacking in various diets and the provision of sulfur in food supplements (sulfur-bearing amino acids like N-acetyl cysteine, taurine, and lipoic acid) or glutathione itself, may be advantageous. 

There is now ample evidence that lutein, a cousin of beta carotene, is essential for maintenance of the human visual system. Lutein requirements increase dramatically among blue-eyed individuals who have far less of this antioxidant pigment at the back of their eyes than brown-eyed individuals and are at a 2000% increased risk of developing loss of central vision (macular degeneration) in their lifetime. Lutein is not currently considered an essential nutrient. It is unlikely that the at-risk population will consume the 3-5 weekly servings of spinach or kale (equivalent to 6 milligrams of daily lutein), required to prevent ocular disease. [Journal Am Medical Assn 272: 1413-20, 1994] Lutein food supplements appear to be practical and economical. 

When husks (bran) were separated from rice, the B vitamins were removed, which led to deficiency diseases of pellagra and beri beri. However, in addition to B vitamins, these rice polishings (bran) provided phytic acid (IP6), also called inositol hexaphosphate, an important mineral binder and antioxidant. [Free Radical Biology Medicine 8: 61-69, 1990; J Biological Chemistry 262: 11647-50, 1987] IP6 is found in every living cell in the body and is also an important second messenger for the nervous system. The low consumption of whole grains has led to reduced consumption of IP6 and the development of iron, copper and calcium overload diseases (hemochromatosis, Wilson's disease, kidney stones, mitral valve, calcium cataracts) and other iron-overload sequelae such as hypertension, atherosclerosis, brain disorders, liver disease, colon cancer and other maladies. IP6-phytic acid has been mistakenly branded as an anti-nutrient because it interferes with mineral absorption among growing children. Nutritionists fail to recognize that most of the anemia in developing countries is caused by intestinal parasites, not the lack of iron, and that nature favors iron anemia over iron overload, since iron is a major growth factor for bacteria, viruses, fungi and tumor cells. Bran has never been fully restored to the food supply, and the world is still suffering from deficiency diseases. 

7. There is concern that the establishment of "tolerable upper limits" would cause some consumers to needlessly seek the counsel of a physician or other health professional when high-dose vitamin usage is in question. Doctors are solely oriented to prescribe prescription drugs and are notoriously known to harbor prejudices against food supplements. Despite their theoretical widespread application in disease prevention and treatment, less than 1 percent of all doctors' prescriptions are for nutritional supplements. 

8. There is concern that high-dose pills would only be available via a doctor's prescription, which would raise costs to consumers. Nutritional supplements that are sold without prescription in the USA are only available through a doctor's prescription in many other countries. If employed in the USA, this practice would serve to drive up consumer costs and stunt the practice of self care and preventive care. 

9. There is concern that the establishment of a "tolerable upper limit," without accompanying information regarding the type, severity and reversibility of any side effects, would induce undue alarm among consumers. For example, if a consumer is only informed of a maximum level of consumption and no further information is provided, then the consumer may be misled into thinking potential side effects are of a serious, or even lethal, nature. Specifically, if an upper limit of consumption is established for magnesium, and excessive dosage may produce known symptoms of "loose stool," then this fact should be provided to consumers with the notation that the remedy is to reduce the dosage and that this symptom is completely reversible. Similarly, excessive consumption of vitamin C may produce temporary symptoms of diarrhea, a symptom that is completely reversible with discontinuance or reduced dosage.  Other examples of reversible side effects are neuropathy  from high-dose vitamin B6 (pyridoxine), nausea from high-dose iron, facial flushing from high-dose niacin, and headaches and breast tenderness from high-dose vitamin E. 

10. There is concern that once maximal limits are established, and the concept has been adopted, it will be easy to arbitrarily change the numbers. 

11. There is concern that health care consumers have no unbiased governing bodies to turn to in regards to accessibility to food supplements. As stated above, physicians have inherent conflicts of interest since nutritional supplements currently do not require their prescription. There has been continued reluctance by the National Academy of Sciences, the National Institutes of Health, the Food & Drug Administration, and other governmental health offices, to endorse habitual use of food supplements. Dietary practices (fruits and vegetables) and food fortification are favored over supplementation. The new standard is likely to stop short of supplementation in favor of dietary consumption at the low end, and will stop short of therapeutic action at the top range. 

The cost of non-supplementation 
Only recently did the US Food & Drug Administration concede to demands for more folic acid via food fortification. Foot dragging on folic acid led to many more babies being born with birth defects. 

After spending millions of dollars, the Five-A-Day program, promoted by the National Institutes of Health, is a failure. Repeated studies indicate only a minority of the population consumes the recommended five servings of fresh fruits and vegetables on a daily basis. After repeated public information campaigns aimed at increasing the consumption of fruits and vegetables, the proportion of adults who actually say they consume 5 servings of plant foods a day only increased from 19 to 23 percent from 1990 to 1996. [Am Journal Public Health 90: 777-81, 2000] Nutritional supplementation may be a practical and economic way of filling nutritional gaps in the population at large. 

The reluctance of the US health authorities to endorse food supplements in favor of plant-food diets and food fortification is costing the US health care system dearly. 

The Western Journal of Medicine reports that the provision of folic acid and zinc containing multivitamins by all women of childbearing age, and daily supplementation of vitamin E for adults over age 50, would reduce hospital charges by $20 billion annually. [Western Journal Medicine 166: 306-12, 1997] If all at-risk Americans took the recommended amounts of vitamin supplements, the managed care industry would save approximately $5.5 billion. [Managed Care Interface 11: 95-99, 1998] The National Defense Council Foundation indicates the provision of food supplements to active and retired military personnel would reduce health care costs by $6.3 billion annually. [Press Release May 22, 1997] 

While pharmaceutical companies lure retirees into lobbying for a national prescription drug program, they are never told that nutritional supplements will do far more to promote health, without the side effects and costs of prescription drugs. 

12. There is concern that maximal upper limits may not accommodate the nutritional needs of specific organs in the body. Nutritional authorities have given too much attention to achieving minimal and maximal blood levels of nutrients, which may not be an adequate measure of nutrients in specific tissues. For example, it has been stated that the blood circulation becomes saturated with vitamin C at about 240 milligrams. Even when saturation has been achieved in the blood plasma, the provision of 2000 milligrams of vitamin C further increases the levels of vitamin C in the aqueous fluid of the human eye by 35 percent. Higher levels of vitamin C are required in the aqueous fluid of the eye than in the blood circulation because the human eye is transparent and is prone to harm by products of oxidation (hydrogen peroxide) emanating from exposure to solar ultraviolet radiation. Much higher levels of vitamin C are required to prevent cataracts than to prevent scurvy. The daily amount of vitamin C required to prevent cataracts is in the range of 300-2000 milligrams (the equivalent of 6-30 oranges), which exceeds the best dietary consumption (about 200-250 milligrams from consumption of five servings of fruits and vegetables). The National Academy of Sciences (NAS) now considers 2000 milligrams of vitamin C as "toxic." [See my addendum regarding the issuance of new recommendations for antioxidants by the NAS below.] The human eye has greater need for vitamin C, lutein, vitamin E, glutathione and vitamin A, than most other tissues in the body. 

13. There is concern that food fortification may be offered as an option to the establishment of higher therapeutic doses of supplemental vitamins and minerals. However, food fortification may not be adequate in all instances. The National Academy of Sciences recently reported that Americans fall short of magnesium requirements by about 200 milligrams per day. It is difficult to fortify food with this bulky mineral, and it is not easily incorporated into flour and bread. Only bottled water provides a medium for the delivery of magnesium in the diet. Thus supplementation rather than food fortification may be required to meet human needs. Furthermore, where foods are heated prior to consumption, nutrient values may be diminished. Consider that flour and cereals are now being fortified with higher levels of folic acid, a B vitamin known to prevent birth defects among newborns (spina bifida). But folic acid, as well as all B vitamins, is easily destroyed by heat from baking or toasting. Food fortification is a success, but it may 
not prevent all nutritional shortages. 

Why no opposition to "harmonization"? 
Why has there been no opposition to the harmonization of dietary supplements? The dietary supplements sector working group of the Trans Atlantic Business Dialogue, Citizens for Health, the Council for Responsible Nutrition, the National Nutritional Foods Association, and other organizations, have not voiced serious objection to the establishment of tolerable upper limits of nutritional supplements. This goes unexplained. Either ignorance or conflicts of interest within these organizations, has resulted in inaction and a lock-step movement towards the establishment of "tolerable upper limits." Vital health freedoms are about to be swept under the bus in the name of harmonization. 

Centuries ago mankind could only dream of finding remedies that would prevent infections, eradicate blinding cataracts, avert heart stoppage, hinder tumors, and forestall aging. Now that mankind has discovered that these health benefits are achieved through the provision of concentrated nutritional factors, the idea to establish harmonized dosages runs contrary to the progress of western civilization. Consumer access to high-dose vitamin and mineral supplements may save the economies of western civilizations. 

(Previously published in Whole Foods Magazine)

Recently the National Academy of Sciences (NAS) issued dietary antioxidant recommendations. The new recommendations call for 90 mg. for vitamin C for healthy adults, up from 60 mg per day under the previous standard. Yet the government keeps preaching five servings of fresh fruits and vegetables, which supplies more than 200 mg. of vitamin C. [Am J Clin Nut 62: 1347-56S, 1995] These two figures don't correlate. Just months before the 90 mg vitamin C recommendation was issued, various government scientists were calling for 120-200 mg per day in published reports. [Proc Natl Acad Sci 93: 3704-09, 1996; Nutrition Reviews 57: 222-24, 1999; Am J Clin Nut 69: 1086-1107, 1999] One researcher at the Massachusetts Institute of Technology, Laboratory of Human Nutrition, using a technique called saturation kinetics, suggested that even the 200-mg level was not adequate to meet individual vitamin! C needs by as much as 2-3 fold. [Proc Natl Acad Sci 93: 14344,48, 1996] 

While the Food & Nutrition Board suggested adding another 35 mg of vitamin C for smokers (125 mg total), researchers at the Medical College of Wisconsin found that it takes 200 mg of vitamin C before smokers achieve the same serum levels of ascorbic acid as non-smokers. [Am J Clin Nut 53: 1466-70, 1991] Other investigators have called for 200-mg daily consumption of vitamin C for smokers. [Ann NY Acad Sci 686: 335-46, 1993] Swedish investigators demonstrated that a single 2000 mg dose of vitamin C can completely abolish the typical reduction in blood circulation that occurs while smoking a cigarette. A 1000 mg dose had no effect. [Microvascular Res 58: 305-11, 1999] 

What happened to these recommendations? The NAS recommendations conveniently stopped short of recommending levels of vitamin C that would require supplementation. The Academy of Sciences set the tolerable upper limit at 2000 mg, but a recent review indicated doses of vitamin C up to 4000 mg. are well tolerated. [Nut Rev 57: 71-77, 1999] Eight placebo-controlled, double-blind studies and six non-placebo clinical trials in which up to 10,000 mg of vitamin C was consumed daily for up to 3 years confirm the safety of vitamin C in high doses. [J Am Coll Nut 14: 124-36, 1995] Yet the headline in the press release from the National Academy of Sciences concerning antioxidants read "huge doses considered risky." 

Furthermore, Maret Traber PhD, a member of the NAS panel, says there is "no evidence that proves antioxidant supplements will help people live better longer." [Whole Foods Magazine, August 2000]  Really? There was a UCLA study, which showed that greater than 300 mg of daily vitamin C increases the male life span by six years, a report that was widely reported in Newsweek and other periodicals. [Epidemiology 3: 194-202, 1992] A recent study confirms that finding. [Epidemiology 11: 440-45, 2000] 

Furthermore, one study shows that about 294 mg of vitamin C significantly decreases the risk of cataracts compared to 77 mg. per day (about the level set by the Academy of Sciences). [Clin Chem 39: 1305, 1993] To get that much vitamin C a person would have to consume 5 oranges per day. Daily consumption of vitamin C supplements for 10 years or more results in a 77-83 percent reduction in the prevalence of cataracts. [Am J Clin Nut 66: 911-16, 1997] 

One of the fallacies of current vitamin C research is the use of blood serum levels as the gold standard for establishing recommended daily consumption levels. A 1991 study, conducted at the USDA Human Nutrition Research Center on Aging at Tufts University, found that there were "striking differences" in ocular levels of vitamin C among older adults who consume 148 mg of vitamin C from their daily diet (which is 2.5 times the old 60 mg RDA and 1.6 times the current 90 mg recommendation) compared to adults who took 2000 mg daily from supplements. The level of vitamin C in the focusing lens and aqueous fluid of the eye increased by 22-32 percent with consumption of 2000 mg of daily vitamin C supplementation, which affords protection against cataracts. Thus the idea that vitamin C levels reach a saturation point at about 240 mg in the blood serum, and that additional vitamin C is worthless and only washes out in the urine, is dispelled by this research. [Current Eye Research 8: 751-59, 1991] This is the same level of vitamin C that the National Academy of Sciences now considers "risky." [NAS press release April 10, 2000] 

The message the National Academy of Sciences sends is always the same, regardless of the evidence, which is that you can get all the nutrients you need from your diet, not pills. But this recommendation comes with asterisks. The fine print reads that the NAS recommendation is only for healthy individuals, and it only spells out "the minimum amount of a nutrient that has beneficial health effects." The NAS says the effects of antioxidants are "promising but unproven." 

How much evidence is enough? The answers provided by the NAS Food and Nutrition Board members amount to doublespeak. The discussion becomes almost unintelligible with all the talk about daily value, Recommended Daily Allowance (RDA), USRDA, daily reference intake (DRI) and tolerable upper level. Which consumer, let alone rocket scientist, can decipher these standards so they can make an intelligent health decision? 

One assumption is that people don't need antioxidant supplement until they become unhealthy. But the Journal of the American Medical Association admits the destructive process of oxidation is involved in virtually every disease. [J Am Med Assn 271: 1148-49, 1994] Aging, disease and antioxidant status often parallel each other. Living tissues slowly age or wear out, they don't become ill overnight. For example, the focusing lens of the human eye loses about 1 percent of its clarity for every year of life. Cataract formation is universal and slowly progressive with advancing age. By age 60 only about 35 percent of light reaches the retina. By age 85 a person needs a 250-watt light bulb to see what they saw with a 60-watt light bulb when they were 20 years old. The level of vitamin C in the lens of the eye has been correlated with severity of cataract. Internatl J Vitamin Nutr Res 68: 309-15, 1998] If an individual consumes the minimum amount of vitamin C that produces healthful benefits (90 mg. per day by the NAS standards), and waits till they develop a cataract to take more vitamin C, it will probably be too late to reverse a cataract. About 300-2000 mg per day of vitamin C would be required to prevent cataracts, according to the data at hand. 

NAS panel member Maret Traber, Ph.D., says "it was disappointing that the news media focused on the 'new' upper limits for vitamin C, vitamin E and selenium, rather than the 'new requirements'." But it was the NAS themselves who chose to issue a press release that carried the headline "Antioxidants' role in chronic disease prevention still uncertain; huge doses considered risky." Their own press release didn't emphasize the fact that their report called for an increase in the daily intake of vitamins C and E. The NAS can't entirely shift the blame onto the news media. While these experts admit that the news media mistakenly emphasized the tolerable-upper limits issued by the NAS panel of experts, the panel members apparently did nothing to correct the problem either. They could have written to the news media. Apparently none did. 

Email your Senators and Congressperson today!  http://congress.org/

Article copyright 2000 Knowledge of Health, Inc. Reprinted with permission of the author.
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Notes below by John Hammell, of International Advocates for Health Freedom (http://www.iahf.com), whom I thank for first bringing Mr. Sardi's article to my attention:

"Bill Sardi (BSardi@aol.com) is one of the unsung heros, and he has really come through for the vitamin consumers of the world with this well researched, well written, well documented report. 

"Sardi asks a very good question at the end of his article: he wants to know why there has been NO EFFORT on the part of supposed "Health Freedom Organizations" world wide to bring the information contained within his article to light? 

"Is our health freedom being hijacked? In another 5 months, unless massive grass roots opposition can be mustered within the EU, all 15 EU countries will soon walk in lockstep with Germany and France, and the USA could be set up like a bowling pin at CODEX in 2002. 

"You think your access to dietary supplements is secure here in the USA or anywhere else in the world? Better think again! Jeanne Grimmett of the Congressional Research Service published an article titled "Dispute Settlement" which documents the fact that NONE of our (US) domestic laws is safe from harmonization to rapidly emerging international standards, most of which go diametrically against the environment and against the public health. 

http://www.iahf.com Telephone Toll-Free 1-800-333-2553" 


Andrew Saul, PhD

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