Cross Review: Legality of water fluoridation

Two substances, hexafluorosilicic acid (H2SiF6) and sodium hexafluorosilicate (Na2SiF6) are used industrially in water fluoridation. They are known popularly both as fluorosilicates and as silicofluorides. In this analysis I have used the term silicofluorides throughout when referring to them. Sodium fluoride, (NaF) is no longer used in water fluoridation, but is registered as a medicinal substance with strictly limited applications in the UK and the European Union (EU).

The following analysis deals with the use of silicofluorides in water fluoridation in England. It also briefly reviews the situation with regard to the practice of adding sodium fluoride to milk targeted on children. It has relevance to other administrative regions within the UK, such as the Scottish Parliament and the Welsh Assembly. It is also of concern to water undertakers and any other persons or organisation involved in water fluoridation, or the addition of these chemicals to other ingestible products.

Elsewhere in the EU, national legislation notwithstanding, the use of these substances and the practice of water fluoridation itself are violations of Union-wide Directives on the use of pharmaceutical products, and of reputable codes of medical ethics. Consequently, their use for fluoridating public water supplies constitutes violation of numerous Articles of the European Human Rights legislation.

The status of water fluoridation can be clarified by examining three basic statements of fact.

1.1 Authorised products and processes in the treatment of water for human consumption.

In England, Council Directive 98/83/EEC on the quality of water intended for human consumption (1)was incorporated into the English legislation as the Water Supply (Water Quality) Regulations 2000 (S.I. 3184 2000) (2) , (The equivalent Scottish legislation of 2000 also implements this Directive ).(3) This updated, and to some extent replaced, earlier provisions included in the Water Supply (Water Quality) Regulations 1989 (4), as amended by the Water Supply (Water Quality)(Amendment) Regulations 1991 .(5)

However, the relevant section of the earlier Act - sections 25 and 26 - are effectively unchanged in the 2000 Regulations, and are entirely compliant with the wording in section 31 of 98/83/EEC.

In support of the 1989/91 legislation, the Government has published a 'List of products and processes approved under section 25 and 26 for use in connection with the supply of water for drinking, washing, cooking and food production purposes'. The most recent publication of this List is dated December 2001. (6)

The commonly used fluoridation chemicals are hexafluorosilicic acid H2SiF6 and, far less commonly, sodium hexafluorosilicate Na2SiF6 - these are referred to below by their familiar name 'silicofluorides'. Sodium fluoride is no longer used in water fluoridation. None of these substances, nor the process of fluoridation itself, are included as recognised products or processes in the December 2001 List.

Both the EU and the English (and Scottish) legislatures have already accepted that fluoridation is not a water treatment process. Since the process has been excluded from this category for at least a decade, any attempt now to include fluoridation as a water treatment process under an amendment to the existing Water Supply Regulations can therefore be challenged. Fluoridation has no technical role in water treatment, and its sole role is one of public medication.

Sections 87-91 of the Water Industry Act 1991 (7) incorporate the principal provisions of the Water (Fluoridation) Act 1985 (8) into current legislation. However, the Water Supply (Water Quality) Regulations (and its amended version) 1989/1 post-date the Water (Fluoridation) Act 1985, but do not include fluoridation as a permissible water treatment process. Fluoridation therefore cannot be defined as a water treatment process. Since the relevant authority in the existing English legislation for adding 'fluoride' to the public water supply derives from 'a written request from a District Health Authority', the action of fluoridation is clearly not aimed at water treatment, but is a purely medical intervention.

Water fluoridation is not a water treatment process, and silicofluorides are not water treatment chemicals. The sole objective of their addition to the public water supply is to medicate the general public.

The manufacture of silicofluorides for use under the provisions of the Water Industry Act is controlled under BS EN 12174 and 12175.(9) It is important to understand that these merely specify the standards to which these substances must adhere in manufacture - they do not authorise their use as medicinal substances for human use.

The manufacture of all medicinal substances must comply with the provisions of the 'Guide to Good Manufacturing Practices for Medicinal Products' (75/319/EEC) . (10) The provisions of this code are not identical to those included in the specifications of BS EN 12174/5.

The Codified Pharmaceuticals Directive 2001 (2001/83/EC) (11) replaces the earlier Medicines Directive 65/65/EEC , (12) incorporated into English law in the Medicines Act 1968 .(13) A major defect in 65/65/EEC was that there was no differentiation between medicinal substances, cosmetics and foods - a defect that the MCA and other Government sources invariably exploit to confuse questioners, by claiming that the use of 'fluoride' (not silicofluorides) is controlled under a range of legislation, including that relating to food and cosmetics.

Any substance marketed as a remedy or preventative for any specified medical condition is a medicinal substance under Article 1 of this Directive. The definition of medicinal substances in 2001/83/EC is absolutely clear - i.e.,

Fluoridated water is presented to the public by the Health and Dental Sectors as being an effective remedy in the prevention or reduction of the incidence of dental caries in young children. Many dental public health officers state that it is beneficial throughout life, and virtually all over-the-counter dental preparations contain some form of added fluoride.

As a direct result of this promotion, the average person in Britain generally believes this to be so. Non-fluoridated water is not so promoted, and is not regarded by the public as having this medicinal property. Fluoridated water is therefore deliberately marketed as a product that has specific medicinal properties that are absent from non-fluoridated water.

The European Court of Justice has ruled that if a product is represented to the public so that any averagely well-informed person gains the impression that the substance might have a beneficial effect on some medical condition, then that substance is a medicine under the terms of this Directive, even if it is in fact ineffective.(14)

The concentration of 'fluoride' present in fluoridated water is that which is considered to produce the required remedial or preventative effect, particularly on juvenile tooth decay. The product as a whole is therefore a medicinal product. Dilution is not a relevant issue, and both the product - fluoridated water - and the active ingredients contained in it must be classified as medicinal substances under 2001/83/EC.

Silicofluorides are not included in the Community Register of Medicinal Products for Human Use ,(15) nor are they included in the Medicinal Products (Prescription and Control of Supply) Regulations 1996 (S.I. 256/1996) .(16) They are therefore unregistered medicinal products, and as such their use in medicating any human condition is unlawful, enabling legislation with respect to fluoridation notwithstanding.

Within the European Community, any ingestible substance is either a food or a medicine, and the definition of 'food' includes drinks. Any ingestible product containing a medicinal substance is expressly prohibited from being classified as a 'food' (and therefore also as a drink), and must be classified as a medicine. There is an absolute prohibition on attributing to any food (or drink) any properties of preventing, treating, or curing any human disease.

Under Article 6 of the Food Supplements Directive - 2002/46/EC ,(17) no food supplement - including any mineral - may be presented to the public as having medicinal properties. Article 1.1 states that all food supplements must be delivered to the consumer in pre-packed form, unless they are registered as medicinal products under 2001/83/EC. Sodium and potassium fluoride are the only two fluorides permitted to be classed as minerals that may be used in the manufacture of food supplements. Each is registered separately. There is no presumption that it is merely the fluoride component of the substance that is a registered mineral. Neither of the two silicofluoride chemicals is registered as a mineral, nor as a medicinal product.

Fluoride of any kind, if marketed as a water fluoridation agent claiming to have a beneficial effect on tooth decay, is therefore expressly excluded from eligibility as a food supplement or a mineral supplement, and must be registered under 2001/83/EC. The silicofluorides therefore would not be permissible substances under the new EU regulations concerning vitamins, minerals and nutraceuticals, even if they were to be pre-packed and sold in discrete dose form.

Since there is no requirement for fluoride in any normal biochemical process in the human body, claims that some potable water supplies may be 'deficient' in fluoride has no scientific validity. In this respect, it is therefore unsound to consider fluoride - in any form - as a nutrient. Nor is it possible to 'supplement' a diet with it. Since it is purely a cumulative toxin, any additional body burden, from whatever source, merely contributes to a lifetime's accumulation and the consequent increasing challenge to normal body functioning. The inclusion of sodium and potassium fluorides as 'minerals' under the Food Supplement Directive therefore has no scientific validity.

The MCA claims that the use of 'fluoride' is also controlled under regulations covering cosmetics. Article 1 of the Cosmetics Directive 1976 (76/768/EEC) (18) defines cosmetic products as

If a preparation is marketed in a form designed to be swallowed, it cannot be classed as a cosmetic substance, and it is either a medicine, a food or a food supplement. Any cosmetic preparation that makes a medicinal claim of any sort is automatically designated as a medicinal product, and is regulated accordingly under 2001/83/EC, and not solely under 76/768/EEC. Fluoridated toothpastes that are claimed to have cariostatic properties are therefore medicines as well as cosmetic products.

Fluoridated water is routinely presented to the public as having such cariostatic properties when drunk - it therefore could not be classed solely as a cosmetic product, even when used to simply rinse the mouth. If swallowed, it becomes a medicine.

In English law, both sodium fluoride and the silicofluorides are scheduled as Part II Poisons under the Poisons Act 1972.(19) A reference in that Act to a poison includes substances that contain that poison. Section 1.4 states that

Part II poisons may only be sold to individual customers under strictly regulated conditions and safeguards by a qualified person (such as a pharmacist). Products containing sodium fluoride cannot be sold except within the specified products listed
in S.I. 256/1996. If silicofluorides are not classified as medicinal substances and water containing them is not a medical product, as the MCA claims, then they can only be sold under the controls imposed by the Poisons Act, regardless of any authorisation under the Water Industry Act.

If, however, it is a medicine then their sale and use in fluoridated water is subject to control under 2002/83/EC. But since the MCA has refused to designate silicofluorides as medicinal substances, they remain solely Part II Poisons, and are subject to control under the Poisons Act.

This is quite independent of the legislation relating to the processing and sale of potable water in England. Attempting to permit the use of silicofluorides under the Water Industry Act does not over-ride the requirements of 2001/83/EC - if the fluoridating substance is not registered as a medicinal substance under the Pharmaceuticals Directive, then its use in any product or preparation is unlawful. It is important therefore to note that no dossier on the safety of silicofluorides for administration to humans in the public water supply has been presented for evaluation. This is obviously of relevance to those constraints on its sale to the public under the provisions of the Poisons Act.

All substances permitted to be used as a medicine in England are listed in the Medicinal Products (Prescription and Control of Supply) Regulations 1996 (S.I. 256/1996 ). (20) Sodium fluoride is registered in Schedule 3, part 2 only as a medicinal substance for use in dentifrices, mouthwashes and tablets for dental hygiene. Silicofluorides are not included in any Schedule of this Instrument.

However, sodium fluoride is used in Britain to fluoridate milk targeted at juveniles. A dose of approximately 2 mg of fluoride per day is administered in 190 ml of milk (The maximum permissible daily dose for an adult under SI 256/1996 is 2.2 mg) This milk appears to be recognised as a medicinal product, because parental consent is required to administer it to minors. The World Health Organisation stipulates that when fluoride is administered to minors in this way, their urine must be tested for fluoride, a requirement that appears not to be adhered to in British schools.

If sodium fluoride is used outside its authorised range of medicinal products, it reverts to its classification as a poison. Its use in milk is therefore subject to (and contravenes) the restrictions set out in the Poisons Act, a fact of which parents are almost certainly unaware. It is therefore remarkable that, regardless of this, fluoridated milk should be accepted and treated as a medicine by some British Health Authorities.

It is even more extraordinary that fluoridated water, an entirely equivalent product, marketed with the intent to medicate the identical medical condition, is permitted to contain substances that are not registered for any medicinal use whatever. In the English legislation, the silicofluorides are in fact classified solely as poisons, and are currently dispensed to the public without any regard to European legislation designed to protect the public against unlawful exposure to such substances.

As used in water fluoridation, silicofluorides are not foods, food supplements, food additives or cosmetic substances. They are purely medicinal substances, and must be registered as such before they may be administered to the public with the intention to medicate against tooth decay.

Both the silicofluorides and sodium fluoride are scheduled poisons, and their sale in commercial ingestible products such as water and milk violates the provisions of both the UK and EU pharmaceutical legislation and the Poisons Act.

The Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine; Convention on Human Rights and Biomedicine .(21) (for convenience below, the 'Biomedicine Convention') sets out to protect the rights of people as they are affected by the fast-changing advances in modern biology and medicine. In particular, it establishes their right to prevent the imposition of such advances by the State upon their persons. The term "human rights" refers to the principles laid down in the European Convention for the Protection of Human Rights and Fundamental Freedoms (1950).(22)

The British Government is notably one of the few in the EU that have refused to sign up to what is now the most widely adopted Code of Practice covering medical ethics within the Union. However, this failure does not absolve it from challenge under its failure to comply with recognised standards of medical ethics, as an entirely similar ethical approach to the principles of medical practice is endorsed in principle by all responsible medical professionals, in both the private and the State medical sectors.

Indeed, any medical practitioner who fails to adhere to an equivalent Code of Practice would be exposed to civil action for malpractice. The British Government's attempts to enforce fluoridation on the public, through the actions of the Medicines Control Agency and those Health Authorities pressing for the imposition of fluoridation, therefore place all parties to this action at risk under current Human Rights legislation.

The following statements summarise the ethical provisions of the Biomedicine Convention as it relates to the practice of compulsory fluoridation of public water supplies.

· Fluoridation is a State-imposed medical intervention. The term "intervention" covers all medical acts, including any action performed for the purpose of preventive care.
The interests of the individual take precedence over those of the State (Article 2).
There is no over-riding Public Health interest that justifies fluoridation - tooth decay is neither contagious nor life- threatening.
The existence of laws permitting the State to adopt policies supporting or imposing an intervention does not imply that the practices that it legitimises are themselves ethical, or that they do not infringe the personal rights of the subjects over whom the State has domain.
People must be able freely to give or refuse their consent to any intervention involving their person (Article 5). Consent must be based on a full understanding by the subject of the nature and the potential consequences of fluoridation and its alternatives.
Freedom to consent to an intervention also demands that such consent may be withdrawn completely at any time. Since fluoride is a cumulative toxicant, once exposed a subject cannot effectively opt out.

Fluoridation is a State-sponsored (and in Ireland, State-mandated) medical intervention without the express and informed consent of each legally competent member of the public. The Code of Ethics defined under the Convention on Biomedicine can be relied upon within Europe in assessing the ethical issues raised by water fluoridation. By such criteria, fluoridation represents extreme violation of medical ethics, particularly as the substances concerned have not been subjected to full appraisal and licensing under the relevant regulations of the European Community.

As demonstrated above, water fluoridation is a medical intervention by the State, and not a water treatment process. It is effectively unavoidable by the majority of the public. It employs unregistered medicinal substances (but which are, in England at least, registered and controlled poisons) for which there is no mandate in the relevant medical legislation.

Administration of these substances may lead to serious medical and psychological side effects, but no clinical or epidemiological trials have been presented to formally support any application to register them as medicinal substances. The human rights issues raised by State-sponsored water fluoridation are therefore extensive.

The Universal Declaration of Human Rights (23) proclaimed by the General Assembly of the United Nations on 10th December 1948 led to the development of the European Convention on Human Rights and Fundamental Freedoms 1950 .(24) It came into force on 3 September 1953, and over the years has been repeatedly modified, up to the latest version, in which Protocol No. 11 (ETS No. 155) came into force on 1 November 1998. (25)

The case law of the European Court of Justice governs how the rights guaranteed under the Convention are applied in the EC in accordance with the general principles of Community law. To ensure uniformity of application within the EU, the acquis communautaire is based on a common foundation of rights and obligations binding member states together. Countries wishing to have the same status and the same privileges as existing Member States must accept these rights and obligations in toto.

To a limited extent, the English Human Rights Act 1998 (26) implements the European Convention. Originally, in Britain in the 1960s the decision on whether or not to fluoridate was the responsibility of elected local authorities, and therefore clearly an official political issue. But the subsequent transfer of responsibility to unelected Area Health Authorities represented an attempt to turn it into a purely medical issue, with no overt political status.

The official Guidance Notes (27) recently issued by the British Home Office for the benefit of Government Departments provide an indication of the way that the Civil Service proposes to regard issues arising under the new legislation. Referring particularly to Articles 3 and 8 of the Act, the Guidance Notes state

Under the Human Rights Act, the validity of any oppressive enabling legislation may be challenged if it appears that the State has given itself the power to carry out a medical intervention which is incompatible with the fundamental rights of the populace, as specified for example under the provisions of the Convention on Biomedicine. So it appears that there should be an effective remedy to the injustice of compulsory fluoridation under the Human Rights Act. Regrettably, in England at least, assuming this to be the case would be a grave error. Section 25 of the Home Office Guidance Notes states,

However, it is important to note the use of the words 'may' and 'can' in this extract - no element of compulsion is denoted by this statement, nor supported by subsequent qualifying text in the Act itself. Section 6 of the Act states that an infringement is exempt if primary legislation exists that dictates that a Public Authority could not have acted differently, and the Guidance Notes make no mention that striking out oppressive existing legislation is compulsory - the Government may or may not take remedial action according to its whim. Indeed,

With such wording there is ample scope for the State to procrastinate or avoid actually striking out existing legislation, especially s 87 of the Water Industry Act 1991 permitting water fluoridation, even if it is declared incompatible with the provisions of the Human Rights Act.

The European Charter of Fundamental Rights (28) is entirely distinct from the European Convention on Human Rights. It is a separate set of rights which are to be interpreted by the judges at the European Court in Luxemburg, which will eventually become incorporated into European law, alongside the Convention on Human Rights and the English and Scottish domestic versions of it.

In September 2000 the EU Justice and Home Affairs Commissioner said that the European Court of Justice would use the Charter as a reference text in reaching decisions, even if it was purely a declaratory document. With Britain's assent to the

Draft, all aspects of criminal and civil law will eventually come under the control and interpretation of the European Court of Justice.

Any Parliamentary Act which is deemed to contravene the new legal framework must (and not simply 'may' as the English version of the Human Rights Act specifies) be struck down by European judges if a British citizen petitions for an end to the violation of his/her new rights under the Charter.

Under Article 35 of the Charter, the public can now take the Department of Health or a water undertaker to the European Court to establish their right to receive particular drugs or treatments - or, of course, to prevent them from having such treatment administered to them against their wishes. The right to health care (Article 35) includes the right to refuse health care, for whatever reason. Remedial action will not need first to go through the English courts, as do actions brought under the Human Rights Act.

So if a water company complies with a request or demand by the Government or a Health Authority to implement fluoridation policy, it will be guilty of administering an unlawful medical intervention which is prohibited by medical ethics rules such as those set out in the Convention on Biomedicine. Moreover, since the silicofluorides are unregistered as permissible medicinal substances, their use contravenes the regulations of both the Codified Pharmaceuticals Directive and the Poisons Act. This is an issue of direct personal relevance to all Board Members of a water undertaker, as well as to their Shareholders.

All types of fluoride antagonise iodine metabolism, leading to hypothyroidism. This has been attributed as the primary cause of skeletal fluorosis, and the initiation of a range of medical defects associated with that condition. There is increasing sound scientific evidence of the widespread incidence of damaging medical conditions induced by fluoride overload in consumers, particularly dental fluorosis, even at presently permitted levels. Article 38 could be invoked directly by any member of the public in an action against the water undertakers, for deliberately increasing their environmental exposure to fluoride by adding it as an unlawful contaminant of their product.

Since water is a consumer product, action could also be taken against water undertakers under Article 38 of the Charter, which requires that 'Union policies shall ensure a high level of consumer protection'. The fact that silicofluorides are not licensed as medicinal substances, despite being used as such, means that water undertakers that do fluoridate their product are at considerable risk. They have already indicated an awareness of their vulnerability by stating that they require from Government "full legal indemnity - i.e. absolute indemnity on civil liability and indemnity on strict criminal liability as far as public policy allows" if a Health Authority orders them to implement fluoridation.

Human Rights legislation protects the rights of every individual, and in the case of State medication without consent, this right is absolute unless there is an over-riding public health threat from those not so medicated. Any attempt by Government to circumvent those opposed to the practice of fluoridation by basing future action on the wishes of the majority, as expressed by a public vote, would be unlawful, as it would deprive the minority of their right to refuse medication. In such a case, fluoridating the public water supply must be deemed in violation of the Human Rights legislation. Those wishing to medicate themselves with fluoride are able to do so individually by using one of the many fluoridated dental products freely available from retail outlets. (29)

Under Article 37 of the Charter the public has a right to a high level of environmental protection. Apart from the deliberate contamination of drinking water, which is itself part of the human environment, more than 99% of all fluoridated water enters the wider environment, via the sewage system, without being drunk. This represents the dumping of large quantities of silicofluorides directly into the surface waters of the country, yet there has been no Environmental Risk Analysis of the issues raised by this. This is a clear failure on the part of the English and other Environment Agencies to ensure that such toxic products are not released into the environment without regulation. It clearly is not in accord with the objective of Article 37 to maintain a high level of environmental protection.

Failing to ensure that the public is not exposed to silicofluorides could also be held to be a violation of the public's right to be protected from general environmental pollution. In a more general perspective, there is a Union-wide requirement to protect vulnerable natural communities and, where possible, improve environmental conditions, under the Habitats Directive (92/43/EEC) .(30) In England, s.4 (i) of the Environment Act 1995 (31)imposes a similar requirement on the Environment Agency. Therefore the Environment Agency, Local Authorities and Councils could all be held accountable under Article 38.

Fluoridation violates numerous Articles of the European Human Rights legislation. Complainants have the right to appeal directly to the European Court for redress.

Action may be brought against both public medical and private water sector bodies for Human Rights violations.
In addition, private sector water suppliers are vulnerable under product liability legislation, and to criminal action under the Poisons Act for administering unlicensed medicinal substances to the public.

Regardless of the medicinal status of fluoride, whether it be sodium fluoride, the silicofluorides, or any other fluoride-containing substance, and irrespective of whether or not it provides the benefits claimed by its proponents, the practice of fluoridating the public water supply with the intent to medicate the populace as a whole is inconsistent with the principles of medical ethics and violates the Human Rights of the Citizens of the European Union.

Since alternative methods of adding fluoride to the diet are available to all individuals wishing to add fluoride to their own diet, and are permitted by law, the practice of water fluoridation should be declared unlawful, and prohibited throughout the European Union forthwith.

Douglas Cross, 18th January 2003.

References (Note: All referenced internet links active as of 19 Janruary 2002)