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Fluoridated drinking water is used to prevent disease - why does it evade your regulation?

Zac Cox made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,

Fluoridated drinking water is used to prevent disease - why does it evade your regulation?

Plainly non-fluoridated drinking water does NOT require your regulation.

However fluoridated water is clearly VERY different. Fluoride is deliberately added to the water supply in order to prevent/ and or treat a disease ie tooth decay. In other words it clearly fits the dictionary definition of a medicine.
Further it is your bounden duty to regulate all medicines.
Further I submit that you must now regulate fluoridated drinking water as per all other medicines.

Yours faithfully,

R Zac Cox BDS
Dentist

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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Medicines and Healthcare products Regulatory Agency
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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Dr R Zac Cox,

Thank you for your recent enquiry to the MHRA Information Centre

The decision as to whether a particular product is a medicinal product is made by the Medicines and Healthcare products Regulatory Agency (MHRA) using the definition of that term in Article 1 of Directive 2001/83/EC, relevant legal precedent and its own published guidance. The question as to whether fluoridated water is a medicinal product has been put to the MHRA on a number of occasions over the past few years. The MHRA does not consider fluoride added to drinking water to be medicinal products which require marketing authorisations as medicines. As drinking water is clearly a normal part of the diet the MHRA does not regard it to be a medicinal product. Because drinking water is not a medicinal product it is not subject to medicines legislation and the safety and quality controls which are contained in that legislation. There is specific legislation which controls water quality and safety; this is administered by the Department of Environment, Food and Rural Affairs.

Licensed medicinal products containing a form of fluoride mainly contain sodium fluoride, the various forms of fluoride have many uses and it is not correct to say that their inclusion in an ingested product automatically makes that product a medicine. As an example, some are permitted in oral hygiene products under the legislation which applies to cosmetics. Some are also permitted under the Directives on Food Supplements and the Addition of Nutrients to Foods. The legislation which controls cosmetic products and foods contains safety requirements, details of these can be obtained from the Trading Standards Service of your Local Authority.

Yours sincerely

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected

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George Robinson left an annotation ()

So this type of fluoride which harms people does not need regulating, yet GcMAF which would financially cripple big pharma does need regulating?

Dear MHRA Customer Services,

Thank you for your reply

You have ignored the basis of my enquiry - namely that non-fluoridated drinking water is CLEARLY very different to fluoridated drinking water. Fluoridated drinking water is medicated to reduce the incidence of a disease - namely dental caries.

Please respond in full and in depth as to why you feel it unnecessary to legislate on medicated (fluoridated) drinking water

Yours sincerely,

Zac Cox

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. 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 requests within the Department of Health’s target response time
of 18 working days; or 20 working days if your request is a Freedom of
Information request; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:

[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dr R Zac Cox,

 

Thank you for your email of 23 February and my apologies for the delay in
responding.

 

MHRA has not ignored the basis of your enquiry.  Any decision as to
whether a particular product is a medicinal product is made by the
Medicines and Healthcare products Regulatory Agency (MHRA) using the
definition of that term in Article 1 of Directive 2001/83/EC, relevant
legal precedent and its own published guidance.

 

MHRA has regularly been approached for a view as to whether fluoridated
water is a medicinal product. As noted in my previous email, MHRA does not
consider fluoride added to drinking water to be a medicinal product which
requires marketing authorisation as a medicine. Drinking water is clearly
a food and a normal part of the diet;  it is not subject to medicines
legislation and the safety and quality controls which are contained in
that legislation. There is specific legislation which controls water
quality and safety; this is administered by the Department of Environment,
Food and Rural Affairs.

              

I would also reiterate that the various forms of fluoride have many uses
and inclusion in a product does not automatically make that product a
medicine. Some are permitted in oral hygiene products under the
legislation which applies to cosmetics and others are permitted under food
law and have approved health claims.

 

As noted in my previous email, legislation which controls cosmetic
products and food includes safety requirements, and details of these can
be obtained from the Trading Standards Service of your Local Authority.

 

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

Telephone: 020 3080 6000
Email: [1][MHRA request email]
[2]Stay connected

 

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