|Health Canada's Tactics|
Losing NHPs Over Safety Or Corporate Profits?
Where we were. Where we’re going.
For almost all of our history Natural Health Products (“NHPs”) have been unregulated. The Food and Drugs Act was introduced to protect against fraud, adulteration, and access to dangerous substances. Because NHPs are not dangerous, they have traditionally been largely ignored by Health Canada. Almost all NHPs could not comply with the drug regulations which are designed for dangerous chemicals. If a complaint was made concerning an NHP, Health Canada would apply the chemical drug regulations against the NHP and drive it from the market. This was, however, sporadic. The natural health community thrived because Health Canada ignored it.
Although, unregulated, NHPs were not posing a safety risk. Several federal laws prevented fraud or adulteration. In all of Canadian history there has not been a single death caused by a NHP. To understand how significant this is, we only have to compare the NHP track record with some over-the-counter pain medications or common foods such as nuts and shellfish. These common medications/foods kill a number of Canadians each year, including children. More are hospitalized. At the same time, although they carry a risk, we do not ban or over-regulate common medications/foods because we do not consider the risk high enough. NHPs which have never caused a single death in Canadian history can be properly called ultra-safe. They are dramatically safer than peanuts, shellfish, and some over-the-counter pain medications.
Because NHPs are so safe, Canadians were not asking the government to regulate them. Nor did it seem that Health Canada was concerned about them. The best way to determine if a product is safe is to actually test the product. At one time Health Canada had one of the best labs in the world for testing NHPs for safety. The lab was headed by Dr. Dennis Awang who is recognized as a leader in the field. However, around 1990, Health Canada closed the lab. NHPs did not pose enough of a risk to justify the cost of the lab. For a few more years NHPs were largely ignored by Health Canada. Then things changed.
In the mid 1990s Health Canada started attacking NHPs. Products were taken away from Canadians because they were not complying with the chemical drug regulations. Canadians became so alarmed that they rebelled. This was perhaps the largest citizen movement in Canadian history. I was told by a parliamentary aid that more Canadians signed the petition to protect their access to NHPs than any petition in Canadian history. The message from Canadians was clear: we wanted our access to NHPs protected. The Government backed down. The Minister of Health at the time, Alan Rock, asked Parliament’s Standing Committee on Health to look into how NHPs should be regulated. The Committee held wide consultations and made recommendations intended to protect Canadians’ access to NHPs. There was no misunderstanding with the Government or with the Committee with what the wishes of Canadians were: Canadians not only wanted their access to NHPs protected, they wanted increased access to NHPs. Remember citizens did not become involved because of their concern over the safety of NHPs, rather they became involved because of their concern over the danger of taking NHPs away. Canadians were relying on NHPs to protect their health and did not want their health in jeopardy.
In response to our demands for increased access to NHPs, Health Canada came out with the NHP Regulations. The NHP regulations are chemical drug-style regulations. They presume NHPs to be dangerous. Under them the NHPs we have traditionally relied upon must be taken away unless it is proved to Health Canada that they are safe and effective. In 2004 when the Regulations started to be phased in, Health Canada estimated that there were 40 – 50,000 NHPs being used in Canada. NHPs had several years to come into compliance and so the number of NHPs continued to grow. By some estimates there were 70,000 NHPs available in Canada around 2007. Then the numbers began to drop. The numbers are declining for 3 reasons.
One reason we are losing NHPs is that they are not getting through the licensing process.
Of all the NHP license applications that Health Canada has processed to date, slightly more than 50% have failed. The thousands of products that failed to get licensed are illegal and must be removed. Some in the media focus on the licensing statistics and predict that this 50 – 55% will represent the total loss of our NHPs. They are underestimating the number of products we are losing because they are not looking at the other reasons we are losing products.
Another reason we are losing products is that producers are taking them all off of the market without ever submitting a product license. The reason for this is simple. The cost of complying with the Regulations and obtaining a license is so high, that they cannot afford to comply. Let me give you two examples. One of Canada’s most well respected herbalists who grew his own organic herbs and harvested wild herbs for his products simply stopped selling when the regulations came into force because the cost of complying was too high. We can no longer access these top quality products, but their loss does not show up in the licensing statistics. Similarly a medium sized manufacturer explained to me when the regulations came into force that they would only be trying to license 20 of their 100 products. The other 80 products were low sellers and they believed they would go bankrupt trying to get licenses for all of them. Most of their products are still on the market because Health Canada has not yet demanded unlicensed products to be removed. When the transition period is over the 80 low sellers will all be removed. Again this will not be accounted for in the licensing statistics.
The third reason we are losing products is that foreign products are being stopped at the border. By 2009, John Biggs of Optimum Health in Edmonton had calculated that there were at least 20, 000 U.S. products that he could no longer get for his stores. The number has since grown. These are products that are completely legal in the U.S. The loss of these products will not show up in the licensing statistics.
How Bad Will It Get?
My prediction is that we will go from 70, 000 products to around 20, 000. The type of product available will also change. Most will be single ingredient products. So for example, of the 20, 000 products there could be a 100 different ginseng NHPs. Innovative and effective multi-ingredient product development will stop (indeed it is already grinding to a halt) as it becomes clear that licenses will not be granted. Rather, we will move to a monograph system where Health Canada will publish monographs for ingredients. Producers will be able to make multi-ingredient products with monograph ingredients providing they stay within the terms of the monograph.
The danger of a monograph system is that it is easy for NHPs to be rendered ineffective by lowering the allowable monograph amounts.
Are the Regulations really about safety?
The question of another agenda
By Shawn Buckley, August 2009
It is a statistical scientific fact that peanuts are more dangerous than the entire NHP industry. Peanuts kill Canadians every year. NHPs have never caused a death in Canada. It is also a fact that millions of Canadians rely upon NHPs for their health. If the actual danger is taking NHPs away from Canadians, then what is the real purpose of the NHP Regulations? The purpose cannot be about safety.
It was also clear to anyone paying attention that the regulations were not about safety. One of my favorite anaylsis or this point came from Dr. Michelle-Brill-Edwards. Dr. Brill-Edwards is a former Health Canada Scientist. She used to supervise other drug-approval scientists. In an interview on CKNW radio on April 25, 1997, Dr. Brill-Edwards made the following comments:
There is no question that what is going on at Health Canada does not really protect citizens. The provisions that have just come into place are paper processes. No one, for example, at Health Canada is analyzing the product that is actually in the bottle so you have no assurances as a citizen that what you are seeing on the label is actually what is in the bottle. Now if Health Canada were really rigorous that’s what they would be doing. They would be taking those kinds of safety measures. But in essence they’re putting in a paper process that will push the small people out of the market place and leave it open for the larger pharmaceutical firms who will then come in and try to tell us that the product are now safer. They won’t be safer because there’s no real scrutiny about the quality of the product and the information about the product.
Regulations are not always enacted for the benefits of the citizens. Often Regulations are imposed that benefit the industry being regulated and the regulating body. The industry being regulated is benefited by an onerous regulatory scheme which drives smaller players out of business and which creates a barrier of entry for new businesses. The regulating body benefits by creating a need for its expansion. This process was outlined in detail by constitutional lawyer Jonathan Emord in his book The Rise of Tyranny. Mr. Emord’s analysis includes the following:
In 1967 economist Gordon Tullock first identified the substantive aspects of what later came to be known as “rent-seeking” in his study of monopolies. In 1974 economist Anne Krueger coined the term, which may be understood as the means by which a party can manipulate the market or the law to bring about what is effectively a non-consensual transfer of wealth, causing one party or a small group to experience financial gains at the expense of all others. Typically lawyers and lobbyists for industry leaders will urge agency heads to promulgate regulations (prior restraints) upon an entire industry (not just those engaged in the disfavored activities) ostensibly to improve safety or quality or to eliminate certain politically disfavored outcomes. The underlying motive for the industry is, however, not a public good but private gain. The regulations recommended usually impose significant costs on all market participants, creating barriers to entry and new costs of doing business that may be unaffordable for smaller firms, driving them from the market. The result is a reduction in competition that redounds to the benefit of large firms that may enjoy a new ability to raise prices or consolidate market share and reduce funding for advertising, promotion, and innovation. Over time, consumers watch as the competitive market gives way to a government sponsored oligopoly or monopoly, leading to higher prices, lower quality, and fewer choices.
Is it possible that our Regulations are intended to favour large industry players at the expense of the natural health community and Canadians that rely on NHPS? I think it is instructive to consider a research piece called The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors found at BMC Health Services Research 2006, 6:63. The authors investigated the attitude of small, medium, and large manufacturers of NHPs. Unsurprisingly, the large players supported the regulations because they are too onerous for the small players. The following quote is suggestive of the “rent-seeking” described by Mr. Emord:
On the other hand, some representatives from large companies are disappointed with the time frames provided by the NHPD but for different reasons than representatives from SMEs [small and medium sized enterprises]. Large firm employees are frustrated that the implementation stage is moving slowly:
“the faster the weaker players get out of the business, the better, from a commercial side or predatory side…there’s only going to be 3 or 4 big players that are going to survive. We intend on being one of them. So I’m saying if you’re going to cause that, then do it faster. Quit slow bleeding us.
To accept the Government line that the NHP Regulations are about safety requires one to:
Health Canada’s Tactics
In this video clip Shawn Buckley refers to Bill C-51, yet this the issues he raises are as relevant today. Shawn makes it clear that Health Canada inspectors are not qualified to make health decisions. Yet the regulations currently in place give Health Canada power to decide whether or not you can have access to a natural health product you rely on for health. That is a health decision.
In healthcare, well-stocked health food stores are the last meaningful avenue for self-medicating without pharmaceuticals. This conflicts with transnational pharmaceutical interests, which collectively represent trillions of dollars. They have huge and largely undisclosed influences on Government policy, particularly in regulatory agencies such as Health Canada.
Health Canada is responsible for enforcing the same legislation that it creates, and its officials do not change with the governments. This makes it a prime target for conflicts of interests, and control by the corporations it is supposed to be regulating.
This is the public’s health care system. Parliament is our trustee. More Canadians than ever favour natural health. We will fight until we see the public interest on natural health respected in policy and practice.
The Charter of Health Freedom calls on Parliament and the government to re-assert proper management of Canadians health and call for a thorough reform.
The Charter of Health Freedom offers a relevant solution that can plug into the terrain of Canada’s legislative imperative and work to give the public and natural health stakeholders confidence in the intentions of its legislators.
Thirty Three Million Reasons To Get Involved
If we get 10% of Canada’s population, three million people active, we can make the change.
Each and every one of us who believes in their rights and freedoms needs to speak out. Not just speaking out amongst ourselves. But speaking out in public. Our concepts will be challenged and the Charter of Health Freedom questioned. We can address any concerns or questions the public, industry, researchers or complimentary and allopathic professionals may have.
Give your MP a chance to protect your rights. It’s their job.
There is nothing your MP can do for you unless they know how you feel.
Ignore What They Say. Watch What They Do.
These articles, commentaries, critiques, open letters and personal stories about Health Canada are must reads. You will find criticism and argument in all of the following pieces. Since Health Canada is a ministry of the government; and Canada is a democratic nation; we can openly oppose “it’s” inappropriate regulations, unconstitutional over-sight and seemingly illegal actions.
Opposition is necessary to a healthy democracy. And literally, in this case, a healthy life.
The Charter of Health Freedom is an all-party legislation. It is not government or Parliament that we oppose; it is the actions, as described throughout this site, of “an over-ruling” Health Canada.
We must build our opposition, again. Policies and regulations have become too one-sided. The NHP Regulations clearly do not match Canadian systems of law (rights). Nor do the NHP Regulations meet the requests made by Canadians over 10 years ago.
Government parties have a vested interest in listening to the opposition (that’s all of us). Granting our demands allows them to re-think existing systems, become fair, open and accountable.
What is valuable and powerful in any democracy is the system of checks and balances it gives us to vocalize what laws we feel are, or are not, in our best interests. Natural health and wellness is being embraced by people who understand self-care, personal responsibility and prevention. It is in our personal, economic, political and social best interest to manage NHPs with a law as proposed in the Charter of Health Freedom.
The following writings are selections that give voice to only a few instances on record regarding Health Canada’s actions. There are many more examples throughout this website. We will add to this page as more accurate accounts are sent in.
Bill C-6: Canada Safety Council Presentation to the Standing Committee on Health
The Canada Safety Council submits that a new consumer protection act is not needed. Rather, the government
A Stakeholder’s Frustration With The 2004 Drug Style Regulations
The 2004 regulations are very stressful and financially overwhelming for most small and medium businesses. First of all, unless you understand the beaurocratic red tape, or even have the time to do this yourself, you will have to pay a consultant approximately $1200 for each product submission to Health Canada. Even consultants have difficulty figuring out what paper work to fill out for Health Canada.
Strauss Herb Company Lost A Crucial Decision
The Kamloops based firm had taken Health Canada to court in 2005 over a new policy interpretation they had instituted which seemed to subvert their own long standing policy.
Loving Family Treated As “Criminals” By Health Canada
Never in a million years would I expect to be telling fellow god-fearing Canadians what happened to my family and I. Having a life-time of working for the community, and caring for people, it seems hardly possible that this kind of humiliation would be allowed. Instead of being applauded for being a good citizen and helping people recover their health in a safer, more natural way, we were treated as if we were nasty criminals, dealing in drugs. I have never been more? ashamed of my fellow Canadians as now, and I am very willing to talk about it.
Final Letter To Customers
TO ALL OF OUR DEVOTED CUSTOMERS,
A few days have passed since our last correspondence but since that time much has happened.
Decision Letter: Strauss vs Health Canada (Yohimbe Bark)
The list of plants from which you can extract prescriptions substances is long, and includes very common things such as green tea, black tea, and cocoa (chocolate).? It also includes common foods such as eggs, carrots, milk, broccoli, etc.
“Health Canada holds that if a lab can take a plant or an NHP and can extract from the plant or NHP a substance listed as a prescription drug, then the plant or the NHP is a prescription drug and can only be sold to the public by prescription.”
No one knows how many plants this new policy will cover.
This loss means, Health Canada has a powerful weapon to drive NHPs from the market.
Bill C-51: Brook No Moderation
By now, many people in the Natural Health Product (NHP) community are pulling their hair out over Bill C-51, An act to amend the Food and Drugs Act. They worry about problematic definitions in the bill, increased powers of the Inspectorate, increased fines and lack of respect for Constitutionally-guaranteed rights. They worry how this bill, if passed, will affect their access to the products and treatments they rely on for their health. They use words like ‘undemocratic,’ ‘fascist’ and ‘police state.’…
Recent Developments Re: C51 & NHP Industry
While the Canadian election has come and gone, substantial problems still remain with the natural health products industry and the federal government’s intentions to regulate this business.
Familiar to most, has been the Conservative government’s tabling of Bill C51 & its companion, Bill C52 this past April, 2008. Due to the timely critique by Shawn Buckley, a lawyer from Kamloops BC, members of the NHP industry and the public raised the alarm all across Canada. This resulted in sufficient delays in advancing the federal government’s agenda, such that the two Bills died on the order table when the election was called in September.
David Rowland to Tony Clement
Dear Mr. Clement,
Elections 2008: Restoring The Health Of The Nation
On September 10 the Canadian Charter of Health Freedom was launched by lawyer Shawn Buckley, president and co-founder of the Natural Health Products Protection Association which co-ordinated the national resistance to the Harper government’s proposed bills C-51 and C-52.? Buckley has successfully defeated health Canada in court several times on issues of patients’ rights and natural health products. He said: “This Charter is an initiative to bring regulatory sanity back to the natural health products industry… [it] lists a bunch of rights that we already have… like sovereignty of our own bodies. Health Canada has basically taken those rights away.”
Threats to the Natural Health Products Industry
Food and Drug Regulations
We are giving you this link for easy access to educate yourself. The puzzle has to come together in your own mind as you begin to learn the centre most reasons for these challenging issues. Remember, ignore what they say (or write) and watch what they do.
Drugs and Health Products
The public and industry cannot afford to be inactive while:
NHP Regulations are driving small and medium manufacturers out of business;
manufacturers continue to drop low selling NHPs due to the high cost of compliance;
NHP Regulations unduly increase the cost of products;
NHP Regulations drive products from the market that Canadians depend upon for their health;
the majority of NHP License applications are denied under Regulations that were to legitimize the industry. At this point over 50% of licence applications have been either refused or withdrawn. These are primarily license applications for single ingredient products. The NHPPA expects that the percentage of license refusals will increase as the NHPD starts considering multi-ingredient products. In short, the industry will remain largely illegal, or the majority of NHPs will have to be taken off of the market;
innovation on new products grinds to a halt as it becomes clear that novel multi-ingredient products will not pass Health Canada’s scrutiny without drug-style evidence in the form of clinical trials;
natural health products that consumers, retailers and distributors depend upon are stopped at the border due to non-compliance with the NHP Regulations.