TrueHope Nutritional Support Limited v. Canada (Attorney General)

TrueHope Nutritional Support Limited v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2010-01-20
Neutral citation
2010 FC 63
File numbers
T-880-03
Decision Content
Federal Court
Cour fédérale
Date: 20100120
Docket: T-880-03
Citation: 2010 FC 63
Toronto, Ontario, January 20, 2010
PRESENT: The Honourable Mr. Justice Campbell
BETWEEN:
TRUEHOPE NUTRITIONAL SUPPORT LIMITED
AND DAVID HARDY
Applicants
and
THE ATTORNEY GENERAL OF CANADA AND
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] In the present Application, the Applicants challenge the constitutionality of the seizure provisions of the Food and Drug Act, R.S., 1985, c. F-27 (FDA) as offending Section 7 and Section 8 Charter rights.
[2] The Applicant, Mr. David Hardy, is a co-founder and the operating mind of the corporate Applicant TrueHope Nutritional Support Limited (TrueHope). TrueHope manages the production, sale of, and consumer support for a natural health product called EMpowerplus which is promoted
as a treatment for mental illness. The conduct which grounds the constitutional challenge is the seizure of two shipments of EMpowerplus by officials of Health Canada which, under the auspices of the Minister of Health, is the Federal Department responsible for helping Canadians maintain and improve their health.
[3] Section 23 of the FDA allows a Health Canada inspector to seize articles which he or she believes, on reasonable grounds, contravene the FDA and its regulations at any given point in time (the FDA Regulations). Section 26 of the FDA allows the detention of articles seized until the inspector who executed the seizure is satisfied that they comply with the FDA and the FDA Regulations. The seizures of EMpowerplus under review occurred in April and May, 2003, and the product in the April shipment seized has remained in detention since that time.
[4] The seizures are the seminal event in a history of conflict between Mr. Hardy and Health Canada over the sale in Canada of EMpowerplus. In April 2001, Health Canada served notice that TrueHope’s conduct of offering the product for sale in Canada is unlawful, and Truehope’s refusal to cease the practice resulted in the seizures. At the time of the seizures, hundreds if not thousands of people were dependent on EMpowerplus as a treatment for their poor mental health. Because the seizures were perceived by these users to be a direct threat to secure access of the product, an immediate intensive public informational campaign was launched against Health Canada’s enforcement action. The campaign proved to be effective; within a year of the seizures an agreement was reached between TrueHope and Health Canada with respect to the conditions of sale
of EMpowerplus and which resulted in the same access by users to the product that existed prior to the seizures.
[5] Nevertheless, the present Application which was launched immediately after the seizures has been pursued to hearing. The critical relief sought are two declarations: the Section 7 and 8 Charter rights of Truehope and Mr. Hardy are infringed by the seizures; and s. 23(1)(d) and s. 26 of the FDA infringe Sections 7 and 8 of the Charter and are, therefore, of no force and effect. The constitutional challenge to the seizure provisions of the FDA is advanced in an effort to reduce the restricted access to health products imposed by the FDA and the FDA Regulations. While the present Application does not challenge the statutory and regulatory control measures directly, the objective is to reduce their effectiveness by fundamentally altering the provisions used for their enforcement.
[6] The Applicants argue that the seizure provisions of the FDA offend Sections 7 and 8 of the Charter because the provisions do not provide, before a seizure takes place, statutory access to argue the health risks that will be caused by the seizure. The necessary change to the FDA regime is argued to be the introduction of a form of procedural fairness that will provide a measure of judicial control over the enforcement of the FDA and the FDA Regulations.
[7] Mr. Hardy is not a user of EMpowerplus for a treatment purpose; his purely personal Charter challenge is based in his Section 7 right to security being his right to be free from the
psychological stress he suffered as a result of the seizures. Thus, to achieve success in introducing
procedural fairness into the seizure process under the FDA it is necessary for the Section 7 rights to life, liberty, and security of users of EMpowerplus for a therapeutic purpose to be brought into play. To achieve this result, Counsel for the Applicants argues that Mr. Hardy’s personal Charter standing in the present Application opens an opportunity to argue that the presently deficient enforcement provisions breach the Charter rights of non-Applicant users of EMpowerplus and, thus, they are unconstitutional.
[8] For success, Mr. Hardy’s personal Charter claim depends on the quality of the evidence on the record, and the argument that Charter claims of non-Applicant users can be considered depends on a correct interpretation of the law with respect to standing to bring a Charter challenge. For the reasons which follow, I find that the Application fails on both grounds.
[9] At the outset, a preliminary matter requires attention. In the course of oral argument, Counsel for the Respondents argued that a question exists as to whether, because of events which have transpired since the seizures took place, the present Application is moot. However, given that Health Canada concedes that because the product seized in 2003 is still in detention and a live controversy still exists as to whether it should remain in detention, I find that the Application is not moot on any ground.
I. The Factual History Leading to the Present Application
[10] For clarification, in the narrative of these reasons the spelling of EMpowerplus and TrueHope is that used by Mr. Hardy in his affidavit. The spelling and format used by other participants are variable in the documents referred to in these reasons.
[11] The history of the development and marketing of EMpowerplus, and Health Canada’s involvement in restricting access to the product, is not contested. However, because the history provides the basis of Mr. Hardy’s Charter challenge, the major events in his relationship with Health Canada are necessary to state to support the reasons for the final determination of the present Application.
A. The development of EMpowerplus
[12] As an animal nutritionist, Mr. Hardy discovered that feeding certain nutrients to pigs helped alleviate their ear and tail biting syndrome. Mr. Hardy observed that certain behaviors in humans such as hyper-irritability as well as symptoms related to bipolar disorder are similar to what he observed in pigs and speculated that if people were given certain nutrients, their symptoms could also be alleviated.
[13] In 1995, Mr. Anthony Stephan, also a co-founder of TrueHope, sought Mr. Hardy’s advice about treating the poor mental health of his children: his daughter Autumn was delusional and suicidal, and his son, Joseph suffered from bursts of uncontrollable rage. Given Mr. Hardy’s positive experience with treating similar conduct in pigs as a nutrient deficiency, they placed
Autumn and Joseph on a course of off-the- retail-shelf nutrients. The mental health of both improved.
[14] In 1996, the positive experience with using nutrients to help people deal with their mental problems led Mr. Hardy and Mr. Stephan to develop the Quad Program, a treatment protocol of supplement vitamins and mineral nutrients. In 1996, Mr. Hardy and Mr. Stephan incorporated the Synergy Group of Canada Inc. (Synergy) to promote research into the Quad Program and observe its results. A Quad Program study at the University of Lethbridge and the University of Calgary revealed that due to inconsistency in the mineral supplements, people on the protocol faltered. Mr. Hardy and Mr. Stephan sought to improve the Quad Program and did so by developing a single and consistent product, being EMpowerplus.
[15] In 1998, Mr. Hardy’s son and daughter started on the Quad program: for his son Landon, it was to treat his schizophrenia and psychotic episodes; and for his daughter, Cherilea, it was to treat postpartum psychosis after having her first child. Both benefited and continue to use EMpowerplus for a therapeutic purpose.
[16] In 1999, Mr. Hardy and Mr. Stephan founded TrueHope as a program to support users of EMpowerplus. An essential feature of the program is that EMpowerplus is only sold to persons who agree to enroll in the TrueHope program and the product is only made available for sale to users enrolled in the program.
[17] The rationale for the management structure developed is that EMpowerplus requires users to reduce or eliminate entirely their intake of psychiatric medication on the belief that the transition from psychiatric medication to EMpowerplus causes symptoms of mental disorders to return temporarily. Because of safety concerns arising from the transition, TrueHope addresses these concerns by helping new users adapt to EMpowerplus through counselling and nutrient management. TrueHope also provides continued support through trained staff to help manage participants and trains psychiatrists and physicians to help their patients adapt to EMpowerplus.
[18] Early development of EMpowerplus took place in the United States in cooperation with American partners. In late 2002, TrueHope moved its support program to Raymond Alberta, and TrueHope’s corporate partner Synergy started to be used as a revenue bearing company to manage sales of EMpowerplus. At all times material to the seizures under review, warehousing, and distribution occurred in the United Stated through the Utah firm Pharos DTB LL (Pharos) and manufacturing took place in the United States. However, it is uncontested that EMpowerplus was sold to users in Canada by Synergy through offering the product for sale on the TrueHope website as a treatment for mental disorders.
[19] At the time of the seizures, the selling practice was as follows: Synergy took orders through a toll-free number advertised on TrueHope’s website; the orders were relayed to and filled by Pharos; Pharos shipped the orders to Synergy in Canada through United Parcel Service (UPS) as a customs agent; to save shipping costs, many orders were shipped together as a single shipment but
each shipment contained separately-invoiced packages each addressed to TrueHope users; and once in Canada each package was delivered to each user by UPS.
[20] The fact that TrueHope offered EMpowerplus for sale in Canada for the treatment of mental disorders proved to be highly contentious to Health Canada.
B. Health Canada’s enforcement action and TrueHope’s response
[21] It is not contested that, in 2003, Truehope was offering EMpowerplus for sale in Canada through its website without the required Health Canada authorization. It is also not contested that the seizures under review were conducted as a direct result of TrueHope’s failure to comply with Health Canada’s demand, first made in 2001, that it cease its unauthorized conduct. Therefore, apart from the Charter challenge aspect of the present Application, there is no question that Health Canada had sound legal reasons to perform the seizures for breaches of the FDA and the FDA Regulations as they existed in 2003.
[22] Because the reasons for the seizures are not contested, it is unnecessary to elaborate on the various provisions of the FDA and FDA Regulations that ground the seizures. Indeed, these provisions are clearly summarised in Health Canada’s April 27, 2001 warning letter from Health Canada Inspector Mr. Miles E. Brosseau to Synergy that it was operating in violation of the law:
Mr. Anthony Stephan
Synergy Group of Canada, Inc.
635 – 2nd Avenue West
Cardston, Alberta T0K 0K0
Attention: Mr. Stephan
RE: WARNING: Violation of Sections 3(1), 3(2), 9(1), 9(2), C.01.003, C.01.005, C.01.004.1, C.01.014(1), C.01A.004.(1), C.08.002, and C.08.005 of the FOOD AND DRUGS ACT AND REGULATIONS.
-----------------------------------------------------------------------------------
It is apparent that the Synergy Group of Canada Inc. is advertising and selling the unapproved drug product, “E.M.Power”, through your website at www.truehope.com.
The website solicits participation in a clinical trial research and seeks to attract parents of children with mental illness with statements such as “finding true hope in despair”. The product is being promoted for the study and treatment of serious disorders such as anxiety and panic disorder, bipolar affective disorder, fibromyalgia, schizophrenia, attention deficit hyperactive disorder, clinical depression, Tourett’s Syndrome, etc. which are not amenable to self diagnosis or self-monitoring.
The activities of the Synergy Group of Canada Inc. are considered violative of the above noted sections and compliance with the regulatory requirements is necessary.
The sale and advertisement of a drug, and in this case a new drug, prior to receipt of a Notice of Compliance (NOC) and a Drug Identification number (DIN) is in violation of sections C.01.014(1), and C.08.002.
E.M.Power has not received a DIN or NOC for any of the indications for which it is being sold and advertised and is not properly labelled. Consequently, the false, misleading, and deceptive selling/advertising of this unapproved and improperly labelled drug product is in violation of sections 9(1), 9(2), C.01.003, C.01.004.01, and C.01.005.
As well, marketing E.M.Power for diseases that are listed in Schedule A is a violation of sections 3(1) and 3(2).
As per section C.01A.04(1), no person shall distribute a drug product in Canada without an establishment licence.
You were previously advised [by letter dated October 20, 2000] that the Food and Drugs Act and Regulations require that an Investigational New Drug Submission (IND) be filed for
evaluation prior to initiating a clinical trial. A “No Objection Letter” would be issued, should review of the proposed clinical trial be considered satisfactory. Failure to submit an IND with respect to the research conducted with E.M. Power is in violation to section C.08.005.
A copy of definitions, Schedule A, and the violated sections is attached for your reference. It is my recommendation that you disseminate this information to the parties involved (ie. Corporate directors, clinical trial investigators, the manufacturer, and Synergy research assistants).
It is imperative that the sale, distribution, any form of advertising, and research with the product E.M.Power be concluded immediately. I am requesting, by May 31, 2001, your written response confirming that the violative activities have ceased and that the Synergy Group of Canada Inc. will maintain compliance with the Food and Drugs Act and Regulations.
If you have further questions or wish discussion please call […]
[Emphasis in the original]
(Respondents’ Record, Vol. 2, p. 382)
[23] The key provisions of the FDA mentioned in the April 27, 2001 letter are as follows:
Foods, drugs, cosmetics and
devices
Aliments, drogues, cosmétiques
et instruments
3. (1) No person shall advertise any food, drug, cosmetic or device to the general public
as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical
states referred to in Schedule A.
(2) No person shall sell any food, drug, cosmetic or device
(a) that is represented by label, or
(b) that the person advertises to the general Public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical
states referred to in Schedule A.
3. (1) Il est interdit de faire, auprès du grand
public, la publicité d’un aliment, d’une drogue,
d’un cosmétique ou d’un instrument à titre de
traitement ou de mesure préventive d’une maladie,
d’un désordre ou d’un état physique anormal
énumérés à l’annexe A ou à titre de moyen de guérison.
(2) Il est interdit de vendre à
titre de traitement ou de mesure préventive d’une maladie,
d’un désordre ou d’un état
physique anormal énumérés à l’annexe A, ou à titre de moyen de guérison, un aliment, une drogue, un cosmétique
ou un instrument :
a) représenté par une étiquette;
b) dont la publicité a été faite auprès du grand public par la personne en cause.
[…]
Drugs
Drogues
9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner
that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit
or safety.
(2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary
to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).
9. (1) Il est interdit d’étiqueter, d’emballer, de traiter, de préparer ou de vendre une drogue — ou d’en faire la publicité — d’une manière
fausse, trompeuse ou mensongère ou susceptible de créer une fausse impression quant à sa nature, sa valeur, sa quantité, sa composition,
ses avantages ou sa sûreté.
(2) La drogue qui n’est pas étiquetée ou emballée
ainsi que l’exigent les règlements ou dont l’étiquetage ou l’emballage n’est pas conforme aux règlements est réputée contrevenir
au paragraphe (1)
[24] Health Canada’s enforcement powers are provided by s. 23(1) and s. 26 of the FDA:
23. (1) Subject to subsection (1.1), an inspector may at any reasonable time enter any place where the inspector believes on reasonable grounds any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged or stored, and may
23. (1) Sous réserve du paragraphe (1.1), l’inspecteur peut, à toute heure convenable, procéder à la visite de tout lieu où, à son avis, sont fabriqués, préparés, conservés, emballés ou emmagasinés des articles visés par la présente
loi ou ses règlements. Il peut en outre :
(a) examine any such article and take samples thereof, and examine anything that the
inspector believes on reasonable grounds is
used or capable of being used for that manufacture, preparation, preservation, packaging or storing;
a) examiner ces articles et en prélever des échantillons, et examiner tout objet qui, à son
avis, est utilisé — ou susceptible de l’être —
pour la fabrication, la préparation, la conservation, l’emballage ou l’emmagasinage de semblables articles;
(a.1) enter any conveyance that the inspector believes on reasonable grounds is used to carry any article to which section 6 or 6.1 applies and examine any such article found therein and take samples thereof;
a.1) procéder à la visite de tout moyen de transport qui, à son avis, est utilisé pour le transport d’un article visé par l’article 6 ou 6.1, examiner l’article qui s’y trouve et en prélever des échantillons;
(b) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any article to which this Act or the regulations apply;
b) ouvrir tout contenant ou emballage qui, à son avis, contient un article visé par la présente loi ou ses règlements;
(d) seize and detain for such time as may be necessary any article by means of or in relation to which the inspector believes on reasonable
grounds any provision of this Act or the regulations has been contravened.
[…]
d) saisir et retenir aussi longtemps que nécessaire tout article qui, à son avis, a servi ou donné lieu à une infraction à la présente loi ou à ses règlements. L’avis de l’inspecteur doit dans tous les cas être fondé sur des motifs raisonnables.
[…]
26. An inspector who has seized any article under this Part shall release it when he is satisfied that all the provisions of this Act and the regulations
with respect thereto have been complied with.
26. L’inspecteur, après avoir constaté que les dispositions de la présente loi et de ses règlements applicables à l’article qu’il a saisi en vertu de la présente partie ont été respectées, donne mainlevée de la saisie.
[Emphasis added]
[25] During the course of conduct leading to the present Application, Health Canada also expressed concern about the safety of the composition of EMpowerplus and whether it met the FDA Regulations. It is agreed that this concern is not relevant to the present Application.
1. Events leading to the seizures
[26] Health Canada’s warning letter of April 27, 2001 was the lead event in an adversarial relationship in which Health Canada attempted to gain TrueHope’s compliance, and to which TrueHope objected.
[27] In response to the April 27, 2001 letter, Mr. Hardy and Mr. Stephan contacted Mr. Dennis Shelley and Mr. Rob Neske of Health Canada by teleconference to discuss the issues raised in the letter. As a follow-up to the teleconference, Mr. Hardy and Mr. Stephan sent a letter to Mr. Shelley
dated June 17, 2002 explaining the merit of their activities and expressing the desire “that this letter may be only the beginning of an ongoing dialogue with yourself and others in government who may have an interest in the health and well being of Canadians specifically those who suffer the stigma of mental illness”. Attached to the letter were letters of support from over 200 TrueHope participants and letters and articles from psychiatrists outlining the “significant” effects of EMpowerplus on users. However, the fifth page of the letter reads as follows:
Of course, Synergy – Truehope is not seeking for a product endorsement but rather a clearing of the roadblocks which impede the progress of this critical research. Legislation should never be used as an excuse for extending human suffering to protect the vested interests of a small minority, however powerful that minority might be perceived.
[…]
We do not feel we should have to heap embarrassment upon the government nor any of its departments in order to obtain the confirmation that we are being heard in this request. Nor do we feel that we should have to stir the ire of thousands of Canadian families who continue to be aggravated with both the government action and inaction in this matter to date.
(Applicants’ Record, Vol. 3, p. 705)
[28] Health Canada’s response to the June 2002 letter came from Mr. Shelly by letter dated December 4, 2002. Mr. Shelly reaffirmed the continuing FDA and FDA Regulations violation by Synergy and TrueHope with the statement that “Synergy/Truehope is required to immediately stop all sale, offering for sale, exposing for sale, promotion or advertising of E.M.Power+”. The letter concludes by stating that “FDA compliance is requested not later than the close of business on December 18, 2002” (Respondents’ Record, Vol. 2, p. 390).
[29] Mr. Hardy and Mr. Stephan wrote a responding letter dated December 10, 2002 in which they mention that they had had telephone conversations with Mr. Shelly on December 9th, 10th, and 11th and confirmed that they would attend a meeting with him on January 14, 2003 in the Health Canada office in Burnaby, B.C. They also made the following statements:
[…]
In light of the content of your letter of December 4, 2002, we reiterate that it is not our desire to violate the law. We find ourselves very confused as we had requested assistance (please see our June 17th letter) from your department as to what would be acceptable, and have received nothing but a cease and desist order. Our efforts to set up a meaningful dialogue with your Minister, requested now three times in writing and with at least a dozen phone calls have like wise [sic] been met with no response. We are, therefore, very happy to be able to meet with you.
In the second paragraph of your letter you indicate that we have a Canadian Website. Please be advised that there is no Canadian website. The website is now operated in the U.S. by a U.S. corporation.
You also claim that we are in breach of the law. As we have explained previously, it is our view that we are not in violation of the Food and Drugs Act. We have provided you with the case law that indicates that we are not involved in selling a product within Sec. 2 of the Food and Drugs Act.
[…]
(Applicants’ Record, Vol. 3, p. 932)
[30] Indeed the meeting did take place on January 14, 2003 attended by Messrs. Hardy, Stephan, Shelley, Brosseau, and Ms. Lorill Zandberg who was a TrueHope participant and EMpowerplus user. A report prepared by Miles Brosseau after the meeting explains what was discussed. At the meeting, Mr. Stephan and Mr. Hardy expressed their wishes to be compliant with the FDA with respect to the sale of their product but also expressed their frustration over the response Health
Canada gave them to their request for assistance to ensure their compliance. They also expressed concern over the clinical trials on EMpowerplus being “sandbagged”. Further, they requested a Ministerial exemption for their product, adding that they have tried communicating with the Minister to this effect but were ignored. Ms. Zandberg attended the meeting to describe her poor experience with prescription psychiatric drugs and how she had improved with using EMpowerplus. There were discussions about the way in which sales of EMpowerplus were transacted. Ms. Zandberg explained that “she paid for the product by cheque written to Synergy” and “Mr. Stephan stated that since November 2002, cheques for the product are written to Synergy Group of Canada” (Respondents’ Record, Vol. 2, p. 393).
[31] Health Canada representatives at the meeting requested a specific commitment from Mr. Hardy and Mr. Stephan to comply with the legislation and to stop the sale of the product in Canada. They also made a suggestion that “Synergy / Truehope” move its operations to the United States. At the conclusion of the meeting, Mr. Stephan requested seven to ten days to prepare and submit a plan of action (Respondents’ Record, Vol. 2, p. 394).
[32] Following the January 14, 2003 meeting, Mr. Hardy telephoned Mr. Shelley and told him that TrueHope would not be able to comply with the Regulations, and that he was frustrated and wanted to write-up what he was thinking. He asked Mr. Shelley if he could send his drafted thoughts to Ottawa to which Mr. Shelley replied he could (Applicants’ Record, Vol. 2, para. 91). As a result, the next step in the relationship was Mr. Hardy and Mr. Stephan writing an “Open Letter” to Health Canada on TrueHope letterhead dated March 6, 2003 and addressed to Mr. Neske:
AN OPEN LETTER TO HEALTH CANADA
March 6, 2003
Mr. Rod Neske, Compliance Officer
Health Canada
Health Products and Food Branch Inspectorate
3155 Willingdon Green
Burnaby, BC
V5G 4P2
Dear Mr. Neske,
It appears that our letter for clarification dated June 17, 2002 to Mr. Shelly copied to your Minister and to Director General Phil Waddington (ONHP) was completely ignored since we received no response to it whatsoever. In addition to this, we have sent three letters to your Minister and placed over twenty logged telephone calls to which we have received no reply either.
Nevertheless, further to our January 14, 2003 meeting in Burnaby, B.C. with Mr. Dennis Shelly and Mr. Miles Brosseau of the inspectorate, we provide the attached information.
Mr. Shelly has recognized that the communication with us has not been appropriately handled and has requested that we outline all of our concerns in letter form and forward them to him.
It is with the continuing desire to receive a detailed response to our concerns that we submit them to you.
Sincerely,
Anthony F. Stephan David L. Hardy
Co- Founder Co-Founder
XC: The Honourable Anne McLellan, Minister of Health.
ATTACHMENT: 6 PAGES
[The Attachment]
PROLOGUE:
Truehope Nutritional Support Ltd. is an Alberta company which has developed a protocol addressing nutrient deficiencies which are the evident cause of some mental disorders. The efficacy of the protocol is supported by three peer reviewed publications in medical journals, as well as a number of studies awaiting publication. Experiential observation of many doctors worldwide, as well as over 2,500 published studies showing the positive influence of nutrients on mental disorders, also contribute to the weight of scientific evidence supporting the discovery. Truehope offers support to the mentally-ill at no-cost by way of telephone and internet and also provides free nutrients to the mentally-ill who cannot afford them. Over four thousand people in Canada have been touched through the use of this support system. Many of these individuals have been able to find normality and have returned to their families, careers, and educational pursuits. Although the supplement has not worked for all who have taken it, an increasing number of participants are finding total relief from their symptoms.
1. CURRENT CONDITION: Truehope’s seven-year search for answer to the causes of mental disorders and the ensuing independent but parallel scientific research has clearly confirmed that addressing nutritional deficiencies ameliorates symptoms of mental illness [footnotes omitted]. Our results are consistent with a worldwide movement towards treating mental illness with natural remedies, a topic that is drawing much attention in North America (Note: the first ever university conference on the treatment of mental disorders with nutrient supplementation will take place at Harvard University on April 25-27, 2003.)
CONCERN: It’s obvious that a government department entrusted with the health of Canadians should be interested in fostering, expediting, and assisting such research so clearly important to the health of Canadians. Instead of investigating and confirming our breakthrough research, Health Canada has criminalized both the efforts of Truehope and the University researchers. An Alberta Government funded double blind study has been shut down at the University of Calgary and Truehope has been issued a cease and desist order. Health Canada employees have shown their bias as demonstrated in comments while turning back university clinical trial
applications and within their own internal communications referring to us as “TRUEDOPE” for example. Health Canada has further violated the privacy rights of Truehope and its founders by releasing confidential information to parties outside of Truehope, without due process under access to information legislation. Is Health Canada really concerned with improving the access to health for all Canadians? Are they appropriately respectful of academic freedom in Canada as well as the rights of Canadian citizens?
2. CURRENT CONDITION: Health Canada has issued a cease and desist order against Truehope which effectively denies to every Canadian the access to our supplement.
CONCERN: For hundreds of Canadians who have found restored mental health through the Truehope program, this action denies them their right to health as guaranteed by the Charter of Human Rights. Such action forces these individuals back onto [sic] less effective and more dangerous medications (medications that are clearly addictive or which dramatically increase the risk of cancer or liver or kidney failure for example. See CONCERN #7). Does this seem to be a responsible action by those entrusted with the responsibility to ensure the health of Canadians?
3. CURRENT CONDITION: Health Canada is using Schedule “A” and Section 3(1) and 3(2) of the outdated Food and Drugs Act to eliminate alternative treatments that effectively alleviate various health concerns.
CONCERN: Over a million consumers across Canada sent a strong message to government in 1997, making it clear such legislation as Schedule “A” and Section 3(1) and 3(2) of the antiquated Food and Drugs Act could no longer be used to deny Canadians health freedom or relegate foods to a drug status. The government responded in November of 1998 by setting up the Standing Committee on Health which sought input from citizens across Canada before bringing forward 53 recommendations for change. These recommendations were tabled in the House of Commons and accepted on March 26, 1999 by the Minister of Health, the Honorable Allan Rock on behalf of Parliament [footnote omitted]. Further to that process the government set up the Office of Natural Health Products Transition Team (a committee of experts formed from Health Canada, consumers and consumer groups) and accepted their clarification and expansion of the 53 recommendations as
submitted in their March 31, 2000 report [footnote omitted]. One important segment of the Transition Team report reads as follows:
Natural Health Products: A New Vision
Section 3 and Schedule A (As They Currently Stand)
3(1) “No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases or disorders or abnormal physical states referred to in Schedule A.”
3(2) “No person shall sell any food, drug, cosmetic or device
(a) that is represented by label, or
(b) that the person advertises to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.”
In Response to the above quoted section of the act the Transition Team comments:
“Sections 3(1) and 3(2) and Schedule A of the Food and Drugs Act are no longer relevant. They do not serve any purpose that cannot be accomplished adequately by other sections of the legislation or regulations.
More importantly, the schedule does not reflect contemporary scientific thought. The weight of modern scientific evidence confirms the mitigation and prevention of diseases and disorders listed in Schedule A through the judicious use of NHPs. It is time that the legislation and regulations reflect the prevailing science.
Section 30(1) (m) of the Act grants the authority to add anything to, or delete anything from, the Schedules of the Act.
The Transition Team recommends that:
Section 30(1) of the Food and Drugs Act should be invoked to remove all diseases listed in Schedule A; sections 3(1) and 3(2) should be revoked through the Legislative Renewal Initiative.”
Health Canada was then charged with the responsibility to translate these recommendations from the Transition Team report into law in Gazette1 submitted Dec 22, 2001 and in Gazette 2 due by June 22, 2003. Glaring omissions in Gazette 1 such as the recommended elimination of Schedule “A” and Sections 3(1) and 3(2) of the act and Health Canada’s sudden renewed attempts to enforce selectively
and unfairly these sections clearly demonstrate their abrogation of the spirit and intent of the aforementioned recommendations. Indeed it is difficult to not see this as an attempt on the part of certain civil servants within Health Canada to become a law unto themselves, ignoring the will of Canadians by implementing their own agenda in contempt of parliamentary process. Their actions certainly fly in the face of the stated intent of Parliament and once again are raising the ire of consumer groups across Canada. Does Health Canada know something more about the intent of government in this issue than we are being told?
4. CURRENT CONDITION: Health Canada is imposing sanctions against those who speak the truth about the effectiveness of nutrient supplements and other alternative health remedies.
CONCERN: True statements made about the efficacy of treatments other than pharmaceuticals but which clearly are supported by the weight of scientific evidence are within every Canadian’s right of expression according to constitutional law. Health Canada is acting out of synch with the constitutional guarantee allowing “freedom of thought, belief, opinion, and expression including freedom of the press and other media of communication” [footnotes omitted]. Isn’t it time that we hold such rights (outlined in the Canadian Bill of Rights and the Canadian Charter of Rights and Freedoms) inviolable and amend all old legislation to so conform [footnote omitted]? In relation to a similar constitutional consideration, if it’s deemed unconstitutional to deny Canadians the right to use marijuana (a controlled substance) for medicinal purposes, why would Health Canada deny Canadians the right to use vitamins and minerals for the same purpose? [footnotes omitted]
5. CURRENT CONDITION: Health Canada sustains the indefensible position of allowing products to be sold into Canada without DIN numbers under NAFTA but denies Canadians the right to produce or sell these same products in Canada.
CONCERN: Such action is a slap in the face to Canadians who experience this as a clear attempt to legislate an unfair trade practice, allowing foreign vendors to rob Canadian business. Many of the products banned in Canada for sale are sold in supermarkets in the U.S. The fact that these products are imported into Canada for personal use says that there is no health concern, but rather Health Canada is involved in a discriminatory trade practice outside of its stated mandate. In addition, the practice of selective enforcement of
this discriminatory regulation is proof that it cannot be administered equitably or fairly. How can Health Canada continue to sustain such a policy?
6. CURRENT CONDITION: Health Canada is making it difficult if not impossible for academic research to proceed in Canada on products for which there are no health concerns.
CONCERN: Health Canada is in contempt of the constitutional rights of Canadians by blocking academic freedom in research and the potential benefit of the research to the health and well being of all Canadians. They have successfully terminated a double blind study, using minerals and vitamins, at the University of Calgary which was showing impressive benefits of nutritional supplementation in the alleviation of psychiatric disorders. Further, they have held up that research for over a year and a half. Their attempts to muzzle efforts to educate the public on such important findings are another breach of constitutional rights and are a discriminatory practice against the mentally disabled [footnote omitted]. (Section 15 (1) of the Charter specifically states: “Every individual is equal before and under the law and has right to the equal protection and equal benefit of the law without discrimination and, in particular without discrimination based on race, national or ethnic origin, colour, religion, sex, age or mental or physical disability”) One must ask why it is Health Canada’s agenda to drive such research out of the country when expectation from Canadians would be to foster and expand research showing such promise?
7. CURRENT CONDITION: Health Canada is inadequately informing the public of both the lack of efficacy and of the significant dangers of psychiatric medications.
CONCERN: The above stated reality is the very reason for the existence of Truehope. As we have looked into the current system of treatment of those suffering with mental illness it is little wonder that so many seek help in vain. Hundreds of studies over the past twenty years identify the addictive natures and carcinogenic effects of many medications [footnotes omitted]. (Note: the authors have over 400 studies that demonstrate the addictive – carcinogenic effects of commonly used psychiatric medications). Health Canada continues to ignore current research identifying these realities, hence, the drugs become a significant part of the problem with many Canadians being put at increased risk by Health Canada’s inaction. We advised you of this in our June 17, 2002 letter and no action was taken to reduce
the risk to Canadians. For a public service body which is supposedly set up to enhance and protect the health and well being of Canadians, this could be viewed as a criminal action or a “ Breach of Public Trust” as defined in Section 122 of the Canadian Criminal Code. Does this seem a responsible act by those entrusted with the responsibility to ensure the health and well being of all Canadians?
8. CURRENT CONDITION: Truehope exists because it is literal