Water Fluoridation Violates the Natural Health Products Regulations, under the Food and Drug Act

Waterloo: Legality of fluoride questioned

Source: Waterloo Chronicle | Chronicle Staff

Posted on April 14th, 2010
Location: CanadaOntario

A local woman is challenging the legality of using hydrofluorosilic acid to fluoridate Waterloo’s drinking water by filing a complaint with Health Canada.

Carole Clinch, research coordinator for People for Safe Drinking water, said under the new Natural Health Products Regulations, under the Food and Drug Act enacted in 2006, all substances claiming to have a therapeutic effect have to be regulated for use by Health Canada.

Any approval would have to follow a review by Health Canada for the product’s safety, efficacy and quality. “They (the fluoride producers) would have to obtain a market authorization, product license and a site license in order to be sold,” said Clinch.

She said that due to a backlog of requests from manufacturers for regulatory approval that Health Canada provided a moratorium for manufacturers of fluoridation products until Jan. 1, 2010. That moratorium was extended to March 31 of this year.

That deadline has since come and gone.

But when Clinch went to find any evidence that the importers or producers of hydrofluorosilicic acid had complied with the new standard, including producing any new research to back up its claims of reducing dental caries without causing any health harms, she was told they hadn’t even applied for approval.

“I have a statement from Health Canada after I asked them if any manufacturer or importer has made a submission for the approval process?” said Clinch. “They said ‘No’ — not one manufacturer or importer has applied.”

That makes artificial water fluoridation products unregulated, unapproved, uncontrolled and illegal under the new Health Canada standard. Clinch called on the federal government body charged with protecting Canadians health to stop the importation of hydrofluorosilicic acid, or the production of the water additive.

She filed a formal complaint with Health Canada just before the end of the deadline and received confirmation of its receipt from Tom Barker, supervisor of Health Canada’s Drug Compliance and Verification and Investigation Unit. He said the matter would be forwarded to an inspector for appropriate action.

“Thank you for bringing this potential violation of the Food and Drugs Act to our attention,” said Baker in a letter obtained by the Chronicle. “Such information helps us to meet our mission which is, ‘To ensure that the drugs, medical devices and other therapeutic products available in Canada are safe, effective and of high quality.”

The Chronicle called Barker for confirmation of the complaint about hydrofluorosilicic, and about the process Health Canada’s Drug Compliance and Verification unit would follow, but he has not returned the calls.

Without that approval Clinch said that it puts the “lie” to claims by dentists and various other health authorities that hydrofluorosilicic acid is safe because it is certified.

“The onus is on the manufacturer to be in compliance with Canadian law,” said Clinch. “They are not in compliance with Canadian law.”

This development has already caused a stir in several Quebec jurisdictions that use hydrofluorosilicic acid, and led to a call to stop using it immediately, said Clinch.

She’s calling on the Region of Waterloo to follow suit and stop putting hydrofluorosilicic acid into Waterloo’s water.

“The onus is on the Region of Waterloo to make sure the product they’re buying and putting into our drinking water is legally being sold in Canada,” said Clinch. “This is now a legal requirement under the Natural Health Products Regulations which is a subset of the new Food and Drug Act.

“The citizens of Waterloo deserve better than this, and they should be protected by this regulatory approval process by the highest health authority in the country, Health Canada.”

 

 

 

The regulation and approval of fluoridation products added to drinking water

Petition: 299

Issue(s): Compliance and enforcement, human/environmental health, and water

Petitioner(s): Pierre Jean Morin and Gilles Parent

Date Received: 19 May 2010

Status: Completed

Summary: The petitioners are concerned about the addition to drinking water of fluoridation products that they claim are not regulated or approved as drugs or natural products under federal law. They ask Health Canada to explain how it ensures that these products conform with federal food and drug standards. They also ask the Department to explain what the petitioners believe are contradictory statements about fluoridation products added to drinking water. In addition, they ask Health Canada and Justice Canada to provide examples of other anthropic chemicals with claimed health benefits that have been added to drinking water without regulatory approval or informed consent.

Federal Departments Responsible for Reply: Health CanadaJustice Canada

Petition

[OAG translation]

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

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

  • Section 34(1), which contains the provisions to conserve and protect fish habitat that sustains Canada’s fisheries resources, and to prevent its harmful alteration;  
  • Section 35(1), which prohibits the harmful alteration, disruption or destruction of fish habitat; and
  • Sections 36-42, which control the deposit of any deleterious substance in water, which is fish habitat.

[Original signed by Gilles Parent n.d.A.]
Gilles Parent, NDA
1505 Decelles St., Office 2 (Signature)
SAINT-LAURENT, QC
H4L 2E1
514-747-2259

[Original signed by Pierre J. Morin]
Pierre Jean Morin, PhD (experimental medicine), former advisor to the Quebec department of environment, the Ministère de l’Environnement du Québec
336 Rang Castor (Signature) 
LECLERCVILLE, QC
G0S 2K0
819-292-3045

Office of the Auditor General of Canada
Commissioner of the Environment and Sustainable Development
Subject: Petitions
240 Sparks Street
Ottawa, Ontario K1A 0G6
Toll-free number: 1-888-761-5953 
Telephone: 613-995-3708
Fax: 613-941-8286
Email: petitions@oag-bvg.gc.ca

Need to opt for sustainable development
Each year, in Ontario alone, billions of litres, the equivalent of 840,000 Olympic-size pools contaminated with fluosilicates, are discharged into the environment. In Lake Ontario and the St. Lawrence River, the ambient level of fluoride is already double the level considered safe set as the standard in the Canadian Water Quality Guidelines (CWQG), i.e. 0.12 mg/L.
http://www.ene.gov.on.ca/envision/water/dwsp/0002/eastern/eastern.htm

The evidence indicates that the fluoride concentrations in secondary discharges of wastewater from fluoridated communities vary between 1.0 ppm and 1.5 ppm, i.e. about ten times the standard of 0.12 mg/L set in the Canadian Water Quality Guidelines for the Protection of Aquatic Life (Hamilton Board of Health Report, July 2008; Camargo, 2003). Such exceedance in Canada of the water quality guidelines set by Environment Canada—and by so much—presents a serious hazard for aquatic organisms, in violation of the Fisheries Act. From an environmental point of view, these violations are a threat to sustainable development.

This document seeks to demonstrate that the fluoridation products added to drinking water and then discharged into the environment are unregulated, unlicensed, uncontrolled and unethical “natural products” that also contravene a number of Health Canada regulations and the provincial pharmacy acts.

The legislation on natural health products, under the Food and Drugs Act (FDA), was enacted into law in January 2004. Producers, distributors, purchasers and sellers of these products had until 31 December 2009 to comply with this new legislation. However, Health Canada informed us that no producer, distributor, purchaser or seller of natural fluoridation health products submitted any application for a licence for fluoridation agents. Consequently, and in accordance with the legislation, these fluoridation agents are illegal and should neither be sold nor purchased in Canada. Any municipality purchasing these products would therefore be contravening the legislation.

In short, on every level—legal, ethical, environmental, and moral—artificial fluoridation of water cannot be considered a sustainable or acceptable measure.

Fluorides added to drinking water are unregulated and unlicensed drugs
The false labelling of fluoridation agents and fluoridated water as a simple water treatment “additive,” rather than as a “drug,” has enabled government agencies to circumvent the federal and provincial legislation on drugs for over 60 years. The political implications are clear. Without the normal constraint of the regular drug approval process (e.g. the Food and Drugs Act and the Natural Health Products Regulations), a municipality could decide to add any drug to its drinking water, on the pretext that it is nothing more than a simple “additive.” In Canada, a “drug” is defined as any substance or mixture of substances produced, sold, or represented for use in (http://laws.justice.gc.ca/en/F-27/): “the diagnosis, treatment, mitigation or preventioof a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals.” In accordance with this definition, fluoridation products used in artificial fluoridation of water that are expressly added to treat, mitigate, or prevent dental caries are subject to the legislation on drugs.

Dr. Philip Michael, Vice-President (Europe) of the International Society of Doctors for the Environment (ISDE), recently explained that assessment of the risks associated with chemical fluoridation products must meet the clinical requirements for active pharmacological substances (http://fluoridealert.org/michael-2009.html):

These are that they should be safe and effective after clinically conducted trials, and the quality and dissemination of information about these substances to citizens must be such as to enable them to make informed choices about their own treatment.

Note also that Health Canada does not recommend ingestion of regulated fluoride supplements, but, surprisingly, encourages ingestion of unregulated drugsin the context of artificial fluoridation of water. This is illogical. http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/environ/fluor-eng.php

Health Canada does not consider fluoride as an essential nutrient.” AG Petition 221, Response # 22 http://www.oag-bvg.gc.ca/internet/English/pet_221_e_30308.html

Since Health Canada has clearly demonstrated that fluoride is not essential, the reason for adding it to drinking water specifically validates its role as a drug, since the “nutritional” argument does not hold, given that fluoride is simply not an essential nutrient.

Dr. Bill Osmunson, DDS, MPH, obtained the opinion of the Washington State Board of Pharmacy:

Fluoride is a legend drug regulated under chapter 69.41 RCW. RCW 69.41.010 defines a ‘legend drug’ as drugs ‘which are required by state law or regulation of the state board of pharmacy to be dispensed on prescription only or are restricted to use by practitioners only.’ IN WAC 246-883-020(2), the Board specified that ‘legend drugs are drugs which have been designated as legend drugs under federal law and are listed as such in the 2002 edition of the Drug Topics Red Book.’

The Chair of the 2000 York Review states in the British Medical Journal:

If fluoride is a medicine, evidence on its effects should be subject to standards of proof expected of drugs, including evidence from randomised trials (…) There have been no randomised trials of water fluoridation.” Source: Cheng, KK, Chalmer, I, Sheldon, TA 2007 British Medical Journal, 6 October, Vol. 335: 699-702.

Under the federal Pharmacy Act, these drugs are listed and published by NAPRA (National Association of Pharmacy Regulatory Authorities). (See http://www.napra.org and search for “sodium fluoride.”)

  • Schedule 1 drugs require a prescription for a dosage of more than 1 mg.
  • Schedule 3 drugs may be purchased only in a pharmacy and in a dosage of less than 1 mg.

Although it is not licensed by Health Canada, and although it is has not been the subject of any “new drug submission,” fluoride intended for ingestion to prevent disease is distributed in two ways:
1) in pharmacies, on prescription and as an over-the-counter drug; and
2) through mass medication, via fluoridated water, without a prescription, unregulated and unlicensed by Health Canada and without the informed consent of citizens.

In a letter dated 7 January 2010, sent to Carole Clinch by Health Canada’s Drug Product Database section, the following statement is made:

Note that the fluorinated compounds added to drinking water are not the same as the compounds used by dentists and are not regulated as drugs by Health Canada.
Petition #221, Q/R #15:
http://www.oag-bvg.gc.ca/internet/English/pet_221_e_30308.html
Q: “Is fluoride considered to be a drug that is subject to Health Canada or any other regulation(s)?
R: When fluoride is (…) labelled for therapeutic use (or makes therapeutic claims), the products are considered drugs under the Food and Drugs Act and are regulated under the Natural Health Product Regulations(…).

In a letter dated 9 February 2010, sent to Carole Clinch by Health Canada’s Drug Product Database section and Health Products and Food Branch, Health Canada states:

“[translation] Fluorides are classed as NHPs (…) but no application has as yet been received by the Therapeutic Products Directorate.”
In other words, no producer, distributor, buyer, or seller of these products has even tried to comply with the legislation. Petition #221, A #15 & -#16:
http://www.oag-bvg.gc.ca/internet/English/pet_221_e_30308.html

In its response to Environmental Petition No. 221B, submitted by Carole Clinch under Section 22 of the Auditor General Act, Health Canada stated that it had no toxicological study on fluosilicates and that it acknowledges no responsibility for research into their safety:

Health Canada has not conducted toxicology studies on fluorosilicates (…) The department works with certification and accreditation bodies to meet this goal, but has no mandate or authority regarding the certification process.

At no time has the certification process of a body such as the National Sanitation Foundation ensured the efficacy, safety, or pharmaceutical quality of the fluorides used for water fluoridation. This certification process is used only for the “additives” put into water, not for products for which therapeutic claims are made, be they natural health products or drugs.

Pursuant to the Food and Drug Regulations and the Natural Health Products Regulations, fluorides sold in Canada must comply with the following legislative requirements (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/complian-conform_pol-eng.php):

1) Product licensing: All natural health products require a product licence before they can be sold in Canada (…) A system of site licensing requires that all Canadian manufacturers, packagers, labellers and importers of natural health products be licensed.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php

2) Clinical trials: to discover or verify the product’s clinical, pharmacological or pharmacodynamic effects; to identify any adverse events that are related to its use; to study its absorption, distribution, metabolism and excretion; or to ascertain its safety or efficacy.”
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#ct

3) “Good Manufacturing Practices (GMPs) for natural health products must be employed to ensure product safety and quality. This requires that appropriate standards and practices regarding product manufacturing, storage, handling, and distribution of natural health products be met.”
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php

4) Notice of Compliance and Drug Identification Number (DIN) or Natural Health Product Number (NHPN) to ensure compliance with the Health Canada regulations required for protecting the public.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licenprod/lnhpd-bdpsnh-eng.php

5) Sale in a pharmacy and/or on prescription from a physician with a licence to practise, depending on the dosage. http://www.napra.org

6) Scientific assessment of the risk (toxicology/pharmaceutical trials) based on the appropriate (clinical) principles and procedures for products playing a prophylactic role.

7) Informed consent obtained from all patients, in accordance with the Nuremberg Code, the Canadian Charter of Rights and Freedoms, and the Government of Canada.
http://www.pre-ethics.gc.ca/policy-politique/initiatives/revised-revisee/Default.aspx

8) Freedom of choice: Health Canada assures that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.”
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php

9) Health claims must be validated: “Provisions for a full range of health claims that will be supported by evidence.
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php

Fluosilicates have never been added to the list of “Fluoride-Containing Anti-Caries Products.”

Impact

The use of fluoride drugs and natural health products added to drinking water and the related claims concerning H2SiF6 and Na2SiF6 do not meet the legal requirements of the Natural Health Products Regulations under the Food and Drugs Act.

Health Canada seems to be aware that these natural health products are not in compliance with Health Canada’s regulatory requirements. Health Canada also recognizes the responsibility for the application of these requirements to artificial water fluoridation products (H2SiF6 and Na2SiF6). In spite of this knowledge and this responsibility, Health Canada has allowed the use of these products for over 6 years, from the time the natural health products legislation was put in place to the present day. Producers, distributers, buyers (municipalities, provinces), and sellers continue to fail to comply with the law. Health Canada must now rigorously take the steps necessary for regulation of these fluorinated drugs/natural health products, failing which, it must prohibit the sale of these products in Canada.
http://www.chfa.ca/LinkClick.aspx?fileticket=Lp%2fKxMx6zHI%3d&tabid=360&language=en-US

In the absence of licensing, it seems clear that any Health Canada claim made on the Department’s website, by Health Canada’s Chief Dental Officer or by anyone else, to the effect that these unlicensed and unregulated drugs are “safe and effective” would be FALSE OR UNFOUNDED, since the reason for these Health Canada regulatory requirements is precisely to demonstrate their “safety and efficacy,” which has not, in fact, been demonstrated.

Consequently, in the absence of Health Canada’s regulatory approval, these products should be considered ILLEGAL and potentially DANGEROUS, in accordance with the Food and Drug Regulations andthe Natural Health Products Regulations, and according to the National Association of Pharmacy Regulatory Authorities. SEE: http://www.napra.org/Content_Files/Files/Position_Statement_Sale_of_
nonapproved_marketed_health_products_January2010.pdf

Experimental research and informed consent
http://pre.ethics.gc.ca/policy-politique/initiatives/revised-revisee/Default.aspx

Since the fluoridation products added to drinking water (>95% being H2SiF6 and Na2SiF6) have not been licensed by Health Canada or any Canadian regulatory authority, and since no random trial has been done on these products, fluoridation necessarily constitutes experimentation, research or a study under way. In such a case, the law is very clear: the cohorts of experimentation subjects must be accorded the right to consent or refuse to participate in such an experiment. It is stipulated in the federal and provincial legislation that

(1) the voluntary consent of the study subject must be obtained before the latter ingests a prescription drug;
(2) the subject must have the capacity to consent or be legally represented; and
(3) it is the duty of the party initiating the experiment to ascertain the quality of the consent.

Informed consent requires that citizens be informed of the precise nature of the fluoridation products used in artificial fluoridation of water. To date, the chemicals used in artificial fluoridation of water have been “[translation] mislabelled” as simple “[translation] additives” and as “natural (…) safe and effective” products; these descriptions appear to be incomplete or misleading, false or fallacious.

Ultra vires
The addition of substances towater to make it “[translation] safe, palatable (pleasant-tasting) or acceptable in appearance” is an administrative action. However, distribution of a prescription drug by a person other than a physician, as with the distribution of a Schedule III drug outside a pharmacy, is outside the area of jurisdiction of a municipality; it is an ultra vires action, invalid in legal terms.

QUESTIONS
1. In Canada, “drug” is defined as any substance or mixture of substances produced,……..

http://www.oag-bvg.gc.ca/internet/English/pet_299_e_34270.html

 

 

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

Petition: 299C

Issue(s): Compliance and enforcement, human and environmental health, toxic substances, and water

Petitioner(s): Gilles Parent and Pierre Jean Morin

Date Received: 20 December 2010

Status: Completed

Summary: In this follow-up petition, the petitioners refer to a Supreme Court decision that they claim describes fluoridation products as medication, and they ask Health Canada to reconcile this with its claim that fluoridation products are mineral nutrients. The petitioners ask the Department of Justice Canada whether the fluoridation of drinking water respects the Canadian Charter of Rights and Freedoms. They also ask Environment Canada and Health Canada to describe the studies done and actions taken to assess the impact of fluoridation on aquatic ecosystems.

Federal Departments Responsible for Reply: Environment CanadaHealth CanadaJustice Canada

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.
Gilles Parent, ND.A
1505 Decelles St., Suite 2
SAINT-LAURENT, QC  H4L 2E1
514-747-2259
Gilles.parent-nd@bellnet.ca

[Original signed by Gilles Parent, N.D.A.]

Pierre Jean Morin, Ph.D. (Experimental Medicine)
Former Advisor to the Ministère de l’Environnement du Québec
336, Rang Castor
LECLERCVILLE, QC  G0S 2K0
819-292-3045

[Original signed by Pierre-Jean Morin, Ph.D.]

http://www.oag-bvg.gc.ca/internet/English/pet_299C_e_35212.html

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