§ The Countess of Marasked Her Majesty's Government:
Whether they were represented at the symposium on the safety of Vitamin B6 held at the Royal College of Physicians on 8 September; and whether they have responded to the recommendation of that symposium that Vitamin B6 supplements should be unrestricted up to levels of 200mg.
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§ Baroness Jay of PaddingtonGovernment officials attended the symposium on 8 September and received an edited transcript of the proceedings. The Government have noted these recommendations. However the Government have every confidence in the advice of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment and the Food Advisory Committee that retail sale of Vitamin B6 be limited to 10mg.
§ The Countess of Marasked Her Majesty's Government:
What are the terms of reference of the Committee on Toxicity; and under which of those terms the Committee was qualified to consider the safety of nutrients, such as Vitamin B6, in addition to toxins.
§ Baroness Jay of PaddingtonThe terms of reference of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment are set out in the 1995 Annual Report, which has been placed in the Library. The COT considered the safety of Vitamin B6 under the term of reference "to assess and advise on the toxic risk to man of substances which are…produced in industry".
§ The Countess of Marasked Her Majesty's Government:
Which pharmaceutical companies submitted comments to the Committee on Toxicity in support of the restriction of the retail sale of Vitamin B6.
§ Baroness Jay of PaddingtonNo pharmaceutical companies have submitted such comments to the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment.
§ The Countess of Marasked Her Majesty's Government:
By what factor the Committee on Toxicity divided the daily dose of Vitamin B6 which it concluded could cause toxicity in order to reach its recommended dose of 50mg a day; whether they will indicate the safety levels which would be derived if an identical division was undertaken by toxicity levels of (a) zinc; (b) potassium; and (c) Vitamin D; and whether they will indicate in each of those cases how the safety level so calculated compares with the average adult daily requirement for such substances.
§ Baroness Jay of PaddingtonThe Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) recommended that the maximum daily intake of Vitamin B6 as a dietary supplement should be restricted to 10 milligrams. It did not recommend doses of 50mg a day. The COT based its conclusions on evidence which showed the lowest dose to have adverse effects in humans is 50mg per day.
The COT has not had occasion to identify the lowest doses of zinc, potassium or Vitamin D at which clinical symptoms of toxicity would occur in humans. Therefore it is not possible to make calculations equivalent to those used in its consideration of Vitamin B6.
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§ The Countess of Marasked Her Majesty's Government:
How many members of the Committee on Toxicity have declared financial or other links with pharmaceutical companies which would benefit from restrictions on the retail sale of Vitamin B6 supplements; and, if any, what assessment of those links was made when considering the recommendations of that Committee in relation to Vitamin B6.
§ Baroness Jay of PaddingtonThe Government have no information as to which pharmaceutical companies would benefit, or be adversely affected by, restrictions on the retail sale of Vitamin B6 supplements. Such information was not relevant when the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment considered Vitamin B6 dietary supplements.
§ The Countess of Marasked Her Majesty's Government:
Whether, in considering the advice of the Committee on Toxicity (COT) on Vitamin B6 supplementation, they noted the assessment by Professor Andre McLean of University College, London (presented at the symposium on the safety of Vitamin B6 at the Royal College of Physicians on 8 September) that the paper by Dr. K. Dalton showed that "science was not her strong point" and that "fundamentally this is an uncontrolled study of anecdotal type"; and what role the Dalton paper played in the decision-making process of the COT; and
Whether, in considering the advice of the Committee on Toxicity (COT) on Vitamin B6 supplementation, they noted the assessment by Dr. Ian Munro (presented at the symposium on the safety of Vitamin B6 at the Royal College of Physicians on 8 September) that the study conducted by Dr. K. Dalton "lacked any detailed neurological assessment of the individuals who were consuming Vitamin B6" and "was not done under clinically blinded conditions"; and
Whether, in considering the advice of the Committee on Toxicity (COT) on Vitamin B6 supplementation, they noted the assessment by Dr. Allan Bernstein, Chief of Neurology at the Kaiser Permanente Medical Centre (presented at the symposium on the safety of Vitamin B6 at the Royal College of Physicians on 8 September) that the paper by Dr. K. Dalton referred to symptoms which were "not typical of neuropathy, but were typical manifestations of hyperventilation and anxiety."
§ Baroness Jay of PaddingtonThe Government are aware of the assessments made by Professor McLean, Dr. Munro and Dr. Bernstein. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) made its recommendation to the Government after considering over 100 scientific papers from national and international journals; the study by Dalton and Dalton was just one of this number.