Written evidence submitted by Douglas Cross (HSC0896)
Summary of main points.
1. The primary issue – legitimacy. The primary issue with respect to the proposal to retain the practice of water fluoridation as a public health policy is that it is incompatible with established legislation on water, foods, medicines and human rights.
2. Misrepresentation. Neither the general public nor the majority of Councillors have the necessary knowledge to discern the truth from the fraudulent in evidence relied on by both sides of the argument over fluoridation. In addition, Members of both Houses have been advised by the MHRA that, in its opinion, fluoridated water is not a medicine. The MHRA has no authority to issue any such opinion [1] and has never revealed the substance of any such advice. This advice, relied on by Members of Parliament, is in direct conflict with the Jauncey LJ decision of 1983 that "Section 130 [of the Medicines Act 1968] defines "medicinal product" and I am satisfied that fluoride in whatever form it is ultimately purchased by the respondents falls within the definition." [2]
3. The 'legal fiction' that fluoridated water is not a medicine. As Shaw has pointed out: UK legislation currently permits the addition of a medicine to public water supplies, which in effect makes the water itself a medicine. It is unsurprising that government agencies would prefer to deny that this is the case through the use of a legal fiction. In plain language, this 'legal fiction' is a lie.[3]
4. Abolition of the public right to drinking water. The addition of 'fluoride' to a public water supply converts it to a medicinal water. Fluoridated water is subject solely to medicinal regulation. The drinking water quality standards established under water law do not apply to a medicinal water. The public right of access to drinking water is withdrawn, and statutory access to remediation in law for any harm caused by chemical or biological contamination of a fluoridated supply is abolished.
5. Eligibility for Judicial Review. Any further debate by this Committee is contingent upon establishing the correct legal status of this product. In considering whether or not to endorse this practice, and in view of the deliberate obstruction of the legal issues by Public Authorities, the Committee is obliged to obtain independent legal advice on the tension between fluoridation and other arms of law. In the event of failure to resolve this issue, Judicial Review becomes essential. Debate on its claimed safety and efficacy as a public health intervention is entirely subordinate to the resolution of its alleged legitimacy.
6. Constraint on evidence submitted to the Committee. Under current food and medicinal law, it is a criminal offence to issue any medicinal claim for a food or an unlicensed medicine. Regardless of whether a witness asserts that this product is subject to food or medicinal law, making any claim that it has any medicinal property to the Committee is prohibited. Publishing any such claim in evidence heard by the Committee may itself be an offence.
7. Catch 22. 'Ingestible products' are classed as either foods or medicines. If a proponent of fluoridation argues that the product is either a food or a medicine, and asserts that it prevents dental decay, that person commits a criminal act under the relevant arm of law. Attempting to evade this constraint, by asserting that the product is neither one nor the other, implies that fluoridated water is not ingestible. In that case it must be classed as a poison. The Committee should then consider the implications of supplying a poison to the public in the water supplies
8. Conclusion. The continued reliance on water fluoridation as a prophylactic treatment for dental decay must be permanently removed from public health policy.
1. My credentials and reason for providing this evidence.
I am a professional Biological Consultant, and a Fellow of the Royal Society of Biology. I have extensive international experience at Executive and Mission Leader level, and as an Expert Witness, in the assessment of projects and policies, including those in which public health issues arise. As a former Director of the NGO, UK Councils Against Fluoridation, for many years we have provided independent analyses of fluoridation proposals for Local Authorities in the North West and Northern Ireland, as well as elsewhere.
At one time we successfully represented the interests of up to 75 Member Councils in the UK opposed to fluoridation. During our period of operation, no new fluoridation schemes were introduced in England. Regional Governments other than that of England have all accepted our information, and rejected the policy of water fluoridation on principle. These decisions were made on purely democratic grounds – once the public was provided with the full evidence, for and against the practice, it enjoyed the democratic right to decide through liaison with their Local Authority.
The recent statement by Mr. Matt Hancock, Secretary of State for Health that under the proposed reorganization of the Health and Social Care sector, the government plans to 'seize back control', and transfer authority to impose fluoridation is a clear admission that relying on the democratic approach to government obstructs the ability of the public health sector expand its preferred policy when confronted by an informed general public.
It reveals that the public health sector now considers that only government by diktat will circumvent this democratic inconvenience. It is an implicit admission by Government that our collaboration with the public, through their Local Authorities, ensured the application of full democratic process, and that it was effective. The Committee should take note of the ethical implications of this fact.
2. Fluoridation – the reality.
The public rejection of water fluoridation is founded on the entirely justified stance that it is a State-imposed form of non-consensual mass medication. The assertion to Parliament by Mr. Matt Hancock, Secretary of State for health, that fluoridation is supported by 'the vast majority of the public', and that opposition is 'held back by the very small number of people who disagree' is false. [1] It reflects the ignorance and deceit that pervades the entire debate on fluoridation.
The reliance on the heavyweight 'experts', on both sides of the controversy, on scientific 'evidence' of generally execrable quality may be academically satisfying, but it simply baffles an uncomprehending public – and that includes almost all members of Local Authorities as well. In exactly the same fashion as it has misrepresented statistical data on Covid19 infections, PHE has in the past persistently misrepresented dental public health statistical data to Councils, in its desperate efforts to 'sell' them a false belief in the doctrine of water fluoridation. [2]
This deluge of fraudulent information obstructs the understanding of Councils and the public of the actual facts relating to the effects of this controversial public health intervention. We have considered that the role of UKCAF has been to interpret the technical data, and to provide it in a form that Councils are able to understand. This has provided better access of the general public and Councillors to the facts in each case as it has emerged. Contrary to Mr. Hancock's belief, and as we have repeatedly discovered, once the public becomes better aware of the full range of arguments for and against the practice, fluoridation proposals are always strongly rejected. For example, 72 per cent of the 10,000 respondents of a 2007 poll of Southampton residents who lived in areas in which fluoridation was proposed said they did not want fluoride. [3] A similar proposal received almost unanimous public rejection by the Isle of Man population in 2009.
3. Deception of Parliament
But the deceit does not end there. Members of both Houses have been advised by the MHRA that, in its opinion, fluoridated water is not a medicine. In debates preceding the passing of the Health and Social Care Act in 2012, for example, Earl Howe, at that time Parliamentary Under-Secretary of State for Health, reported to the Upper House that The Medicines and Healthcare products Regulatory Agency considers that fluoridated water falls outside the definition of a medicinal product. [4]
The MHRA still maintains this position, despite the fact that, as the Curt of Justice of the European Union (CJEU) has ruled, Member State regulators of medicinal products have no legal authority to issue any such opinion [5] Yet the agency has never disclosed the provenance of any such advice. Although relied on by Members of Parliament, it directly rejects the Jauncey LJ decision of 1983 that "Section 130 [of the Medicines Act 1968] defines "medicinal product" and I am satisfied that fluoride in whatever form it is ultimately purchased by the respondents falls within the definition." [6] As Shaw has pointed out: UK legislation currently permits the addition of a medicine to public water supplies, which in effect makes the water itself a medicine. It is unsurprising that government agencies would prefer to deny that this is the case through the use of a legal fiction. In plain language, this 'legal fiction' is a lie.[7]
As I shall show, any statement that fluoridation prevents dental decay is a prohibited claim in English law, regardless of whether this product be regarded as a food or a medicine. Its persistence is absolutely reliant on the refusal of the MHRA, to accept that fluoridated water is a medicinal product. But because the agency itself is responsible for policing such illegal claims, it chooses to ignore its statutory duty, thus enabling the public health sector to continue to attempt to coerce both the public and Parliament into supporting fluoridation.
4. Approach to this Consultation.
I am not concerned here with the controversy of whether or not the practice of adding the chemical, substance hexafluorosilicic acid, (not 'fluoride') to drinking water is either safe or effective. My aim is to show that Parliament, in attempting to impose this practice on the generally non-consensual public, has negligently created tension between fluoridation law and pre-existing water, medicinal, food and human rights legislation. The relevant legal issues have all been clarified by decisions of the CJEU prior to Brexit, and these decisions and sources remain applicable to English law by reference to relevant domestic case law and pre-exit EU case law, and to the general principles of EU law, insofar as these have been retained. [8].
5. The priority of legal compliance over medical efficacy.
In my experience, the deliberate misrepresentation of factual information on fluoridation has invariably side-tracked debate away from the central issue – the actual legitimacy of the practice itself. Discussions now are dominated by pointless and irrelevant analyses attempting to decide whether the claims forwarded by proponents are of sufficient quality to justify the retention of this contentious practice. They are not. None of the 'evidence' in support of fluoridation is of the quality deemed to be essential for the granting of a license for a medicinal product for the purpose of imposing an invasive medicinal intervention on an entire State population.
However, scientific quality is not the sole, or even the primary, concern, of any proposed new intervention. Until any such policy can be shown to be entirely compliant with all relevant arms of non-competing law, any consideration of its efficacy and safety is irrelevant, no matter the circumstances that are alleged to require its use. To put it bluntly, if a medical intervention is unlawful, then its actual safety and efficacy are irrelevant, and I shall not consider the validity of these clinical arguments further.
6. Breach of Institutional Duty of Care in the regulation of medicinal products.
In defiance of relevant rulings of the CJEU and Lord Jauncy, the MHRA has persistently refused to comply with its statutory duty in the case of fluoridated water. The primary responsibility for this institutional malpractice within the public health sector rests squarely on its corporate shoulders, since its opinion has been enthusiastically relied upon by Public Health England (PHE) as the foundation for its continued dream of enforced fluoridation for the masses.
The reason for MHRA's reluctance to revise its opinion is entirely obvious. Were fluoridation to be regarded, correctly, as a medicinal intervention, then there would be no more water fluoridation. As a medicinal product, it would have to be subjected to full clinical appraisal, since this is mandatory for all such products. Only if it were able to pass such a detailed clinical scrutiny – and, on presently available evidence, this would be out of the question - would it then be eligible for the issue of a medicinal product marketing authorization ('license'). At that stage, and only then, would the question of seeking public acceptance of the merits and disbenefits of any proposed fluoridation be a question for further debate.
7. Fluoridation as medical malpractice.
Without a valid product license, no medicine may be used to prevent or treat a human disease. An exception to this embargo exists if a prescribing professional has an individual patient for whose urgent and serious condition no suitable medicine is available. Then, and only then, may the 'off-label' use of an authorized medicinal product be permissible, but even then only under strictly constrained medical terms and conditions, limited to the duration of the necessity.
The issue of 'need' in such cases is paramount. In the case of dental decay, especially among children, education in oral health has been shown to provide an excellent alternative non-interventional form of prophylaxis. In this case, the alleged unique 'need' for any alternative therapy is therefore not proven, and even then the use of this unlicensed product, 'fluoride', would be entirely inadmissible. Yet the government is now considering proposals to impose this controversial form of unethical and illegal preventive treatment on the entire population, of all ages and medical conditions, including those without dental decay, and even those without teeth at all.
It is medical malpractice to attempt to carry out any such emergency intervention on multiple patients, for most of whom there is no imperative need. This is precisely the obstacle that prevents the Government from imposing legislation permitting compulsory vaccination in the current Covid19 pandemic. This is so even though there is clear evidence of a severe threat to the survival of Covid19 patients, resolvable by the use of licensed vaccines. Even so, proposals to make vaccination compulsory for care workers are highly controversial. This constraint is also seen right now in the caution expressed regarding the proposed 're-purposing' of existing medicines, it their off-label use for treating Covid19-related conditions. In comparison, the belief that the effectively compulsory dosing of an entire population with this unlicensed medicine, fluoridated water, is even considered permissible should be treated with the contempt that this grossly improper policy deserves.
In the evasion of due process, and the consequent existing legal tension between relevant arms of law, the implementation of water fluoridation under the existing fluoridation legislation is unenforceable. Full Judicial Review of this situation and the legal tension on which it exists is essential.
8. The real legal status of fluoridated water.
English laws on water, food and medicine have been established in compliance with the Directives and Regulations of the European Union. Questions arising regarding the precise interpretation of such sources have been settled by judgements of the CJEU. The Committee will be aware that the relevant legal issues clarified by decisions of the Court prior to Brexit continue to be applicable to the English law, since they are 'retained law' under the European Union (Withdrawal) Act 2018.[8]. The arguments that follow rely on such sources and rulings where appropriate.
Discussion on the legitimacy of water fluoridation is deliberately misrepresented by the public health sector to both Local Authorities and the public. The right to a supply of drinking water is established under Chapter 3, Section 52, of the Water Industry Act 1991, while the quality of water intended for human consumption is set out in Council Directive 98/83/EC. In English law, the quality of drinking water is specified in Schedule 1 of the Water Supply (Water Quality) Regulations 2018. This is all perfectly clear.
However, what is invariably ignored is the simple fact that the Water Quality Directive (98/83/EC) specifically removes medicinal waters from the scope of drinking water law. Article 3 states ‘Exemptions: This Directive shall not apply to . . . waters which are medicinal products within the meaning of Council Directive 65/65/EEC . . . relating to medicinal products.’ The Directive does not recognise any medicinal water as drinking water. The 1965 Directive 65/65/EEC mentioned here provides the foundation of the Medicines Act of 1968, on which Lord Jauncey's decision that fluoridated water is a medicine is established.
The relevance of the Jauncey decision to this is entirely clear – fluoridated water is indeed, not drinking water, and as such subject to neither water law nor any dependent food law. While there appears to be no formal definition of a 'medicinal water', the matter is clarified by the ruling of the CJEU in 2005.
Where two different arms of law appear to apply to any drink, one arm of which is medicinal, then medicinal legislation must take precedence. 'Near-water drinks with added minerals' are specifically named as being subject to this ruling, and this unquestionably includes fluoridated water. All such products are classed as 'functional drinks', and are medicinal products under the provisions of EU law, and thus also of English law.
Significantly for the position improperly adopted by the MHRA, the Court emphasised that medicines regulators in Member States do not have the authority to exercise their discretion on the classification of such dual-function products - they must regulate them as medicines. [5] This exclusion of any medicinal water from being regarded as a food is also entirely consistent with other relevant arms of law. Only two classes of products are recognised as 'ingestible' - foods and medicines. Any other, such as recreational drugs or poisons, are not regarded as ingestible. It is a criminal offence in domestic laws, punishable on conviction by fine and/or imprisonment, to make any claim for a medicinal property for any food or any unlicensed medicine.
9. 'Quis custodiet ipsos custodes? (Who will guard the guards themselves? )
Regardless of the MHRA's refusal to issue any such license for fluoridated water, it is medicinal by both formulation and presentation, and so is subject to these prohibitions under food and medicinal law. Proponents who assert the claim that it prevents dental decay are in jeopardy of prosecution. That this has not actually happened is a matter for urgent investigation. The only authorised enforcement agency empowered to deal with such offenses is itself the MHRA. It seems that PHE and dental public health officials who make the prohibited claim are considered by the MHRA to be exempt from prosecution.
10. Implications for drinking water supply in the UK.
The addition at the water treatment works of 'fluoride', with the intent to prevent dental decay among consumers, instantly converts drinking water into a medicinal water at the treatment works itself, and before it reaches the 'point of compliance' (the consumers' taps), and thus before it falls within the scope of food law. (Pharmaceutical manufacturing legislation kicks in here, but I will leave that subject for others to debate.) As a medicinal water, all legislation relating to drinking water no longer applies.
The inclusion of 'fluoride' as a parameter for drinking water applies only to any fluoride naturally present (as calcium fluoride) in natural – i.e., untreated - raw drinking water. The substance added to fluoridate water is principally hexafluorosilicic acid, not 'fluoride'. If fluoridated water were indeed still held to be 'drinking water', then this addition is itself an offence in food law, since hexafluorosilicic acid is not an authorised 'source material' for adding fluoride to a food product.
The implications of this 'legal black hole' for the safety of the public are profound. The purpose of the formal drinking water quality standards is to provide redress in law for any harm caused by contamination of a public drinking water supply greater than permissible limits – for example, as occurred in North Cornwall in 1988.[9] The Committee should therefore consider the implications of this abolition of legal protection of the safety of the public when a fluoridated water supply Is substituted for the statutory product.
The public in areas in which the water supply is fluoridated has no access to the legal protection and recompense that is currently available to those whose water is not fluoridated. This is even now an issue in those areas of the UK in which this product substitution has been permitted by existing fluoridation provisions. Six million people are currently deprived of the protection afforded by water quality legislation against harm that may result from any dangerous contamination of their (medicinal) water supplies.
In addition, the Committee should be aware that the use of any medicinal product for the preparation of any food is generally prohibited under food law. This includes fluoridated water. To ignore this renders the food product itself a medicinal product, and as such subject to marketing only with a relevant medicinal product license. Again this is a consequence of the MHRA's refusal to comply with its statutory duty of care. This is a matter that is relevant to all processors and product manufacturers in both domestic and export food sectors
11. Is any form of public consultation on water fluoridation legally valid?
As a final point, I suggest that any attempt to hold a valid public debate on this subject is now seriously compromised by the past and present actions of the dental health advocates of water fluoridation. This is very real and urgent concern, since bias is evident even in documentation related to this Consultation. At S.5.132 it states that: Water Fluoridation is clinically proven to improve oral health and reduce oral health inequalities. [9] This is a clear medicinal claim, and as such is prohibited. Yet it issues from the Department of Health itself.
Through the failure of the MHRA and PHE to act in accordance with relevant law, and enforce compliance with the prohibition on medicinal claims for unlicensed medicines, the public has been bombarded with illegal claims such as this. So people have been coerced into accepting that fluoridated water prevents tooth decay, especially in young and vulnerable children, on the basis of illegal claims. When such claims are issued by authority figures within the profession, they are inevitably widely believed by most of those towards whom they are directed. Since the claims are in fact in violation of medicinal law, any opinions formed by members of the public in support of such false information may be regarded as having been improperly influenced through the prohibited actions of the proponents of fluoridation. Their opinions are therefore inadmissible in evidence. Public consultations founded on such improperly influenced evidence are unreliable as sources of reliable guidance for political policy decision making.
12. Sources.
1. Oral evidence: Department's White Paper on Health and Social Care, HC 1274 Tuesday 16 March 2021
https://committees.parliament.uk/oralevidence/1881/pdf/
2. Cross D.(2015) An unhealthy obsession with fluoride. Nanotechnology Perceptions 11.(2015) 169–1
DOI:10.4024/N11CR15A.ntp.15.03
3. Southampton Daily Echo: 5th June 2009.
https://hampshireagainstfluoridation.blogspot.com/2009/06/daily-echo_05.html
4. Hansard (Citation: HL Deb, 15 September 2011, c87W) Earl Howe
5. HLH Warenvertriebs and Orthica (Joined Cases C-211/03, C-299/03, C-316/03 and C-318/03) 9 June
2005 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62003J0211:EN:NOT
6. Opinion of Lord Jauncey in causa Mrs Catherine McColl (A.P) against Strathclyde Regional Council. The
Court of Session, Edinburgh, Case no 23 of June 29, 1983, pages 243-246..
7. Shaw D (2012) Weeping and wailing and gnashing of teeth: The legal fiction of water fluoridation.
Medical Law International, 12(1): 11-27)
8. European Union (Withdrawal) Act 2018, s 6(3)).
9. Cross D. (1990). The politics of poisoning. The Ecologist. 20(6): 228-233. (Nov/Dec 1990)
10. Department of Health and Social Care's legislative proposals for a Health and Care Bill CP 381,
February 2021
March 2021