The Medicinal Status of Fluoridated “Water”
This paper is in two parts. They have been written so that intending responders to the North -East Public Consultation can be in possession of all the arguments against water fluoridation practice. Having explored the circumstances surrounding the issue, responders would then be free to decide for themselves which aspects of WF concern them more. As already emphasised, it’s vital that opinions are accompanied by citations (references) to improve the credibility of the responders’ objections.
1.1 Fluoridated water is a medicinal substance
1.2 Fluoridated “water” is not drinking water
1.3 Does fluoridated water harm the consumer?
1.4 Could we accept that fluoridated “water” is food?
1.5 Is fluoridated water “food” before or after it leaves the water treatment works?
1.1. Fluoridated water is a medicinal substance
Before launching into the lack of ethics in water fluoridation (WF) practice in Part 2, we first need to establish that fluoridated “water” is a medicine and that it is not drinking water.
A. In the UK Medicines Act 1968, “medicinal product” has the same meaning given by regulation 2 of the UK’s Human Medicines Regulations 2012″.
Referring to the Regulations:
2.—(1) In these Regulations “medicinal product” means—
(a) Any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
(b) Any substance or combination of substances that may be used by or administered to human beings with a view to—
(i) Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
(ii) Making a medical diagnosis.
(2) These Regulations do not apply to—
(a) Whole human blood; or
(b) Any human blood component, other than plasma prepared by a method involving an industrial process. (Our emphasis)
So, fluoridated “water” is a “medicinal product”. Even though the product is not in a container and does not have a label, it is clearly a product in the same way that treated drinking water is a product, the only difference being that Drinking Water is food when it comes out of the kitchen tap whilst fluoridated “water” is medicine.
To underpin this interpretation, British Standard 12175:2022 , p. 19 and extracts from the websites of three of the five fluoridating water companies implicitly admit to the prophylactic nature of fluoridated “water”.
“Hexafluorosilicic acid is used for the fluoridation of drinking water to increase the resistance of consumers to dental decay.”
Severn Trent Water:
South Staffs Water:
Anglian Water no longer admits this function and United Utilities has not admitted the function publicly for at least ten years.
The medicinal status of fluoridated “water” has been tested three times in a court of law since 1958. In all three cases, the Courts ruled that fluoridated water was a medicine:
Ref: The Supreme Court of Canada, 1957-88.
Ref: Mrs. Catherine McColl v Strathclyde Regional Council 1983, High Court of Scotland
Ref: New Zealand 2018, New Health New Zealand Incorporated v South Taranaki District Council, NZSC 59, 27 June 2018
1.2. Fluoridated “water” is not drinking water
When the UK left the EU, its primary legislation was retained. All Directives were subsumed and appear on the UK Government website as being law applicable to the UK. The most important Directive for our purposes is the Drinking Water Directive, 98/83/EC, Article 3.
“The Drinking Water Directive [retained post Brexit] doesn’t apply to:
1(a) Natural mineral waters recognised as such by the competent national authorities, in accordance with Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters.
1(b) Waters which are medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products”
Directive 65/65/EEC was superseded by Directive 2001/83/EC which in turn was superseded by Directive 2004/27/EC. The definition of a medicinal product was retained throughout the Directives’ transition. (Our emphasis)
So, according to the Drinking Water Directive, medicinal “water” is not drinking water. Therefore, such products do not come under the provisions and protections of the Directive. Consumers who are made ill after drinking such a medicinal product cannot appeal to the courts for redress by citing the Drinking Water Directive (retained) because they are not protected by the Directive.
Another angle on this issue is that if we are not being sold drinking water, then why should we pay for something which is not drinking water?
Since fluoridated consumers are drinking a medicinal product which is not licensed as such and which is variable in the concentration of its numerous ingredients and hasn’t been subjected to clinical examination, it can be argued that the product is not permitted in law. People who are made ill after drinking such a medicinal product may not have been injured from the fluoride content but from other ingredients in the medicinal “water”, whether or not they were introduced into the water when hexafluorosilicic acid was added.
1.3. Does fluoridated water harm the consumer?
Article 3(2) of the Drinking Water Directive goes on to state:
“2. Member States may exempt from the provisions of this Directive:
(a)water intended exclusively for those purposes for which the competent authorities are satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the consumers concerned;
(b)water intended for human consumption from an individual supply providing less than 10 mZ3 a day as an average or serving fewer than 50 persons, unless the water is supplied as part of a commercial or public activity.
3.Member States that have recourse to the exemptions provided for in paragraph 2(b) shall ensure that the population concerned is informed thereof and of any action that can be taken to protect human health from the adverse effects resulting from any contamination of water intended for human consumption. In addition, when a potential danger to human health arising out of the quality of such water is apparent, the population concerned shall promptly be given appropriate advice.”
(b) and 3 are not applicable to fluoridated tap “water” and can be ignored for our purposes.
Therefore, we are left with unpicking 2(a) above.
“2 Member States may exempt from the provisions of this Directive:
(a)water intended exclusively for those purposes for which the competent authorities are satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the consumers concerned;”
Let’s assume that a small town is provided with desalinated water and that the Government has decided that consumers should not be regarded as being given drinking water. The water is safe to drink but it does not contain any chemical parameters whatsoever. So, there is no need to police the production and sale of the desalinated water. The implication is that the UK Government can if they wish to do so, remove certain types of water from coming under the provisions of the retained Directive if the Government is satisfied that the water will not harm the consumer. Why they would wish to do so is a mystery. If this decision had been taken by the UK Government in relation to fluoridated water, then that would have been an admission that fluoridated “water” was altogether different from drinking water and they couldn’t do that because, since 1955, successive UK Governments have claimed that fluoridated water is not a medicine and that it should not be regarded as anything other than drinking water.
So, successive Governments have probably decided to do nothing and hope that no-one will read the Drinking Water Directive and that the contradiction would go unnoticed.
In the meantime, fluoridated “water” has been causing harm and there is copious high quality research in the public domain which demonstrates harm would overturn the Government’s right to exempt it from the provisions of the Directive if it had decided to apply for exemption.
1.4 Could we accept that fluoridated “water” is food?
The Medicines’ Regulator, The Medicines Healthcare Regulatory products Agency (MHRA) has steadfastly refused to classify fluoridated “water” as medicine and instead claims that it is “food”.
But … “Fluoride is not essential for human growth and development.”
Ref: European Commission (2011). Critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking water. Scientific Committee on Health and Environmental Risks (SCHER), page 4.
“Fluoride is not in any natural human metabolic pathway.”
Ref: Cheng KK, et al. 2007. Adding fluoride to water supplies. British Medical Journal 335:699-702.
It is clear that “fluoride” is not a food. Can the water which conveys it into the body be regarded as food? Despite it containing heavy metals and contaminants, it is still able to nourish us, so it is food, even though it is undesirable.
To draw a helpful analogy: a dissolvable aspirin is added to a glass of water. Is the resultant solution a dilute solution of aspirin or a glass of water to which an aspirin has been added?
In full knowledge of the facts, an individual faced with a choice of distilled water and water containing a soup of injurious chemicals would choose distilled water.
No-one should be expected to drink deliberately contaminated food compulsorily and it is the compulsory nature of having to drink contaminated “water” which makes its identification as a health-giving substance challengeable, even though all the chemicals present are within maximum allowable concentrations as defined for drinking water. But fluoridated liquid is not drinking water, so the guidelines don’t apply (see below).
The medicinal substance is clearly contaminated because BSEN 12175:2022 states that the hydrofluoric acid which is present in the hexafluorosilicic acid is a contaminant (p. 7). There are also several heavy metals in the product: antimony, arsenic, cadmium, chromium, lead, mercury, nickel and selenium If they were in the raw source water and attempts were made to remove them during water treatment, then we would have to accept their presence in drinking water. However, adding them after water treatment is a different case altogether and completely unsupportable.
The Drinking Water Inspectorate polices a long list of chemical parameters together with the maximum allowable per litre for each chemical. None of the undesirable chemicals in fluoridated water exceed the maximum allowable and that is where our case could come up against the bumpers. However, fluoridated water is not drinking water and the drinking water guidelines do not apply to such water. This means that any concentration of an injurious chemical is too much.
1.5 Is Fluoridated Water “food” before or after it leaves the Water Treatment Works?
A final piece of UK law, the Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 does not permit the addition of hexafluorosilicic acid to food. The schedule which lists permitted substances is in the retained EU Reg 1170/2009, Annex III.
We have been told that this piece of legislation does not apply to the addition of hexafluorosilicic acid to treated water before it leaves the Water Treatment Works because, in law, treated water in the Water Treatment Works and in the water mains is not food.
Treated water is only food when it emerges from the kitchen tap, some hours after the fluoridating acid has been added. This is the point of compliance for Drinking Water Guidelines – which do not apply to fluoridated water.
If we must accept this legal reasoning, our only recourse would be to object to fluoridated water being added to manufactured foods because this is not permitted in law, whether deliberate or accidental. Nor can such adulterated foods be exported to EU Countries. For example, we would not be able to export manufactured foods made with fluoridated water to the Republic of Ireland while at the same time, Ireland would not be able to export foods containing fluoridated water to the UK or to Member States of the EU. That could cause a political stink. It is also a moot point if we could export food made with calcium fluoride or magnesium fluoride to the EU because neither compounds are permissible in manufactured food.
We now proceed to part 2 to explore whether it’s ethical to force a medicine onto people without their consent.
Disclaimer: Nothing in this paper should be taken as constituting legal of medical advice.