Examination of Witnesses (Questions 1
- 19)
TUESDAY 19 MAY 1998
Mrs Susan Croft, Professor André McLean,
Dr John Marks and Dr Jean Monro
Chairman
1. Mrs Croft and colleagues, welcome to the
first session of our inquiry into the government's proposals for
vitamin B6. Thank you very much indeed for your written evidence
and indeed for the evidence we have received from many other people,
I suspect stimulated by your organisation. Can I begin just by
asking you to clarify exactly who you are, the organisation you
represent and indeed who the scientific colleagues you have brought
with you today actually are?
(Mrs Croft) Yes. I am here as Mrs Susan
Croft. I am known as Sue Croft. I am a director of Consumers for
Health Choice. This is not my paid job in life; I am actually
a publisher. Perhaps I could introduce my team. Then, if you would
like me to, I could tell you a little bit about CHC. On my left
here we have Dr John Marks. He is a Life Fellow of Girton College,
Cambridge. He is a trustee of various medical and university trusts
and he is a former lecturer and Director of Medical Studies at
Girton. On my right, I have Professor Andreé McLean. He
is a professor of toxicology at the University College London
Medical School and a former member of COT. To his right we have
Dr Jean Monro, who is a medical director of Breakspear Hospital
in Hertfordshire. Her work has involved the study of vitamin B6
from a function point of view for many years. I did not know whether
it would be helpful to give you a short statement about vitamin
B6 and how it is essential for the body and its long term use?
2. I am grateful for the offer. I think that
will probably come out during the questioning. We will obviously
be focusing primarily on your written memorandum, E24, which you
provided us with. We have a letter from your director of political
campaigns, Christopher Whitehouse, as well, which deals with the
alleged shortcomings of the process which the government's proposals
have followed. We also have memoranda from Professor McLean, Dr
Monro and Dr Marks and from the Vitamin B6 Scientific Task Group
of which I think, Dr Marks, you are a member? Is that correct?
(Dr Marks) In which I have been a signatory of some
of the comments that they have made. I have contributed but I
am not a member of the group per se.
3. Your names all crop up in a lot of the other
evidence we have received as well. We are very grateful indeed
to all of you for coming today. Mrs Croft, could I begin by just
asking you to tell us a little bit more about Consumers for Health
Choice as an organisation? Are you solely concerned with health
foods and dietary supplements?
(Mrs Croft) Yes, we are. That is absolutely right.
We are known as CHC so perhaps I may use that as I speak. We are
a non-profit making alliance of consumer organisations and practitioner
organisations, companies and individuals. We were set up in 1996
to monitor possible adverse legislation coming from Brussels that
might affect the rights of consumers to take responsibility for
their own health without the use of pharmaceutical drugs. The
proposed restriction on vitamin B6 we feel is a domestic issue
and nothing to do with what is happening in Europe at the moment.
You will know that there are various activities taking place in
Brussels at the moment to determine the European wide sale of
vitamin supplements. All of our members, of which we have very
many, use higher range supplements that are safe.
4. Can I just clarify who your members are?
You talk about consumer organisations, practitioner organisations,
companies and prominent individuals forming part of your international
alliance.
(Mrs Croft) The majority of our members are members
of the public. We have a database that contains, at the moment
I believe, 267,000 names. These are people who use higher range
supplements on a regular basis and they have used them for many
years.
5. Of all kinds?
(Mrs Croft) Of all kinds, not just vitamin B6, although
it is because the B6 campaign started last July that we have gained
a good deal of those members, in many ways, because we set up
a helpline to advise people about vitamin B6. A lot of our membership
has come through that system. We were originally set up to work
in Europe. We have, through our advisers, managed to set up offices
in Europe, in the Netherlands and in Belgium so far, and soon
to be in Ireland. The aim was to persuade Europe, because we always
knew there would be legislation on supplements, and we wanted
that legislation to be positive, based on upper, safe levels and
not on nutritional need.
6. Your letterhead has a list of organisations
at the bottom in Germany, France, Belgium, Ireland, the Netherlands,
the UK and Portugal. Are those organisations you have established
or are they sister organisations affiliated to you?
(Mrs Croft) Most of them are affiliated to us. We
have a number of supporting organisations here. Just to tell you
a few of them: the Bristol Cancer Help Centre, the British Society
for Nutritional Medicine, the Hyperactive Children's Support Group,
the Institute for Complementary Medicine, Foresight, Mayday—that
is an organisation in Denmark—the National Society for Research
into Allergies. All these people are supportive of CHC and if
you put their membership together we are actually representing
people, here in Britain and in Europe, in excess of 20 million.
7. Are they formally in association with you
or do they just support your work?
(Mrs Croft) They support our work. They back our work.
Sometimes they attend our meetings and they have a great input
into what we do. We seek their advice on a regular basis.
8. Where does your money come from? How are
you funded as an organisation?
(Mrs Croft) The consumer members of our organisation
send us donations from time to time and I have to tell you that
they are very small. They can be one pound; they can be a postal
order for 50 pence even or five pounds or ten pounds. These are
the small donations that we receive from our consumers. When B6
hit us last year, I went out into the market place because I knew
we had to run a consumer campaign and we had no funds. I went
to seek help from the health food industry, from the manufacturers
and retailers. Some of them have been supportive and have given
us funds. We have also received funds from Belgium and from America.
9. Some of the manufacturers of vitamin B6 are
now funding your campaign?
(Mrs Croft) Some of the manufacturers of dietary supplements,
not necessarily B6, are helping to fund this campaign, yes.
10. Would they see it as possibly the beginning
of a wider attack on their industry?
(Mrs Croft) Yes indeed but also it clearly is against
the rights of consumers and it is consumers that buy their products.
11. One last question from me, Mrs Croft. Your
database is of 267,000?
(Mrs Croft) Yes.
12. You gave some hints as to how that was compiled.
Could you give us just a little bit more detail about how that
was brought together? How many of them would use B6? How many
of them would support your stance on B6?
(Mrs Croft) I would say that everybody supports our
stance on B6 because we have a statement—and I wish I had
it here today.
13. I know that one of your colleagues has a
document she wishes the Committee to see. That is fine. If there
is anything you wish you had brought, afterwards, let the clerks
have it and they can circulate it to Members.
(Mrs Croft) Thank you. In essence, they are supporting
CHC's work in defending their right to choose safe supplements,
to take responsibility for their health. The particular issue
at the moment is vitamin B6 but we are very concerned that, unless
B6 is right, unless the science is proven, unless we can make
this government understand that any legislation should be based
on safety, we may lose other of our supplements or at least they
may be restricted. It may be B6 today; it could be C tomorrow
and E the next day. We do not know.
14. That database came from health food shops?
(Mrs Croft) It came from consumers who came to us
direct when they heard about the B6 restriction. It came from
lists compiled by some health food stores, but a lot of them came
to us direct and through our helpline.
Chairman: Most of them seem to have written
to me in the last few weeks. Thank you. That is very helpful in
putting your organisation into context. I expect we will probably
direct most of our questions to you and perhaps you may wish to
invite your colleagues to answer individual points.
Mrs Organ
15. Before we come to the particular question
of the toxicity of vitamin B6, I wonder if you could give your
general view about the regulatory framework for dietary supplements
under food law? Do you think that they are acceptable as they
are? What changes would you like to see for the regulatory framework
for dietary supplements?
(Mrs Croft) I will start on that and then perhaps
Professor McLean can follow. We would like them to remain under
food law. They are food supplements. I have to say that we are
gravely worried about the new, ad hoc committee that has been
set up to examine all vitamins. We are worried about that simply
because the leader of that group is the COT Committee and they
are the people who advised this government on vitamin B6. We believe
very strongly that the advice given to the government should include
advice from nutritional experts, people who understand nutrients
and how they work in the body. There is no such person on that
COT Committee. We feel that nutritional experts should be part
of the decision making process and so far they have not been.
16. Can I just refer to your memorandum? On
page nine you say that the industry does have an existing science-based
voluntary limit of 200 mg per daily dose. Does it concern you
that there are at least two products on the market, according
to the Society for the Promotion of Nutritional Therapy, with
a 250 mg daily dose?
(Mrs Croft) We know of one product on the market and
that is an American product. There were two others at the time
of the restriction when it was first announced on 4 July last
year. The manufacturers agreed at that time to withdraw their
products and they have done so. There is just one product on the
market. Yes, we would like to see the one 250 mg product removed
from the market, or reduced down to the 200 mg level which we
believe to be safe.
(Professor McLean) I wrote to the Committee in my
personal capacity, before I was approached by Mrs Croft, and she
has kindly given me the opportunity to speak personally, not as
a member of her organisation, but because of my experience in
regulatory life for many years. To answer your question, I would
regard the present arrangement as unsatisfactory. I would agree
with the Consumers' Association that we badly need better labelling
for food supplements and we need proper warnings where there is
scientific evidence or medical evidence that something is not
safe over a particular dose. What has happened now is that it
has gone to the wrong committee, a group which is normally concerned
with substances which consumers do not want at all. Consumers
do not actually want residues of pesticides in their food and
so one regulates them in a particular way giving a very big safety
margin with toxic effects. Of course, we do not and cannot do
that for products which the consumer is actually going there to
buy. For instance, you cannot have a big safety margin for salt
or for coffee or flour. For practically anything that you buy
because you want it, you cannot have a safety margin, but you
can and should have good safety margins for the contaminants in
it. If a committee is used to a certain way of working and you
present it with something, the machine seems to chug along. In
this instance, it has treated B6 as if it were just another question
of a food contaminant for which we must put in a huge safety margin.
17. You are saying that you would like to see
better labelling and proper warnings to people. Would that also
apply to the products that were on the market with a 250 mg daily
dose, because your colleague has said you wanted the industry
to withdraw those products.
(Professor McLean) I absolutely agree. We have very
good evidence that, for vitamin B6, the safe, upper limit is about
200 mg a day for a human. We know that 500 mg a day is a dose
which will cause injury. That is the sort of safety margin that
you would have for, say, coffee or for lots of things which we
normally consume. For instance, we would not allow a soft drink
with 100 mg of caffeine in it because that is getting too close
to the danger level.
Mr Mitchell
18. Are you saying therefore that this is a
dietary supplement, not a medicine; therefore, it is not relevant
to the Committee on the Safety of Medicines unless it has proven
safety hazards? It is as relevant to that committee as coffee?
(Professor McLean) I think we are in real difficulties.
I have sat on the Committee on the Safety of Medicines as well.
I seem to have sat on every committee from radioactive waste to
child nutrition. We would like to have clear-cut demarcations
like job demarcations, but the truth of the matter is that in
reality there are not such clear-cut demarcations. We use food
law, for instance, for dealing with caffeine in coffee even though
pharmacologically caffeine is regarded as a drug. One can use
caffeine containing medicines. We have quite arbitrary distinctions
for what is a food, what is a medicine, and sometimes things are
neither food nor medicines and I think food supplements are in
a difficult position, but fundamentally we regulate as medicines
things which (a) have a medicinal claim and (b) where we think
that there is a requirement to regulate them because of issues
of safety or information or use. For food supplements, it is my
personal view that, for instance, the information requirements
are greater than for normal foods. We ought to have proper statements
of use and upper safe limits on food supplements.
19. We accept that. That is obvious common sense
but it means that, if this diet supplement is being treated as
a medicine, it is going to have to jump higher hurdles and be
treated in a different kind of fashion than if it is treated as
a diet supplement. Therefore, it follows that the problem we are
now encountering is that it is being treated in the wrong category.
(Professor McLean) I do not think we could treat it
as a medicine for reasons which are nothing to do with science
but to do with the market place, because I think the market, although
big, is not one which is likely to support the £50 million
of expenditure which would be required to get the product licence
for it. When I look at it in comparison with some of the things
which I have seen as licensed medicines, although the evidence,
for instance, for its usefulness in premenstrual tension and premenstrual
syndrome is not strong, in the sense that it would be hard to
get a product licence, I think it is about as good as some of
the things that have a product licence. It is just that there
is not a market situation which would allow that kind of push.
In effect, we have probably got something which is effective for
some people but, while it is treated as a food, efficacy as a
medicine is not really the issue.
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