Artificially Fluoridated Water Satifies Definition of Medicine

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Our Ref: FOI 11/339

Dear Enquirer,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 31 August 2011.

I confirm that your request is being handled under the Freedom of
Information Act and you should receive a reply within 20 working days
from our date of receipt.

If you need to contact us again about this request, please quote the
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Our Reference: FOI 11/399

Dear Trevor Allport

Thank you for your Freedom of Information Request dated 31 August 2011.

Fluoride as a substance is not regarded as medicinal by the MHRA.
Products containing fluoride are subject to a number of different
regulatory regimes in the UK.

The MHRA believes that drinking water clearly falls within the
definition of food and notes that the legislation which controls the
quality and safety of drinking water does not derive from medicines
legislation. The MHRA considers that neither fluoride added to drinking
water nor the resulting fluoridated water are medicinal products which
require marketing authorisations as medicines.

Claims made for non-medicinal products fall outside the MHRA's
jurisdiction.

If you are unhappy with these decisions, you may ask for them to be
reviewed. That review will be undertaken by a senior member of the
Agency who has not previously been involved in your request. If you wish
to pursue that option please write to the Communications Directorate,
4-T, Medicines and Healthcare products Regulatory Agency, 151 Buckingham
Palace Road, London, SW1W 9SZ, or by response to this email, quoting our
reference.

After that, if you remain dissatisfied, you may ask the Information
Commissioner at

The Information Commissioner's Office,
Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF

to make a decision on whether or not we have interpreted the FOIA
correctly.

Yours Sincerely

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

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Dear Mr Allport,

Thank you for your follow up enquiry to the MHRA.

This is to acknowledge receipt of your email, and we will be sending a
formal response in due course.

Please contact us again if you need further assistance with this, or any
other queries.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

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Dear Trevor Allport,

Thank you for your further email of 26 September 2011.

In responding to the points you make it may be helpful if we summarise
how decisions about whether a product is a medicinal product are made in
the UK.

A relevant "medicinal product" is defined in Article 1 of Council
Directive 2001/83/EEC as:

"Any substance or combination of substances presented as having
properties for treating or preventing disease in human beings

Any substance or combination of substances which may be used in or
administered to human beings either with a view to restoring, correcting
or modifying physiological functions by exerting a pharmacological,
immunological or metabolic action, or to making a medical diagnosis"

The case law of the European Court of Justice indicates that it is for
the national authorities of each Member State, subject to review by the
national courts, to determine whether either limb of the definition is
satisfied.

In particular, in the European Court of Justice, in The Commissioner of
the European Communities v The Federal Republic of Germany [Case
C290/90], the Court reviewed precedent and said:

"It is for the national authorities to determine, subject to review by
the courts, for each product, whether or not it constitutes a medicinal
product, having regard to all its characteristics, in particular its
composition, its pharmacological properties as they may be ascertained
in the current state of scientific knowledge, the way in which it is
used, the extent to which it is sold, its familiarity to consumers and
the risks which its use may entail."

In the UK, it is the MHRA, on behalf of the UK licensing authority and
subject to review by the national courts, which has the "important
initial responsibility to decide what is or is not a medicinal product."
[Court of Appeal judgement in the Case of The Queen v. Medicines Control
Agency ex parte Pharma Nord (UK) Ltd [1998]].

Applying the above tests, the MHRA has determined that the inclusion of
fluoride in the water supply, in the concentration in which it is
included, does not make that supply a licensable medicinal product
within Directive 2001/83/EC. This is also the view of other Member
States of the European Union. Specifically, it has determined that such
a water supply is not a substance or combination of substances
"presented for treating or preventing disease in human beings".

On the same basis, the Agency does not classify some other substances
which have properties which modify physiological function (for example
vitamin and mineral supplements) as medicines unless they carry claims
"for treating or preventing disease". The MHRA notes that, at the
present time products containing fluoride are legally available under a
number of different regulatory regimes, these include medicines
legislation, cosmetics legislation and food legislation.

If you are unhappy with these decisions, you may ask for them to be
reviewed. That review will be undertaken by a senior member of the
Agency who has not previously been involved in your request. If you wish
to pursue that option please write to the Communications Directorate,
4-T, Medicines and Healthcare products Regulatory Agency, at the above
address quoting our reference.

After that, if you remain dissatisfied, you may ask the Information
Commissioner at:

The Information Commissioner's Office,
Wycliffe House,
Water Lane,
Wilmslow,
Cheshire
SK9 5AF

to make a decision on whether or not we have interpreted the FOIA
correctly.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

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Dear Enquirer,

Thank you for your enquiry to the Central Enquiry Point at the MHRA. 

This automated response confirms that we have received your email and that
it will be dealt with as quickly as possible.

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request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
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time of 20 working days. For further information about our service and how
we handle different types of request, please view the information
published at the ‘Central Enquiry Point’ section of our website at the
following link:

[1]http://www.mhra.gov.uk/Contactus/Central...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
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Communications via the GSi may be automatically logged, monitored and/or
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Dear Trevor Allport,

Thank you for your further email of 13 October 2011.

It is not the role of the MHRA to comment on why fluoride is added to
tap water. Our responsibility is to decide whether or not a product is a
medicine and then to ensure that medicines on the UK market have the
appropriate authorisation.

If you are unhappy with these decisions, you may ask for them to be
reviewed. That review will be undertaken by a senior member of the
Agency who has not previously been involved in your request. If you wish
to pursue that option please write to the Communications Directorate,
4-T, Medicines and Healthcare products Regulatory Agency, at the above
address quoting our reference.

After that, if you remain dissatisfied, you may ask the Information
Commissioner at:

The Information Commissioner's Office,
Wycliffe House,
Water Lane,
Wilmslow,
Cheshire
SK9 5AF

to make a decision on whether or not we have interpreted the FOIA
correctly.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

Stay safe when using herbal remedies, follow us on Twitter
@staysafeherbals

show quoted sections

Dear Enquirer,

Thank you for your enquiry to the Central Enquiry Point at the MHRA. 

This automated response confirms that we have received your email and that
it will be dealt with as quickly as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. For further information about our service and how
we handle different types of request, please view the information
published at the ‘Central Enquiry Point’ section of our website at the
following link:

[1]http://www.mhra.gov.uk/Contactus/Central...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
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Communications via the GSi may be automatically logged, monitored and/or
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Dear Mr Allport,

Thank you for your further email of 16 October 2011.

The MHRA makes decisions on the status of products on a case by case
basis, rather than on the status of substances. The MHRA believes that
drinking water clearly falls within the definition of food (whether
fluoridated or not) and is controlled by particular legislation.
Toothpastes are not foods and individual toothpastes can be regulated as
cosmetics, medicines or medical devices depending on claims and
ingredients. Claims made for non-medicinal products fall outside the
MHRA's jurisdiction.

If you are unhappy with these decisions, you may ask for them to be
reviewed. That review will be undertaken by a senior member of the
Agency who has not previously been involved in your request. If you wish
to pursue that option please write to the Communications Directorate,
4-T, Medicines and Healthcare products Regulatory Agency, at the above
address quoting our reference.

After that, if you remain dissatisfied, you may ask the Information
Commissioner at

The Information Commissioner's Office,
Wycliffe House,
Water Lane,
Wilmslow,
Cheshire
SK9 5AF

to make a decision on whether or not we have interpreted the FOIA
correctly.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

Stay safe when using herbal remedies, follow us on Twitter
@staysafeherbals

show quoted sections

Dear Enquirer,

Thank you for your enquiry to the Central Enquiry Point at the MHRA. 

This automated response confirms that we have received your email and that
it will be dealt with as quickly as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. For further information about our service and how
we handle different types of request, please view the information
published at the ‘Central Enquiry Point’ section of our website at the
following link:

[1]http://www.mhra.gov.uk/Contactus/Central...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
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and may be unlawful.

 

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Communications via the GSi may be automatically logged, monitored and/or
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References

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