TORONTO (PasseportSanté.net), September 16, 2003 – Companies hoping to bring a new natural health product to market will first need to demonstrate its safety.
This is what astonished participants at a conference on Canada’s new regulation of natural health products, which is taking place this week in Toronto, learned this.
Thus, the company that intends to market an extract taken from the root of a Brazilian tree, a product hitherto completely unknown, will first have to carry out multiple toxicity studies, to assess its impact on metabolism, and then to a study of its possible interaction with other substances, whether natural products or drugs. Then came clinical trials on humans, which led many to say that we are now seriously approaching the standards governing the approval of new drugs.
What is more, these same rules could apply to a well-known product, such as aloe, if its nature were to have been slightly altered by a new manufacturing process.
Companies that want to market an already existing product will need to provide some evidence of its effectiveness, ranging from traditional use to modern scientific studies.
“Take garlic, for example,” joked Paul Saunders, who sits on the Advisory Council for the Natural Health Products Directorate. If a company comes to us with a traditional use of repelling vampires, this is what they will be allowed to advertise. But if she also wants to announce that garlic contributes to the elasticity of the arteries in postmenopausal women, she will have to provide us with the scientific evidence to this effect ”.
Several speakers then took the floor to ask which business manager will invest millions of dollars to provide the required evidence, if he knows that his work will not be protected by any concept of intellectual property and can be used by his competitors.
“I wonder if someone will be able to meet this new requirement,” notably dropped the president of Omega Alpha Pharmaceuticals, Dr. Gordon Chang.
Health Canada noted that companies will be able to obtain expedited approval for a product if they can demonstrate that the product meets the monograph published by the government. However, of the thousands of natural health products currently on the market, only about 100 monographs are now in preparation, and no one knows when they will be released.
Several participants underlined the Herculean scale of the work that awaits the federal government, if it intends to certify all natural products currently on the market. Going from a quick calculation and using utopian figures, an expert calculated that the work could not be completed for at least ten years.
Jean-Benoit Legault – PasseportSanté.net
