Examination of Witnesses (Questions 80
- 99)
TUESDAY 19 MAY 1998
Mr Maurice Hanssen, Mr Anthony Bush and Mr Derek
Shrimpton
80. Would that be, in your judgment, if it is
specifically for PMT, would you be concerned that there appears
to be two-thirds who are taking the product continuously rather
than at the appropriate times?
(Mr Hanssen) This is a question, of course, of what
is being effective. Is it PMS or something else? The interesting
thing that the Taylor Nelson survey showed was that of people
taking continual high levels of B6, 7 per cent suffered from the
type of manifestations seen in the Dalton paper; and of a rather
larger number of people who never took B6, 8 per cent suffered
from these manifestations. So one was led to the conclusion that
the side effects are common to people anyway. Derek can talk more
about mood swings and PMS which might answer your question.
(Dr Shrimpton) The PMS one is interesting. As you
will know, there has been great debate medically as to whether
PMS exists or not, although it is hardly for those of us who are
men to comment upon. What has come from further study is that
this is a mood effect. Dr Marks explained something of the mechanism
of pyridoxine in this context. The substance which works on the
receptors is called serotonin, which may be known to some of you
as a word. It would seem that this mood swing is not a sex orientated
thing. It applies to males as well as females. In the survey Mr
Bush referred to, 25 per cent of the usage was by men. My comment
related quite specifically to the PMS usage, which I think I would
regard as a nutritional use in the sense that it is optimising
a feeling of health as distinct from curing a problem. That would
seem to be the effect on mood and I am not surprised that data
is coming forward which shows that there is a considerable usage,
not just when you are moody at its worst, but generally to take
the insurance of keeping the good mood for a long period. That
seems to be the explanation for its long-term usage.
81. Is that upon the lines of the previous witnesses
who referred us to the ones with the sugar tablets for curing—
I am not sure if you were here.
(Mr Hanssen) The sugar tablet placebo effect.
(Dr Shrimpton) It may or it may not. I think you have
both. A placebo effect is well known in almost every activity.
It does not really matter what it is. I know in discussing, as
Professor Dayan said, for instance. He said he was surprised that
you only picked up 7 or 8 per cent. He would have expected 10
as a going rate. So, yes, but in addition to that you have the
other 90 per cent who think that something is happening. I think
that in this area of science we learnt a long time ago that it
is a mistake to decry what people believe is happening, merely
because you do not understand what is happening. The work on serotonin
is relatively recent and we are starting to understand that there
really are such things as biochemical triggers of mood. That would
seem to be what this is doing. I would maintain that a good mood
is a happier state of health than a bad mood. That is why I am
interested as a nutritionist.
Mr Mitchell
82. You say that a 6 milligram daily dosage
of vitamin B6 can improve the condition of the heart. What is
the scientific evidence for that?
(Dr Shrimpton) It is extensive. I was mentioning to
a colleague outside that I began my work in vitamin research in
1950 when vitamin B12 was newly discovered and I thought there
was a wonderful future. In fact, it was the only microbiologically
produced vitamin so everything went dull and I did something else.
I am excited to have come back to the field some 15 years ago
in some detail. The reason is the interplay between vitamins and
some components of protein amino acids, which was the field I
had moved into when vitamins got dull. This is one such. It relates
to the production of amino acid called cysteine from a product
called homocysteine. The names are really irrelevant. It is simply
that you move from one substance to another. The one you move
to is what you need in building up proteins. It would seem from
clinical studies, epidemiological studies, that a high blood level
of this substance before cysteine, called homocysteine, is undesirable
and is associated with the risk of heart attack, principally coronary
disease not stroke. That a high blood level of pyridoxine causes
this to be lowered. It is also true that a high level of folic
acid causes this to be lowered. This was the first observation.
The pyridoxine observation came later. It has been a trend of
research, say over the last 20 years, that although focus has
gone on to one particular vitamin, when you look at the others,
especially in this B group, you find that they also have a part
to play. So even in the case of spina bifida, although folic is
the dominant one, we now know that B12 has a part to play.
83. Since the Kelloggs campaign to start eating
more cornflakes, I am now straining my heart by putting on weight,
which is a rather sad outcome. Is this work for normal people
or for people with a heart condition?
(Dr Shrimpton) No, no, it is for everyone. A complete
answer to your question is not possible now because although we
know that the signs are so strong—that there is a gene interaction
with heart disease—one cannot say at the moment that every
individual can benefit from nutrition because they may have a
gene which will override that. Professor McLean quoted ten per
cent as having problems in relation to folic. One assumes, and
I agree it is an assumption, that the number with the problem
gene is less than half. If it were more than half some of us,
like me, in this room would not be here. It is probably between
ten and 20 per cent but we do not know until, when, just outside
Cambridge, you have this whole genome project finished in ten
years' time, what this will be. That is the sort of thing one
could look at.
84. Can I turn to manufacturers now. Is your
position really that a nice little earner has been threatened
by Jeff Rooker and his proposed Statutory Instrument?
(Mr Hanssen) I think that a nice little earner negates
the way in which we operate. Obviously businesses, in order to
be economic, have to make profits, that is important but we are
built on three planks. The first one is safety because clearly
a supplement that is unsafe is extraordinarily bad for long term
business. Secondly, it is good manufacturing practice and quality
because a consumer demands quality. It is important to mention
something where the pharmaceutical people get it all wrong by
saying that this would be safer if it were pharmaceutical. In
fact, pharmaceuticals are less safe than things under food law.
One or two simple examples would be, for example, the heavy metal
content. Pharmaceuticals can have been 10 and 50 milligrams of
lead whereas MAFF—as you will shortly find out when they
publish it—quite rightly goes berserk when you get more
than one part per million of lead.
85. Somebody else gets the profit from making
them.
(Mr Hanssen) Of course there is a profit. What we
are saying is if it were pharmaceutical it would not be safer.
We have got two things, we have got good manufacturing practice
to food standards which should be very high. The third thing is
honesty of claim. One of the problems we have with promoting a
product like B6 is that you cannot promote it or any of these
things we talk about, it is a food. You cannot promote food—and
I hope this changes one day—in the greengrocer as well for
what it does that is good for you because that comes under prevention
which is part of the definition of a medicine. I think the mood
is changing, both in Brussels and here, where we have a task force
working on food claims where interventions have helped the health
of the nation by giving accurate information which of course has
to be accurate and is something that we would really like rather
than it being a criminal offence. Nonetheless these products have
built themselves up entirely through consumers wanting them.
86. What would the effect on you or your businesses,
indeed on the consumer, be if Rooker's Statutory Instrument became
effective?
(Mr Bush) I think the effect would be bad for consumers
because at the moment the consumers can go into shops, whether
it is your health food shop, your Tesco or a pharmacy, and choose
and make an informed decision. That informed decision is being
removed by these proposed regulations and I think, therefore,
it will be bad for consumers.
87. Bad for you as well.
(Mr Bush) It will be bad for me but I have to say
that what is bad for consumers will be bad for me, yes. Going
back to your other point, my main concern is meeting consumer
needs. Most marketing textbooks will tell me that. If I do not
meet the consumer need for safe products then I will not be in
business. Safety is the principle and why we are here today.
88. Do you feel threatened by this proposed
new Advisory Committee on Vitamin Supplements?
(Mr Hanssen) I would only feel threatened if they
used the principles of toxicological evaluation that we have faced
with the COT decision. You probably also know that a decision
has been made in the EU to set up a similar body with the Scientific
Committee on Foods in Brussels so there will be two lots going
at it. You also probably know, because we sent it to you, that
the Americans have started a big major study on this whole thing
and have got out there a 220 odd page book on the B vitamins,
including 27 pages on B6. A lot of different groups around the
world are, as far as I can see, doing exactly the same job. Interestingly,
the figures coming up in most places are very much those that
we have been using as upper safe levels since 1985 with variations
when the science changes. We keep them under considerable review.
We had to put in these levels in 1985 because until then there
were provisions under the Medicines Regulations to call them medicines
exempt from licensing. There was a takeover by the Ministry of
Food and we said immediately that this could have dangers to the
consumer so we had to set upper safe levels using the best scientific
advice.
89. Is there not a case for looking at the regulation
of these supplements. They fall into a grey area between food
and medicines—
(Mr Hanssen) No, they do not.
90. Should there not be some kind of new look
at the regulation?
(Mr Hanssen) If we obeyed the regulations as they
stand, instead of ignoring them as I fear some of the regulatory
authorities do, there is no grey area. A food has to be safe in
the quantity likely to be consumed. This does not stop you selling
salt whereas three ounces of salt, if you take it in a glass of
water, would kill you but it does not stop us doing it. What we
need is the information which you probably did not have on salt.
The regulations are there. The enforcement is not always there.
We will be very happy to work with the authorities to increase
the level of enforcement and have tried so to do.
91. Does there not need to be a more strict
examination of the claims made for vitamin supplements?
(Mr Hanssen) If the claims are not true, and as with
any walk of life you will find people who do go over enthusiastic
and are wrong, the first thing we have got is the Advertising
Standards Authority on whose Health and Nutrition Committee I
sat when it existed for ten years. The HFMA has had, since 1978,
developed under the then Department of Health and Social Security,
a code of advertising practice which is quite strict and we regulate
anything that goes into an advertisement of one of our members
or on the pack. We get an immense degree of compliance. Where
we would like to tighten it up is when somebody does something
which is a blatant breaking of the law, we report them to the
authorities and absolutely nothing happens.
92. Just one final point. We have heard arguments
about levels of intake over 200 and over 500 milligrams. The proposed
Statutory Instrument talks about ten milligrams. Clearly there
might well have to be a compromise somewhere between these two
figures. Could you live with a limit on a daily intake of 100
milligrams?
(Mr Hanssen) There is a difference between ten and
100 of ten times.
93. Yes but could you live with 100?
(Mr Hanssen) I am sure we could because that also
is compatible with what the Americans have decided. So, 200 milligrams
was safe, let us divide it by two. We would not have difficulty
in living with 100 at all.
94. If we followed the American pattern and
took the same level that would be a satisfactory situation for
the manufacturers?
(Mr Hanssen) Yes, and for the consumer.
Mr Todd
95. As I understand it, you class your products
as foods?
(Mr Hanssen) We have no other option.
96. That is how you see them?
(Mr Hanssen) We see them as foods.
97. Correct. The question then is how do you
sell them to your consumers because to me it is clear we have
drawn the analogy with salt and there are many other things which,
consumed in the wrong quantities, can do you harm. It is a question
of what claims you make. Can you give some examples of how you
market your products currently?
(Mr Hanssen) We certainly can.
(Mr Bush) One of the things we are very careful about
is not to make medicinal claims.
98. Right.
(Mr Bush) Then we say "What can we say about
our products?" There are certain things we say like "help
to maintain a healthy heart" or something like that—
(Mr Hanssen) Not the B6 we hasten to add.
(Mr Bush) Not the B6 but core products
within this industry.
99. What do you say about B6?
(Mr Bush) There are certain things one can say but
they are not medicinal claims. We have already said, as far as
the HFMA is concerned, any advertising copy or what people say
about their products is first of all checked.
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