Here come the regulations.
**Major NHP manufacturer discontinues 53 safe, popular NHPs, including GABA, Resveratrol, Grapeseed extract, and Bee Pollen….due to Health Canada’s NHP Regulations and inappropriate Standards of Evidence.**
What is the Cost of the NHP Regulations?
Though Health Canada constantly maintains, in hypnotic style, that the Natural Health Product (NHP) Regulations are simply meant to ensure the “safety and efficacy” of NHPs, in reality, since coming into effect in 2004, the NHP Regulations have had the overall effect of decreasing the number, complexity, and effectiveness of the NHPs on the Canadian market. To understand the game Health Canada is playing, and how they are eliminating products, consider the following:
When the regulations started in 2004, Health Canada classified NHPs as “DRUGS”. This meant that there were now two classes of drugs: synthetic pharmaceuticals, which are patentable, and NHPs, (vitamins, minerals, herbs, probiotics, etc.), which are not. Despite this significant difference, NHPs were none the less, assigned a definition virtually identical to that of pharmaceuticals. And, as “DRUGS”, all NHPs were forced to make a claim, and then to prove that claim. This involves a detailed, often very costly, application to be submitted to Health Canada for each product.
Within three years, this requirement had eliminated well over 20,000 imported American products from Canada, because their makers couldn’t justify the cost or hassle. Canada simply isn’t a large enough market, so most U.S. companies pulled-out…despite the fact that many of their products had been sold here for decades. As I have said before, Canadians would be furious if they knew about the thousands of well-researched, effective U.S. products that they cannot buy here simply because of the expense and effort involved in the application process. Health Canada knew full-well this would happen.
Further, though a product may be both popular and effective, because there are over 80,000 different substances in the human diet, formal evidence of effectiveness in humans often doesn’t exist. This is particularly true for innovative combinations of ingredients, which are often the most effective products, since natural herbs and foods tend to act synergistically. Yet, it is too costly for most companies to perform trials, since their competitors can simply copy the product, and use the research.
So if a company sells a combination, or even a single ingredient product that may be very effective, as indicated by robust and ongoing sales, (e.g. Oregano oil), it has three options: 1) prove that the product works with pre-existing evidence…which may not exist 2) Perform your own trial, which is too expensive, or 3) Discontinue the product. That people are getting good results, and would be happy to continue buying the product is irrelevant.
Therefore, what are companies doing…they are discontinuing products that they foresee they will not be able to get licences for, due to lack of human evidence, even though there maybe ample evidence in other forms such as animal or test-tube studies. Or they are simplifying their complex combinations so they conform to the regulations, even though they will likely be less effective.
And for products like oregano oil, for which no licenses have been issued to date, discontinuing them is the only option that is financially feasible…and on the other hand, doing so will put some companies out of business.
You think Health Canada didn’t know this was going to happen?.....Of course they did! That is why despite massive public protest, they were so intent on classifying NHPs as “DRUGS”: because it gave them the perfect mechanism to get rid of NHPs.
As of Health Canada’s last reports, only 23,889 NHP licenses have been issued, and 17,602 applications rejected. If you add these numbers to the approximately 10,000 products still awaiting approval, and the 20,000 plus discontinued U.S. imports, you get what we have always maintained: that when the regulations started in 2004, there were over 70,000 products on the Canadian market. Now, 6.5 years into the regulations, even if all 10,000 products waiting are given a license, we will still be left with less than half the number of products we had in 2004.
And what about safety? Well, before the regulations started, there were a grand total of zero (0) Canadian deaths from a natural health product on record. And now, with the Regulations in place, the grand total is…still zero. At last count, out of all the license refusals, only THREE (3) were due to safety concerns.
You see, as deaths from cigarettes, alcohol, and pharmaceutical drugs clearly indicate, major regulation does not ensure safety. Rather, it simply ensures that only large corporations can afford to do business.
Of course we all want safe, effective health products, but if Canadians don’t get active in preserving their rights and freedoms from Health Canada, they are soon going to have far fewer and less effective means with which to maintain their own health.
John Biggs BSc. NCP
Optimum Health Vitamins
If you would like to help change the NHP regulations to make them more appropriate, send donations to support the Natural Health Product Protection Association, and their Three Part Plan. See www.nhppa.org. Also, for more information see www.suspendandreview.com, or consult our stores.
