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.