To: "Marjory Loveys"
Subject: Urgent - grassroots' briefing from Trueman Tuck as promised for the Prime Minister's immediate attention
Date: Mon, 16 Jun 2003 20:04:41 -0400
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PMO's Office
Health Desk
Attention Marjory Loveys:
Thank you for speaking with me last week.
I was very shocked that you were not aware of the ground swell of anger from grassroots' citizens concerning the total sell out and betrayal occurring with the PHARMACARTEL controlled Health Canada officials that has been brewing since Gazette 1 came out in December 2001, and Kava Kava was needlessly removed instantly and totally from the Canadian market in August 2002.
As we discussed, our organizations representing literally millions of
Canadians, organized the largest grassroots protest in Canadian history in
1997 and 1998 over these same issues. One of our coalition partners -
Freedom of Choice in Health Care submitted a 250,000-name petition in 1998 saying, "Our foods are not drugs".
In our new 2003 coalition campaign we have already collected and had filed with the House, 100,000 signatures in May and June alone, with more pending and a summer of campaigning ahead of us.
Our target is 500,000 petitions supporting "OUR FOODS ARE NOT DRUGS"
regulatory regime via new legislation [see Bill C-420 which was drafted by
our permanent "Health Freedom Legal Defense Team"].
The details are on the Friends of Freedom website at
www.friendsoffreedom.org - see especially the MAIN MENU - top left - Health Freedom Action Campaign downloads - HC regulatory history.
There are currently three lawsuits filed and pending one on June 26, 1997
being brought back first court date June 20, 2003, another filed May 29,
2003, and another filed June 12, 2003 all of which our permanent legal team are assisting in.
Unless Gazette 2 is stopped, and our groups are "Let Inside" as concerned
stakeholders to help design "Appropriate Legislative Renewal" several other complementary suits are planned as well.
Gazette 1 is a complete betrayal of all recommendations and promises and
must be stopped this week. It is also legally outside the delegated
authority of the Governor General to implement under the 1920 drafted Food and Drugs Act, made law in 1927, amended in 1934, and last before Parliament in 1952.
There have been over 400 pages added by questionable regulatory delegation to this 20 page 1952 legislation. This was commented on in the introduction of the 1998 Standing Committee Report see our referenced section of our website for copy.
Even DIN's are legally questionable, as is most current Food and Drugs
policy and regulations.
Our groups finally met with Heather Watson from the Minister's office, after
over 8 months of being refused any meeting, on May 29, 2003. We calmly,
professionally, and with full documentation, presented our case for stopping the drug-style third category regulations that will actually make some 60,000 very safe, and affordable food-based, non-drug medicines "DRUGS' subject to equal or greater control than deadly and dangerous synthetic prescription drugs.
You had asked me for a briefing on the major issues that several million
concerned Canadians have with Gazette 1, and the just released Gazette # 2, that the PHARMACARTEL INTERESTS IN HEALTH CANADA ARE TRYING TO FORCE INTO LAW THIS COMING WEDNESDAY, JUNE 18, 2003.
BRIEFING
In general, the concerns that our groups, (including the millions of
citizens and countless industry members who's views we represent), have
regarding the upcoming NHPD regulations, (Gazette 2 poised for imminent
release), include the following:
A partial list of potential problems and pitfalls of the new Natural Health
Products Regulations:
BRIEFING
In general, the concerns that our groups, (including the millions of
citizens and countless industry members who's views we represent), have
regarding the upcoming NHPD regulations, (Gazette 2 poised for imminent
release), include the following:
FACT 1: The new Natural Health Products regulations have taken a much
different course than that which was set out for them by the Standing
Committee on Health and the Transition Team. In the Transition Team's final report document, which was signed-off on by the Minister of Health, a
process of Legislative Renewal was stated to be unavoidable if the
recommendations of these groups were to be achieved, [ref: live]. This
means that a new Act separate from the Food and Drugs Act would be necessaryto achieve a true third category for Natural Health Products, (NHP's),separate from either foods or drugs.
CONCERNS: In the process that has taken place over the past five years,
Health Canada has refused to engage in a process of Legislative Renewal,
instead opting for a separate directorate and regulatory framework in which NHP's are classified as a subset of drugs, (all of which are subject to
restriction using the devices of Schedule A, Sections 3(1), 3(2), and
Schedule F, [see below]). In this light, the current regulatory proposals
are in contempt of Parliament. They seem to be following a much different
agenda than that prescribed for them, and have not even come close, to
protecting the rights of Canadians to freely access NHP's of their choice.
FACT 2: The regulations maintain complete power to arbitrarily restrict any given NHP by blocking its sale, and/or make it available by prescription
only [ref: Section 96, Gazette 1, entitled: Prescription Natural Health
Products]. Health Canada has refused to implement the Transition Team's
recommendations to revoke sections 3(1), 3(2) and Schedule A of the Food and Drugs Act dealing with disease claims.
CONCERNS:The regulations reserve the right of the Minister to issue a
direction to stop sale of any product, [ref: Section 15], suspend or cancel
any given product license, [ref: Section 16], and/or suspend a product
license before giving the licensee an opportunity to be heard, [ref: Section
17], all based on the Minister having "reasonable grounds to believe that a
Natural Health Product may no longer be safe." The critical words here are
"believe" and "may". Human history is replete with examples of horrendous acts and tyranny carried out under the pretense of belief; and "may" automatically implies "may not". In these Sections it is not even mentioned that this "belief" has to be supported by reasonable and adequate evidence and that this evidence must be presented prior to a restrictive action.
Furthermore there are no mechanisms in the regulations providing for
accountability of the department officials administering them. If an
official had the intention, these clauses could be dramatically abused.
Given that the HPB over the last 25 years has continually demonstrated its
bias against, and its will to suppress the Natural Health industry, wording
such as this is of grave concern.
Additionally, given that NHP's under these regulations will be forced to
state a claim on their labels, it is of great concern that Health Canada has
refused to delete Sections 3(1), 3(2), and Schedule dealing with disease
claims. This creates a huge "gray zone" in terms of which claims will be
considered structure function, and which will be considered disease claims.
Health Canada's dramatic inconsistencies dealing with such issues in the
past may mean that a claim acceptable today may not be tomorrow, and
provides another mechanism by which products may be restricted or blocked from market. Furthermore, in some instances natural products have been extremely well scientifically validated, (as stated in the Transition Team report [ref: live]), to be effective in mitigating disease.
FACT 3: The three criteria that were stated by the Natural Health Product
Directorate to have been continually asked for by Canadians as consultations took place, and hence, three of their main stated objectives for the regulations were that (1) first and foremost, Canadians wanted increased access to a wider range of NHP's including many that are available in the United States, but restricted for sale in Canada, (2) they wanted assurance that what was on the label was in the bottle, (3) they wanted more information on the label regarding what the product was for. To achieve these objectives the regulations will mandate that every NHP make a claim, which is to be supported, must pass through a Standards of Evidence Procedure. [Ref: Standards of Evidence Draft Document; live], and then appear on an approved label for that product.
CONCERNS:The regulations are attempting to implement standards, which are inappropriately rigorous for NHP's. They fail to acknowledge the
long-standing safety and low risk of NHP's, (fully acknowledged by the
Standing Committee on Health), and insist on the continued application of a
pharmaceutical drug model of regulation. Moreover, the Standards of
Evidence Procedure can easily be abused to block a product access to market if that is the will of the officials administering it. NHP's are once again being made to justify their existence, when their longstanding safe usage should be justification enough. NHP's are once again being treated like drugs when the entire point of the third category was to differentiate the two. If this wasn't acceptable to the public when they protested in 1997, why is it acceptable now?
Fears regarding inferior and/or dangerous NHP's that do not meet their
label claims are largely unsubstantiated by actual examples. A huge
majority of Canadian NHP suppliers already strictly follow Good
Manufacturing Practices and the last death attributed to an NHP in Canada
occurred in the 1950's, (administered by a physician). There is a much
better method of ensuring public safety without over regulating, (see: The
Natural Health Industry Wants Appropriate Regulations document).
FACT 4: Due to labeling and claim requirements, once these regulations are enforced strictly, they will be a barrier to the import of countless
products from the U.S. and abroad.
CONCERNS:This may include products that Canadians have been safely using for decades and are perfectly happy with. The regulations do not take such citizens into account. Aspects such as this meant that instead of
protecting Canadians rights to access NHP's of their choosing, the
regulations seriously threaten this right. Given the regulatory history of
the Health Protection Branch, as written, the regulations will almost surely
result in decreased, not increased, access to NHP's.
FACT 5: The regulation's requirements are not financially feasible for many small to medium sized producers of NHP's, whose companies would be seriously destroyed.
CONCERNS:There is a much more effective method of achieving the above
stated objectives without shutting down small manufacturers, and/or
employing methods which can be applied in a biased manner, (see "The Natural Health Industry Wants Appropriate Regulations" document).
FACT 6: The regulations demonstrate a failure to consider crossover effects into and from other legislation. i.e. GST, Income Tax act, Excise Act,
Canada Health Act, etc.
CONCERNS:For example, due to these regulations, GST has been charged
retroactively, back to 1998, to companies based on the claim by CCRA that
due to the new definition of a Natural Health Product, (i.e. acting on
legislation that has not even been passed yet), these companies should have been charging GST on a wide variety of products, [ref: CCRA document P-240].
Given their regulatory history, and the involvement of an immensely powerful drug lobby, the Health Protection Branch cannot be trusted to administer the new regulations fairly. Despite the verbal assurances of well-meaning NHPD officials, the words that are written on paper in Gazette 1 mean that if these regulations are at any point administered by officials with a bias against NHP's it could mean the end of the industry as it now exists.
The regulations, take a market in Canada with approximately 60,000
food-based, non-drug medicines that should be if the promises made in 1998 were kept somewhere over 75,000 products without decades of unnecessary HEALTH CANADA interference, and take everything off the market unless site and product is properly licensed by the PHARMACARTEL DRIVEN Health Canada officials.
The 1994 DSHEA in the US was the leading edge "Food-based, non-drug
medicines act in the world. Its weakness was GMP which we all want
"appropriate GMP" in our new Canadian legislation. Unlike the drug style
regulatory third category DSHEA grand fathered every existing safe product
into the new regulatory regime.
The new regulatory regime in Canada is a "WHITE LIST" regulatory regime -
totally unacceptable. IT WILL ONLY SERVE THE FINANCIAL INTERESTS OF MEDICAL DOCTORS, PHARMACISTS, PRESCRIPTION DRUG INVESTMENT INTERESTS, LARGE HEALTH INDUSTRY INVESTMENT INTERESTS, AND RELATED FINANCIAL INVESTMENT INTERESTS!
Health Canada admits that only 10,000 of the 60,000 NHP's [more properly
called food-based, non-drug medicines] have DIN's now. Health Canada also admits that hundreds of small and medium wholesalers and manufacturers in Canada, and outside Canada will not be able to afford to make the transition.
It is also fact, which in the early 1990's when the "Modern Medical
Investment Interests" were successful with drug style regulatory regime in
Australia over 30% of independent health food stores was put out of business in the next few years. This really pleased the mass-market grocery and drug store, and the chain health food retailers.
There has been no effort to truly implement what non-trade associations
requested. Public interest is not in anyway being properly incorporated into
the new regulatory regime. Legal issues constitutionally are also being
ignored, as well as the need to fully integrate "Modern medicine" with
"Traditional Health Care".
These regulations are not delivering what the involved parliamentary groups prescribed, and seem to be following a much different agenda. As a result, if these regulations proceed as written, Canadians will in due time not have their unfettered access to NHP's as promised to them by the Government of Canada.
Politically, this is a time bomb, that will be very dangerous to any
politician that chooses "Bottom line support of Modern Medical Investment
Interests" over that of the good health and well-being of Canadian voters.
If Gazette 2 is published the attached E-Protests [they are addressed to me as an insert in the federal MP list to obtain copies] will grow into over 1,000,000 very upset citizens literally chasing every MP in their riding all
summer.
Every MP received a personally addressed copy of these, and this is just via
the www.friendsoffreedom.org website.
Our coalition is expanding exponentially daily. Also, go to our www.friendsoffreedom.org website scroll down on the left side and click on
TRUEHOPE VS HEALTH CANADA for one of many stories that we are assembling and posting.
There will be several new websites dedicated to what the PHARMACARTEL driven Health Canada officials have been doing since the "PHARMACARTEL 1934 Food and Drugs Act Amendment" was passed [see copy on our website]. Attached is an industry brief 'save our Industry" for your information as well.
I will call you tomorrow morning as a follow-up.
PLEASE HAVE THE PRIME MINISTER STOP GAZETTE 2 NOW.
Thank you for listening.
Trueman Tuck
National Coordinator
Friends of Freedom
Freedom of Choice in Healthcare
The Canadian Coalition for Health Freedom
International Advocates for Health Freedom
POB 10632 Blacksburg VA 24062 USA
http://www.iahf.com; http://iadsa-exposed.tripod.com
800-333-2553 N.America
540-961-0476 World
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