Health Supreme by Sepp Hasslberger

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July 18, 2003

Government vitamin safety data slanted says ION

The Institute for Optimum Nutrition said today that restrictions for the dosage of vitamin B6 proposed by the UK government are not based on proper science and will have troublesome effects for those who rely on high dose vitamin B6 to alleviate conditions such as pre menstrual stress and chronic fatigue.

"Vitamin B6 supplements at doses higher than 10 mg per day may start to disappear from shelves in all retail stores. The three million Britons who rely on taking 100 mg per day of this supplement to relieve symptoms of PMS and chronic fatigue syndrome will be forced to find alternative ways of treating their illnesses. Many studies, including the newly published study by the Institute for Optimum Nutrition, have demonstrated that taking B6 at 100 mg per day is safe..."

Vitamin B6 is one of several nutrients and natural products that have been found to be very effective in prevention or treatment of some prevalent medical condition and are therefore making deep inroads lowering pharmaceutical profit margins. "People healthy on pennies of vitamins a day" means less sales of high-tech and high-cost (high profit?) pharmaceutical drugs.

Several of these natural substances have been removed from the market in the last decade, such as kava kava, hypericum, the aminoacid l-tryptophan, germanium sesquioxide, DHEA and melatonin, all of them "too effective" for some condition that was a big earner for pharmaceuticals. The justification for action was always a trumped-up "safety issue" which "forced" the authorities to clamp down in protection of their friends with pharmaceutical interests - oops, that should have been consumers.

Since vitamin B6 cannot possibly be removed from the market - it is one of those vital substances that the human body cannot do without - the move is to at least limit dosage to where the vitamin tablets can no longer have a real preventive or therapeutic effect. Slanted interpretation of scientific data is what seems to be the tool for lowering the dosage of freely available vitamin B6 to zilch. What some people will do for a buck!

Read the story of B6 as told by ION today.

Government Trivalises the Dispute Against the Vitamins Directive

The new research study on vitamin B6 by the Institute for Optimum Nutrition submitted to the Government's Food Standards Agency had been a 'waste of time'. This study showed no harm and considerable benefit from B6 supplements ten times higher than the upper safety level recommended by the Government Agency.

Vitamin B6 supplements at doses higher than 10 mg per day may start to disappear from shelves in all retail stores. The three million Britons who rely on taking 100 mg per day of this supplement to relieve symptoms of PMS and chronic fatigue syndrome will be forced to find alternative ways of treating their illnesses. Many studies, including the newly published study by the Institute for Optimum Nutrition, have demonstrated that taking B6 at 100 mg per day is safe yet the UK's Food Standards Agency (FSA) have chosen to ignore all this research and continue to recommend an upper safe level of vitamin B6 at 10 mg per day.

Recent correspondence with the FSA regarding this recently published vitamin B6 study has proved useless. The FSA, having no research on the safety of vitamin B6 between the doses of 10 mg and 200 mg per day, requested for long term published studies to be brought forward and invited various complementary therapies as well as other health-related organisations to provide evidence that taking vitamin B6 between the above dose ranges is safe.

The Institute for Optimum Nutrition duly accepted this invitation and published a study in the Journal of Orthomolecular Medicine. This study was carried out on 555 subjects aged between 14 and 76 years. The study concluded that there was "no association between symptoms associated with vitamin B6 toxicity and vitamin B6 daily dose (between 30 mg and 230 mg) during a period of 3 - 27 months."

This new research was submitted to the FSA in order for them to reconsider the level presently recommended and which is set at 10 mg per day. The FSA's Expert Group for Vitamins and Minerals derived this level by basing their risk assessment calculations on an animal study! The FSA are not impressed with our study and are unwilling to revise their 10 mg level for vitamin B6 in light of the continuous empirical evidence at safe higher dose ranges.

The FSA also inaccurately reported the conclusions of our study by commenting that they "noted sporadic adverse neurotoxic effects in subjects taking 200 mg per day vitamin B6 for some years". This was not the case. In fact our study showed that improvements were seen: "An analysis of the findings indicated that the dose range of 101 mg - 200 mg (per day) demonstrated statistical significant improvements in these symptoms (associated with B6 toxicity)."

It is in our interest for public safety to establish both safe upper and lower levels of vitamin B6 since setting too low levels is potentially as dangerous as setting too high levels. Twenty years clinical experience tells us that an appropriate upper safety level is in the region of 100 mg. To date there is no human clinical evidence that refutes this and many to support it.

The study has also been sent to the EU Commission. We now hope that they will look at the study in an unbiased way and make an informed decision of what the upper safe level for vitamin B6 should be in the UK.

Institute for Optimum Nutrition contact: Aliya Chaudary

Related articles

More than 50 genetic diseases

EU supplements directive

Orthomolecular solutions


posted by Sepp Hasslberger on Friday July 18 2003
updated on Tuesday December 21 2010

URL of this article:





Readers' Comments

Orthomolecular Medicine News Service, November 9, 2005


(OMNS) The most elementary of forensic arguments is, where are the bodies?

The 2003 Annual Report of the American Association of Poison Control Centers Toxic Exposures Surveillance System (1) states that there have been only two deaths allegedly caused by vitamins. Almost half of all Americans take nutritional supplements every day, some 145,000,000 individual doses daily, for a total of over 53 billion doses annually. And from that, two alleged deaths? That is a product safety record without equal.

Conversely, pharmaceutical drugs, properly prescribed and taken as directed, kill 106,000 Americans each year. That is over 2,000 each week, dead from their prescriptions. (2) Some physicians estimate the true number of drug-induced deaths to be far higher. (3)

Fatalities are by no means limited to drug products. In the USA in the year 2003, there was a death from "Cream / lotion / makeup," a death from "Granular laundry detergent," one death from plain soap, one death from baking soda, and one death from table salt.

Other deaths reported by the American Association of Poison Control Centers included:

aspirin: 59 deaths
aerosol air fresheners: 2 deaths
perfume/cologne/aftershave: 2 deaths
charcoal: 3 deaths
dishwashing detergent: 3 deaths
(and interestingly, weapons of mass destruction: 0 deaths)

On the other hand, nutritional supplements have proven to be exceptionally safe. Specifically:

* There were no deaths from B-complex vitamin supplements.

* There were no deaths from niacin.

* There were no deaths from vitamin A.

* There were no deaths from vitamin D.

* There were no deaths from vitamin E.

There was, supposedly, one alleged death from vitamin C and one alleged death from vitamin B-6. The accuracy of such attribution is highly questionable, as water-soluble vitamins such as B-6 (pyridoxine) and vitamin C (ascorbate) have excellent safety records extending back for many decades. The 2003 Toxic Exposures Surveillance System report states that reported deaths are "probably or undoubtedly related to the exposure," an admission of uncertainty in the reporting. (p 340)

Even if true, such events are aberrations. For example, previous American Association of Poison Control Centers' Toxic Exposure Surveillance System reports show zero fatalities from either vitamins C or B-6.


The Journal of the American Medical Association has published the recommendation that every person take a multivitamin daily saying that "(S)uboptimal intake of some vitamins, above levels causing classic vitamin deficiency, is a risk factor for chronic diseases and common in the general population, especially the elderly." (4) It is a sensible idea whose time should have come generations ago.

It is curious that, while theorizing many "potential" dangers of vitamins, critics fail to point out how economical supplements are. For low-income households, taking a two-cent vitamin C tablet and a five-cent multivitamin, readily obtainable from any discount store, is vastly cheaper than getting those vitamins by eating right. The uncomfortable truth is that it is often less expensive to supplement than to buy nutritious food, especially out-of-season fresh produce.

According to David DeRose, M.D., M.P.H., "300,000 Americans die annually from poor nutrition choices." (5) Supplements make any dietary lifestyle, whether good or bad, significantly better. Supplements are an easy, practical entry-level better-nutrition solution for the public, who are more likely to take convenient vitamin tablets than to willingly eat organ meats, wheat germ, and ample vegetables. Scare-stories notwithstanding, taking supplements is not the problem; it is a solution. Malnutrition is the problem.

Public supplementation should be encouraged, not discouraged. Supplements are a cost-effective means of preventing and ameliorating illness. Vitamin safety has been, and remains, extraordinarily high.


1. American Journal of Emergency Medicine, Vol. 22, No. 5, September 2004.

2. Lucian Leape, Error in medicine. Journal of the American Medical Association, 1994, 272:23, p 1851. Also: Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA. 2000 Jul 5;284(1):95-7.

3. Dean C and Tuck T. Death by modern medicine. Belleville, ON: Matrix Verite, 2005.

4. Fletcher RH and Fairfield KM. Vitamins for chronic disease prevention in adults: Clinical applications JAMA. 2002; 287:3127-3129. And: Fairfield KM and Fletcher RH. Vitamins for chronic disease prevention in adults: Scientific review. JAMA. 2002; 287:3116-3126.


What is Orthomolecular Medicine?

Linus Pauling defined orthomolecular medicine as "the treatment of disease by the provision of the optimum molecular environment, especially the optimum concentrations of substances normally present in the human body." Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information:

Posted by: Sepp on November 9, 2005 07:30 PM


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The Individual Is Supreme And Finds Its Way Through Intuition


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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.



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