Pressure by the UK and EU governments to limit the maximum allowed dosage of vitamin B6 continues, despite good evidence that doses at least 10 times greater than the upper safe level recommended by the UK's Food Standards Agency are safe.
The UK's Institute of Optimum Nutrition claims that their new research on B6 has been ignored by the UK Government (see below).
The Alliance for Natural Health Expert Committee's consultation response to the Expert Group on Vitamins and Minerals (EVM) report on Upper Safe Levels was also ignored.
How is it then possible to shape legislation by way of good science?
Increasing numbers of innovative companies, practitioners, retailers and consumers are appreciating that the legal challenge being developed by the Alliance for Natural Health provides us with one of the few remaining routes towards a precedent to fair legislation for natural products.
Government Trivialises 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.
Notes to Editor: -
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