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Wednesday, March 09, 2011

REPORT: Why the Natural Health Product Regulations should be Suspended and Reviewed

How Health Canada diverted what was intended for Natural Health Products and the associated industry; how they have hidden it from the elected representatives, and what it means for Canadians

A report prepared for Canadian MPs Submitted March 2, 2011

On behalf of Freedom of Access to Dietary Supplements Association

**Note: This report does NOT pertain to Bill C-36.

As Bill C-36 excludes the Food & Drugs Act, it does not apply to Natural Health Products.

Suspend and Review the Natural Health Product Regulations - Summation for Canadian MPs Recommendation: That the enforcement of the Natural Health Product (NHP) Regulations be suspended pending a

review by the Standing Committee on Health.


A. The NHP Regulations were never supposed to take the form that they did, and opposed the will of the Canadian Public and Parliament.

B. The NHP Regulations are unconstitutional for numerous reasons.

C. The NHP Regulations are damaging Canadian citizens, both physically and economically.

D. The NHP Regulations are adding to already astronomical government/public expenditures on healthcare by eliminating self-help options that Canadians want access to, and are willing to pay for privately.

The Solutions:

A. Remove NHPs from the DRUG category, and create a truly distinct category. Regulate them via a separate Ministry as set out in “The Charter of Health Freedom”.

B. Define NHPs according to what they are, and their relative levels of risk, rather than on what they are intended to be used for, as is currently the case.

C. Create a situation within the distinct category where claims are voluntary. IF a Natural Health Product makes an official claim, THEN it has to be substantiated with appropriate evidence, while allowing safe products with no claim to remain on the market with a general discussion on the label to inform consumers of their purpose.

D. Award a government-issued seal of approval for approved claims, to indicate to consumers which claims have met standards, and to provide a market advantage to those companies that achieve this.

Discussion of Rationale

A. The Natural Health Product Regulations were never supposed to take the form they did, and opposed the will of the Canadian Public and Parliament.

As administered by Health Canada, the regulations have taken a drastically different direction, and produced many outcomes opposite to what was loudly demanded by the Canadian public majority, and what was set out by the Standing Committee on Health, and Parliament.

When Health Canada tried to pass the Establishment Licensing Act in 1997, Canadians protested loudly that they did not want Natural Health Products regulated as “DRUGS”. The largest petition ever at the time, called “Our Foods are Not Drugs”, gathered over 150,000 signatures. The Act was halted, and a lengthy review by the Standing Committee on Health culminated in 53 recommendations to Parliament, all of which were accepted. Recommendation #1, was that “There shall be legislative reform... [i.e. changes made to the Food and Drugs Act] provide a category for Natural Health Products that was distinct from either Foods or Drugs, and which recognized their low risk nature. This general directive was echoed repeatedly in the Standing Committee’s final report, and in the final report of the Transition Team... but it never happened.

Health Canada failed to create a truly distinct category by amending the Act, as was specifically recommended on page 11 of the Standing Committee’s final report. Had they done this, the Food and Drugs Act, in essence, would have become the “Food, Drugs, and Natural Health Products Act”.

Instead, Health Canada took advantage of loopholes in the wording of the Report and the 53 Recommendations, and placed NHPs as a subset of DRUGS. They simply created a separate directorate and a new set of regulations for NHPs, claiming that amending the Food and Drugs Act would take too long.

That Natural Health Products are regulated as DRUGS is commonly known in the NHP industry, and is reflected in their definition, which is largely verbatim of that for pharmaceuticals. However, to find published evidence of this fact is difficult. One of the only references in government records indicating that NHPs are actually regulated as DRUGS is found under the Natural Health Products Regulations Regulatory Impact Analysis Statement, published in the Canada Gazette part I, page 4913, Dec.22, 2001, where it is stated bilingually:

“NHPs would be considered a subset of drugs under the Act. The new Regulations would apply

to products falling within the definition of an NHP.

The very next line in the text carries on: “Based on recommendations from the Standing Committee (set out in its report entitled A New Vision), the main components of the Regulations are definitions, product licensing, adverse reactions reporting, site licensing, good manufacturing practices, clinical trials, and labelling and packaging.”

This provides the definite impression that Health Canada was simply proceeding based on the recommendations from the Standing Committee. But Health Canada failed to follow the most important one, i.e. Natural Health Products were never supposed to be regulated as Drugs. Such a regulatory arrangement was specifically ruled out by the Standing Committee in Chapter 4 of its final report.

The “OPTIONS FOR THE NEW REGULATORY AUTHORITY” are depicted in Table 1, page 13 of the Report. On page 14 it is stated: “The Committee in rejecting Option 3 and Option 4... [i.e. regulating NHPs under Drugs or Foods]... gave serious consideration to these views. However, its final assessment is based on its own belief that the assessment of NHPs would benefit from a fresh approach, one where NHPs are evaluated in a forum and through a process detached from either pharmaceuticals or foods.” (Insert and emphasis added.)

As the DRUG assessment model currently being applied to NHPs was originally formed, and used for decades, to assess pharmaceuticals, this is not using a process detached from pharmaceuticals, as was recommended. What was meant, as is very apparent when one reads the report, is that in order to be regulated fairly, NHPs must be regulated out of the DRUG category. So, Natural Health Products were never given the distinct category everyone was expecting. Furthermore, since as DRUGS, Natural Health Products are presumed dangerous until proven safe, this fails to recognize their high safety levels, as was repeatedly referred to by the Committee.

Since sidestepping what they were told to do, and simply giving NHPs a separate directorate and regulations, Health Canada has been able to obscure the situation by advising MPs and the public alike that: “Natural Health Products and drugs are regulated separately, and have been since 2004”, (which many MPs in turn have told their constituents.) The wording of this statement is deceptive and inaccurate. It plays on the fact that when someone hears the word “drugs”, they automatically assume it to mean pharmaceuticals. The accurate way to state the situation is to say that: Though NHPs and pharmaceuticals are regulated separately, the fact is that BOTH are regulated as subsets of DRUGS under the Food and Drugs Act, and as such both must meet certain “drug” standards, discussed below. Yet, Health Canada fully knew the majority of NHPs would not be able to achieve this.

Why so many NHPs are being forced off the Canadian market

Moving NHPs into the DRUG category ensured the majority would be eliminated by creating a “rock and a hard place” scenario for proving claims in humans.

As “DRUGS”, in order to gain market approval, each NHP is forced to make a claim as to its intended use, and then must prove that claim in humans. Yet, until 2004, the majority of NHPs were classified as FOODS. Therefore, studies proving efficacy in humans were seldom done since there was no financial or legal incentive to do so. (As an analogy, bananas may provide a health benefit, but how many human trials have actually been performed to prove this?) There may be plenty of other forms of evidence for a given natural ingredient, but because of their expense, human trials are uncommon. So, for thousands of NHPs, official evidence proving benefits in humans is not pre-existing. Therefore it cannot be included in “the broad range of evidence” Health Canada claims to accept for NHPs.

Yet, creating this type of evidence is simply not financially feasible, because Natural Health Products are not patentable. When the evidence for an NHP does not meet Health Canada’s Standards of Evidence, the agency is demanding double-blind human trials. Such trials are extremely expensive, and at their conclusion, with no patent protection any competitor can simply copy the product in question and use the study results, without incurring the costs. The sponsoring company is practically guaranteed to lose money, so the product is simply discontinued.

So, on one hand, the necessary evidence to prove their claims often doesn’t exist, and on the other, it is not financially feasible to create it, because NHPs are not patentable. Health Canada knew this.

Outcomes: Out of the 70,000+ NHPs that they had access to in 2004, Canadians have lost access to well in excess of 40,000 products, i.e. they have been pushed off the market by the Regulations, and are no longer available for domestic purchase. This includes over 20,000 documented U.S. imports that retailers used to be able to order and sell in their stores, and in excess of 18,000 licence application refusals by Health Canada.

In addition, since the regulations began in 2004, virtually all Canadian NHP suppliers have continually reduced the number of products they offer due to the cost of compliance, and/or the likelihood of license refusals. At first, slow sellers were discontinued, followed by a continual onslaught of multiple ingredient products. They have been eliminated not because they are unsafe, or unpopular, but simply cannot meet Health Canada’s burden of proof for efficacy in humans for the reasons mentioned above.

Alternatively, Health Canada commonly decides that in order to meet regulatory requirements and remain on the market, long-standing effective herbal combinations need to be withdrawn and reformulated. However, when they return, they are rarely, if ever, as effective as the original formula. This is quickly reflected in their sales.

To compound the problems, a high number of U.S. companies that were actually stationed in Canada in 2004, either with their own manufacturing plants or through distributors, have simply stopped doing business in Canada, taking their products with them. Many had been sold in Canada for decades, with no problems or issues. The most recent of many examples is EAS, a sports nutrition icon in Canada that has been here since the 1980’s. As of January 2011, they pulled all of their operations out of Canada. These companies simply can no longer justify the expense or hassle of doing business in Canada.

Meanwhile, Health Canada has awarded less than 25,000 NHP#s. This number does not include product duplicates that simply piggyback off an awarded licence, which Health Canada commonly quotes, inflating their stated numbers.

Between 6000 and 8000 NHPs are still in the queue, having been given “Exemption Numbers” (EN#) while they are waiting to have their applications processed. Many have had their applications submitted for five or more years. If the ratio of approved to unapproved products continues, 5000 or less of these NHPs will likely be approved, bringing the total to approximately 30,000 or less...just over 40% of what we had in 2004. How does eliminating 60% of our choices achieve Health Canada’s stated intention for the Regulations of increasing Canadian’s access to NHPs?

Health Canada keeps maintaining that safety is their utmost priority for the Regulations, but the vast majority of refused applications have been denied for failing to prove efficacy, based on inappropriate standards, as mentioned. Out of the 18,000+ product license applications that have been refused by Health Canada, less than 1% of them have been denied for failing to prove safety, including a parsley product. Be clear, this does not necessarily mean that these products weren’t safe. It simply means that according to Health Canada, their applications did not prove safety, even if other products with identical ingredients received approval on their application.

It is often not the NHPs themselves that are being refused. Rather, it is just the paperwork. (One supplier got a refusal for not putting down a fax number!) Moreover, if Health Canada doesn’t want to approve an application, it doesn’t matter what evidence is presented, they don’t approve it. Products that work too well are particularly prone to such treatment. The standing joke is: “If it really works, you better buy lots, because it won’t be around for long.”

Also, the individuals now processing NHP applications are simply bureaucrats with no expertise in the field. Leading up to the NHP Regulations, another change in policy direction that was repeatedly identified as necessary by all involved groups was to have people with expertise in the field of natural health making the decisions. (See Chapter 4 of the Standing Committee Report.) But this was only adhered to very briefly after 2004.

Health Canada is playing regulatory games with potentially serious consequences for Canadians who were relying on NHPs they can no longer purchase. The agency is simply not applying the NHP Regulations based on what is reasonable, or what is good for Canadians. They are taking natural substances which have been part of the global food chain for millennia, and with regulations that are totally out of proportion to the levels of risk involved, making all manner of NHPs unavailable to consumers, practitioners, and/or the stores that sell them. They are driving up costs, and are on the verge of putting many companies out of business.

Health Canada was fully aware of the effects that regulating NHPs as DRUGS would have on the availability of NHPs. This is presumably why they were so stubborn about putting NHPs into the “DRUG” category. They tried in 1997, and despite all the public protests and government directives against it, ended up doing it anyway in 2004.

As mentioned, the Standing Committee spent the better part of two years establishing that NHPs do not belong in the DRUG category, which is clearly reflected in all the tone and rhetoric in their Final Report. This intention was also very apparent in the Final Report of the Transition Team, which was established to ensure that Regulations arrived at were fair and balanced. However, several members of the Transition Team simply quit because they weren’t being listened to, saying that Health Canada had already made-up their minds, so what was the use.

**Eliminating so many NHPs is the opposite of Canadians #1 stated desire, as identified by Health Canada.

After Parliament accepted the 53 Recommendations from the Standing Committee, Health Canada embarked on cross-country consultations with the Canadian public and stakeholders, with the stated intention of finding out what Canadians wanted. As was publicly announced by Health Canada, “By far” the number one request received from Canadians was that they wanted “greater access to a broader range of NHPs.” (Note: they did not say they wanted Health Canada to go on a witch hunt for efficacy, and eliminate over half the market.)

This overwhelming request is what resulted in Health Canada’s expressed purpose of the NHP Regulations becoming to: “increase Canadian’s access to Natural Health products.” How does eliminating 60% of the products on the market achieve this?

Moreover, what is the use of having a democratic mechanism if, after the people and the elected officials spend years establishing what they want, it is simply steamrolled by the bureaucracy?

With all the talk about a distinct category that is in both the final reports mentioned, and with Health Canada’s own announcements about what Canadians asked for, there is ample evidence that regarding the NHP Regulations, Health Canada has acted against the will of the Canadian people and Parliament.

Discussion of Rationale B. The Natural Health Product Regulations are unconstitutional for numerous reasons.

**Reason 1: Section 7 of The Canadian Charter of Rights and Freedoms guarantees the right of Canadians to life, liberty, and security. By restricting access to natural products that a Canadian may require to be healthy, the NHP Regulations interfere with the right to life. This interference with life is amplified when, after losing access to a natural product previously used for a health problem, Canadians substitute a much higher risk pharmaceutical for the NHP they can no longer buy here, (which, after over 40,000 NHPs have been eliminated, has no doubt happened many times since 2004). Since pharmaceuticals have a much higher risk level associated with them, this makes adverse side effects, including death, more likely. This interferes with the right to life.

In Canada, pharmaceuticals are responsible for thousands of deaths each year, versus zero recorded deaths ever for all NHPs. When an NHP used successfully for a health problem is eliminated by the NHP Regulations, and a Canadian who can no longer buy it uses a pharmaceutical in its place, it is clear that the risk of death and side-effects becomes

substantially greater. In such circumstances, by making death, and/or injury requiring medical attention more likely, the NHP Regulations interfere with life. (They also increase government expenditures on healthcare, discussed below.)

When the Regulations force an NHP off the market, it should only happen if the question of who it will harm has been addressed. Yet, Health Canada has carried out no risk analyses whatsoever regarding what the risks are of blocking or eliminating access to any of these NHPs will be. In some circumstances, consumers have tried every possible treatment for serious health concerns, and found that the only effective treatment for improving and/or maintaining their wellness is a Natural Health Product. If Health Canada then restricts access to the NHP they need via the NHP Regulations, once again, they make illness, pain, and/or death more likely. This is unconstitutional.

How many deaths will the NHP Regulations ultimately cause by making necessary, useful health support products unavailable to Canadians, forcing them to suffer, and/or use far higher risk treatments? This question becomes all the more relevant when the extremely small risk/benefit ratio of NHPs is considered, i.e. their relative risks are very small, and they have potential for meaningful benefit in a wide range of situations.

That the risks of using NHPs are relatively small is evidenced by their safety record. As mentioned, in Canada, according to poison control statistics, the total number of Canadian deaths on record as being caused by a Natural Health Product is ZERO (0)...EVER.

If, as is stated in section 3 of the CANADA HEALTH ACT, (Chapter C-6, Dept of Justice, current to Jan. 31, 2011), under the heading: CANADIAN HEALTH CARE POLICY, (quote)

“3. It is hereby declared that the primary objective of Canadian Health Care Policy is to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers. 1984, c. 6 s. 3.

And if, as the Minister of Health always states in her letters to citizens:

“Maintaining the health and safety of Canadians is a priority for the Government of Canada. Health Canada’s mandate is to ensure that Canadians have access to the safest possible products.”

Why then are so many Natural Health Products being eliminated in the face of such overwhelming evidence that NHPs are indeed relatively extremely safe? Is it really because they don’t work?

If so many natural health products don’t work, why are they so popular, and continuing to grow in popularity? And if the NHP Regulations are reasonable, as Health Canada claims, why are so many people upset about losing their access to NHPs? It is more likely true that most NHPs actually do work for the people who use them, but just can’t PROVE efficacy according to Health Canada’s standards in their current classification as DRUGS. Further it is evident that Health Canada knew full well what they were doing when they set it up this way. As evidenced by their ever growing popularity, and the 2,000,000 plus peer reviewed papers being published on them annually around the globe, the potential benefits of NHPs can be many, and varied.

Moreover, particularly for the products that waited, or have been waiting, for years to have their applications assessed, if an NHP is safe enough to be on the market since 2004 without problems, and is effective enough to survive market pressures, (i.e. it must be working for someone if people are still buying it) what valid rationale is there for eliminating it now? This same question can also be applied to the countless products already eliminated after being sold here for decades.

The Standards of Evidence that Health Canada is using to eliminate NHPs for failing to prove efficacy are invalid.

They are structured around a pre-existing drug-model template that was originally designed for assessing single- molecule pharmaceuticals. In contrast, many NHPs, particularly herbal combinations, are extremely complex. NHPs can consist of hundreds of identified constituents. Accordingly they can have multiple effects on multiple systems in the human body. With over 88,000 identified substances in the human food chain, there is simply no way Health Canada can accurately account for all the potential benefits of NHPs, or the reasons people may use them with the current DRUG assessment methods.

Yet, Health Canada can control the direction of future innovations and discoveries. Given the expense of “proving” NHP claims in human trials, and considering that NHPs are non-patentable, any future discoveries are now, for the most part, the domain of large (presumably pharmaceutical/transnational) corporations, as they are the only ones with enough resources. Very few NHP suppliers or manufacturers can afford such trials. But, with NHPs not being patentable, chances are no one is going to do the studies anyway.

Hence, the Regulations have ground product innovation in the NHP industry to a virtual standstill. By stifling future discoveries and innovations, the NHP Regulations are exerting control over Canadian consumers’ health options and preventing an untold number of NHP benefits from ever reaching the public.

As Health Canada obviously knew the implications of their own regulations, whose purposes are the Regulations really serving? Is it those of the Canadian people?

With the burgeoning popularity of NHPs, a good argument can be made that what Health Canada is really doing with the Regulations is collaring the direction and development of the NHP market. There are many indications that the market is being pruned, simplified, and made less effective overall, as innovative and effective products made by smaller companies are forced off the market, while what remains on store shelves are simpler, more mainstream products from large corporations. (Ironically, the first product awarded a Natural Health Product licence by Health Canada was the sugar and caffeine-rich stimulant drink, Red Bull, produced by an Austrian transnational giant.)

On the other hand, there has been more than one instance where if an NHP works too well, and supplies too much evidence, indicating that a product is extremely effective for a serious health issue, the therapy is usurped by the medical/pharmaceutical industries.

An excellent example of this is an anti-inflammatory proteolytic (protein digesting) enzyme NHP called Serrapeptase. Since entering the market in the late 1990’s, it has been used with great success for pain relief, and to clear arterial plaque by slowly digesting proteins that hold the plaques together. After more than 5 years of submitting ever more evidence to answer Health Canada’s Information Request Notices, the NHP applications for the two highest strength products in the most popular brand were denied. Within six weeks of this occurring, a new medical procedure was approved by Health Canada for injecting proteolytic enzymes into the arteries to clear plaque. This would seem to be more than just coincidence.

It is also relevant to note that even though Natural Health Product themselves are not patentable, if an identified constituent in a botanical can be isolated, and a unique use identified for it, that use CAN be patented.

Bayer, for example, reportedly owns several hundred of these patents on such isolated constituents from botanicals, and this is to become the new frontier in drug development. Yet such drugs will be much less marketable if the whole plant form, from which the isolated constituent was derived, is still widely available as an NHP.

Not surprisingly, Bayer, along with several other pharmaceutical groups, is a member of the Program Advisory Committee for the NHP Regulations.

In the regulation of NHPs there needs to be a mechanism in place where claims are not mandatory, and/or if claims for a product are disallowed, it is still at least allowed market access with a general discussion as to its purpose, and a name that simply identifies what it contains. This way Canadians can still get products that they need to be healthy, or that they felt they were getting benefits from. Due to the complexity inherent in many NHPs, Health Canada can simply not account for all of the reasons a person may use it, or why it may benefit them. If the product truly does not work people will stop buying it, and it will be culled by free market pressures.

**Reason 2: Health is a provincial jurisdiction. In order for the federal government to exercise authority, a matter must be criminal. To be considered criminal, it is necessary for a matter to exceed a threshold of risk. With zero Canadian deaths on record where a Natural Health Product is listed as being the cause, NHPs do not reach this threshold. Therefore Health Canada is out of its jurisdiction.

Every year Canadians die from anaphylactic reactions to nuts. (This is why we have “nut free zones” in many Canadian schools.) Anaphylactic reactions to shellfish and various other foods also occur, and according to CBC News, one in nine Canadian emergency room visits are due to side effects or negative reactions to prescription drugs. It is well established that pharmaceuticals account for thousands of Canadian deaths each year. Therefore, being on record as having caused zero Canadian deaths ever, it can be easily established that NHPs as a group are safer than either FOODS or DRUGS. As such they do not pose enough of a risk to be governed by criminal legislation at a federal level.

Health is the jurisdiction of the provinces, and as their title assigned by Health Canada indicates, Natural Health Products are most commonly used for maintaining wellness and prevention, or for treating concerns before they require medical attention. As such, given their safety, NHPs should be regulated at a provincial level.

It is relevant to note that natural health practitioners are a Provincial jurisdiction. As stated in the NHPR Regulatory Impact Statement mentioned above, (pp. 4913-4914), a practitioner can compound any natural formulation they want for someone they are advising. This begs the questions: If practitioners are allowed to compound anything they want, why is Health Canada blocking so many imports that health practitioners were formerly using, and striking so many products off pricelists where the company only sells to health professionals? Why is the practitioner granted autonomy in one situation, but not the other? By overriding the practitioner’s decisions about whether or not these products are needed, is Health Canada not practicing medicine without a licence? Are the bureaucrats making these decisions trained in the appropriate areas, and who is being put at risk? If a practitioner offers a general formulation to the public meant to simply enhance vitality, and be healthy overall for anyone, why isn’t it still a provincial jurisdiction? Why is it suddenly a criminal matter, where it wasn’t before? What gives Health Canada jurisdiction?

This same type of inconsistency exists regarding personal importation of NHPs. As long as an NHP is not banned, or provided only by prescription in Canada, a person can import a three month personal supply of any NHP from the U.S., or abroad. Yet, when it comes to importing that same product for resale, Health Canada claims jurisdiction, and blocks the import, saying that the product must have an NHP#. So, if the NHP in question was safe enough for any individual to import privately and use, why does Health Canada’s jurisdiction over safety and fraud suddenly kick in when it comes to importing the exact same product for the purpose of resale, when anyone purchasing it here could have imported it from the U.S. anyway?

Recently, Health Canada has also claimed jurisdiction over NHP exports to other countries, stating that with the exception of the U.S., (with whom we have a free trade deal), any exported product must have an NHP#, even when the country of destination does not require it. Moreover, is Health Canada’s actual concern safety, fraud, or simply controlling the commerce of NHPs, and what are the implications for Canadians?

In their Regulatory Impact Analysis Statement, (Canada Gazette, Part I, Dec 22, 2001, Pg. 4914) Health Canada states:

“The Regulations are not aimed at regulating the activities of retailers of NHPs.”

Yet they have several times provided deadlines after which retailers are no longer able to sell an NHP that does not have either an NHP# or an EN#. After that, it has been made very clear to all retailers that Health Canada will be launching enforcement, as inspectors go to health food stores around the country to remove products from the shelves that they deem are non-compliant. (So much for not regulating the activities of retailers.) Health Canada is constantly engaging in a process of “Bureaucratic Creep”, where they expand their actions into an increasing number of areas, whether they have jurisdiction or not. The NHP Regulations are a perfect example.

Overall, it appears Health Canada is much more concerned about controlling NHP commerce, than they are with remaining in their area of jurisdiction over fraud, and safety issues involving risks worthy of criminal legislation.

**Reason 3: When applied to NHPs, which pose relatively very low levels of risk, the "use based” definition of a drug is unconstitutional, because it regulates the intended use of a safe substance, instead of the substance itself. When it comes to NHPs that are established as being safe, this amounts to censoring an individual’s actions for no reason, and is unwarranted State control that serves no benefit, and can be detrimental.

For a banned street drug like crystal meth, it doesn’t matter whether it is in powder, or capsule form, it is still treated the same, i.e. the substance itself is regulated. But when it comes to turmeric, cinnamon, or parsley for example, if they are bagged, and you use one of them in cooking, Health Canada considers them FOODS. Yet, if you put any of these same substances in capsules, and swallow them for their health benefits, they are considered DRUGS. What changed was the "intended use", i.e. your intention. But you were going to ingest it one way or another, so regulating your intention served no rational purpose other than unwarranted State control. They are the same substances considered safe one moment, but considered “dangerous until proven safe” in the next. This is invalid and unconstitutional, because it isn't the State's business why you are putting a safe substance in your body.

With pharmaceuticals, there are risks involved which can be used to rationalize this. But for Natural Health Products, with zero deaths ever in Canada, regulating your intention of what you are going to use for cannot be rationalized.

As an analogy, if you buy a hairbrush, what business does the State have in telling you whether you can brush your hair with it, or scratch your back? It is safe either way, and having the State regulate your intention of what you are using it for is unwarranted and unconstitutional.

NHPs need to be regulated according to what they are, and their safety level, rather than what they are intended to be used for, as is currently the case. The creation of a truly distinct third category, completely out of the DRUG category, is necessary if fairness to consumers is to be maintained.

Furthermore, with skyrocketing healthcare expenditures, the time has come to enact new legislation that would protect Canadians’ rights to maintain their own health and wellness, free of bureaucratic or political interference. Such legislation could be overseen by a new ““Ministry of Wellness”, and has already been written. It is entitled the “Charter of Health Freedom”.

Discussion of Rationale

C. The NHP Regulations are damaging to Canadians, both physically and economically.

There are many indications that Health Canada’s true intent for the Regulations right from the start was to reduce the NHP market, both in terms of the number of products, as well as the companies that supply them.

The NHP Regulations are having many damaging effects at every level of the supply chain in the NHP industry.

Consumers are frustrated because they can no longer get many safe products they want, and/or need. Furthermore, due to their inappropriately onerous demands, the Regulations have driven up NHP prices for the consumer. And whether a product is unavailable, or simply unaffordable, the net effect is still reduced access.

Natural Health Practitioners are being hobbled both professionally and financially, because they can no longer get the products they were formerly using to help the people seeking their advice. In this regard, the net effect that the agency is achieving is health suppression, not health protection.

Retailers are losing all manner of unique specialty products, whose NHP license applications are failing. As more and more of these innovative products disappear, the selection in health food stores increasingly becomes the same as mass market, against whose prices they simply can’t compete. (In essence, the Regulations are removing the “specialty” from the specialty market.)

Distributors are having all manner of products blocked and disallowed at the Canadian border, putting many of them in an extremely tenuous business situation, with an ever-looming question of whether they will be able to continue.

Manufacturers are having all manner of products eliminated due to license application failures for a variety of reasons, mentioned above. Cross-country scores of NHP manufacturers are nervously wondering which of their products will be “picked off” next.

Was this really what was intended by the Standing Committee when they came out with their recommendations, or what was asked for, or wanted by Canadians? The answer would seem to be a resounding “NO”.

Discussion of Rationale

D. The NHP Regulations are adding to already astronomical government/public expenditures on healthcare by eliminating self-help options that Canadians want access to, and are willing to pay for.

That the government is allowing Health Canada to remove so many NHPs, and drive up prices, when medical and pharmaceutical-dominated, publically funded healthcare is bankrupting the nation defies logic. Then again, very few M.P.s are aware of what is going on with NHPs, or actually understand the issues at hand. Many MPs respond to their constituents who voice their concerns about the Natural Health Product Regulations as if their inquiries are being made about Bill C-36, even though this is never mentioned.

It is high time the MPs educate themselves on the matter. The huge majority of the NHPs that have been eliminated to date were safe self-help alternatives that people want, and are willing to pay for! If, as the Globe and Mail on Feb. 27, 2011 states: “Health care costs could eventually swallow all levels of government if left unchecked”, why aren’t we increasing our access to these products, rather than eliminating so many of them?

And what about the cost of the NHP Regulations to taxpayers, which long ago was well in excess of 100 million? (Updated figures not released.) Canadians are paying the wages of Health Canada bureaucrats to wipe-out their health options. Yet, Health Canada claims that they are increasing our access to NHPs. This is simply untrue.

Even the most patriotic of government officials wouldn’t have a hard time believing that these NHPs are being eliminated en masse because of influence from some of the largest corporations, and vested interests in the world. Hopefully our MPs can come to the aid of their constituents who want to maintain their ability to take care of themselves before all of their tools have been eliminated, and the industry as we know it know has been transformed, becoming exclusively controlled by big business and pharmaceutical/ transnational corporations.

Discussion of Solutions

If Natural Health Products were removed from the DRUG category, and a truly distinct category was created, then NHPs could be regulated based on what they are, and their relative levels of risk, rather than what they are intended to be used for, as is currently the case. A situation could then be created within the distinct category where claims are voluntary. IF a Natural Health Product displays a claim, THEN it must be proven, while still allowing products deemed safe to remain on the market with general discussions, and names that simply identify what they contain.

If one of Health Canada’s goals is actually to provide the consumer with more information on what a product is for, then more explicit product discussions than the restrictive ones Health Canada has permitted to date should be allowed. Further, standardized symbols, (similar to universal washing instructions), could be displayed on labels to indicate what level of testing a product has undergone. (Given the relative safety of NHPs, why not allow more information, and leave the decision to purchase or not up to the consumer and free market pressures?)

If the right to display a seal of approval, (akin to the CSA approval sticker found on helmets) was awarded to products with an approved claim, this would provide them with a definite competitive advantage in the marketplace. In fact, achieving this could easily become a much stronger motivating factor for proving claims and quality assurance than the current regulatory situation, which is considered onerous, and unwarranted.

Apart from that, the wheel doesn’t need to be reinvented. There are many aspects of the Regulations that are workable and reasonable if administered properly. So the parts that work can still be used. Yet, to achieve fairness, history has clearly shown that NHPs cannot be regulated by Health Canada. A separate Ministry, i.e. the Ministry of Wellness needs to be created, from which the savings to healthcare budgets could be substantial.

Contrary to media portrayals, the NHP industry wants regulations. They want confidence and acknowledgement from public and government that they are following high standards for testing materials, and other forms of quality assurance, including Good Manufacturing Practices, to ensure that what is on the label is in the bottle. But, it makes it very difficult to achieve when the bureaucracy seems intent on squeezing you out of business, and disrupting streams of income from all manner of products that suppliers want to, or used to, offer.

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