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Jim Wright -v- The Law
Jim Wright received a letter from the MHRA saying that an anonymous complaint had been made against him. It is surely one of the basic principles of the legal system in any civilised society that we should know the identity of those who accuse us of misdemeanours, otherwise we are powerless against the State's machinery, should they wish to 'rid themselves of this troublesome priest'.
The letter is reproduced below in full. Jim Wright's reply can be found at Reply
Our ref: CB/2002/000277
22 April 2002
Mr J Wright
Natural Health Alternatives
Support@healing4all.co.uk
Dear Mr Wright
VITAMIN B-17
A complaint has been received about the above product. This has been
referred to us as the Agency responsible for the administration and
enforcement of medicines legislation in the UK. It is possible they may be
subject to the Medicines For Human Uses (Marketing Authorisations, etc.
Regulations) 1994 (S.I. 1994/3144). The complaint concerns the
marketing of an unlicensed product. For reasons of confidentiality, I will
be unable to supply details of the complainant's identity.
p Medicines legislation
In the UK, as in the rest of the EC, medicinal products which are placed
on the market, are required to have marketing authorisations (formerly
product licences) in accordance with The Medicines For Human Use
(Marketing Authorisations) Regulations 1994 (S.I.1994/3144). Amongst
other things these provide that, unless exempt, no medicinal product shall
be placed on the market unless a marketing authorisation has been
granted in accordance with Community provisions by the licensing
authority or the European Commission. It is an offence to sell or supply or
to advertise a medicinal product which does not have a marketing
authorisation.
A "medicinal product" is defined in Article 1 of Directive 2001/83/EEC and
this definition is now part of UK law as a result of S.I.1994/3144. The
definition is:
" Any substance or combination of substances presented for treating or
preventing disease in human beings or animals.
Any substance or combination of substances which may be
administered to human beings or animals with a view to making a medical
diagnosis or to restoring, correcting or modifying physiological function in
human beings or in animals is likewise considered a medicinal product ".
In practice, in coming to a view about any product, the Agency considers
all the characteristics of the individual product and any information which
may have a bearing on the product's status. A product may be viewed
as a medicinal product because of the way in which it is presented.
Although the claims are not the only factor, they are a significant part of
the presentation. The Agency also considers the effect the product has
on human physiology. If it satisfies one or both of the criteria, it is
classed as a medicine. A product presented as a nutritional substance or
cosmetic may still be a medicinal product if it contains ingredients which
have a significant pharmacological effect.
p Advertising
The Medicines (Advertising) Regulations (S.I. 1994/1932) prohibit the use
of medicinal claims for unlicensed products. Section 3 (1) of The
Medicines (Advertising) Regulations 1994 provides that "... no person
shall issue an advertisement relating to a relevant medicinal product in
respect of which no product licence is in force."
"Advertisement" is defined broadly under Section 92 of the Act to cover
"every form of advertising whether in a publication or elsewhere."
Unfortunately, what constitutes a "medicinal claim" is not closely defined
in the legislation but as a rough guide unacceptable medicinal claims
include the following:-
- references to medical conditions,
- references to treatment or alleviation of adverse conditions,
- references to interference with the normal operation of a physiological
function.
p Herbal Remedies
Medicinal herbs may only be legally marketed in the UK with a marketing
authorisation or, if they qualify, as exempt herbal remedies under section
12 of the Medicines Act 1968.
Section 132 of the Medicines Act 1968 defines an herbal remedy as:
" a medicinal product consisting of a substance produced by subjecting a
plant or plants to drying, crushing or any other process, or of a mixture
whose sole ingredients are two or more substances so produced, or of
a mixture whose sole ingredients are one or more substances so
produced and water or some other inert substance."
Section 12(1) allows a person to make, sell and supply a herbal remedy
during the course of their business provided the remedy is manufactured
or assembled on the premises and that it is supplied as a consequence
of consultation between the person and their patient.
Section 12(2) allows the manufacture, sale or supply of herbal remedies
(other than by personal consultation) where:-
i) the process to which the plant or plants are subjected consists only of
drying, crushing or comminuting;
ii) the remedy is sold without any written recommendation as to its use,
and
iii) the remedy is sold under a designation which only specifies the
plant(s) and the process, and does not apply any name to the remedy.
It must be noted that in order for a medicinal product to qualify for
exemption from licensing it must be a herbal remedy as defined above
and meet the criteria set out in Section 12. Products which are combined
with non-inert substances such as vitamins, do not come within the
definition of a herbal remedy and therefore, can not meet the section 12
criteria.
p Your products
I have also taken the opportunity to visit your web-site and I should be
grateful if you could provide the following information on the following
products:
DHEA Jatoba
Vitamin B-17 Cansema Tonic III & Capsules
Bloodroot Paste Cansema Salve
Eczema Colds & Flu
Andean Calm N-TENSE
Graviola N-TENSE 2
Fybromialgia Complex Anti-Viral
Virex Complex Calcium Aspartate
Osteo Complex Allergy Herbs
Pain Complex Cyprenil
Chromium Complex Echinacea
Maca Insomnia Complex
Joint Relief Formula Infla Cream
Old Amish Dewormer Anti Depression
Please send me the following information within 14 days.
1. Details of the product and formulation.
2. Copies of all labels, packaging, etc under which the products are sold,
or supplied.
3. Copies of any package inserts and other product literature, including
any sent out on request.
4. Copies of current information leaflets and order forms.
5. Copies of any advertisements and other material used in their
promotion including Internet advertising.
6. Information as to the method of marketing, particularly whether the
products are sold through retail outlets at any time.
7. If you are a member of a Trade Association, please provide evidence
that your products have been approved by them, e.g. Stamp of Approval.
8. Samples of the products.
Please send me the following information within 14 days for each of your
CanSupport Products
1. Details of the product and formulation.
2. Copies of all labels, packaging, etc under which the products are sold,
or supplied.
3. Copies of any package inserts and other product literature, including
any sent out on request.
4. Copies of current information leaflets and order forms.
5. Copies of any advertisements and other material used in their
promotion including Internet advertising.
6. Information as to the method of marketing, particularly whether the
products are sold through retail outlets at any time.
I attach a copy of MCA Guidance Note No.8 for your information. After
reading this and the information in this letter, you may, if you wish, add
some written comments.
When replying please use my reference number CB/2002/000277.
Thank you for your co-operation and I look forward to hearing from you.
Yours sincerely
Caroline A Beaumont
Classifier, Borderline Section
Inspection & Enforcement Division
Enc.
Some useful links:-
http://www.laleva.cc/supplements/vitc_cancer.html
Vitamin B-17
Cancer Diary - What Doctors Don't Tell You
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