Concerning Health Canada’s Natural Health Product (NHP) Regulations, there are some very disturbing developments. Though the MPs are obviously not to blame for this bureaucratic initiative, they may be the only chance to stop it.
A moratorium needs to be placed on enforcement of the NHP Regulations so they can be revised to provide the truly unique third category that was repeatedly promised to the natural health industry…neither drug nor food. The alternative is continued gross injustice for Canadian citizens and businesses at the hands of Health Canada.
As detailed in the report, “Facts on Prescription Drug Deaths and the Drug Industry”, by Terence Young M.P., Health Canada has ‘partnered’ with the pharmaceutical industry. When “debts of gratitude” for lucrative opportunities go from bureaucrats to the industry, glaring evidence of adverse reactions or deaths due to drugs under review are often purposely overlooked, and this has resulted in many thousands of deaths. Yet, with NHPs, where there is an absence of harm, (zero Canadian deaths on record ever), Health Canada acts on purely theoretical concerns, ignoring decades of safe use, and
misusing NHP’s classification as “Drugs” to eliminate useful health products. This acts to rid the pharmaceutical industry of competition, or hand them control of therapeutic NHPs, while harming Canadians in the process.
For example, presently, Scott Sawler, Director General for the NHPD, is said to be the driving force behind the push to remove all digestive enzymes from store shelves. This represents an entire sector of the NHP industry. The rationales being offered for removing digestive enzymes after over 30 years of safe, widespread usage are a lack of documented proof in humans, and also that ONE naturopathic doctor has been consulted. Dr. George Tardik has given his opinion that based on the available evidence, enzymes cannot be established as safe when used continuously for more than three days,
due to the possibility that they may shut down the body’s own production.
Besides the obvious question of how ONE naturopath’s opinion can be used to justify overturning more than three decades of safe use, the fact is that due to inflamed digestive tracts, tens if not hundreds of thousands of Canadians do not produce their own digestive enzymes properly in the first place. For these people digestion can be a tortuous process, and failure to absorb nutrients can lead to many other conditions, also requiring treatment. Though this may be a dream come true for the pharmaceutical industry, it can be a “living hell” for the people experiencing it.
Using digestive enzymes often allows them to digest and absorb properly, without discomfort. If these products are removed countless Canadians will experience digestive difficulties once again, suffering unnecessary misery, with little option but to turn to our badly overburdened medical system, using more services, and more drugs.
Scott Sawler also recently signed letters sent to suppliers warning that a stop-sale order may be issued for Oregano oil if impossible standards for safety were not met. Oregano oil has been a wildly popular NHP, because it works so effectively as a natural antimicrobial, without side effects. In excess of 20 million bottles have been sold since its emergence in the 1990’s without a single hospital or doctor’s visit. One manufacturer alone reports selling over a 1,000,000 bottles in 9 years with no serious incidents, and complaints limited to only nuisance effects like upset stomach, or “it tastes bad”.
Due to an immediate backlash, Health Canada now says they may perform a study on Oregano oil. But what are they trying to find out? Obviously, its rampant and ever-increasing sales history shows that it is both safe, and effective. Further, it is obvious that the real issue isn’t safety, because products that add Vitamin A or D to virtually identical concentrations of the oil, then list it as a non-medicinal ingredient, have been approved.
So, on what grounds are these longstanding safe and effective sectors of NHPs being attacked?
Health Canada’s notice sent out to industry regarding enzymes reads as follows: “the risk associated with the lack of safety data for enzymes outweighs the therapeutic benefits for their use in natural health products. Consequently, enzymes may not be safe when used under the existing recommended conditions of use outlined on product licences and Product Licence Applications (PLA) (i.e. long term use). Additionally, it has been determined that there is a lack of
efficacy data to support certain enzymes.” [emphasis added]
Notice, the basis for assessment is 100% to do with the “lack of data”, and makes no mention of the fact that countless millions of bottles of digestive enzymes have been safely sold to Canadians since the 1970s. In other words, it doesn’t matter if enzymes (or any other NHPs) are actually safe or effective, what matters is if they can produce documented evidence in humans to prove it…, i.e. it is just a paper-chase that has nothing to do with reality.
The reason so many NHPs lack documented evidence in humans is because until 2004, most NHPs were classed as “Foods”, and performing expensive human trials was out of the question. There was no legal requirement, and the nonpatentable status of NHPs provided a financial disincentive, because all your competitors could use your results for free. Many NHPs also do not qualify to make a “Traditional Use” claim because they cannot produce documented evidence they have been in use for at least 50 years, yet they have been in the food chain for hundreds, or thousands of years.
Health Canada was 100% aware that tens of thousands of NHPs would be unable to meet the basic documentation requirements in their new classification as “Drugs”. This is presumably why they were so intent on reclassifying them. They tried in 1997, and despite the huge public protests and the Standing Committee’s direct recommendations against it, did so anyway in 2004. The NHP Regulations have eliminated well over 40,000 products from the Canadian market, and many more are still on the chopping block. As of June 30/11, 23,818 NHPs, representing fully 45% of license applications submitted, have been unsuccessful, and well over 20,000 U.S. imports have been blocked. The amount of revenue the Canadian economy has lost to cross-border shopping for supplements in the States is in the billions. (For more specific details on these numbers and issues, please consult the updated report for MPs entitled “Why the Natural Health Product Regulations Should be Suspended and Revised” at www.suspendandreview.com .)
How is this being allowed in what is supposedly a democracy, when the Canadian public and Parliament spoke so clearly about what they wanted? Obviously, Health Canada doesn’t have to answer to the Canadian public or to Parliament, and when they lose in court they just ignore the ruling. They are operating outside the law, and no one holds them to account. Where does this leave Canadian citizens?
Working with many enormous transnational interests, Health Canada has the power to create, introduce, and then enforce regulatory legislation that has its roots in international globalization initiatives. This offers potential for huge conflicts of interest. What protection do Canadians have when the agency’s agenda serves international and big-business interests, but makes our citizens sick in the process? The civil servants involved are committing an absolute disservice to the health
and wellbeing of Canadians, while their salaries are being funded by taxpayers.
As one of those taxpayers, I think Scott Sawler should be replaced as NHPD Director General. His background and connections to the pharmaceutical industry are so extensive that his appointment as head of the NHPD is completely inappropriate. For evidence of this, see his online LinkedIn profile at
http://ca.linkedin.com/pub/scott-sawler/17/a92/890 , including his listed “Groups and Associations” at the end. These include, among others: Biotech and Pharma Professional Network, Biotech Investment Group, Drug Information Association (DIA)- Biopharmaceutical Professionals, Pharmaceutical Jobs Biotech Life Sciences and Medical Devices, and Schering-Plough Colleagues. This is before even
considering that his training and knowledge of the substances he is regulating would appear to be non-existent.
As Health Canada was established via an “Order in Council”, the Privy Council needs to initiate a new Order in Council that allows elected MPs a voting mechanism to over-rule inappropriate Health Canada initiatives, legislation or actions. Our officials, acting on the public’s behalf, would then have some way to protect Canadian citizens.
As has been so clearly stated by Prime Minister Harper, all matters of health are a provincial jurisdiction., and this includes Natural Health Products. Actions to deliver this responsibility to the provinces need be initiated immediately. Otherwise, the issue must go to court to prevent further illegal assumption of authority by Health Canada.
Thank you for your time and attention. Please reply in writing to the above concerns.
On behalf of Citizens for Choice in Healthcare.