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Follow-up petition on the regulation and approval of fluoridation products added to drinking water

Petition

[OAG Translation]

Saint-Laurent and Leclercville, 2 December 2010

Fluorides Added to Drinking Water Are Unregulated,
Unlicensed, Uncontrolled, Unethical and Illegal Drugs

Petition under s. 22 of the Auditor General Act for the discontinuation of the addition of toxic substances (inorganic fluorides, inorganic arsenic, lead) to drinking water, which is in violation of the Fisheries Act, specifically:

• s. 34(1), containing provisions to conserve and protect the fish habitat that sustains Canada’s fishery resources, and to prevent its harmful alteration;
• s. 35(1), prohibiting the harmful alteration, disruption or destruction of fish habitat; and
• ss. 36-42, controlling the deposit of any deleterious substance into water, which is fish habitat.

Office of the Auditor General of Canada
Commissioner of the Environment and Sustainable Development
Subject: Petitions
240 Sparks Street
Ottawa, Ontario  K1A 0G6
Email: petitions@oag-bvg.gc.ca

The Environment Is Not a Trash Can
The environment is not a trash can and the aquatic freshwater environment is especially sensitive to fluorides. Fluorides accumulate in the food chain and may have adverse effects on some aquatic species at lower concentrations but over longer periods. The environmental impacts are not restricted to aquatic species. However, adverse effects on farm animals are poorly understood.

We must ensure that fluoridation agents added to water for the therapeutic purpose of preventing dental cavities, and then released into the environment in wastewater, do not affect Canadians’ health or Canada’s aquatic freshwater flora and fauna.

Can the Government of Canada seriously claim that it is developing a management plan to reduce or eliminate the harmful effects of fluorides on the environment and on the health of Canadians when it promotes the addition of that same toxic element to drinking water? Does the Government of Canada not see the inconsistency when, on the one hand, it asks industry to reduce fluoride emissions and, on the other, Health Canada encourages the use of fluoridation, resulting in the release of large quantities of those very pollutants into the environment. Yet inorganic fluorides are among the “toxic substances” that have been identified by Environment Canada.

We must ensure that fluoridation of water for the therapeutic purpose of preventing or reducing dental cavities in humans respects the Food and Drugs Act, the Canadian Charter of Rights and Freedoms (“the Charter”) and Canadian and provincial environmental legislation.

In previous petitions to the Auditor General of Canada concerning the fluoridation of water, different petitioners sought to identify the acts or regulations that govern fluoridation agents for drinking water, to ensure compliance of those therapeutic agents in terms of dietary or pharmaceutical quality. They also asked how Health Canada could scientifically ensure the efficacy and safety of fluoridation agents if Health Canada did not control or monitor them. We were under the impression that the duty, role and mission of Health Canada was to ensure that drugs, natural health products, and foods distributed in Canada were, at the very least, safe. We must now conclude that Health Canada is not fulfilling its public health protection role and duty under the legislation, with respect to fluoridation agents. Why not?

In order to protect the health of Canadians, Health Canada is supposed to ensure that drugs and natural health products are approved in accordance with good manufacturing practices by manufacturers licensed by Health Canada. All products for which a therapeutic claim is made are normally considered drugs and must comply with all regulations made pursuant to the Food and Drugs Act. Although fluoridation agents are very actively promoted by the dental and medical professions, and by Health Canada, for their therapeutic action of preventing and reducing dental caries, and are perceived in this way by the public, those agents are not subject to control or monitoring by Health Canada.

Supreme Court of Canada: Fluoridation Agents Are Drugs Under the Act

In response to question 1 of our Petition 299, Health Canada states the following:

In response to questions 2 and 3 of the Petition, Health Canada continues:

Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569:
If the purpose of adding fluorides to drinking water is to prevent or reduce dental cavities, as Health Canada admits In response to Petition 299, those fluorides then become drugs or medication. This is not just an opinion but the basis for the Supreme Court of Canada judgment reached by justices J. Rand and J. Cartwright. Health Canada’s opinion on the nature and purpose of the fluorides added to drinking water does not seem sustainable in the least. The nature of the fluorides is determined by their purpose. If the purpose of adding those fluorides to drinking water were to treat the water to make it potable, they would not be drugs and would be legal as long as they met applicable American National Standards Institute/National Sanitation Foundation (ANSI/NSF) standards. However, this is by no means the case: their purpose is to prevent dental cavities. Justices J. Rand and J. Cartwright accordingly reached the following conclusion:

Fluoridation thus constitutes “compulsory preventive medication.” As this judgment of the Supreme Court of Canada was never appealed by the Government of Canada, it must have force of law and, in our view, Health Canada’s opinion that fluorides added to drinking water are not drugs has no legal or judicial value.

Need we remind Health Canada that, under the Food and Drug Regulations, C.R.C., c. 870, C.01.021, a drug includes any product having a sodium fluoride dose greater than 0.1 mg? Now then, drinking water fluoridated with sodium fluoride, sodium fluorosilicate, or hexafluorosilicic acid has a concentration of 0.6–1.0 mg fluoride per litre, which is 6–10 times higher than the dosage required to declare the product a drug.

Health Canada’s position on fluorides verges on inconsistency. The Department argues in response to questions 2 and 3 of Petition 299 that “the products used for fluoridation of drinking water do not fall under the regulatory framework of the Food and Drugs Act.” Yet the Food and Drug Regulations clearly state in s. D.02.001(k) that fluoride is one of the mineral nutrients permitted in the fortification of foods (water) and that fluorides and fluoridation agents fall under the Act:

Food and Drug Regulations, Part D,Vitamins, Minerals and Amino Acids, Mineral Nutrients in Foods

D.02.001. (1) In this Division, “mineral nutrient” means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements:
k) fluoride;»

Under the Food and Drugs Act, it would be both inconceivable and irresponsible of Health Canada not to exert control over the quality of nutrients used to fortify food by requiring that manufacturers follow good manufacturing practices and that the products used be listed in the Codex or equivalent authority. Fluoridation agents are not simply water treatment additives but sources of [TRANSLATION] “the element fluoride considered as a nutrient” by Health Canada. Therefore, we would expect s. 4 of the Food and Drugs Act to be applicable to all nutrients used to fortify food, including fluoride:
Food and Drugs Act, R.S. (1985), c. F-27, Part I, s. 4; 1993, c. 34, s. 72(F). (http://laws.justice.gc.ca/eng/F-27/index.html):

Prohibited Sales of Food
4. (1) No person shall sell an article of food that:
(a) has in or on it any poisonous or harmful substance;
(b) is unfit for human consumption;
(c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
(d) is adulterated;
(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

National Sanitation Foundation Standard 50

Fluorides as fluoridation agents are highly toxic, harmful substances that accumulate in the environment (see Environment Canada) and, even when they do meet applicable ANSI/NSF standards, they do not meet those of the Food and Drugs Act in terms of toxicity and sanitary conditions of manufacture, preservation, transportation or storage. To our knowledge, the applicable ANSI/NSF standards bear absolutely no relation to the standards and regulations governing the production of food or drugs as set out in the Food and Drugs Act. Moreover, according to the Food and Drug Regulations, the only acceptable form of fluoride is sodium fluoride.

The ANSI/NSF standards provide no assurance as to the food or drug quality, effectiveness, or safety of fluoridation agents. The applicable ANSI/NSF standards only manage the chemical quality of products used in water treatment to make it potable and do not apply to products used to feed or treat humans or animals. Moreover, ANSI/NSF strongly rejects such a role. While Health Canada can recommend [TRANSLATION] “that we ensure that these products comply with applicable ANSI/NSF standards,” compliance with those standards will never [TRANSLATION] “ensure that treated water does not pose a risk to consumer health, whether because of the fluoride itself or because of its impurities” (Petition 299). On this point, the NSF asserts that NSF Standard 60:

The NSF also states that it is not responsible for the reliability of Standard 60:

The NSF is quite clear: it does not assess the safety of fluorides added to water for the purpose of treating or mitigating disease in humans.

At the present time, neither Health Canada, nor ANSI/NSF is in a position to [TRANSLATION] “assure the public that water treated by fluoridation agents does not pose a risk to consumer health, whether because of the fluoride itself or because of its impurities.” Yet Health Canada has the responsibility under the Food and Drugs Act to ensure that food, natural health or pharmaceutical products comply with the Act. Certification of water treatment additives is unrelated to fluoridation, and fluoridation of drinking water is unrelated to water treatment.

Unregulated, Unlicensed, Uncontrolled, Unethical and Illegal

Health Canada bears full responsibility for ensuring that fluoridation agents are in compliance with the legislation and that the Department’s attempt to shirk its obligations by stating that it “has no mandate or authority regarding the certification process” is unacceptable (Environmental Petition OAG 221B).

The purpose of fluoridating drinking water is not water treatment. Fluoridation agents are “fraudulent” products because claims are made as to their efficacy and safety when the elements required to establish those facts are not in place (see Food and Drugs Act, R.S. (1985), c. F-27, Part I, s. 4). It is abundantly clear that Health Canada is trying to sow confusion over the purpose of water fluoridation.

Given the judgment of the Supreme Court of Canada, it is our view that Health Canada has no choice but to consider fluoride added to water a drug. It is not a simple drug but one forcibly administered to communities, and the judgment clearly states that it constitutes “compulsory preventive medication” of the inhabitants of the area. Most seriously, Health Canada, the body responsible for ensuring the safety of Canadian drugs, is promoting and endorsing the use of a drug that is literally illegal, for the following reasons: it has not been licensed; it is not subjected to the requisite toxicology and efficacy tests; distributed drug lots do not undergo the appropriate quality control tests; good manufacturing practices are not followed; manufacturers have not obtained a manufacturing licence; the drug is not manufactured, packaged, transported, or stored under the required sanitary conditions; and fluoride is a highly toxic element, having a toxicity approaching that of arsenic and lead and, therefore, cannot be considered safe. If it is not safe, then Health Canada has the urgent duty to take action and withdraw the product immediately. Yet, rather than taking immediate action to withdraw the product, Health Canada appears to be trying to excuse itself by misrepresenting or ignoring the legislation and officially offloading all its responsibilities onto a foundation representing the water treatment additive industry. Health Canada has a duty to protect the health of Canadians.

Duty of the Department of Justice Canada to Ensure Compliance with the Legislation

It now appears to be up to the Department of Justice Canada to ensure that Health Canada enforces the Food and Drugs Act as enacted with respect to fluoridation agents and based on the Supreme Court of Canada judgment. The Department of Justice Canada is also responsible for ensuring compliance with s. 7 of the Charter of Rights and Freedoms as it relates to the protection of life, liberty and security of the person. Fluoridation of drinking water, where it is applied, represents the administration of “compulsory preventive medication” without the patient’s consent and is therefore in breach of s. 7 of the Charter, which consecrates the inviolability of the person. Violation of an individual’s basic right to liberty and security of the person as a result of fluoridation of his/her drinking water compels immediate action by the Department of Justice Canada. The Department of Justice Canada should therefore immediately order that fluoridation be discontinued. It should also order Health Canada to arrange for the immediate withdrawal of the fluoridation agents, as the latter are in violation of the Food and Drugs Act, and to declare those agents illegal, because they are not licensed. It is entirely within Health Canada’s authority and responsibility to apply the Food and Drugs Act to fluoridation agents. In our view, the Department of Justice Canada also has the duty to ensure compliance with environmental legislation prohibiting the release into the environment of toxic substances such as fluorides at concentrations that may negatively impact aquatic freshwater ecosystems, which are highly sensitive to fluorides.

Responsibility of the Department of Environment Canada with Respect to Fluoridation

The Department of Environment Canada also has legal authority over this public health measure since the latter entails the deposit of a substance that the Department considers toxic for aquatic flora and fauna into Canada’s rivers and Great Lakes. The fluoride effluents deposited by cities that fluoridate their drinking water are 5–8 times higher than the limits set in the Canadian Water Quality Guideline (CWQG) for the protection of freshwater life (see citations in Petition OAG 221). Since the Department of Environment Canada has a duty to protect aquatic flora and fauna, it must enforce the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the Fisheries Act (R.S., 1985, c. F-14, ss. 34(1), 35(1) and 36-42), which implies the discontinuation of fluoridation throughout Canada.

QUESTIONS

1. In response No. 1 to our Petition 299, Health Canada states that fluoride added to water is not considered a drug or a natural health product but, in its opinion, a nutrient used to fortify foods or water. However, in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957, the Supreme Court of Canada found that fluoridation of drinking water constituted compulsory preventive medication:

2. In the view of the Minister of Justice, does the judgment of the Supreme Court of Canada in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957, that fluoridation of drinking water constituted compulsory preventive medication, and which the Government of Canada never appealed to the Supreme Court of Canada:

3. In the view of the Minister of Justice, does the judgment of the Supreme Court of Canada in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957, that fluoridation of drinking water constituted compulsory preventive medication, which the Government of Canada never appealed, set a judicial precedent having force of law with respect to the medicinal nature of the addition of fluorides to drinking water for the purpose of preventing and treating dental cavities?
4. Given the judgment of the Supreme Court of Canada in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957, defining the fluoridation of drinking water as compulsory preventive medication, and given the fact that the Government of Canada never appealed the judgment to the Supreme Court of Canada:

5. How much time must pass before Health Canada acts to discontinue distribution and order the recall of a drug, in this case fluoridation agents, that has not been licensed by Health Canada, given the fact that the Supreme Court of Canada has determined that fluoridation of drinking water constitutes compulsory preventive medication?
6. What action can the Department of Justice Canada take against Health Canada if the latter fails to discharge its responsibility to protect the health of Canadians in allowing use of an unlicensed, untested, uncontrolled or unidentified drug, i.e., fluoridation agents, given the fact that the Supreme Court of Canada determined in 1957 that fluoridation of drinking water constituted “compulsory preventive medication,” that the judgment was never appealed, and that Health Canada never took into account this crucial judgment which, in fact, defines “fluoridation agents” as drugs, based on their purpose of preventing and treating tooth decay (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957)?
7. How much time must pass before the Department of Justice Canada takes action against Health Canada which, despite its responsibility for drug safety, continues to allow the distribution of a drug of highly dubious quality, in this case fluoridation agents, which have been neither licensed by Health Canada nor tested, controlled or identified, to discontinue distribution and order the recall of the drug, if Health Canada fails to take immediate action to protect the health of the millions of Canadians who are exposed to fluoridation of their drinking water, given the fact that the Supreme Court of Canada determined in 1957 that fluoridation constituted “compulsory preventive medication” (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957)?
8. Since, in the judgment of the Supreme Court of Canada, water fluoridation constitutes “compulsory preventive medication of the inhabitants of the area” through drinking water, and since the “compulsory preventive medication of the inhabitants of the area” implies the administration of a drug without the informed consent of the patients, and since such a practice is in violation of s. 7 of the Canadian Charter of Rights and Freedoms, what immediate action does the Department of Justice Canada plan to take to ensure that the rights of all Canadians, such as the fundamental right to life, liberty and security of the person granted under s. 7 of the Charter, are immediately respected? Administration of a drug without the informed consent of a patient is a violation of a fundamental right under the Charter and demands immediate action (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957).
9. What action has Health Canada taken with legal counsel to establish the status of fluoridation agents, i.e., whether they are drugs, water fortification agents or water treatment additives, in light of the judgment by the Supreme Court of Canada in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957?
10. In the opinion of Health Canada, has there been a requirement on manufacturers or distributors of fluoride supplements approved to date by Health Canada under the Food and Drugs Act (drugs with a Drug Identification Number [DIN] or natural health products with a Natural Product Number [NPN]) to conduct chronic toxicology tests, including carcinogenicity, neurotoxicity and toxicokinetics tests, to obtain an operating licence, to provide evidence of good manufacturing practices and to submit evidence of efficacy and safety before Health Canada licenses them for those drugs?
11. In the opinion of Health Canada, what dosage of fluoride expressed in mg/kg/d would be considered nutritional, as opposed to therapeutic? (Please provide data on the recommended therapeutic dosage for each age group and include the equivalency in litres of water considered effective for nutritional purposes.)
12. How does Health Canada explain the fact that the nutritional dosage of fluoride obtained from water can easily equal and, indeed, often exceed the therapeutic dosage offered by fluoride supplements which, for their part, are considered drugs and must be licensed for distribution, while fluoridation agents are not? Both forms of treatment have the same purpose, i.e., to reduce the incidence of dental cavities, both offer a daily dosage equivalent, both have harmful effects on dental health as they cause dental fluorosis in up to 75 percent of the population in municipalities that fluoridate their water, with up to 11% found in the moderate to severe range.
13.  Given the fact that the National Sanitation Foundation (NSF), an agency of the water treatment agent industry, is not accountable to any government or public health agency and not responsible for demonstrating compliance with federal requirements applicable to drugs, natural health products, or nutrients, and given the fact that Health Canada rejects any such responsibility, stating that it considers fluoridation agents to be nutritional rather than therapeutic, contrary to the judgment of the Supreme Court of Canada (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 26 June 1957), which government or department is accountable for ensuring the efficacy and safety of fluoridation agents in Canada’s drinking water and thereby ensuring the protection of Canadians’ health?
14. Is Health Canada under the impression, or is it suggesting, that the regulatory requirements of NSF Standard 60 include the necessary assessments to ensure the efficacy of fluorosilicates used to add fluoride nutrients to drinking water, when the NSF denies any such responsibility?
15. What actions and steps has Health Canada taken and what studies has it conducted over the last ten years to assess the impacts of fluoridation on freshwater ecosystems in Canada (in collaboration with the Department of Environment Canada, or not) in order to demonstrate Health Canada’s concern with protecting the environment on which human health depends?
16. Of the total expenditures by Health Canada since 2000 (i.e., over the last ten years) on reviews, assessments and promotion of fluoridation of drinking water as a public health measure, what was the estimated percentage expended on the environmental aspects of fluoridation of drinking water with respect to the deposit of municipal effluents? (We would appreciate an estimate of both the total budget for all of Health Canada’s expenditures on fluoridation and the proportion relating to the environmental impacts. We realize that Health Canada is not directly involved in administering the fluoridation programs, which come under provincial and territorial jurisdiction.)
17. Since s. C.01.021 of the Food and Drug Regulations, C.R.C., c. 870,whichsets the dosage limits for drugs, classes any product having a sodium fluoride dosage greater than 0.1 mg as a drug, how has Health Canada managed to circumvent the Food and Drugs Act and the Food and Drug Regulations to avoid classifying bottled water fortified with sodium fluoride at a concentration of 1 mg/L and drinking water treated with sodium fluoride, sodium fluorosilicate, or hexafluorosilicic acid at similar dosages as drugs?
18. In the opinion of Health Canada, is there any act or regulation that could prohibit municipalities from adding fortification minerals such as vanadium, chromium or selenium to their drinking water system and, if so, under what act or regulation would fluoride be exempted when vanadium, chromium, and selenium were not?
19. In the opinion of Health Canada, is there any act or regulation that could prohibit municipalities from adding the mineral lithium to their drinking water system and, if so, under what act or regulation would fluoride be exempted when lithium was not?
20. When and how does Health Canada plan to conduct an awareness campaign on the importance of not using artificially fluoridated drinking water in the preparation of infant formula, since the risk of dental fluorosis tends to be greatest in this period of tooth formation, in order to fulfil its duty of protecting the health of Canadians?

Questions to Health Canada, the Department of Justice, and the Department of the Environment further to explanations provided in the matter.

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Minister's Response: Environment Canada

21 March 2011

Dear Messrs. Parent and Morin:

I am writing in response to your Environmental Petition no. 299-C, pursuant to section 22 of the Auditor General Act, regarding added fluorides in drinking water. Your petition was received in Environment Canada on December 22, 2010.

As the questions you raise relate mainly to drinking water, the Minister of Health will respond to your petition questions on behalf of the Government of Canada.

Sincerely,

[Original signed by Peter Kent, Minister of the Environment]

The Honourable Peter Kent, P.C., M.P.

c.c.: The Honourable Leona Aglukkaq, P.C., M.P.
Mr. Scott Vaughan, Commissioner of the Environment and Sustainable Development

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Minister's Response: Health Canada

19 April 2011

Messieurs,

This is in response to your environmental petition no. 299 C of December 2, 2010, addressed to Mr. Scott Vaughan, the Commissioner of the Environment and Sustainable Development (CESD).

In your petition you raised questions about fluorides added to drinking water.

I am pleased to provide you with the enclosed Health Canada response to your petition. I understand that the ministers of Justice and Attorney General of Canada and Environment Canada will be responding separately to questions that come under the purview of their respective departments.

I appreciate your interest in this important matter, and I hope that you will find this information useful.

Sincerely,

[Original signed by Leona Aglukkaq, Minister of Health]

Leona Aglukkaq

Enclosure

c.c. Mr. Scott Vaughan, Commissioner of the Environment and Sustainable Development

Government of Canada Response to
Environmental Petition No. 299C, filed by Mr. Pierre J. Morin and
Mr. Gilles Parent
under Section 22 of the Auditor General Act
Received December 22, 2010

Petition asking for a response to twenty questions on
Fluorides Added to Drinking Water

April 21, 2011

Minister of Health

Introduction:

Health Canada (HC) is the federal department responsible for helping the people of Canada maintain and improve their health.

The following points are provided as preliminary information:

• Any reference to drinking water or water is exclusive and therefore in itself viewed as its essential qualities as is any reference to bottled water and pre-packaged ice.
• Fluoride is considered a drug when it is offered for sale in a final dosage form, used in large concentration and with a drug delivery system, and is labelled for therapeutic use (or makes therapeutic claims). When added to water, at levels in accordance with recommendations of expert advisory bodies such as the Institute of Medicine, National Academies of Science, to meet a nutritional requirement, it is considered a mineral nutrient.
• The National Sanitation Foundation (NSF) International is a standard-setting organization; certification bodies (rather than the standard-writing organization) certify products as meeting the requirements of a specific standard. Standards need to be referenced in legislation or regulation to make them enforceable. They are tools available to regulatory agencies to help ensure the quality of drinking water.
• Drinking water is regulated at the provincial and territorial level. The adoption and enforcement of applicable statutes/regulations would fall within the mandate of the individual provinces and territories. For further information, the individual provincial and territorial government should be contacted directly.
• Fluoride is added to drinking water as a public health measure to protect dental health by preventing or reducing tooth decay. Fluoride added to water in the concentrations available in Canada is considered nutritive as opposed to therapeutic. Fluoridating drinking water is intended to provide a dietary source of fluoride, a mineral nutrient. Products used to fluoridate drinking water do not fall under the regulatory framework of the Food and Drugs Act (FDA). Health Canada does recommend that these products be certified to the appropriate American National Standards Institute (ANSI)/NSF standard, to ensure the treated water would present no health risk to consumers from either the fluoride or any impurity under the recommended conditions of use.
• Fluoride used in drinking water fluoridation is not considered a drug and therefore is not captured under the FDA. Fluoride preparations, such as a dental rinse or toothpaste, that include a therapeutic claim and are represented for sale in Canada, are classified as Natural Health Products (NHPs) and are regulated under the Natural Health Products Regulations (NHPR).
• The suppliers of vitamins, minerals and amino acids used to fortify food or water products (bottled water and prepackaged ice) that are subject to the Food and Drug Regulations (FDR) do not require a licence to manufacture or distribute NHPs or drugs from Health Canada. The NHPR and Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) apply only to NHPs, not foods. Fluoride has not been added as a medicinal ingredient to any NHPs other than toothpastes and gel, rinse and tablet dental health products subject to the NHPR. Each of these products has been through a premarket assessment of safety, efficacy and quality and received a product licence authorizing its sale in Canada.

Question 1 (Q. 1):

In answer #1 to our petition #299, Health Canada stated that the fluoride added to water is not, in its view, a drug or a natural health product, but rather a nutrient used for fortification. However, in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26, the Supreme Court of Canada determined that the fluoridation of drinking water was compulsory preventive medication:

How does Health Canada reconcile the Supreme Court of Canada ruling, which states that fluoridation is compulsory preventive medication, with its opinion to the effect that the fluoride added to water is not medication? The unchallenged ruling by the Supreme Court of Canada is a judicial precedent that legally has the force of law, in the view of many experts.

Response Q. 1:

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 2 (Q. 2):

In the view of the Minister of Justice, does the Supreme Court of Canada ruling in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06‑­26, which determined that the fluoridation of drinking water was compulsory preventive medication and which the Government of Canada never appealed before the Supreme Court of Canada:

Cartwright J, Page 580 have precedence over Health Canada’s opinion with regard to the nature of the fluorides added to drinking water in the fluoridation process, whose admitted purpose is to prevent and treat tooth decay among the inhabitants of communities whose water is thus medicated? Health Canada considers these fluorides thus added to water not to be medication, but rather a nutritional additive to fortify water.

Response (Q. 2):

Department of Justice will respond under separate cover.

Question 3 (Q. 3):

In the view of the Minister of Justice, does the Supreme Court of Canada ruling in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957‑06­‑26, which determined that the fluoridation of drinking water was compulsory preventive medication andwhich was never challenged by the Government of Canada, constitute a legal precedent with the force of law as regards the medicinal nature of the addition of fluorides to drinking water for the purpose of preventing and treating tooth decay?

Response (Q. 3):

Department of Justice will respond under separate cover.

Question 4 (Q. 4):

With regard to the Supreme Court of Canada ruling in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26, which defined the fluoridation of drinking water as compulsory preventive medication and which the Government of Canada never appealed before the Supreme Court of Canada:

Response (Q. 4):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 5 (Q. 5):

How much time is needed for Health Canada to take action against and cease the distribution of a drug, namely, fluoridation agents, that has not been licensed by Health Canada, and for such fluoridation agents to be pulled from the market, in light of the fact that the Supreme Court of Canada has ruled that the fluoridation of drinking water was “compulsory preventive medication”?

Response (Q. 5):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 6 (Q. 6):

What actions can be taken by the federal Department of Justice against Health Canada if it does not fulfill its responsibility to protect the health of Canadians by permitting the use of an unlicensed, untested, uncontrolled and uncharacterized drug, namely, fluoridation agents, in light of the fact that the Supreme Court of Canada ruled in 1957 that the fluoridation of drinking water was “compulsory preventive medication”, that this ruling has never been challenged, and that Health Canada has never given consideration to this albeit crucial ruling, which does, in fact, define “fluoridation agents” as drugs as regards their ultimate purpose, which is to prevent and treat tooth decay? (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957‑06‑26).

Response (Q. 6):

Department of Justice will respond under separate cover.

Question 7 (Q. 7):

How much time is needed for the federal Department of Justice to take action against Health Canada, which, despite its responsibility to ensure drug safety, permits the distribution of doubtful quality drugs that have not been licensed by Health Canada, and further are untested, uncontrolled and uncharacterized, namely, fluoridation agents, and for the distribution of such drugs to be discontinued and the drugs pulled from the market if Health Canada does not act immediately towards protecting the health of millions of Canadians exposed to the fluoridation of their drinking water and in light of the fact that the Supreme Court of Canada ruled in 1957 that fluoridation was “compulsory preventive medication? (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26).

Response (Q. 7):

Department of Justice will respond under separate cover.

Question 8 (Q. 8):

Since the fluoridation of water, according to the Supreme Court of Canada ruling, represents “compulsory preventive medication of the inhabitants” via drinking water and “compulsory preventive medication of the inhabitants” implies the administration of a drug without the informed consent of patients and a practice in violation of section 7 of the Canadian Charter of Rights and Freedoms, what immediate actions does the federal Department of Justice intend to take to ensure that the rights of all Canadians, such as everyone’s fundamental right to the protection of life, liberty and security of their person, as conferred by section 7 of the Canadian Charter of Rights and Freedoms, are upheld immediately? The administration of a drug without a patient’s informed consent constitutes a violation of a fundamental right conferred by the Canadian Charter of Rights and Freedoms and demands immediate action. (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26).

Response (Q. 8):

Department of Justice will respond under separate cover.

Question 9 (Q. 9):

What actions and processes have been initiated by Health Canada with legal authorities to elucidate the status of fluoridation agents, that is, whether they are drugs, water fortification agents or additives for the treatment of water, in consideration of the Supreme Court of Canada ruling in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26?

Response (Q. 9):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 10 (Q. 10):

In Health Canada’s view, have the manufacturers or distributors of fluoride supplements licensed to date by Health Canada under the Food and Drugs Act (drugs with a Drug Identification Number (DIN) or natural health products with a NPN) had to conduct chronic toxicology testing, including carcinogenicity, neurotoxicity and toxicokinetics, be in possession of an operating license to demonstrate good manufacturing practices and submit proof of efficacy and safety before Health Canada granted them a license for such drugs?

Response (Q. 10):

The mandatory premarket review by Health Canada of each product licence application for a health product to receive market authorization, the Drug Identification Number (DIN) or Natural Products Number (NPN), includes a review of all of the evidence necessary to demonstrate that the product is of high quality, safe and effective under the recommended conditions of use. Such evidence may include results of testing for carcinogenicity, neurotoxicity, toxicokinetics and chronic toxicology testing as appropriate for each product.

Manufacturers and distributors of fluoride supplements licensed by Health Canada under the Food and Drugs Act with a DIN or NPN must adhere to Good Manufacturing Practices (GMPs) as set out in Part C Division 2 of the Food and Drug Regulations (FDR) for DINs or Part 3 of the Natural Health Products Regulations (NHPR) for NHPs in order to sell their products in Canada.

Good Manufacturing Practices are the part of quality assurance that ensures that drugs and natural health products are consistently produced and controlled in such a way as to meet the quality standards appropriate to their intended use, as set out in their product licensing requirements. All drugs and natural health products must be manufactured, packaged, labelled, imported, distributed and stored in accordance with GMPs. Importers, manufacturers, packagers, and labellers must obtain an Establishment Licence (FDR Part C Division 1A) for those activities in relation to drugs and a Site Licence (NHPR Part 2) for those activities in relation to NHPs, the issuance of which is based on sufficient evidence of compliance with the GMP requirements set out in the relevant Regulations.

Question 11 (Q. 11):

What is the fluoride dosage in mg/kg/day that would be considered nutritional as opposed to therapeutic in Health Canada’s view? (Provide data on the recommended therapeutic dosage for each age group and include the equivalence in litres of water based on concentrations considered effective from a nutritional standpoint).

Response (Q. 11):

Dietary Reference Intakes (DRIs) are a comprehensive set of nutrient reference values for healthy populations that can be used for assessing and planning diets. The DRIs were established by Canadian and American scientists through a review process overseen by the National Academy of Sciences, which is an independent, nongovernmental body.

The Adequate Intake (AI) is the recommended average daily nutrient intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people who are assumed to be maintaining an adequate nutritional state. The AI for fluoride is 4 mg/day for males over the age of 18 and 3 mg/day for females over the age of 13, including women who are pregnant and lactating. The AI for children is 0.01 mg/day (infants 0-6 months), 0.5 mg/day (7-12 months), 0.7 mg/day (children 1-3 years), 1.0 mg/day (children 4-8 years), 2.0 mg/day (males 9-13 years), 3.0 mg/day (males 14-18 years), and 2.0 mg/day (females 9-13 years).

The levels of fluoride that are found in oral supplements (e.g. chewable tablets or drops) for the nutritional prevention of dental caries are explicitly labelled for use only in children living in areas with little or no natural water fluoride concentration. The dosages are established so that the fluoride intake is similar to that of children whose water is fluoridated, e.g. 1.0 mg/day theoretical total fluoride.

In contrast to fluoridated water supplies which typically provide fluoride in a concentration of approximately 1.0 mg/L, which is 1 ppm, up to a maximum of 1.5 ppm, the dosage of fluoride in dental health products for prevention and therapeutic use is much higher. The recommended range of fluoride concentrations in dentifrice gels and pastes is from 850 to 1150 mg/kg (ppm), average 1000 ppm, minimum twice daily treatment. Regarding different age groups, children under six years of age are recommended to use only a pea-sized amount of dentifrice and parents are cautioned to consult a health care practitioner before using in children younger than two years of age. For fluoride treatment gels and rinses, the fluoride concentration ranges from 14 ppm to 970 ppm, with the most concentrated products not being recommended for use in children younger than six years of age. Professional use (dentist only) fluoride treatment products range in concentration from 27 to 12,400 ppm fluoride and are used only under the direct supervision of the dentist who uses his or her professional judgement with respect to the age of the patient, although high concentration rinses are not recommended for use in children under six years of age.

Question 12 (Q. 12):

How does Health Canada explain that the nutritional dose of fluoride obtained from water can easily be equal to, and often greater than, the dose considered therapeutic as provided by fluoride supplements, which are considered drugs and need to be licensed in order to be distributed, whereas fluoridation agents do not require to be licensed? Both forms of treatment have the same objective, that is, to reduce the incidence of tooth decay, both offer an equivalent daily dose, both cause harmful effects to dental health by causing mottled teeth in up to 75% of the population in fluoridated municipalities, and moderate to severe cases in up to 11%.

Response (Q. 12):

Fluorides protect tooth enamel against the acids that cause tooth decay. As a public health measure, fluoridated drinking water significantly reduces the number of cavities. Thus, fluoride is used (water fluoridation) in many communities across Canada. While municipal drinking water quality is regulated at the provincial/territorial level, Health Canada strongly recommends that all products added to drinking water during its treatment and distribution be certified as meeting the appropriate ANSI/NSF Standards. This is true for all water treatment products used for fluoridation.

According to the Findings and Recommendations of the Expert Panel Meeting, convened by Health Canada in January 2007 (full description is available on the Health Canada website at www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/2008-fluoride-fluorure/index-eng.php), water fluoridated at an optimal level would not lead to dental fluorosis (mottled teeth) of a cosmetic concern (moderate or severe according to Dean’s Index). The findings from the Canadian Health Measures Survey 2007 – 2009 – Oral Health Module provide validation that dental fluorosis remains an issue of low concern in this country as so few Canadian children had moderate or severe fluorosis that, even combined, the prevalence was too low to permit reporting.

Fluoridated water supplies typically provide fluoride in a concentration of approximately 1.0 mg/L, which is 1 ppm. The maximum acceptable concentration for fluoride in drinking water is 1.5 mg/L (1.5 ppm). The levels of fluoride that are found in oral supplements (e.g. chewable tablets or drops) for the nutritional prevention of dental caries are explicitly labelled for use only in children living in areas with little or no natural water fluoride concentration. The dosages are established so that the fluoride intake is similar to that of children whose water is fluoridated, e.g. 1.0 mg/day theoretical total fluoride.

Fluoride dental health products for prevention and therapeutic use are generally far more concentrated than nutritional supplements. Fluoride dentifrice pastes and gels and fluoride rinses for consumer use contain fluoride at an average concentration of approximately 1000 ppm. Fluoride products for use by a dentist (i.e. professional use only) may be as concentrated as 12,400 ppm.

As with all other oral mineral supplements (e.g. Calcium, Magnesium, Iron) intended for the prevention of symptoms of deficiency or for therapeutic purposes, these finished products in dosage form have long been regulated in Canada as health products and not as foods, first as drugs under the Food and Drug Regulations (FDR) and then, since the coming into force of the Natural Health Products Regulations (NHPR) in 2004, as Natural Health Products.

In accordance with the NHPR, each fluoride supplement must undergo a pre-market assessment of its quality, safety, and efficacy under the recommended conditions of use, before it can receive a product licence authorizing its sale in Canada. All importers, manufacturers, packagers and labellers must also obtain a Site Licence, the issuance of which is based on evidence of compliance with Good Manufacturing Practices (GMPs).

Through this mandatory pre-market assessment of each product's ongoing quality, efficacy and safety, Canadians have ready access to licensed fluoride health products that are not associated with any significant incidence of tooth mottling, when used according to the recommended conditions of use. To date, there are 313 fluoride-containing natural health products authorized by Health Canada. Please consult the Licensed Natural Health Products Database for information regarding these licensed fluoride products (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php).

Question 13 (Q. 13):

Since the National Sanitation Foundation (NSF) is an organization representing the water treatment agents industry that is not accountable to any government or any public health agency, since it is not responsible for demonstrating compliance with respect to the federal requirements applicable to drugs, natural health products or nutrients, and since Health Canada shirks that responsibility by alleging that it considers fluoridation agents to be nutritional rather than therapeutic, contrary to the Supreme Court of Canada ruling (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26), what government or government department is accountable for ensuring the efficacy and safety of the fluoridation agents used in drinking water in Canada and thus protecting the health of Canadians?

Response (Q. 13):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 14 (Q. 14):

Is Health Canada under the impression or does it let believe that the regulatory requirements of NSF standard 60 include the testing needed to ensure the safety and efficacy of the fluosilicates used to add fluoride as nutrients in drinking water, when the National Sanitation Foundation (NSF) takes no accountability in that regard?

Response (Q. 14):

The application of NSF Standard 60 is voluntary, unless required under legislation or regulations. As drinking water quality in Canada is regulated at the provincial and territorial level, the adoption and enforcement of regulatory requirements would fall within the mandate of the individual provincial and territorial governments. For further information, the individual provincial and territorial government should be contacted directly.

Question 15 (Q. 15):

What actions, studies and procedures have been led by Health Canada in the past 10 years to assess all the impacts of fluoridation on fresh-water ecosystems in Canada (with or without the collaboration of the federal Department of the Environment) towards illustrating Health Canada’s concern for protecting the environment on which human health depends?

Response (Q. 15):

Health Canada has not been involved in any studies related to the impacts of fluoridation on freshwater ecosystems.

Question 16 (Q. 16):

Of all the expenditures made by Health Canada for reviews, assessments and promoting the public health measure that is the fluoridation of drinking water since 2000 (i.e., in the past 10 years), what is the estimated percentage of those expenditures on the environmental aspects of the fluoridation of drinking water in relation to the release of fluorides via municipal effluents? (We would appreciate an evaluation of the budget for all fluoridation-related expenditures at Health Canada and the proportion relating to the evaluation of environmental impacts—knowing full well that Health Canada is not directly involved in applying fluoridation programs, which fall within provincial and territorial jurisdiction.)

Response (Q. 16):

Among the roles of Health Canada, one is to present its position on water fluoridation, which is based on internal scientific reviews of original relevant scientific studies (scientific studies as written by the authors) that are published in internationally recognized peer-reviewed journals, as well as to promote effective, preventive public health measures such as the appropriate use of fluoride. Health Canada has a budget for public health activities relating to health promotion and disease prevention from which oral health wellness initiatives are funded. Fluoride is just one part of these activities and is not a specific budget line.

Question 17 (Q. 17):

Section C.01.021 of the Food and Drugs Regulations,C.R.C., c. 870, which concerns the limits of drug dosage, classifies any product whose sodium fluoride dosage is greater than 0.1 mg as a drug. By what misreading of the Food and Drugs Act and the Food and Drugs Regulations does Health Canada manage not to classify as a drug either bottled water fortified with sodium fluoride in a concentration of 1 mg/1 or drinking water treated with sodium fluoride, sodium fluosilicate or fluorosilicic acid in similar doses?

Response (Q. 17):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 18 (Q. 18):

In Health Canada’s view, is there a statute or regulation that would prohibit municipalities from adding fortifying minerals such as vanadium, chromium or selenium to the drinking water supply system and, if so, under what statute or what regulation would fluoride benefit from an exemption any more than vanadium, chromium or selenium?

Response (Q. 18):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 19 (Q. 19):

In Health Canada’s view, is there a statute or regulation that would prohibit municipalities from adding the mineral lithium to the drinking water supply system and, if so, under what statute or what regulation would the drug fluoride benefit from an exemption any more than lithium?

Response (Q. 19):

This question is seeking a legal opinion. It is not appropriate for the Minister of Health to provide private citizens with legal advice.

Question 20 (Q. 20):

When and how does Health Canada intend to lead an awareness campaign on the importance of not using artificially fluoridated drinking water in the preparation of infant formula, since that period of dentition formation is approximately the most at risk for the development of mottled teeth, in keeping with its duty to protect the health of Canadians?

Response (Q. 20):

Health Canada communicates with the public and public health professionals through web publications and by working directly with the provinces and territories in this area. However, there is no evidence to support a link between the exposure to infant formula reconstituted with drinking water at the Maximum Acceptable Concentration (MAC) for fluoride in Canada and moderate and severe forms of dental fluorosis in the population. The incidence of dental fluorosis is best correlated with the total cumulative fluoride exposure to the developing dentition. According to the Findings and Recommendations of the Expert Panel Meeting, an increased risk of dental fluorosis would be associated with extended periods (e.g., multiple years) of exposure to excessive amounts of fluoride. The findings from the Canadian Health Measures Survey 2007 – 2009 – Oral Health Module provide validation that dental fluorosis remains an issue of low concern in this country as so few Canadian children had moderate or severe fluorosis that, even combined, the prevalence was too low to permit reporting.

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Minister's Response: Justice Canada

21 March 2011

Mr. Gilles Parent, ND.A.
1505, rue Decelles, Bureau 2
Saint-Laurent, Québec H4L 2E1

Mr. Pierre Jean Morin, Ph. D.
336, Rang Castor
Leclercville, Québec G0S 2K0

Dear Sirs,

I am pleased to provide my response to the environmental petition you sent to the Office of the Auditor General of Canada, dated December 2, 2010. In the petition, identified at the Office of the Auditor General as Environmental Petition No. 299-C, you contend that fluorides added to drinking water are unregulated, unlicensed, uncontrolled, unethical and illegal drugs.

I received a copy of your petition on December 22, 2010. My response addresses questions 2, 3, 6, 7 and 8, which fall under the mandate of my department. The other ministers addressed in this petition will respond separately to questions that fall under their respective portfolios.

I appreciate your interest in the questions raised in the petition and I hope you will find the attached information useful.

Yours sincerely,

[Original signed by Rob Nicholson, Minister of Justice and Attorney General of Canada]

The Honourable Rob Nicholson

Enclosure: Response of the Department of Justice to Environmental Petition No. 299-C, Pursuant to Section 22 of the Auditor General Act

c.c.: Mr. Scott Vaughan, Commissioner of the Environment and Sustainable Development
The Honourable John Baird, P.C., M.P.
The Honourable Leona Aglukkaq, P.C., M.P.

Response of the Department of Justice to Environmental Petition No. 299-C, Pursuant to Section 22 of the Auditor General Act

Question 2: In the view of the Minister of Justice, does the Supreme Court of Canada ruling in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06 ¬26, which determined that the fluoridation of drinking water was compulsory preventive medication and which the Government of Canada never appealed before the Supreme Court of Canada:

“Its purpose and effect are to cause the inhabitants of the metropolitan area, whether or not they wish to do so, to ingest daily small quantities of fluoride, in the expectation which appears to be supported by the evidence that this will render great numbers of them less susceptible to tooth decay. The water supply is made use of as a convenient means of effecting this purpose. In pith and substance the by-law relates not to the provision of a water supply but to the compulsory preventive medication of the inhabitants of the area.” Cartwright J, Page 580 have precedence over Health Canada’s opinion with regard to the nature of the fluorides added to drinking water in the fluoridation process, whose admitted purpose is to prevent and treat tooth decay among the inhabitants of communities whose water is thus medicated? Health Canada considers these fluorides thus added to water not to be medication, but rather a nutritional additive to fortify water.

This question is a request for a legal opinion. It is beyond the mandate of the Minister of Justice to provide private citizens with legal advice.

Question 3: In the view of the Minister of Justice, does the Supreme Court of Canada ruling in Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957 06¬ 26, which determined that the fluoridation of drinking water was compulsory preventive medication and which was never challenged by the Government of Canada, constitute a legal precedent with the force of law as regards the medicinal nature of the addition of fluorides to drinking water for the purpose of preventing and treating tooth decay?

This question is a request for a legal opinion. It is beyond the mandate of the Minister of Justice to provide private citizens with legal advice.

Question 6: What actions can be taken by the federal Department of Justice against Health Canada if it does not fulfill its responsibility to protect the health of Canadians by permitting the use of an unlicensed, untested, uncontrolled and uncharacterized drug, namely, fluoridation agents, in light of the fact that the Supreme Court of Canada ruled in 1957 that the fluoridation of drinking water was “compulsory preventive medication”, that this ruling has never been challenged, and that Health Canada has never given consideration to this albeit crucial ruling, which does, in fact, define “fluoridation agents” as drugs as regards their ultimate purpose, which is to prevent and treat tooth decay? (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957‑06‑26)

This question is a request for a legal opinion. It is beyond the mandate of the Minister of Justice to provide private citizens with legal advice.

Question 7: How much time is needed for the federal Department of Justice to take action against Health Canada, which, despite its responsibility to ensure drug safety, permits the distribution of doubtful quality drugs that have not been licensed by Health Canada, and further are untested, uncontrolled and uncharacterized, namely, fluoridation agents, and for the distribution of such drugs to be discontinued and the drugs pulled from the market if Health Canada does not act immediately towards protecting the health of millions of Canadians exposed to the fluoridation of their drinking water and in light of the fact that the Supreme Court of Canada ruled in 1957 that fluoridation was “compulsory preventive medication? (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26)

This question is a request for a legal opinion. It is beyond the mandate of the Minister of Justice to provide private citizens with legal advice.

Question 8: Since the fluoridation of water, according to the Supreme Court of Canada ruling, represents “compulsory preventive medication of the inhabitants” via drinking water and “compulsory preventive medication of the inhabitants” implies the administration of a drug without the informed consent of patients and a practice in violation of section 7 of the Canadian Charter of Rights and Freedoms, what immediate actions does the federal Department of Justice intend to take to ensure that the rights of all Canadians, such as everyone’s fundamental right to the protection of life, liberty and security of their person, as conferred by section 7 of the Canadian Charter of Rights and Freedoms, are upheld immediately? The administration of a drug without a patient’s informed consent constitutes a violation of a fundamental right conferred by the Canadian Charter of Rights and Freedoms and demands immediate action. (Metropolitan Toronto v. Forest Hill (Village), [1957] S.C.R. 569, dated 1957-06-26)

This question is a request for a legal opinion. It is beyond the mandate of the Minister of Justice to provide private citizens with legal advice.