Memorandum submitted by the Health Food
Manufacturers' Association (E18)
We are glad to be able to respond to your Committee's
request for written evidence to be considered at their forthcoming
inquiry into Vitamin B6. We would also be ready to give oral evidence
if that would help the Committee with its deliberations.
The HFMA was founded in 1965 and has productively
worked with Government and the regulatory authorities to promote
and maintain the highest reputation of the specialist health product
industry by ensuring that members' products fully comply with
the requirements of good manufacturing practice, product safety
and honesty of promotion. We currently have 160 members of which
more than 90 per cent supply food supplements. They range in size
from small family businesses with turnovers of less than £100,000
to major companies with UK turnovers exceeding £10 million.
THE PUBLIC
USE OF
B6 CONTAINING PRODUCTS
The public have a higher usage of products containing
several or many nutrients as well as B6 than of the single vitamin
alone. We have researched the sale of products containing more
than 10 mg of B6 on sale as food supplements in the UK, with the
following results:
(1) Estimated number of packs purchased per
annum, 5-7 million.
(2) Value of retail sales, £30-35 million.
(3) Average pack size, 1 months supply.
THE SAFETY
OF B6
Since 1984 there has been industry-wide agreement
between the HFMA and CRN membership to observe scientifically
assessed upper safe levels for vitamins and minerals. There is
a standing committee working with the guidance of Dr Derek Shrimpton
and other appropriate nutritionists to revise these levels if
there is sound scientific evidence so to do.
A copy of the current table is to be found as
Appendix 1 [not printed].
You will note that B6 is permitted up to 200
mg per day. We have had no reports of significant adverse effects.
Indeed at the seminar on B6 held on 8 September at The Royal College
of Physicians, a major new study on both users and non-users of
higher dose B6 supplements found that 7 per cent of 1,292 consumers
reported tingling fingers whereas 8 per cent of 1,872 non-users
also had tingling fingers. Indeed it became very clear during
the symposium that the two papers upon which COT is relying were,
in the case of Dalton and Dalton fundamentally flawed, and in
the case of the dog study, Dr Ian Munro who was one of the authors,
disagreed with the way that it had been interpreted by COT. I
understand that the CRN is sending you full transcripts.
We are surprised that, in the face of these
criticisms COT and MAFF declined to re-open the scientific debate
which they conducted behind closed doors without permitting the
attendance of international experts in this field of nutrition.
MAFF issued its comprehensive Surveillance Report
No. 170 on Toxicological Problems relating to exposure to Traditional
Medicines and Food Supplements between 1991 and 1996, more than
a year ago. No adverse reactions were recorded from taking B6.
On 7 April 1998 the US Institute of Medicine,
which sets RDAs in the US, issued their report on the B vitamins.
For the first time this incorporated some upper safe levels for
safe continuous usage. The B6 level was conservatively fixed at
100 mg. The relevant pages are at Appendix 2 [not printed] and
represent the views of a consensus of some of the world's most
distinguished nutritional experts. The ten fold difference to
COT's proposals isolates the UK and will cause substantial trade
barriers.
PRESCRIPTIONS
FOR B6
The proposal to make 11-49 mg B6 pharmacy only
is a restriction on availability that will do nothing to protect
the public—there are no adverse effects at such levels—and
will seriously affect the consumers because many other outlets
can supply at lower prices. Experience has so far demonstrated
in outlets which are enforcing the proposal already, such as most
pharmacies, that very many women are too shy to reveal that they
have an increased need to control their PMS to a shop assistant.
For levels over 49 mg a Doctor's prescription
will be needed. Doctors are often convinced that PMS is all in
the mind, and will not give a prescription. Indeed there are only
4 or 5 licensed higher level B6 products on the market non of
which are intended for PMS.
The new proposals will therefore deny millions
of consumers their freedom of choice to use this safe and useful
nutrient.
THE EXPERT
GROUP ON
VITAMINS AND
MINERALS
The concept of this expert group is excellent,
but the effectiveness will depend on the membership. If we are
faced with a group that treats the safety of essential nutrients
as if they were pesticides, then we will exacerbate the problem
we now face with B6.
There are two crucial additional points that
require consideration:
(1) Why has the new body been denied the
possibility of re-evaluating B6?
(2) Why did HMG not propose an EU group with
the same remit? In view of the likely early proposal of a draft
vitamin and mineral Directive from Brussels, this initiative would
be a most positive manifestation of the effectiveness of the UK
Presidency.
CONCLUSIONS
(1) Vitamin B6 at daily levels of up to 200
mg is demonstrably safe.
(2) The new US data showing safety at 100
mg should be accepted.
(3) The present proposals will bring suffering
to at least a million women.
(4) The manner in which the present UK proposal
was reached defies scientific credibility.
(5) We are most willing to work with the
Government to ensure that supplements are safe, made to high standards
of GMP and sold with honesty.
16 April 1998
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