A natural products regulatory cliff

Open letter to the natural health community, the Canadian public, CHFA board and members, retailers, manufacturers, by authors who request anonymity due to concerns they have about Health Canada or NHPD’s vengeance.

If the natural health industry continues along the current path allowing Health Canada to apply the synthetic pharmaceutical type regulations to specialty Natural Health Products (NHPs), we will invariably end up with a Big Pharma-dominated marketplace similar to Europe and Australia where:

1. Under the influence of Big Pharma, government regulators have successfully outlawed common safe, efficacious and cost effective Natural Health Products using drug style regulations.
2. Traditional independent boutique health food stores are rapidly disappearing or already gone.
3. Multi-national pharmacies and mass market retailers are dominating a diminishing selection with their overpriced and sub-therapeutic, diluted, commodity-type supplements (500mg/90tabs of vitamin C retails for approximately $45 in Germany; prescription Omega 3 is currently 10 times more expensive via prescription, compared with the equivalent over-the-counter (OTC) product in your local health food store.

Health Canada allegedly promotes its new NHP regulations as necessary to ensure safety, efficacy and quality. Let’s examine these three points:

1. Safety: A recent study shows the risk of mortality from taking vitamin food supplements is actually far less than the chance of being struck by lightning. Safety is clearly not a real issue, but rather a scare tactic used by Big Pharma-influenced regulators to justify drug style regulations. If Health Canada is sincere about protecting Canadians, it could start by addressing the 10,000 pharma deaths a year in Canada due to drug dosage errors and adverse reactions.
2. Efficacy: Canadians are not stupid. If a product does not work or there is no reasonable evidence supporting its effectiveness, people will choose not to buy it. If Canadians learn the health benefits associated with oranges and desire their vitamin C or fibre content, they currently have the freedom to make that choice. Similarly, if people want to consume Nattokinase or any other natural product with an impeccable safety record, they should not be denied the freedom to make that choice.
3. Quality: Quality (i.e.: ingredient identification, stability, heavy metal testing, microbiological testing) is already addressed via site licensing and Good Manufacturing Practices (GMP) regulations; this is a non-issue.

Specialty NHPs – false presumption of guilt: From a safety perspective, pre-existing or unlicensed specialty NHPs in Canada are currently in “Natural Product Number (NPN) jail” with a false pre-declaration of guilt awaiting an uncertain acquittal from the judges at Health Canada’s Natural Health Products Directorate (NHPD) kangaroo court. Further, NHPs with NPNs are merely “on probation” awaiting threats of recall or permanent incarceration via random Information Request Notices (IRN) from the NHPD, as we recently experienced with Oregano Oil, Digestive Enzymes and Probiotics. Recognizing that NHPs have decades of safe and effective use begs the question: Why are we allowing government to pre-designate NHPs as dangerous and forcing suppliers to invest millions to prove otherwise, whereas, tobacco and alcohol are known killers, but Health Canada has not banned these products. How long will it be before we need Health Canada’s permission to eat grapefruit because more than 85 drugs, many of them highly prescribed for common medical conditions, are known to interact (sometimes fatally) with the pink fruit, according to research published in the medical journals?

More taxpayer dollars wasted: When it comes to protecting the public, the NHP regulations are wasting taxpayers’ money. Further, recognizing NHPs offer a net benefit to Canada’s overburdened public health care system, why is the government not marketing them in the same fashion they over-promote the flu, H1N1 or HPV vaccines?

Big Pharma control: As you may have recently become aware, huge multinational companies are systematically buying (AKA “mergers”) natural health food suppliers. Acquisition and consolidation are the first step towards market control and commoditization. These market activities will ultimately have a trickle-down effect – whereby only huge corporations will be allowed to “play” in the NHP manufacturing and retail space. Here is a comparison of the Big Pharma prescription business model versus the traditional health food store:

Comparison to the US “Generally Regarded as Safe” (GRAS) style regulations: In the US, citizens are free to consume the NHPs of their choice without predatory government interference. Health claims are addressed on each product’s packaging with a boilerplate disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.” Why can’t we reduce our federal tax burden and cost of NHPs by adopting this regulatory model in Canada? Further, it is important to note Americans have greater access to NHP potency and variety. For example:

1. Vitamin D is limited to 1,000 IU per capsule in Canada; 5,000 IU per capsule is widely available in the USA.
2. Red Yeast Rice Extract with naturally occurring lovastatin is widely available in the USA. In Canada, Red Yeast Rice Extract is not allowed to contain any significant amount of naturally occurring lovastatin – thus making it therapeutically ineffective.
3. Nattokinase has been widely available in the US for over two decades. In Canada, NHPD recalled Nattokinase from the market based on theoretical safety concerns. In the absence of any Canadian adverse reaction report associated with Nattokinase for the last 10 years in Canada, expert observers are dumbfounded as to why Health Canada recalled a safe and effective natural product like Nattokinase while simultaneously allowing known synthetic pharma killers to remain in the market.

Geographic revenue leakage – cost to the Canadian economy: Canadian suppliers and retailers are currently being forced to lose business to US internet sites that offer all the products and potencies unavailable in Canada due to regulations. Canadian revenue “leakage” to USA domiciled internet retailers will only increase in future years as Health Canada continues to increase its predatory stranglehold on NHPs.

Injurious effect on the health of Canadians: There is no public evidence Health Canada has ever formerly studied or quantified the damaging effect of removing pre-existing Natural Health Products from the market prior to doing so. Failure to comprehensively quantify how the removal of pre-existing NHPs would affect the future health of Canadians amounts to governmental gross negligence.

Sources:
~ http://www.anh-europe.org/news/anh-exclusive-lightning-more-dangerous-than-herbs-or-vitamins
~ Dr. Joel Lexchin, associate professor, School of Health Policy and Management, York University, Emergency Physician, University Health Network and associate professor, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario.